U.S. patent application number 14/705822 was filed with the patent office on 2015-10-29 for follicular extraction punch and method.
The applicant listed for this patent is John P. Cole. Invention is credited to John P. Cole.
Application Number | 20150305767 14/705822 |
Document ID | / |
Family ID | 34919795 |
Filed Date | 2015-10-29 |
United States Patent
Application |
20150305767 |
Kind Code |
A1 |
Cole; John P. |
October 29, 2015 |
FOLLICULAR EXTRACTION PUNCH AND METHOD
Abstract
Provided herein is an instrument and method useful to incise in
to the skin to a precise depth and at a specific angle with respect
to the surface of the skin of a patient, for the extraction of
individual follicular groups or individual follicular units. An
instrument according to the invention precisely limits the depth of
incision, and creates a circular incision around a hair, follicular
unit, or follicular cluster in a manner such that no damage occurs
to any of the hair shafts.
Inventors: |
Cole; John P.; (Atlanta,
GA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Cole; John P. |
Atlanta |
GA |
US |
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|
Family ID: |
34919795 |
Appl. No.: |
14/705822 |
Filed: |
May 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11565553 |
Nov 30, 2006 |
9028507 |
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14705822 |
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10795835 |
Mar 9, 2004 |
7172604 |
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11565553 |
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11506564 |
Aug 17, 2006 |
8182493 |
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10795835 |
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10795835 |
Mar 9, 2004 |
7172604 |
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11506564 |
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Current U.S.
Class: |
606/133 |
Current CPC
Class: |
A61B 17/32053 20130101;
A61B 17/3403 20130101; A61B 17/3496 20130101; A61B 2090/036
20160201; A61B 17/322 20130101; A61B 2017/00752 20130101; A61B
2017/00902 20130101; A61B 2017/00969 20130101; A61B 2017/3492
20130101; A61B 17/3468 20130101; A61B 2017/320064 20130101; A61B
2090/062 20160201 |
International
Class: |
A61B 17/3205 20060101
A61B017/3205 |
Claims
1-37. (canceled)
38. An apparatus to extract one or more hair follicles from skin
tissue, the apparatus comprising: a nipple end portion, the nipple
end portion having a length dimension and further including a bore
disposed therethrough having an axis approximately parallel to the
length dimension; a dissection punch to extract the one or more of
the hair follicles from the skin tissue via the bore, the
dissection punch being disposed within the bore and comprising a
cutting edge to pierce the skin tissue.
39. The apparatus of claim 38, wherein the cutting edge is
approximately circular.
40. The apparatus of claim 38, wherein the cutting edge has an
inner diameter of from about 0.5 mm to about 4.5 mm.
41. The apparatus of claim 38, wherein the nipple portion is to
limit a depth of insertion of the dissection punch into the skin
tissue.
42. The apparatus of claim 41, wherein the nipple portion is to
limit a depth of insertion of the dissection punch into the skin
tissue to about 0.5 mm.
43. The apparatus of claim 38, further comprising a handle to
rotate the dissection punch.
44. The apparatus of claim 38, where the nipple portion is to
separate a bottom portion of the one or more hair follicles from a
fatty layer of the skin tissue.
45. The apparatus of claim 38, wherein the dissection punch is
tapered.
46. An apparatus to extract a follicular unit from an area of skin,
comprising: a main body comprising a handle to be gripped by an
operator, the main body having first and second ends; and at least
one punch to score an area of skin and to extract the follicular
unit from the area of skin, the at least one punch to be disposed
at the first end of the main body.
47. The apparatus of claim 46, wherein the at least one punch
comprises a cutting edge.
48. The apparatus of claim 47, wherein the cutting edge has an
inner diameter of from about 0.5 mm to about 4.5 mm.
49. The apparatus of claim 46, further comprising a nipple portion
to limit a depth of insertion of the at least one punch into the
area of skin.
50. The apparatus of claim 49, wherein the nipple portion is to
limit a depth of insertion of the dissection punch into the skin
tissue to about 0.5 mm.
51. The apparatus of claim 49, where the nipple portion is to
separate a bottom portion of the one or more hair follicles from a
fatty layer of the area of skin.
52. The apparatus of claim 46, wherein the at least one punch is
tapered.
53. An apparatus to extract one or more hair follicles from skin
tissue, the apparatus comprising: means for gripping the apparatus
by an operator; means for scoring the skin tissue; and means for
extracting the one or more of the hair follicles from the skin
tissue.
54. The apparatus of claim 53, means for stabilizing the means for
extracting.
55. The apparatus of claim 54, wherein the means for extracting
comprises a tapered shape.
56. The apparatus of claim 53, wherein the means for extracting
comprises a means for cutting having an inner diameter of from
about 0.5 mm to about 4.5 mm.
57. The apparatus of claim 53, further comprising a means for
limiting a depth of insertion of the means for extracting into the
skin tissue.
Description
TECHNICAL FIELD
[0001] This invention relates generally to surgical instruments
useful for extracting live hair follicles from mammalian subjects
for transplantation on other parts of the body of such subjects.
More specifically, the invention provides a surgical instrument
useful for extracting live hair follicles from human skin for
transplantation to other portions of the skin, such as the scalp.
An instrument according to the invention precisely controls the
depth to which an incision is made during the follicular extraction
process.
BACKGROUND
[0002] The prior art contains numerous examples of instruments
useful for extracting live hair follicles from the skin of human
subjects, and methods associated with the use thereof. U.S. Pat.
No. 4,476,864 teaches a light weight, portable, hand held power
actuated hair transplant plug cutting device that is capable of
making either simultaneous multiple punches or a single punch in
the scalp of a patient. In the device, a single shaft member with a
removable cutting tip extends through one wall of the housing unit,
while a plurality of shaft members with removable cutting tips
extends through the opposite wall of the housing unit. Actuation of
a power drive causes rotation of both the single shaft member and
the plurality of shaft members so that only the single cutting
device is needed to make all of the punches required for the hair
transplant operation. Tools are also provided for placing and
removing disposable cutting tips on and from the shaft members.
U.S. Pat. No. 5,507,765 describes a punch-type surgical instrument
for skin incision along a closed line, such as a substantially
elliptical line, that includes a handle, a blade unit and a means
for attaching the handle to the blade unit in a way which achieves
high stability between the handle and blade unit and which allows
the two parts to be made as ones easily connectable to and
dis-connectable from one another. The blade unit may be made and
furnished in different sizes to cause the instrument to be one
selectably variable in size. U.S. Pat. No. 5,578,054 sets forth a
method for transplanting hair, which method comprises: a) inserting
an instrument having a shaft with a proximal end, a sharpened
distal end forming a blade thereon, and a longitudinal axis
extending between the proximal end and the distal end, into the
skin to a pre-selected depth as determined by a stop disposed along
the shaft to form an incision, wherein the blade is normal to the
longitudinal axis of the shaft, and wherein the stop prevents the
blade from extending beyond about 5 mm into the scalp, and wherein
the distance between the blade and the stop is adjusted before
inserting the blade; b) removing the instrument from the skin; and
c) placing a graft of skin having at least one hair into the
incision. U.S. Pat. No. 5,766,177 provides a rongeur which
comprises: a) a body having a distal end, a tubular portion and a
proximal end, wherein the body at the distal end includes an
elongated member terminating in an anvil and at the proximal end
terminating in handle means; b) a tubular cutting member, wherein
the cutting member is movable within and guided by the tubular
portion and extending beyond the body at the proximal end; and c) a
means for actuating the cutting member to cut bodily material
placed between the anvil and the distal end of the cutting member.
U.S. Pat. No. 5,792,169 discloses an instrument for placement of
hair grafts in the tissue of a patient, comprising: a) a first
plate comprising a base member having a number of first bores
passing therethrough, and a number of hollow first catheters
extending therefrom and aligned with the first bores; b) a second
plate comprising a base having a number of first spikes extending
therefrom, the spikes arranged and sized for location within the
first catheters; c) a third plate having a base with a number of
second bores passing therethrough and a number of hollow second
catheters extending therefrom and aligned with the second bores,
the second catheters sized for location within the first catheters;
and d) a fourth plate having a base with a number of second spikes
extending therefrom, wherein the second spikes are arranged and
sized for location within the second catheters. U.S. Pat. No.
5,817,120 teaches an instrument for implanting hair grafts into a
patient's scalp, comprising: a) an elongate housing adapted to be
manipulated by a surgeon during implanting of the hair grafts,
wherein the elongate housing has a throughbore extending at least
partway therealong from a first end thereof, and having a slot
defining a slotted loading position adjacent to the throughbore for
loading hair grafts into the instrument; b) a cutting device
affixed to the first end of the elongate housing by which the
surgeon may make an incision in the patient's scalp, into which a
hair graft is to be implanted; and c) an implanting member,
disposed axially movably within the throughbore of the elongate
housing, wherein the implanting member includes a forwardly
projecting finger. The implanting member is movable from a first
position in which the finger is positioned adjacent to the slotted
loading position so as to be able to load a hair graft, to a second
position in which a loaded hair graft is bounded between the finger
and the cutting device, and to a third position in which the finger
extends beyond the cutting device. U.S. Pat. No. 5,895,403
describes a surgical cutting tool with vacuum clearance capability,
comprising a length of cylindrical surgical steel having an axial
bore therethrough, a proximal end cutting tip terminating in a
cutting edge, and a distal end. The axial bore has a first inside
diameter at the cutting edge, a second inside diameter greater than
the first inside diameter forming a first relief near the cutting
edge, and a third inside diameter greater than the second inside
diameter forming a second relief upstream of the first relief. As
vacuum is applied at the distal end of the tool, tissue plugs cut
at the cutting edge pass easily through the first and second
reliefs to exit the axial bore.
[0003] However, of all the prior art, none has thus far provided an
instrument through the use of which the precise depth of incision
is repeatedly and precisely controlled to result in the vast
majority of follicles extracted to continue to furnish hair at the
new site to which they are transplanted. The present invention
provides such an instrument, which is also simplistic in design and
easy to use by the skilled practitioner.
SUMMARY OF THE INVENTION
[0004] The present invention provides an instrument useful for
extracting live hair follicles from mammalian skin tissue, which
device comprises a main body portion having a first end portion, a
second end portion, and a longest length dimension. The main body
portion further comprises a first bore centrally disposed
therethrough, wherein the axis of the first bore runs parallel to
the longest length dimension of the main body portion. The first
bore comprises an inner surface within the main body. There is a
nipple end portion having a first end portion and a tip portion,
which nipple end portion further includes a second bore centrally
disposed therethrough. The first end portion of the nipple end
portion is attached to the second end portion of the main body
portion, and the second bore comprises an inner surface within the
nipple end. There is a tubular punch means having a first end
portion and a sharp end portion. In one preferred form of the
invention, the tubular punch exists substantially in the form of a
hollow cylinder having an interior space and an outer diameter,
wherein the outer diameter of the tubular punch means is slightly
larger than the inner diameter of the second bore, and wherein the
tubular punch means is slidably disposed within the second bore, so
as to provide a slight interference fit. There is a stabilizer
means disposed within the first bore and in contact with the first
end portion of the tubular punch means. There is an adjustment
screw comprising a threaded outer surface and an end. The
adjustment screw is disposed within the first bore such that its
threaded outer surface is in contact with the inner surface within
the main body. The end of the adjustment screw is in contact with
the stabilizer. According to one preferred form of the invention,
the stabilizer includes a third bore disposed therethrough that is
adapted to receive the first end portion of the tubular punch
means. In one embodiment, the first end portion of the tubular
punch means is disposed within the third bore through the
stabilizer means such that the stabilizer means and the tubular
punch means are both slidably disposed as a unit within the first
bore and the second bore respectively. In one preferred form of the
invention, the adjustment screw includes a head portion and an end
portion, and further comprises a fourth bore centrally disposed
through its length. The fourth bore may extend from the head
portion to the end portion. Thus, in one form of the invention, the
interior space within the tubular punch means is in fluid
communication with the fourth bore disposed within the adjustment
screw.
[0005] Yet another embodiment of the invention provides that the
first bore extends from the first end portion to the second end
portion of the main body portion. In yet another embodiment of the
invention the main body portion is substantially cylindrically
shaped. In yet another embodiment of the invention the tubular
punch means has an outer surface, and the outer surface of the
tubular punch means is in contact with the inner surface of the
second bore disposed within the nipple end portion. In yet another
embodiment of the invention the nipple end portion is substantially
cylindrically shaped. In yet another embodiment of the invention
the first bore and the second bore have the same diameter. In yet
another embodiment of the invention the diameter of the second bore
is less than the diameter of the first bore. In yet another
embodiment of the invention the diameter of the second bore is
greater than the diameter of the first bore. In yet another
embodiment of the invention the outer diameter of the tubular punch
means is smaller than the inner diameter of the second bore. In yet
another embodiment of the invention the nipple end and main body
comprise a single construct, and are a single article comprising a
plastic, which is made using an injection molding process. In yet
another embodiment of the invention the sharp end of the tubular
punch means comprises a beveled edge. In yet another embodiment of
the invention the stabilizer means is comprised of an elastomeric
material selected from the group consisting of: polyolefin
homopolymers, polyolefin copolymers, thermoplastic vulcanizates,
and thermoset elastomers. In yet another embodiment of the
invention the tubular punch means is metallic. In yet another
embodiment of the invention the tubular punch means further
includes an inner diameter which is substantially uniform along the
entire length of the tubular punch means. In one preferred form of
the invention the inner diameter of the tubular punch means is any
diameter in the range of between about 0.5 millimeters and about
4.5 millimeters. In one preferred embodiment of the invention the
nipple end portion comprises a flat surface which is adapted to
contact the skin of a patient, and the total surface area of the
nipple end which contacts the patient is in the range of between
about 5 square millimeters and about 25 square millimeters.
[0006] In a more general sense, the invention provides an
instrument useful for extracting live hair follicles from mammalian
skin tissue, which device comprises: a nipple end portion having a
first end portion and a tip portion. The nipple end portion has a
longest length dimension and further includes a bore disposed
therethrough whose axis is parallel to the longest length
dimension. The bore comprises an inner surface within the nipple
end. There is a tubular punch means which exists substantially in
the form of a hollow cylinder having two open ends, an interior
space, and an outer diameter not exceeding about 5.0 millimeters.
At least one end of the tubular punch means is a cutting end which
is capable of piercing the skin. The tubular punch means further
includes an inner diameter between about 0.5 millimeters and 4.5
millimeters, which is substantially uniform along the entire length
of the tubular punch means. The tubular punch means is slidably
disposed within the bore such that its cutting end is capable of
coinciding with the tip portion of the nipple end portion when the
tubular punch means does not protrude outward from the tip portion.
There is a means for adjusting the position of the tubular punch
means within the bore, including control of the amount which the
cutting end protrudes from the tip portion of the nipple end
portion. The nipple end portion may comprise a flat surface which
is adapted to contact the skin of a patient, wherein the total
surface area of the nipple end which contacts the patient is in the
range of between about 5 and about 25 square millimeters. According
to one preferred form of the invention, the means for adjusting the
position of the tubular punch means within the bore comprises a
threaded screw having an end portion which is in effective
mechanical contact with the tubular punch means, and a stationary
portion capable of engaging with the threads on the screw, wherein
the stationary portion is in effective mechanical contact with the
nipple end portion. In one form of the invention, such means
includes the main body portion 3, adjustment screw 15, and
stabilizer 11, as described elsewhere herein.
[0007] The invention further provides a process for extracting a
live hair follicle from a mammalian subject comprising the steps
of: a) providing a tubular punch means which exists substantially
in the form of a hollow cylinder having and axis, a first open end,
a second open end, an interior space, and an outer diameter not
exceeding about 2.0 millimeters, wherein the first end of the
tubular punch means is a cutting end which is capable of piercing
the skin; b) contacting the cutting end to the skin of a mammalian
subject, such that a hair on the skin of the mammalian subject is
disposed within the interior space, and such that the axis of the
cylinder is disposed at a first angle with respect to the surface
of the skin of the subject, wherein the first angle is between
about 85 degrees and 95 degrees; c) causing the cutting end to
penetrate the skin of the subject to a depth of at least 0.05
millimeters but no greater than about 0.3 millimeters; d) tilting
the tubular punch means so that it is disposed at a second angle
with respect to the surface of the skin of the subject, which
second angle is any angle between about 20 degrees and about 70
degrees; e) causing the cutting end to further penetrate the skin
of the subject to a depth of at least 1 millimeter but no greater
than about 7 millimeters (with an average of about 4.15 mm) while
maintaining the tubular punch means at the second angle with
respect to the surface of the skin of the subject and while
maintaining the hair within the interior space so as to cause to
follicle within which the hair grows to be disposed within the
interior space; and f) removing the follicle from the subject. In a
preferred process according to the invention, the first angle is
about 90 degrees and wherein the second angle is about 56 degrees
or the corresponding acute angle of hair growth to the surface of
the skin. According to one preferred process according to the
invention, the step of removing the follicle from the subject
comprises applying a vacuum to the second end of the tubular punch
means, or may be accomplished by cutting the follicle from the
subject using a sharp instrument, such as a scalpel or modified
scalpel, which is available from the instant inventor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1a shows an exploded perspective view of the various
components of a tool according to the invention;
[0009] FIG. 1b shows an overhead view of the body portion 3 of a
tool according to one preferred form of the invention;
[0010] FIG. 1c shows a perspective view of a tubular punch means
element of a tool according to the invention;
[0011] FIG. 1d shows an end view of the tubular punch means element
of the invention;
[0012] FIG. 1e shows an end view of the main body portion of an
instrument according to the invention as viewed from the nipple end
perspective;
[0013] FIG. 1f shows a side perspective view of a tubular punch
means according to an alternate form of the invention;
[0014] FIG. 1g shows a side perspective view of a tubular punch
means according to an alternate form of the invention;
[0015] FIG. 2 shows a cutaway view of a tool according to the
invention in its assembled form;
[0016] FIG. 3 shows a cutaway view of a tool according to an
alternate form of the invention in its assembled form;
[0017] FIG. 4 shows a section of skin containing a hair follicle in
contact with a portion of a tool according to the invention;
[0018] FIG. 5 shows a section of skin containing a hair follicle in
contact with a portion of a tool according to the invention;
[0019] FIG. 6 shows a section of skin containing a hair follicle in
contact with a portion of a tool according to the invention;
[0020] FIG. 7 shows a section of skin containing a hair follicle in
contact with a portion of a tool according to the invention;
and
[0021] FIG. 8 shows a section of skin containing a hair follicle in
contact with a portion of a tool according to the invention.
DETAILED DESCRIPTION
[0022] Referring to the drawings and initially to FIG. 1a there is
shown an exploded perspective view of the various components of a
tool according to the invention, including the main body portion 3,
tubular punch means 9, stabilizer means 11, and adjusting screw 15.
The main body portion 3 in a preferred form of the invention is a
construct which is substantially cylindrically shaped, having an
open first end portion 37 and a second end portion 39. The main
body portion 3 further includes a bore 5 centrally disposed
therewithin along its longest length dimension, which bore in one
preferred form of the invention extends from the first end portion
37 to the second end portion 39. The walls of the main body portion
3 at the second end portion 39 are tapered inwards towards the axis
of the bore 5, and coextensively intersect a nipple end portion 19,
which nipple end portion 19 is substantially cylindrically shaped
and includes a first end portion 41 and a tip portion 43. Such an
arrangement provides for the second end portion 39 of the main body
portion 3 to be attached to the nipple end 19 at the first end
portion 41 of the nipple end 19. The nipple end 19 includes a bore
21 centrally disposed therewith along its longest length dimension,
which bore extends from the first end portion 41 of the nipple end
19 to the tip portion 43 of the nipple end 19, and the bore 5 and
bore 21 are thus in fluid communication with one another in a main
body portion 3 provided in accordance with a preferred form of the
invention. Further, the bore 5 is open to the ambient surroundings
at the first end portion 37, and the bore 21 is open to the ambient
surroundings at the tip portion 43. The main body portion is thus
reminiscent of the body portion of common polyolefin syringes which
are in common use in the medical arts. According to a preferred
form of the invention, the main body portion 3 and the nipple end
19 are both elements of a single common construction provided for
example, by an injection molding process. The length of the nipple
end 19 is preferably in the range of between about 0.03 millimeters
and about 10 millimeters, with a preferred length of about 6
millimeters. When an instrument according to the invention is
fabricated from a plastic material, it is preferred that the bore
21 is slightly smaller than the outside diameter of the tubular
punch means 9, to preclude the tubular punch means from motion
induced either by the surgeon moving the instrument of the
invention around and about, or the influences of gravity. In one
form of the invention when the nipple end 19 is fabricated from a
polyolefin, it is preferred that the bore 21 within the nipple end
19 is at least about 0.1 millimeter smaller than the outside
diameter of the tubular punch means 9.
[0023] The main body portion 3 is preferably comprised of a
translucent material, such as a thermoplastic polyolefin such as
homopolymers of polypropylene or polyethylene, including copolymers
of the foregoing with any C.sub.1-6 olefinic monomer, as such
materials are well known to those in the polymer arts. However,
other materials of construction including glass, various metals
such as stainless steels, etc. are also suitable materials from
which the main body portion of a tool according to the invention
may be constructed. The main body portion 3 is also preferably
provided with graduation markings on its outer surface, to assist
in setting the depth of the tubular punch means 9 as is explained
later in this specification. The main body portion 3 in a preferred
form of the invention also optionally includes a plurality of
gripping means 7 disposed at the first end portion 37 of the main
body portion 3. These optional gripping means 7 in one form of the
invention are flanges which extend perpendicularly with respect to
the axis of the bore 5 and overall length dimension of the main
body portion 3.
[0024] FIG. 1b shows an overhead view of the body portion 3 of a
tool according to one preferred form of the invention, as viewed
from the first end portion 37 looking down into the bore 5 and
showing the respective locations of the gripping means 7, the bore
5, and the thickness W of the wall portion of the main body 3
itself. Also visible in this view is the bore 21 of the nipple end
at the far end of the bore 5.
[0025] FIG. 1c shows a perspective view of a tubular punch means
element 9 of a tool according to the invention. The tubular punch
means is a hollow tube, preferably comprised of a metal or metal
alloy such as stainless steel or titanium. However, any metal or
alloy recognized as being useful for the manufacture of surgical
equipment may be used as a raw material from which the tubular
punch means 9 is fabricated, including various different grades of
stainless steels, and protective coatings subsequently applied
thereto, such as titanium, zirconium, coatings, etc., whose use is
well known in the art. The tubular punch means 9 includes a first
end portion 35 and a sharp end portion 33. The sharp end portion in
one preferred form of the invention includes a bevel 45 which is
coextensively disposed about the sharp end portion, which
constitutes a cutting edge. The tubular punch means 9 in its
simplest form a hollow tube which is shaped in the form of a hollow
cylinder having an open top portion, an open bottom portion, and a
wall portion, with a bore disposed longitudinally therethrough.
Preferably, the inside diameter of the tubular punch means 9 is any
diameter in the range between about 0.5 millimeters to about 4.5
millimeters, and preferably the outside diameter of the tubular
punch means 9 is about 0.2 millimeters to about 0.3 millimeters
greater than the inside diameter.
[0026] FIG. 1d shows an end view of the tubular punch means 9, and
FIG. 1e shows an end view of the main body portion of an instrument
according to the invention as viewed from the nipple end
perspective, and the respective locations of the nipple end 19 and
the bore extending therethrough 21. The thickness of the wall
portion W of the main body 3 is also shown. In this FIG. 1e it can
be seen that the portion of the nipple end which is intended to
contact the skin of the patient is shaped like a donut; stated
another way, the portion of the nipple end which contacts the
patients' skin is in one preferred form of the invention a
substantially planar surface that is bounded by two concentric
circles in a preferred form of the invention. Preferably, the total
amount of surface area which contacts the skin is in the range of
between about 5 square millimeters and about 25 square millimeters,
and is obtained by subtracting the surface area of the circle
represented by the bore 21 from the surface area of a circular area
having the diameter of the nipple end 19, when the nipple end is
circular in cross section.
[0027] FIG. 1f shows a side perspective view of a tubular punch
means 9 according to an alternate form of the invention. In this
embodiment, the sharp end 33 of the tubular punch means 9 is shown
to be angled. The value of B/2 is about 0.5 millimeters; D is about
1 millimeter; E is about 0.32 millimeters, and the shaded area
represents that section of the tubular punch means which preferably
comprises titanium, or a titanium coating.
[0028] FIG. 1g shows a side perspective view of a tubular punch
means according to an alternate form of the invention. In this
embodiment, A is about 0.58 millimeters; B is about 1 millimeter; C
is about 1.15 millimeters; and the angle theta is about 60 degrees.
However, any angle of theta in the range of between about 30
degrees and 90 degrees is within the scope of the present
invention.
[0029] There is a stabilizer means 11 which in one form of the
invention is a solid cylindrical construct made preferably from an
elastomeric substance, such as a molded rubber, wherein the
stabilizer means 11 has an outside diameter which is slightly
greater than or approximately the same size as the diameter of bore
5, to enable the stabilizer means 11 to reside within the bore 5 in
a sufficiently snug manner so as to enable the stabilizer means to
be retained within the bore 5 in the event that the main body 3
containing the stabilizer means 11 within its bore 5 is inverted
and the stabilizer means is subject to normal gravitational forces.
In another embodiment, the stabilizer means 11 includes a bore 13
whose axis coincides substantially with the axis of the stabilizer
means itself. In such an embodiment, the diameter of the bore 13 is
preferably slightly smaller than the outer diameter of the tubular
punch means 9 (the diameter of which is uniform along its length),
so as to enable the first end portion 35 of the tubular punch means
9 to be retained within the bore 13 within the stabilizer means 11
by a snug interference fit caused to exist by the slight expansion
of the elastomeric stabilizer means 11 from the insertion of the
tubular punch means in to the bore 11. The bore 13 is preferably
centrally disposed within the stabilizer so that the punch means 9
is maintained in a central axis. The stabilizer 11 limits movement
of the punch means 9 in a lateral direction within bore 5, and
maintains proper alignment of punch means 9 with the angle and
direction of hair growth. The stabilizer may be comprised of:
polyolefin homopolymers, such as polypropylene or polyethylene;
polyolefin copolymers, including ethylene-propylene copolymers,
propylene butene copolymers, and propylene-octene copolymers;
thermoplastic vulcanizates; and thermoset elastomers.
[0030] In FIG. 1a there is also shown an adjustment screw 15, which
includes threads on its outer surface, which are of such dimension
to cause them to effectively mate with the inner surface of the
bore 5 of the body portion 3. The inner wall of the bore 5 of the
main body portion 3 may or may not include threads. Thus, in
constructing a tool according to the invention, the adjustment
screw 15 is inserted into the bore 5 and the adjustment screw 15 is
rotated to cause it to reside at a desired depth or location within
the bore 5. The adjustment screw 15 includes a head portion 17
which is convenient for a user of an instrument according to the
invention to grasp. In one embodiment, the adjustment screw 15 may
be coated with tape to improve its contact with bore 5 and to
reduce slippage.
[0031] FIG. 2 shows an assembled tool 10 according to the invention
and illustrating the respective positions of the various elements
of the invention including the adjustment screw 15, within the main
body 3. The tubular punch means 9 is shown disposed within the bore
21, whose inner diameter is slightly larger than the outside
diameter of the tubular punch means 9 so as to enable the nipple
end 19 to act as a bearing for movement of the tubular punch means
laterally within the bore 21. Stabilizer means 11 is shown disposed
between first end portion 35 of the tubular punch and end 39 of the
body portion 3 such that it is coextensively disposed about tubular
punch 9 at the end of tubular punch 9 closest to end 39 but not in
contact with stabilizer 11. Under such an arrangement, turning the
adjustment screw inwards into the bore 5 of the main body portion
causes the sharp end 33 of the tubular punch means to protrude from
the tip portion 43 of the nipple end 19 in an amount proportional
to the amount the adjustment screw enters the bore 5 by virtue of
its being rotated.
[0032] FIG. 3 shows an assembled tool 10 according to an alternate
form of the invention and illustrating the respective positions of
its various elements including the adjustment screw 15, within the
main body 3. In this embodiment, the adjustment screw includes a
bore 23 disposed through its center along its entire length,
providing a hole 25 to exist at the top of the head portion 17. The
head portion 17 can take on a variety of shapes, dimensions, and
surface coatings. According to one preferred form of the invention,
the width of the head portion 17 is greater than about 9
millimeters. The tubular punch means 9 is shown disposed within the
bore 21, whose inner diameter is slightly larger than the outside
diameter of the tubular punch means 9 so as to enable the nipple
end 19 to act as a guide for movement of the tubular punch means 9
within the bore 21. Stabilizer means 11 is shown disposed between
the first end portion 39 of the tubular punch means 9 and the
second end portion 39 of the main body portion 3. In this
embodiment, the stabilizer means 11 includes a bore 13 as shown in
FIG. 1, in which is disposed a section of the tubular punch means.
Thus, the interior space within the tubular punch means in this
embodiment is in fluid communication with the hollow interior space
within the bore 23, which also means that the space within the hole
25 is in fluid communication with the most distal (tip) portion of
the tubular punch means 9. This provision enables a vacuum source
to be selectively applied to the hole at 25 to assist in the
successful extraction of a follicle, blood, fluid, or serum through
use of the device 10. Again, turning the adjustment screw inwards
into the bore 5 of the main body portion 3 causes the sharp end 33
of the tubular punch means to protrude from the tip portion 43 of
the nipple end 19 in an amount proportional to the amount the
adjustment screw enters the bore 5 by virtue of its being
rotated.
[0033] The assembly of an instrument according to the invention is
a straightforward undertaking. First, the main body portion 3 is
provided. Next, the tubular punch means 9 and stabilizer means 11
are caused to reside at their earlier-specified locations within
the bores 21 and 5 respectively. This may be accomplished by first
placing the tubular punch means into the bore 21, and separately
placing the stabilizer means 11 into the opening at the first end
portion 37 of the main body portion and forcing it downwards (such
as with a rigid rod such as a pencil, screwdriver, etc.) into the
bore 5 until the stabilizer means 11 comes into contact with the
tubular punch means. Alternatively, as mentioned above, the
stabilizer means 11 itself may be provided with a bore 13 into
which the dull end of the tubular punch means 9 is first partially
inserted, thus forming a sub-assembly consisting of the tubular
punch means 9 and stabilizer means 11. This sub-assembly may then
be placed into the opening at the first end portion 37 of the main
body portion 3 with the tubular punch means 9 end of the
sub-assembly being inserted first and forced downwards, taking care
that the tubular punch means enters the bore 21 as the sub-assembly
approaches the second end portion 39 of the main body 3. Subsequent
to the placement of the tubular punch means 9 and stabilizer means
11 at their respective locations within the main body portion, the
adjustment screw 15 is next placed into the bore 5, preferably by
turning the screw head 17 or other convenient grasping means for
manipulating the rotational motion of the adjustment screw. The
adjustment screw is caused to enter the bore to a depth at which it
just first touches the stabilizer means, and then care is taken to
continue slowly admitting more of the screw into the bore so as to
cause the sharp end portion of the tubular punch means 9 to be just
flush with the distal end of the nipple end 19. In accordance with
the use of an instrument according to the invention, it will be
found necessary at times to precisely adjust the distance or amount
that the end portion of the tubular punch means 9 protrudes from
the end of the nipple end 19, as it is shown to do so a distance
denoted D in FIG. 7, as later explained. Turning the adjustment
screw 15 is thus useful in accomplishing the task of forcing the
tubular punch means 9 out of the nipple end 19 a precise desired
amount, as is necessary to provide statistically large proportions
of hair grafts having a high probability of survival, which may
often be greater than such numbers provided by many, if not all,
devices of the prior art having similar intended functions. This
action is assisted using the presence of graduation marks disposed
along the translucent main body 3 as a guide. The graduation marks
may be printed on through the use of inks or etchings, or may be
milled or ground into the body 3 itself.
[0034] Although the stabilizer means 11 is shown in one location
within the bore 5 in FIG. 1a and at another location in FIG. 3, and
is thus moveable within the bore 5, it is within the scope of the
present invention that the stabilizer means 11 is disposed in a
stationary position within the bore, at any location within the
bore 5. According to one preferred form of the invention, the
stabilizer means 11 is bottomed out within the bore 5 at a position
which represents its furthest possible travel position against the
nipple end portion 19. In addition, it is within the scope of the
present invention that the tubular punch means 9 is slidably
disposed with respect to the stabilizer means 11, i.e., in one
embodiment the tubular punch means may move with respect to the
stabilizer means 11 by motion through the bore 13, and in another
embodiment the tubular punch means 9 is not moveable with respect
to the stabilizer means 11, especially in the embodiment when the
stabilizer means 11 is not fixed in a stationary position within
the bore 5. It is especially preferred that the user be able to
visually observe the first end portion 35 of the tubular punch
means 9 within the bore 5, and towards this end it is preferred
that the material from which the main body portion 3 is comprised
to be visually translucent or to comprise a window to enable such
observation. In FIG. 3 is shown the first end portion 35 of the
tubular punch means 9 in contact with the end 47 of the adjusting
screw 15. In one embodiment the diameter of the bore 23 through the
adjustment screw is larger than the outer diameter of the tubular
punch means 9. In another embodiment, the diameter of the bore 23
through the adjustment screw is smaller than the outer diameter of
the tubular punch means 9. In another embodiment, the diameter of
the bore 23 through the adjustment screw is substantially
equivalent to the outer diameter of the tubular punch means 9. In
another embodiment, the diameter of the bore 23 through the
adjustment screw is larger than the outer diameter of the tubular
punch means 9 and the tubular punch means 9 protrudes above the
surface of the stabilizer means 11 only slightly, so as to enable
the stabilizer means 11 to function as a gasket in providing a
tight seal between the inner space within the tubular punch means 9
and the bore 23. The end portion 35 of the tubular punch means may
be disposed within the bore 23.
[0035] FIG. 4 shows a section of skin 31 containing a hair follicle
27 with a hair 29 disposed therein, wherein the surface of the skin
is in contact with the tubular punch means 9 portion of a tool
according to the invention. This FIG. 4 illustrates the first step
in illustrating generally a process for extracting a live hair
follicle from the skin using an instrument according to the
invention as a tool. In this first step, which may be called the
initial alignment step, the tubular punch means 9, after its having
been caused to protrude from the nipple end 19 of an instrument
according to the invention a pre-determined amount, is contacted
with the skin at an angle alpha of approximately 90 degrees with
respect to the skin's surface, over the location at which a hair 29
is growing out of the skin while attempting to keep the hair
centered in the bore of the tubular punch means 9. This angle is
preferably 90 degrees to the surface of the skin, but may be any
angle between about 80 and 100 degrees.
[0036] Next, as shown in FIG. 5, the sharp end portion 33 of the
tubular punch means 9 is caused to penetrate the skin over the
location at which a hair 29 is growing, an amount equal to the
distance denoted D, while the angle alpha with which the tubular
punch means 9 is disposed with respect to the skin's surface is
maintained at an angle between about 80 and about 100 degrees with
an angle alpha of 90 degrees being especially preferred. The
distance D is preferably any distance between about 0.05
millimeters and 0.5 millimeters with a depth D of about 0.2
millimeters typically being most preferred when proceeding
according to this initial penetration step of the instant method.
After the initial penetration step has been accomplished and the
sharp end of the tubular punch means 9 has penetrated the skin to
the desired depth within the above range, the device of the
invention, in the hands of a skilled surgeon, is next precisely
angled by the surgeon while still at depth D to an angle of
orientation such as that shown in FIG. 6 as alpha-2, and the
tubular punch means is inserted into the dermis to a second depth
D2 while the tubular punch means 9 is maintained at the precise
depth angle denoted as alpha-2 during the entire timespan of the
insertion to the new depth D2, while ensuring that the incision is
along the same axis as the hair growth. All follicular clusters
that consist of more than one hair will have splaying or widening
of the distance between the hairs as the hairs enter the skin
surface, which is similar to a vase containing a cluster or
plurality of stemmed flowers, in which the clusters of flowers
narrows at the neck of the vase, which corresponds to the
follicular canal for multiple hairs comprising a follicular group.
Like a vase of flowers, the distance between stems (or the hairs)
becomes more random and wider as the flowers (or hairs) proceed to
their maximal depth. A tubular punch means of one millimeter
diameter will not fit around all the hairs if the splaying is great
or if the number of hairs in the follicular groups is large.
Therefore, it is very important to limit the depth of the incision.
Making an incision so deep that the hairs within the follicular
cluster no longer fit inside the inside diameter of the tubular
punch means 9 will result in cutting one or more hair follicles
into two segments or a "transection".
[0037] The insertion of the tubular punch means 9 into the skin may
occur by applying a straight pressure to the device as a whole and
is accomplished by the sharp end of the tubular punch means 9
cutting its way through the skin; alternatively, the entire device
may be rotated (uni-directionally or in a reciprocation fashion)
while under slight force by the surgeon during the insertion. The
depth D2 may be any depth in the range of about 2 millimeters to
about 7 millimeters, with the preferred depth of D2 being typically
about 3.8 millimeters. Once the critical depth D2 has been reached,
the follicles may be removed by gently tugging on the top of the
follicles so that the follicular group is removed in its entirety
or the follicular cluster is teased out, using sharp dissection
with a surgical needle, a modified scalpel available from the
present inventor, or a hair extractor forecep available from the
present inventor. Application of a vacuum to hole 25 is
instrumental in assisting removal of follicles and/or follicular
groups. The critical depth is important to the success of a
procedure according to the invention because if the depth is too
shallow, it will be very difficult to remove the follicles. On the
other hand, if the depth is too deep, the risk of follicular damage
including transection becomes detrimentally significant.
[0038] Owing to variance amongst individuals within a race or class
of mammalian species with respect to the ultimate average depth of
their hair follicles and root below the surface of the skin, and
also depending on the location of the hair follicles on the body, I
have discovered that by precisely controlling the amount which the
tubular punch means 9 protrudes from the nipple end 19 of the
device of this invention, that great reproducibility of consistency
of hair follicles extracted having identical depths is now made
possible through the use of my invention. Once the average critical
depth of the follicles for a particular individual has been
determined, this consistency afforded by my invention allows for
the vast majority of follicles extracted using my device and method
to survive as fertile potential implants for transplantation to
other parts of the same subject's dermal areas, with a success rate
exceeding 90% in most cases being readily achievable, which
represents a major advance in this art.
[0039] In FIG. 7 is shown a section of skin 31 containing a hair
follicle 27 in contact with a portion of an instrument according to
the invention. In this figure, the initial penetration step has
been accomplished, and the sharp end of the tubular punch means 9
has penetrated the skin to the desired depth within the range
specified earlier for the depth D. This figure illustrates how the
nipple end acts as a stop, in limiting the depth of penetration
allowed by the tubular punch means into the skin. The depth of
penetration is limited to the amount that the tubular punch means 9
protrudes from the nipple end 19, which is readily controllable by
the surgeon by adjusting the adjustment screw 15. In this FIG. 7 is
shown the first end portion 35 of the tubular punch means 9 in
contact with the end 47 of the adjusting screw 15.
[0040] In FIG. 8 is shown a section of skin 31 containing a hair
follicle 27 in contact with a portion of an instrument according to
the invention. In this figure, the initial penetration step has
been accomplished, and the sharp end of the tubular punch means 9
has penetrated the skin to the desired depth within the range
specified earlier for the depth D2. This figure also illustrates
how the nipple end acts as a stop, in limiting the depth of
penetration allowed by the tubular punch means into the skin. The
depth of penetration is again seen to be limited to the amount that
the tubular punch means 9 protrudes from the nipple end 19, which
is readily controllable by the surgeon by adjusting the adjustment
screw 15.
[0041] In one particularly preferred embodiment, the length of the
tubular punch means 9 is 2.5 centimeters in length. The width of
the adjustment screw 15 is about 4.5 millimeters and the length of
the adjustment screw 15 is about 10 centimeters, and the width of
the head portion 17 is about 9 millimeters. However, the head
portion 17 could be much wider and have a variety of geometrical
shapes, and the present invention includes embodiments wherein the
adjustment screw 15 has any length, while enabling the device as a
whole to retain its intended functionality. In one form of the
invention, the nipple end portion 19 is tapered, and has an outside
diameter of about 4.38 millimeters at the top which tapers down to
about 4.22 millimeters at the bottom, with an overall length of
about 8 millimeters. However, the present invention includes
embodiments wherein the nipple end portion is of any length, while
enabling the device as a whole to retain its intended
functionality. In one preferred form of the invention, the main
body portion 3 is about 8 centimeters long, and has a width between
about 6.55 millimeters and 6.67 millimeters. However, the present
invention includes embodiments wherein the main body portion 3 is
of any dimensions, wider, narrower, thinner, thicker, longer or
shorter, as prescribed herein, provided that the functionality of
the device as specified herein is maintained.
[0042] Consideration must be given to the fact that although this
invention has been described and disclosed in relation to certain
preferred embodiments, obvious equivalent modifications and
alterations thereof will become apparent to one of ordinary skill
in this art upon reading and understanding this specification and
the claims appended hereto. The present invention further includes
all possible combinations of the features recited in the
specification and/or any one of the various claims appended hereto
with the features recited elsewhere in the specification and/or in
any one or more of each of the remaining claims. Accordingly, the
presently disclosed invention is intended to cover all such
modifications, alterations, and combinations.
* * * * *