U.S. patent application number 12/555914 was filed with the patent office on 2009-12-31 for skin rejuvination resurfacing device.
This patent application is currently assigned to SPAMEDICA INTERNATIONAL SRL. Invention is credited to R. Stephen Mulholland.
Application Number | 20090326571 12/555914 |
Document ID | / |
Family ID | 38175461 |
Filed Date | 2009-12-31 |
United States Patent
Application |
20090326571 |
Kind Code |
A1 |
Mulholland; R. Stephen |
December 31, 2009 |
SKIN REJUVINATION RESURFACING DEVICE
Abstract
A skin rejuvenation resurfacing apparatus comprising an
oscillating, reciprocating high speed, non-thermal, needle-based
device for inducing mechanical trauma to an area of the skin to be
treated.
Inventors: |
Mulholland; R. Stephen;
(Toronto, CA) |
Correspondence
Address: |
DENNIS G. LAPOINTE;LAPOINTE LAW GROUP, PL
PO BOX 1294
TARPON SPRINGS
FL
34688-1294
US
|
Assignee: |
SPAMEDICA INTERNATIONAL SRL
Warrens
BB
|
Family ID: |
38175461 |
Appl. No.: |
12/555914 |
Filed: |
September 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11315841 |
Dec 22, 2005 |
7618429 |
|
|
12555914 |
|
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Current U.S.
Class: |
606/186 |
Current CPC
Class: |
A61B 2017/00747
20130101; A61B 17/205 20130101; A61B 2017/00792 20130101; A61B
2017/00765 20130101 |
Class at
Publication: |
606/186 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. An apparatus for use in a skin rejuvenation resurfacing
procedure comprising: a non-thermal needle base device configured
for inducing a mechanical trauma transdermally into the epidermis,
dermis and subcutaneous fat; means for oscillating and
reciprocating at a high speed an elongated needle portion of said
needle-based device and means for operating said needle based
device at about 40 cycles per second to 100 cycles per second to
induce a purposeful full skin thickness injury and inflammatory
response that leads to collagen, elastic and ground substances to
resurface a patient's skin; the needle-based device including
needle depth adjustment means for obtaining a desired transdermal
penetration needle tip depth sufficient to penetrate through said
epidermis, dermis and into said subcutaneous fat of needle tips of
a plurality of needles for the appropriate treatment of the area of
the skin being treated; and the needle-based device further
comprising: a hand-held portion comprising means for oscillating
and reciprocating an elongated needle portion, the elongated needle
portion being connected at one end to said hand-held portion and in
mechanical communication with said means for oscillating and
reciprocating said needle portion, the elongated needle portion
having at its opposite end, the plurality of needles configured in
a desired array.
2. The apparatus according to claim 1, wherein the needle-based
device is a hand-held, mechanical device and is controllable by
hands-free means.
3. The apparatus according to claim 2, wherein the hands-free means
for controlling the needle-based device is a foot control switch
between a power controller source and the hand-held needle-based
device.
4. The apparatus according to claim 1, wherein the plurality of
needles are arranged in an array comprising between eight to
sixteen needles.
5. The apparatus according to claim 1, wherein the needle-based
device further comprises: a needle sheath generally covering said
elongate needle portion and connected to the hand-hand portion and
ending near the plurality of needles, said needle sheath further
serving as means for preventing a side to side movement of the
elongate needle portion; and a needle tip protector attached over
the plurality of needles, said needle tip protector being slidably
operable over the plurality of needles for serving as the needle
depth adjustment means for obtaining the desired depth of needle
penetration of said needle tips to the skin area being treated.
6. The apparatus according to claim 5, wherein the plurality of
needles are arranged in an array comprising between eight to
sixteen needles.
7. The apparatus according to claim 6, comprising twelve needles.
Description
RELATED APPLICATION
[0001] This application is a continuation application of
nonprovisional application Ser. No. 11/315,841 filed Dec. 22,
2005.
FIELD OF THE INVENTION
[0002] The invention relates to a punctile device in the field of
aesthetic and reconstructive medicine and cosmetic surgery to
enhance the appearance of skin wrinkles, skin texture and
scars.
BACKGROUND OF THE INVENTION
[0003] The device and the procedure with which the device is used
and referred to herein using punctile resurfacing was developed as
a safe and effective skin rejuvenation system for the improvement
of moderate wrinkles, scars, pores, pigmentation and skin
texture.
[0004] In the aesthetic industry there are many procedures using
devices that improve the appearance of the skin. These devices can
be divided into laser, broad band light, mechanical and
radiofrequency systems.
[0005] Lasers use specific wavelengths of light that penetrate the
skin, bind to specific chromophores and, through a process called
selective photothermolysis remove various colors and pigments from
the skin. Other lasers with longer wavelengths of light enter the
skin, cause nonspecific heating and improve the texture and fine
wrinkling of the skin. Intense pulse light systems release many
wavelengths of light at once and also improve the color and texture
of the skin through selective photothermolysis. RadioFrequency
technologies, use electrical current to heat the dermis
(undercarpet of the skin) and stimulate some production of collagen
and elastin Fibers that firm and tighten the skin. More ablative
technology, CO.sub.2 and Erbium laser resurfacing, chemical peels,
plasma resurfacing and mechanical dermabrasion remove the outer
layers of the skin, in a relatively precise fashion and through the
natural healing process, new collagen and elastin is produced in
the skin, improving wrinkles and texture.
[0006] Pin point, segmental or fractional injuries to the skin and
dermis can be delivered by laser systems such as Fraxel.TM., which
sends small beams of erbium glass laser wavelengths into the dermis
or the Medical Roll CIT.TM., which is a hand held roller with
widely spaced needles. The advantage of these segmental, fractional
injury and puncturing procedures, is the dermis is stimulated with
either a heat or mechanical trauma and the inflammatory response
results in dermal remodeling and the production of new collagen,
elastin and ground substance and ultimately, skin enhancement and
rejuvenation.
[0007] The development of the device described herein and the
punctile remodeling procedure was designed to deploy, through the
proven efficacy of the fractional approach to dermal injury,
remodeling and rejuvenation with a precision, high speed,
mechanical needle puncture system and procedure that would safely
and effectively improve the texture and appearance of skin with out
the need for laser heating.
Industry and Device Comparisons
Monochromatic Lasers:
[0008] These devices use specific wavelengths of light that
penetrate the skin, bind to specific chromophores and, through a
process called selective photothermolysis, remove various colors
and pigments from the skin. The lasers are large, expensive pieces
of capital equipment, only attack specific problems or colors in
the skin, are prone to laser bums, scars, can cause hyper and/or
hypopigmentation and may result in user and patient ocular
injuries.
Intense Broad Band Light Systems:
[0009] These systems emit multiple wavelengths of light, and
through selective photothermolysis, also improve skin discoloration
and, through skin heating, non-specific skin texture improvement.
The systems are also larger and expensive, the skin textures and
wrinkle improvements are minimal and there is also the risk of skin
bums, hypo or hyperpigmentaiton and scars.
RadioFrequency Devices:
[0010] RadioFrequency technologies, use electrical current to heat
the dermis (undercarpet of the skin) and stimulate some production
of collagen and elastin fibers that firm and tighten the skin. The
devices are relatively expensive, have only modest skin texture or
wrinkle improvements, being more designed for modest skin
tightening. There is also a risk of localized fat necrosis, with
permanent dimpling, damage to sensory nerves and scarring.
Plasma Technology:
[0011] Plasma technologies use saline and electrical current to
induce a thin burn on the outer surface of the skin, inducing a
dermal injury which heals with increase collagen, elastin and
dermal ground substance. Although these devices do produce a good
improvement in wrinkles, skin tightening and texture, they are
expensive pieces of capital equipment and also run the risk of
scarring, hyper or hypopigmenation. The recovery from the procedure
is characterized by oozing and discharge and patients are not ready
for make up for 2 weeks.
Laser Resurfacing and Chemical Peel:
[0012] Carbon Dioxide or Erbium lasers are used to burn off the
outer layer of skin inducing a thermal injury in the dermis which
heals by remodeling and increased collagen and elastin production.
Resurfacing lasers also produce good wrinkle and texture
improvements with skin tightening, but are expensive can
potentially cause scars and profound hypopigmentaion and ocular
injury and blindness to the user and the patient. The recovery from
the procedure is characterized by oozing and discharge and patients
are not ready for make up for 2 weeks.
Fraxel Laser:
[0013] Is a fractional dermal injury system that functions by
emitting beams of erbium glass laser energy that creates multiple
small holes in the dermis, alongside uninjured skin. The fractional
dermal injury results in the remodeling without the significant
recovery. The fraxel laser is expensive, and has modest results at
best.
Medical Roll CIT:
[0014] This is also a fractional dermal injury system. It is a hand
held roller with needles mounted on the roller. It is passed
repeatedly by hand across the skin creating a dermal injury but
leaving a large portion of the epidermis intake. There is some
bruising and swelling, but very little pain, weeping or oozing. The
mechanical injury to the dermis results in some structural collagen
and elastic, smoothening out fine winkles. The needles are very
long and widely spaced and the patients experience a significant
amount of discomfort due to the length of the needle. The hand held
nature of the device, make predictable spacing of the segmental
injury imprecise.
[0015] What is needed is a procedure using a Pixelatory.TM. and
Punctile Resurfacing device. The inventor herein has developed a
more efficient, fast, predictable and less painful device and
procedure than the above described Medical Roll CIT device and its
procedure. The present inventive using the inventor's developed
Pixelator.TM. device provides for a resulting dermal remodeling
that improves fine to moderate wrinkles, pigmentation and obtains
skin texture improvement. Because there is no laser or thermal
component to the injury, there is very little risk of
hypopigmentation or scarring.
SUMMARY OF THE INVENTION
[0016] The present invention is a procedure and apparatus using a
foot pedal controlled power source, that sends electrical energy to
a reciprocating hand piece, that is, a hand piece that contains the
equipment that causes the reciprocating and oscillating action of
the device. The reciprocating hand piece provides the rapid
oscillating, reciprocating back and forth ("in and out") motion of
the needle tips. The tip of the reciprocator device has a screw on
tip to which the needle tip attaches.
[0017] The working tip of the Pixelator.TM. reciprocator or
needle-based device is the needle tip. It is a series of a number
of needles in a desired array, typically 12 needles, two rows of 6
needles affixed in a rectangle, to a long stainless steel shaft and
it screws onto the tip of the handpiece or headpiece. Other needle
arrays are contemplated such as 8 needles up to 16 needles, with
different configurations to the needle tips themselves.
[0018] The needle tip while reciprocating in and out rapidly will
have some toggle and to prevent this, a sheath is inserted over the
needle tip and a disposable plastic tip protector is inserted
inside the sheath. The plastic tip can be pushed in or withdrawn to
expose more or less of the needle tip. Thus, the plastic tip
controls the depth of penetration.
[0019] The Pixelator.TM. needle-based device is a skin rejuvenation
device that works on the principle of fractional dermal injury, but
induced through a high speed, non-thermal, needle based mechanical
trauma. Once the Midas headpiece is assembled, the plastic tip
protector is advanced in or out of the sheath to set the length of
the punctile needles that will be exposed to the skin during the
treatment, providing a controllable "depth gauge" for the depth of
dermal injury.
[0020] Anesthesia: The patient is usually anesthetized with local
anesthesia. The upper and lower lips, lower eyelids, frown line
region and any area of acne scarring can by infiltrated with local
anesthesia and treated.
[0021] Punctile Resurfacing: The hand piece and tip is placed over
the skin with direct contact of the needle tip with the skin. By
depressing the foot pedal, the 40 Hz reciprocating oscillations
("in and out" motions of the needle tip) begin and with each
reciprocation the needles penetrate into the dermis, according to
the depth that was set on by the adjustment of the plastic tip
protector. The Pixelator.TM. hand piece is then passed in one
direction across the whole surface area to be treated. The
movements are gentle but fast and move in one direction. Once one
pass of the entire treatment area has been completed the hand piece
and needle tip are then passed in the opposite direction, about 90
degrees to the first pass. Once this pass is completed a third pass
is made 90 degrees to the previous pass. With this criss-crossing
pattern, up 6-9 passes may be made in each treatment zone. With
each pass there is a small amount of pin-point bleeding, which
stops very quickly, due to the fractional nature of the injury and
the presence of bridging epthermal skin segments. Most of the
trauma is dermal and ecchymosis (bruising) is induced under the
skin. It is the post dermal inflammation that will determine the
level of new dermal substrate formation. After each pass, the small
amount of blood residual on the surface is wiped off, clotting
occurs very quickly and the next pass initiated.
[0022] Punctile Resurfacing End Point: After about 6-9
criss-crossing passes on the skin, there will be a deep bruised
discoloration to the skin and edema. Once the ecchymotic, bruised
discoloration and edema has eliminated or greatly reduced the
wrinkle, scar or textural abnormality and the color of the dermal
bruise is dark blue, the end point of treatment has arrived.
Generally an upper lip or lower lid sized zone takes 10 minutes to
reach the therapeutic end point.
[0023] Post-Punctile Resurfacing Care: As punctile resurfacing is a
fractional injury, there is a microscopic but substantial area of
the epidermis that is intact. The intact epidermis affects a very
rapid hemostatic effect and re-epithelialization repair. As a
consequence, the patients punctile resurfacing area, although
bruised in appearance, exhibits minimal oozing and discomfort as
the superficial epidermis is re-epithelialize within 24-48 hours.
Cleansing with water and a topical emollient, such as
Polysporin.TM. ointment is the only after care.
[0024] Punctile Resurfacing Results: Over the 6-12 weeks
post-punctile resurfacing, the bruising and edema resolves in 4-5
days and the patient may wear makeup. By 3-4 months, the mechanical
trauma and inflammation that was induced by the fractional needle
punctures has induced and post inflammatory reaction resulting in
new dermal collagen, elastin and ground substance production. The
clinical results are smoother wrinkles, improvement in depressed
scars, pores, brown discoloration and enhanced skin texture.
[0025] Features of the Pixelator.TM. needle-based device that are
used and/or beneficial in the novel procedure are the more closely
spaced needle configuration for more precise fractional dermal
injury, the reciprocating mechanical handpiece for more rapid and
predictable treatment of areas, the adjustable tip for more control
over the depth of the dermal injury, the hand held, comfortable,
light and 110-volt out of the wall power source (although DC
current is also contemplated), the disposable needle tip and
plastic tip guide, the device headpiece and sheath can be reused,
the low cost of operation, the fact that the procedure does not use
a laser device, making it safer for the operator and patient, and
that there is little risk of scars or hypopigmenation as
Pixelator.TM. needle-based device causes a non-thermal mediated
injury.
[0026] The inventive procedure is a skin rejuvenation resurfacing
procedure comprising performing a punctile resurfacing procedure
using an oscillating, reciprocating high speed, non-thermal,
needle-based device for inducing mechanical trauma to an area of
the skin to be treated.
[0027] A desired number of passes are made over the surface area of
the skin to be treated in a criss-crossing pattern until there is a
deep bruised discoloration and edema to the area of the skin being
treated such that a wrinkle, scar or textural abnormality being
treated has been eliminated or greatly reduced.
[0028] After the procedure is completed using the needle-based
device, the area of the skin treated is cleansed and a topical
emollient is applied.
[0029] The resultant bruising and edema resolves in 4-5 days such
that make-up may be worn on the treated area, and the mechanical
trauma and inflammation that was induced by fractional needle
punctures and the post inflammatory reaction results in new dermal
collagen, elastin and ground substance production thereby resulting
in smoother wrinkles, improvement in depressed scars and enhanced
skin texture.
[0030] Prior to starting the resurfacing treatment, the patient
being treated is anesthetized with local anesthesia to the area of
the skin to be treated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] In the accompanying drawings:
[0032] FIG. 1 is a schematic depiction of one example of the major
system components used in the inventive procedure;
[0033] FIG. 2A is a cross-sectional view of the needle tip
area;
[0034] FIG. 2B is an end view of the needle tip area of FIG.
2A;
[0035] FIG. 3 is a depiction of a typical needle, needle tip sheath
and needle tip plastic protector;
[0036] FIG. 4A is a depiction of the end of the needle tip area
being directed in a path with the needles in a partially retracted
position; and
[0037] FIG. 4B is a depiction similar to FIG. 4A with the needles
in an extended position.
DETAILED DESCRIPTION OF THE INVENTION
[0038] Referring now to the drawings, FIGS. 1, 2A, 2B, 3, 4A and 4B
disclose an example of the major system components used in the
inventive procedure. Reference to these components will be made in
describing the inventive procedure.
[0039] The invention is a skin rejuvenation resurfacing procedure
and its associated apparatus wherein a punctile resurfacing
procedure is performed on a subject patient using an oscillating,
reciprocating high speed, non-thermal, needle-based device 12 for
inducing mechanical trauma to an area of the skin to be treated.
Prior to commencing the procedure, the patient being treated is
anesthetized with local anesthesia to the area of the skin to be
treated.
[0040] A desired number of passes are made over the surface area of
the skin to be treated in a criss-crossing pattern until there is a
deep bruised discoloration and edema to the area of the skin being
treated such that a wrinkle, scar or textural abnormality being
treated has been eliminated or greatly reduced.
[0041] The skin area to be treated is treated using the
needle-based device 12 by passing in a first direction. Then an
alternating pass is done in a generally criss-crossing pattern to
the first direction and the treatment is repeated in this
alternating criss-crossing pattern. The typical desired number of
passes made over the area of the skin to be treated in the
criss-crossing pattern is six to nine passes in each direction of
the criss-crossing pattern.
[0042] After this step is completed, the area of the skin treated
is cleansed and a topical emollient, such as Polysporin.TM.
anti-bacterial ointment is applied.
[0043] The resultant bruising and edema resolves in 4-5 days such
that make-up may be worn on the treated area, and the mechanical
trauma and inflammation that was induced by fractional needle
punctures and the post inflammatory reaction results in new
collagen, elastin and ground substance production thereby resulting
in smoother wrinkles, improvement in depressed scars, lessened
pigmentation and enhanced skin texture.
[0044] The needle-based device 12 is a hand-held device and is the
power is controlled by a hands-free means. For example, a foot
pedal or foot control switch 16 is typically used in the control
circuit between a power controller source 14 and the hand-held
needle-based device 12. The power controller source is depicted in
FIG. 1 as being powered by an alternating current source but
alternatively could be powered by a direct current source.
[0045] The needle-based device includes needle depth adjustment
means for obtaining a desired skin penetration depth of needle tip
12b of a plurality of needles 12d for the appropriate treatment of
the area of the skin being treated. The plurality of needles 12d
are preferably arranged in an array comprising between eight to
sixteen needles. For example, FIG. 2b depicts an array of 12
needles arranged in a 2.times.6 configuration.
[0046] The needle-based device 12 comprises a hand-held portion 12a
housing means for oscillating and reciprocating an elongate needle
portion 12b. This a commercially available hand piece, also
referred to as head piece, which houses the motor and oscillating
means (not shown) and to which the elongate needle portion 12b is
connected at one end and in mechanical communication with the means
for oscillating and reciprocating said needle portion 12b.
Typically, the needles 12d oscillate/reciprocate at about 40 cycles
per second to about 100 cycles per second.
[0047] As mentioned above, the elongate needle portion 12b has at
its opposite end, a plurality of needles 12d configured in a
desired array, such as 2.times.6.
[0048] A needle sheath 12c is provided to slide over the needle
portion 12b and attach to the hand piece 12a. The attachment can be
by threaded means or other methods known in the art. Sheath 12c
generally covers the elongate needle portion 12b and is connected
to the hand-hand portion 12a and ends with the array of the
plurality of needles 12d. The needle sheath 12c further serves as
means for preventing a side to side movement of the elongate needle
portion 12b.
[0049] A needle tip protector 12e is attached over the plurality of
needles 12d and is slidably operable over the plurality of needles
12d for serving as the needle depth adjustment means for obtaining
the desired depth of needle penetration of said needle tips to the
skin area being treated. Typically, the protector is slidably
engaged with the end of the sheath 12c and is pushed into or pulled
away from the end of the sheath 12c so that when the needle tips
are extended at the maximum reciprocation distance away from hand
piece 12a, the distance between the tips and the protector edge
equates to the maximum penetration depth desired to accomplish the
desired treatment.
[0050] It should be understood that the preceding is merely a
detailed description of one or more embodiments of this invention
and that numerous changes to the disclosed embodiments can be made
in accordance with the disclosure herein without departing from the
spirit and scope of the invention. The preceding description,
therefore, is not meant to limit the scope of the invention.
Rather, the scope of the invention is to be determined only by the
appended claims and their equivalents.
* * * * *