U.S. patent application number 17/401623 was filed with the patent office on 2021-12-02 for systems and methods for removing exogenous particles from the skin of a patient.
The applicant listed for this patent is THE GENERAL HOSPITAL CORPORATION. Invention is credited to Richard Rox Anderson, William Farinelli, Lilit Garibyan, Martin Purschke, Fernanda H. Sakamoto.
Application Number | 20210369502 17/401623 |
Document ID | / |
Family ID | 1000005771413 |
Filed Date | 2021-12-02 |
United States Patent
Application |
20210369502 |
Kind Code |
A1 |
Garibyan; Lilit ; et
al. |
December 2, 2021 |
SYSTEMS AND METHODS FOR REMOVING EXOGENOUS PARTICLES FROM THE SKIN
OF A PATIENT
Abstract
The present disclosure is directed to systems and methods that
removing exogenous particles from a target region of the skin of a
patient. The systems and methods can employ dermal lavage to remove
the exogenous particles from the target region. In some instances,
the exogenous particles can be residual tattoo ink after a tattoo
removal process. A conduit can be sized and dimensioned for
insertion into or around the target region to inject an irrigation
fluid that defines an irrigation area. The exogenous particles can
be suspended in the irrigation fluid. A device can be configured to
form one or more channels in the irrigation area so that the
exogenous particles are removable from the irrigation area.
Inventors: |
Garibyan; Lilit; (Boston,
MA) ; Anderson; Richard Rox; (Boston, MA) ;
Farinelli; William; (Boston, MA) ; Sakamoto; Fernanda
H.; (Boston, MA) ; Purschke; Martin; (Boston,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE GENERAL HOSPITAL CORPORATION |
Boston |
MA |
US |
|
|
Family ID: |
1000005771413 |
Appl. No.: |
17/401623 |
Filed: |
August 13, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16069339 |
Jul 11, 2018 |
11103387 |
|
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PCT/US17/13548 |
Jan 13, 2017 |
|
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17401623 |
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62278014 |
Jan 13, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 13/0203 20130101;
A61B 2017/00769 20130101; A61M 37/0076 20130101 |
International
Class: |
A61F 13/02 20060101
A61F013/02; A61M 37/00 20060101 A61M037/00 |
Claims
1. A device configured to remove exogenous particles from skin, the
device comprising: a housing; at least one fluid injection
mechanism within an outer section of the housing configured to
inject an irrigation fluid into the skin to define an irrigation
area, wherein the exogenous particles are removeable from the
irrigation area with the irrigation fluid; and a pressure/suction
mechanism within an inner section of the housing configured to
alternate pressure and suction to the irrigation area to facilitate
removal of the irrigation fluid and at least a portion of the
exogenous particles from the irrigation area.
2. The device of claim 1, wherein the inner section of the housing
is configured to form one or more channels within a portion of the
irrigation area, wherein the irrigation fluid and the at least the
portion of the exogenous particles are removed through the one or
more channels.
3. The device of claim 2, wherein the inner section of the housing
comprises at least one microneedle or coring needle to form the one
or more channels within the portion of the irrigation area.
4. The device of claim 2, wherein the inner section of the housing
is configured to draw a portion of the irrigation area therein to
form the one or more channels within the portion of the irrigation
area.
5. The device of claim 1, wherein the irrigation area is within a
dermis of the skin.
6. The device of claim 1, further comprising an adhesive material
along at least a portion of the housing to attach the housing to
the skin.
7. The device of claim 6, wherein the housing comprises a domed
portion to be placed away from the skin and a substantially flat
portion to be placed on the skin, wherein the adhesive material is
along at least a portion of the substantially flat portion.
8. The device of claim 1, wherein the irrigation fluid comprises a
biocompatible fluid and an additive.
9. The device of claim 8, wherein the additive is a pharmaceutical
agent, an enzyme, a natural product, and/or a venom.
10. The device of claim 8, wherein the additive is capable of at
least one of lysing cells, making the skin more porous, preventing
or inhibiting phagocytosis, creating localized edema, and
facilitating removal of the irrigation fluid.
11. The device of claim 8, wherein the biocompatible fluid
comprises at least one of saline and water.
12. The device of claim 1, wherein the irrigation fluid comprises a
pressurized fluid.
13. A method for removing exogenous particles from skin, the method
comprising: attaching a device to the skin; injecting an irrigation
fluid into the skin to define an irrigation area, wherein the
exogenous particles are removeable from the irrigation area with
the irrigation fluid; and alternating pressure and suction to the
irrigation area to remove the irrigation fluid and at least a
portion of the exogenous particles from the irrigation area.
14. The method of claim 13, wherein the device comprises a housing,
at least one fluid injection mechanism within an outer section of
the housing configured to inject the irrigation fluid into the skin
to define the irrigation area, and a pressure/suction mechanism
within an inner section of the housing configured to alternate
pressure and suction to the irrigation area.
15. The method of claim 14, further comprising forming one or more
channels within a portion of the irrigation area, wherein the
irrigation fluid and the at least the portion of the exogenous
particles are removed through the one or more channels.
16. The method of claim 15, further comprising drawing a portion of
the irrigation area into the inner section of the housing to form
the one or more channels within the portion of the irrigation
area.
17. The method of claim 13, wherein the applying further comprises
using an adhesive material along at least a portion of the housing
to attach the housing to the skin.
18. The method of claim 17, wherein the housing comprises a domed
portion to be placed away from the skin and a substantially flat
portion to be placed on the skin, wherein the adhesive material is
along at least a portion of the substantially flat portion.
Description
RELATED APPLICATIONS
[0001] This application is a Divisional of U.S. application Ser.
No. 16/069,339, entitled "SYSTEMS AND METHODS FOR REMOVING
EXOGENOUS PARTICLES FROM THE SKIN OF A PATIENT," filed Jul. 11,
2018, which U.S. National Stage under 35 USC 371, claiming priority
to Serial No. PCT/US2017/013548, entitled "SYSTEMS AND METHODS FOR
REMOVING EXOGENOUS PARTICLES FROM THE SKIN OF A PATIENT," filed
Jan. 13, 2017, which claims the benefit of U.S. Provisional
Application No. 62/278,014, entitled "SYSTEMS AND METHODS FOR
REMOVING EXOGENOUS PARTICLES FROM THE SKIN OF A PATIENT," filed
Jan. 13, 2016. The entirety of these applications is hereby
incorporated by reference for all purposes.
TECHNICAL FIELD
[0002] The present disclosure relates generally to systems and
methods for removing exogenous particles from a target region of a
patient's skin and, more particularly, to systems and methods for
tattoo removal.
BACKGROUND
[0003] Tattoos are made by inserting ink or other colorant into the
dermis of the skin. More than forty million people in the United
States have tattoos, and many people will seek to have them
removed. While tattoos are considered permanent, it is sometimes
possible to fully or partially remove tattoos. Current tattoo
removal technologies involve laser treatments (e.g., using
Q-switched lasers, picosecond lasers, or the like). To remove the
tattoo completely, a patient may be required to undergo a series of
painful laser treatments (e.g., requiring 10-20 sessions). Even
with multiple sessions, the laser treatments can leave tattoo
pigments remaining in the skin and/or create textural changes to
the skin, including scarring. Accordingly, many patients are
unwilling to have their tattoo removed (even though they no longer
want the tattoo) due to the associated time, cost and/or pain.
SUMMARY
[0004] The present disclosure relates generally to systems and
methods for removing exogenous particles from a target region of a
patient's skin and, more particularly, to systems and methods for
tattoo removal.
[0005] In one aspect, the present disclosure can include a method
for removing exogenous particles from a target region of the skin
of a patient. The method can include inserting one or more fluid
conduits (e.g., perforated fluid conduits, needles, or the like)
into a portion of the patient's skin to define an irrigation area
in or around the target region. The method can also include
injecting an irrigation fluid into the irrigation area so that the
exogenous particles become suspended in the irrigation fluid. The
method can also include removing the irrigation fluid from the
irrigation area. In some instances, the method also can include
creating localized edema through endogenous fluid accumulation by
injection of histamine, lipases, phospholipases, canthrone,
podophylin, or the like.
[0006] In another aspect, the present disclosure can include a
system for removing exogenous particles from a target region of the
skin of a patient. The system can include at least one conduit
sized and dimensioned for insertion into or around the target
region to define an irrigation area. The at least one conduit can
be configured to inject an irrigation fluid into the irrigation
area. The system can also include a device configured to form one
or more channels in the irrigation area so that the exogenous
particles are removable from the irrigation area with the
irrigation fluid.
[0007] In a further aspect, the present disclosure can include a
method for removing a tattoo from a target region of skin of a
patient. The method can include shattering the tattoo in the target
region into pigment particles. In some instances, the tattoo can be
shattered by a laser removal process. In some instances, the method
can also include the use of enzymes (e.g., lipases, phospholipases,
or the like) to free the tattoo particles from the cells. The
method can also include suspending the pigment particles in the
irrigation fluid. In other instances, the method can also include
adding chemicals to prevent re-phagocytosis of the tattoo particles
with the use of sucrose, colchine, podophylin, etc. The method can
also include removing the irrigation fluid and the suspended
pigment particles from the irrigation area. For example, the
irrigation fluid can be removed from the irrigation area via at
least one channel through the surface of the skin of the
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The foregoing and other features of the present disclosure
will become apparent to those skilled in the art to which the
present disclosure relates upon reading the following description
with reference to the accompanying drawings, in which:
[0009] FIG. 1 is a block diagram illustrating an example of a
system for removing exogenous particles from a target region of the
skin of a patient according to an aspect of the present
disclosure;
[0010] FIG. 2A is a block diagram illustrating an example of a
wearable device;
[0011] FIG. 2B represents a top view indicating alternating
pressure (o) and suction (x) that can be applied by the example
wearable device of FIG. 2A;
[0012] FIG. 3 is a process flow diagram illustrating a method for
removing exogenous particles from a target region of skin of a
patient according to another aspect of the present disclosure;
[0013] FIGS. 4, 5, and 6A are schematic illustrations showing
removal of the exogenous particles from the target region of the
skin using the system in FIG. 1;
[0014] FIG. 6B represents a top view indicating an example of
alternating pressure (o) and suction (x) that can be applied by
FIG. 6A.
DETAILED DESCRIPTION
Definitions
[0015] In the context of the present disclosure, the singular forms
"a," "an" and "the" can also include the plural forms, unless the
context clearly indicates otherwise.
[0016] The terms "comprises" and/or "comprising," as used herein,
can specify the presence of stated features, steps, operations,
elements, and/or components, but do not preclude the presence or
addition of one or more other features, steps, operations,
elements, components, and/or groups.
[0017] As used herein, the term "and/or" can include any and all
combinations of one or more of the associated listed items.
[0018] Additionally, although the terms "first," "second," etc. may
be used herein to describe various elements, these elements should
not be limited by these terms. These terms are only used to
distinguish one element from another. Thus, a "first" element
discussed below could also be termed a "second" element without
departing from the teachings of the present disclosure. The
sequence of operations (or acts/steps) is not limited to the order
presented in the claims or figures unless specifically indicated
otherwise.
[0019] As used herein, the term "exogenous" can refer to an element
or substance that is placed into the body from an external source
(e.g., not natural to the body). Accordingly, the term "exogenous
particle" can refer to a particle that is placed into the body from
an external source. In some instances, an exogenous particle can be
an ink pigment that is placed in the skin of a patient. For
example, the ink pigment can be a remnant of a tattoo created by a
laser removal process.
[0020] As used herein, the term "laser removal process" can refer
to a process that uses a laser to shatter or fragment ink
comprising a tattoo. Examples of laser removal processes can
include Q-switched laser removal processes, picosecond laser
removal processes, and the like. The terms "laser removal process"
and "laser removal therapy" can be used interchangeably herein.
[0021] As used herein, the term "skin" can refer to the soft outer
covering of vertebrates, including the epidermis (e.g., the
outermost layers of cells in the skin) and the dermis (e.g., a
layer of skin between the epidermis and subcutaneous tissue that
cushions the body from stress and strain).
[0022] As used herein, the terms "target region" and "target area"
can be used interchangeably and can refer to an area of a patient's
skin from which one or more exogenous particles will be
removed.
[0023] As used herein, the term "irrigation area" can refer to an
area of a patient's skin that will be irrigated to remove exogenous
particles. In some instances, the irrigation area can be less than,
greater than, or equal to the target area.
[0024] As used herein, the term "conduit" can refer to an element,
structure, or component for conveying a fluid. The conduit can be
internal (e.g., needles, microneedels, or the like) and/or external
(e.g., a container housing the solution) to a patient's skin.
Additionally, when the conduit refers to an external conduit, the
conduit can be in contact with the patient's skin (e.g., a
component used for electrophoresis, iontophoresis, or the like) or
not in contact with the patient's skin.
[0025] As used herein, the term "channel" can refer to a passageway
or conduit extending from an opening or hole at the surface of the
skin to a depth under the skin.
[0026] As used herein, the term "microchannel" can refer to a
channel with a diameter less than about 1 mm. For example, a
microchannel can be a channel that extends from an opening or hole
in a patient's skin, through the epidermis, and into the dermis. As
an example, a microchannel can be created in a patient's skin by a
needle, a laser, or the like.
[0027] As used herein, the term "lavage" can refer to washing or
irrigating with repeated injections of a fluid (e.g., water,
saline, or other biocompatible fluid, which may include a
pharmaceutical agent and/or an enzyme and/or any natural products
or toxins, such as spider venom, snake venom, beetle venom, bee
venom, or the like).
[0028] As used herein, the terms "subject" and "patient" can be
used interchangeably and refer to any warm-blooded living organism
including, but not limited to, a human being, a pig, a rat, a
mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a
rabbit, a cow, etc.
[0029] As used herein, the term "operatively coupled" can refer to
two or more components that are linked so that they perform their
associated function cooperatively and/or in combination.
Overview
[0030] The present disclosure relates generally to systems and
methods for removing exogenous particles from a target region of a
patient's skin and, more particularly, to systems and methods for
tattoo removal. After a single laser removal treatment, thousands
of microscopic tattoo particles (e.g., exogenous particles) are
released from cells in the dermis of the skin. While some of the
exogenous particles are washed away by the patient's lymphatic
system, other exogenous particles remain in the skin. The remaining
exogenous particles, which are engulfed by macrophages and other
phagocytes in the skin, essentially preserve the tattoo image. To
remove these remaining exogenous particles completely, further
laser removal treatments are required. Advantageously, the present
disclosure describes systems and methods that can reduce or
eliminate the need for further laser removal treatments. In some
instances, the systems and methods themselves can eliminate
exogenous particles from the patient's skin without the need for an
initial laser removal treatment. As discussed in more detailed
below, the present disclosure provides systems and methods that
employ dermal lavage to remove the remaining exogenous particles
from a target region of the patient's skin.
Systems
[0031] One aspect of the present disclosure can include a system
for removing exogenous particles (e.g., ink particles from a tattoo
or residual ink particles in a patient's skin after a tattoo
removal process) from a target region of the skin of the patient.
The system can utilize dermal lavage to remove the exogenous
particles. In some instances, a fluid conduit (e.g., a perforated
conduit, one or more microneedles, one or more coring needles, or
the like) can be inserted into or around the target region to
define an irrigation area. An irrigation fluid can be injected into
the irrigation area via the fluid conduit. A device (e.g., a
channel formation device) can be configured to form one or more
channels in the irrigation area so that the exogenous particles are
removable from the irrigation area (e.g., via suction or passive
diffusion) along with the irrigation fluid.
[0032] FIG. 1 illustrates one example of a system 10 for removing
exogenous particles from a target region of the skin of a patient.
In some instances, before removing the exogenous particles from the
skin, one or more layers of the skin (e.g., the epidermis) can be
removed to facilitate removal of the exogenous particles. For
example, a suction blister can be created to remove one or more
layers of skin. In another example, a fractional laser (e.g., an
ablative laser, such as an erbium ablative laser or a CO.sub.2
ablative laser) can be used to remove one or more layers of skin.
The layers of skin can be removed without scarring (e.g., by use of
coring needles or a laser) to improve conventional tattoo removal
(e.g., 10% ablation can lead to 10% of the skin/tattoo being
removed).
[0033] The system 10 can include a fluid source 12, a fluid conduit
14, and a channel formation device 16. Further, as described below,
the system 10 can additionally or optionally include one or more
pressure devices (not shown) or device(s) (not shown) for imparting
a mechanical force on the skin surface. Such pressure devices
and/or devices for imparting a mechanical force on the skin surface
can be integrated with, operably coupled to, or entirely separate
from the fluid source 12, the fluid conduit 14, and/or the channel
formation device 16.
[0034] As an example, at least a portion of the system 10 can be
integrated within a wearable device for removal of the exogenous
particles. In the simplest example, the fluid conduit 14 can be one
or more hypodermic needles that inject the irrigation fluid from
the fluid source 12 into the irrigation area of the patient. The
wearable device, which can include the channel formation device 16
(e.g., a laser, one or more needles, one or more microneedles, a
coring needle, one or more rolling needles, or the like), can be
placed over the irrigation area for a time period to facilitate the
removal of the irrigation fluid and the exogenous particles from
the irrigation area. In this example, an external negative pressure
can be created in a passive manner, such as by movement of the
patient's body, which can facilitate the removal of the irrigation
fluid and the exogenous particles. The wearable device can also
include a reservoir or absorbent material to store the fluid and
the exogenous particles removed from the patient's skin. As another
example, the wearable device can also include an active pressure
source and an accompanying battery. In a further example, the
wearable device can include the fluid conduit 14 and the fluid
source 12 as a plurality of dissolvable needles (e.g.,
carbodymethyl cellulose) arranged in an array, each composed of
(e.g., filled with) a bolus of irrigation fluid. As the dissolvable
needles dissolve, the irrigation fluid can be transported to the
irrigation area. In addition to these examples, the wearable device
may include additional components. Additionally, it will be noted
that the suction can be more effective the longer the alternating
pressure, such as positive and negative pressure, suction or
pressure is applied (e.g., the suction or pressure being applied
for 0, 2, 4, 6, 8, 12, or 24 hours or more would be increasingly
more effective).
[0035] FIG. 2A shows an example of a wearable device to aid in the
lavage of the tattoo ink. The device is held tightly to the skin
with an adhesive patch. Small conduits (fluid conduit 14) can enter
the skin and pressurized fluid could pass through them. The center
chamber (channel formation device 16) allows alternating suction
(o) and pressure (x) (shown in FIG. 2B) to flow such that when
suction is on, the skin is pulled into the chamber and small
conduits pierces the skin and allows suction (o) within the skin to
occur, simultaneously causing fluid flow through. After a time,
pressure (+) is forced into the chamber and pushes down on to the
skin causing movement of the ink particles and flow through the
conduits stops. This cycle continues in an alternating pattern.
Suction and pressure times could be equal or suction time could be
longer then pressure time.
[0036] Referring again to FIG. 1, the fluid source 12 can supply an
irrigation fluid to the fluid conduit 14, which can be operatively
coupled to the fluid source. The irrigation fluid can be a bolus of
liquid (e.g., in the range of about 10-50 mL), which is injected
through the fluid conduit 14 (e.g., a needle, catheter, or cannula)
to the target area to be irrigated. In one example, the fluid
source 12 can be a reservoir for the irrigation fluid (e.g., an IV
bag). In some instances, the irrigation fluid can be a
biocompatible fluid, such as saline, sterile water, or the like. In
other instances, the exogenous fluid can include an enzyme, natural
compound, and/or a pharmaceutical agent. The enzyme or
pharmaceutical agent can at least one of lyse cells, make the skin
more porous (e.g., by breaking up the tight connections between
collagen fibers in the dermis), prevent or inhibit phagocytosis, or
otherwise facilitate removal of the irrigation fluid. Examples of
enzymes or pharmaceutical agents that can be within the irrigation
fluid include hyuronidase, collegenase, phospholipase, cantherone,
colchicine, podophylin, hyaluronic acid, pederine, and sucrose.
Examples of a natural compound (e.g., a venom or poison) that can
be included in the irrigation fluid include natural or diluted
forms of venoms, such as spider, snake, beetle, or bee. In other
instances, the enzyme or other chemical agent can be injected
before or after the exogenous fluid. For example, the target area
can undergo a pre-treatment with histamine, lipase, and/or
phospholipase, causing the target area to undergo an inflammatory
reaction, which can induce edema and endogenous fluid
collection/flow to improve draining of the exogenous particles.
[0037] In other instances, the fluid can be an endogenous fluid
(e.g., derived or obtained from the patient's body). For example,
the endogenous fluid can come from local dermal edema. The patient
can be injected with a drug, such as a histamine, that is known to
cause local dermal edema in the target region of the skin. The
fluid can leave the target region through holes or channels formed
by the channel formation device 16, thereby removing the edema and,
in the process, washing out the exogenous particles.
[0038] In one example, the exogenous particles can include ink
particles from a tattoo. In another example, the exogenous
particles can be residual tattoo ink particles formed as a result
of a tattoo removal process. In either example, the dermal lavage
can inject an irrigation fluid into an irrigation area (e.g., an
area including at least a portion of the residual tattoo ink) so
that the fluid and the residual tattoo ink particles are removed
from the skin via one or more holes or channels formed in the
target area of the skin by the channel formation device 16.
[0039] The fluid conduit 14 can be inserted into a subject's skin
in the proximity of the target area. In some instances, the fluid
conduit 14 can be inserted around the target area. In other
instances, the fluid conduit 14 can be inserted into the target
area. The irrigation area can be defined by the injected irrigation
fluid , which can be from the fluid source 12.
[0040] At least a portion of the exogenous particles in the
irrigation area can be suspended in the irrigation fluid as a
result. In one example, at least 50% of the exogenous particles in
the irrigation area can be suspended in the irrigation fluid. In
another example, at least 75% of the exogenous particles in the
irrigation area can be suspended in the irrigation fluid. In yet
another example, 100% of the exogenous particles in the irrigation
area can be suspended in the irrigation fluid.
[0041] The channel formation device 16 can be configured to create
one or more holes or channels that extend through a portion of the
irrigation area. In some instances, the channel formation device 16
can include one or more microneedles. In other instances, the
channel formation device 16 can include a laser or an array of a
plurality of lasers. In further instances, the channel formation
device 16 can be a tattoo gun without any ink ("reverse
tattooing"). In one example, the channel formation device 16 is
configured to form one or more holes or channels, each of which
extends through the epidermis into the dermis. Holes or channels
formed by the channel formation device 16 can each have a hydraulic
diameter of about 10 mm or less, about 5 mm or less, or about 1 mm
or less. In some instances, holes or channels formed by the channel
formation device 16 can be microchannels (e.g., having a diameter
of at least about 500 .quadrature.m). In other instances, an
anti-clotting drug, like heparin, aspirin, an NSAID, or other
anticoagulant can be used to prevent the closure of the holes or
channels formed by the channel formation device 16.
[0042] Irrigation fluid, in some instances containing a
pharmaceutical agent and/or an enzyme, can be injected into the
skin and flow into the one or more holes or channels and then exit
the skin with the suspended exogenous particles. In some instances,
fluid flow through the holes(s) or channel(s) happens automatically
when the hole(s) or channel(s) is/are created in the skin. In other
instances, fluid flow occurs upon application of an external
stimulus to the target area (e.g., pressure on the surface of the
skin by a gloved finger of a medical professional). In still other
instances, fluid flow occurs upon application of suction or
negative pressure (e.g., from a suction device, such as a breast
pump, a wound vacuum, or the like) to the target region. Prior to
applying suction, a mechanical force (e.g., a vibration or shock
wave) can be applied to the target region to break up attachment of
the exogenous particles from the surrounding tissue and make the
particles more mobile. As an example, a vibrator can be used as a
tool to loosen the exogenous particles. Alternatively, the
mechanical force(s) can be applied to the target region following
laser therapy (but before formation of the holes or channels)
and/or at any point prior to applying suction to the target
region.
[0043] Suction can be applied continuously or intermittently.
Alternatively, suction can be applied in a cyclic manner along with
positive pressure to generate a massaging action on the skin and
thereby facilitate migration of the exogenous particles to the skin
surface. In some instances, the intensity of the suction can be
changed over time and thus be applied as a gradient of increasing
or decreasing negative pressure.
[0044] In some instances, fluid flow can remove about 25% or more
of the exogenous particles from the irrigation area, about 50% or
more of the exogenous particles from the irrigation area, or about
75% or more of the exogenous particles from the irrigation
area.
Methods
[0045] Another aspect of the present disclosure can include a
method 20 (FIG. 3) for removing exogenous particles (e.g., a
tattoo, residual ink particles in a patient's skin, or the like)
from a target region of a patient's skin. The method 20 of FIG. 3
is illustrated as a process flow diagram. For purposes of
simplicity, the method 20 is shown and described as being executed
serially; however, it is to be understood and appreciated that the
present disclosure is not limited by the illustrated order as some
steps could occur in different orders and/or concurrently with
other steps shown and described herein. Moreover, not all
illustrated aspects may be required to implement the method 20. The
method 20 will be explained with regard to FIGS. 4-6, which
illustrate the removal of exogenous particles from a target region
of a patient's skin (e.g., using the system 10 described
above).
[0046] FIG. 4 is a schematic illustration 30 showing exogenous
particles 38 located under the surface of a patient's skin 32. The
exogenous particles 38 can include residual tattoo ink particles
that remain in the patient's skin after a tattoo removal process
(e.g., a Q-switched laser tattoo removal procedure, a picosecond
laser tattoo removal procedure, or the like). For example, the
exogenous particles 38 can be located in the dermis 36 within a
target area 39. In this case, the target area 39 can be defined as
an area within the dermis 36 that includes a majority of the
exogenous particles 38. For example, the target area 39 can include
about 50% or more of the exogenous particles 38, about 75% or more
of the exogenous particles, or about 100% of the exogenous
particles (e.g., at least about 98% or more). In some instances,
before removing the exogenous particles from the skin, one or more
layers of the skin (e.g., the epidermis 34) can be removed to
facilitate removal of the exogenous particles (as discussed
above).
[0047] At Step 22, a fluid conduit 14 (FIG. 5) can be inserted into
a portion of a patient's skin. The fluid conduit 14 can be
operatively coupled to the fluid source 12 and then inserted
through the dermis 36 of the patient's skin 32 to define the
irrigation area. As shown in FIG. 5, the fluid conduit 14 can be a
tube-like structure (e.g., made of a biocompatible polymer) and/or
one or more needles (e.g., microneedles, coring needles, or the
like), which can inject the irrigation fluid into the target area.
Although a single fluid conduit 14 is illustrated, it will be
appreciated that a plurality of fluid conduits can be placed to
inject the irrigation fluid that defines the irrigation area. It
will also be appreciated that multiple fluid sources 12 can be used
to deliver fluid to the irrigation area.
[0048] Next, at step 24, the irrigation fluid can be injected
through the fluid conduit 14 to irrigate the irrigation area. For
example, a bolus of the irrigation fluid (e.g., in the range of
about 10-50 mL) can be flowed from a fluid source 12, through the
fluid conduit 14, and into the target region. In some instances,
the exogenous fluid can include an enzyme or a pharmaceutical agent
(e.g., hyuronidase, collegenase, phospholipase, cantheradin,
cochicine, sucrose, or any other type of enzyme or pharmaceutical
agent that can lyse cells, inhibit phagocytosis, keep the exogenous
particles free for as long as possible, or the like) or other
chemical agent capable of breaking up the tight connections between
collagen fibers in the dermis, thereby allowing the irrigation
fluid and the exogenous particles to more easily flow out of
dermis. In some instances, the enzyme or pharmaceutical agent can
be a part of the irrigation fluid. However, in other instances, the
enzyme or other chemical agent can be injected before or after the
irrigation fluid.
[0049] In other instances, the irrigation fluid can be an
endogenous fluid. For example, the endogenous fluid can come from
local dermal edema. The patient can be injected with a drug, such
as a histamine that is known to cause local dermal edema in the
target region of the skin. The fluid can leave the target region
through holes or channels formed by the channel formation device
16, thereby removing the edema and, in the process, washing out the
exogenous particles.
[0050] As shown in FIG. 5, the irrigation fluid exits fluid conduit
14 to irrigate the irrigation area (Step 26). As a result,
exogenous particles 38 located in the irrigation area are suspended
in the irrigation fluid.
[0051] At Step 26, the irrigation fluid is removed from the
irrigation area through holes or channels formed in the portion of
the patient's skin. As shown in FIG. 6A, a plurality of channels
62-68 (e.g., that enter the dermis 36 through the epidermis 34) can
be created within the irrigation area by the channel formation
device 16 using, for example, one or more microneedles, one or more
coring needles, and/or one or more lasers. In further instances,
the channel formation device 16 can be a tattoo gun without any
ink. Although four channels 62-68 are illustrated, any number of
one or more channels can be created. Additionally, although the
channels 62-68 are illustrated as being rectangular, other shapes
can be used to perform the same function (e.g., triangular,
rounded, square, or the like). Moreover, the channels 62-68 can be
separate channels (as illustrated) or at least partially connected
or overlapping. The channels 62-68 can be created while the
irrigation area is being irrigated. However, it will be appreciated
that the channels 62-68 can be created either before the irrigation
or after the irrigation. In other instances, an anti-clotting drug,
like heparin, aspirin, an NSAID, or other anticoagulant can be used
to prevent the closure of the channels formed by the channel
formation device 16.
[0052] In some instances, the fluid can be removed automatically.
In other instances, the fluid requires a catalyst for removal, such
as pressure on the patient's skin 32 by a gloved finger of a
medical professional or a device that introduces suction. In some
instances, about 25% or more of the exogenous particles can be
removed along with the fluid. In other instances, about 50% or more
of the exogenous particles can be removed along with the fluid. In
still other instances, about 75% or more of the exogenous particles
can be removed along with the fluid.
[0053] In some instances, fluid flow into the channel(s) happens
automatically when the channel(s) is/are created in the skin. In
other instances, fluid flow occurs upon application of an external
stimulus to the target area (e.g., pressure on the surface of the
skin by a gloved finger of a medical professional). In still other
instances, fluid flow occurs upon application of suction, positive
pressure (+), negative pressure (-), or a combination thereof
(e.g., from a suction device, such as a breast pump, a wound
vacuum, or the like) to the target region. As one example,
different pressure patterns can be applied, like -+-, ---+---+---+,
or the like). As another example, pressure (+) and suction (o) can
be applied as shown and described with respect to FIG. 2B. As a
further example, shown in FIGS. 6A and 6B, the pressure (+) and
suction (o) can be applied together through alternating
conduits.
[0054] Prior to applying suction, a mechanical force (e.g., a
vibration or shock wave) can be applied to the target region to
break up attachment of the exogenous particles from the surrounding
tissue and make the particles more mobile. Alternatively, the
mechanical force(s) can be applied to the target region following
laser therapy (but before formation of the channels) and/or at any
point prior to applying suction to the target region.
[0055] Suction can be applied continuously or intermittently.
Alternatively, suction can be applied in a cyclic manner along with
positive pressure to generate a massaging action on the skin and
thereby facilitate migration of the exogenous particles to the skin
surface. In some instances, the intensity of the suction can be
changed over time and thus be applied as a gradient of increasing
or decreasing negative pressure.
[0056] The dermal lavage provided by the method 20 facilitates
removal of exogenous particles 38 from the patient's skin 32. For
example, the dermal lavage provides a more effective treatment for
tattoo removal by reducing the number of laser therapies required
to remove the tattoo. This is accomplished by removing the
exogenous particles 38 before and/or after they are engulfed by
macrophages or other phagocytes in the patient's skin 32.
Consequently, any residual tattoo particles remaining after laser
therapy are less visible and/or invisible.
[0057] From the above description, those skilled in the art will
perceive improvements, changes and modifications. Such
improvements, changes and modifications are within the skill of one
in the art and are intended to be covered by the appended
claims.
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