U.S. patent application number 17/577873 was filed with the patent office on 2022-05-05 for cerumen removal apparatus.
The applicant listed for this patent is EARWAYS MEDICAL LTD.. Invention is credited to Miri FAHN, Amir KRAITZER.
Application Number | 20220133543 17/577873 |
Document ID | / |
Family ID | 1000006090646 |
Filed Date | 2022-05-05 |
United States Patent
Application |
20220133543 |
Kind Code |
A1 |
FAHN; Miri ; et al. |
May 5, 2022 |
CERUMEN REMOVAL APPARATUS
Abstract
A cerumen removal apparatus for removing cerumen from an ear
canal. The apparatus includes a body having a distal end and a
proximal end interconnected by a main longitudinal axis; said
distal end including a hollow collector head having at least one
spiral vane or ridge projecting radially inward from an inner
surface thereof and enclosing a lumen ending with an opening opened
to said lumen for amassing said cerumen in said lumen via said
opening; wherein said at least one spiral vane or ridge is adapted
to guide the cerumen in a proximal direction into said hollow
collector head when said hollow collector head rotates in the ear
canal.
Inventors: |
FAHN; Miri; (Tel-Aviv,
IL) ; KRAITZER; Amir; (Herzelia, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EARWAYS MEDICAL LTD. |
ROSH HA'AYIN |
|
IL |
|
|
Family ID: |
1000006090646 |
Appl. No.: |
17/577873 |
Filed: |
January 18, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16174908 |
Oct 30, 2018 |
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17577873 |
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14408000 |
Dec 15, 2014 |
10154927 |
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PCT/IL2013/050511 |
Jun 13, 2013 |
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16174908 |
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61659523 |
Jun 14, 2012 |
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Current U.S.
Class: |
606/162 |
Current CPC
Class: |
A61F 11/006
20130101 |
International
Class: |
A61F 11/00 20060101
A61F011/00 |
Claims
1-168. (canceled)
169. A cerumen removal apparatus configured to remove cerumen from
an ear canal, the apparatus comprising a device body and a
collector head interconnected by a main longitudinal axis; wherein
said collector head is having a helical shape and is designed to
collapse under a predetermined pressure which is less than the
pressure required to push the cerumen into the ear canal, and
wherein said collector head has low resistance to bending so as to
facilitate its insertion into the inner part of the ear canal and
allow bending in all three dimensions.
170. The apparatus of claim 169, wherein said collector head is
deformable, wherein said collector head is configured to fit a size
and a shape of said ear canal when said collector head is inserted
into said ear canal.
171. The apparatus of claim 170, wherein at least a portion of said
collector head has a cross sectional diameter that fits the
diameter of the ear canal to allow rotation of said collector head
within said ear canal.
172. The apparatus of claim 169, wherein said collector head is
having a milling bit or archimedes screw-like structure.
173. The apparatus of claim 169, further comprising a flexible
section between said collector head and said device body, wherein
said flexible section is designed to enable bending in all three
dimensions.
174. The apparatus of claim 173, wherein said flexible section is
configured to change shape so as to follow a tortuosity of said ear
canal via at least one of: deformation, bending, twisting, and
rotation.
175. The apparatus of claim 173, wherein said flexible section
includes at least one of: accordion pleating, a spiral spring, a
flexible material, and a plurality of hingedly connected
segments.
178. The apparatus of claim 169, wherein said collector head is
configured to be movable along said main longitudinal axis such
that said collector head is extendable from said device body.
179. The apparatus of claim 169, further comprising a retraction
mechanism configured to enable retraction of said collector head
into said device body.
180. The apparatus of claim 169, further comprising at least one
rotating mechanism configured to rotate said collector head,
wherein rotation of said collector head causes said collector head
to amass said cerumen and to remove said cerumen from said ear
canal.
181. The apparatus of claim 169, wherein at east a portion of said
collector head comprises a deformable spring-like material
configured to apply radial forces that press said portion against
the walls of said ear canal.
182. The apparatus of claim 181, wherein said deformable
spring-like material is selected from silicone, fiber mesh,
cellulose, polyurethane, polyethylene, polyamide, polypropylene,
and any combination thereof.
183. The apparatus of claim 169, wherein said helix ends at said
distal end.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/174,908, filed Oct. 30, 2018, which is a
continuation of Ser. No. 14/408,000, filed Dec. 15, 2014, which is
a National Phase of PCT Patent Application No. PCT/IL2013/050511
having International filing date of Jun. 13, 2013, which claims the
benefit of priority of U.S. Provisional Patent Application No.
61/659,523, filed Jun. 14, 2012, the contents of which are all
incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[0002] The invention relates to ear wax removal or cerumen
impaction relief.
BACKGROUND OF THE INVENTION
[0003] Ear wax (cerumen) build-up and impaction m the external ear
canal is a common problems faced by primary care physicians such as
family practitioners, pediatricians and internists. Cerumen
impaction is the presence of obstructing masses of earwax that
block the ear canal. Cerumen accumulation can affect up to 6% of
the general population and a much higher percentage of older people
and people with cognitive impairment. In the US, cerumen
accumulation leads to 12 million patient clinic visits and 8
million cerumen removal procedures annually.
[0004] In most cases of cerumen impaction, the removal is clone by
an Ear, Nose and Throat (ENT) doctor who usually removes the
cerumen under vaccum, with a curette, or by water irrigation using
a syringe. Each approach is associated with risks and benefits.
Using a curette allows a clinician to view the procedure and safely
remove the cerumen while the lack of water lowers infection risk.
However, using a curette requires considerable skill.
[0005] Irrigation or "syringing" is a standard method of wax
removal and approximately 150,000 ears are irrigated each week in
the US. Irrigation, however, involves insertion of liquids using
high pressure that might damage the eardrum (Tympanic
membrane).
[0006] Ear care products for home use include wax softeners or
Q-tips, which have very low effectiveness and sometimes involve
safety issues. Softeners are often sufficient to treat mild cases
of impacted cerumen, as well as reducing the need to be removed by
a specialist in some cases. Wax softeners usually used to soften
the wax in the ear are baby oil, glycerin, mineral oil, glycerol,
olive oil, almond oil, hydrogen peroxide, docusate sodium (dioctyl
sodium sulphosuccinate), dichlorobenzene, and carbamide peroxide.
Hydrogen peroxide and 10% solution of sodium bicarbonate were found
as effective means of removing or softening cerumen.
[0007] Current clinical practice for removing cerumen depends
heavily on specialized clinicians such as ENT (ear, nose and
throat) doctors. Home use products such as earwax softeners do not
remove cerumen in the state of impaction but can be useful when
used in conjunction with treatment by a ENT doctor or by a general
practitioner (either by using irrigation, curette, vacuum,
etc.).
[0008] Therefore, there is a long-felt need for a means and method
for safe and mechanical removal of cerumen which can be carried out
in its entirety without a clinician. Moreover, there is a need to
simplify the procedure for general practitioners in order reduce
the costs of and burden on ENT doctors.
SUMMARY OF THE INVENTION
[0009] It is an object of the present invention to disclose an
apparatus for and method for mechanically removing impacted cerumen
from the ear.
[0010] It is another object of the present invention to disclose a
cerumen removal apparatus for mechanically removing cerumen from an
ear canal, comprising: a device body having a distal end and a
proximal end interconnected by a main longitudinal axis; said
distal end comprising at least one collector head for amassing said
cerumen; said proximal end comprising at least one rotating
mechanism adapted to rotate said at least one collector head;
wherein said rotation of said collector head amasses said cerumen
and removes said cerumen from said ear canal.
[0011] It is another object of the present invention to disclose
the apparatus as defined above, wherein said device body comprises
at least one reservoir, in fluid communication with said at least
one collector head, said reservoir containing cerumen softening
liquid, adapted to dispense said cerumen softening liquid within
said ear canal.
[0012] It is another object of the present invention to disclose
the apparatus as defined above, wherein said reservoir is allocated
within at least one selected from a group consisting of said
collector head, said device body, a fluidly connected container
emplaced above the level of the ear canal and any combination
thereof.
[0013] It is another object of the present invention to disclose
the apparatus as defined above, wherein said amassing occurs
simultaneously with the dispensing of said softening liquid.
[0014] It is another object of the present invention to disclose
the apparatus as defined above, wherein said amassing occurs after
said liquid is dispensed.
[0015] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
adapted to be movable along said main longitudinal axis, such that
said collector head is extendable from said device body.
[0016] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
adapted to be reversibly movable along said main longitudinal axis,
such that said collector head is extendable from said device body
and retractable into said device body.
[0017] It is another object of the present invention to disclose
the apparatus as defined above, wherein said apparatus is removable
from said ear canal in a configuration selected from a group
consisting of: with said collector head at least partially extended
from said device body, and with said collector head retracted into
said device body.
[0018] It is another object of the present invention to disclose
the apparatus as defined above, additionally comprising a
retraction mechanism adapted to enable retraction of said collector
head into said device body.
[0019] It is another object of the present invention to disclose
the apparatus as defined above, wherein said retraction mechanism
is connected to at least one of a group consisting of said rotating
mechanism and said device body via a means selected from a group
consisting of a pullable cable, a pullable wire, a rotatable cable,
a collapsible shaft, a rotatable shaft, a direct coupling and any
combination thereof.
[0020] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
connected to said rotating mechanism via a means selected from a
group consisting of a cable, a wire, a shaft, a direct coupling and
any combination thereof.
[0021] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shaft is adapted to
change shape in a manner selected from a group consisting of
deform, bend, twist, rotate and any combination thereof so as to
follow the tortuosity of said ear canal.
[0022] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shaft comprises a
flexible section, said flexible section comprising at least one of
a group consisting of accordion pleating, a spiral spring, flexible
material, a plurality of hingedly connected segments and any
combination thereof.
[0023] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
adapted to change shape in a manner selected from a group
consisting of deform, bend, twist, rotate and any combination
thereof so as to follow the tortuosity of said ear canal.
[0024] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises a flexible section, said flexible section comprising at
least one of a group consisting of accordion pleating, a spiral
spring, flexible material, a plurality of hingedly connected
segments and any combination thereof.
[0025] It is another object of the present invention to disclose
the apparatus as defined above, wherein said accordion pleating is
arranged in a manner selected from a group consisting of a
plurality of substantially straight, substantially parallel rows, a
spiral, and any combination thereof.
[0026] It is another object of the present invention to disclose
the apparatus as defined above, wherein each said hinged connection
is adapted to enable bending of said shaft in at least one
direction, thereby enabling said shaft to follow the tortuosity of
said ear canal.
[0027] It is another object of the present invention to disclose
the apparatus as defined above, wherein said hinged connection is
selected from a member of a group consisting of a segment comprised
of thinner material, a segment comprised of a material of greater
flexibility than the connected segments, and any combination
thereof.
[0028] It is another object of the present invention to disclose
the apparatus as defined above, wherein rotational force is applied
to said collector head by said rotating mechanism.
[0029] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises an Archimedes screw.
[0030] It is another object of the present invention to disclose
the apparatus as defined above, wherein the distal end of said
Archimedes screw comprises at least one aperture; said aperture
fluidly connected to said reservoir, said aperture adapted to
enable fluid to flow from said reservoir into said ear canal.
[0031] It is another object of the present invention to disclose
the apparatus as defined above, wherein said Archimedes screw is
comprised of soft material, such that said Archimedes screw can
deform to follow the tortuosity of said ear canal.
[0032] It is another object of the present invention to disclose
the apparatus as defined above, wherein said soft material is
selected from a group consisting of silicone, fiber mesh,
cellulose, polyurethane, polyethylene, polyamide, polypropylene,
and any combination thereof.
[0033] It is another object of the present invention to disclose
the apparatus as defined above, wherein said Archimedes screw
comprises a plurality of hingedly connected segments, such that
said Archimedes screw can deform to follow the tortuosity of said
ear canal.
[0034] It is another object of the present invention to disclose
the apparatus as defined above, wherein said Archimedes screw
comprises a plurality of segments, said segments connected via a
hingedly connected shaft, such that said Archimedes screw can
deform to follow the tortuosity of said ear canal.
[0035] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises a milling bit; said milling bit comprising a proximal end
and a distal end, wherein said proximal end is substantially
cylindrical and said distal end is shaped substantially as the
frustum of a cone; said distal end and at least a portion of said
proximal end being characterized by at least one spiral groove.
[0036] It is another object of the present invention to disclose
the apparatus as defined above, wherein said distal end of said
milling bit comprises at least one aperture in fluid connection
with said reservoir, said aperture adapted to enable fluid to flow
from said reservoir into said ear canal.
[0037] It is another object of the present invention to disclose
the apparatus as defined above, wherein said milling bit is
comprised of soft material, such that said milling bit can deform
to follow the tortuosity of said ear canal.
[0038] It is another object of the present invention to disclose
the apparatus as defined above, wherein said soft material is
selected from a group consisting of silicone, fiber mesh,
cellulose, polyurethane, polyethylene, polyamide, polypropylene,
and any combination thereof.
[0039] wherein said milling bit comprises a plurality of hingedly
connected segments, such that said milling bit can deform to follow
the tortuosity of said ear canal.
[0040] It is another object of the present invention to disclose
the apparatus as defined above, wherein said milling bit comprises
a plurality of segments, said segments connected via a hingedly
connected shaft, such that said milling bit can deform to follow
the tortuosity of said ear canal.
[0041] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises a plurality of fibers braided into a form which, at least
when fully extended, resembles a basket, said collector is
characterized by a proximal end and a distal end, said proximal end
comprising a shaft, said distal end comprising said braided basket;
said braided basket is characterized by at least two positions, a
retracted position wherein said braided basket is substantially
contained within said shaft and an extended position wherein at
least a portion of said braided basket extends beyond the distal
end of said shaft.
[0042] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shaft is fluidly
connected to said reservoir.
[0043] It is another object of the present invention to disclose
the apparatus as defined above, wherein said braided basket is
reversibly transformable between said retracted position and said
extended position.
[0044] It is another object of the present invention to disclose
the apparatus as defined above, wherein said rotation of said
rotating mechanism reversibly transforms said braided basket from
said retracted position to said extended position.
[0045] It is another object of the present invention to disclose
the apparatus as defined above, wherein retraction of said braided
basket into said shaft occurs either before or during removal of
said apparatus from said ear canal.
[0046] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shaft is at least
partially an open bore shaft.
[0047] It is another object of the present invention to disclose
the apparatus as defined above, wherein said braided basket is
comprised of at least one elastic fiber.
[0048] wherein said at least one elastic fiber is made of a
material selected from a group consisting of steel,
nickel-titanium, beta-titanium, plastic and any combination
thereof.
[0049] It is another object of the present invention to disclose
the apparatus as defined above, wherein said elastic fiber
comprises at least one filament.
[0050] It is another object of the present invention to disclose
the apparatus as defined above, wherein said elastic fiber
comprises at least one selected from a group consisting of fibers
wound without a core, fibers wound around a core, braided fibers
and any combination thereof.
[0051] It is another object of the present invention to disclose
the apparatus as defined above, wherein at least one of said at
least one elastic fiber is coated.
[0052] It is another object of the present invention to disclose
the apparatus as defined above, wherein said coating is comprised
of at least one selected from a group consisting of metal, plastic,
Teflon, natural fibers, polyester, rayon, nylon, woven material,
non-woven material and any combination thereof.
[0053] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises a sponge.
[0054] It is another object of the present invention to disclose
the apparatus as defined above, wherein said sponge is fluidly
connected to said reservoir, said sponge is adapted to allow fluid
selected from cerumen softening fluid, softened cerumen and any
combination thereof to pass therethrough.
[0055] It is another object of the present invention to disclose
the apparatus as defined above, wherein the shape of said sponge is
selected from a group consisting of substantially cylindrical in
shape, substantially shaped as a frustum of a cone, substantially
conic, and any combination thereof.
[0056] It is another object of the present invention to disclose
the apparatus as defined above, wherein said sponge is comprised of
at least one selected from a group consisting of cellulose,
polyurethane, polyethylene, polyamide, polypropylene and any
combination thereof.
[0057] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head
comprises a thin foil, said collector head further comprises a
proximal end and a distal end, said proximal end comprising a shaft
and said distal end comprising said thin foil.
[0058] It is another object of the present invention to disclose
the apparatus as defined above, wherein said thin foil is formed
into the shape of the frustum of a cone.
[0059] It is another object of the present invention to disclose
the apparatus as defined above, wherein the cone comprises at least
one longitudinal slit such that said foil comprises at least two
longitudinal free edges.
[0060] It is another object of the present invention to disclose
the apparatus as defined above, wherein said thin foil has a
thickness between approximately 0.05 mm thick and approximately 0.5
mm thick.
[0061] It is another object of the present invention to disclose
the apparatus as defined above, wherein the material of which said
foil is comprised is selected from a group consisting of:
polyimide, polyvinyl chloride (PVC), Polyethylene (PE),
polypropylene (PP), Polyether ether ketone (PEEK), laminates of
thermoplastic elastomers, thermoplastic plastics and any
combination thereof.
[0062] It is another object of the present invention to disclose
the apparatus as defined above, wherein at least one of said distal
end of said foil and the proximal end of said foil further
comprises a ring, said ring adapted to plastically deform such that
said ring retains its deformed shape at such time as said apparatus
is removed from said ear.
[0063] It is another object of the present invention to disclose
the apparatus as defined above, wherein the material of which said
ring is comprised is selected from a group consisting of:
polyimide, polyvinyl chloride (PVC), Polyethylene (PE),
polypropylene (PP), Polyether ether ketone (PEEK), laminates of
thermoplastic elastomers, thermoplastic plastics, metal and any
combination thereof.
[0064] It is another object of the present invention to disclose
the apparatus as defined above, wherein said foil is stiffened with
at least one strut, said at least one strut extending in at least
one direction selected from a group consisting of: longitudinally
along said foil, transversely around said foil, and spirally along
said foil.
[0065] wherein the material of which said at least one strut is
comprised is selected from a group consisting of: polyimide,
polyvinyl chloride (PVC), PEEK, PE, PP, Polyamid, laminates of
thermoplastic elastomers, thermoplastic plastics, metal and any
combination thereof.
[0066] It is another object of the present invention to disclose
the apparatus as defined above, wherein said foil additionally
comprises interior face collection/guidance means selected from a
group consisting of protrusions, vanes, ridges, and any combination
thereof, said guidance means adapted to collect said cerumen and
guide said cerumen towards the proximal end of said collector
head.
[0067] It is another object of the present invention to disclose
the apparatus as defined above, wherein minimum height of said
collection/guidance means is at its distal end.
[0068] It is another object of the present invention to disclose
the apparatus as defined above, wherein maximum height of said
collection/guidance means is substantially at its proximal end.
[0069] It is another object of the present invention to disclose
the apparatus as defined above, wherein the material of which said
collection/guidance means is comprised is selected from a group
consisting of: the foil itself, polyimide, polyvinyl chloride
(PVC), PEEK, PE, PP, Polyamid, laminates of thermoplastic
elastomers, thermoplastic plastics, metal and any combination
thereof.
[0070] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
formed substantially as a scoop, said scoop having a transverse
cross section shaped substantially as a segment of a circle.
[0071] It is another object of the present invention to disclose
the apparatus as defined above, wherein said segment of a circle is
approximately semicircular.
[0072] It is another object of the present invention to disclose
the apparatus as defined above, wherein said scoop is connected to
said device body by a shaft
[0073] It is another object of the present invention to disclose
the apparatus as defined above, wherein said scoop is fluidly
connected to said device body.
[0074] It is another object of the present invention to disclose
the apparatus as defined above, wherein said scoop comprises on its
interior face collection/guidance means selected from a group
consisting of vanes, ridges, and any combination thereof, said
collection/guidance means adapted to collect said cerumen and guide
it towards the proximal end of said collector head.
[0075] It is another object of the present invention to disclose
the apparatus as defined above, wherein minimum height of said
collection/guidance means is at its distal end.
[0076] It is another object of the present invention to disclose
the apparatus as defined above, wherein maximum height of said
collection/guidance means is substantially at its proximal end.
[0077] It is another object of the present invention to disclose
the apparatus as defined above, wherein said collector head is
formed substantially as a shovel, said shovel having a transverse
cross section shaped substantially as a U.
[0078] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shovel is connected to
said device body by a shaft.
[0079] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shovel is fluidly
connected to said device body.
[0080] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shovel comprises on
its interior face collection/guidance means selected from a group
consisting of vanes, ridges, and any combination thereof, said
collection/guidance means adapted to guide said cerumen towards the
proximal end of said collector head.
[0081] It is another object of the present invention to disclose
the apparatus as defined above, wherein minimum height of said
collection/guidance means is at its distal end.
[0082] It is another object of the present invention to disclose
the apparatus as defined above, wherein maximum height of said
collection/guidance means is substantially at its proximal end.
[0083] It is another object of the present invention to disclose
the apparatus as defined above, wherein said apparatus is
implantable into said ear canal manually or automatically.
[0084] It is another object of the present invention to disclose
the apparatus as defined above, wherein at least a part of said
apparatus is enclosed within a shell.
[0085] It is another object of the present invention to disclose
the apparatus as defined above, wherein said shell is adapted to be
biodegradable, and further wherein said shell is adapted to
biodegrade prior to amassing cerumen to said apparatus.
[0086] It is another object of the present invention to disclose
the apparatus as defined above, wherein said biodegradable shell is
comprised of at least one selected from a group consisting of:
biodegradable polythene, beeswax, biodegradable polyethylene,
biodegradable polypropylene, poly(lactic-co-glycolic acid) (plga),
Poly-L-Lactides (plla), Polyglycolide (pga), Poly
Lactic-co-Glycolic Acid (PLGA) and any combination thereof.
[0087] It is another object of the present invention to disclose
the apparatus as defined above, wherein said softening liquid is
selected from a group consisting of baby oil, glycerin, mineral
oil, glycerol, olive oil, almond oil, hydrogen peroxide, docusate
sodium (dioctyl sodium sulphosuccinate), dichlorobenzene, and
carbamide peroxide, Hydrogen peroxide, solution of sodium
bicarbonate, commercial earwax removal liquid, and any combination
thereof.
[0088] It is another object of the present invention to disclose
the apparatus as defined above, wherein the longitudinal section of
said collector head comprises a cylinder; the longitudinal section
of the collector head comprises a frustum of a cone.
[0089] It is another object of the present invention to disclose
the apparatus as defined above, wherein rotation of the knob is
adapted to enable collection of said cerumen in a manner selected
from a group consisting of: collecting said cerumen without
dispensing softening liquid; dispensing said softening liquid
followed by collection of said cerumen; dispensing said softening
liquid and collecting said cerumen simultaneously; and any
combination thereof.
[0090] It is another object of the present invention to disclose
the apparatus as defined above, wherein said rotating mechanism
comprises a decoupling mechanism such that rotation of said
rotating mechanism extends the collector head no more than a
predetermined amount.
[0091] It is another object of the present invention to disclose
the apparatus as defined above, wherein, in the device's undeformed
configuration, the main longitudinal axis of said spiral spring is
substantially collinear with the main longitudinal axis of said
collector head.
[0092] wherein at least a portion of said collector head is
comprised of elastic spring-like material adapted to apply radial
forces that press said portion of said collector head against the
walls of said ear canal.
[0093] It is another object of the present invention to disclose a
method for mechanically removing cerumen from an ear canal,
comprising: [0094] a. providing a cerumen removal apparatus for
mechanically removing cerumen from the ear canal, comprising: a
device body having a distal end and a proximal end interconnected
by a main longitudinal axis; said distal end comprising at least
one collector head for amassing said cerumen; said proximal end
comprises at least one rotating mechanism to rotate said at least
one collector head; [0095] b. emplacing said cerumen removal
apparatus in said ear canal; [0096] c. rotating said rotating
mechanism, thereby amassing said cerumen; thereby removing said
cerumen from said ear canal.
[0097] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing at least one reservoir, in fluid communication with said
at least one collector head, said reservoir containing cerumen
softening liquid, said reservoir is for dispensing said cerumen
softening liquid within said ear canal.
[0098] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
dispensing said cerumen softening liquid within said ear canal.
[0099] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
allocating said reservoir within a member of a group consisting of
said collector head, said device body, a fluidly connected
container emplaced above the level of the ear canal and any
combination thereof.
[0100] It is another object of the present invention to disclose
the method as defined above, wherein said step of amassing occurs
simultaneously with the dispensing of said softening liquid.
[0101] It is another object of the present invention to disclose
the method as defined above, wherein said step of amassing occurs
after said liquid is dispensed.
[0102] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
moving said collector head along said mam longitudinal axis,
thereby extending said collector head from said device body.
[0103] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
reversibly moving said collector head along said main longitudinal
axis, thereby extending said collector head from said device body
and retracting said collector head into said device body.
[0104] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
removing said apparatus from said ear canal in a configuration
selected from a group consisting of: with said collector head at
least partially extended from said device body, and with said
collector head retracted into said device body.
[0105] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
retracting said collector head into said device body by using a
retraction mechanism.
[0106] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
connecting said retraction mechanism to at least one of a group
consisting of said rotating mechanism and said device body via a
means selected from a group consisting of a pullable cable, a
pullable wire, a rotatable wire, a collapsible shaft, a rotatable
shaft, a direct coupling and any combination thereof.
[0107] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
connecting said collector head to said rotating mechanism via a
means selected from a group consisting of a cable, a wire, a shaft,
a direct coupling and any combination thereof.
[0108] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
reorienting at least a portion of said shaft by at least one
selected from a group consisting of deforming said at least a
portion of said shaft, bending said at least a portion of said
shaft, twisting said at least a portion of said shaft, rotating
said at least a portion of said shaft and any combination thereof
so as to follow the tortuosity of said ear canal.
[0109] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said shaft of a flexible section, said flexible section
comprising at least one of a group consisting of accordion
pleating, a spiral spring, flexible material, a plurality of
hingedly connected segments and any combination thereof.
[0110] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
reorienting at least a portion of said collector head by at least
one selected from a group consisting of deforming said at least a
portion of said collector head, bending said at least a portion of
said collector head, twisting said at least a portion of said
collector head, rotating said at least a portion of said collector
head and any combination thereof so as to follow the tortuosity of
said ear canal.
[0111] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said collector head with a flexible section, said
flexible section comprising at least one of a group consisting of
accordion pleating, a spiral spring, a flexible material, a
plurality of hingedly connected segments and any combination
thereof.
[0112] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
disposing said accordion pleating in a manner selected from a group
consisting of substantially straight, substantially parallel rows,
a spiral, and any combination thereof.
[0113] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
connecting said hingedly connected segments via a hinge, each said
hinge bending said shaft in at least one direction, said shaft
thereby following the tortuosity of said ear canal.
[0114] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said hinged connection of a member selected from a group
consisting of a segment comprised of thinner material, a segment
comprised of a material of greater flexibility than the connected
segments, and any combination thereof.
[0115] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
applying rotational force to the collector head by said rotating
mechanism.
[0116] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said collector head comprising an Archimedes screw.
[0117] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising the distal end of said Archimedes screw of at least one
aperture; said aperture fluidly connected to said reservoir such
that fluid can flow from said reservoir into said ear canal via
said aperture.
[0118] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said Archimedes screw of soft material, said Archimedes
screw thereby following the tortuosity of said ear canal.
[0119] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting said soft material from a group consisting of silicone,
fiber mesh, cellulose, polyurethane, polyethylene, polyamide,
polypropylene, and any combination thereof.
[0120] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said Archimedes screw of a plurality of hingedly
connected segments, said Archimedes screw thereby following the
tortuosity of said ear canal.
[0121] It is another object of the present invention to disclose
the method as defined above, additionally comprising steps of
comprising said Archimedes screw of a plurality of segments,
connecting said segments via a hingedly connected shaft, said
Archimedes screw thereby following the tortuosity of said ear
canal.
[0122] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said collector head comprising a milling bit; said
milling bit comprising a proximal end and a distal end, wherein
said proximal end is substantially cylindrical and said distal end
is shaped substantially as the frustum of a cone; said distal end
and at least a portion of said proximal end being characterized by
at least one spiral groove.
[0123] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said distal end of said milling bit of at least one
aperture in fluid connection with said reservoir, fluid flowing
from said reservoir into said ear canal via said aperture.
[0124] additionally comprising a step of comprising said milling
bit of soft material, said milling bit thereby following the
tortuosity of said ear canal.
[0125] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting said soft material from a group consisting of silicone,
fiber mesh, cellulose, polyurethane, polyethylene, polyamide,
polypropylene, and any combination thereof.
[0126] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said milling bit of a plurality of hingedly connected
segments, said milling bit thereby following the tortuosity of said
ear canal.
[0127] It is another object of the present invention to disclose
the method as defined above, additionally comprising steps of
comprising said milling bit of a plurality of segments, connecting
said segments via a hingedly connected shaft, said milling bit
thereby following the tortuosity of said ear canal.
[0128] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
constructing said collector head of fibers braided into a form
which, at least when fully extended, resembles a basket, said
collector characterized by a proximal end and a distal end, said
proximal end comprising a shaft, said distal end comprising said
braided basket; said braided basket is characterized by at least
two positions, a retracted position wherein said braided basket is
substantially contained within said shaft and an extended position
wherein at least a portion of said braided basket extends beyond
the distal end of said shaft.
[0129] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said shaft fluidly connected to said reservoir.
[0130] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
reversibly transforming said braided basket between said retracted
position and said extended position.
[0131] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
reversibly transforming said braided basket from said retracted
position to said extended position by rotating said rotating
mechanism.
[0132] additionally comprising a step of retracting said braided
basket into said shaft at least one of before or during removal of
said apparatus from said ear canal.
[0133] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said shaft as an at least partially an open bore
shaft.
[0134] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said braided basket of at least one elastic fiber.
[0135] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
making said at least one elastic fiber of a material selected from
a group consisting of steel, nickel-titanium, beta-titanium,
plastic and any combination thereof.
[0136] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said elastic fiber of at least one filament.
[0137] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said elastic fiber of at least one selected from a group
consisting of fibers wound without a core, fibers wound around a
core, braided fibers and any combination thereof.
[0138] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
coating at least one of said at least one elastic fiber.
[0139] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said coating of at least one selected from a group
consisting of metal, plastic, Teflon, natural fibers, polyester,
rayon, nylon, woven material, non-woven material and any
combination thereof.
[0140] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said collector head of a sponge.
[0141] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
fluidly connecting said sponge to said reservoir, fluid selected
from cerumen softening fluid, softened cerumen and any combination
thereof thereby passing through said sponge.
[0142] additionally comprising a step of selecting the shape of
said sponge from a group consisting of: substantially cylindrical,
substantially shaped as a frustum of a cone, substantially conic,
and any combination thereof.
[0143] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said sponge of at least one selected from a group
consisting of cellulose, polyurethane, polyethylene, polyamide,
polypropylene, and any combination thereof.
[0144] It is another object of the present invention to disclose
the method as defined above, additionally comprising steps of
comprising said collector head of a thin foil, said collector head
comprising a proximal end and a distal end; comprising said
proximal end of a shaft comprising flexible section and comprising
said distal end of said thin foil.
[0145] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said thin foil in the shape of the frustum of a cone.
[0146] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said cone with at least one longitudinal slit such that
said foil comprises at least two longitudinal free edges.
[0147] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said thin foil in the range of approximately 0.05 mm
thick and approximately 0.5 mm thick.
[0148] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said thin foil approximately 0.1 mm thick
[0149] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting the material of which said foil is comprised from a group
consisting of: polyimide, polyvinyl chloride (PVC), Polyethylene
(PE), polypropylene (PP), Polyether ether ketone (PEEK), laminates
of thermoplastic elastomers, thermoplastic plastics and any
combination thereof.
[0150] It is another object of the present invention to disclose
the method as defined above, additionally comprising steps of
comprising a ring at at least one of said distal end of said foil
and the proximal end of said foil; and plastically deforming said
ring, thereby retaining said ring in its deformed shape at such
time as said apparatus is removed from said ear.
[0151] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said ring of material selected from a group consisting
of: polyimide, polyvinyl chloride (PVC), Polyethylene (PE),
polypropylene (PP), Polyether ether ketone (PEEK), laminates of
thermoplastic elastomers, thermoplastic plastics, metal and any
combination thereof.
[0152] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
stiffening said foil with at least one strut, said at least one
strut extending in at least one direction selected from a group
consisting of: longitudinally along said foil, transversely around
said foil, and spirally along said foil.
[0153] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting the material of which said at least one strut is
comprised from a group consisting of: polyimide, polyvinyl chloride
(PVC), PEEK, PE, PP, Polyamid, laminates of thermoplastic
elastomers, thermoplastic plastics, metal and any combination
thereof.
[0154] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising on the interior face of said foil collection/guidance
means selected from a group consisting of protrusions, vanes,
ridges, and any combination thereof, said guidance means enabled to
collect said cerumen and guide said cerumen towards the proximal
end of said collector head.
[0155] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that minimum height of
said collection/guidance means is at its distal end.
[0156] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that maximum height of
said collection/guidance means is substantially at its proximal
end.
[0157] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting the material of which said at least one strut is
comprised from a group consisting of: polyimide, polyvinyl chloride
(PVC), PEEK, PE, PP, Polyamid, laminates of thermoplastic
elastomers, thermoplastic plastics, metal and any combination
thereof.
[0158] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting said collector head formed substantially as a scoop, said
scoop having a transverse cross section shaped substantially as a
segment of a circle.
[0159] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting said segment of a circle to be approximately
semicircular.
[0160] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
connecting said scoop to said device body by a shaft.
[0161] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said scoop fluidly connected to said device body.
[0162] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising on the interior face of said scoop collection/guidance
means selected from a group consisting of vanes, ridges, and any
combination thereof, said collection/guidance means enabled to
guide said cerumen towards the proximal end of said collector
head.
[0163] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that minimum height of
said collection/guidance means is at its distal end.
[0164] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that maximum height of
said collection/guidance means is substantially at its proximal
end.
[0165] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said collector head formed substantially as a shovel,
said shovel having a transverse cross section shaped substantially
as a U.
[0166] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
connecting said shovel to said device body by a shaft.
[0167] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said shovel fluidly connected to said device body.
[0168] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising on the interior face of said shovel guidance means
selected from a group consisting of vanes, ridges, grooves and any
combination thereof, said guidance means enabled to guide said
cerumen towards the proximal end of said collector head.
[0169] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that minimum height of
said collection/guidance means is at its distal end.
[0170] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
shaping said collection/guidance means such that maximum height of
said collection/guidance means is substantially at its proximal
end.
[0171] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
implanting said apparatus into said ear canal manually or
automatically.
[0172] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
enclosing at least a part of said apparatus within a shell.
[0173] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said shell comprised of biodegradable material, and
biodegrading said shell prior to amassing cerumen to said
apparatus.
[0174] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising said biodegradable shell of at least one selected from a
group consisting of: biodegradable polythene, beeswax,
biodegradable polyethylene, biodegradable polypropylene,
poly(lactic-co-glycolic acid) (plga), Poly-L-Lactides (plla),
Polyglycolide (pga), Poly Lactic-co-Glycolic Acid (PLGA) and any
combination thereof.
[0175] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
selecting said softening liquid from a group consisting of baby
oil, glycerin, mineral oil, glycerol, olive oil, almond oil,
hydrogen peroxide, docusate sodium (dioctyl sodium
sulphosuccinate), dichlorobenzene, and carbamide peroxide, Hydrogen
peroxide, 10% solution of sodium bicarbonate, commercial earwax
removal liquid, and any combination thereof.
[0176] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising the longitudinal section of said collector head of a
cylinder; comprising the longitudinal section of the collector head
of a frustum of a cone.
[0177] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
collecting said cerumen in a manner selected from a group
consisting of: collecting said cerumen without dispensing softening
liquid; dispensing said softening liquid followed by collection of
said cerumen; dispensing said softening liquid and collecting said
cerumen simultaneously; and any combination thereof.
[0178] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
decoupling said rotating mechanism, thereby extending said rotating
mechanism no more than a predetermined amount.
[0179] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
providing said device configured such that, in the device's
undeformed configuration, the main longitudinal axis of said spiral
spring is substantially collinear with the main longitudinal axis
of said collector head.
[0180] It is another object of the present invention to disclose
the method as defined above, additionally comprising a step of
comprising at least a portion of said collector head of elastic
spring-like material adapted to apply radial forces that press said
portion of said collector head against the walls of said ear
canal.
BRIEF DESCRIPTION OF THE FIGURES
[0181] In order to better understand the invention and its
implementation in practice, a plurality of embodiments will now be
described, by way of non-limiting example only, with reference to
the accompanying drawings, wherein
[0182] FIG. 1 illustrates the outer ear, showing impacted cerumen
in the ear canal;
[0183] FIG. 2A-C schematically illustrates operation of a device
for removing cerumen from the ear;
[0184] FIG. 3A schematically illustrates a process of using a
device for removing cerumen from the ear and FIG. 3B-3D
schematically illustrates designs for the exterior of the part of
the device which fits into the ear;
[0185] FIG. 4 schematically illustrates a process of using a device
for removing cerumen from the ear;
[0186] FIG. 5 depicts the softening of cerumen exposed to a cerumen
softening liquid;
[0187] FIG. 6A-E schematically illustrates an embodiment of the
device;
[0188] FIG. 7 schematically illustrates an embodiment of the
collector head;
[0189] FIG. 8A-D schematically illustrates an embodiment of the
collector head formed as a plurality of braided fibers;
[0190] FIG. 9A-B schematically illustrates an embodiment of the
collector head formed of a sponge;
[0191] FIG. 10A-C illustrates functioning of a hollow pipe design
of an embodiment of the collector head
[0192] FIG. 11A-C illustrates another embodiment of the collector
head having a hollow pipe design;
[0193] FIG. 12 schematically illustrates a shaft for a collector
head;
[0194] FIG. 13 schematically illustrates an embodiment of the
collector with a scoop head; and
[0195] FIG. 14 schematically illustrates an embodiment of the
collector with a shovel head.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0196] The following description is provided, alongside all
chapters of the present invention, so as to enable any person
skilled in the art to make use of said invention and sets forth the
best modes contemplated by the inventor of carrying out this
invention. Various modifications, however, will remain apparent to
those skilled in the art, since the generic principles of the
present invention have been defined specifically to provide a means
and method for and method for providing mechanical removal of
cerumen from the ear canal.
[0197] The term `approximately` hereinafter refers to within 20% of
the value.
[0198] The term `plurality` hereinafter refers to any integer
greater than one.
[0199] The term `amass` hereinafter refers to accumulating or
assembling a quantity of material.
[0200] The term `distal` hereinafter refers to the part which, m
use, is further into the external ear canal.
[0201] The term `proximal` hereinafter refers to the part which, in
use, is closer to the exterior of the ear. In a device comprising 2
parts, a first part resting against the external ear and a second
part extending into the ear canal, the proximal part is the first
part and the distal part is the second part. The proximal end of
the distal (second) part is that end of the distal part which is
within the first (proximal) part.
[0202] The term `plurality` hereinafter refers to any integer
greater than or equal to one.
[0203] The term `hingedly connected` hereinafter refers to a
connection which functions as a hinge, such that there exists at
least one connecting part, each connecting part linking two
connected parts, each connecting part being more flexible than the
connected parts it joins, so that each connecting part functions as
a hinge, allowing the adjoining connected parts to bend relative to
each other in at least one direction.
[0204] The term `main longitudinal axis` refers hereinafter to the
axis extending along the long axis of the device. According to one
embodiment, said device can be either a linear or a non linear
device.
[0205] The term `deform` refers hereinafter to any mechanical
deformation e.g., bending, stretching, compression, twisting and
any combination of these.
[0206] The term `plastically deform` or `plastic deformation`
refers hereinafter to any permanent mechanical deformation.
[0207] The term `braided basket` refers hereinafter to a plurality
of fibers braided into a form which, when fully extended, resembles
a basket. The action of the basket is to expand and collect cerumen
during expansion and then capture it during contraction.
[0208] The term `accordion pleat` refers hereinafter to
substantially evenly spaced, substantially parallel folds. The
accordion pleating can form, for non-limiting example, a series of
parallel rows, or a spiral.
[0209] The term `outgoing soft cerumen` or `soft cerumen` refers
hereinafter to any form of cerumen mixture e.g., a paste, a wax, a
liquid, or a semi-solid. Typically, the soft cerumen will have high
viscosity.
[0210] The terms `all three directions` and `all three dimensions`
refer hereinafter to three directions that form the axes of a three
dimensional coordinate system. For non-limiting example, an object
whose tip can bend in all three directions can be pointed at any
desired point in space.
[0211] In the figures hereinbelow, identical numbers refer to
similar parts.
[0212] Cerumen is a naturally occurring substance that under normal
conditions cleans, protects and lubricates the external auditory
canal. Cerumen is eliminated by a self-cleaning mechanism which
causes it to migrate out of the ear canal, assisted by jaw
movement. Excessive ear wax can harden in the ear canal and block
the ear.
[0213] Cerumen is composed of sheets of corneocytes, originating
from the deep and superficial external auditory canal, mixed with
glandular secretions whereas keratin accounts for up to 60% of the
cerumen plug phenotypes. In FIG. 1, a schematic of the ear canal is
shown, containing impacted cerumen (2000).
[0214] Cerumen is a relatively hard material. Therefore, in order
to simplify its removal it needs to be dissolved or wetted to
eventually become a soft paste-like material. In some embodiments,
the current invention combines the effects of liquid immersion,
cerumen soaking, and mechanical collection of the cerumen. In other
embodiments, the cerumen is softened by other means, such as by a
doctor syringing the ear, and the current invention mechanically
collects the softened cerumen.
[0215] It should be pointed out that, while the cerumen softening
fluids are low viscosity softening fluids, the outgoing softened
cerumen, which could be in the form of a liquid, a paste or a wax,
and which has high viscosity since it is a cerumen/softening fluid
mixture.
[0216] The core concept behind the present invention is to provide
a simple mechanical device for cerumen removal.
[0217] According to some embodiments, the device described
hereinafter is useable without the need for a physician to
present.
[0218] According to other embodiments, the device is intended for
the use of physicians such as general practitioners or ENT doctors.
In these embodiments, the cerumen is softened by the doctor or
other clinician using conventional techniques such as syringing or
otherwise inserting into the ear canal a cerumen softening liquid,
preferably (but not limited to) hydrogen peroxide. After the
cerumen has softened, the doctor or other clinician will employ the
device of the present invention to remove from the ear canal the
softened cerumen. It is another core concept of the invention that
the softened cerumen is amassed in the device and is removed, with
the device, from the ear canal.
[0219] FIGS. 2A-C describe an operational concept of the invention,
rather than its final design. The liquid remains within the ear
canal while being in contact with the cerumen for a certain amount
of time. Optionally, the liquid may contain medications in the form
of liquid, gel, or powder that are sometimes required for topical
treatment such as external otitis or mycosis. Therefore, the
current invention suggests a cerumen removal treatment using three
sequential steps: [0220] 1. First step (FIG. 2A)--Cerumen
immersion. With the device (1000) in the ear canal, fluid (1500)
exits the device and wets the cerumen (2000). [0221] It should be
noted that in some variants of the device, the softening fluid is
introduced into the ear in any manner known in the art, e.g. via a
syringe, before insertion of the device into the ear. [0222] Since
hydrogen peroxide is a good cerumen softener and is often used in
wax softeners, in preferred embodiments it is used as the softening
agent. In other embodiments, the softening agent can be (but is not
limited to) baby oil, glycerin, mineral oil, glycerol, olive oil,
almond oil, docusate sodium (dioctyl sodium sulphosuccinate),
dichlorobenzene, and carbamide peroxide, Hydrogen peroxide,
solution of sodium bicarbonate, commercial earwax removal liquid,
and any combination thereof. [0223] 2. Second step (FIG.
2B)--Cerumen collection. A collection mechanism, the collector head
(1300) is introduced into the ear canal, in order to mechanically
collect cerumen. Once the cerumen is soft (2300), the collector
head (1300) of the device (1000) collects the softened cerumen
(2300). [0224] 3. Third step (FIG. 2C)--Cerumen extraction. After
the cerumen has been collected in the collector head (1300) of the
device (1000), the device (1000), including the collector head
(1300) and the softened cerumen (2300) held by it is removed from
the ear canal.
[0225] The invention provides a single use, disposable product,
designed, in some embodiments, for self-treatment by a patient at
home. It can also be used, for non-limiting example, by a clinician
or other caregiver treating a patient, in a clinical or residential
setting. Non-limiting examples of treatment in a residential
setting include a person treating himself or a parent treating a
child. Other non-limiting examples include care of the physically
frail (such as the elderly) or the physically or mentally disabled.
Such care can be provided by the patient's family, by a caregiver,
or by a physician. A non-limiting example of treatment in a
clinical setting is use of the product by a doctor in the office as
part of treatment.
[0226] In preferred embodiments, the overall process takes less
than 5 minutes; in most embodiments, it takes less than 20
minutes.
[0227] The operation is quite simple; the device is inserted into
the ear canal and rotational force is applied to a knob, the knob
remaining on the exterior of the ear. The device is designed such
that, when used properly, the user can not apply sufficient force
in a longitudinal direction, inward along the ear canal, to force
the cerumen inward. Furthermore, the device is designed such that,
when used properly, the user exerts a substantially rotational
force to the knob, e.g. by rotating it at a constant speed.
[0228] Safety considerations: the maximal travel of the cerumen
collecting mechanism is about 0.5-1.5 cm so that the maximal ear
canal penetration is 1.5-2.5 cm from the external ear, leaving a
safety distance of a minimum of 0.5-1 cm from the tympanic
membrane. Furthermore, only moment forces can be exerted by the
user, as opposed to forces that might push the device towards the
tympanic membrane thus significantly reducing the risk of tearing
the membrane.
[0229] FIG. 3 illustrates the concept mechanism and its general
action. The entire process is managed through an applicator (1000)
that has several components: [0230] 1. A static mechanism (1100),
referred to hereinbelow as the "device body", that is lodged in the
external ear canal and which, in preferred embodiments, comprises a
reservoir filled with about 1-5 ml of liquid. In preferred
embodiments, the liquid is hydrogen peroxide 3%. Other possible
liquids include, but are not limited to, other concentrations of
hydrogen peroxide, oils such as mineral oil, baby oil or medicinal
olive oil, sodium bicarbonate ear drops, and commercial ear drops
such as, but not limited to, Earex.TM..
[0231] In some embodiments, the device does not comprise a
reservoir of softening liquid. In such embodiments, the softening
liquid is inserted into the ear by a physician or other clinician,
in any manner known in the art, such as, but not limited to
syringing. After insertion of the liquid and the passage of
sufficient time for the liquid to soften the cerumen, the physician
or other clinician inserts the device into the ear and operates it,
thereby gently and reliably removing the softened cerumen from the
ear.
[0232] In some embodiments, the reservoir of liquid is not within
the main body of the device, but is within a container fluidly
connected to the device and situated above the ear canal, for
non-limiting example, at eye height, or resting above the ear
between the upper portion of the pinna and the head, or on top of
the head. In some of these embodiments, the reservoir can be held
to the head by a ribbon tied around the head or by an elastic band,
or by any other means known in the art of holding objects in place
on the head. In embodiments where the reservoir is above the ear
canal, liquid flow into the ear canal is aided by the force of
gravity. [0233] 2. 2. A dynamic mechanism (1200), referred to
hereinbelow as the "knob", that uses the rr rotational forces
exerted by the user for powering the device throughout the at
treatment. [0234] A mechanism (not shown) that wets the cerumen's
(2000) front, comprising a reservoir of softening liquid (not
shown), an orifice (1400) to deliver the liquid to the ear canal
and a fluid connection (not shown) between the reservoir (not
shown) in the device body (1000) and the orifice (1400). [0235] 3.
A mechanism (1300) that collects the cerumen (2000).
[0236] The applicator operates in the following manner: The
applicator (1000) is inserted into the opening of the ear canal and
the distal end (1500) of the static mechanism (1100) is lodged in
the outer part of the ear. The user turns the knob (1200). This has
two effects. The first is that the cerumen's front is wetted via
the wetting mechanism (not shown) with a softening fluid such as,
but not limited to, hydrogen peroxide. The wetting liquid is
preferably delivered to the ear canal via the cerumen collector
(1300) via at least one opening (1400) in the cerumen collector
(1300). The second effect is that the knob (1200) imposes
rotational maneuvers (curved arrow) that advance the collector
(1300) in the direction (straight arrow) of the cerumen (2000).
When the cerumen (2000) is soft, the collector head (1300) collects
the soaked cerumen paste at the interface between the device and
the hard cerumen. The tip of the cerumen collector (1300) does not
progress into the ear canal if the cerumen is not soft enough.
[0237] If the cerumen is too hard to be collected, the cerumen
collector (1300) can collapse, it can rotate in place, or any other
means known in the art can be used to prevent forward motion of the
part of a collector head (1300) in contact with hard cerumen.
[0238] The distal end of the static mechanism, the nosepiece
(1500), can be shaped like an earplug. Non-limiting examples of
earplug shapes are shown in FIGS. 3B to D. The distal end of the
earplugs, the end which extends furthest into the ear canal, is to
the right in FIGS. 3B to 3D.
The Knob (1200)
[0239] The knob comprises a dynamic mechanism (not shown) that uses
the rotational forces exerted by the user to power the device
during treatment. In some embodiments, a wire or cable (1110) is
connected to the static mechanism (1100), the wire or cable
transmitting the rotational motion of the knob to the collector in
order to mechanically clean the ear canal. The device constrains
the user so that the only allowed maneuvers are those that impose
rotational forces rather than compression forces so as to prevent
the possibility of injury in the region of the tympanic membrane.
The rotational force is used to both direct the collector into the
inner part of the ear canal while rotating (i.e. a screw motion) as
well as to transfer liquids to the cerumen's front through the
orifice (1400, not shown). It is possible, that the liquid will be
transferred using another instrument such as a piston/syringe
device. It is possible, as a safety measure, that an element that
prevents pushing the cerumen is added such that, when cerumen
blocks the way or is still hard, the collector will remains in its
position rather than be pushed in the direction of the tympanic
membrane so as not to impose an unnecessary risk such as tearing
the membrane.
[0240] In preferred embodiments, the knob mechanism comprises a
clutch or other decoupling mechanism such that, after the collector
head has been extruded by a predetermined distance, preferably no
more than 1 cm, further rotation of the knob produces no further
extrusion of the collector head.
Collector Head (1300)
[0241] The cerumen collector head (1300) "digs" the cerumen and
collects it, but cannot push cerumen. The reason it cannot push
cerumen into the ear canal is because it is designed to collapse
under a predetermined pressure which is less than the pressure
required to push cerumen; the collector head (1300) has low
longitudinal rigidity.
[0242] Furthermore, the collector head (1300) is designed to have
low resistance to bending so as to facilitate its insertion into
the inner part of the ear canal (note that the ear canal is
tortuous in all three dimensions).
[0243] Embodiments for a mechanism for the collector head (1300)
include, but are not limited to, a collector head comprised of soft
material and shaped like a milling bit or Archimedes screw
(diameter about 4-5 mm, length about 10 mm); a thin-walled hollow
pipe with the ability to vary at least a portion of its cross
sectional diameter to fit the diameter of the ear canal and the
ability to vary the direction of portions of its longitudinal axis
to follow the sigmoid shape of the ear canal; a thin-walled hollow
pipe design having inner protrusions; a braided basket design; a
sponge design, a scoop design and a shovel design. Other
embodiments will be obvious to persons skilled in the art.
[0244] In embodiments with integral reservoir of cerumen-softening
liquid, the reservoir can be within the collector, within the
device body (static mechanism), and any combination thereof. In
other embodiments comprising a reservoir, the reservoir can be
fluidly connected to the device body, and be emplaced above the
level of the device body (and the ear canal), such as on top of the
ear between the pinna and the head, or at eye level or on top of
the head. In the last two embodiments, the reservoir can be held in
position by a ribbon or by an elastic band, or by any other means
known in the art of holding objects in place on the head.
[0245] In an exemplary embodiment of the concept (FIG. 4A-F), a
procedure for using the device is shown. In the first step (FIG.
4A), the device (1000) is inserted into the outer part of an ear
canal contained impacted cerumen (2000).
[0246] In the second step (FIG. 4B), the knob (1200) of the device
(1000) is turned (arrow) by a hand (3000). This induces flow of
cerumen-softening liquid (1500) into the ear canal, where it
contacts the cerumen (2000) and softens it.
[0247] In the third step (FIG. 4C), further rotation of the knob
(1200) extrudes the collector head (1300) from the device body
(1100), causing it to contact the cerumen (2000), which is now at
least partly softened. collector head (1300) extends further from
the device body (1100), thereby collecting the softened cerumen
(2300).
[0248] In the fourth step (FIG. 4D), the user continues to rotate
the knob (1200), so that the collector head (1300) extends further
from the device body (1100), thereby collecting the softened
cerumen (2300).
[0249] The wetting process can be intermittent or continuous. In
some embodiments, intended primarily for use by physicians or other
clinicians, the cerumen is wetted and softened by the softening
liquid separately, for example, by a syringe, before the device is
inserted in the ear. In such embodiments, the device does not
comprise a reservoir and operating the device comprises collecting
the softened cerumen and removing it from the ear canal.
[0250] In other embodiments, at the start of the process, all of
the softening liquid is dispensed into the ear, after which the
softened cerumen is collected and removed from the ear canal.
[0251] In yet other embodiments, the softening liquid is dispensed
continuously, simultaneously with collection of the softened
cerumen. In these embodiments, it is preferred that the dispensing
of softening liquid begins before collection starts, so that, by
the time the collector head reaches the cerumen, the cerumen has
been softened and is collectable.
[0252] In still other embodiments, release of the softening liquid
and operation of the collector are both intermittent. In these
embodiments, softening liquid is released, after which the
collector head collects the softened cerumen. Then further
softening liquid is released, followed by collection of the
softened cerumen. The steps of releasing softening liquid and
collecting cerumen can be repeated a plurality of times.
[0253] As a non-limiting example, (a) the softening liquid is
dispensed for 2 rotations of the knob, followed by (b) 2 rotations
of the knob during which there is neither dispensing of liquid nor
rotation of the collector head. This is followed by (c) 10
rotations of the knob during which the collector head collects
softened cerumen. The process (a), (b), and (c) is repeated 20
times, for a total of 280 rotations of the knob. The device is then
removed from the ear canal.
[0254] In the last step (FIG. 4E), the device (1000) is removed
from the ear canal (arrow), with the softened cerumen (2300) being
thereby removed from the ear canal, since it is held by the
collector head (1300).
[0255] In some variants, the collector head (1300) is retracted
into the device body (1100) during the removal step, in other
embodiments (shown), the collector head (1300) is partially
retracted into the device body (1100), in yet other variants, the
collector head (1300) remains extended during removal of the device
(1000) and the softened cerumen (2300) from the ear canal.
[0256] Any mechanism known in the art can be used to retract the
collector head into the device body. Typical mechanisms include,
but are not limited to, a wire or cable attached at one end to the
collector head or to some portion of the distal end of the shaft,
wherein, if a portion of the wire or cable is pulled, the collector
head is withdrawn into the device body; a collapsible or telescopic
shaft that, when collapsed, pulls the collector head into the
device body, a rotatable shaft that, when rotated, screws the
collector head into the body, a direct coupling, e.g., to the knob
or to a second knob, that, when the knob is rotated, the collector
head retracts into the body, or any combination thereof.
[0257] FIG. 5 shows the effects of cerumen softening liquid on a
plug of hardened cerumen.
[0258] The plug of hardened cerumen is shown. It is a hard mass
with a density is such that it floats in the liquid close to the
bottom of the tube (slightly above the bend in the tube,
arrow).
[0259] The cerumen has absorbed some of the softening liquid; its
density has decreased so that part of it floats higher up in the
liquid. Its volume has also increased and it has become softer.
[0260] The softening process continues; small fragments of the
cerumen are detaching from the plug and are drifting to the top of
the tube (circle).
[0261] The process is complete; the cerumen is now a soft paste
with some cerumen particles floating at the top of the liquid
(dotted arrow).
[0262] In some embodiments, the device is inserted into the ear
canal manually. In other embodiments, the device comprises an
insertion mechanism whereby, when the device is placed against the
external ear, it is automatically inserted therein.
[0263] In some embodiments, at least a portion of the device body
comprises a biodegradable shell. In such embodiments, the device is
placed in the ear canal and left there. The shell biodegrades and,
after a predetermined time, it ceases to restrict the movement of
the collector head, which is extended into the ear canal by a
spring-like device in the device body.
[0264] The biodegradable shell can be comprised of biodegradable
polythene, beeswax, biodegradable polyethylene, biodegradable
polypropylene, Poly-L-Lactides (polylactic acid, plla),
Polyglycolide (polyglycolic acid, pga), Poly Lactic-co-Glycolic
Acid (PLGA) any other material that degrades within less than an
hour when in contact with an ear canal, and any combination
thereof.
[0265] Devices with an automatic insertion mechanism and devices
which operate automatically (such as, but not limited to, the
device with biodegradable shell) are especially useful in the care
of persons who, due to physical or mental infirmity, have
difficulty inserting the device or for whom it is difficult for a
physician or caregiver to insert the device.
[0266] Examples of embodiments of collector head designs are
disclosed hereinbelow.
EXAMPLE 1
[0267] FIG. 6 illustrates an embodiment of the collector head in
the form of an Archimedes screw with soft blades (1300). In this
embodiment, the Archimedes screw is rotated by a rotational force
applied to the collector head (1300) via the knob (1200) by the
user. The blade tips (1312) remove the softened cerumen from the
impacted mass; the removed cerumen then travels along the blades
toward the outside of the ear canal. Note that the blades' soft and
narrow design allows bending and thus the collector head fits the
dimension of the ear canal at different depths of the canal (note
that the ear canal is not homogenous in its diameter along its
length, and also differs between different users).
[0268] FIG. 6A illustrates the Archimedes screw design with the
screw (1310) at its innermost position (within the device
body).
[0269] FIG. 6B illustrates the Archimedes screw design with the
screw (1310) at an outer position, showing the screw (1310) and the
blade tips (1312).
[0270] FIG. 6C illustrates the Archimedes screw design partially
disassembled, with the knob (1200) removed, showing the extruding
mechanism (1314) for the Archimedes screw and the device body
(1100). A clutch like mechanism (1316) disconnects the motion
between knob (1200) and the extruding mechanism (1314) when the
extruding mechanism is displaced about 1 cm. The extruding
mechanism (1314) is connected to the Archimedes screw (1310) so
that its disconnection is required so as prevent it from advancing
further in the direction of tympanic membrane, although the user
may continue to tum the knob (1200). The clutch mechanism ensures
that, although the Archimedes screw continues to turn, it cannot
advance further.
[0271] FIG. 6D illustrates an exploded view of the Archimedes screw
design. The exploded view shows the knob (1200), the extruding
mechanism (1314) for the Archimedes screw (1310), the outer housing
(1100) for the device, the clutch like mechanism (1316), and the
nosepiece (1500) which fits into the outer ear and from which the
Archimedes screw (1310) will protrude.
[0272] FIG. 6E illustrates two different Archimedes screw (1310)
designs. The left Archimedes screw (1317) has a coarse pitch, while
the right Archimedes screw (1318) has a fine pitch.
[0273] The Archimedes screw (1310) can be composed of soft
materials such as, for non-limiting example, silicone, fiber mesh,
cellulose, polyurethane, polyethylene, polyamide, polypropylene,
and any combination thereof.
[0274] The Archimedes screw (1310) can comprise a single piece, or
it can comprise a plurality of segments connected by a flexible
section, said flexible section comprising accordion pleating, a
spiral spring or a hinging means, the flexible section allowing the
Archimedes screw (1310) to deform to follow the tortuosity of the
ear canal. The hinging means can comprise a hinging mechanism, or
it can comprise a shaft comprising a plurality of hinging sections,
as described hereinbelow.
[0275] The flexible section, by enabling bending in all three
dimensions, prevents resistance of the collector head to bending,
especially about its longitudinal axis and ensures that the
Archimedes screw conforms to the tortuosity of the ear canal.
EXAMPLE 2
[0276] FIG. 7 discloses an embodiment of the collector head in the
form of a milling bit (1320) composed of soft materials, for
non-limiting example, silicone, fiber mesh, etc. In the bit design,
cerumen is wetted by fluid supplied from a reservoir (not shown)
through an inner pipe (not shown) and orifice (1400). Cerumen is
collected within the bit's grooves (1325) as the bit is rotated
within the ear canal.
[0277] The milling bit (1320) can be composed of soft materials
such as, for non-limiting example, silicone, fiber mesh, cellulose,
polyurethane, polyethylene, polyamide, polypropylene, and any
combination thereof.
[0278] The milling bit (1320) can comprise a single piece, or it
can comprise a plurality of segments connected by a flexible
section, said flexible section comprising accordion pleating, a
spiral spring or a hinging means, the flexible section allowing the
milling bit (1320) to deform to follow the tortuosity of the ear
canal. The hinging means can comprise a hinging mechanism, or it
can comprise a shaft comprising a plurality of hinging sections, as
described hereinbelow.
[0279] The flexible section, by enabling bending in all three
dimensions, prevents resistance of the collector head to bending,
especially about its longitudinal axis and ensures that the milling
bit conforms to the tortuosity of the ear canal.
EXAMPLE 3
[0280] FIG. 8 discloses an embodiment of the collector head formed
as a plurality of fibers braided into a form which, when fully
extended, resembles a basket. This embodiment will be referred to
hereinafter as the "braided basket" (1340). In the braided basket
design, the braiding forms a hollow, preferably closed-ended pipe
composed of elastic fibers. The braiding facilitates the expansion
of the braided basket to match the dimensions of the ear canal at
any location within the ear canal. With this design, the basket
(1346) is in its minimal diameter mode when it is retracted and at
least substantially inside a sleeve (1343) and it opens to an
expanded position when extended at least partly outside the sleeve
(1343). In its open state, the basket (1346) captures the cerumen
and, when the sleeve (1343) covers the basket (1346) entirely or
partially, it reduces the diameter of the basket (1346) and thereby
collects the cerumen within the bore of the braided basket
(1346).
[0281] In use, the device is inserted into the ear canal with the
braided basket (1346) in its retracted position. The knob is
rotated, which extends the braided basket (1346) from the sleeve
(1343) and rotates the braided basket (1346). Rotation of the
braided basket (1346) collects the softened cerumen within the
basket. When the device is to be removed from the ear canal, the
braided basket (1346) is retracted into the sleeve (1343), thereby
trapping the cerumen inside the collector head (1340) and ensuring
its removal from the ear canal.
[0282] The fibers comprising the basket can be of any sufficiently
stiff, sufficiently elastic material. Fiber materials include, but
are not limited to, steel, nickel-titanium, beta-titanium, plastic
and any combination thereof. The material can be monofilament i.e.,
comprising a single fiber, or multifilament, comprising a plurality
of fibers.
[0283] Multifilament fibers can comprise filaments wound around
each other without a core, filaments wound around a core, filaments
braided together, and any combination thereof. The filaments can be
identical or can differ. For example, the core can comprise a
filaments thicker or of a stiffer material than the wrapping
filaments.
[0284] The fibers can be coated. Each filament of a multifilament
fiber can be individually coated, or the fiber itself can be
coated.
[0285] Coatings can improve, among other factors, stiffness,
breaking strength, flexibility, slidability of the fibers against
each other (non-stick coatings), and biocompatibility.
[0286] Fiber materials can include, but are not limited to, metal,
plastic, natural fibers, polyester, rayon, nylon, woven material,
non-woven material and any combination thereof.
[0287] Fiber coatings can include, but are not limited to, metal,
plastic, Teflon, natural fibers, polyester, rayon, nylon, woven
material, non-woven material and any combination thereof.
[0288] FIG. 8A shows an embodiment of a braided basket design in a
retracted position. Part of the braided basket (1346) is visible at
the end of the sleeve (1343).
[0289] FIG. 8B shows an embodiment of the braided basket design
when slightly extended. The braided basket (1346) is clearly
visible at the end of the sleeve (1343) and has expanded so that it
is significantly wider than the sleeve (1343).
[0290] FIG. 8C shows an embodiment of the braided basket design
when significantly extended. The braided basket (1346) is wider
than when slightly extended and extends further from the end of the
sleeve (1343).
[0291] FIG. 8D shows an embodiment of the braided basket design
when in a fully extended state. The shaft (1343) holding the
braided basket (1346) can be clearly seen, and the braided basket
(1346) is now basket-shaped rather than the more conical shape seen
in FIGS. 8A-8C.
[0292] It is clear that fluid can easily pass from the hollow
sleeve and through the braiding of the basket to reach the
cerumen.
EXAMPLE 4
[0293] FIG. 9A illustrates an embodiment of the collector head
formed of a sponge (1350). In this design, the collector head is of
a substantially cylindrical shape and is formed of a spongy
material. The sponge is kept wet by the fluid from the reservoir;
the fluid flows through the sponge and wets portions of the
cerumen's front. Rotation of the sponge causes collection of the
softened cerumen within the pores of the sponge. The sponge is
elastic so that it can deform to fit the size and shape of the
external ear canal.
[0294] The sponge can be formed in other shapes such as, but not
limited to, a cone or the frustum of a cone.
[0295] The sponge can be mounted directly to the knob or can be
connected to the knob via a shaft or sleeve or other connecting
mechanisms as is known in the art. One embodiment of such a shaft
is described hereinbelow.
[0296] The sponge can be comprised of materials including, but not
limited to, cellulose, polyurethane, polyamide, Polypropylene,
polyethylene, and any combination thereof.
[0297] FIG. 9B illustrates another embodiment (1355), in which the
sponge is composed of fine fiber twisted, crumpled, bent or braided
so as to form a body composed of fiber. The exemplary embodiment of
FIG. 9B is formed of fiber bent into the form of a cylinder; the
fiber body can be formed in other shapes such as, but not limited
to, a cone or the frustum of a cone.
[0298] It should be pointed out that, while the cerumen softening
fluids are low viscosity softening fluids, the outgoing soft
cerumen, which could be in the form of a liquid, a paste or a wax,
has high viscosity since it is a cerumen/softening fluid
mixture.
EXAMPLE 5
[0299] FIG. 10 illustrates a method of using a collector head in
the form of a hollow pipe (1360). With the hollow pipe design, as
the leading (distal) edge of the pipe advances inward toward the
eardrum, a new front of cerumen (2000) is wetted and is collected
by the cerumen collector. This process is repeated constantly until
the ear canal is cleared.
[0300] The hollow pipe is composed of a very thin elastic foil. The
elastic foil is folded around and is made of sufficiently elastic
spring-like material so that it has radial elastic forces (like a
watch spring) towards the ear canal walls in order to increase or
reduce its diameter according to its location within a tunnel such
as the ear canal. The rationale is that the elastic foil is
spring-like enough that it is pressed against the walls of the ear
canal. This, along with the thinness of the foil, ensures that the
elastic foil collector head passes between the cerumen in the ear
canal and the walls of the ear canal, so that the cerumen is
surrounded by the foil collector head and collected within it.
Furthermore, the radial forces ensuring that the elastic foil is
pressed against the walls of the ear canal prevent the foil
collector head from pushing the cerumen deeper into the ear
canal.
[0301] FIGS. 10A-C show the functioning of the hollow pipe design.
Liquid (1500) exiting the pipe (1360) wets the cerumen (2000) and
softens it, producing fully wetted cerumen (2300) and, further from
the pipe opening, partially wetted cerumen (2200), while unwetted
cerumen (2100) remains in the regions furthest from the pipe.
[0302] FIG. 10A illustrates the situation at the start of the
process. At this point, the pipe (1360) has not reached the cerumen
(2000), although the wetting fluid (1500) has, producing partly
wetted cerumen (2200) and fully wetted cerumen (2300), although
some of the cerumen (2100) is still unwetted.
[0303] FIG. 10B illustrates the situation after the pipe (1360),
moving inward (arrow), has reached the cerumen (2000). Some of the
fully-wetted cerumen has been collected inside the pipe (2350) and
the wetting fluid (not shown) is softening additional portions of
the cerumen plug (2200). The amount of unwetted cerumen (2100) has
decreased.
[0304] As the process continues (FIG. 10C), the pipe (1360)
continues to move inward toward the base of the external ear canal
(arrow) and to collect the wetted cerumen within it (2350). Near
the end of the process, as shown in FIG. 10C, most of the wetted
cerumen (2300) has been collected; only small amounts of partially
wetted (2200) and unwetted cerumen (2100) remain.
[0305] FIG. 11 illustrates another embodiment of a hollow pipe
design, comprised of a very thin (in the range of 0.05 mm thick to
0.5 mm thick, preferably approximately 0.1 mm thick) elastic foil.
The elastic foil is made of a spring-like material and is folded
around so there exist in it radial elastic forces which enable it
to increase or decrease its diameter in order to conform to the
shape of the walls of the ear canal. The rationale is that the
elastic foil is spring-like enough that the elastic foil is pressed
against the walls of the ear canal. This, along with the thinness
of the foil, ensures that the elastic foil collector head passes
between the cerumen in the ear canal and the walls of the ear
canal, so that the cerumen is surrounded by the foil collector head
and collected within it. Furthermore, the radial forces ensuring
that the elastic foil is pressed against the walls of the ear canal
prevent the foil collector head from pushing the cerumen deeper
into the ear canal.
[0306] Because the diameters of collector leading (distal) edge,
ear canal and cerumen plug are approximately the same, the
collector can encompass the cerumen and because of the thinness of
the material of the thin hollow pipe, the collector can advance
between the cerumen and the wall of the ear canal. As the collector
advances, its diameter and especially the diameter of its leading
portion reduces, since the diameter of the ear canal is
decreasing.
[0307] At some point, some portion of the leading (distal) portion
of the collector will undergo plastic deformation. Having undergone
plastic deformation, the leading (distal) portion of the collector
will remain in approximately its final, deformed shape and will not
regain its original expanded shape upon removal from the ear,
thereby ensuring retention of the cerumen within the collector.
[0308] In preferred embodiments, the elastic foil material does not
undergo plastic deformation. In these embodiments, the collector
comprises a ring, preferably a metal ring (hereinafter referred to
as the `deformable ring`), approximately at the collector's leading
(distal) edge, which undergoes the appropriate plastic deformation
when the foil collector head is approximately at its furthest depth
within the ear canal.
[0309] In preferred embodiments, the collector, at the end of
treatment, has been reshaped into a substantially conical shape
and, therefore, a substantially closed-sided and closed-ended shape
so that, when the device is removed from the ear, the collector
retains the captured cerumen.
[0310] Since the cerumen is efficiently collected within the foil,
removal of the device from the ear also removes the cerumen
therefrom. The plastic deformation of the deformable ring by the
ear canal, by tending to close the opening at the distal end of the
foil collector head, increases the efficiency of removal of the
cerumen from the ear.
[0311] In some embodiments, the foil collector head further
comprises a deformable ring at its proximal end; in these
embodiments, the foil collector head comprises deformable rings at
both the distal and the proximal ends.
[0312] The pipe can be composed of any material capable of forming
a very thin, highly elastic foil. In some embodiments, the foil is
comprised of polyimide. Other foil materials comprise polyvinyl
chloride (PVC), PEEK, PE, PP, Polyamid and laminates of
thermoplastic elastomers and thermoplastic plastics. Any material
capable of forming a very thin, highly elastic, foil (between 0.05
mm thick and 0.5 mm thick, preferably approximately 0.1 mm thick)
known in the art can be used. The foil can, optionally, also be
stiffened with struts or other stiffening mechanisms known in the
art.
[0313] FIG. 11A illustrates a perspective view of an embodiment of
the thin hollow pipe collector (1360), while FIG. 11B illustrates a
side view of the collector (1360). The collector (1362) is attached
to a, preferably, flexible shaft (1370) with a flexible section
(1372). In this embodiment, the elastic foil (1362) comprises gaps
(1364) adapted to fine-tune the flexibility of the foil By using
gaps of different sizes and/or shapes, the same thickness of foil
can be used for ear canals of different sizes, for non-limiting
example, for adults and for children.
[0314] The flexible section, by enabling bending in all three
dimensions, prevents resistance of the shaft to bending, especially
about its longitudinal axis, and ensures that the longitudinal axis
of the foil distal end conforms to the tortuosity of the ear
canal.
[0315] In the embodiment shown in FIG. 11, the flexible section
(1372) comprises accordion pleating. The flexible section (1372) in
the shaft, by enabling bending in all three dimensions, increases
the flexibility of the collector head while within the ear canal,
prevents resistance of the shaft to bending, especially about its
longitudinal axis, and directs the head towards the cerumen, by
providing sufficient flexibility to the shaft in all three
dimensions that the foil is in the same orientation as the
cerumen.
[0316] The accordion pleating can be in the form of a plurality of
substantially straight, substantially parallel rows, or it can be
in the fom 1 of a continuous spiral, or any combination thereof, so
that the accordion pleating allows the shaft to bend in all three
dimensions.
[0317] In other embodiments (described hereinbelow), the flexible
section can comprise a spiral spring, a more flexible material, a
plurality of thin regions hingedly connecting stiffer regions, a
plurality of regions comprised of a more flexible material hingedly
connecting stiffer regions, and any combination thereof.
[0318] FIG. 11C illustrates a front view of the deformable ring in
its compressed state (1366).
[0319] In FIGS. 11A and B, the thin foil (1362) comprises
substantially the frustum of a cone, open at one edge to allow the
cone to easily change its diameter and cone angle to match those of
the ear canal, where the narrow end of the cone (at the right in
FIGS. 11A and B) forms the leading (distal) edge and is deeper in
the ear canal than the wide (proximal) end of the cone (at the left
in FIGS. 11A and B).
[0320] In some embodiments, the elastic foil comprises, on its
inner side, protrusions (not shown) adapted to collect the cerumen
and guide the cerumen in the foil proximally, toward the shaft
(1370), thereby clearing the distal portion of the elastic foil and
allowing the elastic foil to collect further cerumen.
[0321] The height of the protrusions varies, starting from zero at
their distal end and increasing towards their proximal end. In
preferred embodiments, the height of the protrusions is a maximum
near their proximal end, so that the protrusions collect the
cerumen but do not push it, thereby preventing the device from
forcing the cerumen deeper into the ear canal.
[0322] In preferred embodiments, the protrusions form at least the
segment of a spiral, the spiral wrapping around the side of the
frustum of the cone.
[0323] The protrusions can, in addition to guiding the cerumen,
also function as struts to stiffen the elastic foil.
[0324] The leading (distal) edge (at the right in FIGS. 11A and B)
can also comprise a deformable ring (1366) which will plastically
deform if compressed sufficiently and, in use, will deform at
approximately the point when the leading (distal) edge of the
collector reaches its maximum depth in the ear canal.
[0325] FIG. 12 illustrates another embodiment of a shaft (1370) to
hold the elastic foil collector head and direct it to the cerumen
site. One of the main obstacles to inserting instruments into the
ear canal is the tortuous shape of the canal and thus the high
chance of injuring the ear canal wall during entry. In order to
prevent pain and/or injury, the shaft is designed to bend in all
three axes to follow the ear canal whenever it encounters a bend in
any of the three dimensional directions.
EXAMPLE 6
[0326] FIG. 13 illustrates an embodiment of a collector (1300) with
a scoop head (1380). The embodiment comprises a, preferably,
flexible shaft (1370), a flexible section (1372) comprising, in
this embodiment, accordion pleating, to provide flexibility, and a
collector head (1380) shaped substantially like a scoop with a
transverse cross-section which forms a segment of a circle, in this
embodiment, approximately a half-circle. As the collector rotates,
the sides of the collector head (1380) will scrape at or near the
wall of the ear canal, thereby collecting the cerumen within the
scoop (1380).
[0327] The material of the scoop is of a spring-like elastic
material, such that the scoop, especially the edges thereof, is
gently pressed against the walls of the ear canal. This ensures
that the scoop passes between the cerumen and the walls of the ear
canal, facilitating collection of the cerumen and preventing the
scoop from pushing the cerumen deeper into the ear canal.
[0328] The flexible section, by enabling bending in all three
dimensions, prevents resistance of the collector head to bending,
especially about its longitudinal axis and ensures that the
collector conforms to the tortuosity of the ear canal along its
entire length.
[0329] The accordion pleating can be in the form of a plurality of
substantially straight, substantially parallel rows, it can be in
the form of a continuous spiral, or any combination thereof, so
that the accordion pleating allows the shaft to bend in all three
dimensions.
[0330] In other embodiments (described hereinbelow, the flexible
section can comprise a spiral spring, a more flexible material, a
plurality of thin regions hingedly connecting stiffer regions, a
plurality of regions comprised of a more flexible material hingedly
connecting stiffer regions, and any combination thereof.
[0331] In preferred embodiments, the scoop head also comprises at
least one vane (1382) to collect the cerumen and guide the cerumen
in the scoop proximally, toward the shaft (1370), thereby clearing
the distal portion of the scoop and allowing the scoop to collect
further cerumen. The embodiment shown comprises two such vanes.
[0332] The height of the vanes varies, starting from zero at the
vanes' distal end and increasing towards the vanes' proximal end.
In preferred embodiments, the height of the vanes is a maximum near
their proximal end, so that the vanes collect the cerumen but do
not push it, thereby preventing the device from forcing the cerumen
deeper into the ear canal.
[0333] In another variant of the scoop head collector, the means of
guiding the cerumen to move proximally is at least one ridge. In
all variants, the collection/guidance means varies in height from O
at the distal end to a maximum near the proximal end.
[0334] The vanes or ridges preferably form segments of a spiral
around the inside of the collector head. Spiral vanes or ridges can
be arranged such that the distal ends of the spirals are separated
longitudinally, as shown in FIG. 14, they can be separated
transversely, for non-limiting example, such that two spirals both
end at the distal end of the collector, and any combination
thereof.
[0335] In some embodiments, the scoop has no vanes or ridges.
EXAMPLE 7
[0336] FIG. 14 illustrates an embodiment of a shovel collector
(1300) with a shovel head (1390). The embodiment comprises a,
preferably, flexible shaft (1370), a flexible section (1374) to
provide flexibility and a collector head (1390) shaped
substantially like a shovel, with a transverse cross-section which
is substantially U-shaped, being slightly curved in its center,
with curved, nearly vertical sides. As the collector rotates, the
sides of the collector head (1390) will scrape at or near the wall
of the ear canal, thereby collecting the cerumen within the shovel
(1390).
[0337] The material of the shovel is of a spring-like elastic
material, such that the shovel, especially the edges thereof, is
gently pressed against the walls of the ear canal. This ensures
that the shovel passes between the cerumen and the walls of the ear
canal, facilitating collection of the cerumen and preventing the
shovel from pushing the cerumen deeper into the ear canal.
[0338] The flexible section, by enabling bending in all three
dimensions, prevents resistance of the collector head to bending,
especially about its longitudinal axis and ensures that the
collector conforms to the tortuosity of the ear canal along its
entire length.
[0339] The flexible section can comprise accordion pleating, a
spiral spring, a more flexible material, a plurality of thin
regions hingedly connecting stiffer regions, a plurality of regions
comprised of a more flexible material hingedly connecting stiffer
regions, and any combination thereof.
[0340] The accordion pleating can be in the form of a plurality of
substantially straight, substantially parallel rows, it can be in
the form of a continuous spiral, or any combination thereof, so
that the accordion pleating allows the shaft to bend in all three
dimensions.
[0341] In preferred embodiments, the scoop head also comprises at
least one vane (1382) to collect the cerumen and guide the cerumen
in the shovel proximally, toward the shaft (1370), thereby clearing
the distal portion of the shovel and allowing the shovel to collect
further cerumen. The embodiment shown comprises two such vanes.
[0342] The height of the vanes varies, starting from zero at the
vanes' distal end and increasing towards the vanes' proximal end.
In preferred embodiments, the height of the vanes is a maximum near
their proximal end, so that the vanes collect the cerumen but do
not push it, thereby preventing the device from forcing the cerumen
deeper into the ear canal.
[0343] In another variant of the shovel head collector, the means
of guiding the cerumen to move proximally is at least one
ridge.
[0344] In all variants, the collection/guidance means varies in
height from 0 at the distal end to a maximum near the proximal
end.
[0345] The vanes or ridges preferably form segments of a spiral
around the inside of the collector head. Spiral vanes or ridges can
be arranged such that the distal ends of the spirals are separated
longitudinally, as shown in FIG. 14, they can be separated
transversely, for non-limiting example, such that two spirals both
end at the distal end of the collector, and any combination
thereof.
[0346] In some embodiments, the shovel has no vanes or ridges.
[0347] In the embodiment shown, the flexible section (1374)
comprises triangular segments connected by linear sections
providing hinging between the triangular segments. In this
embodiment, the hinging sections are thinner than the triangular
segments they connect.
[0348] It is obvious that the flexible section can have accordion
pleating (1372), can comprise a spiral spring, can be segmented and
connected by hinging sections (1374), or any combination thereof.
Other means of providing flexible connections, as is known in the
art, may be used.
[0349] Preferred embodiments of collector heads designs such as the
scoop or shovel or variants thereof.
[0350] Preferred shaft embodiments incorporate at least one
flexible section, in addition to the flexibility comprised in the
shaft by virtue of the flexible material of which it is comprised.
Preferred embodiments of the shaft comprise a flexible section near
the distal end of the shaft and, therefore, close to the collection
portion of the collector head. The flexible section, by enabling
bending in all three dimensions, both prevents resistance of the
collector head (including the shaft, if present) to bending,
especially about its longitudinal axis and enables the collection
portion, the distal end of the collector head, to accurately
conform to the orientation of the ear canal.
[0351] The flexible section can comprise accordion pleating, a
spiral spring, a more flexible material, a plurality of thin
regions hingedly connecting stiffer regions, a plurality of regions
comprised of a more flexible material hingedly connecting stiffer
regions, and any combination thereof. The main purpose of the
flexible section is to allow the shaft to bend in all three
dimensions so as to enable the collector head to follow the
tortuosity of the ear canal.
[0352] The accordion pleating can be in the form of a plurality of
substantially straight, substantially parallel rows, or it can be
in the form of a continuous spiral, or any combination thereof, so
that the accordion pleating allows the shaft to bend in all three
dimensions.
[0353] The spiral spring can be inserted within a flexible region
of the shaft can be attached to the shaft, preferably on its
interior, or can be embedded within the shaft material. It can be
made of metal, plastic, glass fiber, carbon fiber, any combination
thereof, or of any other suitable material as is known in the art.
The plastic can be polycarbonate, plastic composites, Ultem.RTM.
polyetherimide resin or any other suitable plastic as is known in
the art,
[0354] The spiral spring is firmly attached to the device at both
ends, preferably to the collector head at its distal end and to the
knob, shaft or other rotation mechanism at the proximal end, so
that the spring enables the collector head to bend in all three
directions (providing the same with at least 3 degrees of freedom),
thereby allowing it to follow the tortuosity of the ear canal.
[0355] In preferred embodiments, in the device's undeformed
configuration, the mam longitudinal axis of the spiral spring is
collinear with the main longitudinal axis of the collector
head.
[0356] It is a core concept behind the present invention is to
provide a simple mechanical device for cerumen removal.
[0357] It is another core concept of the invention is that soft
cerumen is amassed in or on the device by mechanical action of at
least a portion of the device and that the amassed cerumen is
removed, with the device, from the ear.
[0358] All of the above are merely examples of embodiments of the
core concepts. Any combination of the above examples remains within
the scope of the invention.
[0359] In the foregoing description, embodiments of the invention,
including preferred embodiments, have been presented for the
purpose of illustration and description.
[0360] They are not intended to be exhaustive or to limit the
invention to the precise form disclosed. Obvious modifications or
variations are possible in light of the above teachings. The
embodiments were chosen and described to provide the best
illustration of the principals of the invention and its practical
application, and to enable one of ordinary skill in the art to
utilize the invention in various embodiments and with various
modifications as are suited to the particular use contemplated. All
such modifications and variations are within the scope of the
invention as determined by the appended claims when interpreted in
accordance with the breadth they are fairly, legally, and equitably
entitled.
* * * * *