U.S. patent application number 17/329944 was filed with the patent office on 2021-09-09 for personalizable system and method for anesthetizing tympanic membrane.
This patent application is currently assigned to TUSKER MEDICAL, INC.. The applicant listed for this patent is TUSKER MEDICAL, INC.. Invention is credited to Bernard H. ANDREAS, Nikhil BHAT, Alfredo CANTU, Rohit GIROTRA, Mansour SALEKI.
Application Number | 20210275759 17/329944 |
Document ID | / |
Family ID | 1000005608767 |
Filed Date | 2021-09-09 |
United States Patent
Application |
20210275759 |
Kind Code |
A1 |
ANDREAS; Bernard H. ; et
al. |
September 9, 2021 |
PERSONALIZABLE SYSTEM AND METHOD FOR ANESTHETIZING TYMPANIC
MEMBRANE
Abstract
Systems and methods are provided for anesthetizing a tympanic
membrane of an ear. The systems are personalizable to ensure proper
anesthetizing solution administration. The systems and methods may
also be useful for administering a solution to the ear canal of a
human patient and for maintaining the solution therein.
Inventors: |
ANDREAS; Bernard H.; (Los
Altos, CA) ; SALEKI; Mansour; (Cupertino, CA)
; GIROTRA; Rohit; (San Francisco, CA) ; CANTU;
Alfredo; (Pleasanton, CA) ; BHAT; Nikhil;
(Fremont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TUSKER MEDICAL, INC. |
Menlo Park |
CA |
US |
|
|
Assignee: |
TUSKER MEDICAL, INC.
Menlo Park
CA
|
Family ID: |
1000005608767 |
Appl. No.: |
17/329944 |
Filed: |
May 25, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16267010 |
Feb 4, 2019 |
11045614 |
|
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17329944 |
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15165660 |
May 26, 2016 |
10195369 |
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16267010 |
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13551965 |
Jul 18, 2012 |
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15165660 |
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61511270 |
Jul 25, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 11/00 20130101;
A61M 2210/0662 20130101; A61B 17/12159 20130101; A61F 2011/085
20130101; A61F 11/12 20130101; A61M 11/006 20140204; A61M 19/00
20130101; A61M 31/00 20130101; A61F 11/004 20130101 |
International
Class: |
A61M 11/00 20060101
A61M011/00; A61F 11/12 20060101 A61F011/12; A61F 11/00 20060101
A61F011/00; A61M 19/00 20060101 A61M019/00; A61B 17/12 20060101
A61B017/12; A61M 31/00 20060101 A61M031/00 |
Claims
1. A method, comprising: engaging an ear plug with an ear canal of
a subject such that a shaft extending through a passageway defined
by the ear plug has a distal end disposed between the ear plug and
a tympanic membrane of the subject, an outer surface of a portion
of the shaft disposed within the passageway being spaced from an
inner surface of the ear plug, the shaft defining a lumen extending
from a proximal end of the shaft to the distal end of the shaft,
the distal end of the shaft defining a plurality of spray holes in
fluid communication with the lumen, and delivering a solution to a
region of the ear canal between the ear plug and the tympanic
membrane via the lumen of the shaft and the plurality of spray
holes to fill the ear canal with the solution from a portion near
the tympanic membrane out toward an outer ear portion.
2. The method of claim 1, further comprising: evacuating air from
the region of the ear canal between the ear plug and the tympanic
membrane.
3. The method of claim 1, wherein the plurality of spray holes face
the tympanic membrane upon the ear plug being engaged with the ear
canal of the subject.
4. The method of claim 1, further comprising: coupling a return
electrode to a skin of the subject, the return electrode
electrically coupled to a control unit; and applying a current to
the solution delivered to the region of the ear canal via an
iontophoresis electrode coupled to the solution, the iontophoresis
electrode electrically coupled to the return electrode via the
control unit.
5. The method of claim 1, wherein an electrode is at least
partially disposed between the ear plug and the portion of the
shaft disposed within the passageway.
6. The method of claim 1, wherein the portion of the shaft disposed
within the passageway has a smaller outer diameter than a portion
of the shaft disposed distal to the ear plug.
7. A system, comprising: an ear plug defining a passageway; and a
shaft partially disposed within the passageway defined by the ear
plug, the shaft having a distal end and a proximal end and defining
a lumen extending from the proximal end to the distal end, the
shaft including a tip portion at the distal end of the shaft, the
tip portion defining a plurality of spray holes in fluid
communication with the lumen, the tip portion disposed distal to
the ear plug and having an outer diameter greater than an outer
diameter of a portion of the shaft proximal of the tip portion.
8. The system of claim 7, further comprising an electrode at least
partially disposed between the ear plug and the portion of the
shaft disposed within the passageway, the ear plug including a vent
system via which accumulated air from a portion of the ear canal
distal to the electrode can be evacuated to a portion of the ear
canal proximal to the electrode.
9. The system of claim 7, further comprising an electrode at least
partially disposed between the ear plug and the portion of the
shaft disposed within the passageway.
10. The system of claim 8, wherein the tip portion is disposed
distal to the electrode.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 16/267,010 filed Feb. 4, 2019 titled "Personalizable
System and Method for Anesthetizing the Tympanic Membrane," which
is a continuation of U.S. patent application Ser. No. 15/165,660,
filed May 26, 2016 titled "Personalizable System and Method for
Anesthetizing the Tympanic Membrane," which is a divisional of U.S.
patent application Ser. No. 13/551,965, filed Jul. 18, 2012 titled
"Personalizable System and Method for Anesthetizing the Tympanic
Membrane," which claims the benefit of U.S. Provisional Patent
Application No. 61,511,270, filed Jul. 25, 2011 titled
"Personalizable System and Method for Anesthetizing the Tympanic
Membrane." All the noted applications are incorporated herein by
reference herein as if reproduced in full below.
TECHNICAL FIELD
[0002] The present invention is generally related to medical
devices and methods and, in particular, to devices and methods for
filling and retaining fluid drug in the ear canal of a human
patient.
BACKGROUND
[0003] The present invention provides systems and methods useful
for anesthetizing the tympanic membrane and/or the ear canal of a
patient in preparation for a surgical procedure, including the
placement of a tympanostomy tube (or pressure equalization tube)
across a tympanic membrane of an ear. Additionally, the invention
provides systems and methods for administering and retaining fluid
in the ear canal of a human patient for treatment of the ear canal
and/or the tympanic membrane.
[0004] Otitis media is among the most common diagnoses made by
pediatricians. A majority of children may have at least one episode
of otitis media ("ear infection") prior to their third birthday.
Otitis media is often caused by an inability of the Eustachian tube
to drain fluid from the middle ear. Otitis media is often treated
with antibiotics.
[0005] A significant number of children exhibit recurrent episodes
of otitis media and/or otitis media with effusion. Treatment of
these more severe cases often involves the placement of a
tympanostomy tube across the tympanic membrane to provide adequate
drainage and/or ventilation of the middle ear and reduce the
likelihood of future infections. Tympanostomy tubes provide fluid
communication between the middle and outer ear (e.g., pressure
equalization) and typically fall out spontaneously within about a
year of placement. Tympanostomy tube placement is among the most
frequent surgical procedures performed in the pediatric population.
It has been estimated that more than a million tympanostomy tubes
may be placed each year, with typical patients being between about
18 months and 7 years of age at the time of the procedure.
[0006] Tympanostomy tube placement is typically performed in an
out-patient surgery setting under general anesthesia. After
administering the general anesthesia, the physician typically first
examines the external auditory canal and tympanic membrane under
microscopic visualization through a hand-held conical shaped
speculum. The physician then makes an incision in the tympanic
membrane (a "myringotomy"), typically using a standard, small
profile scalpel which the physician advances through the conical
speculum. The physician may then pass a suction device through the
myringotomy into the middle ear, to aspirate fluid/effusion from
the middle ear. The physician will then place the tympanostomy tube
across the tympanic membrane, typically using a basic tool, such as
forceps, for holding and advancing the tube into the
myringotomy.
[0007] Systems and methods have been proposed for deploying
tympanostomy tubes without having to use general anesthesia. Such
systems are described for example in U.S. Patent Application
Publication No. 2011/001564 ("Tympanic Membrane Pressure
Equalization Tube Delivery System"), U.S. Patent Application
Publication No. 2010/0198135 ("Systems and Methods for
Anesthetizing Ear Tissue"), U.S. Patent Application Publication No.
2009/0163848 ("Iontophoresis Methods"), and U.S. Patent Application
Publication No. 2009/0262510 ("Disposable Iontophoresis System and
Tympanic Membrane Pain Inhibition Method"), each of which is
incorporated by reference in their entirety. These publications
describe integrated methods for delivering tympanostomy tubes and
appropriate anesthesia, but do not describe how to personalize
these systems for a particular patient, so that delivery of a
tympanostomy tube can be achieved with minimal discomfort to the
patient.
[0008] In light of the above, it would be desirable to provide
improved devices, systems, and methods for delivering an
anesthetizing solution into the ear canal. Such systems and methods
would also be useful for administering other therapeutic solutions
to the ear canal and tympanic membrane. It would generally be
beneficial if these improvements facilitated tympanostomy tube
placement without requiring multiple devices and operator-performed
steps. At least some of these advantages may be provided by the
embodiments described herein.
SUMMARY
[0009] The present invention provides systems and methods for
administering a therapeutic solution to the ear canal and/or for
anesthetizing a tympanic membrane of an ear for surgical procedures
such as placing a tympanostomy tube (or pressure equalization tube)
across the tympanic membrane. The systems are personalizable to
ensure proper anesthetizing solution and/or therapeutic solution
administration.
[0010] In one aspect, the invention is directed to a method for
administering a therapeutic solution to the ear canal of a patient.
The method includes selecting or adjusting a headset based on a
size and shape of the patient's head, positioning the headset about
the patient's head and filling the ear canal with the therapeutic
solution. An ear plug is inserted into the ear canal either prior
to or following filling the ear canal.
[0011] In one embodiment, the method further includes selecting an
ear plug based on a size and shape of the ear canal and positioning
the selected ear plug onto the headset. In another embodiment, the
method includes inserting the ear plug into the patient's ears
prior to filling the ear canal with the therapeutic solution. In
still another embodiment, the method includes inserting the ear
plug into the patient's ear following filling the ear canal with
the therapeutic solution. In yet another embodiment, the
therapeutic solution may be administered to a second ear canal
either simultaneously or sequentially. In a further embodiment, the
headset comprises a first fill system valve through which the
solution is administered to a first ear canal; and in another
embodiment, the headset comprises a second fill system valve
through which the solution is administered to a second ear canal.
In a further embodiment, the solution is administered using a
manual fill nozzle and in another, the therapeutic solution is
retained in the ear canal throughout a predetermined treatment
period. In another embodiment the method further includes removing
the solution from the ear canal following the predetermined
treatment period.
[0012] In another aspect, the invention is directed to a device for
administering a therapeutic solution to the ear canal of a patient.
The device includes a headset having a headset frame that is
designed to conform to the size and shape of the patient's head and
an ear plug that is designed to conform to the size and shape of
the patient's ear canal.
[0013] In one embodiment of the device, the headset further
comprises a fill system for filling the ear canal with the
therapeutic solution. In another embodiment, the fill system
includes a valve for attachment to a therapeutic solution delivery
device, the valve being fluidly connected to a spray tip. In a
further embodiment, the fill system includes a second valve, the
second valve being fluidly connected to a second spray tip. In yet
another embodiment, the headset includes locking arms, the locking
arms having a first position and a second position, the first
position permitting visualization of the ear canal, and the second
position providing for sealing of the ear canal by the ear plug. In
still another embodiment, the ear plugs further include a venting
system selected from the group consisting of vent holes, vent slits
and vent screens.
[0014] In a further aspect, the invention is directed to a method
for administering a therapeutic solution to the ear canal of a
patient and for delivering the solution to the tympanic membrane
using iontophoresis. The method includes selecting or adjusting a
headset based on a size and shape of the patient's head, the
headset including an iontophoresis electrode connected to a control
unit and a return electrode, positioning the headset about the
patient's head, filling the ear canal with the therapeutic
solution, attaching the return electrode to the patient and
activating a control unit to initiate an iontophoresis procedure.
The ear plug is inserted into the ear canal either prior to or
following filling the ear canal.
[0015] In one embodiment, the method includes selecting an ear plug
based on a size and shape of the ear canal and positioning the
selected ear plug onto the headset. In another embodiment, the
method includes inserting the ear plug into the patient's ears
prior to filling the ear canal with the therapeutic solution where
the iontophoresis electrode establishes electrical connection with
the therapeutic solution during filling of the ear canal. In yet
another embodiment, the ear plug is inserted into the patients ears
following filling the ear canal with the therapeutic solution where
the iontophoresis electrode establishes electrical connection with
the therapeutic solution and in another, the therapeutic solution
may be administered to a second ear canal either simultaneously or
sequentially. In a further embodiment, the headset includes a first
fill system valve through which the solution is administered to a
first ear canal; and in another embodiment, the headset includes a
second fill system valve through which solution is administered to
a second ear canal. In a further embodiment, the substance is
administered using a manual fill nozzle and in another, the
therapeutic solution is retained in the ear canal throughout a
predetermined treatment period. In yet another embodiment, the
solution is removed from the ear canal following the predetermined
treatment period.
[0016] In another aspect, the invention is directed to a device for
administering a therapeutic solution to the ear canal of a patient
and for iontophoresis delivery to the tympanic membrane. The device
includes a headset having a headset frame that is designed to
conform to the size and shape of the patient's head and an
iontophoresis electrode that is connected to a control unit and a
return electrode for delivering the solution into the tympanic
membrane, and an ear plug that is designed to conform to the size
and shape of the patient's ear canal.
[0017] In one embodiment, the headset further includes a fill
system for filling the ear canal with the therapeutic solution. In
another embodiment, the fill system includes a valve for attachment
to a therapeutic solution delivery device, the valve being fluidly
connected to a spray tip. In a further embodiment, the fill system
includes a second valve, the second valve being fluidly connected
to a second spray tip. In still another embodiment, the headset
includes locking arms, the locking arms having a first position and
a second position, the first position permitting visualization of
the ear canal and the second position provides for sealing of the
ear canal by the ear plug. In yet another embodiment the ear plugs
further include a venting system selected from the group consisting
of vent holes, vent slits and vent screens.
[0018] In a further aspect, the invention is directed to a method
for anesthetizing a tympanic membrane of a human patient. The
method involves inserting an ear plug sizer into a patient's ear
canal to determine the appropriate ear plug size, and positioning
the ear plug onto a headset. The headset is then positioned about
the patient's head. The ear canal is filled with an anesthetizing
solution and the ear plug of the headset is inserted into the
patient's ear. The control unit is activated to begin the
iontophoresis procedure.
[0019] In one embodiment, the method includes preparing the
anesthetizing solution and warming it to body temperature. In a
further embodiment the method of the invention includes filling the
headset by injecting the solution into a fluid delivery channel of
the headset until the solution exits the ear plugs. In yet another
embodiment, the method of the invention includes removing air from
the fluid delivery channel. The removal of air may be accomplished
using a dual chamber instillation port, or by incorporating a
semi-porous material into the fluid delivery channel.
[0020] In another aspect, the invention is directed to a method for
filling and retaining fluid in the ear canal of a human patient.
The method includes inserting an ear plug sizer into a patient's
ear canal to determine the appropriate ear plug size and selecting
an ear plug based on the determined appropriate ear plug size. The
method further includes positioning the selected ear plug onto a
headset, positioning the headset about the patient's head, and
inserting the ear plug of the headset into the patient's ear for
retaining said fluid in the patient's ear canal. The ear canal is
filled with the fluid during the method for filling and retaining
fluid in the patient's ear canal.
[0021] In a second aspect, the invention is directed to a system
for anesthetizing a tympanic membrane of a human patient. The
system includes ear plug sizers, iontophoresis electrodes, and ear
plugs sized by said ear plug sizers for fluidly sealing an ear
canal of the patient. The ear plugs are positioned about the
iontophoresis electrodes. The system further includes a control
unit and a headset. The headset includes a headset frame that
fluidly connects the iontophoresis electrodes to a source of
anesthetizing solution, and electrically connects the two
electrodes to the control unit.
[0022] In one embodiment, the system includes temporal pads
attached at the ends of the headset frame. In another embodiment,
the system includes a wire support frame to support the ear plug in
the x, y, and z directions. In a further embodiment, the headset
frame is sized according to the size of the patient's head. In yet
another embodiment, the headset frame includes accessories useful
for watching and/or listening to movies, music or video games or
attachments such as horns, antlers, antennas and elephant ears. In
another embodiment, the anesthetizing solution includes lidocaine,
lidocaine plus epinephrine or lidocaine, epinephrine and sodium
bicarbonate.
[0023] In another aspect, the invention is directed to a headset
for use in anesthetizing a tympanic membrane of a human patient.
The headset includes a headset frame with a first headset arm and a
second headset arm. The first headset arm includes a first
iontophoresis electrode and a first fill system tip and the second
headset arm includes a second iontophoresis electrode and a second
fill system tip. The headset frame fluidly connects the
iontophoresis electrodes and the fill system tips to a source of
anesthetizing solution. The fill system tip has an atraumatic tip
and at least one spray hole for delivering the anesthetizing
solution to the tympanic membrane.
[0024] In one embodiment, the fill system tips comprise three spray
holes spaced 120 degrees apart.
[0025] In a further aspect, the invention is directed to a headset
for use in administering a solution into the ear canal of a human
patient and retaining the solution in the ear canal. The headset
has a headset frame with a first headset arm having a first fill
system tip and a first earplug, and a second headset arm having a
second fill system tip and a second earplug. The headset frame
fluidly connects the fill system tips to a source of solution and
the fill system tip has an atraumatic tip and spray holes for
delivering the solution to the ear canal. The ear plugs retain the
solution in the ear.
[0026] In one embodiment, the solution is selected from the group
consisting of an anesthetizing solution, an antibacterial solution,
an antifungal solution, an anti-inflammatory solution or a
ceruminolytic solution.
[0027] In another aspect, the invention is directed to a device for
administering a solution into the ear canal of a human patient. The
device has a distal end with an atraumatic tip and at least one
spray hole, a proximal end with a luer connector for attachment to
a source of solution and a lumen between the proximal end and the
distal end. The lumen has a bend angle of between about 0 and 140
degrees.
[0028] In one embodiment, the lumen has a bend angle of between
about 120 and 140 degrees. In another embodiment, a speculum is
fixedly attached to the device. In still another embodiment, the
solution is selected from the group consisting of an anesthetizing
solution, an antibacterial solution, an antifungal solution, an
anti-inflammatory solution or a ceruminolytic solution.
[0029] In another aspect, the invention is an ear plug sizer kit
for determining the appropriate ear plug for use in a human
patient. The kit includes a first ear plug sizer having a first lug
with a first outer diameter and a first ear plug with a first
sealing diameter. The first lug is fixedly connected to a first end
of a first shaft and the first ear plug is detachably connected to
a second end of the first shaft. The kit further includes a second
ear plug sizer having a second lug with a second outer diameter and
a second ear plug with a second sealing diameter. The second lug is
fixedly connected to a first end of a second shaft and the second
ear plug is detachably connected to a second end of the second
shaft. The first outer diameter is equivalent to the first sealing
diameter and the second outer diameter is equivalent to the second
sealing diameter.
[0030] In another aspect, the invention is a method for filling a
patient's ear canal with a therapeutic solution while minimizing
air bubbles in the ear canal. The method includes sealing the ear
canal with an ear plug such that there is minimal leakage of the
therapeutic solution from the ear canal, providing ear canal vents
for venting air from within the ear canal, and turbulently filling
the ear canal by administering the therapeutic solution through one
or more spray holes in a fill system while venting the ear canal as
a result of low pressure escape of air through the ear canal
vents.
[0031] In one embodiment, the ear canal vents comprise ear plug
vent holes and in another embodiment, the ear canal maintains a
maximum pressure in the ear canal of 25 kilopascals.
[0032] In yet another aspect, the invention is a device for filling
a patient's ear canal with a therapeutic solution while minimizing
air bubbles in a patient's ear canal. The device includes an ear
plug that is designed to conform to the size and shape of the
patient's ear canal to seal the ear canal from leakage of the
therapeutic solution, a fill system including an atraumatic tip
portion and one or more spray holes to turbulently fill the ear
canal with the therapeutic solution, and a vent system that is
designed to maintain a maximum pressure in the ear canal at or
below 25 kilopascals.
[0033] In one embodiment, the vent system comprises ear plug vent
holes. In another embodiment, the fill system comprises three or
more spray holes.
[0034] For a further understanding of the nature and advantages of
the invention, reference should be made to the following
description taken in conjunction with the accompanying figures.
However, each of the figures is provided for the purpose of
illustration and description only and is not intended to limit the
scope of the embodiments of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1A shows a frontal view of an outer ear.
[0036] FIG. 1B shows a partial cross-sectional view of an outer,
middle and inner ear.
[0037] FIG. 2 shows a perspective view of a headset for
iontophoretic substance delivery, according to one embodiment of
the invention.
[0038] FIG. 3A shows a perspective view of a set of ear plug sizers
according to one embodiment of the invention.
[0039] FIG. 3B shows a perspective view of a set of ear plugs for
iontophoretic substance delivery according to one embodiment of the
invention.
[0040] FIG. 3C shows a side view of an ear plug for iontophoretic
substance delivery according to one embodiment of the
invention.
[0041] FIG. 4 shows a perspective view of a return electrode patch
for iontophoretic substance delivery according to one embodiment of
the invention.
[0042] FIG. 5 shows a perspective view of a control unit for
iontophoretic substance delivery according to one embodiment of the
invention.
[0043] FIG. 6 shows a perspective view of the proper positioning of
the headset on a patient's head.
[0044] FIG. 7A shows a perspective view of a manual fill nozzle
according to one embodiment of the invention.
[0045] FIG. 7B shows a perspective view of the nozzle tip of the
manual fill nozzle of FIG. 7A.
[0046] FIG. 7C shows a perspective view of the manual fill nozzle
of FIG. 7A in combination with a speculum according to a further
embodiment of the invention.
[0047] FIG. 8 is a flow diagram showing the method of the invention
for anesthetizing the ear canal.
[0048] FIG. 9 is a perspective view of a headset for iontophoretic
drug delivery according to the invention.
DETAILED DESCRIPTION
[0049] The embodiments of the invention are intended to provide
systems that are useful for delivering and retaining a drug
solution in a patient's ear canal that are individually and
uniquely adapted to be used for a particular patient. In this way,
variations in patient anatomy can be accommodated while maintaining
patient comfort. Further, efficient filling of the ear canal can be
accomplished under direct visualization with a microscope, limiting
the amount of air bubbles in the ear canal, and facilitating the
venting of excess air or fluid.
[0050] FIG. 1A shows a view of an outer ear 10. The outer ear 10
includes a major element known as the auricle 100. The outer ear
serves as a funnel for directing sounds into the internal portions
of the ear. The major physical features of the ear include the
lobule, 102, concha 104, anthelix 106, helix 108, scapha 110,
triangular fossa 112, tragus 114, antitragus 116 and ear canal
118.
[0051] FIG. 1B shows a cross-section of the inner and outer
portions of the ear. The outer ear 10 is shown connected to the ear
canal 118. The ear canal is shown as a relatively straight passage,
but is often a more curved, tortuous passageway. The ear canal is
connected to the middle ear 120, which includes the tympanic
membrane 122. The middle ear 120 in turn is connected to the
internal ear 124 which leads to the auditory tube 126 (also known
as the Eustachian tube). The middle ear 120 normally has a pocket
of air behind the tympanic membrane 122. When the middle ear 120 is
infected, fluid swells behind the tympanic membrane 122. Fluid
expansion causes extreme pain to an individual with a middle ear
infection, as often occurs in young children.
[0052] As can be imagined from FIGS. 1A and 1, the anatomies of the
ear canal 118 and the tympanic membrane 122 are quite variable
across individuals of different ages, and even among those of the
same age. The length and diameter of the ear canal 118 may vary, as
well as its shape. Further, the size and position of the tympanic
membrane 122 is not constant. Accordingly, it would be useful for
treatment of middle ear infection, to be able to individualize the
systems that are used to perform procedures in the ear.
[0053] FIG. 2 shows a headset 200 according to one embodiment of
the invention. The headset 200 includes a headset frame 202, dual
temporal pads 204a and 204b, temporal cushions 206a and 206b,
locking arms 208a and 208b, electrodes 210a and 210b, locking arm
elbows 212a and 212b, fill system valves 214a and 214b, fill system
tips 224a and 224b, fill system tubing 226a and 226b, a return
electrode connector 216, the electrode wiring 218 and the control
unit connector 220.
[0054] The headset 200 is useful for administering an iontophoretic
substance to the ear canal and retaining it in the ear canal for
anesthetizing the ear canal and tympanic membrane prior to
treatment. The frame 202 serves to connect the portions of the
headset together. These portions extend from the right side to the
left side of the head and extend to the temporal pads 204a and 204b
on the right and left side, respectively. The frame 202 is thus
configured to be placed around or over a patient's head. Further,
the frame 202 secures the headset 200 on the patient's head. In
this way, the frame 202 is sized appropriately for the patient such
that when in position over the patient's ears, the frame supplies a
compressive force to the patient's head. A sizing aid may be used
to determine the appropriate headset size. In some embodiments, the
frames come in 3 sizes, small, medium and large, and in other
embodiments, they may come in 2, 4, 5, 6 or more sizes. Further, in
another embodiment, the frame may be expandable such that a single
size may be supplied that can be adjusted according to the size of
the patient's head. In other embodiments, accessories may be
attached to the frame base to entertain a patient during the
iontophoresis procedure. These accessories include, but are not
limited to be re-usable glasses that can stream movies, music,
and/or video games, fun attachments such as horns, antler,
antennas, elephant ears, etc. Bone conduction could also be
included such that a sound vibration element may be incorporated
into the headset to entertain and/or distract a patient.
[0055] In a further aspect, the headset 200 may be useful for
administering a drug solution or other therapeutic solution to the
ear canal and retaining the solution in the ear canal for treating
the ear canal or the tympanic membrane or for anesthetizing the ear
canal or tympanic membrane. The electrodes, return electrode
connector, electrode wiring and control unit connector would not be
present in such system. Such solutions include but are not limited
to antifungal or antibacterial agents such as benzalkonium
chloride, boric acid, acetic acid, and clotrimazole,
anti-inflammatory agents such as beclamethazone and antibiotic and
steroids such as betnesol, prednisolone sodium phosphate,
gentamycin, neomycin, and quinolones, astringent agents such as
aluminum acetate, ceruminolytics such as sodium chloride solution,
hydrogen peroxide or sodium bicarbonate solution. The solutions may
be administered to one ear or both ears (unilaterally or
bilaterally) and the solutions may be administered sequentially or
simultaneously.
[0056] In order to ensure that the ear canal is completely filled
with the drug solution, the ear canal may be initially filled
manually with the therapeutic solution. Such filling of the ear
canal may be done through the use of the manual fill nozzle shown
in FIGS. 7A and 7B and described further below. To ensure that the
ear canal is completely filled and that there are no air pockets
remaining, the patient's head may be tilted to one side, the ear
canal filled using the manual fill nozzle, and then the ear canal
is sealed using the appropriate headset 200 and ear plug 304
combination compatible with the size and shape of the patient's
head and the size and shape of the patient's ear canal, as will be
described further below.
[0057] Once the appropriate headset 200 has been chosen, the
appropriate ear plugs may be chosen such that the plugs can be
attached to the headset and can provide a seal to keep
anesthetizing solution or other therapeutic solution in the ear
canal 118. As shown in FIG. 3A, a set 300 of ear plug sizers 302a,
302b, 302c, 302d, 302e and 302f may be provided that will aid in
determining which size will best fit the patient's anatomy. The ear
plug sizers 302a-f are provided with lugs 303a-f and ear plugs
304a-f In the illustrative embodiment, there are 6 different ear
plug sizes, but in other embodiments there may be 1, 2, 3, 4, 5, 7,
8 or even more than 8 ear plug sizes. The lugs 303a-f are
constructed for example of a rigid plastic material for insertion
past the concha 104 (see FIG. 1A) and into the ear canal (118) for
initial selection of the size of the ear plugs 304a-f. The outer
diameters of the lugs are equivalent to the sealing diameters of
the ear plugs. The ear plugs 304a-f are further shown in FIG. 3B.
Each ear plug 304a-f is made of a flexible material that can
conform to the contours of the ear canal and may be made of
silicone rubber or other similar materials such as polyurethane,
styrene butadiene, butyl, and fluorosilicone rubbers. Each ear plug
304a-f is constructed of a rounded distal end 306 a-f for insertion
into the ear canal 118 and orientation toward the tympanic membrane
122 (see FIG. 1B) and a tubular proximal end 308a-f for attachment
to the ear plug sizer 302a-f (See FIG. 3A) or for attachment to the
headset 200 over electrodes 210a and/or 210b. As shown in FIG. 3C
an exemplary umbrella shaped ear plug 312 has a sealing diameter
(SD) 314 that fits against the ear canal for sealing the
iontophoresis solution into the ear canal and a maximum outer
diameter (OD) 316 contains one to ten vent holes 318 with diameters
between 0.001 and 0.050 inches that enable air and excess fluid to
escape during iontophoresis solution delivery.
[0058] In one embodiment, the ear plugs sizers 302a-f are provided
as a set of six (6) color-coded parts and correspond to six (6)
color-coded ear plug 304a-f sizes. Size 0 (the smallest) is purple
(SD=0.276'', OD=0.323''), Size 1 is orange (SD=0.315'',
OD=0.364''), Size 2 is green (SD=0.354'', OD=0.408''), Size 3 is
yellow (SD=0.394'', OD=0.452''), Size 4 is red (SD=0.433'',
OD=0.497'') and Size 5 is green (SD=0.472'', OD=0.548''). The
shafts 310a-f of the ear plug sizers 302a-f are color-coded, rigid
and attached to the ear plugs 304a-f, so that a health care
professional can hold one of the ear plug sizers 302a-f and insert
it into the ear canal of the patient prior to treatment to
determine the appropriate size useful for the particular anatomy of
the patient. The ear plug sizer that is believed to best match the
opening of the ear canal should be used, and the health care
professional should try one size larger and one size smaller to
confirm the appropriate size. Once the proper ear plug is
determined, it is placed over the locking arm elbow of the headset
200. The lumen of the tubular portion of the selected ear plug is
pushed over the fill system tip 224a or 224b of the headset arm
208a or 208b until it seats into place against the lips 222a and
222b of the locking arm elbows 212a and 212b. The fill system tips
224a and 224b of the headset have three spray holes in an
atraumatic tip for easy filling of the ear canal 118 through the
fluid delivery channels 226a or 226b attached to the fill system
valves 214a and 214b. The spray holes and atraumatic tip portion of
the fill system tips 224a and 224b are similar to the spray holes
806 and atraumatic tip 808 of the manual fill nozzle 800 described
below with regard to FIGS. 7A and 7B. In addition, a design of the
fill system tips 224a and 224b more similar in shape to the ear
canal 118 may be useful. The most distal portion of the fill system
tip 224a and 224b should be near the tympanic membrane such that
the spray holes face the tympanic membrane. Accordingly, the fill
system tips 224a and 224b may essentially span the distance from
the locking elbows 212a and 212b to the tympanic membrane. The
number of spray holes range from one to three or more and are
evenly distributed one from the other (where there are three spray
holes, they are spaced 120 degrees apart) to create turbulence in
the ear canal 118. Further, the most distal portion of the fill
system tip 224a or 224b is designed to face the tympanic membrane
122 such that during iontophoresis, the ear canal fills from the
portions closest to the tympanic membrane out towards the outer ear
10 and air that has accumulated in the ear canal 118 will be
evacuated as a result of low pressure escape of air through vent
holes 318 in the ear plugs 312 as shown in FIG. 3C. In this way,
air bubbles in the ear canal are minimized, leakage of therapeutic
solution from the ear canal is minimized and pressure in the ear
canal is maintained at below about 50 kilopascals and often below
about 25 kilopascals.
[0059] The electrodes 210a and 210b consist of a solid silver
electrode with a cylindrical shape attached to the electrode wiring
218 (see FIG. 2). Small openings in the fluid delivery channels
226a and 226b near the electrodes 210a and 210b ensure that the
electrodes are submerged in and establish electrical connection
with the anesthetizing solution and the system operates properly.
During the iontophoresis procedure, the electrode conductivity
changes due to electrochemical reactions between the electrode and
the anesthetizing solution. This change may raise the voltage from
the iontophoresis system. An electrode with greater surface area
may be desirable. In one embodiment, the electrode may be made of a
single wound coil and in another embodiment, it may be made of two
concentric-oppositely wound coils of silver wire may be provided
with a gap between the inner surface of the outer coil and the
outer surface of the inner coil. The inner coil may have an open
space on the inner diameter. The outer coil may be right hand wound
and the inner coil may left hand wound, or alternatively, the outer
coil may be left hand wound and the inner coil may be right hand
wound. In another embodiment, the coil wire may be formed against
the inside wall of the ear plug lumen and integrated into the ear
plug to provide maximum surface area and maximum space between
electrode elements. The anesthetizing solution flowing in around
the lumen will encounter little interference and therefore will
submerge the electrode efficiently, ensuring good contact with the
electrode. The electrode material can be silver, gold, platinum,
silver-silver chloride, stainless steel or any other materials that
can achieve the electrochemical function of the electrode.
[0060] Once the appropriate ear plug 304 has been placed on the
appropriate headset 200, return electrode patch 400 is attached to
the headset at the return electrode connector 220 by connection at
the mechanically conductive return electrode snap 402. The return
electrode patch 400 is shown in FIG. 4 and may be adhered to the
patient's skin at a clean, dry site, such as the arm or back, that
is clear of lesions, bony protuberances, and excessive hair. A
protective lining may be supplied on the base of the patch 400,
such that when the lining is removed, an adhesive layer on the
patch 400 may be adhered to the skin.
[0061] Following positioning of the headset 200 on the patient's
head and the return electrode patch 400 on the patient's skin as
will be described below, the control unit 500 shown in FIG. 5 may
be connected to the control unit connector 220 on headset 200 as
shown in FIG. 2 and the headset 200 will be clipped to the
patient's or the parent's clothing.
[0062] The method according to the invention is carried out
according to FIG. 8. The anesthetizing solution is prepared (in
this case a solution of 1:12,000 epinephrine, 3.3% lidocaine and
0.7% sodium bicarbonate but may be any appropriate combination
thereof such as lidocaine, lidocaine plus epinephrine, or lidocaine
plus epinephrine and sodium bicarbonate or other anesthetizing
solution known in the art) and warmed to body temperature. A
syringe is filled with approximately 10 cc of anesthetizing
solution. The headset 200 is prepared for placement on the patient
as follows. As previously described above with regard to FIGS. 3A,
3B and 3C, an ear plug sizer is placed into a patient's ear canal
to determine the appropriate ear plug size for personalization of
the headset according to the size and shape of the patient's ear
canal (610). The appropriate ear plug is positioned onto the
headset (620). The spring loaded locking arms 208a and 208b are
opened and locked by rotating them outwards until they click and
until they hold a position pointing in the outward direction. While
being held at the site of the temporal pads 204a and 204b, the
headset 200 is carefully placed about the patient's head (630) such
that the temporal cushions 206a and 206b are resting on the
patient's temporal bone and the headset frame 202 is routed around
the back of the patient's head (see FIG. 6). The return electrode
patch 400 is connected to the headset 200 via the return electrode
snap 402 on the electrode patch 400 and the return electrode
connector 216 on the headset 200 and the adhered to the patient.
The integrated fill system of the headset is primed with the
anesthetizing solution by attaching the syringe to the fill system
valves 214a and 214b and injecting until the solution exits the ear
plug 312. The syringe is disconnected and reconnected to the other
side if both ears are being treated. The syringe is then connected
to the manual fill nozzle 800 (See FIGS. 7A and 7B).
[0063] Once the headset 200 is properly primed and positioned, the
auricle 100 of the ear is gently pulled to straighten the ear canal
118. Using the syringe with the manual fill nozzle 800 attached at
the luer connector 802, the ear canal 118 is manually filled with
anesthetizing solution (640), taking care to eliminate air bubble
formation during the fill (see FIGS. 7A and 7B). The manual fill
nozzle 800 has a proximal end 812, a distal end 814 and a lumen 816
therebetween that may have a bend angle 804 of 130 degrees (or
between about 120 degrees and 140 degrees, or it may have an angle
of between 0 and 140 degrees to enable microscopic visualization of
the ear canal while the solution is administered) and 3 spray holes
806 in an atraumatic tip 808 for easy filling of the ear canal 118
under direct visualization. A typical ear canal 118 will
accommodate approximately 1-2 cc of fluid. The anesthetizing
solution is administered via the manual fill nozzle 800 at a flow
rate of approximately 0.5 cc/sec and is overfilled to ensure that
all air has been evacuated. The three spray holes distributed 120
degrees apart on the tip provide for solution turbulence when
filling the ear canal. There may be any number of spray holes
between 3 and 12, for example 4, 5, 6 or more spray holes that are
distributed about the atraumatic tip 808 of the manual fill nozzle
800. After the anesthetizing solution has been administered to the
ear canal, while holding the auricle 100 with one hand, the other
hand may be used to unlock the locking arms 212a and 212b of the
headset 200 and insert the ear plug 312 into the ear canal so that
the tip of the ear plug 312 points towards the tympanic membrane
(650). In addition, the locking and unlocking of the locking arms
212a and 212b may be carried out at any time during the filling ear
canal and iontophoretic delivery of the solution in order to
visually observe the ear canal.
[0064] The headset control unit connector 220 is connected to the
control unit 500 until it snaps in place. The battery tab located
on the back of the control unit case is removed. Empty status bars
should appear on screen once the device is powered on. To start the
iontophoresis procedure, the control unit is activated (660) by
pressing the yellow button 502 and/or the blue button 504 on the
control unit 500 are holding for 2 seconds. Each button controls an
independent channel, with button colors corresponding to the colors
of the left and right sides of the headset. A short beep confirms
when a button has been activated. The control unit 500 is clipped
to the patient's or the parent's clothing. The status bars will
fill up to indicate each channel's progress toward completion. A
typical procedure takes approximately 10 minutes, with each status
bar segment representing approximately 20% of procedure time. A
flashing segment indicates that current is running; a solid segment
indicates the portion already completed. To pause the procedure,
the button for the appropriate channel is pressed and held for 2
seconds. The pause symbol and status bar segment will both flash
and then turn solid when current delivery has stopped. To resume
the procedure, the same button is pressed and held for 2 seconds.
The control unit 500 will play a long beep when each channel
(yellow or blue side) has completed delivering a full dose. The
status bars will also turn completely solid to indicate that full
charge has been delivered through each channel. Once the tympanic
membrane is anesthetized, to deactivate the control unit, the
button for the appropriate channel is pressed and held for 2
seconds (670). Alternatively, the control unit may stop after a
preset period of time of between about 5 minutes and 60 minutes,
often between about 5 minutes and 30 minutes or about 10
minutes.
[0065] The procedure described above may also be useful for
administering a therapeutic solution to the ear canal without the
use of iontophoresis. The headset may be placed on the head of the
patient and the ear may be primed with the therapeutic solution as
described above followed by placement of the ear plugs into the
ears, or the ear plugs may be inserted into the ears and the
therapeutic solution administered through the headset fill system
valves 214a and 214b. One or both of the valves (in this case, one
way valves) are connected to delivery devices such as syringes or
delivery pumps and the therapeutic solution is administered to one
or both ear canals (unilaterally or bilaterally) either
sequentially or simultaneously. As noted above, vent holes 318 are
incorporated in the ear plugs to ensure that the ear canal is not
over filled and thereby cause pressure to build up in the ear
canal. Other vent systems for ensuring proper venting to ensure
that patient comfort is maintained include but are not limited to
vent slits and vent screens.
[0066] Proper sizing of the headset and the ear plugs ensure proper
filling of the ear canal and further aid in retaining the
therapeutic solution in the ear canal for a predetermined period of
time that coincides with the duration of therapy. Such period of
time may be from about five to ten minutes to about one to two
hours. The therapeutic solution may be removed from the ear canal
following the therapy by positioning of the patient's head,
suctioning of the ear canal, or other procedures including but not
limited to tympanocentesis.
[0067] In an alternative aspect of the invention, the manual fill
nozzle 800 shown in FIG. 7A and FIG. 7B may be incorporated into a
rigid speculum 810 and fixedly attached thereto as shown in FIG. 7C
for easy and accurate insertion of the nozzle 800 by the physician
user allowing direct visualization of the outer ear and the
tympanic membrane. Further, the manual fill nozzle may be used for
purposes other than administration of iontophoresis solution. It
may be used for anesthetizing the ear canal or tympanic membrane or
for administering solutions for other therapeutic purposes. Such
solutions include but are not limited to antifungal or
antibacterial agents such as benzalkonium chloride, boric acid,
acetic acid, and clotrimazole, anti-inflammatory agents such as
beclamethazone and antibiotic and steroids such as betnesol,
prednisolone sodium phosphate, gentamycin, neomycin, and
quinolones, astringent agents such as aluminum acetate,
ceruminolytics such as sodium chloride solution, hydrogen peroxide
or sodium bicarbonate solution.
[0068] An alternative headset 700 is shown in FIG. 9. In this
embodiment, a wire support frame 702 is provided to minimize hand
to auricle contact by the healthcare professional, reduce the time
to insert the ear plugs 704a and 704b into the ear canals, and
provide support to the ear plug in the x, y and z axis. A wire
frame 706a and 706b for around each ear is provided to support the
ear plug in the x and y directions and a pad 708a and 708b for each
ear, in this case of white foam Y20 cross-linked closed cell 2
pound density but may be other similar material, is provided to
support the ear plug in the z direction. In this embodiment, and in
the embodiments described above, the headset and fill systems are
designed for maximum patient comfort and stability. The headsets
are designed such that the pressure of the device is distributed
about the patient's head and not solely in or on the ears. The fill
system tubing is routed (and iontophoresis system wiring, if
included) outside of the treatment area, such as behind the
patient's head and may be secured behind the patient's neck with a
system connector such as a tie, clip or other similar
connector.
[0069] As noted above, according to the method of the invention, it
is important to ensure that air bubbles in the anesthetizing
solution or therapeutic solution are minimized Air bubbles may
result from a variety of conditions including but not limited to
orientation of the canal relative to gravity, surface tension of
the liquid and surface conditions of the canal, such as a waxy ear
canal wall. An alternative system is described for evacuating the
external ear canal prior to filling such that minimal air bubbles
are left behind in the anesthetizing solution. To enable reliable
and tolerable filling of an ear canal in an awake patient,
evacuation of entrapped air bubbles may be accomplished by
providing a dual chamber instillation device. A first chamber of
double or triple the volume of the liquid required to fill the
canal is provided. This first chamber has a plunger or other means
to forcibly expel liquid out and through an instillation port. A
second chamber, vented to atmosphere, captures and stores excess
liquid returning from the outlet port. Ear plugs with instillation
and outlet ports are hydraulically balanced to enable filling of
the ear canal with low pressure (supplied through the Instillation
Chamber). Balancing is achieved by orifice diameter selection. The
instillation port is constructed to create a turbulent flow at low
exit pressure such that an irrigation effect is achieved, maximum
surface wetting is obtained with minimum flow rate, and mobility of
air bubbles is maximized. The slight positive pressure created
within the ear canal mobilizes any air bubbles such that they will
travel out of the outlet port. Low exit pressure is required to
minimize the likelihood of pain due to high pressure jetting of
liquid against sensitive tissue of the ear canal wall or tympanic
membrane. Embodiments of the instillation port include tubing with
a fine mesh screen to create separation and reduce fluid head, and
alternatively, providing a tube with a coaxial, protracting
structure to divert and separate flow.
[0070] In operation, the instillation chamber is filled with a
volume greater than the volume of the ear canal. Ear plugs are
inserted into the ear canal. The patient's ear canal is oriented
vertically to reduce the likelihood of bubble entrapment. The
plunger is driven to completely expel all liquid from the
instillation chamber. The instillation device is disconnected from
the plug and a fluid seal is maintained with bubbles evacuated.
[0071] Air in the fluid delivery channel and inside the electrode
must be removed with low fluid pressure in order to minimize
dead-space that would insulate the working electrode from the fluid
and therefore increase system impedance. A method to manage air
entrapment during application and use of anesthesia fluid is
further described herein. Semi-porous material such as expanded
polytetrafluoroethylene (EPTFE) or sintered solid EPTFE may be
incorporated directly into the electrode housing or inside the ear
canal interface of the device. The air in the fluid delivery
channel and inside the electrode housing may be removed with low
anesthetizing solution pressure since the required fluid pressure
is inversely proportional to the porosity of the material used. To
further remove entrapped air such as microbubbles in the system, a
surfactant may be added to the anesthetizing solution to assist
wetting and effectively decrease the surface tension of the
incoming liquid to prevent formation of the bubble. Such
surfactants may be any commonly used surfactant such as
polyethylene glycol. During system filling, this would allow for
dislodgement, coalescence and escape of microbubbles from the
system through the semi-porous material. Other alternatives to
remove entrapped air include a fluid-activated valve that would
allow air to escape but would seal itself upon fluid entry, a
one-way air valve incorporated in vent holes that would allow air
and fluid to overflow but prevent any fluid from re-entering the
system, an air reservoir in the system that would allow entrapped
air to accumulate but strategically located not to disrupt
anesthetizing solution delivery, or reducing surface tension by
cleaning or etching the parts or enhancing their surface finishes
such that microbubble formation is reduced.
[0072] Minimizing surface area on the inside of the ear plugs to
prevent air bubbles from sticking to the inside surface of the ear
ply and travelling into the elbow, blocking the conductance of the
electrode is accomplished by providing 4 slots equally spaced at 90
degrees apart starting on the outside surface of the ear plug and
travelling around to the inside diameter on the distal end of the
ear plug. Flat surface are inside the ear plug creates tension
between the air bubble and the earplug with allow the air bubbles
to block electrode conductance. Slotted surface are minimized
tension between air bubbles and the plug preventing such
blockage.
[0073] Fluid leakage around the earplugs leads to air pockets in
the ear canal that disrupt iontophoresis. With a constant pressure
system, when fluid leaves the ear, it is immediately replaced,
reducing air pocket development and further reducing user
variability in delivering the fluid and the possibility of
insufficient fluid in the ear canal. In an alternative embodiment
of the invention, a compressed air canister is preloaded with a
desired pressure. This air pressure is allowed to press against a
piston, thereby delivering anesthetizing solution at a desired
pressure. In an alternative embodiment, an expanding polymer such
as polyacrylic acid can be used to created pressure, thereby
propelling the anesthetizing solution once the polymer is wetted.
Further embodiments would involve the use of a spring or rubber
band to propel the anesthetizing solution or the use of a weight to
press down on the anesthetizing solution with a constant
gravitational force. Yet another embodiment would contemplate the
acceleration of anesthetizing solution using an electrical charge
to deliver precise pressure levels for delivery of the
anesthetizing solution.
[0074] The invention has been described with reference to certain
examples or embodiments of the invention, but various additions,
deletions, alterations and modifications may be made to those
examples and embodiments without departing from the intended spirit
and scope of the invention. For example, any element or attribute
of one embodiment or example may be incorporated into or used with
another embodiment or example, unless otherwise specified or if to
do so would render the embodiment or example unsuitable for its
intended use. Also, where the steps of a method or process have
been described or listed in a particular order, the order of such
steps may be changed unless otherwise specified or unless doing so
would render the method or process unworkable for its intended
purpose. All reasonable additions, deletions, modifications and
alterations are to be considered equivalents of the described
examples and embodiments and are to be included within the scope of
the following claims.
* * * * *