U.S. patent application number 12/553953 was filed with the patent office on 2010-03-04 for apparatus, system, and method for treating atypical headaches.
Invention is credited to Stephen Eldredge.
Application Number | 20100057048 12/553953 |
Document ID | / |
Family ID | 41726469 |
Filed Date | 2010-03-04 |
United States Patent
Application |
20100057048 |
Kind Code |
A1 |
Eldredge; Stephen |
March 4, 2010 |
Apparatus, System, and Method for Treating Atypical Headaches
Abstract
An apparatus, system, and method are disclosed for facilitating
intranasal administration of a medication to a patient's
sphenopalatine/pterygopalatine recess. The apparatus includes a
catheter having a lumen disposed therethrough, the catheter
comprising an insertion end and a manipulation end, the insertion
end having an intrinsic curvature with respect to a longitudinal
axis of the catheter such that the insertion end of the catheter
lies in a first plane and the manipulation end lies in a second
plane, wherein the catheter smoothly transitions between the first
plane and the second plane, the intrinsic curvature conforming to a
patients nasal anatomy such that the catheter may be inserted into
a sphenopalatine/pterygopalatine recess. The apparatus also
includes a straightening member configured to removably engage the
catheter. The straightening member straightens the intrinsic
curvature such that the first plane and the second plane are
aligned when the catheter is engaged by the straightening
member.
Inventors: |
Eldredge; Stephen; (Orem,
UT) |
Correspondence
Address: |
Kunzler & McKenzie
8 EAST BROADWAY, SUITE 600
SALT LAKE CITY
UT
84111
US
|
Family ID: |
41726469 |
Appl. No.: |
12/553953 |
Filed: |
September 3, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61094323 |
Sep 4, 2008 |
|
|
|
Current U.S.
Class: |
604/514 ;
604/528 |
Current CPC
Class: |
A61B 17/24 20130101;
A61M 2025/0004 20130101; A61M 25/0032 20130101; A61M 2025/0681
20130101; A61M 25/0071 20130101; A61M 25/0021 20130101; A61M 15/08
20130101; A61M 25/0041 20130101; A61M 11/007 20140204; A61M 31/00
20130101; A61M 2025/0008 20130101; A61M 11/06 20130101 |
Class at
Publication: |
604/514 ;
604/528 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 19/00 20060101 A61M019/00 |
Claims
1. An apparatus facilitating intranasal administration of a
medication to a patients sphenopalatine/pterygopalatine recess, the
apparatus comprising: a catheter having a lumen disposed
therethrough, the catheter comprising an insertion end and a
manipulation end, the insertion end having an intrinsic curvature
with respect to a longitudinal axis of the catheter such that the
insertion end of the catheter lies in a first plane and the
manipulation end lies in a second plane, wherein the catheter
smoothly transitions between the first plane and the second plane,
the intrinsic curvature conforming to a patients nasal anatomy such
that the catheter may be inserted into a
sphenopalatine/pterygopalatine recess; a straightening member
configured to removably engage the catheter, wherein the
straightening member straightens the intrinsic curvature of the
insertion end such that the first plane and the second plane are
aligned when the catheter is engaged by the straightening
member;
2. The apparatus of claim 1, wherein the catheter further
comprising a second lumen, wherein the straightening member
comprises a stylus configured to be received within the second
lumen.
3. The apparatus of claim 2, wherein the stylus is keyed to fit
within the second lumen in one predefined orientation, the stylus
identifying a direction of the intrinsic curvature when the stylus
is disposed within the second lumen.
4. The apparatus of claim 1, further comprising a spray orifice and
a medication delivery port, the spray orifice disposed adjacent to
the insertion end of the catheter, the spray orifice in fluid
communication with the lumen, the medication delivery port
configured to receive a medication and deliver the medication
through the lumen to the spray orifice.
5. The apparatus of claim 1, wherein the straightening member
comprises a sleeve configured to receive the catheter, wherein the
sleeve straightens the intrinsic curvature of the catheter when the
catheter is received within the sleeve.
6. The apparatus of claim 1, further comprising a rotational
direction indicator disposed on the catheter, the rotational
direction indicator identifying a direction of the intrinsic
curvature.
7. The apparatus of claim 1, further comprising a depth indicator
disposed on the catheter, the depth indicator identifying a defined
depth.
8. The apparatus of claim 7, wherein the defined depth comprises a
depth equaling a distance between an entrance to a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril.
9. The apparatus of claim 7, further comprising a second depth
indicator disposed on the catheter, the second depth indicator
identifying a second defined depth, the second defined depth
comprising a depth equaling a distance between a location at a
posterior position within a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril.
10. The apparatus of claim 7, wherein the depth indicator is
moveable on the catheter such that a physician can adjust a
position of the depth indicator according to a patient's nasal
anatomy.
11. The apparatus of claim 7, wherein the depth indicator
identifies the typical distance between a patient's external
opening of a nostril and the patient's
sphenopalatine/pterygopalatine recess according to a criteria
selected from a patient's gender and age.
12. An apparatus facilitating intranasal administration of a
medication to a patients sphenopalatine/pterygopalatine recess, the
apparatus comprising: a catheter having a first lumen and a second
lumen, the catheter comprising an insertion end and a manipulation
end, the insertion end having an intrinsic curvature with respect
to a longitudinal axis of the catheter such that the insertion end
of the catheter lies in a first plane and the manipulation end lies
in a second plane, wherein the catheter smoothly transitions
between the first plane and the second plane, the intrinsic
curvature conforming to a patients nasal anatomy such that the
catheter may be inserted into a sphenopalatine/pterygopalatine
recess; a stylus configured to be removably received within one of
the first lumen and the second lumen, wherein the stylus
straightens the intrinsic curvature of the insertion end such that
the first plane and the second plane are aligned when the stylus is
received within one of the first lumen and the second lumen; a
spray orifice disposed adjacent to the insertion end of the
catheter, the spray orifice in fluid communication with at least
one of the first lumen and the second lumen; and a medication
delivery port disposed adjacent to the manipulation end of the
catheter, the medication delivery port configured to receive a
medication and deliver a medication through at least one of the
first lumen and the second lumen to the spray orifice.
13. The apparatus of claim 12, wherein the stylus is keyed to fit
within at least one of the first lumen and the second lumen in one
predefined orientation, the stylus identifying a direction of the
intrinsic curvature when the stylus is disposed within one of the
first lumen and the second lumen.
14. The apparatus of claim 12, further comprising a rotational
direction indicator disposed on the catheter, the rotational
direction indicator identifying a direction of the intrinsic
curvature.
15. The apparatus of claim 1, further comprising a depth indicator
disposed on the catheter, the depth indicator identifying a defined
depth, wherein the defined depth comprises a depth equaling a
distance between an entrance to a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril.
16. The apparatus of claim 15, further comprising a second depth
indicator disposed on the catheter, the second depth indicator
identifying a second defined depth, the second defined depth
comprising a depth equaling a distance between a location at a
posterior position within a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril.
17. The apparatus of claim 15, wherein the depth indicator is
moveable on the catheter such that a physician can adjust a
position of the depth indicator according to a patient's nasal
anatomy.
18. A method for treating migraines, the method comprising:
inserting a catheter and a straightening member into a nostril of a
patient, the catheter comprising an insertion end and a
manipulation end, the insertion end having an intrinsic curvature
with respect to a longitudinal axis of the catheter such that the
insertion end of the catheter lies in a first plane and the
manipulation end lies in a second plane, wherein the catheter
smoothly transitions between the first plane and the second plane,
the intrinsic curvature conforming to a patients nasal anatomy such
that the catheter may be inserted into a
sphenopalatine/pterygopalatine recess, the straightening member
removably engaging the catheter, wherein the straightening member
straightens the intrinsic curvature of the insertion end such that
the first plane and the second plane are aligned when the catheter
is engaged by the straightening member; advancing the catheter and
the straightening member past a middle sinus turbinate in the
nostril of the patient; removing the straightening member from the
catheter such that the catheter bends in a direction towards a
sphenopalatine/pterygopalatine recess of the patient; advancing the
catheter into the sphenopalatine/pterygopalatine recess; and
dispensing a medication to a sphenopalatine/pterygopalatine ganglia
disposed within the sphenopalatine/pterygopalatine recess of the
patient.
19. The method of claim 18, further comprising identifying a
direction of the intrinsic curvature and aligning the intrinsic
curvature of the catheter with the patient's
sphenopalatine/pterygopalatine recess.
20. The method of claim 18, further comprising identifying a
defined depth of the catheter, the defined depth comprising a depth
equaling a distance between an entrance to a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/094,323 entitled "Apparatus, system and method
for treating atypical headaches" and filed on Sep. 4, 2008 for
Stephen Eldredge, which is incorporated herein by reference.
FIELD
[0002] This invention relates to parasympathetic nerve blockade and
more particularly relates to blockade of
sphenopalatine/pterygopalatine ganglia.
BACKGROUND
Description of the Related Art
[0003] Sympathetic pain is a type of nerve pain that arises due to
abnormalities in the function of the sympathetic nervous system.
With sympathetic pain an abnormality in a group of nerves called a
ganglion cause pain to an organ or body region. To treat
sympathetic pain physicians can block a ganglion with the injection
of medication into a specific area of the body. To therapeutically
treat acute pain a physician injects a local anesthetic into the
affected neuronal ganglion. This type of treatment may be referred
to as a nerve block.
[0004] The sphenopalatine/pterygopalatine ganglia is a neuronal
structure located principally in the center of the head in the
pterygopalatine fossa posterior to the middle turbinate. The
sphenopalatine/pterygopalatine ganglia comprises the largest
cluster of sympathetic neurons in the head outside of the brain.
The sphenopalatine/pterygopalatine ganglia interfaces and directs
nerve impulses to the majority of the head's autonomic or
parasympathetic pathways. Therefore, any abnormality or injury to
this structure may cause severe pain. A nerve block of the
sphenopalatine/pterygopalatine ganglia is effective in relief in a
variety of pain conditions ranging from headache to lower back
pain. Additionally, other disease processes such as headache
disorders and other neurological conditions can be arrested, or
improved by local anesthetic blockade, and/or other pharmacological
augmentation or mechanical alteration of the
sphenopalatine/pterygopalatine ganglia and surrounding
structures.
[0005] Unfortunately, because of the anatomical position of the
sphenopalatine/pterygopalatine ganglia, the structure is very
difficult to block with a local anesthetic solution. The anatomical
location of the sphenopalatine/pterygopalatine ganglia is
dangerously close to many vital and delicate mid brain structures.
Although direct needle placement can be employed under fluoroscopic
guidance to administer anesthetic to the
sphenopalatine/pterygopalatine ganglia, most practitioners will not
attempt the procedure due to the technical difficulty and extreme
dangers of an aberrant needle placement.
SUMMARY
[0006] From the foregoing discussion, it should be apparent that a
need exists for an apparatus, system, and method for treating
parasympathetic nerve pain in the sphenopalatine/pterygopalatine
ganglia. Beneficially, such an apparatus, system, and method would
administer medication directly to the
sphenopalatine/pterygopalatine ganglia.
[0007] The present invention has been developed in response to the
present state of the art, and in particular, in response to the
problems and needs in the art that have not yet been fully solved
by currently available local anesthetic blockade methods, systems
and apparatus for administering medication to a patient's
sphenopalatine/pterygopalatine ganglia. Accordingly, the present
invention has been developed to provide an apparatus, system, and
method for performing a nerve block of the
sphenopalatine/pterygopalatine ganglia that overcome many or all of
the above-discussed shortcomings in the art.
[0008] The apparatus, in one embodiment, includes a catheter, a
straightening member, a spray orifice and a medication delivery
port. In certain embodiments the catheter has a lumen disposed
therethrough. The catheter includes an insertion end and a
manipulation end. The insertion end of the catheter has an
intrinsic curvature with respect to a longitudinal axis of the
catheter such that the insertion end of the catheter lies in a
first plane and the manipulation end lies in a second plane. The
catheter smoothly transitions between the first plane and the
second plane such that the intrinsic curvature is rounded and
conforms to a patient's nasal anatomy. In certain embodiments the
intrinsic curvature allows the catheter to be inserted into a
sphenopalatine/pterygopalatine recess with minimum discomfort to
the patient.
[0009] In one embodiment the straightening member is configured to
removably engage the catheter. The straightening member straightens
the intrinsic curvature of the insertion end such that the first
plane and the second plane are aligned when the catheter is engaged
by the straightening member. Thus, with the intrinsic curvature of
the catheter straightened, the catheter can easily be inserted into
a patients nasal cavity.
[0010] The spray orifice is located adjacent to the insertion end
of the catheter. The spray orifice is in fluid communication with
the lumen which is in communication with the medication delivery
port. The medication delivery port is located adjacent to the
manipulation end of the catheter and is configured to receive a
medication and deliver the medication through the lumen to the
spray orifice.
[0011] The apparatus, in one embodiment, also includes a second
lumen. The straightening member in certain embodiments includes a
stylus configured to be received within the second lumen. In one
embodiment the stylus is keyed to fit within the second lumen in
one predefined orientation. In such an embodiment the stylus may
identify a direction of the intrinsic curvature when the stylus is
disposed within the second lumen. The stylus may also include a
finger tab for manipulating the catheter.
[0012] In another embodiment the straightening member may be a
sleeve configured to receive the catheter. In such an embodiment
the sleeve may be configured to straighten the intrinsic curvature
of the catheter when the catheter is received within the
sleeve.
[0013] In one embodiment the apparatus may also include a
rotational direction indicator that identifies a direction of the
intrinsic curvature when the catheter is placed within the
patient's nasal cavity. Thus, a physician may be able to identify
the rotational direction of the spray orifice without being able to
see the spray orifice or intrinsic curvature. Similarly, in certain
embodiments the apparatus may include a depth indicator located on
the catheter to identifying a defined depth. In one embodiment the
defined depth is a depth equaling a distance between an entrance to
a patient's sphenopalatine/pterygopalatine recess and an external
entrance to the patient's nostril. In certain embodiments the
apparatus includes a second depth indicator located on the
catheter. The second depth indicator may identify a second defined
depth. The second defined depth may be a depth equaling a distance
between a location at a posterior position within a patient's
sphenopalatine/pterygopalatine recess and an external entrance to
the patient's nostril. In one embodiment the depth indicators are
moveable on the catheter so that a physician can adjust a position
of the depth indicator according to a patient's nasal anatomy. In
another embodiment the depth indicators may be preposition to
identify the typical distance between a patient's external opening
of a nostril and the patient's sphenopalatine/pterygopalatine
recess. The typical distance between a patient's external opening
of a nostril and the patient's sphenopalatine/pterygopalatine
recess may vary according to a patient's gender or age.
[0014] A method of the present invention is also presented for
treating migraines. The method in the disclosed embodiments
substantially includes the steps necessary to carry out the
functions presented above with respect to the operation of the
described apparatus. In one embodiment, the method includes
inserting a catheter and a straightening member into a nostril of a
patient, advancing the catheter and the straightening member past a
middle sinus turbinate in the nostril of the patient. The catheter
includes an insertion end and a manipulation end. The insertion end
has an intrinsic curvature with respect to a longitudinal axis of
the catheter such that the insertion end of the catheter lies in a
first plane and the manipulation end lies in a second plane. The
catheter smoothly transitions between the first plane and the
second plane with the intrinsic curvature conforming to a patient's
nasal anatomy. This allows the catheter to easily be inserted into
a sphenopalatine/pterygopalatine recess. The straightening member
removably engages the catheter and straightens the intrinsic
curvature of the insertion end such that the first plane and the
second plane are aligned when the catheter is engaged by the
straightening member.
[0015] The method also may include removing the straightening
member from the catheter such that the catheter bends in a
direction towards a sphenopalatine/pterygopalatine recess of the
patient and advancing the catheter into the
sphenopalatine/pterygopalatine recess. In certain embodiments the
method also includes dispensing a medication to a
sphenopalatine/pterygopalatine ganglia disposed within the
sphenopalatine/pterygopalatine recess of the patient.
[0016] In a further embodiment, the method includes identifying a
direction of the intrinsic curvature and aligning the intrinsic
curvature of the catheter with the patient's
sphenopalatine/pterygopalatine recess. In another embodiment the
method includes identifying a defined depth of the catheter. In one
embodiment the defined depth is a depth equaling a distance between
an entrance to a patient's sphenopalatine/pterygopalatine recess
and an external entrance to the patient's nostril.
[0017] Reference throughout this specification to features,
advantages, or similar language does not imply that all of the
features and advantages that may be realized with the present
invention should be or are in any single embodiment of the
invention. Rather, language referring to the features and
advantages is understood to mean that a specific feature,
advantage, or characteristic described in connection with an
embodiment is included in at least one embodiment of the present
invention. Thus, discussion of the features and advantages, and
similar language, throughout this specification may, but do not
necessarily, refer to the same embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] In order that the advantages of the invention will be
readily understood, a more particular description of the invention
briefly described above will be rendered by reference to specific
embodiments that are illustrated in the appended drawings.
Understanding that these drawings depict only typical embodiments
of the invention and are not therefore to be considered to be
limiting of its scope, the invention will be described and
explained with additional specificity and detail through the use of
the accompanying drawings, in which:
[0019] FIG. 1 is a cutaway view illustrating one embodiment of the
facial anatomy of a patient upon which the apparatus, system and
method of the present invention may be employed;
[0020] FIG. 2 is a cutaway view illustrating a prior art method of
treating headaches;
[0021] FIG. 3 is a cutaway view illustrating a prior art method of
treating headaches;
[0022] FIG. 4 is a side view illustrating one embodiment of a
sphenocath apparatus for treating headaches in accordance with the
present invention;
[0023] FIG. 5A is a side view illustrating one embodiment of a
sphenocath apparatus with a stylus inserted into a lumen to
straighten the sphenocath in accordance with the present
invention;
[0024] FIG. 5B is a side view illustrating one embodiment of a
sphenocath with a stylus partially removed from the lumen such that
the sphenocath curves according to an intrinsic curvature in
accordance with the present invention;
[0025] FIG. 5C is a side view illustrating one embodiment of a
sphenocath apparatus with a catheter having an intrinsic curvature
received within a sleeve to straighten the intrinsic curvature in
accordance with the present invention;
[0026] FIG. 5D is a side view illustrating one embodiment of a
sphenocath with a catheter having an intrinsic curvature partially
removed from a sleeve such that the intrinsic curvature curves in
accordance with the present invention;
[0027] FIG. 6A is a cutaway view illustrating one embodiment of a
catheter with a keyed lumen in accordance with the present
invention;
[0028] FIG. 6B is a cutaway view illustrating one embodiment of a
catheter with three lumens in accordance with the present
invention;
[0029] FIG. 6C is a cutaway view illustrating one embodiment of a
catheter with four lumens in accordance with the present
invention;
[0030] FIG. 7 is a cutaway view illustrating one embodiment of a
sphenocath inserted within the nasal cavity of a patient in
accordance with the present invention;
[0031] FIG. 8 is a cutaway view illustrating one embodiment of a
sphenocath advanced into the sphenopalatine/pterygopalatine recess
of a patient in accordance with the present invention; and
[0032] FIG. 9 is a side view illustrating one embodiment of a
sphenocath apparatus for treating headaches in accordance with the
present invention;
[0033] FIG. 10 is a schematic block diagram illustrating one
embodiment of a method for treating headaches in accordance with
the present invention.
DETAILED DESCRIPTION
[0034] Reference throughout this specification to "one embodiment,"
"an embodiment," or similar language means that a particular
feature, structure, or characteristic described in connection with
the embodiment is included in at least one embodiment of the
present invention. Thus, appearances of the phrases "in one
embodiment," "in an embodiment," and similar language throughout
this specification may, but do not necessarily, all refer to the
same embodiment.
[0035] Furthermore, the described features, structures, or
characteristics of the invention may be combined in any suitable
manner in one or more embodiments. In the following description,
numerous specific details are provided to provide a thorough
understanding of embodiments of the invention. One skilled in the
relevant art will recognize, however, that the invention may be
practiced without one or more of the specific details, or with
other methods, components, materials, and so forth. In other
instances, well-known structures, materials, or operations are not
shown or described in detail to avoid obscuring aspects of the
invention.
[0036] The schematic flow chart diagrams included herein are
generally set forth as logical flow chart diagrams. As such, the
depicted order and labeled steps are indicative of one embodiment
of the presented method. Other steps and methods may be conceived
that are equivalent in function, logic, or effect to one or more
steps, or portions thereof, of the illustrated method.
Additionally, the format and symbols employed are provided to
explain the logical steps of the method and are understood not to
limit the scope of the method. Although various arrow types and
line types may be employed in the flow chart diagrams, they are
understood not to limit the scope of the corresponding method.
Indeed, some arrows or other connectors may be used to indicate
only the logical flow of the method. For instance, an arrow may
indicate a waiting or monitoring period of unspecified duration
between enumerated steps of the depicted method. Additionally, the
order in which a particular method occurs may or may not strictly
adhere to the order of the corresponding steps shown.
[0037] FIG. 1 is an illustration of the environment in which the
present invention may be practiced. In particular, FIG. 1 depicts a
cutaway view of the anatomical features of a typical human nasal
cavity. One skilled in the art will recognize that certain
anatomical features and structures of the human nasal cavity have
been omitted to avoid obscuring the structures relevant to the
practice of the current invention. To help orient the reader, the
mouth 106 is illustrated with teeth 108 and tongue 110. The
anatomical structures relevant to the practice of the current
invention include the palate 100 which separates the oral cavity
102 from the nasal cavity 104, the inferior sinus turbinate 112,
the middle sinus turbinate 114 and the superior sinus turbinate 116
as well as the nasal bone 122. The middle sinus turbinate 114 and
superior sinus turbinate 116 define the
sphenopalatine/pterygopalatine recess 118. Deep within the
sphenopalatine/pterygopalatine recess 118 at the posterior 124 of
the sphenopalatine/pterygopalatine recess 118 lies the
sphenopalatine/pterygopalatine ganglia 120.
[0038] One skilled in the art will recognize that the medical
community is not uniform in the terminology with regard to the
sphenopalatine or pterygopalatine ganglia. Certain practitioners
use sphenopalatine while others use pterygopalatine. Therefore, the
present description will refer to the ganglia labeled 120 as the
sphenopalatine/pterygopalatine ganglia 120. Similarly, the recess
labeled 118 will be referred to as the
sphenopalatine/pterygopalatine recess 118. However, this
terminology is in no way limiting on the structure for which the
present invention is intended. Where practitioners or scientist
differentiate between the sphenopalatine ganglia or the
pterygopalatine ganglia, the present disclosure will be understood
to apply to either structure.
[0039] Sympathetic pain is a type of nerve pain that arises due to
abnormalities in the function of the sympathetic nervous system.
The majority of the "treatment resistant" headache population in
the world suffers from what is now properly identified as
"Sympathetic Mediated Cephalgia" a particular type of sympathetic
pain. With sympathetic pain an abnormality in a group of nerves
called a ganglion cause pain to an organ or body region. To treat
sympathetic pain physicians can block a ganglion with the injection
of medication into a specific area of the body. To therapeutically
treat acute pain a physician injects a local anesthetic into the
affected neuronal ganglion. This type of treatment may be referred
to as a nerve block.
[0040] The sphenopalatine/pterygopalatine ganglia 120 is a neuronal
structure located principally in the center of the head in the
pterygopalatine fossa posterior to the middle turbinate 114. The
sphenopalatine/pterygopalatine ganglia 120 comprises the largest
cluster of sympathetic neurons in the head outside of the brain.
The sphenopalatine/pterygopalatine ganglia 120 interfaces and
directs nerve impulses to the majority of the head's autonomic or
parasympathetic pathways. Therefore, any abnormality or injury to
this structure may cause severe pain. A nerve block of the
sphenopalatine/pterygopalatine ganglia 120 is effective in relief
in a variety of pain conditions ranging from headache to lower back
pain. Additionally, other disease processes such as headache
disorders and other neurological conditions can be arrested, or
improved by local anesthetic blockade, and/or other pharmacological
augmentation or mechanical alteration of the
sphenopalatine/pterygopalatine ganglia 120 and surrounding
structures.
[0041] Unfortunately, because of the anatomical position of the
sphenopalatine/pterygopalatine ganglia 120, the structure is very
difficult to block with a local anesthetic solution. The anatomical
location of the sphenopalatine/pterygopalatine ganglia 120 is
dangerously close to many vital and delicate mid brain structures.
Although direct needle placement can be employed under fluoroscopic
guidance to administer anesthetic to the
sphenopalatine/pterygopalatine ganglia 120, most practitioners will
not attempt the procedure due to the technical difficulty and
extreme dangers of an aberrant needle placement.
[0042] As shown in the prior art illustration depicted in FIG. 2,
the sphenopalatine/pterygopalatine ganglia 120 lies deep within the
sphenopalatine/pterygopalatine recess 118. Conventional methods
undertaken by pain specialists, neurologists, and neurosurgeons,
include the use of an eight inch cotton-tipped applicator 200
saturated with a local anesthetic. Because a cotton-tipped
applicator 200 is used, the procedure is referred to as the "Q-tip"
procedure. The cotton-tipped applicator 200 is soaked in a vial of
concentrated local anesthetic solution. In certain embodiments the
anesthetic solution is lidocaine, cocaine, etidocaine or
prilocaine, or other non-specified local anesthetic agents. The
cotton-tipped applicator 200 is then advanced into the nostril 202
and through the nasal cavity 104. To reach the
sphenopalatine/pterygopalatine ganglia 120 in the
sphenopalatine/pterygopalatine recess 118, the cotton-tipped
applicator 200 must be advanced into the nasal cavity 104 past the
middle sinus turbinate 114 and into the
sphenopalatine/pterygopalatine recess 118.
[0043] FIG. 3 illustrates the tortuous path the cotton-tipped
applicator 200 of the prior art must traverse to reach the
sphenopalatine/pterygopalatine recess 118. To perform the procedure
the patient is placed in a supine position. The cotton-tipped
applicator 200 is soaked in a vial of concentrated local anesthetic
solution. The physician then inserts the cotton-tipped applicator
200 into the patients nostril 202 and through the nasal cavity 104.
Advancing the straight, rigid cotton-tipped applicator 200 into the
sphenopalatine/pterygopalatine recess 118 can be difficult and
painful for the patient as the cotton-tipped applicator 200 must be
inserted almost parallel to the patient's face to clear the
anterior ridge 302 of the middle sinus turbinate 114. The
cotton-tipped applicator 200 must then make an almost 90.degree.
bend to avoid the inferior surface 304 of the nasal bone 122 and
access the sphenopalatine/pterygopalatine recess 118. The
cotton-tipped applicator 200 is left in the patient's
sphenopalatine/pterygopalatine recess 118 for approximately 20
minutes to allow diffusion of the local anesthetic through the
sinus mucosa to depolarize the sphenopalatine/pterygopalatine
ganglia 120 to block nerve transmission.
[0044] The use of a straight and rigid cotton-tipped applicator 200
that must make some fairly tortuous directional changes around some
very sensitive, richly vascular, friable, highly innervated
structures complicates the procedure to the point that many
practitioners will not attempt it. Known complications include
extreme patient discomfort, nosebleeds and the complications
associated with nosebleeds including venous-irritating nuisances,
arterial hemorrhaging, aspiration, hematochezia or even death.
Other complications include local anesthetic toxicity, seizure,
iatrogenic foreign bodies such as a broken cotton-tipped applicator
200, sinus mucosal tears and infection.
[0045] Anesthetic blockade of any neuronal structure requires
direct physical interaction between the anesthetic solution and the
targeted tissue. Therefore, to work, the cotton-tipped applicator
200 must deliver the anesthetic solution directly to the
sphenopalatine/pterygopalatine ganglion 120. The correct placement
of the cotton-tipped applicator 200 is technically challenging and
many practitioners simply miss the desired structure, the
sphenopalatine/pterygopalatine ganglion 120 when attempting to
perform the procedure. To help make the complicated bend required
to reach the sphenopalatine/pterygopalatine recess 118 many
practitioners will soak the top 2 inches of the cotton-tipped
applicator 200 and manipulate the stem to render it flexible so
that the patient is less agitated and bleeding risks are lessened.
Even with a flexible cotton-tipped applicator 200 the procedure is
difficult. Common failure placements include the inferior surface
304 of the nasal bone 122 and the anterior ridge 302 of the middle
sinus turbinate 114. When the cotton-tipped applicator 200 is
misplaced, a "wring-out" effect may occur wherein the anesthetic is
wrung out of the cotton-tipped applicator before it is delivered to
the sphenopalatine/pterygopalatine ganglion 120 resulting in an
ineffective procedure. Further, as discussed above, the rich
vascular and neuronal structure of the nasal cavity 104 makes any
misplacement of the cotton-tipped applicator 200 both dangerous and
painful.
[0046] FIG. 4 illustrates a sphenocath 400 including a catheter 402
having an insertion end 405 and a manipulation end 407. In certain
embodiments the catheter 402 includes multiple lumens 401 and 403.
The catheter 402 has an intrinsic curvature 404, a spray orifice
406, depth indicators 408, a straightening member 409 such as
stylus 410 with a pull tab 412, a medication delivery port 414, a
syringe 416, a rotational direction indicator 418 and a rotation
tab 420.
[0047] In certain embodiments the sphenocath 400 comprises a soft
sialastic double lumen catheter 402 which is about 24 cm long. One
of skill in the art will recognize that the length of the catheter
402 may be varied according to the anatomy of the patient. One of
the lumens 401 or 403 is configured to deliver an anesthetic or
medication to the sphenopalatine/pterygopalatine recess 118. In
certain embodiments the other lumen 401 or 403 is closed distally
approximately 1.5 cm from spay orifice 406. For example, in certain
embodiments lumen 401 comprises a housing for stylus 410 and is
closed at its distal end near the spray orifice 406. The stylus 410
is slideably received within the lumen 401 and may be removed from
within the lumen 401 by pulling on the pull tab 410.
[0048] As discussed in further detail below with reference to FIGS.
7 and 8, the sphenocath 400 is inserted into the nasal cavity 104
of a patient lying in a supine position. Depth indicators 408
identify when the sphenocath 400 has been inserted into a patients
nasal cavity 104 at a depth sufficient to pass the middle sinus
turbinate 114. In certain embodiments additional depth indicators
(not shown) may indicate a depth sufficient to identify when the
tip of the sphenocath 400 is within the
sphenopalatine/pterygopalatine recess 118. One skilled in the art
will appreciate that depth indicators 408 may vary depending on
anatomical variables of the patient such as age and/or gender. The
depth indicators 408 may comprise a visual cue such as a line or
other such indicator or the depth indicators 408 may comprise a
physical structure configured to arrest further insertion of the
sphenocath 400. In certain embodiments the sphenocath 400 may be
individually sized to fit only one size of a patient. Thus, the
sphenocath 400, in certain embodiments, may comprise a large,
medium or small size to be used with patients with large, medium or
small anatomies. In another embodiment the depth indicators 408 are
adjustable such that the depth indicators 408 can be slid along the
sphenocath 400 to a position which indicates a depth sufficient to
identify when the tip of the sphenocath 400 is within the
sphenopalatine/pterygopalatine recess 118 of a particular
patient.
[0049] The intrinsic curvature 404 of the catheter 402 causes the
catheter 402 to bend such that the insertion end 405 of the
catheter 402 lies in a first plane as indicated by line 411 while
the manipulation end 407 of the catheter 402 lies in a second plane
as indicated by line 413. The catheter 402 smoothly transitions
between the first plane 411 and the second plane 413 such that the
intrinsic curvature 404 conforms to a patient's nasal anatomy. The
intrinsic curvature 404 allows the catheter 402 to be inserted into
a patient's sphenopalatine/pterygopalatine recess 118 to direct a
medication to the patient's sphenopalatine/pterygopalatine ganglia
120.
[0050] Rotational direction indicator 418 identifies the rotational
configuration of the sphenocath 400. Because the end of the
sphenocath 400 has an intrinsic curvature 404, it is beneficial for
the physician to know which direction the curvature is pointing to
manipulate the sphenocath 400 into the
sphenopalatine/pterygopalatine recess 118. In certain embodiments
the rotational direction indicator 418 is configured to signal the
physician that the intrinsic curvature 404 and thus the spray
orifice 406 is pointing in a downward angle when the rotational
direction indicator 418 is pointing up. While the embodiment
illustrated in FIG. 4 shows the rotational direction indicator 418
as a separate structure, one skilled in the art will recognize that
the rotational direction may simply be a line on top of the
sphenocath indicating which direction the spray orifice 406 is
pointing. In one embodiment, such as the embodiment shown in FIG.
4, the rotational direction indicator 418 may also comprise a
rotation tab 420 to assist the physician in manipulating the
sphenocath 400 into the sphenopalatine/pterygopalatine recess 118
by providing the physician a leverage point to rotate the
sphenocath 400 and align the spray orifice with the
sphenopalatine/pterygopalatine recess 118 or
sphenopalatine/pterygopalatine ganglia 120.
[0051] Once the sphenocath 400 is manipulated into the
sphenopalatine/pterygopalatine recess 118 the syringe 416 injects
an antisthetic or medication into the medication delivery port 414
and through one of the lumens 401 or 403. The spray orifice 406 is
in fluid communication with the lumen (401 or 403) that receives
the medication, thus, as the physician injects or dispenses the
medication into medication delivery port, the medication travels
through the lumen (401 or 403), through the spray orifice 406, and
into the sphenopalatine/pterygopalatine recess 118. One skilled in
the art will recognize that any metered medicinal or anesthetic
delivery means may be substituted for the syringe 416 without
departing from the scope of the present invention.
[0052] The spray orifice 406 may be configured to deliver a stream
of medication or anesthetic. In one embodiment the spray orifice
406 may be configured to disperse the medication or anesthetic such
that the area surrounding the sphenopalatine/pterygopalatine
ganglia 120 is completely saturated with anesthetic or medication.
In certain embodiments the spray orifice 406 may be configured to
administer the medication or anesthetic in a controlled fine mist.
Further, one of skill in the art will recognize that in certain
embodiments the spray orifice 606 may be adjustable such that the
physician may dispense the medication in a broader or narrower
pattern as dictated by the procedure and the patient's nasal
anatomy.
[0053] FIG. 5A illustrates one embodiment of the catheter 402
portion of the sphenocath 400 with a rigid member 501 inserted into
one of the lumens 401 or 403. The rigid member 501 in the
embodiments illustrated in FIGS. 5A and 5B is a stylus 410 inserted
into lumen 401 such that the sphenocath 400 is forced straight by
the stylus 410. The stylus 410 comprises a rod, wire or other rigid
device having sufficient strength to straighten the intrinsic curve
404 of the catheter 402. With the sphenocath 410 straightened the
catheter 402 can be inserted into the nasal cavity 104 until it
reaches a point past the anterior ridge 302 of the middle sinus
turbinate 114.
[0054] FIG. 5B illustrates an embodiment of the catheter 402
portion of the sphenocath 400 with the rigid member 501, in this
case the stylus 410, partially removed from lumen 401. As the
stylus 410 is removed from lumen 401, the catheter 402 bends due to
the intrinsic curvature 404 of the catheter 402. Thus, once the
sphenocath 400 has been inserted deep enough into the patient's
nasal cavity 104 such that the tip has passed the middle sinus
turbinate 114, the stylus 410 is withdrawn from lumen 401 to allow
the catheter to bend at the intrinsic curvature 404. The sphenocath
400 may then be inserted all the way into the
sphenopalatine/pterygopalatine recess 118 to deliver the anesthetic
or medication to the sphenopalatine/pterygopalatine ganglia 120 or
surrounding anatomical structure. In certain embodiments the radius
of the intrinsic curvature 404 is sufficient to allow the catheter
402 to bend within the nasal cavity 104 to align the spray orifice
406 with the sphenopalatine/pterygopalatine recess 118. In one
embodiment the intrinsic curvature 404 may bend between about
45.degree. and about 90.degree. to allow the catheter 402 to be
placed within the sphenopalatine/pterygopalatine recess 118 without
hitting the inferior surface 304 of the nasal bone 122 of the
patient.
[0055] FIG. 5C illustrates another embodiment of the catheter 402
portion of the sphenocath 400 with a rigid member 501 which
surrounds the catheter 402. In this embodiment, the rigid member
501 is a sleeve 504 surrounding the catheter 402. In certain
embodiments the sleeve 504 is sufficiently rigid to straighten the
intrinsic curvature 404 when the catheter 402 is received within
the sleeve 504. One of skill in the art will recognize that in
certain embodiments, such as where a sleeve 504 is used in place of
a stylus 410, the sphenocath 400 may include a single lumen
catheter 402 rather than the multiple lumen catheter 402
illustrated in FIGS. 5A-5D. As discussed below with reference to
FIGS. 6A-6C, in other embodiments, the catheter 402 may be
configured with as many additional lumens as may be required for
additional complex procedures such as fiber optics for visually
guiding the catheter into the sphenopalatine/pterygopalatine recess
118 or vacuum tubes configured to aspirate substances from within
the sphenopalatine/pterygopalatine recess 118.
[0056] FIG. 5D illustrates an embodiment of the catheter 402
portion of the sphenocath 400 with the sleeve 504 partially
withdrawn from the catheter 402 to expose the intrinsic curvature
404 of the catheter 402. As the sleeve 504 is removed from catheter
402 in the direction of arrow 506 the intrinsic curvature 404 of
the catheter is no longer straightened by the sleeve 504.
Therefore, the catheter 402 bends at the intrinsic curvature 404.
Thus, once the sphenocath 400, including the sleeve 504, has been
inserted deep enough into the patient's nasal cavity 104 such that
the spray orifice 406 has passed the middle sinus turbinate 114,
the sleeve 504 is withdrawn from catheter 402 to allow the catheter
to bend at the intrinsic curvature 404. The sphenocath 400 may then
be inserted all the way into the sphenopalatine/pterygopalatine
recess 118 to deliver the anesthetic or medication to the
sphenopalatine/pterygopalatine ganglia 120 or surrounding
anatomical structure.
[0057] FIG. 6A through FIG. 6C illustrate various embodiments of a
cross section of the catheter 402 of the sphenocath 400. In certain
embodiments, such as the embodiment illustrated in FIG. 6A one of
the lumens may be keyed to receive the stylus 410 in only one
direction such as lumen 602. By keying lumen 602 to receive the
stylus 410 in only one configuration, the pull tab of the stylus
410, such as pull tab 502 of FIGS. 5A and 5B, may be configured to
indicate the rotational direction of the spray orifice 406.
Further, by keying one of the lumens to receive the stylus 410 in
only one direction the entire sphenocath 400 may be rotated by the
pull tab 502. Thus, in certain embodiments the rotational direction
indicator 418 and a rotation tab 420 may be omitted where one of
the lumens is keyed to receive the stylus 410 in only one
direction. While the catheter 402 illustrated in FIG. 6a comprises
a round structure with two lumens 602 and 604, one skilled in the
art will recognize the catheter 402 structure may comprise any
number of shapes such as the shapes illustrated in FIGS. 6B and 6C.
One skilled in the art will recognize that the shape illustrated in
FIG. 6A through FIG. 6C are for illustrative purposes only and are
in no way limiting of the shapes which may comprise the catheter
402 and lumens 602, 604, 606, 608, 610, 612, 614, 616, 618 and
620.
[0058] In certain embodiments an additional orientation identifier
622 may be disposed on the top surface of the catheter 402. In one
embodiment the orientation identifier 622 serves as an additional
visual cue to assists the physician in determining the rotational
orientation of the sphenocath 400 so that the physician will know
which direction the intrinsic curvature 404 will bend when the
stylus 410 is removed.
[0059] In the embodiments illustrated in FIG. 6A the catheter 402
comprises two lumens 602 and 604. In the embodiment illustrated in
FIG. 6B the catheter 402 comprises three lumens 606, 608 and 610
and in the embodiment illustrated in FIG. 6C the catheter 402
comprises four lumens 612, 614, 618 and 620. One skilled in the art
will recognize that the catheter 402 may be configured with as many
additional lumens as may be required for additional complex
procedures such as fiber optics for visually guiding the catheter
into the sphenopalatine/pterygopalatine recess 118 or vacuum tubes
configured to aspirate substances from within the
sphenopalatine/pterygopalatine recess 118.
[0060] FIG. 7 illustrates one embodiment of the present invention
wherein the sphenocath 400 is inserted through the nostril 202 into
the nasal canal 104 and past the anterior ridge 302 of the middle
sinus turbinate 114. To maintain a straight sphenocath 400 the
stylus 410 is fully inserted into lumen 401 (note that either lumen
401 or 403 may be configured to receive the stylus 410). Depth
indicator 408 is configured to signal the physician when the spray
orifice 406 of the sphenocath 400 is sufficiently deep enough
within the patient's nasal cavity 104 to clear the anterior ridge
302 of the middle sinus turbinate 114.
[0061] FIG. 8 illustrates one embodiment of the present invention
wherein spray orifice 406 of the sphenocath 400 has passed the
middle sinus turbinate 114 and the stylus 410 has been partially
withdrawn from within lumen 401. As the stylus is withdrawn from
lumen 401 the catheter 402 bends due to intrinsic curvature 404 of
the catheter 402. The sphenocath 400 can then be further inserted
into the nasal cavity 104 deeper within the
sphenopalatine/pterygopalatine recess 118. In certain embodiments a
second depth indicator 802 may be disposed on the sphenocath 400 to
identify the correct depth for administering the anesthetic or
medication to the sphenopalatine/pterygopalatine ganglia 120 or
surrounding anatomical structure. Once the sphenocath 400 is
inserted to the correct depth the syringe 416 or other dispensing
means delivers a desired amount of medication or anesthetic into
the medication delivery port 414, through the lumen 403 to be
dispersed at the spray orifice 406 to the
sphenopalatine/pterygopalatine ganglia 120. Because the patient is
in a supine position the medication or anesthetic pools in the
sphenopalatine/pterygopalatine recess 118.
[0062] The schematic flow chart diagram that follows is generally
set forth as a logical flow chart diagram. As such, the depicted
order and labeled steps are indicative of one embodiment of the
presented method. Other steps and methods may be conceived that are
equivalent in function, logic, or effect to one or more steps, or
portions thereof, of the illustrated method. Additionally, the
format and symbols employed are provided to explain the logical
steps of the method and are understood not to limit the scope of
the method. Although various arrow types and line types may be
employed in the flow chart diagrams, they are understood not to
limit the scope of the corresponding method. Some arrows or other
connectors may be used to indicate only the logical flow of the
method. For instance, an arrow may indicate a waiting or monitoring
period of unspecified duration between enumerated steps of the
depicted method. Additionally, the order in which a particular
method occurs may or may not strictly adhere to the order of the
corresponding steps shown.
[0063] FIG. 9 illustrates another embodiment of a sphenocath 900
having a catheter 902 portion which includes an intrinsic curvature
904 near an insertion end 906 and a rotation tab 908 near a
manipulation end 910. In certain embodiments the sphenocath 900
also includes a medication delivery port 912 located near the
manipulation end 910 and a spray orifice 914 located at the
insertion end 906.
[0064] In the embodiment illustrated in FIG. 9, the medication
delivery port 912 includes a Luer fitting 916 keyed to fit a
syringe (not shown). The medication delivery port 912 is fluidly
connected to the catheter 902 portion through a stylet tube 918. In
certain embodiments the stylet tube 918 is sufficiently rigid to
straighten the intrinsic curvature 904 in the insertion end 906 of
the catheter 902 when the stylet tube 918 is inserted into the
catheter 902 in the direction of arrow 920. As the stylet tube 918
is withdrawn from the catheter 902 in a direction opposite arrow
920, past a point where the stylet tube 918 support the intrinsic
curvature 904, the catheter 902 bends due to the intrinsic
curvature 904. For example, once the stylet tube 918 is withdrawn
from the catheter 902 past a certain point (such as point 922) the
catheter 902 bends in the direction shown due to the intrinsic
curvature 904. In certain embodiments the catheter 902 may begin to
bend immediately as the stylet tube 918 is withdrawn from the
catheter 902. In other embodiments catheter 902 only bends once the
stylet tube 918 has been removed past a point 922 where the
intrinsic curvature 904 begins.
[0065] In certain embodiments the manipulation end 910 of the
spenocath 900 includes a rotation tab 908 for directing the spray
orifice 914 in the direction of the sphenopalatine/pterygopalatine
recess 118 when the spray orifice 914 has passed the middle sinus
turbinate 114. The rotation tab 908 may be aligned with the
intrinsic curvature 904 in a predefined orientation to signal to
the physician the direction of the spray orifice 916 when the
sphenocath 900 is disposed within a patient's nasal cavity 104. As
discussed above, the sphenocath 900 may include depth indicators
924 to signal a proper depth within the nasal cavity 104 to insert
the sphenocath 900 into sphenopalatine/pterygopalatine recess
118.
[0066] FIG. 10 is a schematic flow chart diagram illustrating one
embodiment of a method 1000 for treating sympathetic mediated
cephalgia (headaches.) In one embodiment the method starts 1002 and
the patient is placed in a supine position. In certain embodiments,
the patient may already be in the supine position. In other
embodiments, the physician may wish to administer the treatment
with the patient in a standing or seated position and thus, this
step may be omitted.
[0067] The physician inserts 1006 a stylus, such as stylus 410 into
a lumen within a sphenocath such as the sphenocath 400 of FIG. 4.
The stylus 410 may act to straighten the sphenocath 400 to allow
for easy insertion into a patients nasal cavity 104. In certain
embodiments the stylus 410 may already be inserted within the lumen
and thus this step may be omitted.
[0068] The sphenocath 400 is inserted 1008 into the patient's
nostril 202 and advanced through the nasal cavity 104 to a position
wherein the spray orifice 406 of the sphenocath 400 has passed the
middle sinus turbinate 114. The stylus 410 is withdrawn 1010 from
the sphenocath 400 such that the sphenocath 400 curves due to an
intrinsic curvature 404 of the catheter 402. The sphenocath 400 is
advanced 1012 into the sphenopalatine/pterygopalatine recess 118.
Anesthetic is dispensed 1014 into the
sphenopalatine/pterygopalatine recess 118.
[0069] The anesthetic may cause a temporary loss of sensation in
the nasal cavity and may, in certain instances, drain into the
patients throat causing a loss of sensation in the patients throat.
Therefore, in certain embodiments the physician may monitor 1016
the patient in the supine position for a period of time to make
sure that the patient does not have any adverse reactions to the
anesthetics. In one embodiment the patient may be observed 1018 to
determine the efficacy of the procedure and the method ends
1020.
[0070] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *