U.S. patent application number 12/984354 was filed with the patent office on 2011-04-28 for devices and methods for minimally invasive access to sinuses and treatment of sinusitis.
Invention is credited to Leonard V. Covello.
Application Number | 20110098659 12/984354 |
Document ID | / |
Family ID | 43497938 |
Filed Date | 2011-04-28 |
United States Patent
Application |
20110098659 |
Kind Code |
A1 |
Covello; Leonard V. |
April 28, 2011 |
Devices And Methods For Minimally Invasive Access To Sinuses And
Treatment of Sinusitis
Abstract
The present invention provides minimally invasive devices and
methods for accessing the sinuses and their surrounding structures
for surgery and other treatments. The anterior ethmoid and
maxillary sinuses are accessed and treated under minimal anesthesia
with little or no postoperative limitation of activity or adverse
symptoms. Direct visual verification of the sinuses and their
natural ostia is utilized. Other paranasal sinuses may be treated
by this method as well. The sinuses, in particular the maxillary
and anterior ethmoid, are accessed via a direct anterior to
posterior axis and the natural ostia of those sinuses is directly
visualized for placement of a guide-free dilator, in the desired
location within the natural ostia. That access to the maxillary
ostium is accomplished by the anterior transuncinate "keyhole"
approach in which a hole is punched in the uncinate process with
the described devices according to the described methods. The
properly placed dilator is expanded to allow drainage of the
inflamed sinus and then withdrawn. An analogous ethmoid bulla
"keyhole" approach and subsequent dilation are used for the
anterior ethmoid sinus ostia. Pharmaceutical agents may be placed
at desired locations in the sinuses using the same access
technique.
Inventors: |
Covello; Leonard V.;
(Munster, IN) |
Family ID: |
43497938 |
Appl. No.: |
12/984354 |
Filed: |
January 4, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12804398 |
Jul 20, 2010 |
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12984354 |
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61271500 |
Jul 21, 2009 |
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Current U.S.
Class: |
604/227 ;
604/218 |
Current CPC
Class: |
A61B 2017/320048
20130101; A61M 25/1002 20130101; A61B 17/32053 20130101; A61M
2205/04 20130101; A61B 17/3468 20130101; A61M 2210/0681 20130101;
A61B 17/295 20130101; A61M 29/02 20130101; A61B 17/24 20130101;
A61B 2090/0817 20160201; A61B 17/3478 20130101; A61B 90/08
20160201 |
Class at
Publication: |
604/227 ;
604/218 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Claims
1. A drug insertion device for delivery of a drug into a sinus
cavity comprising: i. a rigid shaft containing a lumen, said rigid
shaft angled distally at an angle between about 55 degrees to about
60 degrees; ii. a piston slidedly connected to said lumen of said
rigid shaft; iii. a receptacle for holding a drug or drug delivery
device, said receptacle mounted at the distal end of the rigid
shaft; and iv. a means for moving the piston through the lumen of
the rigid shaft to the receptacle, causing release of the drug or
drug delivery device.
2. The drug insertion device of claim 1, wherein the length of the
receptacle is between about 1.0 cm and about 2.0 cm.
3. The drug insertion device of claim 1, wherein the width of the
receptacle is about 5 mm.
4. The drug insertion device of claim 1, wherein the receptacle
comprises flexible flanges which grip the drug or drug delivery
device.
5. The drug insertion device of claim 1, wherein the receptacle
comprises a sleeve which wholly encompasses the drug or drug
delivery device.
6. The drug insertion device of claim 1, further comprising a
plunger on attached to the rear end of said piston to accommodate
the thumb of a surgeon.
7. The drug insertion device of claim 1, wherein the piston is
composed of flexible plastic.
8. The drug insertion device of claim 1, wherein the piston is
composed of malleable metal.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of application Ser. No.
12/804,398, filed Jul. 20, 2010, which claims the benefit of
Provisional Application No. 61/271,500, filed on Jul. 21, 2009, the
contents of which are incorporated herein by reference.
FIELD OF INVENTION
[0002] The present invention relates to minimally invasive devices,
systems and methods for accessing the sinuses of a human patient
and for treating sinusitis.
BACKGROUND OF INVENTION
[0003] There are a substantial number of people with sinus
inflammatory disease--sinusitis--that could benefit from sinus
surgery. Patients with sinusitis can be grouped according to the
severity of their sinusitis into those with mild and those with
severe anatomic evidence of sinusitis. The latter category includes
those patients with significant anatomic anomalies, patients
previously operated on who have substantial postoperative defects
in the diseased areas, and those with significant paranasal sinus
polyps. The remaining group with mild anatomic evidence of
inflammation, which makes up the largest portion of those suffering
from sinusitis, may nonetheless have significant and persistent
symptoms despite undergoing medical therapies. Many patients are
understandably resistant to traditional surgery, such as functional
endoscopic sinus surgery (FESS), in particular if their symptoms
are mild. Thus, that is the target group for non-invasive
treatments. The goal is a procedure that is reliable, long lasting,
pain free, safe, has no tissue removal, and allows an immediate
return to full activities.
[0004] Development of non-invasive procedures requires an
understanding of the anatomical features of the sinuses and the
nasal cavity as well as an appreciation of the mucus drainage
pathways. Clinically, there are five major groups of sinuses in a
human patient: frontal, anterior ethmoid, posterior ethmoid,
maxillary, and sphenoid. The ethmoid is divided into anterior and
posterior portions to account for the clinical observation that
sinus cells anterior to the basal lamella (the lateral attachment
of the middle turbinate) have a separate mucus drainage pathway
from those posterior to the basal lamella. The maxillary, anterior
ethmoid and frontal sinuses often are affected by inflammatory
disease in unison. That tendency is believed by some to be due to a
shared common drainage location; in any case, current dogma holds
that inflammation in the anterior ethmoid is an indication of
inflammation in the maxillary and frontal sinuses. For the
maxillary sinus, the drainage site is the ethmoid infundibulum, the
very narrow space between the uncinate process medially and the
orbit laterally. For drainage of the anterior ethmoid sinuses,
there are multiple sites, usually including the ethmoid
infundibulum for a small portion, and relying on the hiatus
semilunaris superior for most of the cells. That anatomic
observation is not universally known to routine practitioners of
the current art. For the frontal sinus, the ostium usually just
posteromedial to the superior end of the uncinate (or just external
to the ethmoid infundibulum proper), but sometimes is lateral to
the uncinate, and therefore within the infundibulum. That slight
anatomic separation coheres with the clinical observation that the
maxillary and anterior ethmoid are very frequently inflamed in
unison, with the frontal sinus also inflamed somewhat less
often.
[0005] The posterior ethmoid and sphenoid sinuses are believed to
have individual drainage sites posterior to the basal lamella. For
the sphenoid, it is indisputable--the ostium can be easily seen at
the sphenoid rostrum in nearly every patient if proper exposure can
be obtained. For the posterior ethmoid, the putative drainage sites
are not so explicit. There is some sharing of inflammatory disease
by the sphenoid and posterior ethmoid sinuses. Analogous to the
maxillary/anterior ethmoid/frontal system, it is believed that
there is a shared pathway for the posterior ethmoid and sphenoid
sinuses in the sphenoethmoid recess, the space just anterior to the
sphenoid rostrum (where, as noted above, the sphenoid ostium is
found) and extending laterally. (Stammberger, H. Functional
Endoscopic Sinus Surgery. Mosby (St. Louis) 1991. See pp.
49-67.)
[0006] The vast majority of the patient group with mild anatomic
sinusitis, regardless of symptom severity, has maxillary or
anterior ethmoid inflammation, which also is referred to as limited
maxillary and anterior ethmoid disease. If a minimally invasive
treatment is to be effective for a majority of patients, it must be
effective for patients with maxillary or anterior ethmoid
inflammation.
The Maxillary Sinus
[0007] The maxillary sinus is a large air space, filling
essentially the entire cheekbone in the typical patient. From the
transnasal aspect, that air space lies just lateral to the entire
lower half of the lateral wall of the nose. From the oral/sublabial
aspect, it lies just superior to the tooth roots from the canine to
the last molar and extends to the orbit. The maxillary sinus is
relatively large and most of it is relatively far from the eye,
which is the most important structure in that area. Traditional
access to the maxillary sinus involved either forcing a trocar
through the low lateral nasal wall or sublabially through the
anterior wall of the sinus just lateral to the canine root or both,
followed by the enlargement of the resulting hole via removal of
bone to drain the sinus and remove any diseased tissue. Those
approaches were developed to best avoid damaging the eye, yielding
a suitable surgical margin of error for that purpose. At the end of
the procedure, one sought to preserve the intranasal hole in the
belief that the sinus would continue to drain through it for the
rest of the patient's life, an assumption later realized to be
incorrect.
[0008] A seminal development in sinus surgery was Messerklinger's
work in the 1960's (and applied clinically in the 1980's) on the
physiology of sinus clearance of mucus, and its rather rigid
connection to sinus microanatomy. (Messerklinger, W., multiple
references quoted in Stammberger, ibid., pp. 27-28.) Among other
observations, Messerklinger's work involved placing traceable,
visible granules into the maxillary sinuses. Using a high
resolution endoscope, he observed that the granules would migrate
along the lining in a very specific path, exiting the maxillary
sinus through an ostium near the anterior superior extreme of the
sinus, lateral to the uncinate process, and following an explicit
and narrow stream just above the inferior attachment of the
uncinate to the lateral wall, before exiting that narrow space
posteriorly. Of crucial interest, that pathway was preserved
independent of any other, even larger, holes that might exist,
naturally or surgically, in the medial wall of the sinus. In
effect, the cilia always push sinus mucus in the direction of the
so-called natural ostium, whether or not other ostia exist or are
created. That observation suggested that the previously-held belief
in the benefit of surgically-created sinus ostia was misplaced. The
new paradigm was to become surgical enlargement of the natural
ostium explicitly, finally gaining wide adoption in the early
1990's with utilization of functional endoscopic sinus surgery
(FESS), particularly among new trainees and professors. That
strategy subsequently has been validated clinically. Placement of
ostia elsewhere was too often found to be useless or injurious and,
crucially, those problems could be reliably corrected only by
addressing the natural ostium in an appropriate way. That principle
continues to be important, beneficially if honored, detrimentally
if neglected.
[0009] In state-of-the-art endoscopic maxillary sinus surgery
today, the uncinate process first is removed from its posterior
margin back to its anterior maxillary attachment, revealing the
(often small) natural ostium just posterior to the anterior
maxillary attachment. The natural ostium is assessed. If deemed too
small to effectively permit long-term drainage from the sinus (an
arbitrary decision), it is enlarged posteriorly. In approximately
one-third of patients, there is a naturally occurring accessory
ostium posterior to the natural ostium. In those patients, the
surgeon enlarges the natural ostium to broadly connect with and
encompass the accessory ostium to avoid having mucus recirculate;
i.e., to prevent mucus that is exiting the sinus via the augmented
natural ostium from reentering via the accessory ostium. It is not
clear how often that pathway is utilized for recirculation, if
ever. A problem results, however, if a surgeon creates a new ostium
posterior to the natural ostium, which often does cause
recirculation, or if a surgeon enlarges an accessory ostium
thinking it to be the natural one, which will not achieve the
objective and might, as discussed above, cause recirculation. If
those errors occur, they usually can be corrected by finding the
natural ostium and connecting it with the accessory ostium to
create a single large ostium.
[0010] The minimally invasive balloon sinuplasty surgical method
for application to the maxillary sinus, as exemplified by the
transnasal approach of U.S. Pat. No. 7,500,971, which is
incorporated herein by reference in its entirety, involves placing
a curved, tubular guide into the posterior slit-like opening of the
infundibulum, between the posterior margin of the uncinate medially
and the orbital wall laterally. A guide wire is then fed through
the lumen of the tube and into the infundibulum. The wire is gently
manipulated until it, by trial and error, drops into the ostium.
The tip can be verified to be in the sinus by X-ray fluoroscopy or
more commonly by light from the wire tip seen to transilluminate
the cheek. See, e.g., U.S. Pat. No. 7,559,925. Both X-ray
fluoroscopy and transillumination are cumbersome to a degree,
fluoroscopy especially so as it requires large machines that are
not normally present at sinus surgery and get in the way of easy,
interruption-free operating. The wire transillumination method is
more convenient, but requires the surgeon to juggle instruments in
his/her hands and creates tangles on an operative field already
wound with a variety of suction hoses and cords. Fluoroscopy and
transillumination can assist the surgeon in determining if the
instrument is in the sinus, but do not indicate whether the
instrument is in the natural ostium. Thus, they are not substitutes
for direct visualization. The balloon catheter is passed through
the lumen of the tubular guide over the wire until it is believed
to be spanning the ostium at which point it is expanded, putatively
stretching the ostium and spreading the space between the orbit and
uncinate by stretching the uncinate medially. As noted above, that
action may instead result in dilation of an accessory ostium.
[0011] Another minimally invasive sinuplasty method, as exemplified
by the canine fossa approach of U.S. Pat. No. 7,520,876, which is
incorporated herein by reference in its entirety, utilizes the
older sublabial approach to the maxillary sinus (described above),
which requires puncturing the bone of the alveolus just above the
tooth roots in the canine fossa region. The anterior wall of the
maxillary sinus is punctured a bit lateral to the canine root. A
miniature endoscope is passed coaxially through a tubular guide and
advanced into the sinus and the natural ostium is directly
visualized from this lateral aspect. The balloon catheter is passed
into the ostium by manipulation of the guide according to what is
visualized with the endoscope and the balloon is expanded.
[0012] Both the transnasal and canine fossa approaches have
disadvantages. In the transnasal approach, the advance to the
infundibulum is awkward. Surgical instrumentation--including the
guides, balloon catheter, endoscope and guide wire--is introduced
into the nose from anterior to posterior, but the infundibulum is
entered posteriorly and the wire advanced anteriorly from that
point. Those two maneuvers necessitate a 180 degree turn of the
guide, guide wire and balloon catheter that is difficult to execute
atraumatically in the tight spaces involved.
[0013] Another substantial problem with the transnasal approach is
that the method is performed blindly because the surgeon's view of
the natural ostium and any intervening accessory ostia is blocked
by the more medial uncinate. The instrumentation is rounded and
made flexible to avoid inadvertent introduction into the eye.
However, that does not prevent inadvertent introduction into and
cannulation of an accessory ostium, rather than the natural ostium,
caused by the surgeon's inability to see the position of the
instrument. In fact, in the significant number of cases that an
accessory ostium is present (estimated at about one third of all
patients), the accessory ostium is encountered first by the guide
wire, as it is more posteriorly placed, and is probably more likely
to be dilated than the natural ostium. In such cases, the surgeon
mistakenly enlarges the accessory ostium rather than the natural
ostium. As discussed above, that is not helpful and often harmful.
Protecting against that eventuality is difficult. It is common,
therefore, for surgeons to resort to a "hybrid"
invasive/non-invasive procedure in which the lower uncinate is
surgically removed to visualize the natural ostium in the usual
fashion. Performed appropriately by a competent surgeon, the
"hybrid" approach solves the problem, but necessitates reverting to
an essentially standard approach that is more than minimally
invasive. Using a balloon to dilate the now visible natural ostium
is of questionable benefit compared to the standard surgical
approach of trimming the posterior margin of the ostium--likely a
mere victory of style over substance. Surgeons that would prefer a
minimally invasive method will often revert to the unsatisfactory
"hybrid" procedure because of frustration with the awkward approach
to the natural ostium or because of concern that they will
inadvertently and unknowingly dilate the wrong (accessory)
ostium.
[0014] The canine fossa approach offers the advantage that the
surgeon accesses the maxillary sinus and views the ostia from
inside the sinus, from which they can be seen unobstructed. If more
than one ostium exists, the natural ostium will be the anterior
one, so verification of the natural ostium and avoidance of the
accessory ostium is possible. The route also is direct. It does not
require a 180 degree turn. Proponents of the canine fossa approach
of U.S. Pat. No. 7,520,876 further represent that the balloon
dilation succeeds in also enlarging the ethmoid infundibulum in
that it stretches the uncinate medially, and it certainly seems
that it does so. They claim that balloon dilation of the ethmoid
infundibulum, in addition to treating the maxillary sinus, results
in treating the primary ethmoid drainage, which apparently is
believed to be located in the ethmoid infundibulum. The anatomic
evidence, however, is overwhelmingly against that possibility.
[0015] Nonetheless, the problems with the canine fossa approach are
substantial. It requires a separate incision and access for a
trocar under the lip. Thus, it is not easily and naturally combined
with intranasal procedures. Moreover, it is more difficult or
impossible to access the ethmoid, frontal, and sphenoid sinuses
from the canine fossa access site. Access to the anterior ethmoid
is possible, but cumbersome. Access to the frontal sinus is quite
difficult, and access to the posterior ethmoid and sphenoid is
virtually impossible. Surgeons must utilize another "hybrid"
invasive/non-invasive procedure for those sinuses that require a
second incision site and a cumbersome combination of nasal and oral
procedures. The primary incision required by the canine fossa
approach might be undesirable to patients seeking less rather than
more surgery. Surgeons likewise might hesitate to embrace it.
[0016] The canine fossa procedure also utilizes a miniature
endoscope. The image quality of the miniature endoscopes that are
commercially available are suboptimal due to the very fine
fiberoptic thread transmitting the image. The endoscope is
understandably fragile with a short (25 procedures) life and
therefore carries a rather high cost per use.
[0017] In sum, there is a need for a minimally invasive method to
access and dilate the natural ostium of the maxillary sinus,
preferably via transnasal access, without commonly resorting to
traditional resection as a "hybrid" rescue during the procedure.
Access to the natural ostium should be direct and not awkward so as
to not frustrate the surgeon and to avoid trauma, should be
verifiable, and should be easy to combine with minimally invasive
approaches to the other sinuses.
The Anterior Ethmoid
[0018] The drainage pathways of the anterior ethmoid sinus are less
explicitly defined than in the maxillary sinus. The ethmoid
sinuses, anterior and posterior, are often referred to as a
labyrinth. Unlike the maxillary sinus, the ethmoid is partitioned
into many small contiguous cells, with the anterior cells draining
anterior to the basal lamella (and containing more and smaller
chambers) and the posterior cells draining posterior to the basal
lamella (and containing one to three or so larger chambers). The
labyrinth occupies roughly the upper half of the nose, is bounded
superiorly by the rather thin skull base (and brain beyond), and
laterally by the orbit. Landmarks are less explicit and more
variable than those in the maxillary sinus area. Consequently,
serious injuries to the eye and brain during sinus surgery can
occur in approaches to the ethmoid.
[0019] Traditional invasive ethmoid surgery utilized an incision
between the eye and the nose and a puncture of the medial wall of
the orbit to access the ethmoid. The surgeon penetrated the ethmoid
sinuses below the frontoethmoid suture line (which lies roughly at
the equator of the orbit at the level of the corner of the eye) to
avoid the brain while removing pieces of ethmoid bone and nasal
lining. That approach was rendered obsolete for most cases in the
1990's with the maturation of endoscopic sinus surgery.
[0020] In the current standard of endoscopic surgery of the
anterior ethmoid, the largest and most prominent cell of the
anterior ethmoid, the ethmoid bulla, is opened and its walls and
those of adjacent cells are removed until opened "enough" (an
arbitrary designation). Experience has shown that the opening of
the ethmoid bulla and those adjacent cells fixes mild sinusitis
satisfactorily in most cases.
[0021] Minimally invasive methods for ethmoid surgery have not
progressed as far as those methods for maxillary surgery. This
deficiency is likely due to the significant anatomic variation of
the anterior ethmoid anatomy and confusion within the field as to
the location of its mucus outlets. The accepted minimally invasive
paradigm would require that one identify and open those outlets, an
objective only partially accomplished (usually without specific
identification) in the routine art by resecting most of the
septations of the anterior ethmoid, and not yet addressed in the
prior balloon-dilation art.
[0022] One relatively new method in the minimally invasive realm
avoids the anatomic variation problem entirely by circumventing the
paradigm of dilating natural ostia. Instead, in this method, the
ethmoid bulla is engaged with a trocar that is pushed through its
anterior and posterior walls, into the posterior ethmoid. A
reservoir is then passed into the tunnel to rest in the anterior
and posterior ethmoid. The reservoir contains steroid that elutes
into the sinus over days-to-weeks, decreasing inflammation.
[0023] It is reasonable to speculate that application of targeted
pharmacotherapeutic agents, as in the above method, will be a
helpful adjunct to the treatment of sinusitis. In the current
routine sinus art, topical steroid spray is a mainstay of
treatment, and topical antibiotics and antifungals are occasionally
used to treat select patients. The benefits from these topical
agents, however, have been limited. There is reason to suspect that
the limitation is due to an inability to direct the agents to the
diseased areas of intact sinuses in sufficient concentrations to be
effective, rather than to some more fundamental shortcoming. In an
analogous situation, acute and chronic infections and inflammation
of the ear canal skin are much more rapidly and effectively treated
with topical agents than with oral ones. Topical medications
probably result in local pharmaceutical concentrations that are
several orders of magnitude greater than those safely achievable in
oral administration. Obviously, the ear canal is more easily
targeted with repeated administration of concentrated therapeutic
agents than the more hidden recesses of the paranasal sinuses.
[0024] The aforementioned placement of a pharmaceutical-eluting
implantable device seeks to surmount that largely anatomic
challenge, and has achieved some promising early results. There are
certainly some drawbacks to this method, however. The placement of
the device alters anterior ethmoid anatomy without explicit
attention to the natural drainage pathways thereof, possibly,
although not necessarily, compromising mucus clearance in the
long-term. Taken together, the cost of the device and the nature of
its placement do not lend themselves to repeated use in an office
setting; rather, they are more suited to a single treatment or very
occasional treatments in a surgical setting. As many patients have
some degree of ongoing medical sinus disease, this is a significant
drawback. Ideally, one would prefer that targeted pharmacotherapy
be a viable alternative to oral therapy for many patients,
necessitating a more convenient and inexpensive option. Lastly, the
method by which the trocar is directed into the sinuses is of some
concern. One would prefer, if possible, a more precise and less
traumatic means of accessing the ethmoid sinuses. A reliable means
to treat the maxillary sinus with targeted pharmacotherapy would
also be desirable, an option lacking in the prior art. This gap in
current treatment options is largely because of the presence of the
uncinate, which prevents direct atraumatic access to the maxillary
sinus, frustrating the guide-based system currently used.
[0025] In sum, there is a need for a minimally invasive method for
accessing and treating the anterior ethmoid that augments flow
through natural drainage pathways of the anterior ethmoid. There
further is a need for a minimally invasive means to introduce
targeted pharmacotherapeutic agents to the maxillary and anterior
ethmoid sinuses (as well as others) in a more cost-effective and
atraumatic manner than in the current art.
SUMMARY OF INVENTION
[0026] The present invention provides devices and methods to refine
the existing minimally invasive methods for accessing the sinuses
and their surrounding structures for surgery and other treatments.
In preferred embodiments of the present invention, the anterior
ethmoid and maxillary sinuses are accessed in a minimally invasive
manner for treating mild inflammatory disease of those spaces,
enabling surgical treatment for mild-to-moderate sinusitis to be
performed under minimal anesthesia in an office setting, if
desired, and with little or no postoperative limitation of activity
or adverse symptoms. To facilitate broad application, the devices
of the present invention have a form and maneuverability similar to
those used routinely by practitioners of endoscopic sinus surgery
so that the methods of the present invention can be easily taught,
learned, and executed.
[0027] In one aspect of the present invention, a method of treating
a congested maxillary sinus via a minimally invasive intranasal
approach includes making a perforation ("keyhole") in the uncinate
process, inserting a guide-free dilator through the keyhole
perforation and dilating the natural ostium of the maxillary sinus
or the ethmoid infundibulum.
[0028] In another aspect of the present invention, a method of
treating a congested anterior ethmoid sinus pathway via a minimally
invasive intranasal approach includes dilating the hiatus
semilunaris superior, making a perforation ("keyhole") in the thin
wall surrounding the ethmoid bulla, inserting a guide-free catheter
through the keyhole perforation and dilating the ethmoid bulla
ostium.
[0029] In another aspect of the present invention, a method of
opening a constricted ethmoid sinus passageway includes introducing
a probe into the nose, engaging the ethmoid bulla ostium,
stretching the ethmoid bulla ostium, introducing a guide-free
dilator into the hiatus semilunaris superior and dilating the
hiatus semilunaris superior.
[0030] In yet another aspect of the present invention, a method of
opening a constricted ethmoid sinus passageway includes introducing
a probe into the nose, engaging the ethmoid bulla ostium,
stretching the ethmoid bulla ostium, introducing a guide-free
dilator into the hiatus semilunaris superior, dilating the hiatus
semilunaris superior, making a perforation ("keyhole") in the thin
wall surrounding the ethmoid bulla, inserting a guide-free catheter
through the keyhole perforation and dilating the ethmoid bulla
ostium.
[0031] In yet another aspect of the present invention, a method of
introducing an active agent into a constricted maxillary sinus
includes making a perforation ("keyhole") in the uncinate process,
inserting a drug delivery device containing the active agent
through the keyhole, and eluting the drug in the maxillary
sinus.
[0032] In yet another aspect of the present invention, a method of
introducing an active agent into a constricted anterior ethmoid
sinus, particularly the ethmoid bulla, includes making a
perforation ("keyhole") in the wall of the ethmoid bulla, inserting
a drug delivery device containing the active agent through the
keyhole, and eluting the drug in the sinus.
[0033] In still another aspect of the present invention, a method
of retracting the middle turbinate includes introducing a middle
turbinate retractor into the axilla of the middle meatus and
expanding the middle turbinate retractor to retract the middle
turbinate.
[0034] Another aspect of the present invention includes a middle
turbinate retractor comprising two rigid parallel platforms
composed of metal or plastic and a metal or plastic spring situated
between the rigid platforms and a pair of forceps on the outer
surfaces of the parallel platform that allow for expansion and
compression of the spring.
[0035] Another aspect of the present invention includes a middle
turbinate retractor comprising two parallel arms that are capable
of being expanded or compressed with respect to each other, said
arms crossing each other, thereby forming an upper portion and a
lower portion, a pair of expansion receptacles at the lower portion
of each arm, whereby squeezing of said expansion receptacles
results in expansion of the parallel arms and a ratchet arm
connected at the upper portion of each parallel arm capable of
holding the parallel arms in place.
[0036] Another aspect of the present invention includes a hole
punch capable of making a perforation in the uncinate process
comprising a shaft, a stationary platform mounted on the shaft, a
blade attached to one end of the stationary platform, a mobile
tapered flange containing a receptacle pivotally connected to the
stationary platform, and a means of bringing the blade of the
stationary platform and the receptacle of the mobile tapered flange
together, thereby generating a perforation in the uncinate
process.
[0037] Yet another aspect of the present invention includes a
guide-free dilator comprising a rigid shaft with a bottom portion
and a top portion, a rigid handle mounted at the bottom portion of
the rigid shaft, and a dilator segment mounted at the top portion
of the rigid shaft. The dilator segment is comprised of a semirigid
shaft and a mounting balloon. In one embodiment, top portion of the
rigid shaft is angled in the range of from about 30 degrees to
about 60 degrees.
[0038] Still another aspect of the present invention includes a
medial ethmoid probe comprising a handle having a top portion and a
bottom portion and a shaft having a proximal segment and a distal
segment, said proximal segment comprising a rigid material mounted
on the top portion and the bottom portion of the handle and said
distal segment comprising a semirigid material with a curved tip to
engage an ostium in the ethmoid bulla. Preferably, the distal
segment of the shaft curves to an angle ranging from about 30
degrees to about 60 degrees.
[0039] Still another aspect of the present invention includes a
probe capable of making a perforation in the wall of the ethmoid
bulla comprising a handle having a top portion and a bottom
portion, an upper shaft mounted on the top portion of said handle,
a lower shaft mounted on the bottom portion of said handle, and a
perforator tip with a stop collar, said perforator tip mounted on
the upper shaft.
[0040] Yet another aspect of the present invention includes a drug
insertion device comprising a rigid shaft containing a lumen, said
rigid shaft angled distally at an angle between about 55 degrees
and about 60 degrees, a piston coaxial with and guided by said
lumen of said rigid shaft, a receptacle for holding a drug or drug
delivery device, said receptacle mounted at the distal end of the
rigid shaft, and a means for moving the piston through the lumen of
the rigid shaft to the receptacle, causing release of the drug or
drug delivery device.
[0041] Still another aspect of the present invention includes a
device for controlled delivery of a drug into a sinus, comprising a
drug containing matrix and a degradable framework having a spine
and a series of coplanar ribs protruding radially from the spine,
the tips of the ribs protruding past the outer surface of the drug
containing matrix, wherein the drug containing matrix degrades at a
rate faster than the degradable framework.
[0042] Still another aspect of the present invention includes a
device for controlled delivery of a drug into a sinus comprising a
drug containing matrix and a degradable framework having a spine
and an umbrella of ribs attached to the spine, said umbrella is on
the outside surface of the drug containing matrix, wherein the
umbrella expands upon insertion into the sinus and wherein the drug
containing matrix degrades at a rate faster than the degradable
framework.
BRIEF DESCRIPTION OF DRAWINGS
[0043] FIG. 1A-1C illustrate a sagittal view of the lateral nasal
wall with various anatomical features thereof.
[0044] FIGS. 2A-2B illustrate one embodiment according to the
present invention of an anterior/superior middle turbinate
retractor in compressed and expanded forms, respectively.
[0045] FIGS. 3A-D illustrate one embodiment of the present
invention showing middle turbinate retraction by expansion of an
anterior/superior middle turbinate retractor.
[0046] FIGS. 4A-4B illustrate one embodiment according to the
present invention of a posterior/inferior middle turbinate
retractor in compressed and expanded forms, respectively
[0047] FIGS. 5A-5B illustrate an alternative embodiment according
to the present invention of a posterior/inferior middle turbinate
retractor in compressed and expanded forms, respectively
[0048] FIGS. 6A-6B illustrate an alternative embodiment according
to the present invention of a posterior/inferior middle turbinate
retractor in compressed and expanded forms, respectively
[0049] FIGS. 7A-7B illustrate one embodiment of the present
invention showing middle turbinate retraction by expansion of a
posterior/inferior turbinate retractor.
[0050] FIG. 7C illustrates a sinus in which the middle turbinate is
retracted using a posterior/inferior turbinate retractor of the
present invention.
[0051] FIG. 7D illustrates a sinus in which the middle turbinate is
not retracted.
[0052] FIG. 8A illustrates the anatomical structures observed
during a typical anteroinfermedial-to-posterosuperolateral view
during nasal endoscopy (i.e., endoscopic view).
[0053] FIG. 8B illustrates a medial-to-lateral sagittal view of the
relevant structures of the middle meatus.
[0054] FIG. 8C illustrates a transverse view from
superior-to-inferior of the relevant structures of the middle
meatus.
[0055] FIG. 9A illustrates a backbiting hole punch according to one
embodiment of the present invention.
[0056] FIGS. 9B-9D illustrate a side view, a top view and an end-on
view, respectively, of the mobile tapered flange of the backbiting
hole punch of the present invention.
[0057] FIGS. 9E-9G illustrate a side view, a top view and an end-on
view, respectively, of the stationary platform of the backbiting
hole punch of the present invention.
[0058] FIG. 9H illustrates a view of the handles of the backbiting
hole punch of the present invention.
[0059] FIGS. 9I-9J illustrate an alternative stationary platform of
the backbiting hole punch of the present invention.
[0060] FIGS. 10A-10C illustrates three views (endoscopic, sagittal,
transverse) of the intended site of the uncinate process "keyhole"
formed using instruments and methods of the present invention.
[0061] FIGS. 11A-11C illustrate three views (endoscopic, sagittal,
transverse) of initial placement of the backbiting hole punch into
the posterior opening of the ethmoid infundibulum and the levering
of the uncinate, in accordance with one aspect of the present
invention.
[0062] FIGS. 12A-12C illustrate three views (endoscopic, sagittal,
transverse) of final placement of the backbiting hole punch into
the posterior opening of the ethmoid infundibulum and the levering
of the uncinate, in accordance with one aspect of the present
invention.
[0063] FIGS. 13A-13C illustrate three views (endoscopic, sagittal,
transverse) of creating a keyhole in the uncinate process, in
accordance with one aspect of the present invention.
[0064] FIGS. 14A-14C illustrate three views (endoscopic, sagittal,
transverse) of the keyhole created in the uncinate process, in
accordance with one aspect of the present invention.
[0065] FIG. 15A illustrates one embodiment of a guide-free dilator
of the present invention.
[0066] FIG. 15B illustrates an alternative embodiment of the
guide-free dilator of the present invention.
[0067] FIG. 15C illustrates a view of one embodiment of the dilator
of the guide-free dilator of the present invention.
[0068] FIG. 15D illustrates a view of an alternative embodiment of
the dilator of the guide-free dilator of the present invention.
[0069] FIGS. 16A-16C illustrate three views (endoscopic, sagittal,
transverse) of advancement of a guide-free dilator of the present
invention through the transuncinate keyhole and dilation of the
ethmoid infundibulum, in accordance with one aspect of the present
invention.
[0070] FIGS. 17A-17C illustrate three views (endoscopic, sagittal,
transverse) of dilation of the natural ostium of the maxillary
sinus using a guide-free dilator, in accordance with one aspect of
the present invention.
[0071] FIGS. 18A-18C illustrate three views (endoscopic, sagittal,
transverse) of dilation of the transuncinate keyhole using a
guide-free dilator, in accordance with one aspect of the present
invention.
[0072] FIGS. 19A-19C illustrates attachment of the natural ostium
of the maxillary sinus with an accessory ostium, according to one
aspect of the present invention.
[0073] FIG. 20 illustrates a view from medial to lateral of the
structures lateral to the middle turbinate with the turbinate
removed.
[0074] FIG. 21A illustrates the typical
anteroinferomedial-to-posterosuperolateral view obtained during
nasal endoscopy,
[0075] FIG. 21B illustrates a medial-to-lateral sagittal view of
the relevant structures of the middle meatus.
[0076] FIG. 21C illustrates a transverse view from
superior-to-inferior of the relevant structures of the middle
meatus.
[0077] FIGS. 22A-22C illustrate three views (endoscopic, sagittal,
traverse) of locating the ethmoid bulla ostium using an ethmoid
probe of the present invention.
[0078] FIGS. 23A-23C illustrate three views (endoscopic, sagittal,
traverse) of expansion of the ethmoid bulla ostium using an ethmoid
probe of the present invention.
[0079] FIGS. 24A-24C illustrate three views (endoscopic, sagittal,
traverse) of dilating the hiatus semilunaris superior using a
guide-free dilator, in accordance with one aspect of the present
invention.
[0080] FIGS. 25A-25C illustrate three views (endoscopic, sagittal,
traverse) of dilating the ethmoid bulla ostium using a guide-free
dilator, in accordance with one aspect of the present
invention.
[0081] FIG. 26A illustrates an ethmoid probe of the present
invention.
[0082] FIG. 26B illustrates the axis of approach of the ethmoid
probe of the present invention.
[0083] FIG. 26C illustrates a detail the curved tip of the ethmoid
probe of the present invention.
[0084] FIGS. 27A-27C illustrate three views (endoscopic, sagittal,
traverse) of the desired site of the `keyhole` in the wall of the
ethmoid bulla, using the anterior keyhole approach of the present
invention.
[0085] FIGS. 28A-28C illustrate three views (endoscopic, sagittal,
traverse) of using the ethmoid keyhole probe of the present
invention to make a perforation in the wall of the ethmoid
bulla.
[0086] FIGS. 29A-29C illustrate three views (endoscopic, sagittal,
traverse) of dilating the perforation in the wall of the ethmoid
bulla using the ethmoid keyhole probe of the present invention.
[0087] FIGS. 30A-30C illustrate three views (endoscopic, sagittal,
traverse) of removing the ethmoid keyhole probe of the present
invention following dilation.
[0088] FIGS. 31A-31C illustrate three views (endoscopic, sagittal,
traverse) of enlarging the perforation in the wall of the ethmoid
bulla using a guide-free dilator, in accordance with one aspect of
the present invention.
[0089] FIGS. 32A-32C illustrate three views (endoscopic, sagittal,
traverse) of enlarging the perforation in the wall of the ethmoid
bulla using a sphenoid punch, in accordance with one aspect of the
present invention.
[0090] FIGS. 33A-33C illustrate three views (endoscopic, sagittal,
traverse) of enlarging the ethmoid bulla ostium using a guide-free
dilator, in accordance with one aspect of the present
invention.
[0091] FIG. 34 illustrates an ethmoid keyhole probe of the present
invention.
[0092] FIGS. 35A-B illustrate alternative embodiments of a
guide-free dilator of the present invention.
[0093] FIG. 36A illustrates an endoscopic view (70 degrees) of
introducing an endoscope into the region surrounding the frontal
sinus, in accordance with one aspect of the present invention.
[0094] FIG. 36B illustrates a sagittal view of introducing an
endoscope into the region surrounding the frontal sinus, in
accordance with one aspect of the present invention.
[0095] FIG. 37A illustrates an endoscopic view (70 degrees) of
advancement of a guide-free dilator of the present invention into
the frontal ostium followed by dilation, in accordance with one
aspect of the present invention.
[0096] FIG. 37B illustrates a sagittal view of advancement of a
guide-free dilator of the present invention into the frontal ostium
followed by dilation, in accordance with one aspect of the present
invention.
[0097] FIGS. 38A-C illustrate an embodiment of a guide-free drug
placement device of the present invention.
[0098] FIGS. 39A-C illustrate an alternative embodiment of a
guide-free drug placement device of the present invention.
[0099] FIGS. 40A-40C illustrate three views (endoscopic, sagittal,
transverse) of placement of a pharmaceutical agent in the maxillary
sinus, in accordance with one aspect of the present invention.
[0100] FIGS. 41A-41C illustrate three views (endoscopic, sagittal,
transverse) of placement of a pharmaceutical agent in the anterior
ethmoid sinus, in accordance with one aspect of the present
invention.
[0101] FIGS. 42A-B illustrate a front view and cross-sectional
view, respectively, of a bioerodible drug delivery device of the
present invention.
[0102] FIGS. 43A-B illustrate a front view and cross-sectional
view, respectively, of an umbrella-type bioerodible drug delivery
device of the present invention prior to delivery into the
sinus.
[0103] FIGS. 43C-D illustrate a front view and cross-sectional
view, respectively, of an umbrella-type bioerodible drug delivery
device of the present invention after delivery into the sinus.
[0104] FIGS. 44A-B illustrate a front view and cross-sectional
view, respectively, of an alternative embodiment of a bioerodible
drug delivery device of the present invention.
DETAILED DESCRIPTION OF INVENTION
[0105] The following sections describe exemplary embodiments of the
present invention. It will be apparent to those skilled in the art
that the described embodiments of the present invention provided
herein are illustrative only and not limiting, having been
presented by way of example only. All features disclosed in this
description may be replaced by alternative features serving the
same or similar purpose, unless expressly stated otherwise.
Therefore, numerous other embodiments or modifications thereof are
contemplated as falling within the scope of the present invention
as defined herein and equivalents thereto.
[0106] Throughout the description, if items are described as
having, including, or comprising one or more specific components,
or if processes and methods are described as having, including, or
comprising one or more specific steps, it is contemplated that,
additionally, there are items of the present invention that consist
essentially of, or consist of, the one or more recited components,
and that there are processes and methods according to the present
invention that consist essentially of, or consist of, the one or
more recited processing steps.
[0107] It should be understood that the order of steps or order for
performing certain actions is immaterial, as long as the invention
remains operable. Moreover, two or more steps or actions may be
conducted simultaneously. Scale-up or scale-down of systems,
processes, units, and/or methods disclosed herein may be performed
by those of skill in the relevant art.
[0108] The invention provides novel devices and methods for
accessing the sinuses and their surrounding structures for surgery
and other treatments. The devices and methods are useful in the
treatment of mild or severe sinusitis. The devices of the present
invention have a form and maneuverability that will be suitable for
routine use by current practitioners of endoscopic sinus surgery so
that the methods of the present invention can be easily taught,
learned, and executed. The methods of the present inventions are
substantially non-invasive or minimally invasive and are pain free,
safe and long lasting. The methods of the present invention can be
performed under minimal anesthesia in an office setting, if
desired, and with little or no postoperative limitation of activity
or adverse symptoms.
[0109] In the figures described below, various anatomical
structures of the sinuses and nasal cavity are displayed. The
following reference letters are used in the diagrams to show these
anatomical features.
AAUP anterior attachment of the uncinate process AN agger nasi cell
AO accessory ostium BL basal lamella EB ethmoid bulla EBO ethmoid
bulla ostium EI ethmoid infundibulum FS frontal sinus FO frontal
ostium HSS hiatus semilunaris superior IAUP inferior attachment of
the uncinate process IT inferior turbinate KH keyhole LF lacrimal
fossa LP lacrimal prominence LW lateral wall MS maxillary sinus MSA
maxillary sinus antrum MT middle turbinate MTB middle turbinate
body N nostril NOMS natural ostium of the maxillary sinus OW
orbital wall OZ ostial zone PAUP posterior attachment of the
uncinate process PE posterior ethmoid PRMT posterior root of middle
turbinate SRMT superior root of middle turbinate SS sphenoid sinus
UKP uncinate keyhole punch UP uncinate process VRMT vertical root
of the middle turbinate
[0110] A brief initial overview of some of the relevant anatomy is
in order. In FIG. 1A, the right side of the nose is represented in
a medial-to-lateral sagittal view. The diagram depicts the nostril
(N), the interior turbinate (IT), the middle turbinate (MT), the
frontal sinus (FS) and the sphenoid sinus (SS). The crucial
structures to be manipulated in the method of the present invention
lie lateral to the middle turbinate (MT). If the middle turbinate
is reflected superiorly for clarity (FIG. 1B), we see the largest
cell of the ethmoid complex, the ethmoid bulla (EB) and,
anterior-inferior to it, the uncinate process (UP). Manipulation of
the ethmoid bulla (EB) will be outlined in the description of the
method below. The opening of the maxillary sinus, its natural
maxillary ostium (NOMS), lies just lateral to the anterior-inferior
attachment of the uncinate and can be seen if we remove the
uncinate, again for clarity (FIG. 1C). It should be apparent from
this discussion that both the middle turbinate (MT) and uncinate
process (UP) comprise physical and visual barriers to manipulations
of the ethmoid bulla (EB) and natural ostium of the maxillary sinus
(NOMS). The method and devices of the present invention are
designed accordingly, to address and remedy these challenges.
Retraction of the Middle Turbinate
[0111] As depicted in FIG. 1A and FIG. 1B, the middle turbinate
(MT) obstructs the surgeon from clearly viewing the uncinate
process (UP) and the ethmoid bulla (EB). In the non-invasive
procedures described below, it may be advantageous to first
temporarily retract the middle turbinate from the procedural area
and then restore it once the procedure is complete. To this end, I
have developed turbinate retractors that assist the surgeon in
visualizing the relevant anatomy around the obstructed sinus
cavities. One embodiment of turbinate retractors in accordance with
the present invention is displayed in FIGS. 2A-2B. FIGS. 2A and 2B
depict an anterior/superior middle turbinate retractor (1) in
compressed and expanded states, respectively. The anterior/superior
middle turbinate retractor (1) is compressed (FIG. 2A) for
introduction into the narrow space between the middle turbinate and
lateral nasal wall in which it is allowed to passively expand (FIG.
2B) for gentle retraction. The retractor consists of a thin rigid
metal or plastic frame (2) approximating a V-shape. An intervening
pliable metal or plastic spring (3) enables compression and
expansion upon squeezing and releasing the forceps receptacles (4).
Pads (5) are placed at the contact surfaces of the lateral nasal
wall and middle turbinate. These consist of a slightly compressible
substance (e.g., foam rubber) surfaced with a smooth thin
nonadherent, nonabrasive film to avoid trauma to the nasal lining.
Preferably, the device should compress to a width of less than 3 mm
and should be able to expand to a width that need not markedly
exceed 10 mm.
[0112] FIGS. 3A-3D show application of the use of the
anterior/superior middle turbinate retractor (1) of the present
invention. In the intact and unoperated nose, the middle turbinate
(MT) obstructs the view of the structures practitioners wish to
manipulate from the routine endoscopic vantage point (FIGS. 3A and
3B). Placement of the anterior/superior retractor (1) into the
axilla of the middle meatus (FIG. 3C) and its subsequent expansion
(FIG. 3D) reveals those structures and maintains the view
throughout the procedure without repeated manipulation of the
middle turbinate (MT), which is often otherwise required.
[0113] The middle turbinate (MT) may also be retracted medially by
another device of the present invention depicted in FIGS. 4A-4B.
FIGS. 4A and 4B depict an embodiment of a posterior/inferior middle
turbinate retractor (6) in compressed and expanded form,
respectively. The posterior/inferior middle turbinate retractor (6)
is wedged between the lateral wall of the nose and the middle
turbinate just posterior and inferior to the posterior root of the
uncinate process (refer to FIGS. 7A-7F). The posterior/inferior
middle turbinate retractor (6) functions via a passive spring
compression-expansion mechanism, analogous to that described above
for the anterior-superior retractor shown in FIGS. 2A-2B. The
posterior-inferior middle turbinate retractor consists of two rigid
metal or plastic platforms (7) with an intervening metal or plastic
spring (8). It may be preferable to have the spring encased in a
thin plastic sleeve (9) to aid in spring alignment and to avoid
tangling. The device is manipulated via the forceps receptacles
(10), similar to the anterior/superior middle turbinate retractor.
Similar padding also is present here (11) with a curvature (12)
incorporated to accommodate the anatomy near the middle turbinate
(MT).
[0114] Another embodiment of the posterior/inferior middle
turbinate retractor of the present invention is depicted in FIGS.
5A and 5B. FIGS. 5A and 5B depict an embodiment of a
posterior/inferior middle turbinate retractor (13) in compressed
and expanded form, respectively. In this embodiment,
posterior/inferior middle turbinate retractor (13) expands by a
ratcheting mechanism and passively contracts upon release. The
device (13) consists of two rigid metal or plastic arms. The first
plastic arm (14) comes in contact with the lateral wall of the nose
and the second plastic arm (15) abuts the middle turbinate. The
arms are actively expanded by squeezing the expansion receptacles
(16 and 17) together. The arms are held in expansion by the ratchet
arm (18) at the desired width and released by squeezing the release
receptacle (19) toward the expansion receptacle (17). Pads (20)
also may be present on this device. Dimensions of the arms (14)
should be similar to those described previously for the
anterior/superior middle turbinate retractor.
[0115] Another embodiment of the posterior/inferior middle
turbinate retractor of the present invention is depicted in FIGS.
6A and 6B. FIGS. 6A and 6B depict an embodiment of a
posterior/inferior middle turbinate retractor (21) in compressed
and expanded form, respectively. The retractor consists of a thin
rigid metal or plastic frame (22). An intervening pliable metal or
plastic spring (23) enables compression and expansion upon
squeezing and releasing the forceps receptacles (24). Pads (25) are
placed at the contact surfaces of the lateral nasal wall and middle
turbinate. These consist of a slightly compressible substance
(e.g., foam rubber) surfaced with a smooth thin nonadherent,
nonabrasive film so as to avoid trauma to the nasal lining.
Preferably, the device should compress to a width of less than 3 mm
and should be able to expand to a width that need not markedly
exceed 10 mm.
[0116] FIGS. 7A-7C show application of the use of a
posterior/inferior turbinate retractors of the present invention.
FIGS. 7A-7C depict a cross-section of the lateral wall (LW) and
middle turbinate (MT) in the coronal plane of the bulla. Notably,
the posterior/inferior retractor (FIGS. 4-6) serves the same
purpose as the anterior/superior middle turbinate retractor, but is
placed in a separate location and may have the advantage of
remaining posterior to all surgical maneuvers in subsequent steps.
As depicted in FIG. 7A, the posterior/inferior turbinate retractor
(21) is placed between the lateral wall (LW) and the middle
turbinate (MT). Placement of the posterior/inferior turbinate
retractor (21) is inferior to the ethmoid bulla (not shown in FIG.
7A). It is then expanded (FIG. 7B) to retract the middle turbinate.
FIG. 7C depicts an endoscopic view with the posterior/inferior
turbinate retractor in place. The result of the retraction is to
improve the exposure of vital sinus structures including the
uncinate process (UP), ethmoid bulla (EB), hiatus semilunaris
superior (HSS) and natural ostium of the maxillary sinus (NOMS).
Comparably, without the aid of a posterior/inferior turbinate
retractor (FIG. 7D), these anatomical structures are substantially
unexposed.
[0117] Because both middle turbinate retractors of the present
invention yield improved exposure of the sinus surgical field, they
may be useful in more traditional endoscopic surgeries as well as
methods described in the present invention. It should also be noted
that although these retractors are deemed convenient for the
methods of the present invention, as described below they would not
considered necessary for their execution.
Access to the Maxillary Sinus
[0118] A substantial application for the minimally invasive sinus
access of the present invention is to provide solutions to
mild-to-moderate sinusitis in the maxillary and ethmoid sinuses. In
preferred embodiments of the present invention, the procedures can
be performed in the surgeon's office, under minimal anesthesia, and
after moderate (rather than extensive) medical options are
exhausted. Such a procedure must (1) be easy to learn by
practitioners of current routine sinus surgical art; (2) produce
reliable prolonged improvement after healing rapidly with
little-to-no pain or bleeding; and (3) provide a quick return to
normal activity. As such, the procedure should resemble, as much as
possible, the familiar approaches to the sinuses in question, and
intranasal trauma must be minimized, especially in the sinus
outflow tracts and at the ostium margin, where mucus first exits
the sinus.
[0119] In a preferred embodiment of the present invention, the
procedure of the present invention approaches the maxillary sinus
natural ostium transnasally, from anterior to posterior, avoids
traumatizing the outflow tract of any known sinus, and allows
direct visual verification of a true natural ostium placement of
the dilator before dilation is performed. That is accomplished by
an anterior transuncinate "keyhole" approach to the natural ostium
of the maxillary sinus described in detail below. Safe, reliable
perforation of the uncinate and dilation of the natural ostium and
ethmoid infundibulum are obtained using new devices of this
invention as described below. This approach and these devices
enable the performance of a reliable minimally invasive correction
of maxillary sinusitis under minimal anesthesia.
[0120] Prior to addressing the uncinate process (UP) and ethmoid
infundibulum (EI), it may be convenient to retract the middle
turbinate as described above. However, middle turbinate retraction
is not necessary for performing the procedures described below.
[0121] Relevant anatomy around the maxillary sinus is illustrated
in FIGS. 8A-8C. FIG. 8A shows the typical
anteroinferomedial-to-posterosuperolateral view obtained during
nasal endoscopy; FIG. 8B represents a medial-to-lateral sagittal
view of the relevant structures of the middle meatus; FIG. 8C
represents the same structures in transverse view from
superior-to-inferior. It is noted that each procedure described
below with respect to the maxillary sinus shows these three
separate views for clarity. The patient's right side is chosen for
consistency and convenience. The figures show that the uncinate
process (UP) is anterior and inferior to the ethmoid bulla (EB).
The anterior attachment of the uncinate process (AAUP) and the
posterior attachment of the uncinate process (PAUP) are depicted.
The ethmoid infundibulum (EI) lies in the narrow space between the
uncinate process (UP) and the lateral wall of the nose, just
anterior to the ethmoid bulla (EB) and can be seen most clearly in
FIG. 8C. The maxillary sinus (MS) connects to the natural ostium of
the maxillary sinus (NOMS) which is located lateral to the uncinate
process. Natural drainage of mucous from the maxillary sinus,
indicated by the arrow in FIG. 8A, occurs through the natural
ostium of the maxillary sinus (NOMS) into the ethmoid infundibulum
(EI). The natural ostium of the maxillary sinus (NOMS) cannot be
observed directly because it is blocked by the uncinate process
(UP). The "keyhole" approach of the present invention overcomes
this problem and allows the surgeon a direct view of the natural
ostium of the maxillary sinus (NOMS) and ethmoid infundibulum
(EI).
[0122] In accordance with one aspect of the present invention,
access to the ethmoid infundibulum (EI) is gained at the
anterior-inferior extent of the uncinate using a backbiting hole
punch of the present invention (FIG. 9A) to create a transuncinate
"keyhole". The intended site of the keyhole is indicated with an
asterisk in FIGS. 10A-10C, which show the
anteroinferomedial-to-posterosuperolateral view, medial-to-lateral
sagittal view, and the transverse view from superior-to-inferior,
respectively. The backbiting hole punch (26) depicted in FIG. 9A
enables atraumatic access to the natural ostium. It is configured
much like the backbiting forceps used by most surgeons in the prior
routine sinus art. Unlike that instrument, however, it perforates
the uncinate near its anterior attachment only, rather than
removing it en route from the posterior margin. Perforating the
uncinate process (UP) anteriorly rather than dividing it
transversely into superior and inferior "flail segments" preserves
the overall integrity of the uncinate mucosa and bony framework.
This structural support is key to preserving surgical modifications
that will be described below in the method of the present invention
and avoiding complications of healing.
[0123] The backbiting hole punch (26) depicted in FIG. 9A consists
of a mobile tapered flange (27) and a stationary platform (28)
mounted on a shaft (29) that connects to handles (31) (not shown in
FIG. 9A) that are manipulated by the practitioner. FIGS. 9B-9D show
a side view, a top view and an end-on view of mobile tapered flange
(27), respectively. Likewise, FIGS. 9E, 9F, and 9G show a show a
side view, a top view and an end-on view the stationary platform
(28), respectively. A blow-up of the handles (31) is depicted in
FIG. 9H. As depicted in FIG. 9H, the handles (31) are located at
the proximal end of the shaft (29). The handles (31) are
manipulated by sticking two fingers is the holes and squeezing the
holes together. The instrument can be made wholly of rigid material
like metal or plastic but a portion of the shaft (29) may be
composed of a semirigid material with some flex such as plastic,
fiber compound, or rubber, in order to facilitate intranasal
maneuvering. The shaft (29) may be straight or angled (30) up to
approximately 20 degrees. If an angled shaft is used, the angle
allows the mobile flange (27) and the stationary platform (28) to
be delivered into the target area of the nose parallel to the
orbital wall, uncinate process, and middle turbinate, facilitating
access and limiting trauma. Spreading the handles (31) opens the
gap angle (32) between the mobile flange (27) and the stationary
platform (28) and squeezing them together closes it. Upon closure,
a thin layer of material (in the method of the present invention,
the thin bone and mucosa of the uncinate) is transfixed in between
the flange (27) and platform (28) and creates a perforation
(`keyhole`) in the material as the blade (33) is pushed into the
receptacle (34). In these diagrams, the blade is depicted on the
platform (28) rather than on the mobile flange (27) so as to render
the mobile flange (27) as thin as possible, a desirable
characteristic for atraumatically introducing it into the narrow
ethmoid infundibulum (EI), as described below in the method of the
current invention. Nonetheless, the orientation can be reversed, if
desired. The tip (35) of the mobile flange (27) may be tapered to
facilitate the aforementioned insertion.
[0124] The length of the mobile flange (27) is preferably in the
range of about 1.0 cm to about 2.0 cm. This length is chosen to
maximize the possibility that the perforating tip will reach the
anterior attachment of the uncinate when it is pulled to the
anterior extent allowed by the uncinate atraumatically (see FIGS.
13A-13C and FIGS. 14A-14C) while at the same time maintaining
maneuverability within the nose. A hole of approximately 3 mm is
chosen as this size easily admits the guide-free dilator of this
invention (see FIGS. 15A-15C, below) and a 2.7 mm endoscope (widely
available), but other sizes are admissible, including a blade
design that punctures without removing tissue (FIG. 9I) or one that
removes a strip rather than a circle of tissue (FIG. 9J).
[0125] Referring again to FIG. 10B, the uncinate process (UP) has a
shape similar to a boomerang with its arms directed anterosuperior
and posterior, respectively. The entry site (indicated on FIGS.
10A-10C by an asterisk) of the hole punch mobile flange (27) is in
the crotch of the boomerang and directed anteriorly toward the apex
of the boomerang. As depicted in FIGS. 11A-11C, the mobile flange
(27) of backbiting hole punch (26) is advanced into the posterior
opening of the ethmoid infundibulum (EI) well superior to the
pathway of mucus exit from the posterior ethmoid infundibulum (EI)
and levered gently to assess the location of the anterior and
inferior attachment of the uncinate process (UP). This maneuver
facilitates the anterior advance of the mobile flange (27) within
the ethmoid infundibulum (EI) by stretching the uncinate process
(UP) a bit medially and helps define the anterior and inferior
attachments of the uncinate process (UP) where the "swinging door"
of the uncinate process "hinges" with respect to its skull
attachments (FIGS. 11A-11C). The hinge zone (marked in FIGS.
11A-11C) defines the anterior and inferior extent of the ethmoid
infundibulum (EI). The natural ostium of the maxillary sinus (MOMS)
is reliably found a few millimeters posterior to the
anterior-inferior apex of the ethmoid infundibulum (EI). As such
the surgeon seeks to create the keyhole perforation as anterior and
inferior as possible on the uncinate process (UP). He aims the tip
(35) of the mobile flange (27) of hole punch (26) anterior and
inferior toward the apex of the uncinate "boomerang," roughly the
intersection of the axes of the anterior and inferior attachments
of the uncinate (target sign in FIGS. 10A-10C). The tip (35) is
advanced anteriorly and inferiorly by pulling the instrument toward
the surgeon. It will naturally stop at the anterior inferior extent
of the infundibulum (FIGS. 12A-12C) and the keyhole perforation is
created there by squeezing the finger action together to close the
mobile flange (27) to the stable platform (28) of the backbiting
hole punch (26), transfixing the uncinate process (UP) and excising
the intervening tissue (FIGS. 13A-13C). The tip works much like a
paper hole-punch, scrupulously protecting the orbit while creating
a perforation (`keyhole`) in the uncinate process (UP) in the
appropriate, strategically located position. Reliably, this
maneuver will place the keyhole (KH) immediately medial to the
natural ostium of the maxillary sinus (NOMS) or just anterosuperior
to it (FIGS. 14A-14C). Such a position is ideal to allow anterior
to posterior access to and visual verification of the natural
ostium of the maxillary sinus (MOMS).
[0126] After removal of the backbiter hole punch, a guide-free
dilator of the present invention is used to restore the flow of
mucous from the maxillary sinus to the nasal cavity. An embodiment
of the guide-free dilator of is displayed in FIG. 15A. The
guide-free dilator (39) consists of a rigid handle (40), preferably
composed of metal or plastic, and a sufficiently rigid shaft (41),
similarly composed, that incorporates a specific distal angulation
(42). The range of allowable angles may be anywhere from 0 to 145
degrees from straight, but is preferably in the range of 30 to 60
degrees. The most preferred embodiment for general applicability in
the sinuses is likely to be at or near 45 degrees. This fixed
angulation (42) may be accomplished with a single integrated
instrument as shown in FIG. 15A. Alternatively, multiple fixed
angulations may be accomplished with a two-part embodiment (FIG.
15B). In this embodiment, a single semirigid catheter (44) can be
clipped into a choice of several interchangeable handle-shaft
carriers (45), each of a distinct fixed angle, if such versatility
is desired. The combined instrument (46) would share the other
characteristics of the integrated instrument and would be expected
to function similarly. It will be appreciated that the sufficiently
rigid shaft (41) of the guide free dilator (39) may have a minimal
amount of malleability.
[0127] The dilator segment (43) of guide-free dilator (39) is shown
in FIG. 15C. The dilator segment (43) consists of a semirigid shaft
(47), preferably composed of an external sheath of a plastic or
fiber compound, ending in a spatulate or ellipsoid tip (48), and
mounting a balloon (49). The semirigid shaft (47) is preferably
made from a polymer. Preferable polymers include but are not
limited to silicone rubber, polyurethane, polyethylene
terephthalate, polyethylene, polypropylene, polyvinyl chloride,
polymethyl methacrylate and polytetrafluoroethylene. In the
embodiment shown in FIG. 15C, the balloon (49) can be configured as
a modified "figure-8" (50). Alternatively, in the embodiment shown
in FIG. 15D, the balloon has an ellipsoid configuration (51). The
balloon is inflated and deflated by introduction or withdrawal of
fluid through the inflation port (52) via the inflation conduit
(53) (see FIG. 15A).
[0128] The guide-free dilator of the present invention has several
unique properties that enable it to operate optimally within the
sinuses. The handle (40) is widened to accommodate its fit within
the surgeon's hand. The guide-free dilator is only semirigid
distally but remains stiff for most of its length, facilitating
control, allowing the surgeon to retract or reflect intranasal
structures to a degree and to precisely direct the instrument using
the dominant hand only. The device is intended to be used without a
guide, and therefore, permits only minimal flexion, and only over a
short segment of its total length. After the instrument angles
distally at the bend (41') of substantially rigid shaft (41), it
becomes semirigid in the dilator segment (43). This unique property
is used in order to maintain enough rigidity to pass alongside
walls at sufficiently shallow angles of address but to flex at
sufficiently perpendicular angles. This property facilitates
finding ostia and natural pathways through the paranasal sinuses
and nose while avoiding the creation of false passages. These
characteristics make it easier to navigate existing anatomy while
avoiding damage. A spatulate tip (48) further reinforces these
effects. As indicated above, the approximate angle of curvature is
preferably given at 30-60 degrees, most preferably at about 45
degrees. This general range of angulation is appropriate for the
intended approaches to the superior and inferior ethmoid
infundibulum, natural maxillary ostium, hiatus semilunaris
superior, ostia of the ethmoid bulla, and frontal sinus ostium.
[0129] In a preferred embodiment of the present invention, a
balloon (49) functions as the actively dilating portion of the
instrument. The length of the balloon is chosen to be approximately
1.0-2.0 cm, again appropriate for access to and dilation of the
aforementioned structures. The range of 4-7 mm diameter for the
balloon is chosen as appropriate to the anatomy of the structures
intended for dilation. The modified "FIG. 8" configurations of the
balloon depicted in FIG. 15C may help seat the balloon in the
intended ostium, and if used, the dimensions presented do help the
surgeon to work in these narrow spaces. A standard ellipsoid
configuration of the balloon is also satisfactory. Although the
above dimensions were not chosen expressly for other paranasal
sinuses, they do allow navigation of the posterior ethmoid and
sphenoid as well. Furthermore, its design enables dilation of the
maxillary sinus and ethmoid infundibulum completely independent of
guides or guide wires and only using the dominant hand, unique to
the present invention, and unknown in the minimally invasive
balloon dilation prior art.
[0130] FIGS. 16A-16C depict use of the guide-free dilator (39) of
the present invention. The guide-free dilator (39) can be advanced
readily through the keyhole (KH) perforation in the uncinate
process (UP). Under direct vision with an endoscope, the dilator
tip (48) is advanced through the anterior uncinate keyhole (KH)
into the mid-to-inferior ethmoid infundibulum (EI) and the balloon
(49) is expanded, medializing the uncinate process. The 45 degree
(approximate) angulation of dilator tip to shaft (FIG. 15A) is
expressly chosen to allow easy and accurate advance of the tip into
the ethmoid infundibulum (EI) via the keyhole (KH). This maneuver
helps to open the final pathway of mucus drainage from the
posterior infundibulum, best observed in FIG. 16B. The dilator is
then withdrawn slightly, the tip is turned laterally and inferiorly
and directed into the natural ostium of the maxillary sinus (NOMS)
where dilation can again be accomplished (FIGS. 17A-17C). Again,
the 45 degree angulation of the guide-free dilator (39) is ideal
for this maneuver, with atraumatic, direct, and easy passage
through the natural ostium of the maxillary sinus (NOMS) and into
its antrum.
[0131] Of note, the dilator (39) of the present invention can also
be used to dilate the keyhole (KH), if desired (FIGS. 18A-18C). The
dilation is eccentric as maxillary bone is far more resistant than
uncinate. The resulting dilation of the ethmoid infundibulum,
natural ostium of the maxillary sinus, and, if desired, the keyhole
are all visually verifiable with this approach.
[0132] If an accessory ostium (AO) is identified (FIGS. 19A-19C),
it may be broadly connected to the natural ostium of the maxillary
sinus (NOMS) at this point, according to the surgeon's discretion.
This option is deemed useful to exercise in many patients and is
unique to the present invention in the balloon dilation art.
[0133] There are several key advantages of the present invention
for treating obstructed maxillary sinuses: [0134] 1. Ease of use:
For each maneuver of the present invention, the surgeon uses the
nondominant hand purely for manipulation of the endoscope and the
dominant hand purely for manipulation of a single surgical
instrument. Both minimally invasive approaches of the prior art
(see U.S. Pat. Nos. 7,500,971 and 7,559,925) use tubular guide
catheters to direct the dilator appropriately, requiring more
surgical field clutter and hand-switching maneuvers. These
catheter-guide based systems are well-suited for (and, indeed,
adapted from) percutaneous endovascular procedures like
angioplasty, but foreign to sinus surgeons accustomed to
instruments that enable fine movements of the fingers to translate
directly and reliably into equally fine movements of the working
tip of that instrument, and to do so using the dominant hand
exclusively. [0135] 2. Direct visualization of the operative site:
In the present invention, the surgeon can see the natural ostium
before manipulating it and the approach is, conveniently, along the
axis of the endoscopic view into the nose. In the intranasal
procedure of the prior art, the natural ostium is never actually
seen, but is presumptively identified by the verified presence of
the guidewire in the maxillary sinus after blind passage (see U.S.
Pat. Nos. 7,500,971 and 7,559,925). [0136] 3. Avoidance of trauma
to key structures: The method of the present invention gains access
to the natural ostium of the maxillary sinus without trauma to any
areas that participate in mucus drainage from that sinus. In
contrast, the guide-catheter system of the prior intranasal art
requires a near-180 degree turn within the narrow confines of the
middle meatus, a cumbersome approach that unavoidably traumatizes
the ethmoid bulla and outflow tract of mucus exiting the maxillary
sinus. Although we are proceeding posterior to anterior with the
backbiter of the present invention, due to its design and surgeon
control, it is essentially atraumatic in its passage. Further, one
advances the backbiter from a point much higher in the posterior
infundibulum than is used by the nose for mucus drainage, an area
that is, on the contrary, necessarily traumatized by the guide,
guidewire, and for that matter, withdrawal of the balloon post
dilation in the method of prior intranasal art. [0137] 4.
Identifying and appropriately treating accessory ostia: As noted
above, accessory ostia are frequent anatomic findings. Mistaken
dilation of these structures to the neglect of the natural ostium
results in one of the commonest adverse complications of maxillary
sinus surgery (mucus recirculation and worsening of maxillary
sinusitis). The method of the present invention allows unequivocal
identification of the natural ostium and easily enables
identification of accessory ostia The intranasal procedure of the
prior art may actually be more likely to dilate an accessory
ostium, if present, than the natural ostium because the accessory
ostia are frequently larger and invariably lie along the path that
the guide wire follows in blind search for the natural ostium.
[0138] 5. The procedure is easily combined with other sinus/nasal
procedures: Unlike the canine fossa procedure (U.S. Pat. No.
7,520,876) of the prior art, the method of the present invention
employs a purely intranasal approach that easily marries with the
other intranasal procedures that usually are performed alongside
the maxillary procedure. In addition to the simplicity of the
approach, the method of the present invention uses the same core
device for access to the other paranasal sinuses (as will be seen
below), in marked distinction to the canine fossa approach and to
the multiple guides employed by the intranasal approach of the
prior art.
Access to the Anterior Ethmoid Sinuses
[0139] The important anatomical features discussed in this section
are displayed in FIGS. 20 and 21A-C. FIG. 20 is a view from medial
to lateral of the structures lateral to the middle turbinate with
the turbinate itself removed. Both the superior root of the middle
turbinate (SRMT) and the posterior root of the middle turbinate
(PMRT) can be seen in the diagram. The solid arrows indicate the
path of mucous drainage. As will be discussed in more detail below,
mucous from the anterior ethmoid sinus cells drains primarily
through the ethmoid bulla ostium (EBO) into a narrow passageway
between the ethmoid bulla (EB) and the basal lamella (BL), referred
to as the hiatus semilunaris superior (HSS). Accessory ostia (AO)
cam also be seen in the figure. The ethmoid bulla (EB) and
accessory ostia (OA) are found in the posteromedial wall of the
ethmoid bulla (EB). The ostial zone (OZ) in the ethmoid bulla wall
is depicted in the diagram. FIG. 21A shows the typical
anteroinferomedial-to-posterosuperolateral view obtained during
nasal endoscopy. FIG. 21B represents a medial-to-lateral sagittal
view of the relevant structures of the middle meatus. FIG. 21C
represents the same structures in transverse view from
superior-to-inferior. These three viewpoints will be used to depict
the embodiments discussed below. In these figures, the solid arrows
indicate the path of mucous drainage.
[0140] The anterior ethmoid is that group of pneumatized cells of
the ethmoid that drain anterior to the basal lamella (BL), a
roughly vertical thin bony wall that comprises the attachment of
the middle turbinate to the lateral wall of the nose (FIG. 20).
Those cells are often involved with inflammation synchronously with
their maxillary sinus counterpart, frequently to the exclusion of
the posterior ethmoid (PE)--or, that part of the ethmoid sinuses
posterior to the basal lamella (FIG. 20)--hence, the distinction in
clinical nomenclature within the ethmoid. A preferred embodiment of
the present invention allows for systematically addressing the
anterior ethmoid seamlessly with the maxillary sinus. In
conventional minimally invasive sinus surgery (as per
Messerklinger), the uncinate process (UP) is completely removed and
the ethmoid bulla (EB) and adjacent anterior ethmoid air cells
completely marsupialized (i.e., widely opened to broadly drain into
the main vault of the nose.) With perhaps other minor alterations,
that succeeds in opening all of the major cells and recesses of the
anterior ethmoid. That procedure is largely successful in solving
the inflammatory problems it sets out to treat. Those traumatic
efforts can be painful for the patient, and in any case, moderate
degrees of anesthesia, bleeding or nasal packing, prolonged
stuffiness, and some missed work/activities are to be expected. The
present invention achieves the same clinical results without those
demerits.
[0141] As discussed above, there is greater variability and
uncertainty as to the identity of the true drainage pathways for
the anterior ethmoid. There also is variability among patients in
the structure of the aptly-named ethmoid labyrinth. Many surgeons
believe that the ethmoid infundibulum (EI) is the primary drainage
site for the anterior ethmoid. Indeed, that is the usual drainage
site for the agger nasi cell(s) (AN) (FIG. 20). The hypothesis in
general, however, likely is unsound because the ethmoid bulla
antrum rarely has a drainage communication with the ethmoid
infundibulum (a septum of bone usually separates the two spaces),
and when there is such a communication, it drains only a small
isolated chamber of the ethmoid bulla (EB). In general, the main
outlet from the ethmoid bulla (EB) and its dependent adjacent
anterior ethmoid air cells is an ostium in the posteromedial wall
of the ethmoid bulla, referred to as the ethmoid bulla ostium (EBO)
(FIG. 20). Although the ethmoid bulla ostium (EBO) is not
rigorously defined in the literature, it is invariably present,
occasionally with a second or accessory ostium.
[0142] As depicted in FIGS. 21A-C, Mucus exits the ethmoid bulla
ostium (EBO) into a narrow crescentic space between the
posteromedial wall of the ethmoid bulla (EB) and the anterolateral
wall of the basal lamella (BL) called the hiatus semilunaris
superior (HSS). These anatomic observations are well-supported by
published work dating back over one hundred years. The careful
reader will note the analogy between the described drainage pathway
in the anterior ethmoid and that previously elucidated for the
maxillary sinus. In the anterior ethmoid, as in the maxillary, a
well-defined ostium drains into a narrow secondary space. In the
maxillary sinus, a successful method for augmenting flow will
simultaneously open the natural ostium and ethmoid infundibulum
(EI), as outlined earlier; in the anterior ethmoid sinuses, the
method must open the ethmoid bulla ostium (EBO) and hiatus
semilunaris superior (HSS).
[0143] In the current state of the art, marsupializing the anterior
ethmoid is accomplished by removing most of the walls or septations
of the anterior ethmoid with a microdebrider, cutting forceps, or
some combination thereof. For those few surgeons who feel
comfortable addressing the hiatus semilunaris superior (HSS)
specifically, the same instrumentation is used to remove the medial
wall of the ethmoid bulla (EB), leaving the opening in continuity
with the hiatus.
[0144] With current instrumentation, the hiatus area is opened by
traumatizing it, thereby temporarily obstructing it with eschar
(and possibly permanently with synechiae). There also is the
typical bleeding, pain, healing time, need for anesthesia, and the
use of stents or packing, all of which would be better to minimize
or avoid. Most of these problems can be avoided by a minimally
invasive approach that seeks to dilate the hiatus semilunaris
superior (HSS) and ethmoid bulla ostium (EBO) without significant
resection. To date, no such procedure exists in the prior art of
sinus ostia dilation.
[0145] In a preferred embodiment of the present invention, the
anterior ethmoid is addressed without necessitating prolonged
healing by directly dilating the ethmoid bulla ostium (EBO) and the
hiatus semilunaris superior (HSS). The ethmoid bulla ostium (EBO)
is generally found on the superior posteromedial aspect of the
ethmoid bulla (EB), and as such, is usually hidden from direct
endoscopic view in the intact patient (FIG. 21A, endoscopic view).
In accordance with the present invention, the hiatus can often be
successfully entered from the medial approach, described below. If
the medial approach is not easily successful, and in accordance
with another aspect of the present invention, the surgeon can
reliably perforate the anterior surface of the ethmoid bulla (EB)
inferiorly and probe under direct vision superiorly to access the
ethmoid bulla ostium (EBO) and through it, the hiatus semilunaris
superior (HSS). As discussed below, such an anterior keyhole can
also be used in conjunction with a medial approach to provide
direct visual confirmation that the ethmoid bulla ostium (EBO) has
been entered from without.
[0146] The medial approach is depicted in FIGS. 22-25. For clarity,
these figures each show three different views of the relevant
anatomy, which are identical to the views shown in FIGS. 21A-C. The
procedure may begin, in identical fashion to that described above
for the maxillary sinus, with middle turbinate retraction (FIGS. 3
and 7). Anesthesia is achieved locally and the middle turbinate is
retracted out of the way. In this procedure, the retractor is of
particular use in that here we require as much medial exposure of
the ethmoid bulla as possible, and the middle turbinate otherwise
obscures this area.
[0147] Next, the hiatus semilunaris superior (HSS) is addressed
from the medial approach. Turning to FIGS. 22A-C, curvilinear
recess between the basal lamella (BL) of the middle turbinate and
the posteromedial wall of the ethmoid bulla (EB) is entered with
one or both ends of the medial ethmoid probe of the present
invention. The medial ethmoid probe (60) is displayed in FIG. 26A.
This probe has a handle (61) and shaft (62 and 62') on both sides
of the handle. The shaft is made of a rigid material such as metal
or plastic. The distal segment (63 or 63') of either end may be of
rigid or semirigid material. The distal segment is preferably made
from a polymer including but not limited to silicone rubber,
polyurethane, polyethylene terephthalate, polyethylene,
polypropylene, polyvinyl chloride, polymethyl methacrylate and
polytetrafluoroethylene. The distal segment (63) curves to a final
angle (64) of less than 110 degrees to the axis of approach.
Preferably, the angle (64) is between 20 degrees and 80 degrees.
More preferably, the angle (64) is between 30 and 60 degrees. FIG.
26B shows a distal segment (63) that is angled superiorly
approximately 30 degrees (64) from the axis of approach. It is
noted that the angles (64 and 64') may be the same or different.
The length of the distal segment (63 or 63') preferably ranges from
approximately 0.5 cm to 2.0 cm, more preferably from 0.7 cm to 1.5
cm, and most preferably about 1.2 cm. The materials, curvatures,
angles, and lengths as defined facilitate atraumatically
maneuvering the distal segment within the hiatus semilunaris
superior (HSS) to engage the ethmoid bulla ostium (EBO) with the
curved tip (66), shown in higher magnification in FIG. 26C
[0148] In one embodiment of the present invention, the concave
surface of the distal tip (66) and distal segment (63) may be
wedge-shaped in profile, to facilitate deforming or stretching the
medial margin of the ethmoid bulla ostium (EBO) when the instrument
is pulled toward the operator while engaging the ostium (see FIGS.
23A-23C and discussion below.) The function of the medial ethmoid
probe (60) is to palpably identify an ostium concealed (as it
usually is) on the posterior aspect of the ethmoid bulla (EB) and
to enlarge it medially and anteriorly so that it can be seen and
therefore treated more definitively.
[0149] Manipulation of the medial ethmoid probe (60) is depicted in
FIGS. 22A-22C. In the method of the present invention, the medial
ethmoid probe is grasped by handle and the shaft and distal segment
are introduced into the nose. The distal segment (63) of the medial
ethmoid probe (60) is inserted into the hiatus semilunaris superior
(HSS) and with the manipulated such that the curved tip (66)
engages the rim of the ethmoid bulla ostium (EBO). The procedure is
facilitated owing to the angulations and material composition
outlined previously for the medial ethmoid probe (60). This
interaction is easily palpated and occasionally directly
visualized. If a shallow angulation (64) of medial ethmoid probe
(60) (e.g., 30 degrees) is not able to engage the ostium, a steeper
angle (e.g., 60 degrees) is used.
[0150] In most cases, the ethmoid bulla ostium (EBO) can be
identified at this point and stretched open with a gentle posterior
to anterior traction, indicated by the solid arrow in FIGS.
23A-23C. In FIGS. 23A-23C, the starting point of medial ethmoid
probe (60) is shown with dotted lines and the ending point is
depicted with a solid line. The traction maneuver is facilitated by
a cutting edge on the inner curvature of the distal tip (66) and
distal of the medial ethmoid probe (60). Once identified and gently
stretched, the ethmoid bulla ostium (EBO) of the hiatus can usually
be seen. Whether or not the ostium is directly visualized at this
point, the tip of the guide-free dilator (39) of the present
invention can be passed into the hiatus semilunaris superior
(HSS)--i.e., the space between the ethmoid bulla (EB) and the basal
lamella (BL)--and expanded (FIGS. 24A-24C). The guide-free dilator
(39) is depicted in FIG. 15A and was discussed in reference to the
maxillary sinus embodiments. Expansion of the guide-free dilator
(39) leads to dilation of the hiatus semilunaris superior (HSS),
widening the narrow cleft into which the ethmoid bulla ostium (EBO)
drains and improving further access to the ostium itself. Now that
the ethmoid bulla ostium (EBO) can, in most cases, be directly
seen, it is entered under direct vision with the tip of the
guide-free dilator (39) and dilated (FIGS. 25A-25C). Alternatively,
cannulating and dilating the ostium with the guide-free dilator of
the present invention may succeed in also dilating the hiatus
semilunaris superior (HSS) in a single-maneuver if the ostium can
be easily visualized after the stretching maneuver outlined
earlier. Regardless, as shown in FIGS. 25A-25C, expansion of the
dilator widens the hiatus semilunaris superior (HSS) leading to a
zone of deformity (shaded region in FIGS. 25A-25C).
[0151] Despite appropriate efforts, the medial approach
occasionally will not gain reliable access to the ethmoid bulla
ostium (EBO), usually because the ostium is placed exceptionally
superior and lateral on the posterior wall of the bulla. In such
cases, in accordance with another aspect of the present invention,
an anterior keyhole perforation is created. The anterior keyhole
approach is preferably performed after dilation of the hiatus
semilunaris superior (HSS) using the medial approach described
above. Alternatively, the anterior keyhole approach may be
performed prior to dilation of the hiatus semilunaris superior
(HSS).
[0152] The anterior keyhole approach is depicted in FIGS. 27-33. As
described above, each of these figures depicts three separate views
of the relevant anatomy surrounding the ethmoid bulla (EB). For
ease of approach, the surgeon attempts to remain as lateral as
possible, while still medial to the free posterior margin of the
uncinate process (UP). The point (marked by asterisk in FIG. 27)
chosen is also just below the "equator" of the ethmoid bulla (FIG.
27A-27C, dashed line)--i.e., the anterior extent of the convexity
of the anterior wall of the bulla at about the midpoint of its
inferior-to-superior height--yet above the pathway of mucus exit
from the ethmoid infundibulum (EI). As a practical matter, this
places the perforation in the inferolateral quadrant of the visible
anterior wall of the ethmoid bulla (EB). The chosen site has the
advantage of affording the best view of any ostium likely to escape
probing from the medial aspect (i.e., a superior and lateral ostium
placement) while also remaining out of any known common drainage
pathway for the anterior ethmoid, frontal, or maxillary
sinuses.
[0153] As shown in FIGS. 28A-28C, a perforation is made in the wall
of the ethmoid bulla (EB) at the site indicated in FIGS. 27A-27C.
Such a perforation may be accomplished using the ethmoid keyhole
probe of the present invention, depicted in FIG. 34. Ethmoid
keyhole probe (72) is composed of entirely rigid materials and
consists of a handle (73) with a thin shaft (74 and 74') on both
ends. One end mounts a perforator tip (75) with a stop collar (76).
The perforator tip terminates in a sharp pointed end (77) that is
ideal for making a small perforation in the bone. The distance from
the pointed end (77) to the stop collar (76) is preferably less
than 1.0 cm and most preferably about 0.5 cm. The other end mounts
a dilator tip (78) that is bluntly tapered at the distal end (79)
and rounded at its proximal end (80). The tapered distal tip (79)
has a smaller diameter than the rounded proximal end (80) which is
itself not more than 0.5 cm in diameter. As will be apparent from
the figures below, the ethmoid keyhole probe (72) depicted in FIG.
34 serves the dual purpose of making the perforation in the wall of
the ethmoid bulla (EB) and dilating the resultant perforation.
However, in accordance with another aspect of the present
invention, the perforation and dilation can be accomplished with
separate instruments.
[0154] Perforation of the wall of the ethmoid bulla (EB) using the
anterior ethmoid keyhole method of the present invention is
depicted in FIGS. 28A-28C. In these figures the pointed end (77) of
the perforator tip (75) of the ethmoid keyhole probe (72) engages
the anterior wall of the ethmoid bulla (EB) at the chosen site (see
FIGS. 27A-27C) and penetrates the wall into the antrum of the
ethmoid bulla (EB). The stop collar (76) limits the extent of
penetration.
[0155] As shown in FIGS. 29A-29C, the ethmoid keyhole probe (72)
then is withdrawn, inverted and the dilator tip (78) of the ethmoid
keyhole probe (72) is introduced completely into the ethmoid bulla
antrum through the perforation. The ethmoid keyhole probe (72) is
then withdrawn (FIGS. 30A-30C), everting the mucosa of the wall. At
this point, the perforation can be enlarged with the guide-free
dilator (39) of the present invention (FIGS. 31A-31C).
Alternatively, as depicted in FIGS. 32A-32C, dilation of the
perforation may be accomplished with a conventional sphenoid punch
(83). For example, a 19.5 centimeter sphenoid punch can be obtained
from V. Mueller, catalog no. RH550-452. Note that while the
guide-free dilator (39) expands to a predetermined diameter, the
sphenoid punch (83) can incrementally remove smaller amounts of
tissue to a desired stopping point, at the discretion of the
surgeon. Although this yields control of size, it does so by
cutting rather than stretching tissue and therefore likely
generates a little more bleeding than the dilator.
[0156] Referring back to FIG. 31 or 32, dilation of the keyhole
should provide enough exposure to identify, cannulate, and dilate
the ethmoid bulla ostium (EBO). Hence, similar to the maxillary
sinus embodiments discussed above, the guide-free dilator (39) is
introduced through the perforation and the ethmoid bulla ostium
(EBO) is dilated (FIGS. 33A-33C). It should be noted that the
success of this approach may depend on previously achieving the
dilation of the space of the hiatus semilunaris superior (HSS) from
the medial approach, much as the success of maxillary sinus
approaches depends not only on dilation of the natural ostium but
also on dilation of the ethmoid infundibulum (EI). (cf. FIGS.
16A-16C and FIGS. 24A-24C and FIGS. 25A-25C). The ethmoid keyhole
approach gives the surgeon exposure to the ostia from both
anterolateral (inside the ethmoid bulla) and posteromedial (outside
the bulla, in the HSS). In many cases, this increased exposure will
be crucial to knowing the job was accomplished. One can tell by
working from the outside first, as in the described method, and if
adequate ostium dilation can not be effected easily, gain the
improved exposure through the keyhole, while still limiting or
eliminating resection of tissue.
[0157] The other major cells of the anterior ethmoid bear some
discussion. The space often styled the "sinus lateralis" can also
be subdivided into fairly distinct suprabullar and retrobullar
recesses. Fortunately, these spaces have fairly broad communication
with the nasal vault in most cases; in any case, significant
disease in these areas does not lend itself to minimally invasive
approaches. Similarly, other more distal cells of the anterior
ethmoid often communicate with the aforementioned spaces and the
ethmoid bulla (EB). Accordingly, procedures described above for
dilating the ethmoid bulla ostium (EBO) and the hiatus semilunaris
superior (HSS) should mitigate blockage of these cells as well.
[0158] The agger nasi (AN) also bears special mention. When
present, the agger nasi (AN) is found lateral to the superior
uncinate and has a separate drainage pathway inferiorly, into the
ethmoid infundibulum (EI). It can easily be dilated during the
maxillary procedure, if desired, by directing the tip of the
guide-free dilator (39) of the present invention superiorly, into
the antrum of that cell. The proximal end of the frontal recess is
usually positioned posteromedial to its posteromedial wall; hence,
the agger nasi (AN) and frontal sinus are often involved
synchronously with inflammation. For this reason, one must be quite
careful regarding the use of dilators in this area, so as not to
have the improved drainage of one area compromise the patency of
the other. Alternatively shaped guide-free dilators of FIGS. 35A-B
may be of particular use in this area as they allow for more
limited, small-diameter dilation. Such a dilator tip might be
mounted on a carriage similar to that of the backbiting hole punch
(FIG. 9H) or of the drug delivery devices (FIGS. 38A and 39A) of
the present invention, enabling similar maneuverability within the
nose. The distal tip (90) is rounded in order to allow atraumatic
advancement into the visualized ostium. Just proximally, the
dilating flanges (91) taper to a neck (92) to facilitate seating
them in the ostium when they are expanded to dilate it (FIG. 35B).
Many different mechanisms to obtain the expansion of the flanges
(91) are contemplated.
Access to the Frontal Sinus
[0159] As noted above, the frontal sinus is sometimes inflamed in
concert with, and probably as a result of, inflammation in the
anterior ethmoid. As such, in the minimally invasive arena, frontal
sinusitis can often be treated purely by appropriate treatment of
the anterior ethmoid, as outlined above, or with procedures of the
prior art. There are circumstances, however, in which direct
dilation of the frontal sinus ostium is desirable. An appropriately
trained practitioner of the routine sinus art can directly
visualize the frontal ostium in a predictable manner using a 70
degree endoscope. Subsequently. the curved rigid-semirigid balloon
dilator (39) of the present invention can be passed into the ostium
under direct vision and without resort to a guide. As in the above
approaches, a significant advantage to the dilator of the present
invention is that it can be manipulated just like the probe
employed in frontal sinus identification in routine sinus
procedures.
[0160] The frontal sinus procedure of the present invention is
depicted in FIGS. 36 and 37. These figures each show two views of
the relevant anatomy around the frontal sinus, an endoscopic view
(70 degrees) (FIGS. 36A and 37A) and a sagittal projection (FIGS.
37A and 37B). In the Figures, the relevant anatomy is indicated,
particularly the frontal sinus (FS) and frontal ostium (FO). The
shaded cells in the figures are small ethmoid air cells. The
frontal approach is likely best accomplished before the maxillary
sinus and ethmoid infundibulum are addressed. After anesthesia and
middle turbinate retraction are achieved, as described above, a 70
degree endoscope is advanced into the middle meatus just medial to
the mid portion of the uncinate process, with the view directed
superiorly (FIG. 36B). The frontal ostium is generally found
posteromedial and superior to the posteromedial and superior aspect
of the agger nasi cell (FIG. 36A). The guide-free dilator (39) can
then be directed superior, lateral, and anterior and passed into
the ostium under direct endoscopic vision (FIGS. 37A-37B). The
appearance and position of the ostium are fairly characteristic to
the trained practitioner of the prior routine sinus art, but, as
there may be confounding adjacent small ethmoid cells present, it
would be appropriate at this point to verify placement in the true
frontal sinus ostium via fluoroscopy or other means. Dilation can
then be accomplished. Anatomic variations can be seen. Exhaustive
treatment of the variations is beyond the intended scope of this
description, but suffice it to say that the person of ordinary
skill in the art will recognize that the dilator of the current
invention can be used to treat other anatomic locations of the
ostium in analogous fashion to the above description.
Access to the Posterior Ethmoid
[0161] Definitive and directed treatment of this area is not often
required in the minimally invasive arena, but certainly is amenable
to the use of the guide-free dilator device of the current
invention. The drainage pathways of the posterior ethmoid are quite
variable and need to be assessed on a case-by-case basis. One
constant to the variation is that mucociliary flow proceeds from
the superolateral to the inferomedial direction, exiting in the
superior meatus. This area can be endoscopically assessed using a
70 degree endoscope passed medial to the middle turbinate and with
the view directed laterally. The ostia and recesses of the
posterior ethmoid often can be seen with this approach and dilation
can be accomplished with the guide-free device under direct vision
as deemed necessary and appropriate.
Access to the Sphenoid Sinus
[0162] As in the posterior ethmoid sinuses, the sphenoid does not
frequently require treatment in the minimally invasive arena.
Nonetheless, the sphenoid sinus ostium can be identified posterior
and superior to the body of the superior turbinate by appropriately
trained practitioners of the routine sinus surgical art. This site
is visualized with a 0 or 30 degree endoscope passed medial to the
middle and superior turbinates with the view directed laterally, if
the angled scope is needed. The guide-free dilator (39) of the
current invention is well-suited to direct passage into the
visualized ostium. As in the frontal sinus, proximity to vital
structures and the concomitant hazard of significant morbid
complications suggests that external verification of placement
using fluoroscopy or other methods may be desirable in some cases
before dilation is undertaken.
Delivery of Targeted Pharmacotherapy
[0163] As described in the Background section, it would be
desirable to facilitate treatment of the sinuses with topical
agents as, in an appropriate iteration, one would expect such
treatment to be more effective and have fewer side effects than can
be observed using an oral route of administration. Ideally, the
means for delivery could be used on a repeated basis, if needed,
with topical or no anesthesia, in an office setting. To that end,
there is a need in the prior art for minimally traumatic and
reliable access to the paranasal sinuses and for drug placement
devices that are cost-effective and do not require later
removal.
[0164] The anterior keyhole approach to the maxillary and anterior
ethmoid sinuses and the medial approach to the ethmoid bulla
outlined above satisfy the requirement for minimal trauma and
reliability. Guide-free drug placement devices of the present
invention allow the practitioner to take advantage of the keyhole
access or direct visualization of the sinus ostia to place
pharmaceuticals in solid, powdered, semisolid, or liquid
biodegradable matrices within the appropriate sinus cavities. Of
further benefit, the devices enable placement of the pharmaceutical
strategically, in distal areas of the sinuses in question, so as to
take advantage of the natural mucociliary clearance action of the
sinus lining to spread the therapeutic agent throughout the
sinus.
[0165] The action of placement of the therapeutic agents in each
relevant sinus is entirely analogous to that noted above for the
dilation of the sinus ostia, and is in general even simpler. The
guide-free drug placement devices of this invention take advantage
of the same angled anatomy as employed by the guide-free dilator of
this invention and are easily manipulated by practitioners in
similar fashion to accustomed probes of the routine sinus art.
[0166] In the maxillary sinus procedure of the present invention,
topical infiltration anesthetics are placed. Infiltration
anesthetics may also be used, but may not be needed if a keyhole or
other antrostomy is already present. The creation of a keyhole is
outlined in detail above and surgical maxillary antrostomies can be
created according to the routine surgical art. Having established
either type of opening into the sinus or by means of a naturally
occurring accessory ostium, the surgeon utilizes a drug insertion
device of the present invention to introduce either a drug or a
drug-delivery device of the present invention into the maxillary
sinus antrum. Two embodiments of drug insertion devices used in
accordance with the present invention are depicted in FIGS. 38 and
39.
[0167] The drug insertion delivery instruments (100) depicted in
FIGS. 38A and 39B share a number of common characteristics. Each
consists of a rigid shaft (101) mounted on a handle assembly (102)
held by the surgeon. Here the handle is depicted using a
traditional syringe action with finger holes (103) to accommodate
the surgeon's index and middle fingers and a plunger (104) for the
thumb. The plunger (104) is squeezed toward the finger holes (103),
advancing the piston (105) through the cylindrical shaft (101).
Other mechanisms for the handle assembly are permissible as long as
they succeed in advancing the piston (105). The shaft (101) angles
distally at the intermediate segment (107). Appropriate angulations
at this site are similar to those for the guide free dilator
described above, but here the ideal angle is between about 55-60
degrees. This angle is specifically chosen to enable drug or drug
device insertion through the keyhole in the maxillary sinus while
also being able to easily accommodate a standard surgical maxillary
antrostomy, naturally occurring accessory ostium, anterior ethmoid
keyhole or patent medially dilated ethmoid bulla, as previously
described in the methods of the present invention. All of the
preceding items are of rigid construction, preferably using metal
or plastic, except for the piston (105), which is flexible so as to
accommodate the angled intermediate segment (107) of the shaft
(101). Flexible plastic or malleable metal embodiments (as in a
wire or spring) of the piston (105) are possible. In each device
embodiment, the instrument terminates in a distal receptacle (108).
The distal receptacle (108) segment is shown in the dotted circle
of FIGS. 38A and 39A. The length of the receptacle (108) is
preferably in the range of 1.0-2.0 cm with the most preferred
length about 1.5 cm. The width is approximately 5 mm. These
dimensions are chosen to allow the insertion device to negotiate
the middle meatus and keyhole in a patient with otherwise intact
anatomy.
[0168] The distal receptacles (108) are rendered differently in the
two embodiments depicted in FIGS. 38A and 39A. In the FIG. 38A
embodiment, the receptacle (108) consists of several (at least 3)
flexible flanges (109) which curve to grasp the drug (110) or drug
delivery device. As shown in FIG. 38B, the drug (110) is initially
held in distal receptacle (108) prior to drug delivery. As depicted
in FIG. 39C, the flexibility of the flanges (109) allow them to
spread apart when the piston (105) pushes the drug (110) or drug
delivery device (e.g., drug in controlled release carrier) against
the incurving distal tip (111), thus allowing the drug (110) or
drug delivery device to be extruded from the now-open end of the
insertion device. Again, flexible metal or plastic embodiments are
preferable.
[0169] In the FIG. 39 embodiment, the receptacle (108) consists of
a sleeve which wholly encompasses the drug or drug (110) delivery
device but otherwise functions similarly to that in FIG. 38. The
mechanism of action of pushing out the drug (110) or drug delivery
device is shown in FIGS. 39B and 39C.
[0170] In the method of the present invention, the drug insertion
instrument (100) is grasped by the handle assembly (102). The shaft
(101), intermediate segment (107), and receptacle tip (108) of the
drug insertion instrument (100) are introduced into the nose with a
drug (110) or drug delivery device of choice loaded in the
receptacle (108). The receptacle is directed through the keyhole
(described above), antrostomy, or accessory ostium into the
maxillary antrum (FIGS. 40 A-C) in entirely analogous fashion to
the introduction of the dilator in the previously described
maxillary procedure of the present invention. As noted in the above
description of the drug insertion instrument (100), the handle
assembly (102) is manipulated so as to advance the piston (105)
through the shaft (101), causing the drug (110) or drug delivery
device to be inserted into the antrum (FIGS. 38C and 39C). The
insertion device is then removed. The natural effect of gravity and
the inferior orientation of the tip deliver the drug in the
inferior apex of the sinus. Conveniently, this is an advantageous
position for concentrating the drug where it is most helpful. The
gravitationally dependent areas of the maxillary sinus are
generally the most involved with inflammation. The drug may then
distribute more generally via mucociliary action of the sinus
lining.
[0171] In the anterior ethmoid, topical or local infiltration
anesthetics also can be used. Again, the middle turbinate will
generally not need to be retracted in a stand-alone drug-placement
procedure. If medial access to the bulla is already established, as
outlined earlier in the method of the present invention (FIGS.
22-25), the drug insertion device can be introduced between the
middle turbinate body and the bulla; the receptacle (108) is then
advanced through the enlarged ethmoid bulla ostium (EBO) and
directed lateral and posterior (FIGS. 41A-C). The drug (110) or
drug delivery device is then released into the ethmoid bulla
antrum. This lateral placement takes advantage of natural
mucociliary movement. The insertion device is, however, versatile
enough to allow strategic placement in a number of different
directions. It is ideally suited, for example, to utilize the
anterior keyhole of the bulla, if previously created (method
outlined above), as access to the antrum of the ethmoid bulla. In
this method, the receptacle tip (108) of the insertion device is
introduced straight through the anterior wall of the bulla via the
keyhole, entirely analogous to the use of the dilator in the
anterior ethmoid keyhole method of the present invention (see FIGS.
31A-C).
[0172] The frontal, posterior ethmoid and sphenoid sinuses can be
accessed with the placement device in entirely analogous fashion to
the dilation procedures outlined above.
[0173] The present invention foresees the utility of sinus-specific
biodegradable matrices for the delivery of topical pharmaceuticals
for the sinuses. One would require that the matrix release
medication over the interval of days-to-weeks, in sufficient
concentration for effect, but without toxicity to the sinus mucosa.
In particular, functional disruption of the gel-mucus interface
with the cilia or alterations of ciliary motility would not be well
tolerated. Of interest, substantially smaller doses of the active
agents (e.g., antibiotics) than normally used orally might be
highly effective topically given the immense advantage of
concentration of action in this arena. Appropriate vehicles for
drug release might include timed-release tablets, ointments, gels,
creams, liquids, or powders. The parameters under which the release
is achieved will be unique to the sinuses, both for the reasons
noted above, and for the fact that the conditions anticipated in
the sinuses have little in common with the enteric or intramuscular
environment typically encountered by timed-release agents in
humans.
[0174] Each of the drug delivery vehicles discussed above have
their own problems, however. All are susceptible to rather rapid
clearance by the natural mucociliary clearance function of the
sinus lining. Furthermore, in the maxillary sinus with a large
accessory ostium, or one previously operated with traditional
techniques, and for the anterior ethmoid sinuses in general,
gravity as well as mucociliary clearance may lead to early egress
without some enhanced means of retention. Ideally, and as outlined
below in an embodiment of the present invention, is a biodegradable
retention framework that degrades at different rate than the drug
matrix.
[0175] A drug delivery device of the present invention consists of
a typical timed-release drug containing matrix coupled with a
resorbable framework. The pharmaceutical industry has, over the
years, developed biodegradable matrices for drug delivery, and the
antibiotics and steroids considered for use in this arena are
demonstrably active in the nose and have been coupled with
biodegradable matrices in numerous oral preparations. As for the
coupled framework, many materials are known to degrade in the nose
over weeks-to-months, the ideal time interval for such a framework,
including oxidized cellulose and polymerized sugars used in suture
material. The polymers, in particular, maintain much structural
integrity throughout a large part of the degradation interval and
are relatively inert to nasal and sinus mucosa.
[0176] Several iterations of this drug delivery device have been
conceived; these embodiments are illustrated in FIGS. 42-44. Each
of these embodiments are configured so as to be utilized with the
drug insertion instrument (100) of the present invention, but this
relationship need not be exclusive. The central idea of a
differentially degrading integrated retention framework coupled to
a more traditional timed release drug matrix can certainly be
adapted to other insertion systems, if desired, while still
retaining its central advantages for topical therapies specifically
in the sinuses. Ideally, any such device can be implanted easily
under local anesthesia in the office, will elute drug over several
weeks, and will resist the natural sinus mucociliary clearance to
remain in place while pharmacologically effective. The illustrated
embodiments and, by extension, analogous iterations, will fulfill
these objectives admirably.
[0177] FIG. 42A shows the first embodiment of the drug delivery
device of the present invention, consisting of a drug containing
matrix (120) with an embedded degradable framework (121). The
framework (121) is anchored by a spine (122) that follows the axis
of the ellipsoid matrix. A series of ribs (123) protrude radially
from the spine. Coplanar ribs (123) are depicted here as three in
number, but could be more; ideally, no less than three would occupy
a single transverse plane of the ellipsoid. Alternatively, the ribs
(123) could stack in a spiral. The tip (124) of each rib would
ideally protrude just past the surface of the matrix (120) in the
nondegraded state. A cross-sectional view of the framework (121) is
shown in FIG. 42B. As engineered, the framework (121) should
degrade more slowly than the matrix (120) revealing more and more
of the ribs (123). Thus, as the matrix resorbs and grows smaller,
the retention device remains intact. The tips (124) of the ribs
remain in contact with the sinus mucosa, but with considerably less
surface area of contact than the matrix alone, thus decreasing the
mucociliary clearance action by orders of magnitude. Once the
matrix (120) is completely degraded, some framework (121) elements
would be expected to remain for some finite interval before
degrading completely themselves.
[0178] FIG. 43A shows the second embodiment of the drug delivery
device of the present invention. FIG. 43B shows a cross-sectional
view. The drug delivery device comprises a matrix (130) and an
embedded degradable framework (131) design. In addition, this
framework (131) is also anchored by a coaxial spine (132). Distinct
from the embodiment depicted in FIG. 42A, however, is an expansile
"umbrella" of ribs (133) also attached radially to the spine (132);
here the attachment is outside the matrix (130) at one apex. The
umbrella (134) is collapsed around the surface of the matrix (130)
within the receptacle (see FIGS. 38 and 39) of the insertion
device. As shown in FIG. 43C (and cross-sectional view FIG. 43D),
the umbrella (134) then expands upon extrusion into the sinus. The
retention and degradation properties of the drug delivery device
are similar to those outlined in the discussion of the embodiment
illustrated in FIG. 42A.
[0179] FIG. 44A shows the third embodiment of the drug delivery
device of the present invention. FIG. 44B shows a cross-sectional
view. The drug delivery device shares with the earlier embodiments
the matrix (140) and embedded degradable framework (141) design.
It, too, can be anchored by a coaxial spine (142), though this is
not strictly necessary. Here, the matrix is surrounded at its
surface by a cage (143) that is embedded in but projects just above
the surface of the matrix (140) to enhance its retention properties
at the outset. As the matrix (140) degrades, it remains within the
confines of the cage (143) until the matrix (140) fragments become
small enough to extrude through the openings in the cage (143).
Other retention and degradation properties are similar to those
outlined above.
BENEFITS OF THE PRESENT INVENTION
[0180] Unique to the present invention, the combination of the
minimally invasive anterior keyhole approach, the described
guide-free drug placement devices, and the absence of any retained
reservoir allow surgeons to consider several new uses for targeted
therapeutic agents: [0181] 1. Surgeons will have a reasonable
intermediate option between pure oral medical therapy and even
minimally invasive ostial dilation procedures. A patient that
failed several standard oral medical regimens might reasonably opt
to have in-office placement of pharmaceuticals via the described
approach. Such an option may have a substantial chance of
succeeding where oral therapy failed and without even resorting to
minimally invasive surgical options of the prior art or of the
present invention. [0182] 2. As an adjunct to minimally invasive or
routine sinus surgery of the prior art or of the present invention,
in lieu of oral or other topical agents that are generally given in
the context of sinus surgery. [0183] 3. The treatment of
postoperative patients regardless of the surgical method used to
treat them. This flexibility is quite valuable in that many
postoperative patients will need further medical therapy on a
repeated basis over the long term. For such patients, the major
advantage of the method of the present invention is that it allows
simple in-office treatment of the problem with a lower anticipated
side-effect profile than typical for oral agents, and with a
vehicle that mimics the cost structure and simplicity of
administration of those oral agents, unlike any option available in
the prior art.
* * * * *