U.S. patent application number 14/585427 was filed with the patent office on 2015-05-28 for delivery system for implanting nasal ventilation tube.
The applicant listed for this patent is Cook Medical Technologies LLC. Invention is credited to Thomas Cherry, Kathryn Evert, Kem Hawkins, Cleve Koehler, Patrick C. Melder, Darin Schaeffer, Chase Wooley.
Application Number | 20150148612 14/585427 |
Document ID | / |
Family ID | 46200086 |
Filed Date | 2015-05-28 |
United States Patent
Application |
20150148612 |
Kind Code |
A1 |
Schaeffer; Darin ; et
al. |
May 28, 2015 |
Delivery System for Implanting Nasal Ventilation Tube
Abstract
Delivery systems and methods of creating an accessory maxillary
ostium and implanting a ventilation tube for purposes of
ventilation, irrigation, infusion or procedural work are described.
The delivery systems include an introducer and an associated
ventilation tube. An irrigation and/or infusion catheter may be
advanced through the ventilation tube in order to irrigate or
express the contents of the sinus cavities. A secondary irrigation
and/or infusion catheter or a balloon catheter may be advanced
through an outer irrigation and/or infusion catheter, deeply into
the sinus cavity, in order to irrigate or express the contents of
the sinus cavities. Moreover, the balloon catheter may
alternatively or additionally be employed to for dilation of the
natural ostium. Still further, a device for delivering drugs,
fluids or the like, may be coupled to the ventilation tube for
delivery of same.
Inventors: |
Schaeffer; Darin;
(Bloomington, IN) ; Melder; Patrick C.; (Marietta,
GA) ; Evert; Kathryn; (Bloomington, IN) ;
Koehler; Cleve; (Ellettsville, IN) ; Hawkins;
Kem; (Bloomington, IN) ; Cherry; Thomas;
(Covington, LA) ; Wooley; Chase; (Floyds Knobs,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
|
|
Family ID: |
46200086 |
Appl. No.: |
14/585427 |
Filed: |
December 30, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13158063 |
Jun 10, 2011 |
8945142 |
|
|
14585427 |
|
|
|
|
13059531 |
Mar 9, 2011 |
|
|
|
PCT/US2009/055252 |
Aug 27, 2009 |
|
|
|
13158063 |
|
|
|
|
61092269 |
Aug 27, 2008 |
|
|
|
Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 2017/3437 20130101;
A61B 17/3468 20130101; A61B 2017/345 20130101; A61M 16/0488
20130101; A61B 17/3415 20130101; A61M 27/002 20130101; A61M 16/0463
20130101; A61B 17/3423 20130101; A61F 2250/0067 20130101; A61M
16/0666 20130101; A61M 2210/0618 20130101; A61B 17/0218 20130101;
A61B 2017/0225 20130101; A61B 17/3478 20130101; A61F 2210/0004
20130101; A61M 16/0816 20130101; A61M 2210/0681 20130101; A61B
2017/3425 20130101; A61F 2/04 20130101 |
Class at
Publication: |
600/204 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61M 16/08 20060101 A61M016/08; A61M 27/00 20060101
A61M027/00; A61F 2/04 20060101 A61F002/04; A61B 17/02 20060101
A61B017/02; A61M 16/04 20060101 A61M016/04; A61M 16/06 20060101
A61M016/06 |
Claims
1. A delivery system comprising: an introducer having a first
proximal end and a first distal end; a cannula slidably disposed
over the introducer, the cannula having a second proximal end, a
second distal end, and an outside diameter, the cannula moveable
along the introducer between a first position and a second
position; a ventilation tube releasably disposed on the first
distal end of the introducer, the ventilation tube having a third
proximal end, a third distal end, and a ventilation tube wall
defining a channel extending between the third proximal end and the
third distal end, the channel having a resting diameter and a
loaded diameter; wherein the outside diameter of the cannula is
greater than the loaded diameter of the channel; and wherein
movement of the cannula from the first position to the second
position advances the ventilation tube distally along the
introducer to release the ventilation tube from the introducer.
2. The delivery system of claim 1, wherein the introducer defines a
bend between the first proximal end and the first distal end.
3. The delivery system of claim 2, wherein the ventilation tube is
disposed on the introducer distal to the bend.
4. The delivery system of claim 1, wherein the first distal end of
the introducer defines a first introducer diameter; and wherein the
first introducer diameter is greater than the resting diameter of
the ventilation tube.
5. The delivery system of claim 4, wherein the first distal end of
the introducer is tapered.
6. The delivery system of claim 4, wherein the first distal end of
the introducer defines a circumferential recess; and further
comprising an o-ring disposed within the recess.
7. The delivery system of claim 4, wherein the introducer defines a
second introducer diameter greater than the first introducer
diameter; and wherein the introducer defines a shoulder that
transitions from the first introducer diameter to the second
introducer diameter.
8. The delivery system of claim 1, wherein the introducer is formed
of a malleable material adapted to allow a user to bend the
introducer to conform to actual or expected anatomy of a bodily
passage.
9. The delivery system of claim 8, wherein the cannula is formed of
a malleable material adapted to allow a user to bend the cannula to
conform to actual or expected anatomy of a bodily passage.
10. A delivery system comprising: an introducer having a first
proximal end and a first distal end; a cannula slidably disposed
over the introducer, the cannula having a second proximal end, a
second distal end, and an outside diameter, the cannula moveable
along the introducer between a first position and a second
position; a ventilation tube releasably disposed on the first
distal end of the introducer, the ventilation tube having a third
proximal end, a third distal end, a proximal flange, a distal
flange, and a ventilation tube wall defining a channel extending
between the third proximal end and the third distal end, the
channel having a first resting diameter and a loaded diameter;
wherein the distal flange of the ventilation tube is
frusto-conical; wherein the outside diameter of the cannula is
greater than the loaded diameter of the channel; and wherein
movement of the cannula from the first position to the second
position advances the ventilation tube distally along the
introducer to release the ventilation tube from the introducer.
11. The delivery system of claim 10, wherein the channel of the
ventilation tube is tapered.
12. The delivery system of claim 10, wherein the first distal end
of the introducer defines an introducer diameter; and wherein the
introducer diameter is greater than the first resting diameter of
the ventilation tube.
13. The delivery system of claim 12, wherein the channel of the
ventilation tube defines a second resting diameter greater than the
first resting diameter; wherein the channel defines a shoulder that
transitions from the first resting diameter to the second channel
diameter; and wherein the second resting diameter is greater than
the introducer diameter.
14. The delivery system of claim 10, wherein the proximal flange
defines a passageway extending through a thickness of the proximal
flange.
15. The delivery system of claim 10, wherein the ventilation tube
comprises a drug eluting material.
16. The delivery system of claim 15, wherein the drug eluting
material comprises one of antithrombogenics, antiproliferatives,
antibiotics, antivirals, antifungals, or anti-inflammatories.
17. The delivery system of claim 10, wherein the ventilation tube
comprises a resorbable material.
18. The delivery system of claim 1, further comprising a handle
disposed on the introducer; and further comprising a drum disposed
within the handle, the drum slidably disposed over the introducer
and having a fourth proximal end and a fourth distal end attached
to the second proximal end of the cannula, the drum moveable along
the introducer between a first position and a second position;
wherein movement of the drum between its first and second positions
moves the cannula between its first and second positions.
19. The delivery system of claim 10, further comprising a handle
disposed on the introducer; and further comprising a drum disposed
within the handle, the drum slidably disposed over the introducer
and having a fourth proximal end and a fourth distal end attached
to the second proximal end of the cannula, the drum moveable along
the introducer between a first position and a second position;
wherein movement of the drum between its first and second positions
moves the cannula between its first and second positions.
20. A delivery system comprising: an introducer having a first
proximal end and a first distal end; a cannula slidably disposed
over the introducer, the cannula having a second proximal end, a
second distal end, and an outside diameter, the cannula moveable
along the introducer between a first position and a second
position; a ventilation tube releasably disposed on the first
distal end of the introducer, the ventilation tube having a third
proximal end, a third distal end, and a ventilation tube wall
defining a channel extending between the third proximal end and the
third distal end, the channel having a resting diameter and a
loaded diameter; a handle disposed on the introducer; a drum
disposed within the handle, the drum slidably disposed over the
introducer and having a fourth proximal end and a fourth distal end
directly attached to the second proximal end of the cannula, the
drum moveable along the introducer between a first position and a
second position; wherein the outside diameter of the cannula is
greater than the loaded diameter of the channel; wherein movement
of the drum between its first and second positions moves the
cannula between its first and second positions; and wherein
movement of the cannula from the first position to the second
position advances the ventilation tube distally along the
introducer to release the ventilation tube from the introducer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. Non-provisional
patent application Ser. No. 13/158,063, filed on Jun. 10, 2011,
which is a continuation-in-part of U.S. Non-provisional patent
application Ser. No. 13/059,531, filed Mar. 9, 2011, which is the
U.S. National Stage of International Application No.
PCT/US2009/055252, filed Aug. 27, 2009, which claims the benefit of
U.S. Provisional Application No. 61/092,269, filed Aug. 27, 2008.
The entire contents of each of these related applications are
hereby incorporated by reference into this disclosure.
FIELD
[0002] The present invention relates, in general, to functional
endoscopic techniques and, more particularly, to apparatuses,
systems and methods for ventilating the paranasal sinuses.
BACKGROUND
[0003] There has been resurgence of interest among
otolaryngologists in the morphological features of the lateral wall
of the nasal cavity with the advent of endonasal endoscopic sinus
surgery. Functional endoscopic techniques, being minimally
traumatic, have become increasingly popular in diagnostic and
therapeutic aspects of nasal and sinus problems.
[0004] The area termed the "ostiomeatal complex" of the middle
meatus has not only the primary maxillary ostia ("PMO") opening in
the hiatus semilunaris ("HS") but also often includes, other
"holes" or accessory maxillary ostium (AMO). It has been estimated
that anywhere between 5-30% of the normal population has an AMO
located in the maxillary fontanelle (anterior or posterior).
[0005] AMO is invariably solitary but occasionally multiple, either
congenital or secondary to disease process. A possible mechanism of
formation of accessory ostia is obstruction of the main ostium by
maxillary sinusitis or due to anatomic and pathologic factors in
the middle meatus resulting in the rupture of membranous areas
known as fontanelle (certain regions in the middle meatus located
below the uncinate process and above the inferior turbinate,
covered by nasal mucous membrane medially and mucosa of maxillary
sinus laterally with connective tissue sandwiched between the
two).
[0006] In the past, a naso-antral window procedure was performed
for purposes of ventilation and drainage of the maxillary sinus
cavity. However, the naso-antral window procedure has the
disadvantage of requiring one or more punctures through thick bony
tissues in the inferior meatus.
BRIEF SUMMARY OF THE DISCLOSURE
[0007] The medical devices and delivery systems described herein
provide for the creation of an AMO for purposes of ventilation,
irrigation, drug delivery, or performing procedural work within the
maxillary antrum, or other bodily cavity. In particular, delivery
systems including an introducer having a ventilation tube are
provided to create and then provide access through an AMO. An
irrigation, infusion, or balloon catheter may then be advanced
through the ventilation tube in order to irrigate, deliver drugs,
or express the contents of the sinus cavities. Furthermore, the
balloon catheter may be employed to dilate the natural ostium.
[0008] Various delivery systems are described, including delivery
systems that release a ventilation tube at a point of treatment by
a pull operated functionality and delivery systems that release a
ventilation tube at a point of treatment by a push operated
functionality. Other examples include delivery systems that release
a ventilation tube at a point of treatment using one or more
grasping elements and/or attachment elements.
[0009] Various ventilation tubes are also described, including
examples that have varying central channel configurations which
assist in attaching the ventilation tubes to a delivery system.
Other examples include ventilation tubes that have varying flange
and/or aperture configurations to assist in attaching the
ventilation tubes to a delivery system.
[0010] Various ventilation tube containers are also described,
including examples that house one or more ventilation tubes within
an elongate structure. Other examples include ventilation tube
containers that incorporate a liner to assist with supporting one
or more ventilation tubes within the container.
[0011] Additional understanding of the systems and devices
contemplated and/or claimed by the inventors can be gained by
reviewing the detailed description of exemplary embodiments,
presented below, and the referenced drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 of the drawings is a sectional view of a human skull
showing, in particular, the lateral nasal wall and the orientation
of the introducer and ventilation tube.
[0013] FIG. 2A of the drawings is an enlarged view of a portion of
the antrum, or maxillary sinus showing, in particular, the creation
of an AMO using the introducer, and the placement of the
ventilation tube through the AMO.
[0014] FIG. 2B of the drawings is an enlarged view of the antrum
showing, in particular, another exemplary ventilation tube.
[0015] FIG. 3 of the drawings is an enlarged view of the portion of
the antrum showing, in particular, the obturator disposed through
the introducer and the ventilation tube.
[0016] FIG. 4 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the ventilation tube
in place after removal of the introducer.
[0017] FIG. 5 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the use of an
irrigation and/or infusion catheter in association with the
ventilation tube.
[0018] FIG. 6 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the use of a second,
smaller diameter irrigation and/or infusion catheter within an
outer irrigation and/or infusion catheter in association with the
ventilation tube.
[0019] FIG. 7 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the second
irrigation and/or infusion catheter extended deeply into the sinus
cavity.
[0020] FIG. 8 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the use of a balloon
catheter within the sinus cavity.
[0021] FIG. 9 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the placement of a
balloon catheter within the natural ostium.
[0022] FIG. 10 of the drawings is an enlarged view of a portion of
the lateral nasal wall showing, in particular, the expansion of the
balloon catheter for dilation of the natural ostium.
[0023] FIG. 11 of the drawings shows a perspective view of another
exemplary introducer.
[0024] FIG. 12 of the drawings shows a perspective view of the
introducer in FIG. 11 taken along lines 12-12 in FIG. 11.
[0025] FIG. 13A is a perspective view of an exemplary ventilation
tube.
[0026] FIG. 13B is a perspective view of another exemplary
ventilation tube.
[0027] FIG. 14 is another exemplary catheter for delivering drugs
and pharmaceuticals.
[0028] FIG. 15 is a perspective view of an exemplary delivery
system and an associated ventilation tube.
[0029] FIG. 16 is a partial sectional view of the delivery system
and associated ventilation tube illustrated in FIG. 15.
[0030] FIG. 17 is an exploded view of the delivery system and
associated ventilation tube illustrated in FIG. 15.
[0031] FIG. 18 is an exploded view of another exemplary delivery
system and associated ventilation tube.
[0032] FIG. 19 is a sectional view of a portion of the handle of
another exemplary delivery system.
[0033] FIG. 20 is an exploded view of another exemplary delivery
system and associated ventilation tube.
[0034] FIG. 21 is a sectional view of the distal end of the
delivery system and associated ventilation tube illustrated in
FIGS. 15 through 17.
[0035] FIG. 22 is a sectional view of the distal end of another
exemplary delivery system and associated ventilation tube.
[0036] FIG. 23 is a sectional view of the distal end of another
exemplary delivery system and associated ventilation tube.
[0037] FIG. 24 is a sectional view of the distal end of another
exemplary delivery system and associated ventilation tube.
[0038] FIG. 25 is a sectional view of the distal end of another
exemplary delivery system and an alternative exemplary ventilation
tube.
[0039] FIG. 26 is a sectional view of the distal end of another
exemplary delivery system and another alternative ventilation
tube.
[0040] FIG. 27 is a sectional view of another exemplary delivery
system and associated ventilation tube.
[0041] FIG. 28 is a side view of the distal end of the delivery
system illustrated in FIG. 27 and an alternative ventilation
tube.
[0042] FIG. 29 is a partial sectional view of another exemplary
delivery system and associated ventilation tube in the first
position.
[0043] FIG. 30 is a partial sectional view of the delivery system
and ventilation tube illustrated in FIG. 29 in the second
position.
[0044] FIG. 31 is a top view of an exemplary ventilation tube
container.
[0045] FIG. 32 is a sectional view of the ventilation tube
container illustrated in FIG. 31, taken along lines 32-32.
DETAILED DESCRIPTION
[0046] The following detailed description and the appended drawings
are provided to describe and illustrate exemplary embodiments of
the invention for the purpose of enabling one of ordinary skill in
the relevant art to make and use the invention. The description and
drawings are not intended to limit the scope of the invention or
its protection in any manner.
[0047] Throughout the specification, the terms "proximal" and
"distal" are used to describe opposing axial ends of the particular
elements or features being described. In addition, the term
"device" refers to any device, object, apparatus, or structure,
that supports, repairs, or replaces, a part of the body or a
function thereof, or is configured to do the same, alone or in
combination with other devices or elements.
[0048] A nasal ventilation system 10 is shown in FIG. 1 as
comprising ventilation tube 20 and elongated introducer 30,
suitable for creating an AMO within lateral nasal wall 70 (shown
with the middle turbinate and uncinate removed to allow
visualization of the natural ostium), proximate maxillary ostium
71, maxillary fontanelle 72, and/or inferior turbinate 73.
Furthermore, the nasal ventilation system 10, ventilation tube 20,
and elongated introducer 30 are suitable for creating an AMO in
other targeted tissues, such as walls of the ethmoid, sphenoid and
other paranasal sinuses. A distal tip of introducer 30 is
insertable through a central channel of ventilation tube 20, is
releasably attachable to ventilation tube 20, and includes a sharp,
removable cutting obturator at the distal tip. The cutting
obturator can be, however, integrated with, or fixedly attached to,
the introducer.
[0049] As shown in FIGS. 1 and 3, in operation, introducer 30 with
ventilation tube 20 at its distal end are introduced into the
middle meatus in the region of the fontanelle (anterior or
posterior) under endoscopic assistance, facilitated by the
obturator 100. Referring to FIG. 3, obturator 100 includes proximal
flexible shaft 101 and sharp distal cutting tip 102. Once the
membraneous fontanelle or other targeted area is identified,
obturator 100 is advanced through introducer 30 and ventilation
tube 20 until cutting tip 102 extends beyond ventilation tube 20,
and cutting tip 102 and ventilation tube 20 are pushed through the
fontanelle. Obturator 100 and introducer 30 are then removed. An
endoscope is preferably employed to provide visualization during
this procedure.
[0050] Ventilation tube 20 and introducer 30 are shown in further
detail in FIG. 2A. Ventilation tube 20 includes grommet-like member
or proximal flange 21, retaining member or distal flange 22, and
channel 23 extending through ventilation tube 20, terminating in
opposing apertures extending through grommet-like member 21,
retaining member 22 of ventilation tube 20. As shown in FIG. 2A,
upon placement of ventilation tube 20, grommet-like member 21 and
conical or frusto-conical retaining member 22 are disposed on
opposing sides of the AMO extending through lateral nasal wall 70,
and serve to maintain ventilation tube 20 in place. As indicated by
the phantom lines of FIG. 2A, the introducer 30 can be constructed
of a relatively flexible material to permit the introducer 30 to be
readily advanced through the paranasal sinus passages to the
desired site of the AMO. The introducer 30, or portions thereof,
can be, however, constructed of a semi-rigid or rigid material.
Skilled artisans will be able to select a particular material for
inclusion with an introducer 30 based on various considerations,
including the intended use of the ventilation tube, and others.
[0051] Ventilation tube 20 may be constructed of a variety of
plastic-like materials commonly used in medical devices, including
materials commonly employed in middle ear ventilation tubes.
Examples of suitable materials include compressible materials,
polyetheretherketone, carbothane, nylon, urethane, polyurethane,
polyethylene, polyvinylchloride, and other materials. Materials
hereinafter discovered and/or developed that are determined to be
suitable for use would also be considered acceptable. Moreover,
ventilation tube 20 may be constructed of a drug eluting material,
and may include compounds such as steroids or minerals/elements to
decrease viral contamination, inflammatory reactions, and/or
bacterial colonization. Ventilation tube 20 may include other
drugs, bioactives, and/or other compounds, such as
antithrombogenics, antiproliferatives, antibiotics, antivirals,
antifungals, anti-inflammatories, anti-biofilm, and/or any other
suitable compounds.
[0052] Furthermore, ventilation tube 20 may be constructed of a
resorbable material, similar to those used in bio-absorbable
sutures, and capable of dissolving in situ over time. Examples of
suitable resorbable materials include extracellular matrix
materials (ECMs), such as small intestine submucosa (SIS),
polyglycolic acid, magnesium, chitosan, and other resorbable
materials known in the art.
[0053] An alternative construction of the ventilation tube, namely
ventilation tube 20', is shown in FIG. 2B. In this alternative
construction, the retaining member comprises expandable feet 22'
serving, in cooperation with grommet-like member 21, to retain
ventilation tube 20 in place though the membranous fontanelle or
other targeted tissue.
[0054] As shown in FIG. 4, once ventilation tube 20 is placed and
seated through lateral nasal wall 70 proximate frontal sinus 75,
ethmoid sinus 76, sphenoid sinus 78 and Eustachian tube 78,
introducer 30 and its associated obturator are separated from
ventilation tube 20 and removed. Next, as shown in FIG. 5,
irrigation and/or infusion catheter 40 may be placed, by inserting
distal tip 41 of catheter 40 into, or entirely through, channel 23
of ventilation tube 20. Irrigation fluid and/or a drug 80 may then
be injected into catheter 40 and thus introduced into the desired
treatment area to flush the contents of the sinus cavity. The
contents of the sinus cavity can then be pushed through the
principal or main maxillary ostium to un-block the natural ostium.
As indicated by the phantom lines of FIG. 5, irrigation and/or
infusion catheter 40 is constructed of a relatively flexible
material to permit distal tip 41 of irrigation and/or infusion
catheter to be advanced into the paranasal sinuses and placed
through ventilation tube 20. The irrigation and/or infusion
catheter 40 can be, however, constructed of a semi-rigid or rigid
material.
[0055] As shown in FIG. 6, a separate, smaller diameter secondary
irrigation and/or infusion catheter 50 may be used in conjunction
with irrigation and/or infusion catheter 40. Distal tip 51 of
secondary catheter 50 is inserted through an opening at proximal
end 42 of catheter 40, and is advanced beyond distal tip 41 of
catheter 40 and into the targeted sinus cavity. Irrigation fluid
and/or a drug 80 is then injected into the secondary catheter 50
and is thus introduced to the desired treatment area to flush the
contents of the sinus cavity. Moreover, and as shown in FIG. 7,
distal tip 51 of secondary catheter 50 may be inserted more deeply
into the targeted sinus cavity to deeply instill liquids within the
antrum, by further advancing secondary catheter 50 through catheter
40.
[0056] Alternatively, and as shown in FIG. 8, balloon catheter 60
may be employed in place of secondary irrigation catheter 50.
Balloon catheter 60 includes distal tip 61, and expansile member 62
surrounding a distal portion of the main lumen of the balloon
catheter 60. As shown in FIG. 8, distal tip 61 may be placed
through irrigation and/or infusion catheter 40 and advanced deeply
into the targeted sinus cavity. Expansile member 62 is then
inflated. This, in turn, causes the contents of the sinus cavity,
such as mucous or purulent debris 90, to be expressed through the
natural PMO 71.
[0057] As shown in FIG. 9, distal tip 61 of balloon catheter 60 may
alternative or additionally be advanced through irrigation and/or
infusion catheter 40 and the sinus cavity to extend through the
natural PMO 71. Next, as shown in FIG. 10, expansile member 62 is
inflated, in order to dilate the natural PMO 71.
[0058] Various methods of treating a sinus cavity are described
herein. An initial step comprises inserting a ventilation tube at a
point of treatment (e.g., within an AMO or other opening in a wall
of a sinus cavity, such the paranasal sinus cavities). Another step
comprises advancing the distal end of a catheter (e.g., a
irrigation, infusion, and/or balloon catheter) through the channel
of the ventilation tube such that the distal end of the catheter is
in the targeted sinus cavity. Alternatively, the distal end of the
catheter is advanced partially into the channel such that the
distal end of the catheter is positioned within the channel of the
ventilation tube. Another step comprises introducing an irrigation
fluid or drug into the targeted sinus cavity. This step can be
accomplished by passing the fluid or drug through the catheter
while the distal end of the catheter is disposed in the targeted
sinus cavity or in the channel of the ventilation tube.
Alternatively, this step can be accomplished by passing another
catheter through the previously placed catheter, connecting another
catheter to the previously placed catheter, or other similar
approach. Another step comprises withdrawing the catheter from the
channel of the ventilation tube. Another step comprises removing
the ventilation tube from the point of treatment, if desired.
[0059] Additional, and/or alternative, steps can be included within
the above described method. For example, the step of introducing an
irrigation fluid or drug into the targeted sinus cavity can
alternatively comprise inflating a balloon on the catheter. This
step can be accomplished by passing a material through the catheter
to inflate the balloon while the distal end of the catheter is
disposed in the targeted sinus cavity. Alternatively, this step can
be accomplished by passing another catheter through the previously
placed catheter and past the distal end of the previously placed
catheter.
[0060] In an additional example, the step of advancing the distal
end of a catheter through the channel of the ventilation tube such
that the distal end of the catheter is in the targeted sinus cavity
can alternatively comprise advancing the distal end of the catheter
through a natural PMO. Alternatively, this step can be accomplished
by passing another catheter through the previously placed catheter
and past the distal end of the previously placed catheter. Another
step comprises inflating a balloon on the catheter. This step can
be accomplished by passing a material through the catheter to
inflate the balloon while the distal end of the catheter is
disposed within the PMO.
[0061] Any ventilation tube, including the ventilation tubes
described herein, can be used to assist in performing the
above-described method. For example, the method can comprise the
use of a ventilation tube as described above, and/or below, and
illustrated in FIGS. 2A, 2B, 13A, 13B, 25, 26, 27, 28, 29, 30, or
any alternatives thereof. Alternatively, the method can comprise
the use of a catheter as described below and illustrated in FIG.
14.
[0062] FIG. 11 is a perspective view of another exemplary elongated
introducer 100. The introducer 100 includes a proximal end 102 and
a distal end 104. A tube or shaft 106 extends between the proximal
end 102 and distal end 104. A rod 108 extends within the tube 106.
The rod 108 includes a proximal end 110 extending out of tube 106
and a distal end (not shown) located at the distal end 104 of the
introducer 100. An obturator 112 is located at the distal end 104.
In one configuration, the obturator 112 is secured to the distal
end of the rod 108. FIG. 12 is a view of the elongated introducer
100 taken along line 12-12 in FIG. 11. FIG. 12 shows the obturator
112 includes a shaft 114, a flange 116 and a sharp, distal cutting
tip 118. The shaft 114 may be cylindrical or conical shaped, for
example. The elongated introducer 100 may be coupled to a
myringotomy apparatus or handle. Such an apparatus typically
includes a mechanism to secure the tube 106 in a stationary manner
with respect to the apparatus. The rod 108 may be coupled to a
trigger mechanism for slidingly activating and controlling the rod
108 with respect to the tube 106. Thus, activation of the trigger
of the apparatus controls movement of the obturator 112. The tube
106 of the introducer 100 may be made of a flexible or malleable
material to permit the introducer 100 to be readily advanced
through the paranasal sinus passages to the desired site of the
AMO. The tube 106 can be, however, made of a semi-rigid or rigid
material, and skilled artisans will be able to select an
appropriate material according to a particular embodiment based on
various considerations, include the intended use of the ventilation
tube, and the intended use of the introducer.
[0063] FIG. 13A shows another ventilation tube 130. The ventilation
tube 130 includes the conical or frusto-conical retaining member
132, a shoulder 134, grommet-like member 136 having flat side edges
138, and a wall that defines a central channel or bore 140
extending through the ventilation tube 130 from the proximal end of
the ventilation tube 130 to the distal end of the ventilation tube
130.
[0064] The grommet-like member 136 defines an opening 133 that
extends through the grommet-like member 136 from a proximal surface
135 to an opposing distal surface (not illustrated in Figure).
Alternatively, the opening 133 defined by the grommet-like member
136 extends from the proximal surface 135 to a side surface of the
grommet-like member 136. As such, opening 133 provides access to a
through passageway 137 that extends through a thickness of
grommet-like member 136.
[0065] Opening 133 provides structure useful in retrieval of
ventilation tube 130 prior to, during, or following placement
through the lateral nasal wall. To use opening 133 for this
purpose, a user can pass an elongate member (e.g., thread, suture,
or other suitable element) (not illustrated in Figure) through the
passageway 137 prior to delivering the ventilation tube 130 to a
point of treatment. Both ends of the elongate member can be left
free of the ventilation tube, or one end can be free and the other
end fixed to the ventilation tube 130. When retrieval of the
ventilation tube 130 is desired, the user can simply pull on one or
both ends of the elongate member, as appropriate, to pull the
ventilation tube 130 from the lateral nasal wall. If retrieval is
not necessary, or desired, following placement of the ventilation
tube 130, the elongate member can simply be removed from the
passageway 137 as appropriate (e.g., by pulling on one free end and
allowing the other free end to pass through the passageway
137).
[0066] As understood from the above description, the obturator 112
receives the ventilation tube 130. In particular, the shaft 114 is
designed to be received by the central channel 140. The shaft 114
and channel 140 may be designed to provide a releasable locking
engagement, such as an interference press fit or a snap-fit
engagement. The shaft 114 may be cylindrical or conical, for
example, with the central channel 140 similarly shaped for a mating
engagement. With the obturator 112 inserted into the ventilation
tube 130, the flange 116 and grommet-like member 136 limit the
depth in which the obturator 11 is inserted within the central
channel 140. With the flange 116 engaging the grommet-like member
136, the sharp distal cutting tip 118 projects beyond the conical
retaining member 132. Thus, the combined introducer 100 and
ventilation tube 130 are adaptable for piercing the tissue and
forcing the ventilation tube 130 in place, with the shoulder 134 on
one side of the wall and the grommet-like member 136 on the other
side of the wall.
[0067] The ventilation tube may take other forms such as omitting
the distal flange. In FIG. 13B, another exemplary ventilation tube
is shown. In particular, ventilation tube 170 shows a neck portion
or sleeve 172 having a proximal end 174 with a proximal flange 176.
As an example, the flange may be tab shaped as shown in FIG. 13B or
annular shaped. The distal end 178 includes a beveled edge 180
which provides a sharp cutting tip 182. The ventilation tube 170
shown in FIG. 13B is more readily inserted by use of forceps (not
shown). For example, the forceps may grip the proximal flange or
tab 176. The forceps will be used to guide the tube in place,
urging the sharp cutting tip 182 through the sinus wall, and
wherein the tab will also limit the insertion depth of the
ventilation tube. It will be appreciated that an obturator is not
required for inserting the tube 170 into the wall.
[0068] In addition, it will be appreciated that the forceps may be
used instead of the introducer described above. However, when the
term "introducer" is used herein, it is intended to include
forceps.
[0069] FIG. 14 shows another exemplary catheter used for delivering
a pharmaceutical drug, fluid or the like to the sinus cavity. The
catheter 150 is a graphical representation. The catheter 150
includes a hollow shaft 152. The shaft 152 may be of a malleable
material or flexible material to permit the catheter to be readily
advanced through the sinus passages for creation of an AMO through
a wall of the sinus passage or a sinus cavity by pressing the
distal end 154 through the wall or other targeted area. Also, the
distal end 154 can be advanced through an existing AMO, such as an
AMO within which a ventilation tube has been implanted, as
described herein. It will be appreciated that the shaft 152 will be
proportionally longer than that shown in FIG. 14. The distal end
154 of the catheter 150 includes an irrigation tip 156. The
irrigation tip 156 may be generally conical in shape. The conical
shape more readily accommodates insertion of the tip 156 into the
ventilation tube 130. The irrigation tip 156 may be hollow to
provide for fluid and drug flow from the shaft. The irrigation tip
156 may include a delivery opening 158 at the distal end 154. In
addition, the wall of the irrigation tip 156 may include micro pore
perforations 160. The delivery openings 158 and micro pore
perforations 160 provide delivery of the drug or fluid. A flange
162 is provided to limit the insertion depth of the catheter 150.
The flange 162 will engage the grommet-like member to limit the
insertion of the catheter.
[0070] It will be appreciated that the ventilation tube may be used
to deliver topical fluids, drugs, anti-inflammatory medications,
such as steroids, gene treatments, drug delivery substances, drug
impregnated coils, beads, and others through simple insertion or
via powered pulsation. For example, a device for delivering such
items, such as the catheter 150 for example, may be guided toward
the inserted ventilation tube, whereupon the desired item may be
delivered directly to the sinus, or in a manner consistent with the
description herein. In addition, the delivery device may be adapted
for insertion into the first catheter, to assist in guiding the
delivery device to the ventilation tube.
[0071] Delivery systems for creating an AMO and implanting a
ventilation tube are described below. An exemplary delivery system
200 and associated ventilation tube 300 are illustrated in FIGS. 15
through 17. The delivery system 200 comprises a proximal end 204, a
distal end 206, an introducer 208, a cannula 220, and a handle 230.
The ventilation tube 300 is similar to that described above with
respect to FIG. 13A and is disposed on the distal end 206 of the
delivery system 200. While the illustrated delivery system 200
includes a ventilation tube 300 similar to that illustrated in FIG.
13A, any suitable ventilation tube can be used in combination with
the delivery system 200, and skilled artisans will be able to
select an appropriate ventilation tube for inclusion with a
delivery system according to a particular embodiment based on
various considerations, including the intended use of the delivery
system, the intended use of the ventilation tube, and others.
[0072] The introducer 208 comprises an elongate rigid structure
having a lengthwise axis, a proximal end 210, distal end 212, sharp
distal tip 214, and a bend 216. The proximal end 210 of the
introducer 208 has a semi-circular configuration, or any other
suitable configuration, and the distal end 212 of the introducer
208 includes a region between the sharp distal tip 214 and bend 216
for receiving the ventilation tube 300. As described below, various
configurations of the distal end 212 of the introducer 208 can be
used to releasably attach the ventilation tube 300 to the
introducer 208. While the introducer 208 has been described as
rigid in nature, a semi-rigid, malleable, flexible, or tubular
introducer can be used in combination with the delivery system 200,
and skilled artisans will be able to select a suitable material and
structure for an introducer for inclusion with a delivery system
according to a particular embodiment based on various
considerations, including the intended use of the delivery system,
and the intended use of the introducer.
[0073] The ventilation tube 300 is releasably disposed on the
distal end 212 of the introducer 208 and has a wall which defines a
channel extending between the proximal end and the distal end of
the ventilation tube 300. The channel has a resting diameter and a
loaded diameter, which is described in more detail below.
[0074] The cannula 220 is slidably disposed over the introducer 208
and comprises a flexible tubular structure having a flared proximal
end 222, a distal end 224, and an outside diameter. The flared
proximal end 222 is disposed within the handle. The distal end 224
of the cannula 220 is disposed proximal to the distal end 212 of
the introducer 208, leaving a portion of the introducer 208 exposed
to receive the ventilation tube 300. The distal end 224 of the
cannula 220 is angled to provide a surface to interact with the
proximal end of the ventilation tube 300. For example, the distal
end 224 of the cannula 220 can define an angle which is in a plane
that is substantially parallel to a plane containing the proximal
surface of the ventilation tube 300. The distal end 224 of the
cannula 220 can be, however, straight or otherwise angled. The
cannula 220 has a thickness which allows the distal end 224 to
interact with the proximal end of the ventilation tube 300 and wrap
around bend 216. While the cannula 220 has been described as
flexible in nature and having a flared proximal end 222, a
semi-rigid, malleable, or rigid cannula can be used in combination
with the delivery system 200, and the flared proximal end 222 can
be omitted, and skilled artisans will be able to select a cannula
for inclusion with a delivery system according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, the intended use of the cannula, and
others.
[0075] The length, number of bends, and the angle of the bends
defined by the introducer 208 and/or cannula 220 can vary depending
on the application, and skilled artisans will be able to select a
suitable length, number of bends, and angle based on various
considerations, such as the environment in which the delivery
system is intended to be used, the type of procedure being
performed, and the configuration of the distal end of the delivery
system. Examples of suitable numbers of bends include one, two,
three, four and any other number determined suitable for a
particular application. Examples of angles considered suitable for
the bend include angles in the range from about 0.degree. to about
180.degree.. Exemplary angles considered suitable for the bend
include angles in the range from about 20.degree. to about
160.degree.. Further exemplary angles for the bend include angles
in the range from about 45.degree. to about 135.degree..
[0076] One or both of the introducer 208 and the cannula 220 can be
formed of a malleable material adapted to allow a user to bend
and/or shape the introducer 208 and/or cannula 220 before or during
a procedure in which the delivery system is used 200 to access a
bodily passage of a patient. For example, a delivery system having
one or both of the introducer and cannula formed of a malleable
material can allow a user to bend and/or shape one or both
components to conform to actual or expected patient anatomy, such
as a sinus passage, a bodily passage that provides access to a
sinus passage, or any other bodily passage. The introducer 208
and/or cannula 220 can comprise segments which vary in stiffness
and flexibility. For example, flexible segments can correspond to
bend 216 in the introducer 208 and/or cannula 220, while more rigid
segments could correspond to straight portions of the introducer
208 and/or cannula 220. Example materials considered suitable for
the introducer 208 and/or cannula 220 include 304SS, NiTi,
polymeric materials, or metallic laser cut flexing components.
Braided and/or coiled polymeric materials are also considered
suitable. Skilled artisans will be able to select suitable
materials for the introducer and/or cannula according to a
particular embodiment based on various considerations, including
the intended use of the delivery system, the intended use of the
introducer and/or cannula, and others.
[0077] In these embodiments, it is considered advantageous to
provide a cap disposed on the distal end 212 of the introducer 208
covering the sharp distal tip 214. If included, the cap can
comprise any suitable structure capable of being releasably
attached to the sharp distal tip 214 and of covering the sharp
distal tip 214. The cap can be formed of any suitable material,
including plastic and metal materials. In one embodiment, the cap
is a cup-shaped member that defines a receptacle sized and
configured for receiving the sharp distal tip 214. The cap has an
inner diameter slightly smaller than the outer diameter of the
distal end 212 of the introducer 208 when the cap is free of the
introducer 208. This configuration advantageously provides a
friction fit between the distal end 212 of the introducer 208 and
the cap when the cap is disposed on the distal end 212 of the
introducer 208. Inclusion of the cap is considered advantageous at
least because it can cover the sharp distal tip 214 during an
initial placement of the introducer 208 into a bodily passage, such
as during a preliminary shaping procedure in which a user conforms
the shape and/or configuration of the introducer 208 and/or cannula
220 to the anatomy of a particular patient. When using a delivery
system according to these embodiments, a user initially inserts the
distal end 212 of the introducer 208, with the cap disposed thereon
and covering the sharp distal tip 214, into a bodily passage, such
as a sinus passage or a bodily passage that provides access to a
sinus passage, and manipulates the introducer 208 and/or cannula
220 to conform to the anatomy of the bodily passage. During this
process, the cap provides a barrier between the sharp distal tip
214 and the tissue lining the bodily passage. Once a desired shape
and/or configuration is achieved, the user can then remove the cap
to expose the sharp distal tip 214 and continue with the procedure
(e.g., loading a ventilation tube).
[0078] The handle 230 is disposed on the proximal end 210 of the
introducer 208 and comprises a head member 240, a housing 260, and
a finger retraction handle 290. The head member 240 is disposed on
a distal end of the housing 260, defines a lumen 246 extending
through the length of the head member 240, and has a tapered distal
end 248, an annular proximal end 242, and a proximal edge 252. The
lumen 246 of the head member 240 has a varying diameter and
includes an interior surface 253 defined by the stepped
configuration of the lumen 246. The tapered distal end 248 extends
proximally and away from the center of the lumen 246 to the annular
proximal end 242 which extends proximally to proximal edge 252. The
annular proximal end 242 of the head member 240 has an inner
diameter 258 and depth sufficient to receive a portion of the
distal end 262 of the housing 260.
[0079] The housing 260 has a varying outer diameter and comprises a
proximal end 261, a distal end 262, a cavity 263, an elongate
aperture 264, a rocker arm 265, a pin 266, a drum 267, a spring
268, a cap 269, and channels 270. The distal end 262 of the housing
260 has an outer diameter and length sufficient to be received by,
and attached to, a portion of the head member 240. The elongate
aperture 264 extends through the housing 260 and provides access to
the cavity 263. The cavity 263 is in communication with the lumen
246 of the head member 240 and contains the drum 267 and spring
268. The housing 260 can be attached to the head member 240 using
various methods, and skilled artisans will be able to select an
appropriate method according to a particular embodiment based on
various considerations, including the intended use of the delivery
system, and the intended use of the ventilation tube. Example
methods of attaching the head member 240 and the housing 260
include snap fitting, adhesively affixing, using a set screw and/or
pin, and any other method considered suitable for a particular
application.
[0080] The cavity 263 extends through the length of the housing 260
and defines a lumen 273 at the proximal end of the cavity 263
having a diameter less than the cavity 263. The channels 270 extend
through the housing 260 and provide access to the lumen 273 which
has a proximal end with a semi-circular configuration. The
introducer 208 extends through the drum 267 and spring 268 and
through the cavity 263 and lumen 273. The proximal end 210 of the
introducer 208 has a configuration that mirrors the semi-circular
configuration of the proximal end of the lumen 273 which reduces
and/or eliminates rotation of the introducer 208 when the delivery
system 200 is in use. The proximal end 210 of the introducer 208
can be adhesively affixed within the lumen 273 using channels 270
to apply an adhesive material. Alternatively, the proximal end 210
of the introducer 208 can be releasably affixed, or integrated
with, the housing 260.
[0081] While the introducer 208 has been described as being
adhesively affixed to the housing 260, other methods of attaching
the introducer to the housing can be used, and skilled artisans
will be able to select an appropriate method of attachment
according to a particular embodiment based on various
considerations, including the intended use of the delivery system,
and the intended use of the ventilation tube. Example methods of
attaching the introducer 208 to the housing 260 include insert
molding, using a set screw and/or pin, and any other method
considered suitable for a particular application. For example, the
structure of the introducer 208 can be altered, such as by
roughening the proximal end 210 of the introducer 208, to
facilitate attachment to the housing 260 by applying an adhesive or
insert molding.
[0082] The drum 267 has a threaded distal end 276 that includes a
taper 277 that mirrors the flared proximal end 222 of the cannula
220. The drum 267 is attached to the flared proximal end 222 of the
cannula 220 by sliding cap 269, which has a threaded inner
diameter, over the flared proximal end 222 of the cannula 222 and
attaching the cap 269 to the drum. Alternatively, the threaded
distal end 276 and cap 269 can be omitted and the proximal end 222
of the cannula 220 can be integrated with, or fixedly attached to,
the drum 267 (e.g., insert molding). The drum 267 has an outer
diameter slightly less than the inner diameter of the cavity 263.
Both the drum 267 and the cannula 220 are slidably disposed over
the introducer 208 and the spring 268 is disposed in a slightly
compressed state between the distal end of the drum 267 and the
interior surface 253 of the head member 240.
[0083] The spring 268 can be manufactured out of various materials
and can have varying compressed and uncompressed lengths. An
exemplary spring 268 is illustrated as a compression spring, which
exerts a force resisting compression proportional to the distance
the spring has been compressed. While the illustrated delivery
system 200 includes a single spring 268 in a slightly compressed
state, any suitable type and number of springs can be included in a
delivery system in any suitable state, and skilled artisans will be
able to select an appropriate type and number of springs for
inclusion in a delivery system according to a particular embodiment
based on various considerations, including the intended use of the
delivery system, the expected number of uses of the delivery
system, and the pressure required to retract the cannula after it
has been advanced to release the ventilation tube. Examples of
suitable numbers of springs include one, two, three and any other
number determined suitable for a particular application.
[0084] The rocker arm 265 is pivotally attached to the housing
within the elongate aperture 264 by a pin 266 and has a first
portion 278 that partially extends out of the elongate aperture 264
and a second portion 279 that partially extends into the cavity
263. The second portion 279 of the rocker arm 265 splits over the
introducer 208 and has a distal surface in communication with the
proximal end of the drum 267.
[0085] The finger retraction handle 290 is a tubular member
comprising two finger flanges 292, a proximal end 293, and a distal
end 294. The finger retraction handle 290 is slidably disposed on
the housing 260 between the proximal edge 252 of the head member
240 and the first portion 278 of the rocker arm 265. The finger
retraction handle 290 has an inner diameter slightly larger than
the outer diameter of the housing 260 and an outer diameter sized
to provide a thickness sufficient to interact with the first
portion 278 of the rocker arm 265 and the proximal edge 252 of the
head member 240. The two finger flanges 292 are disposed near the
proximal end 293 of the finger retraction handle 290 and extend
outwardly away from the outer diameter of the finger retraction
handle 290 and have a length and width sufficient to receive a
user's fingers. While two finger flanges 292 have been illustrated
and described, the finger retraction handle 290 can include a
single finger flange, and skilled artisans will be able to select a
suitable number of finger flanges according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, and the intended use of the ventilation
tube.
[0086] While the head member 240, housing 260, and finger
retraction handle 290 have been described as having a particular
configuration, the head member 240, housing 260, and finger
retraction handle 290 can comprise various other configurations,
and skilled artisans will be able to select an appropriate
configuration for the head member, housing, and finger retraction
handle based on various considerations, including the intended use
of the delivery system, and the configuration of the head member,
housing, and/or finger retraction handle.
[0087] The delivery system 200 has a first unextended position and
a second extended position which allows for the cannula 220 to be
moveable along the introducer between a first position and a second
position. In the first unextended position, the spring 268
maintains pressure on the distal end of the drum 267, which forces
the second portion 279 of the rocker arm 265 proximally. This
results in the first portion 278 of the rocker arm 265 being forced
distally and forcing the proximal end 293 of the finger retraction
handle 290 distally. In this first position, the cannula 220 is
located proximal to the proximal end of the ventilation tube 300,
or it can contact the proximal end of the ventilation tube 300. In
the second extended position, force is exerted on the finger
flanges 292 in the proximal direction (e.g., by a physician placing
his thumb on the proximal end 261 of the housing 260 and two
fingers on a distal portion of the finger flanges 292) and the
finger retraction handle 290 pushes the first portion 278 of the
rocker arm 265 proximally forcing the second portion 279 of the
rocker arm 265 distally. This motion forces the drum 267 and
affixed cannula 220 distally applying a force on the proximal end
of the ventilation tube 300, and ultimately pushing the ventilation
tube 300 off of the introducer 208. In this second position, the
cannula is moved along the introducer 208 distally to release the
ventilation tube from the introducer 208. Upon releasing the
proximal force on the finger flanges 292, the spring 268 exerts
pressure on the distal end of the drum 267, returning the rocker
arm 265, drum 267, affixed cannula 220, and finger retraction
handle 290 back to the first unextended position.
[0088] The distance between the finger flanges 292 and the proximal
end 261 of the housing 260 is advantageously sized to fit in a
user's hand, limiting loss of a user's motor skill when using the
delivery system 200. The proximal end 261 of the housing 260
defines a surface for receiving the thumb of a user and can include
an indentation and/or taper allowing the housing 260 to rest in the
hand of a user.
[0089] The head member 240, housing 260, finger retraction handle
290, drum 267, and rocker arm 265, can be manufactured from various
materials, such as polymeric materials, and can be formed using
various methods, such as injection molding. While various
configurations, materials, and methods of forming the head member
240, housing 260, finger retraction handle 290, drum 267, and
rocker arm 265, have been described, skilled artisans will be able
to select suitable configurations, materials, and methods of
forming the head, housing, finger retraction handle, drum, and
rocker arm, according to a particular embodiment based on various
considerations, including the intended use of the delivery system,
and the configuration of the introducer and/or cannula.
[0090] FIG. 18 is an exploded view of another exemplary delivery
system 400 and associated ventilation tube 300. The delivery system
400 illustrated in FIG. 18 is similar to the delivery system 200
illustrated in FIGS. 15 through 17, except as detailed below. The
delivery system 400 comprises an introducer 408, a cannula 410, and
a handle 420. The ventilation tube 300 is similar to that described
above with respect to FIG. 13A. While the illustrated delivery
system 400 includes a ventilation tube 300 similar to that
illustrated in FIG. 13A, any suitable ventilation tube can be used
in combination with the delivery system 400, and skilled artisans
will be able to select an appropriate ventilation tube for
inclusion with a delivery system according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, the intended use of the ventilation
tube, and others.
[0091] The handle 420 is disposed on the proximal end 409 of the
introducer 408 and comprises a head member 422, a housing 434, and
a finger retraction handle 448. The head member 422 is disposed on
a distal end of the housing 434 and has a tapered distal end 423, a
proximal end 424, and a proximal edge 425. The head member 422 also
defines a lumen 426 extending through the length of the head member
422, two apertures 427, and two recesses 428. The two apertures 427
extend through the wall of the head member 422 and provide access
to the lumen 426.
[0092] The tapered distal end 423 extends from the distal end of
the head member 422 proximally and away from the center of the
lumen 426 to the proximal end 424. The proximal end 424 of the head
member 422 has an inner diameter 431 and depth sufficient to
receive a portion of the distal end 436 of the housing 434.
[0093] The housing 434 has a varying outer diameter and comprises a
distal end 435 adapted to be received by a portion of the head
member 422 and includes two projections 436. The projections 436,
apertures 427, and recesses 428 are adapted to provide a snap fit
connection between the housing 434 and the head member 422.
[0094] While a particular type of snap fit and two apertures 427,
recesses 428, and projections 436 have been described and
illustrated, various other types of snap fits and numbers of
apertures, recesses, and projections can be used, and skilled
artisans will be able to select a suitable configuration for the
snap fit and number of apertures, recesses, and projections
according to a particular embodiment based on various
considerations, including the intended use of the delivery system,
and the configurations of the head member and/or housing. Examples
of numbers of apertures, recesses, and projections include one,
two, three, four, five and any number considered suitable for a
particular application.
[0095] FIG. 19 is a sectional view of a portion of the handle of
another exemplary delivery system 450. The delivery system 450
illustrated in FIG. 19 is similar to the delivery system 200
illustrated in FIGS. 15 through 17, except as detailed below. The
delivery system 450 comprises an introducer 452, a cannula 454, and
a handle 456.
[0096] In contrast to delivery system 200, which includes a rocker
arm and pin assembly, the delivery system 450 includes a wire
assembly to advance the drum distally. The handle 456 is disposed
on the proximal end of the introducer 452 and comprises a head
member (not shown), a housing 458, and a finger retraction handle
490. The housing 458 comprises a cavity 460, two apertures 462, and
a ridge 464. The two apertures 462 extend through the housing 458
and provide access to the cavity 460 which extends through the
length of the housing 458 and contains a drum 468 and spring 470.
The ridge 464 of the housing 458 is located proximal to the
apertures 462.
[0097] The finger retraction handle 490 is slidably disposed over
the housing 458 and comprises a tubular member with two finger
flanges 491, a proximal end 492, a distal end 493, and a ridge 494.
The ridge 494 of the finger retraction handle 490 mirrors the ridge
464 of the housing.
[0098] Two flexible lines 495 are connected to the distal end 493
of the finger retraction handle 490, extend through the apertures
462, and are connected to the distal end of the drum 468. The
length of the flexible lines 495 can be equal to, or slightly
greater than or less than, the sum of the distance from the distal
end 493 of the finger retraction handle 490 to the apertures 462,
the depth of the apertures 462, and the distance from the apertures
462 to the distal end of the drum 468. While a particular length
and number of flexible lines 495 has been described and
illustrated, any suitable length and number of flexible lines can
be included, and skilled artisans will be able to select a suitable
length and number of flexible lines according to a particular
embodiment based on various considerations, including the
configuration of the cannula, housing, apertures, and finger
retraction handle.
[0099] The delivery system 450 has a first unextended position and
a second extended position. In the first unextended position, the
spring 470 maintains pressure on the distal end of the drum 468,
which pulls the flexible lines 495 proximally within the cavity
460. This results in the finger retraction handle 490 being forced
distally to a position where the ridge 494 of the finger retraction
handle 490 is in communication with the ridge 464 of the housing
458. In the second extended position, force is exerted on the
finger retraction handle 490 in the proximal direction (e.g., by a
physician placing his thumb on the proximal end of the housing and
two fingers on a distal portion of the finger flanges) and the
finger retraction handle 490 pulls the flexible lines 495 distally
within the cavity 460. This motion forces the drum 468 and affixed
cannula 454 distally applying a force on the proximal end of the
ventilation tube, and ultimately pushing the ventilation tube off
of the introducer 452. Upon releasing the proximal force on the
finger retraction handle 490, the spring 470 exerts pressure on the
distal end of the drum 468, returning the drum 468, affixed cannula
454, and finger retraction handle 490 back to the first
position.
[0100] FIG. 20 is an exploded view of another exemplary delivery
system 500 and associated ventilation tube 300. The delivery system
500 illustrated in FIG. 20 is similar to the delivery system 200
illustrated in FIGS. 15 through 17, except as detailed below. The
delivery system 500 comprises an introducer 506, a cannula 520, and
a handle 530. The ventilation tube 300 is similar to that described
above with respect to FIG. 13A. While the illustrated delivery
system 500 includes a ventilation tube 300 similar to that
illustrated in FIG. 13A, any suitable ventilation tube can be used
in combination with the delivery system 500, and skilled artisans
will be able to select an appropriate ventilation tube for
inclusion with a delivery system according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, the intended use of the ventilation
tube, and others.
[0101] The introducer 506 comprises an elongate rigid structure
with a proximal end 508 and a distal end 510. The cannula 520 is
slidably disposed over the introducer 508 and has a flared proximal
end 522 disposed within the handle 530. The handle 530 is disposed
on the proximal end 508 of the introducer 506 and comprises a head
member 540, a housing 560, and a slider 580. The head member 540 is
disposed on a distal end of the housing 560 and has a tapered
distal end 541, an annular proximal end 542, and a proximal edge
543. The head member 540 also defines a lumen 544 extending through
the length of the head member 540 and two protrusions 545 extending
into lumen 544. The tapered distal end 541 extends proximally and
away from the center of the lumen 544 to the annular proximal end
542 which extends proximally to the proximal edge 543. The annular
proximal end 542 of the head member 540 has an inner diameter and
depth sufficient to receive a portion of the distal end 562 of the
housing 560.
[0102] The housing 560 comprises a proximal end 561 and a distal
end 562 and defines two tracks 564 and an ergonomic grip 565. The
tracks 564 are configured to receive the two protrusions 545 of the
head member 540. The distal end 562 of the housing 560 has an outer
diameter and length sufficient to be received by, and attached to,
a portion of the head member 540.
[0103] The slider 580 comprises a proximal end 581, a distal end
582, two connectors 583 connecting a center tubular member 584. The
center tubular member 584 defines a lumen 585 and has a threaded
distal end 586 that includes a taper 587 that mirrors the flared
proximal end 522 of the cannula 520. The center tubular member 584
is attached to the flared proximal end 522 of the cannula 520 by
sliding a cap 588, which has a threaded inner diameter, over the
cannula 520 and attaching the cap 588 to the threaded distal end
586 of the center tubular member 584. Alternatively, the threaded
distal end 586 and cap 588 can be omitted and the proximal end 522
of the cannula 520 can be integrated with the distal end of the
center tubular member 584.
[0104] The slider 580 has connectors 583 slidably disposed with the
tracks 564 of the housing 560 and is adapted to be moveable within
the tracks 564 between the proximal edge 543 of the head member 540
and the proximal end of the tracks 564. A spring 589 is disposed
between the distal end 582 of the slider 580 and the interior
surface of the head member 540. Both the slider 580 and the cannula
520 are slidably disposed over the introducer 506, which extends
through the spring 589 and slider 580 and has a proximal end 508
affixed to the housing 560.
[0105] Attaching the housing 560 to the head member 540 can be
accomplished using various methods, and skilled artisans will be
able to select an appropriate method according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, and the intended use of the ventilation
tube. Example methods of attaching the head member 540 to the
housing 560 include snap fitting, adhesively affixing, using a set
screw and/or pin, insert molding, and any other method considered
suitable for a particular application.
[0106] The delivery system 500 has a first unextended position and
a second extended position. In the first unextended position, the
spring 589 maintains pressure on the distal end of the slider 580,
which forces the distal end 524 of the affixed cannula 520
proximally. In the second extended position, force is exerted on
the slider 580 in the distal direction and the slider 580 forces
the affixed cannula 520 distally applying a force on the proximal
end of the ventilation tube 300, and ultimately pushing the
ventilation tube 300 off of the introducer 506. Upon releasing the
proximal force on the slider 580, the spring 589 exerts pressure on
the distal end of the slider 580, returning the affixed cannula 520
and slider 580 back to the first position.
[0107] Releasably connecting the ventilation tube 300 to the distal
end of the delivery system can be accomplished using various
configurations. Exemplary configurations are described below, but
are not intended to be limiting in nature. The ventilation tube 300
is configured to have a resting diameter and a loaded diameter. The
ventilation tube 300 defines a channel 312 that has a resting
diameter when the ventilation tube is free of the introducer 208
and a loaded diameter when the ventilation tube is disposed on the
introducer 208.
[0108] FIG. 21 illustrates a sectional view of the distal end of
the delivery system 200 and associated ventilation tube 300
illustrated in FIGS. 15 through 17. The distal end of the delivery
system 200 provides for releasably disposing the ventilation tube
300 on the distal end 212 of the introducer 208 using an
interference fit. The central channel 312 has a resting diameter
when it is free of the introducer 208. When the ventilation tube
300 is loaded on the introducer 208, the central channel expands to
its loaded diameter, advantageously providing an interference fit
between the ventilation tube 300 and the introducer 208.
Alternatively, the central channel 312 of the ventilation tube 300
can be, however, sized larger than the distal end of the introducer
208.
[0109] The ventilation tube 300 is received by the distal end 212
of the introducer 208 which has an introducer diameter sized
slightly larger than inner diameter of the central channel 312,
requiring the central channel 312 of the ventilation tube 300 to be
forced onto the distal end 212 of the introducer 208 and expand
from its resting diameter to its loaded diameter. The ventilation
tube 300 is disposed on the introducer 208 distal to the bend 216.
The bend 216 of the introducer 208 and/or the distal end 224 of the
cannula 220 act as a stop for the ventilation tube 300. The outside
diameter of the cannula 220 is greater than the loaded diameter of
the ventilation tube 300. To release the ventilation tube 300, the
delivery system 200 advances to the second extended position
sliding the cannula 220 distally over the introducer 208 resulting
in a force being exerted on the proximal end 316 of the ventilation
tube 300, which is adapted to interact with the distal end 224 of
the cannula 220. The distal end 224 of the cannula 220 can comprise
a flexible material which allows the cannula 220 to advance over
the bend 216. Once the force is sufficient to overcome the
interference fit, the ventilation tube 300 is released from the
distal end 212 of the introducer 208.
[0110] FIG. 22 is a sectional view of the distal end of another
exemplary delivery system 600 and associated ventilation tube 300.
The introducer 602 comprises a first introducer diameter 604, a
second introducer diameter 606, and a sharp distal tip 608. The
second introducer diameter 606 is greater than, less than, or equal
to, the resting diameter of the ventilation tube 300. When the
second introducer diameter 606 is greater than the resting diameter
of the ventilation tube 300, force is required to load the
ventilation tube 300 onto the introducer 602. The first introducer
diameter 604 is sized slightly larger than the loaded diameter of
the central channel 312 of the ventilation tube 300 and the
introducer 602 defines a shoulder that transitions from the first
introducer diameter 604 to the second introducer diameter 606. The
length of the second introducer diameter 606 is sufficient to
receive the ventilation tube 300 and allow the sharp distal tip 608
to be disposed distal to the ventilation tube 300. The difference
between the first introducer diameter 604 and the second introducer
diameter 606 is less than the difference between the outer diameter
314 of the flange 310 and the loaded diameter of the central
channel 312 of the ventilation tube 300, leaving a contact surface
on the proximal end of the ventilation tube 300 adapted to interact
with the cannula 603.
[0111] FIG. 23 is a sectional view of the distal end of another
exemplary delivery system 610 and associated ventilation tube 300.
The introducer 612 comprises a sharp distal tip 614, tapered distal
end 616, a first outer diameter 618, and a second outer diameter
620. The first outer diameter 618 is positioned proximal to the
sharp distal tip 614 which gradually increases to the second outer
diameter 620 which is proximal to the first outer diameter 618. The
first outer diameter 618 is less than the resting diameter of the
central channel 312 of the ventilation tube 300. The second outer
diameter 620 is slightly larger than the resting diameter of the
central channel 312 of the ventilation tube 300, requiring the
ventilation tube 300 to be forced onto the introducer 612.
[0112] FIG. 24 is a sectional view of the distal end of another
exemplary delivery system 622 and associated ventilation tube 300.
The introducer 624 is similar to that illustrated in FIG. 21 but
defines a circumferential recess 628 located proximal to the distal
end 625 of the introducer 624 and comprises a flexible o-ring 626
disposed within the recess 628. The o-ring 626 is sized to be
larger than the depth of the recess 628 and have an outside
diameter larger than the resting diameter of the channel 312 of the
ventilation tube 300 to provide an interference fit between the
o-ring 626 and the central channel 312 of the ventilation tube 300.
The o-ring 626 advantageously allows for wider manufacturing
tolerances of the central channel 312 of the ventilation tube 300
and provides consistent resistance across a wider range of
interference fits. The o-ring configuration can be used in
combination with the other distal end configurations described with
respect to FIGS. 21 through 26, or independent of these
configurations. For example, the o-ring configuration can be used
in combination with an introducer that does or does not include a
reduced diameter, and/or a tapered distal end.
[0113] Various configurations of the ventilation tube 300 can be
utilized in combination with the exemplary embodiments described
herein. FIG. 25 is a sectional view of the distal end of another
exemplary delivery system 630 and alternative exemplary ventilation
tube 640. The delivery system 630 comprises an introducer 631 and a
cannula 650.
[0114] The delivery system 630 provides for releasably attaching
the ventilation tube 640 to the introducer 631 using an
interference fit. The ventilation tube 640 defines a central
channel 642 and comprises a proximal end 644 and a distal end 646.
The central channel 642 has a first resting diameter 648 and a
second resting diameter 649. The first resting diameter 648 is
located on the distal end 646 of the ventilation tube 640 and is
sized smaller than the second resting diameter 649. The channel
defines a shoulder that transitions from the first resting diameter
648 to the second resting diameter 649. The introducer diameter 631
is sized smaller than the second resting diameter 649 of the
ventilation tube 640 and larger than the first resting diameter 648
of the ventilation tube 640. This configuration allows for the
interference fit to be limited to the distal end 646 of the
ventilation tube 640.
[0115] The cannula 650 includes a proximal portion 654, an
intermediate portion 656, and a distal portion 658. Each of the
proximal 654, intermediate 656, and distal portions 658 is formed
of a different material. For example, the proximal portion 654 can
be formed of a polymer, the intermediate portion 656 can be formed
of a flexible material, and the distal portion 658 can be formed of
a rigid material (e.g., metal). While the cannula has been
described as having a proximal portion 654, an intermediate portion
656, and a distal portion 658 formed of different materials,
skilled artisans will be able to select appropriate material to
include with the cannula, or portions thereof, according to a
particular embodiment based on various considerations, including
the configuration of the distal end of the introducer, the
configuration of the central channel of the ventilation tube, and
the intended use of the delivery system.
[0116] FIG. 26 is a sectional view of the distal end of another
exemplary delivery system 660 and another alternative ventilation
tube 680. The introducer 664 has a sharp distal tip 666 and a
multiple tapered distal end 662. The tapered distal end 662 has a
first introducer diameter 668, a second introducer diameter 670,
and a third introducer diameter 672. The first introducer diameter
668 is positioned proximal to the sharp distal tip 666 and
gradually increases to the second introducer diameter 670, which
gradually increases to the third introducer diameter 672.
[0117] The delivery system 660 provides for releasably attaching
the ventilation tube 680 to the introducer 664 using an
interference fit. The ventilation tube 680 defines a tapered
central channel 682 and comprises a proximal end 684 and a distal
end 686. The tapered central channel 682 has a first resting
diameter 688 and a second resting diameter 690 and tapers from the
proximal end 684 to the distal end 686. The first resting diameter
688 is located on the distal end 686 of the ventilation tube 680
and is sized smaller than the second resting diameter 690. The
first 668 and/or second 670 introducer diameter 664 is sized
smaller than the second resting diameter 690 of the ventilation
tube 680 and larger than the first resting diameter 688 of the
ventilation tube 680. This configuration allows for the
interference fit to be limited to the distal end 686 of the
ventilation tube 680.
[0118] Limiting the interference fit to the distal end 686 of the
ventilation tube 680 advantageously allows for the thinnest portion
of the ventilation tube 680 to be in contact with the introducer
664, allowing for flexibility of the ventilation tube 680. While
the central channel 682 has been described and illustrated as
having a tapered configuration from the proximal end 684 to the
distal end 686, the taper can be configured to limit the
interference fit to the proximal end 684.
[0119] FIG. 27 is a sectional view of another exemplary delivery
system 700 and associated ventilation tube 800. The delivery system
700 comprises an introducer 708, a gripping member 720, a cannula
730, and a handle 740. The introducer 708 is an elongate rigid
structure and comprises a sharp distal tip 710, a proximal end 712,
and a distal end 714 adapted to receive the ventilation tube
800.
[0120] The gripping member 720 is a tubular member disposed over
the introducer 708 and comprises a proximal end 721 and furcated
distal end 722 having multiple grasping elements 724 which
naturally gravitate away from the introducer 708. The cannula 730
is slidably disposed over the a portion of the gripping member 720
and introducer 708 and comprises a flexible tubular structure with
a proximal end 731, and a distal end 732. The proximal end 731 of
the cannula 730 is disposed within the handle 740 and the distal
end 732 of the cannula 730 is disposed proximal to the distal ends
of the gripping elements 724.
[0121] The handle 740 is disposed on the proximal end 712 of the
introducer 708 and comprises a head 750, a housing 760, and a
finger retraction handle 790. The head 750 is disposed on a distal
end of the housing 760 and comprises an annular proximal end 751, a
tapered distal end 752, a lumen 753, and a proximal edge 756. The
tapered distal end 752 extends proximally and away from the lumen
753 to the annular portion 751 that extends proximally to the
proximal edge 756. The annular proximal end 751 of the head 750 has
an inner diameter and depth sufficient to receive a portion of the
distal end of the housing 760.
[0122] The housing 760 comprises a cavity 763, two elongate
apertures 764, two connecting members 765, a drum 766, and a spring
767. The distal end of the housing 760 has an outer diameter and
length sufficient to be received by a portion of the annular
proximal end 751 of the head 750 and includes a ridge 771 which
engages the proximal edge 756 of the of the head 750. The elongate
apertures 764 extend through the housing 760 and provide access to
the cavity 763. The cavity 763 extends through the length of the
housing, defines a first lumen 768 and a second lumen 769 and
contains the drum 766 and spring 767. The second lumen 769 has a
diameter which is less than the first lumen 768 which defines a
reduced step portion 770. The gripping member 720 extends through
the cavity 763, the first lumen 768, the drum 766, spring 767 and
has a proximal end 721 that engages and is adhesively affixed to
reduced step portion 770. The introducer 708 extends through the
gripping member 720 and is adhesively affixed within the second
lumen 769. The drum 766 is affixed to the proximal end 731 of the
cannula 730 and both the drum 766 and cannula 730 are slidably
disposed over the gripping member 720 and introducer 708. The drum
766 has an outer diameter slightly less than the inner diameter of
the cavity 763. The spring 767 is disposed between the proximal end
of the cavity 763 and the proximal end of the drum 766.
[0123] While the gripping member 720 and introducer 708 have been
described as adhesively affixed within the housing 760, other
suitable methods of attachment, either releasably or permanently,
can be used, and skilled artisans will be able to select suitable
methods of attachment according to a particular embodiment based on
various considerations, including the intended use of the delivery
system, and the intended use of the ventilation tube.
[0124] The finger retraction handle 790 comprises a tubular member
having two finger flanges 792. The finger retraction handle 790 is
slidably disposed over the housing 760 and is connected to the drum
766 by the connecting members 765 which extend through the elongate
apertures 764 of the housing. The two finger flanges 792 extend
outwardly away from the finger retraction handle 790 a length and
width sufficient to receive a user's fingers.
[0125] In the first position, the ventilation tube 800 is
releasably connected to the distal end 714 of the introducer 708 by
the grasping elements 724 which are forced towards the introducer
708 by the spring 767 maintaining pressure on the proximal end of
the drum 766. This pressure pushes the affixed cannula 730 over a
portion of the distal end 722 of the gripping member 720 and a
proximal portion of the grasping elements 724. In the second
position, force is exerted on the finger flanges 792 in a proximal
direction, and the attached drum 766 is forced proximally which
retracts the cannula 730 from the grasping elements 724. The
proximal movement of the cannula 730 removes the distal end 732 of
the cannula 730 off of the grasping elements 724, allowing the
grasping elements 724 to expand to their natural position away from
the introducer 708 releasing the ventilation tube 800. Upon
releasing the proximal force on the finger flanges 792, the spring
767 exerts pressure on the proximal end of the drum 766, forcing
the drum 766, affixed cannula 730, finger retraction handle 790,
and grasping elements 724 back to the first position.
[0126] To provide sufficient force to close the grasping elements
724, the cannula 730 can include a distal end 732 made of a
semi-rigid or rigid material. The gripping member 720 and grasper
elements 724 can be manufactured out of any suitable rigid
material, such as, a memory alloy, spring metal, tempered steel,
and the like. While the gripping member 720 and grasping elements
724 have been described as being made from a particular material,
skilled artisans will be able to select a suitable material for the
gripping member and grasping elements according to a particular
embodiment based on various considerations, including the intended
use of the delivery system, the configuration of the distal end of
the gripping member, the configuration of the ventilation tube, and
others.
[0127] Releasably connecting the ventilation tube 800 to the distal
end of the exemplary delivery system illustrated in FIG. 27 can be
accomplished using various ventilation tube 800 configurations.
Exemplary configurations are described below, but are not intended
to be limiting in nature.
[0128] FIG. 27 includes a ventilation tube 800 which is similar to
that illustrated in FIG. 13A, but comprises a proximal end 802, a
distal end 804, conical or frusto-conical retaining member 806, a
shoulder 808, a first flange 810, a central channel 812 extending
through the ventilation tube 800, and a second flange 814 disposed
proximal to the first flange 810. The second flange 814 is spaced
from the first flange 810 a distance equal to or slightly larger
than the width of the grasping elements 724 which grasp the
ventilation tube 800 between the first flange 810 and the second
flange 814.
[0129] FIG. 28 is a side view of the distal end of the delivery
system 700 illustrated in FIG. 27 and includes an alternative
ventilation tube 900. The ventilation tube 900 is similar to that
illustrated in FIG. 13A, but comprises a proximal end 902, a distal
end 904, conical or frusto-conical retaining member 906, a shoulder
908, a flange 910, a central channel 912 extending through the
ventilation tube 900, and multiple cavities 914. The cavities 914
receive a portion of the grasping elements 724 and allow for
releasably connecting the ventilation tube 900 to the delivery
system 700. The configuration and depth of the cavities 914 mirrors
a portion of the grasping elements 724. While the illustrated
ventilation tube 900 includes multiple cavities with configurations
that mirror a portion of the grasping elements 724, any suitable
configuration and number of cavities can be included, and skilled
artisans will be able to select an appropriate configuration and
number of cavities for inclusion in a delivery system according to
a particular embodiment based on various considerations, including
the intended use of the delivery system, the type of procedure
being performed, the configuration of the distal end of the handle,
and others.
[0130] Various compositions can be used to manufacture the
ventilation tubes described herein. For example, the ventilation
tube can be formed of any degradable material, polymeric material,
or the like. In addition, the ventilation tube, introducer, and/or
cannula can be radiopaque or include radiopaque markers to aid the
physician in positioning the ventilation tube at a treatment site.
For example, portions of the ventilation tube, introducer, and/or
cannula can include a radiopaque material that can be identified by
X-ray. Examples of radiopaque material include, but are not limited
to, high-density metals such as platinum, iridium, gold, silver,
tantalum, radiopaque polymeric compounds, and the like.
[0131] While the delivery systems described above have included a
spring to advantageously return the cannula to the first position,
the spring can be omitted, and skilled artisans will be able to
select a suitable configuration for the delivery system according
to a particular embodiment based on various considerations,
including the intended use of the delivery system, the intended use
of the ventilation tube, and the configuration of the handle.
[0132] FIGS. 29 and 30 illustrate a partial sectional view of
another exemplary delivery system 1000 and associated ventilation
tube 1100. The delivery system comprises an introducer 1010, a
handle 1020, a slider 1030, a wire 1040, and a flexible tube 1050.
The ventilation tube 1100 is similar to that described in FIG. 13A,
but comprises a proximal end 1102, a distal end 1104, a conical or
frusto-conical retaining member 1106, a shoulder 1108, a flange
1110, a central channel 1112 extending through the ventilation tube
1100, and two apertures 1114 disposed within the central channel
1112 between the flange 1110 and frusto-conical retaining member
1106.
[0133] The introducer 1010 is a tubular member and has a proximal
end 1011 and a distal end 1012 and defines an elongate proximal
aperture 1013, two distal apertures 1014, and a chamber 1015. A
sharp distal tip 1016 is attached to the distal end 1012 of the
introducer 1010. The elongate proximal aperture 1013 and the two
distal apertures 1014 extend through the wall of the introducer
1010 and provide access to the chamber 1015. The two distal
apertures 1014 are located proximal to the sharp distal tip 1016.
The sharp distal tip 1016 is fixedly attached to the distal end
1012 of the introducer. The sharp distal tip 1016 can be, however,
integrated with or releasably attached to the introducer 1010.
[0134] The handle 1020 is disposed on, and fixedly attached to, the
proximal end 1011 of the introducer 1010 and comprises an elongate
member. The handle 1020 can be, however, integrally formed or
releasably attached to the introducer 1010. The slider 1030 is
slidably disposed within the elongate aperture 1012 of the
introducer 1010. The slider 1030 comprises a first portion 1031 and
a second portion 1032 connected by a connector 1033. The first
portion 1031 has a diameter slightly smaller than the inner
diameter of the chamber 1015 and includes an aperture 1034. The
connector 1033 is sized slightly smaller than the elongate proximal
aperture 1013 and extends through the elongate proximal aperture
1013 connecting the first 1031 and second portion 1032, which are
sized larger than the elongate proximal aperture 1013.
[0135] The wire 1040 comprises a proximal end 1041 and a distal end
1042 having two attachment elements 1043. The proximal end 1041 is
attached to the handle 1020 and extends through the aperture 1034
of the first portion 1031 of the slider 1030. The distal end 1042
branches into the two attachment elements 1043 proximal to the two
distal apertures 1014 of the introducer 1010. The two attachment
elements 1043 are in communication with the two distal apertures
1014 and naturally gravitate away from the center of the chamber
1015.
[0136] The wire 1040 can be preformed and made of a semi-rigid or
rigid material, however, skilled artisans will be able to select a
suitable material for inclusion in a delivery system according to a
particular embodiment based on various considerations, including
the intended use of the delivery system, the intended use of the
ventilation tube, and others. While a single wire 1040 has been
described and illustrated as having two attachment elements 1043,
any suitable number of flexible wires and attachment elements can
be included, and skilled artisans will be able to select an
appropriate number of wires and attachment elements according to a
particular embodiment based on various considerations, including
the configuration of the ventilation tube, and the intended use of
the delivery system. Examples of suitable numbers of wires and
attachment members include one, two, three, four and any number
considered suitable for a particular application.
[0137] The flexible tube 1050 is slidably disposed over the wire
1040 and comprises a proximal end 1051 attached to a distal surface
of the first portion 1031 of the slider 1030 and a distal end 1052
that extends to the branching portion of the wire 1040.
[0138] The delivery system 1000 has a first configuration and a
second configuration. The first configuration allows for a
ventilation tube 1100 to be releasably affixed to the distal end
1012 of the introducer 1010 by the attachment elements 1043
extending within the apertures 1114 of the ventilation tube 1100.
The second configuration withdraws the attachment elements 1043
from the apertures 1114 in the ventilation tube 1100, releasing the
ventilation tube 1100 from the introducer 1010. In the first
configuration, the slider 1030 is positioned at the proximal end of
the elongate proximal aperture 1013 which positions the flexible
tube 1050 slightly proximal to the branching portion of the wire
1040. This configuration allows the attachment elements 1043 to
extend through the two distal apertures 1014 of the introducer 1010
and enter the two apertures 1114 of the ventilation tube 1100,
providing a mechanism for releasably attaching the ventilation tube
1100 onto the distal end 1012 of the delivery system 1000. In the
second configuration the slider 1030 is pushed distally within the
elongate proximal aperture 1013, which advances the flexible tube
1050 past the branching portion of the wire 1040 retracting the
attachment members 1043 from the two apertures 1114 in the
ventilation tube 1100. This releases the ventilation tube 1100 from
the introducer 1010.
[0139] Various methods of treating a sinus cavity are described
herein. An initial step comprises attaching a ventilation tube to
the distal end of a delivery system. Another step comprises
advancing the distal end of the delivery system into the nostril to
a point of treatment. Another step comprises inserting the
ventilation tube at a point of treatment (e.g., lateral sinus
wall). Another step comprises releasing the ventilation tube from
the distal end of the delivery system. Another step comprises
removing the distal end of the delivery system from the nostril.
Another step comprises advancing the distal end of a catheter
(e.g., a irrigation, infusion, and/or balloon catheter) through the
channel of the ventilation tube such that the distal end of the
catheter is in the targeted sinus cavity. Alternatively, the distal
end of the catheter is advanced partially into the channel such
that the distal end of the catheter is positioned within the
channel of the ventilation tube. Another step comprises introducing
an irrigation fluid or drug into the targeted sinus cavity. This
step can be accomplished by passing the fluid or drug through the
catheter while the distal end of the catheter is disposed in the
targeted sinus cavity or in the channel of the ventilation tube.
Alternatively, this step can be accomplished by passing another
catheter through the previously placed catheter, connecting another
catheter to the previously placed catheter, or other similar
approach. Another step comprises withdrawing the catheter(s) from
the channel of the ventilation tube. Another step comprises
removing the ventilation tube from the point of treatment, if
desired.
[0140] Additional, and/or alternative, steps can be included within
the above described method. For example, the step of introducing an
irrigation fluid or drug into the targeted sinus cavity can
alternatively comprise inflating a balloon on the catheter. This
step can be accomplished by passing a material through the catheter
to inflate the balloon while the distal end of the catheter is
disposed in the targeted sinus cavity. Alternatively, this step can
be accomplished by passing another catheter through the previously
placed catheter and past the distal end of the previously placed
catheter.
[0141] In an additional example, the step of advancing the distal
end of a catheter through the channel of the ventilation tube such
that the distal end of the catheter is in the targeted sinus cavity
can alternatively comprise advancing the distal end of the catheter
through a natural PMO. Alternatively, this step can be accomplished
by passing another catheter through the previously placed catheter
and past the distal end of the previously placed catheter. Another
step comprises inflating a balloon on the catheter. This step can
be accomplished by passing a material through the catheter to
inflate the balloon while the distal end of the catheter is
disposed within the PMO.
[0142] Any ventilation tube, including the ventilation tubes
described herein, can be used to assist in performing the
above-described method. For example, the method can comprise the
use of a ventilation tube as described above and illustrated in
FIGS. 2A, 2B, 13A, 13B, 25, 26, 27, 28, 29, 30, or any alternatives
thereof. In addition, any delivery system, including the delivery
systems described herein, can be used to assist in performing the
above-described method. For example, the method can comprise the
use of a delivery system as described above and illustrated in
FIGS. 2A, 3, 6, 8, 11, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27,
29, or any alternatives thereof. Alternatively, the method can
comprise the use of a catheter as described above and illustrated
in FIG. 14.
[0143] The configurations described above relating to the handles,
the distal end of the delivery system, and/or ventilation tube can
be used in combination with one another, or individually, and
skilled artisans will be able to select an appropriate delivery
system according to a particular embodiment based on various
considerations, including the intended use of the delivery system,
the intended use of the ventilation tube, the configuration of the
ventilation tube, and others. Examples of suitable combinations of
delivery systems include, but are not limited to, an introducer
and/or ventilation tube interference fit used in combination with
grasping members, an introducer and/or ventilation tube
interference fit used in combination with a wire configuration,
and/or a grasping member used in combination with a wire
configuration.
[0144] In addition, any configuration of the ventilation tube can
include material to be delivered to a patient. Exemplary materials
are listed herein, and skilled artisans will be able to select
suitable materials according to a particular embodiment based on
various considerations, including the intended use of the
ventilation tube, the configuration of the ventilation tube, the
treatment being administered, and others.
[0145] An exemplary ventilation tube container 1200 is illustrated
in FIGS. 31 and 32. The ventilation tube container 1200 comprises
an elongate rigid body 1202 defining multiple independent recesses
1204 housing a ventilation tube 1250. While the illustrated
ventilation tube container 1200 includes a ventilation tube 1250
similar to that illustrated in FIG. 13A, any suitable ventilation
tube can be used in combination with the ventilation tube container
1200, and skilled artisans will be able to select an appropriate
ventilation tube for inclusion with a ventilation tube container
according to a particular embodiment based on various
considerations, including the intended use of the ventilation tube,
and others.
[0146] Each recess 1204 includes a first portion 1210, a second
portion 1220, and a third portion 1230. The first portion 1210 is
configured to have a diameter slightly smaller than the outer
diameter 1252 of the flange 1254 of the ventilation tube 1250 and a
depth substantially equal to the distance between the proximal end
of the flange 1254 and the proximal end of the frusto-conical
section 1256 of the ventilation tube 1250. Alternatively, the first
portion 1210 of each recess 1204 can be slightly larger than the
outer diameter 1252 of the flange 1254 of the ventilation tube and
include a liner, such as the foam insert 1212 illustrated in the
figures. Foam insert assist with gripping the ventilation tube 1250
when it is housed within the ventilation tube container 1200. The
foam insert 1212 can have a depth equal to, less than, or greater
than, the depth of the first portion 1210 of the recess 1204. These
configurations ensure that the ventilation tube 1250, which is
formed of a compressible material, is snuggly retained within the
recess 1204. While a foam insert has been described and
illustrated, any suitable material can be used to facilitate
gripping the ventilation tube when it is housed within the
ventilation tube container, and skilled artisans will be able to
select a suitable material according to a particular embodiment
based on various considerations, including the type of ventilation
tube being housing in the ventilation tube container, and the
amount of grip desired.
[0147] The second portion 1220 extends from the first portion 1210
to the third portion 1230 and is configured to mirror the
frusto-conical section 1256 of the ventilation tube 1250. The third
portion 1230 extends from the second portion to the bottom of the
recess and is configured to have a depth sufficient to allow the
sharp distal end 1262 of the introducer 1260 to advance through the
central channel 1258 of the ventilation tube 1250 and load the
ventilation tube 1250 onto the introducer 1260. The depth of the
recesses 1210, 1220, and 1230 will be slightly greater than the
length of the introducer 1260 from the distal end 1262 to the bend
or the distal end 1262 of the introducer 1260 to the distal end of
the cannula.
[0148] While the recess 1204 has been described and illustrated as
having a particular configuration, other configurations are
considered suitable, and skilled artisans will be able to select a
suitable configuration for the recess according to a particular
embodiment based on various considerations, including the
configuration of the ventilation tube, the configuration of the
cannula, and the configuration of the introducer.
[0149] The ventilation tube container 1200 allows a user to load a
ventilation tube 1250 onto a delivery system (e.g., introducer)
without having to manually force the ventilation tube 1250 onto the
end of the delivery system using opposing hands, which may reduce
the risk of injury. In addition, the ventilation tube container
1200 aids with proper alignment of the ventilation tube 1250 when
loaded onto a delivery system. Furthermore, the ventilation tube
container 1200 advantageously allows a physician to reuse a
delivery system and reload additional ventilation tubes 1250 on the
delivery system, should more than one be needed.
[0150] While the ventilation tube container 1200 has been described
as having independent recesses to house individual ventilation
tubes 1250, the ventilation tube container 1200 can include a
single elongated recess, with liner partition separating each
ventilation tube, to house multiple ventilation tubes 1250.
Alternatively, the liner, and/or liner partitions can be omitted.
Furthermore, while multiple ventilation tubes 1250 have been
described and illustrated as housed within the ventilation tube
container 1200, the number of ventilation tubes 1250 included in
the ventilation tube container 1200 can vary, and skilled artisans
will be able to select a suitable number of ventilation tubes to
include with a ventilation tube container according to a particular
embodiment based on various considerations, including, the intended
use of the ventilation tube, and the configuration of the
ventilation tube. Examples of suitable numbers of ventilation tubes
include one, two, three, four, five, six and any other number
determined suitable for a particular application.
[0151] The foregoing disclosure includes the best mode of the
inventor for practicing the invention. It is apparent, however,
that those skilled in the relevant art will recognize variations of
the invention that are not described herein. While the invention is
defined by the appended claims, the invention is not limited to the
literal meaning of the claims, but also includes these
variations.
* * * * *