U.S. patent application number 13/471281 was filed with the patent office on 2013-05-23 for transnasal method and catheter for lacrimal system.
The applicant listed for this patent is Bruce B. Becker. Invention is credited to Bruce B. Becker.
Application Number | 20130131713 13/471281 |
Document ID | / |
Family ID | 32029528 |
Filed Date | 2013-05-23 |
United States Patent
Application |
20130131713 |
Kind Code |
A1 |
Becker; Bruce B. |
May 23, 2013 |
Transnasal method and catheter for lacrimal system
Abstract
A balloon catheter for treatment of a patient's lacrimal system
is applied transnasally without the use of a guide wire or a curve
retention member. The catheter is formed of a stainless steel
hypotube and is of sufficient stiffness and column strength to
enable the deflated catheter to be pushed from the patent's nasal
cavity through a prepared small-tight opening, which is formed
through the lateral nasal wall and lacrimal fossa, into the
lacrimal sac. The catheter has a proximal shaft and a distal
segment positioned by a bend at an angle of 70.degree. to
115.degree., preferably 90.degree., to the proximal shaft. An
inflatable member is mounted about the distal segment and is
adhesively bonded to the distal end of the proximal shaft, the
bend, and the proximal end of the distal segment and to the distal
portion of the distal segment. The prepared, small-tight opening is
formed by pushing small holes through the medial sac, lacrimal
fossa, and lateral nasal wall with an instrument and coalescing the
holes to form the prepared small-tight opening. The catheter is
introduced into the nasal cavity and rotated, or moved, to align
the distal segment with the prepared opening. The distal segment is
then pushed through the prepared opening, and fluid under pressure
is applied to the catheter to inflate the inflatable member and
dilate the prepared opening.
Inventors: |
Becker; Bruce B.; (Malibu,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becker; Bruce B. |
Malibu |
CA |
US |
|
|
Family ID: |
32029528 |
Appl. No.: |
13/471281 |
Filed: |
May 14, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11699622 |
Jan 30, 2007 |
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13471281 |
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10259630 |
Sep 30, 2002 |
7169163 |
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11699622 |
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Current U.S.
Class: |
606/196 |
Current CPC
Class: |
A61B 17/24 20130101;
A61M 29/02 20130101; A61F 9/00772 20130101; A61M 2025/1093
20130101; A61M 2210/0618 20130101 |
Class at
Publication: |
606/196 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1. A device for dilating an opening between a patient's lacrimal
sac and nasal cavity to treat the lacrimal system, comprising: a
tubular body, said tubular body having a proximal end, a proximal
segment, a distal end, a distal segment, said distal segment having
a fixed angle relative to said proximal segment, and said tubular
body having sufficient compressive strength to resist buckling and
sufficient lateral stiffness to retain said angle when correctly
utilized during treatment; a luer, said luer fixedly attached to
said proximal end; an inflatable member, said inflatable member
being proximate to said distal segment, said inflatable member,
when inflated, having a center region sufficiently dimensioned to
dilate said opening.
2. The device of claim 1, wherein said body further has a rounded
bend between said proximal segment and said distal segment.
3. The device of claim 2, wherein inflatable member comprises a
working segment located entirely distal to said bend.
4. The device of claim 1, wherein said tubular body is a stainless
steel hypotube having a wall thickness of at least 0.035''.
5. The device of claim 1, wherein said tubular body is a stainless
steel hypotube having an outer diameter of 0.083'' and an inner
diameter of 0.039'' with a wall thickness of 0.044''.
6. The device of claim 1, wherein said angle is from 70.degree. to
115.degree..
7. The device of claim 1, wherein said luer has a means for
improving a user's manipulating of said device during
treatment.
8. The device of claim 1, wherein said inflatable member has a
length of 4 millimeters to 30 millimeters.
9. The device of claim 1, wherein said inflatable member has an
inflated diameter of 2 millimeters to 14 millimeters.
Description
PRIOR APPLICATION
[0001] This is a continuation of U.S. patent application Ser. No.
11/699,622, filed 2007 Jan. 30, which is a divisional of U.S.
patent application Ser. No. 10/259,630, filed 2002 Sep. 30, now
U.S. Pat. No. 7,169,163 issued 2007 Jan. 30.
FIELD OF THE INVENTION
[0002] This invention relates to a method and catheter for treating
the lacrimal system and, more particularly, to a transnasal method
of treating the lacrimal system and a balloon catheter used in this
method.
BACKGROUND
[0003] To fully understand the invention, it is necessary to
consider the anatomy and physiology of the lacrimal system. The
orbital portion of the lacrimal gland is located in the
superotemporal orbit and produces the aqueous layer of the tear
film. Ductules from the orbital portion of the lacrimal gland pass
through the adjacent palpebral lacrimal gland to empty in the
superior conjunctival cul-de-sac. Smaller accessory lacrimal glands
in the upper and lower lids also contribute to tear production. The
tears bathe the surface of the eye and then drain into the puncta
and canaliculi in the medial upper and lower lids. The tears flow
from the canaliculi into the lacrimal sac down the nasolacrimal
duct into the nose.
[0004] The nasolacrimal duct can become obstructed on either a
congenital or acquired basis. When the nasolacrimal duct becomes
obstructed, tears can no longer drain from the surface of the eye
through the lacrimal system into the nose. The tears well up over
the eye and spill over the lids onto the face. The patient has to
constantly dab the eye with a tissue. In addition, tears stagnate
in the lacrimal sac, bacteria multiply, and in many cases the
lacrimal sac becomes infected (dacryocystitis). Dacryocystitis
causes the lacrimal sac to become swollen, red and painful. Pus
exudes from the sac and constantly covers the eye. In time, the
dacryocystitis does not respond to antibiotics and surgery becomes
necessary. At present, there is no medical therapy for acquired
nasolacrimal duct obstruction other than antibiotics to temporarily
suppress infection.
[0005] The condition can, however, be corrected surgically.
Dacryocystorhinostomy (DCR) is the surgery required to correct
nasolacrimal duct obstruction. In a DCR, a new opening (ostium) is
created between the lacrimal sac and the nose. This allows tears to
flow from the lacrimal sac through the DCR ostium into the nose. An
external or incisional DCR required an incision on the side of the
nose. In an open DCR, the surgeon creates a large 17 mm plus
diameter opening in the bone and nasal muscosa. This procedure has
significant morbidity, a prolonged recovery, and the threat of
scarring and hemorrhage. In contrast, an endoscopic DCR has much
less morbidity, no incision, and a quick recovery time. An
endoscopic DCR may be performed using a balloon catheter, a laser,
or traditional surgical instruments. A laser endoscopic DCR
requires expensive and time-consuming lasers, and has a low success
rate. An endoscopic DCR with traditional instruments places the eye
and surrounding structures at risk because tissue is removed from
the lacrimal sac and lateral nasal wall, with the instruments in
the nasal cavity going toward the eye and orbit. Bleeding and edema
may make it difficult to identify the relevant structures.
[0006] It has been found that a balloon catheter DCR is a much
safer and cheaper form of DCR than a laser or an endoscopic DCR
with traditional surgical instruments. The balloon catheter is
positioned so that it extends from the lacrimal sac through the
ostium and extends into the nose. Since the balloon DCR ostium is
created by dilatation, rather than by excision or laser energy,
there is no threat to the surrounding ocular and orbital
structures, and there is less tissue trauma.
[0007] As shown in U.S. Pat. Nos. 5,021,043 and 5,169,043, I have
previously co-invented balloon catheters for use in the lacrimal
system. These balloon catheters are inserted from the eye through
the small diameter (about 0.5 mm) delicate punctum and canaliculus
into the lacrimal sac extending through the planned ostium into the
nose. The deflated profile diameter of the balloon catheter must be
very small in order to be pushed through, and avoid damage to, the
small diameter and delicate canaliculus. The need for such a small
deflated diameter limits the inflated diameter of the balloon to 5
mm. However, a 5 mm diameter ostium is much smaller than the 17 mm
plus diameter ostium of an external DCR and leads to a higher
stenosis rate of the balloon DCR ostium after surgery. A larger
diameter balloon would create a larger-diameter ostium and lead to
a higher surgical success rate.
[0008] This led to the concept disclosed beginning at column 7,
line 29, and FIG. 4 of U.S. Pat. No. 5,021,043 and beginning at
column 8, line 34, and FIG. 4 of U.S. Pat. No. 5,169,386 that a
dilation catheter be introduced transnasally when a larger-diameter
balloon is required. However, as taught in these patents, the
dilation catheter is inserted over a guide wire. Although this
technique is useful, it involves a number of time-consuming steps,
including the insertion of a guide wire through the lacrimal
system, and then separately advancing the balloon catheter over the
guide wire. This technique requires the placement of a guide wire
through the canaliculi into the nose. The surgeon then reaches up
the nose with a hemostat or other instrument to grasp the guide
wire and pull it out of the external naris of the nose. A flexible
balloon catheter is then passed up the nose over the guide wire and
through the lateral nasal wall into the lacrimal sac, or up the
nasolacrimal duct into the lacrimal sac. However, there are
problems with this method. First, there may be difficulty locating
and grasping the guide wire in the nose, especially if even mild
bleeding is present. The guide wire may pass posteriorly into the
throat (pharynx) rather than in the direction of the external
naris. There is often resistance to pulling the balloon from the
nasal cavity into the lacrimal sac and considerable force is
required to pull the balloon and guide wire into the lacrimal sac.
This pull on the guide wire can cause it to slice through the
delicate canaliculi, which may lead to secondary fibrosis and
obstruction of the canaliculi after surgery.
[0009] The U.S. Pat. No. 5,169,386 also discloses an alternative
dilation catheter, which does not use a guide wire, but there is no
suggestion that this catheter be inserted transnasally. The
catheter is constructed to simulate a standard ophthalmic probe in
stiffness, in terms of both column strength and resistance to
lateral bending, with sufficient flexibility to enable it to
conform to the contours of the lacrimal system. The catheter, as
provided, is initially straight, but the catheter may be bent
between 0.degree.-30.degree. to simulate the curvature of an
ophthalmic probe. A curve retention element is inserted in the
catheter to retain the curved shape and to increase the columnar
and flexural stiffness of the distal portion of the catheter to
enhance its ability to be forced through a constricted portion of
the lacrimal system. The catheter is formed of a stainless steel
hypotube having an outer diameter of 0.022'' and an inner diameter
of 0.017''.
[0010] This catheter is not suitable for transnasal insertion. The
tube does not have sufficient stiffness and column strength to
enable the deflated balloon catheter to be pushed from the nasal
cavity through a small, tight opening in the lateral nasal wall and
lacrimal fossa into the lacrimal sac. Moreover, the bent distal
portion is not angled to a degree necessary for ready insertion
through the opening.
SUMMARY
[0011] A balloon catheter of the invention can be introduced
transnasally into the area of a planned DCR ostium. The catheter
has a larger deflated profile and, thus, a larger inflated
diameter, than a balloon catheter introduced through the delicate
canaliculi. The balloon catheter of the invention does not need a
guide wire; and, therefore, there is no chance that a guide wire
will damage the delicate canaliculi. A larger diameter balloon DCR
ostium is less likely to stenose after surgery and results in a
better surgical success rate.
[0012] The balloon catheter of the invention comprises a hypotube
formed of stainless steel of sufficient stiffness and column
strength to enable the deflated balloon catheter to be pushed from
the nasal cavity through a prepared small, tight opening in the
lateral nasal wall and lacrimal fossa into the lacrimal sac. A
distal end segment of the hypotube has a rounded bend, placing the
distal segment at an angle of 70.degree. to 115.degree., preferably
90.degree., to a long proximal segment or shaft. This bend allows
the surgeon to rotate or shift the position of the long proximal
catheter shaft, thus placing the distal balloon catheter segment in
position to enter from the nasal cavity into the lacrimal sac at
various angles appropriate to each individual patient. Due to the
stiffness and strength of the hypotube, neither a guide wire nor a
curve retention element are necessary.
[0013] The distal segment of the balloon catheter from the outside
of the bend to the end of the catheter is 14 mm which is short
enough to allow it to be rotated within the nasal cavity and long
enough to allow a balloon of sufficient length and diameter to be
attached to the hypotube for dilatation of the balloon DCR
ostium.
[0014] The balloon is formed of inflatable material with a first
neck bonded with adhesive to the very distal portion of the distal
segment of the hypotube and a second neck bonded with adhesive to
the distal end of the proximal shaft, the bend, and the proximal
end of the distal segment. This permits a longer working segment of
balloon to be used, because the area of adhesion of the balloon
includes the bend and the adjacent portion of the proximal long
segment of the hypotube. The proximal end of the catheter tube has
a luer lock with wings or an expansion to allow the catheter to be
attached to tubing from the inflation device. The wings or
expansion allow the surgeon to more easily hold, manipulate, and
push the balloon catheter.
[0015] According to the method of the invention, a very large
ostium is formed between the lacrimal sac and the nasal cavity with
the use of a very large balloon inserted transnasally. The balloon
is deflated to allow the catheter, which is of sufficient
stiffness, to be pushed through the prepared opening formed from
the nasal cavity through the lateral nasal wall and lacrimal fossa
into the lacrimal sac. The balloon is then inflated to enlarge the
opening and create the very large ostium. The balloon catheter is
inserted without the use of a guide wire.
[0016] The portion of the distal end after the bend is sufficiently
short to enable the catheter to be positioned in the nasal cavity
to bring the distal end to the level of the prepared opening. The
catheter is then rotated or shifted to align the distal end with
the prepared opening, as required by the anatomy of the individual
patient. The distal end is then pushed through the prepared opening
to position the deflated balloon in the opening. The balloon is
then inflated to enlarge the opening to the outer diameter of the
inflated balloon, thus forming the very large ostium.
[0017] Since the method of the insertion requires insertion of the
balloon catheter transnasally, the trauma associated with insertion
through the delicate canaliculi is avoided. The catheter and method
of the invention provide a satisfactory endoscopic DCR and thus
avoid the trauma associated with an external (incisional) DCR. The
catheter and method of the invention achieve a high surgical
success rate.
BRIEF DESCRIPTION OF THE DRAWING
[0018] FIG. 1 is a schematic drawing of a preferred embodiment of a
lacrimal balloon catheter of the invention;
[0019] FIG. 1a is a close-up schematic drawing of the tip of the
distal segment of the balloon catheter of FIG. 1;
[0020] FIG. 2 is a schematic drawing of a step of the method of the
invention showing a patient with an obstructed nasolacrimal duct in
which a metal probe has been passed through the punctum,
canaliculus, lacrimal sac, and multiple spots in the lacrimal fossa
and lateral nasal wall into the nose;
[0021] FIG. 3 is a schematic drawing showing another step of the
method of the invention in which a nerve hook brought up the nasal
cavity, pushed into the small openings in the lateral nasal wall
and lacrimal fossa, and moved to coalesce these small openings into
a larger opening;
[0022] FIG. 4 is a schematic drawing showing a further step of the
method of the invention in which a deflated balloon catheter of the
invention, which has been brought into the nasal cavity and pushed
through the small opening in the lateral nasal wall and lacrimal
fossa into the lacrimal sac;
[0023] FIG. 5 is a schematic drawing showing a step of the method
of the invention in which the balloon catheter with the balloon
inflated is within the ostium and lacrimal sac; and
[0024] FIG. 6 is a close-up schematic drawing of the tip of the
distal portion of an alternative embodiment of a balloon catheter
of the invention; and
[0025] FIG. 7 is a schematic diagram showing a method step of an
alternative embodiment of the method of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT(S)
[0026] As shown in FIGS. 1 and 1a, a balloon catheter 130 of the
invention is assembled from a tube 136, preferably a stainless
steel hard tempered hypotube which has a circular bend 138 of
0.13'' radius such that distal segment 137 is oriented 70.degree.
to 115.degree., preferably 90.degree., to proximal segment 139. The
distance from the distal tip 184 of distal segment 137 to the outer
wall of proximal segment 139 of hypotube 136 is 4 mm to 30 mm,
preferably 14 mm, as shown in FIG. 1. The distal tip 184 of the
hypotube 136 is closed, whereas the proximal end 142 is open.
However, the lumen of tube 136 may be closed in the distal segment
137, up to 10 mm from the distal tip 184 allowing the distal tip
184 to remain open for engagement with a probe, as shown in FIGS. 6
and 7. The proximal end 142 of hypotube 136 is inserted into a mold
for forming luer 144. Heated plastic is injected into the mold to
form luer 144 attached to proximal end 142. The inner diameter of
the luer 144 matches the external diameter of the hypotube 136. The
luer 144 has wings 143 or other enlargement or expansion on it to
enable the surgeon to better hold and manipulate the balloon
catheter 130. Catheter 130 is 4'' to 10'' long, preferable 6'' in
length as measured from proximal end 142 to distal tip 184, as
shown in FIG. 1. The wall of tube 136 should be of such thickness
that the tube has sufficient stiffness and column strength that
distal segment 137 of a deflated catheter can be pushed through a
prepared small, tight opening in the patient's lateral nasal wall.
This may require considerable pressure in some cases. It has been
found that a tube with a wall thickness of at least 0.035'' will be
satisfactory. A preferred tube has an outer diameter of 0.083'' and
an inner diameter of 0.039'' with a wall thickness of 0.044''.
[0027] The catheter 130 has a port 140 in the distal segment 137,
which is formed by inserting temporarily a discardable wire segment
into the tube 136. This is done before inserting hypotube 136 into
luer 144. A transverse slot is cut in the tube 136 approximately 2
mm to 14 mm, preferably 4 mm, from its distal end 184 to form port
40. The slot extends in depth to approximately one third of the
diameter of tube 136. A wire wheel is used to remove any burrs, and
the discardable core wire is removed and discarded.
[0028] Catheter 130 has sufficient column strength and resistance
to lateral bending (stiffness) to enable the deflated catheter to
be pushed through the initial prepared opening in the lateral nasal
wall and lacrimal fossa into the lacrimal sac. This may require
considerable pressure in some cases.
[0029] A balloon 134 is preferably formed of polyethylene
terephthalate and has a length of approximately 4 mm to 30 mm,
preferably 14 mm, and a working inflated diameter of 2 mm to 14 mm,
preferably 9 mm, for use in the lacrimal system. The balloon has a
distal neck 170, a distal tapered region 172, a center region 174,
a proximal tapered region 176, and a proximal neck 178. During
installation, tube 136 is cleaned with isopropanol and then coated
with a primer, "Loctite 770." The balloon is placed over the distal
end of tube 136 to align the distal end of distal neck 170 with
distal end 184 of tube 136. An adhesive, such as cyanoacrylate, is
used. An acceptable adhesive "Loctite 4081" is available from
Loctite Corporation. The adhesive is applied to distal end of
distal neck 170 and the proximal end of proximal neck 178 to form
bonds 180 and 182, respectively. The adhesive is applied to the
balloon necks 170, 178 using a small mandrel such as a wire
approximately 0.010'' to 0.014'' in diameter. The adhesive wicks
into the necks due to capillary action. Proximal neck 178 and
proximal tapered region 176 may be bonded on distal segment 137 of
tube 136 or extend over bend 138 onto the distal end portion of
proximal segment 139 of tube 136. Extension of the proximal neck
178 onto bend 138 and proximal segment 139 allows a greater length
of the working diameter, i.e., center region 174, to be on distal
segment 137 of tube 136.
[0030] A first step of the method of the invention is shown in FIG.
2. A Bowman probe 102 is brought through superior punctum 4 of the
patient's eye, superior canaliculus 6, common canaliculus 8, and
lacrimal sac 10, and then pushed through the medial sac wall 11,
lacrimal fossa bone 12, and lateral nasal wall 44 into the nasal
cavity 38. Probe 102 is pulled back into lacrimal sac 10, and
pushed through four or fives areas of medial sac wall 11, lacrimal
fossa bone 12, and lateral nasal wall 44 into nasal cavity 38. The
multiple openings 18 in the medial sac wall 11, lacrimal fossa 12,
and lateral nasal wall 44 are coalesced into one prepared opening
19 (FIG. 4) by moving probe 102 in a see-saw fashion or by bringing
a nerve hook 104 into nasal cavity 38, and pushing it into openings
18 and dragging nerve hook 104 across multiple openings, as shown
in FIG. 3.
[0031] Turning to FIG. 4, the deflated transnasal lacrimal balloon
catheter 130 is then brought into nasal cavity 38, and distal
segment 137 is pushed through prepared opening 19 created by
coalescing smaller openings 18 in lateral nasal wall 44, lacrimal
fossa 12, and medial wall 11 of lacrimal sac 10, such that distal
end 184 of distal segment 137 of balloon catheter 130 extends into
lacrimal sac 10.
[0032] The luer lock 144 on proximal end 142 of balloon catheter
130 connects to the distal end 110 of tube 112 of the inflation
device, which supplies fluid under pressure. As seen in FIG. 5,
balloon 134 is inflated to 9 bars for 20 seconds to expand opening
19 to form ostium 120 then deflated. Distal segment 137 is then
slightly repositioned to insure thorough dilation and inflated
again to 9 bars for 20 seconds. Balloon 134 is then deflated and
withdrawn from nasal cavity 38, leaving a large ostium 120 formed
between lacrimal sac 10 and nasal cavity 38.
[0033] An alternative embodiment of the balloon catheter of the
invention is shown in FIG. 6. In this embodiment, the catheter 230
has a distal segment 237, which are identical to catheter 130 and
segment 137, as shown in FIG. 1, except for the point of closure of
tube 136. Whereas, as described above, distal segment 137 in FIG. 1
is closed at its distal end 184, in the embodiment of FIG. 6, tube
236, and distal segment 237 are closed by closure wall 286 that is
located between slot 140 and the distal end 284. Since distal
segment 237 is closed after slot 140, fluid will still flow through
slot 140 to inflate balloon 134 when air under pressure is applied
to tube 236. However, there will now be an open-ended tube segment
288 between closure wall 286 and distal end 284.
[0034] As shown in FIG. 7, this open-ended tube segment 288 may be
used to receive an end of a probe 202, provided that the outer
diameter of probe 202 is slightly smaller than the inner diameter
of tube segment 288. Such a probe engaged with open-ended tube
segment 288 can be useful for moving distal end 284 to a proper
position for engagement with an opening 19 which is to be enlarged
by inflating balloon 134, as described above.
[0035] It should be understood that the foregoing description of
the invention is intended merely to be illustrative and other
modifications, embodiments, and equivalents may be apparent to
those skilled in the art without departing from the spirit and
scope of the invention.
* * * * *