U.S. patent application number 09/862744 was filed with the patent office on 2002-03-14 for transnasal lacrimal insert.
Invention is credited to Moazed, Kambiz Thomas.
Application Number | 20020032400 09/862744 |
Document ID | / |
Family ID | 24961795 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020032400 |
Kind Code |
A1 |
Moazed, Kambiz Thomas |
March 14, 2002 |
Transnasal lacrimal insert
Abstract
A temporary transnasal lacrimal insert is used in a surgical
procedure for improving drainage from a patient's lacrimal sac to
his or her nasal cavity. The insert includes a tubular member with
a proximal end and an enlarged distal end. The insert also includes
an attachment element about which ends of a silastic tube can be
fastened. In the procedure, a hole is created extending from the
lacrimal sac into the nasal cavity using surgical techniques or a
laser probe. Then, opposite ends of a silastic tube are introduced
through the patient's upper and lower puncta, through the patient's
upper and lower canaliculi, through the lacrimal sac, through the
hole, and into the nasal cavity. The ends of the silastic tube are
then threaded through the passage in the insert. The insert is then
placed from the nasal cavity into the hole by forcing the proximal
end of the insert through the hole and into the lacrimal sac, and
abutting the enlarged distal end, which is larger than the hole,
against a surface in the nasal cavity surrounding the hole. The
ends of the silastic tube are then fastened to the attachment
element of the insert. Excess tube extending into the nasal cavity
is then cut short to reduce nasal irritation. After the hole has
sufficiently healed in about 3-6 months, the silastic tube and the
insert are removed.
Inventors: |
Moazed, Kambiz Thomas; (New
York, NY) |
Correspondence
Address: |
KENYON & KENYON
ONE BROADWAY
NEW YORK
NY
10004
US
|
Family ID: |
24961795 |
Appl. No.: |
09/862744 |
Filed: |
May 22, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09862744 |
May 22, 2001 |
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09432132 |
Nov 2, 1999 |
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09432132 |
Nov 2, 1999 |
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08736902 |
Oct 25, 1996 |
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5993407 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61F 9/00772
20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61M 005/00 |
Claims
1. A transnasal lacrimal insert, comprising: a tubular member
having a passage extending therethrough, said tubular member having
a proximal end and an enlarged distal end; and an attachment
element at said distal end of said tubular member about which ends
of a silastic tube can be fastened, wherein said tubular member and
said attachment element comprise biocompatible material.
2. The transnasal lacrimal insert of claim 1, wherein said tubular
member is generally L-shaped.
3. The transnasal lacrimal insert of claim 1, wherein said insert
comprises a soft, flexible material.
4. The transnasal lacrimal insert of claim 1, wherein said insert
comprises silicone.
5. The transnasal lacrimal insert of claim 1, wherein said insert
comprises silastic material.
6. The transnasal lacrimal insert of claim 1, wherein said tubular
member has a wall thickness of about 0.5 mm to 1 mm.
7. The transnasal lacrimal insert of claim 1, wherein said enlarged
distal end comprises a flange projecting about said tubular
member.
8. The transnasal lacrimal insert of claim 7, wherein said flange
has a circular periphery.
9. The transnasal lacrimal insert of claim 8, wherein said flange
has an outer diameter of about 10 mm.
10. The transnasal lacrimal insert of claim 7, wherein said flange
has a thickness of about 0.5 mm to 1 mm.
11. The transnasal lacrimal insert of claim 1, wherein said
proximal end of said tubular member is tapered to facilitate
insertion of the insert in a rhinostomy hole, and said proximal end
is adapted to stay inside the lacrimal sac.
12. The transnasal lacrimal insert of claim 1, wherein said
attachment element comprises an elongated rod extending across an
opening at said distal end of said tubular member leading to said
passage.
13. A surgical procedure for improving drainage from a patient's
lacrimal sac to his or her nasal cavity, comprising the steps of:
(a) inflating the lacrimal sac with Healon; (b) passing a fiber
optic laser probe through the patient's canaliculus and into the
lacrimal sac; (c) placing the tip of an endoscope in the nasal
cavity to facilitate proper positioning of the laser probe; (d)
applying laser energy through the laser probe to form a hole
extending from the lacrimal sac into the nasal cavity; (e) removing
the laser probe and endoscope from the patient; (f) introducing
opposite ends of a silastic tube, each through one of the patient's
upper and lower puncta, through the corresponding upper and lower
canaliculi, through the lacrimal sac, through the hole, and into
the nasal cavity; (g) providing a transnasal lacrimal insert, said
insert comprising a tubular member having a passage extending
therethrough, said tubular member including a proximal end and an
enlarged distal end, said distal end being larger than said hole;
and said insert including an attachment element about which ends of
a silastic tube can be fastened; (h) threading the ends of the
silastic tube through the passage in the insert from the proximal
end through the distal end; (i) introducing the insert from the
nasal cavity into the hole by forcing the proximal end of the
insert through the hole and into the lacrimal sac, and abutting the
enlarged distal end against a surface in the nasal cavity
surrounding the hole; (j) attaching the ends of the silastic tube
to the attachment element of the insert; (k) cutting and removing
excess portions of the silastic tube extending into the nasal
cavity; and (l) removing the silastic tube and the insert from the
patient after sufficient healing of said hole.
14. A method of improving drainage from a patient's lacrimal sac to
his or her nasal cavity, comprising the steps of: (a) creating a
hole extending from the lacrimal sac into the nasal cavity; (b)
introducing opposite ends of a silastic tube through the patient's
upper and lower puncta, through the patient's upper and lower
canaliculi, through the lacrimal sac, through the hole, and into
the nasal cavity; (c) providing a transnasal lacrimal insert, said
insert comprising a tubular member having a passage extending
therethrough, said tubular member including a proximal end and an
enlarged distal end, said distal end being larger than said hole;
and said insert including an attachment element about which ends of
a silastic tube can be fastened; (d) threading the ends of the
silastic tube through the passage in the insert; (e) introducing
the insert from the nasal cavity into the hole by forcing the
proximal end of the insert through the hole and into the lacrimal
sac, and abutting the enlarged distal end against a surface in the
nasal cavity surrounding the hole; (f) attaching the ends of the
silastic tube to the attachment element of the insert; and (g)
removing the silastic tube and the insert from the patient after
sufficient healing of said hole.
15. The method of claim 14, wherein step (a) comprises applying
laser energy from a fiber optic laser probe inserted in the
lacrimal sac.
16. The method of claim 15, further comprising placing the tip of
an endoscope in the nasal cavity to confirm proper positioning of
the laser probe.
17. The method of claim 14, wherein step (a) is performed using
surgical techniques.
18. The method of claim 14, further comprising cutting and removing
excess portions of the silastic tube extending into the nasal
cavity after step (f).
19. The method of claim 14, wherein step (a) comprises creating a
hole having a diameter of approximately 5-7 mm.
20. The method of claim 14, wherein step (g) is performed about 3-6
months after step (f).
21. The method of claim 14, wherein said tubular member of said
insert is generally L-shaped.
22. The method of claim 14, wherein said insert comprises a soft,
flexible material.
23. The method of claim 14, wherein said insert comprises
silicone.
24. The method of claim 14, wherein said insert comprises silastic
material.
25. The method of claim 14, wherein said tubular member of said
insert has a wall thickness of about 0.5 mm to 1 mm.
26. The method of claim 14, wherein said enlarged distal end of
said insert comprises a flange projecting about said tubular
member.
27. The method of claim 26, wherein said flange has a circular
periphery.
28. The method of claim 27, wherein said flange has an outer
diameter of about 10 mm.
29. The method of claim 26, wherein said flange has a thickness of
about 0.5 mm to 1 mm.
30. The method of claim 14, wherein said proximal end of said
tubular member is tapered to facilitate insertion of the insert in
a hole.
31. The method of claim 14, wherein said attachment element
comprises an elongated rod extending across an opening at said
distal end of said tubular member leading to said passage.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical devices
and procedures and, more particularly, to devices and procedures
for lacrimal tract surgery for improving tear drainage.
BACKGROUND OF THE INVENTION
[0002] One of the major problems with known dacryocystorhinostomy
(DCR) procedures for improving lacrimal tract drainage is closure
of the induced drainage hole between the lacrimal sac and the nasal
cavity. The possibility of hole closure exists even with the newer
improved laser DCR techniques.
[0003] In procedures for improving drainage using nasolacrimal
tubes or stents, the tubes are inserted from the conjunctiva or the
lacrimal sac into the nasal cavity. Common problems with these
devices include disinsertion, protrusion and dislocation of and
intolerance to the tubes.
[0004] Accordingly, one object of the present invention is to
provide an insert usable in a procedure for providing lacrimal
tract drainage that is stable, temporary, and that preserves the
draining function of the nasolacrimal duct after surgery. Another
object of the invention is to provide a device that keeps the
rhinostomy hole open during the healing process after surgery. A
further object of the invention is to provide an insert that is
easily inserted and is easily accessible and removable after its
task has been accomplished. Another object of the invention is to
provide an insert that stabilizes and substantially prevents
dislocation of a silastic tube installed in the lacrimal tract.
SUMMARY OF THE INVENTION
[0005] In accordance with the present invention, a transnasal
lacrimal insert is provided for use in a surgical procedure for
improving drainage from a patient's lacrimal sac to his or her
nasal cavity. The insert includes a tubular member having a
proximal end and an enlarged distal end. The insert also includes a
rod about which ends of a silastic tube can be fastened.
[0006] In the procedure, a hole is created extending from the
lacrimal sac into the nasal cavity using surgical techniques or a
laser probe. Then, opposite ends of a silastic tube are introduced
through the patient's upper and lower puncta, through the patient's
upper and lower canaliculi, through the lacrimal sac, through the
hole, and through the nasal cavity. The ends of the silastic tube
are then threaded through the passage in the insert. The insert is
then inserted through the nasal cavity into the hole by forcing the
proximal end of the insert through the hole and into the lacrimal
sac, and abutting the enlarged distal end, which is larger than the
hole, against a surface in the nasal cavity surrounding the hole.
The ends of the silastic tube are then fastened to the rod in the
insert. Excess tube extending from the nasal cavity is then cut
short. After the hole has sufficiently healed in about 3-6 months,
the silastic tube and the insert are removed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a front, part-sectioned view of the human lacrimal
tract.
[0008] FIG. 2 is a front, part-sectioned view of the lacrimal tract
illustrating use of a silastic tube in accordance with a prior art
laser DCR procedure.
[0009] FIG. 3 is a perspective view of a transnasal lacrimal insert
in accordance with the invention.
[0010] FIG. 4 is a side section view of the FIG. 3 insert.
[0011] FIG. 5 is a front, part-sectioned view of the lacrimal tract
illustrating use of the insert in accordance with the
invention.
DETAILED DESCRIPTION
[0012] FIG. 1 illustrates the anatomy of the human lacrimal tract.
Secretory or lacrimal glands 10 above the eye 12 produce tears,
which cover the anterior surface of the eye 12. A lacrimal
excretory system or tear drainage system is provided for draining
tears into the nasal cavity 14. The lacrimal excretory system
includes upper and lower puncta (or openings) 16 at the upper and
lower eyelids, respectively, and upper and lower canaliculi 18
leading from the corresponding puncta 16 into a lacrimal sac 20. A
nasolacrimal duct 22 connects the lacrimal sac 20 to the nasal
cavity 14.
[0013] Obstruction or closure of the drainage system at the
nasolacrimal duct 22 can cause constant tearing, recurrent
infection of the lacrimal sac (Dacryocystitis), and spread of
infection to the adjacent tissues (Orbital cellulitis) and to the
brain (Brain abscess).
[0014] Common causes of nasolacrimal duct obstruction include
congenital occlusion in children, idiopathy, trauma, chronic
infections, tumors, oreign bodies, and heredity.
[0015] There are several known methods of treating nasolacrimal
obstruction. For instance, nasolacrimal obstruction in children can
be treated by probing the nasolactrimal duct. However, this
procedure is only feasible for use in children.
[0016] In another procedure known as
Conjunctivodacryocystorhinostomy, the lacrimal excretory system is
completely bypassed. In this procedure, a passage from the eye to
the nose is opened by surgery and a tube (typically a Jones tube or
a Cooper tube) is installed in the passage to completely bypass the
lacrimal excretory system.
[0017] In DCR procedures, a passage from the lacrimal sac to the
nose is opened by surgery with or without installing a tube.
[0018] A number of problems are associated with these known
procedures. First, they are generally major surgical procedures
that are difficult and time consuming. Also, most of the procedures
require general anesthesia. In addition, most of the procedures
require facial incision and are typically very bloody. Patients are
also likely to feel substantial pain and discomfort in the
postoperative period.
[0019] The tubes used in procedures involving tube installation are
permanent and large. They can become clogged after installation by
mucus or secretions. In addition, in many cases, bacterial
colonization at the tubes will produce odor. Also, dislocation and
protrusion of tubes is not uncommon.
[0020] The newer laser DCR procedure is a significant improvement
over the other known procedures. In the laser DCR procedure, a
passage from the lacrimal sac to the nose is opened by a laser
probe followed by silastic intubation as shown in FIG. 2.
[0021] Unlike the other procedures, laser DCR is a minor surgical
procedure and is performed under local anesthesia. It is also
relatively easy to perform, and it takes only about 10-15 minutes.
No facial incision is involved, and there is substantially no blood
loss. Also, there is minimal post-operative pain. Furthermore, no
permanent tubes are used in the procedure.
[0022] In the laser DCR procedure, the lacrimal sac 20 is first
inflated with Healon, a clear viscous liquid. A fiber optic laser
probe (not shown) is then passed into the puncta 16, through a
canaliculus 18 and into the sac 20. The tip of an endoscope (not
shown) is placed in the nasal cavity 14 to confirm proper
positioning of the probe. Laser energy is then applied by the probe
to form a rhinostomy hole 24 having a diameter of about 5-7 mm
extending from the lacrimal sac 20 into the nasal cavity 14.
Thereafter, the laser probe and endoscope are removed. Next, a
silastic tube 26 is installed. Metal tips (not shown) at opposite
ends of the silastic tube 26 are passed from upper and lower puncta
16 into their respective canaliculi 18, into the sac 20 and then
through the laser induced hole 24 into the nasal cavity 14. The
ends of the silastic tube 26 are then tied in a knot inside the
nasal cavity, and excess tube including the metal tips are cut
short as shown in FIG. 2. The silastic tube 26 is removed after 3-6
months with the expectation that the laser induced hole 24 will
remain open during the healing process.
[0023] There are, however, a number of problems associated with
this procedure. First, the laser induced hole 24 tends to close due
to its small diameter. Also, the silastic knot can be easily
displaced from nasal cavity 14 into the lacrimal sac 20 by, for
example, nose blowing and sneezing. Dislocation of the silastic
tube 26 often results in a spontaneous closing of the hole 24. In
addition, the silastic knot may cause nasal irritation due to its
significant extension into the nasal cavity 14.
[0024] In accordance with the present invention, a transnasal
lacrimal insert 100 is provided for use in a procedure for
providing lacrimal tract drainage. As shown in FIGS. 3 and 4, the
insert 100 comprises a generally L-shaped tubular member 102 with a
circular base 104 flanged at one end 106 (which will be referred to
as the enlarged distal or nasal end 106) of the tubular member 102.
The base 104 includes an opening 108 leading to the passage 110
extending through the tubular member 102. A rod 112 extends across
the opening 108 dividing the opening 108 into two semi-circular
openings 108A and 108B. The rod forms an attachment element about
which ends of a silastic tube can be fastened as will be described
in further detail below. The opposite end 114 of the tubular member
102, which will be referred to as the lacrimal or proximal end, is
tapered forming a generally sharp edge to facilitate penetration of
the insert 100 into a rhinostomy hole as will be further described
below.
[0025] The insert 100 comprises a biocompatible material suitable
for use in contact with tissue. It is preferably a soft, flexible
material such as, for example, silicone and silastic materials.
[0026] The tubular member 102 has a wall thickness of about 0.5 mm
to 1 mm. The base 104 has a thickness of about 0.5 mm to 1 mm and
an outer diameter of about 10 mm.
[0027] A variety of inserts having different tubular member lengths
(indicated by the dimension "L" in FIG. 4) can be provided
depending on the patient on which it is to be used. For example,
inserts having tubular member lengths of 8 mm, 10 mm, 12 mm and 14
mm can be provided.
[0028] The initial steps of the procedure using the insert 100 in
accordance with the invention are similar to those of the laser DCR
procedure previously discussed. The lacrimal sac is first inflated
with Healon. A fiber optic laser probe (not shown) is then passed
into a puncta 16, through a canaliculus 18 and into the lacrimal
sac 20. The tip of an endoscope (not shown) is placed in the nasal
cavity 14 to confirm proper positioning of the probe. Laser energy
is then applied by the probe to open a hole 116 from the lacrimal
sac 20 into the nasal cavity 14. The probe is moved about and back
and forth during this step to enlarge the hole to a diameter of
about 5-7 mm. Thereafter, the laser probe and endoscope are
removed.
[0029] Next, a silastic tube 120 is installed. Metal tips at
opposite ends of the silastic tube are passed from upper and lower
puncta 16, through the respective upper and lower canaliculi 18
into the sac 20, then through the laser induced hole 116, and
through the nasal cavity 14 to outside the patient's nose.
[0030] The metal ends of the silastic tube 120 are then threaded
through the passage 110 in the insert 100. The silastic tube ends
are each introduced through the proximal end 114 of the insert 100
and out of a different one of the openings 108A and 108B in the
base 104. The insert 100 is then introduced from the nasal cavity
14 into the laser induced hole 116 by forcing the tapered proximal
end 114 of the insert 100 through the hole 116 and into the
lacrimal sac 20. The base 104 will abut the surface of the nasal
cavity 14 surrounding the hole 116 since the base 104 will have a
larger diameter than the hole 116. The insert 100 will accordingly
be kept from being displaced into the lacrimal sac 20. The ends of
the silastic tube 120 are then tied about the rod 112 at the base
104. Excess tube extending into the nasal cavity including the
metal tips is then cut short as shown in FIG. 5.
[0031] The silastic tube 120 keeps the insert 100 from falling out
of the hole 116 into the nasal cavity 14. At the same time, the
insert 100 keeps the silastic tube from being displaced into the
lacrimal sac.
[0032] The silastic tube 120 and the insert 100 are removed after
about 3-6 months after the hole 116 has healed sufficiently.
[0033] This procedure has a number of significant advantages over
the conventional laser DCR and other procedures previously
described. First, the insert 100 substantially prevents hole
closure by mechanical resistance. Migration of epithelium occurs
around the insert 100 to reduce the likelihood of closure.
[0034] The insert 100 is also temporary, and it therefore does not
have the problems associated with permanent tubes.
[0035] The presence of the insert 100 enables a significantly
shorter silastic tube extension into the nasal cavity, thereby
reducing nasal irritation. 15
[0036] By tying the knot of the silastic tube to the rod of the
insert 100, the knot is kept from dislocating into the lacrimal
sac.
[0037] In addition, protrusion and loop formation of the silastic
tube is prevented at the medial canthus.
[0038] Also, the insert 100 permits drainage to be preserved
immediately after surgery.
[0039] Furthermore, the insert 100 is easily inserted from the
nasal cavity, and it is easily accessible and removable after its
task has been completed.
[0040] Thus, the insert 100 and procedure for improving drainage in
accordance with the invention offer significant advantages over
conventional devices and procedures.
[0041] While the present invention is described with reference to
specific embodiments, it will be apparent to persons skilled in the
art that many modifications and variations are possible.
Accordingly, the present invention embraces all alternatives,
modifications and variations that fall within the spirit and scope
of the appended claims and all equivalents thereof.
* * * * *