U.S. patent application number 15/976458 was filed with the patent office on 2018-09-13 for system for facilitating intranasal guidance.
The applicant listed for this patent is JET MEDICAL, INC.. Invention is credited to Daryl J. Clark, Frank Debartola, Donald Geer, Christopher Linden, Kevin E. Sanford, Timothy M. Schweikert.
Application Number | 20180256849 15/976458 |
Document ID | / |
Family ID | 52144866 |
Filed Date | 2018-09-13 |
United States Patent
Application |
20180256849 |
Kind Code |
A1 |
Linden; Christopher ; et
al. |
September 13, 2018 |
SYSTEM FOR FACILITATING INTRANASAL GUIDANCE
Abstract
A sphenocath including a sheath assembly including a sheath hub
with a sheath tube extending therefrom with a passage extending
from a proximal end of the sheath hub to a distal end of the sheath
tube; a catheter assembly including a catheter hub with a catheter
tube extending therefrom with a passage extending from a proximal
end of the catheter hub to a distal end of the catheter tube;
wherein the catheter assembly passes through the sheath assembly
with a portion of the catheter hub engaging a portion of the sheath
hub to limit relative rotation between the hubs while permitting
relative axial movement such that in an initial non-extended
position the distal end of the catheter tube is proximate to the
distal end of the sheath tube. A system further including a
guidewire is also provided.
Inventors: |
Linden; Christopher; (Vista,
CA) ; Debartola; Frank; (Roswell, GA) ; Geer;
Donald; (New Port Richey, FL) ; Sanford; Kevin
E.; (Chalfont, PA) ; Clark; Daryl J.; (Drexel
Hill, PA) ; Schweikert; Timothy M.; (West Chester,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
JET MEDICAL, INC. |
Schwenksville |
PA |
US |
|
|
Family ID: |
52144866 |
Appl. No.: |
15/976458 |
Filed: |
May 10, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15803273 |
Nov 3, 2017 |
9999747 |
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15976458 |
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14548860 |
Nov 20, 2014 |
9839770 |
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15803273 |
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61907328 |
Nov 21, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2210/0681 20130101;
A61M 2025/0062 20130101; A61M 25/0108 20130101; A61M 25/0041
20130101; A61M 2025/0681 20130101; A61M 25/0045 20130101; A61B
17/24 20130101; A61M 25/0097 20130101; A61M 25/09 20130101; A61M
25/01 20130101; A61M 2025/0046 20130101; A61M 5/46 20130101; A61M
25/0662 20130101; A61M 5/007 20130101; A61M 2025/0073 20130101;
A61M 2210/0618 20130101; A61M 2025/0008 20130101; A61M 11/00
20130101; A61M 25/0068 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/06 20060101 A61M025/06; A61M 5/00 20060101
A61M005/00; A61M 5/46 20060101 A61M005/46; A61M 11/00 20060101
A61M011/00; A61M 25/09 20060101 A61M025/09; A61B 17/24 20060101
A61B017/24; A61M 25/01 20060101 A61M025/01 |
Claims
1. A sphenocath comprising: a sheath assembly including a sheath
hub with a sheath tube extending therefrom with a passage extending
from a proximal end of the sheath hub to a distal end of the sheath
tube; a catheter assembly including a catheter hub with a catheter
tube extending therefrom with a passage extending from a proximal
end of the catheter hub to a distal end of the catheter tube;
wherein the catheter assembly passes through the sheath assembly
with a portion of the catheter hub engaging a portion of the sheath
hub to limit relative rotation between the hubs while permitting
relative axial movement such that in an initial non-extended
position the distal end of the catheter tube is proximate to the
distal end of the sheath tube.
2. The sphenocath of claim 1, wherein the distal end of the
catheter tube is formed with a preformed curvature.
3. The sphenocath of claim 2, wherein the curvature is such that an
axis of the distal end of the catheter tube is at an angle relative
to the axis of the proximal end of the catheter tube and the angle
is between about 30.degree. to 90.degree.
4. The sphenocath of claim 3, wherein the angle is between about
35.degree. to 55.degree.
5. The sphenocath of claim 2, wherein the sheath hub includes a
marker indicating the direction of the preformed curvature.
6. The sphenocath of claim 1, wherein the catheter hub is rotatable
relative to the sheath hub over a limited range.
7. The sphenocath of claim 6, wherein the limited range extends
approximately 10.degree. in each rotational direction.
8. The sphenocath of claim 1, wherein the catheter tube distal end
is formed with a spraying tip.
9. The sphenocath of claim 8, wherein the spraying tip includes a
substantially closed end except for a slotted passage.
10. The sphenocath of claim 8, wherein the spraying tip includes a
substantially closed end except for a plurality of small
openings.
11. The sphenocath of claim 1, wherein the sheath tube has a
lubricious outer surface.
12. The sphenocath of claim 1, wherein the sheath tube includes a
radiopaque mark proximate the distal end of the sheath tube.
13. A system for positioning a catheter within a nasal cavity
comprising: a guidewire; and the sphenocath of claim 1 wherein the
guidewire is configured to pass through the catheter assembly
passage such that the sphenocath may be guided over the
guidewire.
14. A method for visualization and/or administration of medication
of and into the sphenopalatine/pterygopalatine recess of a patient,
the method comprising: inserting a guidewire into the nostril of a
patient to a target area proximate the
sphenopalatine/pterygopalatine recess of the patient; advancing a
sphenocath according to claim 1 over the guidewire such that the
distal end of the catheter tube is proximal to the target area;
advancing the catheter assembly relative to the sheath assembly
whereby the catheter tube distal end extends from the sheath tube
distal end and bends along the guidewire; advancing the catheter
into the patient's sphenopalatine/pterygopalatine recess; removing
the guidewire; and dispensing contrast media, fluids, and/or
medication to the patient's sphenopalatine/pterygopalatine ganglion
disposed within the sphenopalatine recess of the patient.
15. The method of claim 14, wherein the distal end of the catheter
tube is formed with a preformed curvature and the method further
comprises identifying a direction of the preformed curvature and
aligning the preformed curvature of the catheter tube distal end
with the patient's sphenopalatine/pterygopalatine recess.
16. The method of claim 14, wherein contrast media, fluids, or
medication is delivered over a middle sinus turbinate of the
patient to achieve sphenopalatine ganglion blockade.
17. The method of claim 16, wherein sympathetic nerves of the
patient are impacted by accessing the sphenopalatine recess at the
back of the sinus cavity extending from the top of the middle sinus
turbinate.
18. The method of claim 16, wherein the sphenopalatine ganglion
blockade is not achieved by saturation of different areas within
the sinus cavity or the throat of the patient.
19. The method of claim 14, wherein transnasal sphenopalatine
visualization is achieved by delivery of contrast media over a
middle sinus turbinate of the patient.
20. The method of claim 14, wherein the sheath tube distal end
includes a radiopaque mark and the step of advancing the sphenocath
over the guidewire includes the use of x-ray or fluoroscopy.
21. The method of claim 14, wherein the sheath tube includes a
series of distance markings and the step of advancing the
sphenocath over the guidewire includes advancement based on, at
least in part, the distance markings.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/803,273, filed on Nov. 3, 2017; which is a
continuation of U.S. patent application Ser. No. 14/548,860, filed
on Nov. 20, 2014, now U.S. Pat. No. 9,839,770; which claims the
benefit of U.S. Provisional patent application Ser. No. 61/907,328,
filed on Nov. 21, 2013; the entireties of which are incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to an apparatus and method for
facilitating intranasal guidance. More particularly, the invention
relates an apparatus and method for positioning the tip of a
catheter adjacent to a patient's sphenopalatine/pterygopalatine
recess.
BACKGROUND OF THE INVENTION
[0003] U.S. Pat. No. 8,388,600, incorporated herein by reference,
describes a device and method of positioning a catheter tip within
a patient's nasal cavity in order to deliver an anesthetic to
create a nerve block. As explained in U.S. Pat. No. 8,388,600, FIG.
1 depicts a cutaway view of the anatomical features of a typical
human nasal cavity. One skilled in the art will recognize that
certain anatomical features and structures of the human nasal
cavity have been omitted to avoid obscuring the structures relevant
to the practice of the current invention. To help orient the
reader, the mouth 106 is illustrated with teeth 108 and tongue 110.
The anatomical structures relevant to the practice of the current
invention include the palate 100 which separates the oral cavity
102 from the nasal cavity 104, the inferior sinus turbinate 112,
the middle sinus turbinate 114 and the superior sinus turbinate 116
as well as the nasal bone 122. The middle sinus turbinate 114 and
superior sinus turbinate 116 define the
sphenopalatine/pterygopalatine recess 118. Deep within the
sphenopalatine/pterygopalatine recess 118 at the posterior 124 of
the sphenopalatine/pterygopalatine recess 118 lies the
sphenopalatine/pterygopalatine ganglia 120.
[0004] One skilled in the art will recognize that the medical
community is not uniform in the terminology with regard to the
sphenopalatine or pterygopalatine ganglia. Certain practitioners
use sphenopalatine while others use pterygopalatine. Therefore, the
present description will refer to the ganglia labeled 120 as the
sphenopalatine/pterygopalatine ganglia 120. Similarly, the recess
labeled 118 will be referred to as the
sphenopalatine/pterygopalatine recess 118. However, this
terminology is in no way limiting on the structure for which the
present invention is intended. Where practitioners or scientist
differentiate between the sphenopalatine ganglia or the
pterygopalatine ganglia, the present disclosure will be understood
to apply to either structure.
[0005] As is evident from FIG. 1, the structure of the nasal cavity
makes it difficult to deliver a catheter tip to the
sphenopalatine/pterygopalatine recess 118. While U.S. Pat. No.
8,388,600 describes a device and method of positioning a catheter
tip, such may not be sufficiently accurate and/or may be
complicated in use.
SUMMARY OF THE INVENTION
[0006] In at least one aspect, the present invention provides an
apparatus, system, and method for facilitating intranasal
fluoroscopic guidance, visualization, administration of radiopaque
substances, fluids, and medication to a patients nasal sinus
including the sphenopalatine/pterygopalatine recess. The apparatus
includes a wire in which the internal catheter tracks over the wire
into the desired location, and a catheter having a lumen disposed
therethrough, the catheter comprising an intrinsic curvature, soft
straight proximal end, or a shape memory curvature with respect to
a longitudinal axis of the catheter such that the insertion end of
the catheter lies in a first plane and the manipulation end of the
catheter lies in a second plane, wherein the catheter smoothly
transitions between the wire, the first plane and the second plane,
the intrinsic curvature conforming to the wire and the patients
nasal anatomy such that the catheter may be inserted into a
sphenopalatine/pterygopalatine recess. The external catheter
assists the delivery of the catheter by adding stability and
pushability to the overall system allowing the internal catheter to
be softer and more comfortable to the patient.
[0007] In another aspect, the invention provides a sphenocath
including a sheath assembly including a sheath hub with a sheath
tube extending therefrom with a passage extending from a proximal
end of the sheath hub to a distal end of the sheath tube; a
catheter assembly including a catheter hub with a catheter tube
extending therefrom with a passage extending from a proximal end of
the catheter hub to a distal end of the catheter tube; wherein the
catheter assembly passes through the sheath assembly with a portion
of the catheter hub engaging a portion of the sheath hub to limit
relative rotation between the hubs while permitting relative axial
movement such that in an initial non-extended position the distal
end of the catheter tube is proximate to the distal end of the
sheath tube. A system further including a guidewire is also
provided.
[0008] In yet another aspect, the invention provides a system
including a sphenocath configured to be positioned over and guide
into position by a guidewire.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The accompanying drawings, which are incorporated herein and
constitute part of this specification, illustrate the presently
preferred embodiments of the invention, and, together with the
general description given above and the detailed description given
below, serve to explain the features of the invention. In the
drawings:
[0010] FIG. 1 is a schematic cutaway view of an exemplary facial
anatomy of a patient.
[0011] FIG. 2 is a perspective view of a sphenocath in accordance
with an exemplary embodiment of the invention in an initial,
non-extended position.
[0012] FIG. 3 is a top plan view of the sphenocath of FIG. 2.
[0013] FIG. 4 is an isometric view of an exemplary catheter
assembly of the sphenocath of FIG. 2.
[0014] FIG. 5 is a cross-sectional view along the line 5-5 in FIG.
4.
[0015] FIG. 6 is an elevation view along the line 6-6 in FIG.
4.
[0016] FIG. 7 is a top plan view of a portion of an exemplary
sheath assembly of the sphenocath of FIG. 2.
[0017] FIG. 8 is an elevation view along the line 8-8 in FIG.
7.
[0018] FIG. 9 is a cross-sectional view along the line 9-9 in FIG.
7.
[0019] FIG. 10 is a perspective view similar to FIG. 2 illustrating
the sphenocath in an extended position.
[0020] FIG. 11 is a cross-sectional view along the line 11-11 in
FIG. 10.
[0021] FIG. 12 is an elevation view along the line 12-12 in FIG.
10.
[0022] FIG. 13 illustrates the positioning of an exemplary
guidewire within the nasal cavity of a patient.
[0023] FIG. 14 illustrates the positioning of the sphenocath of
FIG. 2 in the initial position as it is positioned along the
guidewire.
[0024] FIG. 15 illustrates extension of the catheter from the
sheath with the patient's nasal cavity.
[0025] FIG. 16 is a side elevation view of an exemplary catheter
distal end.
[0026] FIG. 17 is an end elevation view of the catheter distal end
of FIG. 16.
[0027] FIG. 18 is a side elevation view of another exemplary
catheter distal end.
[0028] FIG. 19 is an end elevation view of the catheter distal end
of FIG. 18.
[0029] FIG. 20 is a side elevation view of another exemplary
catheter distal end.
[0030] FIG. 21 is an end elevation view of the catheter distal end
of FIG. 20.
DETAILED DESCRIPTION OF THE INVENTION
[0031] In the drawings, like numerals indicate like elements
throughout. Certain terminology is used herein for convenience only
and is not to be taken as a limitation on the present invention.
The following describes preferred embodiments of the present
invention. However, it should be understood, based on this
disclosure, that the invention is not limited by the preferred
embodiments described herein.
[0032] Referring to FIGS. 2-12, a sphenocath 300 in accordance with
an exemplary embodiment of the invention will be described. The
sphenocath 300 generally comprises a catheter assembly 310 and a
sheath assembly 340. As explained in more detail below, the
catheter assembly 310 is configured to be positioned within the
sheath assembly 340 and to be moved between an initial,
non-extended position as illustrated in FIG. 2 and an extended
position as illustrated in FIG. 10.
[0033] Referring to FIGS. 4-6, the exemplary catheter assembly 310
generally includes a catheter tube 330 extending from a catheter
hub 312. The catheter hub 312 has a generally cylindrical body 314
extending between a proximal end 311 and a distal end 313. A
through passage 316 extends through the body 314 from the proximal
end 311 to the distal end 313. The proximal end of the passage 316
may have a larger opening 315 which then tapers at 317 to the
diameter of the lumen 332 of the catheter tube 330. The proximal
end 311 of the catheter hub 312 preferably includes a thread 308 or
the like for connection of the catheter assembly 310 to a syringe
or the like (not shown). The distal end 313 of the catheter hub 312
includes a radial projection 322 configured to guide motion
relative to the sheath hub 342 as described hereinafter. The radial
projection 322 includes a proximal shoulder 321 and a distal
tapered surface 323 which facilitates passage of the catheter hub
312 into the sheath hub 342. The projection 322 has a width w as
illustrated in FIG. 6.
[0034] Between the ends 311, 313, the catheter hub 312 includes one
or more annular rings 318 which define a gripping structure of the
catheter hub 312. A distal most ring 318 defines a stop 319 which
limits the amount of distal movement of the catheter hub 312
relative to the sheath hub 342. The catheter hub 312 is preferably
manufactured from a generally rigid material, for example, a
polymer such as Isoplast.RTM. 2510.
[0035] The catheter tube 330 extends from a proximal end 331
secured within the hub passage 316 to a free distal end 333. The
catheter tube 330 is manufactured from a flexible material, for
example, a polyurethane elastomer such as Pellethane.RTM.. The
catheter tube 330 defines a hollow lumen 332 extending from the
proximal end 331 to the distal end 333 such that a continuous
passage is defined by the catheter hub passage 316 and the lumen
332. Referring to FIGS. 10-12, the distal end 333 of the catheter
tube 330 may be formed with a preformed curvature 335. The
curvature 335 is such that an axis DA of the distal end 333 is at
an angle relative to the axis PA of the proximal end 331. The angle
is preferably between 30.degree. to 90.degree. and more preferably
is between 35.degree. to 55.degree. The angle is preferably chosen
to correspond to the anatomy of the patient's nasal cavity.
[0036] Referring to FIGS. 7-9, the exemplary sheath assembly 340
will be described. The sheath assembly 340 generally includes a
sheath tube 360 extending from a sheath hub 342. The sheath hub 342
has a generally tubular body 344 extending between a proximal end
341 and a distal end 343. A through passage 345 extends through the
body 344 from the proximal end 341 to the distal end 343. The
proximal end of the passage 345 may have a larger opening 349 while
the distal end 343 has a smaller passage 347 which approximates the
diameter of the lumen 362 of the sheath tube 360. The proximal end
341 of the catheter hub 342 preferably includes an annular shoulder
354 about the opening 349 which defines an internal shoulder
356.
[0037] A guide slot 346 extends along the top surface of the sheath
hub body 344 from the shoulder 356 to the distal end 343. As
illustrated in FIG. 8, the guide slot 346 has a width W which is
slightly larger than the width w of the catheter hub projection
322. As illustrated in FIGS. 11 and 12, the distal end of the
catheter hub 312 is received in the passage 345 such that the
projection 322 moves within the guide slot 346. Referring to FIG.
14, contact of the projection proximal shoulder 321 with the
internal shoulder 356 limits proximal movement of the catheter hub
312 relative to the sheath hub 342.
[0038] Positioning of the projection 322 in the guide slot 346 also
controls the relative rotational movement between the hubs 312 and
342. As illustrated in FIG. 12, the larger width W of the guide
slot 346 compared to the width w of the projection 322 allows for
slight rotation of the catheter tube distal end 333 over a limited
range, for example, approximately 10.degree. in each direction. In
this way, the orientation of the preformed curvature 335 of the
catheter tube distal end 333 cannot be modified relative to the
sheath hub 342 beyond the controlled range.
[0039] Referring again to FIGS. 7-9, an indicator member 350 with
an arrow head 352 covers a portion of the guide slot 346,
preferably at least over the range of axial movement of the
projection 322 within the slot 346. The indicator member 350
provides an indication of the orientation of the device 300 and
more specifically the orientation of the preformed curvature 335.
Since, as explained above, the engagement of the projection 322 in
the guide slot 346 limits relative rotation between the hubs 312,
342, the preformed curvature 335 will always be away from the
indicator member 350. As illustrated in FIGS. 2 and 9, the
indicator member 350 may be formed with a curvature that mimics the
preformed curvature 335, i.e. away from a user looking from above
and proximally of the sheath hub 342.
[0040] The sheath tube 360 extends from a proximal end 361 secured
to the sheath hub 342 to a free distal end 363. The sheath tube 360
defines a hollow lumen 362 extending from the proximal end 361 to
the distal end 363 such that a continuous passage is defined by the
sheath hub passage 345 and the lumen 362. The distal end 363 of the
sheath tube 360 preferably has a tapered portion 364 which provides
a tapered contact surface during advancement of the sheath tube 360
and also conforms the sheath tube diameter to that of the catheter
tube 330 outer diameter. The outer surface of the sheath tube 360,
preferably on the top surface, has a plurality of markers 366 which
are spaced a given distance from one another. The markers 366 can
be used to illustrate a depth of insertion of the device, for
example, the defined depth being a depth equaling a distance
between an entrance to a patient's sphenopalatine recess and an
external entrance to the patient's nostril or a depth relative to a
guidewire 370 over which the sphenocath 300 is guided as will be
described hereinafter. The sheath tube 360 may also include a
radiopaque mark 665 adjacent to the distal end 363 to assist with
placement of the sphenocath 300 utilizing x-ray or fluoroscopy.
[0041] The sheath tube 360 is manufactured from a semi-flexible
material that is more rigid than the catheter tube 330, but may
still have some flexibility. In this way, the sheath tube 360
maintains the preformed curvature 335 straight while within the
sheath tube 360. The sheath tube 360 may also be manufactured from,
for example, a polyurethane elastomer such as Pellethane.RTM.,
however, it will be a composition that provides the greater
rigidity. The sheath tube 360 may be formed with a lubricant
blended with the material thereof or may be coated with a lubricant
such that the sheath tube 360 has an external lubricious surface
that minimizes the need for additional lubricants that may irritate
the tracked area.
[0042] Referring to FIG. 13, the system further includes a
guidewire 370 over which the sphenocath 300 is guided. The
guidewire 370 extends from a proximal end 374 to a distal end 372.
The distal end 372 may be formed with a preformed curvature 376
which approximates the preformed curvature 335 of the catheter tube
330, however, it is understood that the curvatures may be
different.
[0043] Having described the components of an exemplary system, an
exemplary method of insertion of the catheter tube 330 into a
patient's nasal cavity will be described with reference to FIGS.
13-15. First, the distal end 372 of the guidewire 370 is inserted
into the nostril 202 as illustrated in FIG. 13. Such insertion may
be done, for example, using fluoroscopic guidance or by physician
feel into the sphenopalatine/pterygopalatine recess or targeted
location to access.
[0044] Referring to FIG. 14, the proximal end 374 of the guidewire
370 is received into the catheter tube distal end 333 and the
sphenocath 300 is advanced over the guidewire 370 as indicated by
arrow A. It is noted that at this stage, the catheter hub 312 is in
the initial, non-extended position and the distal end 333 of the
catheter tube 330 is proximate to the distal end 363 of the sheath
tube 360. The sphenocath 300 is advanced over the guidewire 370 to
the desired position and location, for example, with the distal end
363 of the sheath tube 360 proximate the anterior ridge 204 of the
middle sinus turbinate 114. As explained above, the markings 366
may be utilized to help with the depth of insertion and the
radiopaque mark 665 may further assist with placement.
[0045] Referring to FIG. 15, the catheter hub 312 is then advanced
distally relative to the sheath hub 342 as indicated by arrow B. As
such, the distal end 333 of the catheter tube 330 is extended out
of the distal end 363 of the sheath tube 360. The catheter tube
distal end 333 follows the path defined by the guidewire distal end
372 as indicated by arrow C. The catheter distal end 333 is
advanced into the patient's sphenopalatine/pterygopalatine recess
118 of the patient or another desired position.
[0046] Once the catheter distal end 333 is positioned, the
guidewire 370 is removed and the catheter assembly 310 is ready for
the desired application, with a passage defined from the hub
passage 316 and through the lumen 332. For example, a syringe or
the like (not shown) may be connected to the thread 308 and a
fluid, for example, contrast media, or medication, may be dispensed
to the patient's sphenopalatine/pterygopalatine ganglion 120
disposed within the sphenopalatine/pterygopalatine recess 118.
[0047] Referring to FIGS. 16 and 17, the configuration of an
exemplary catheter 310 distal end 333' will be described. The
distal end 333' has a substantially closed end 336 except for a
slotted passage 337 extending across the closed end 336. The
slotted passage 337 will cause fluid expelled from the catheter 310
to fan out and provide a spraying or "painting" of the entire
target area. FIGS. 18 and 19 illustrate another spraying tip
wherein the catheter distal end 333'' has a similar slotted passage
337, however, the closed end 336'' tapers to the passage 337,
rather than the rounded end in the previous embodiment. In both
embodiments, the slotted passage 337 preferably extends
horizontally relative to the angle of the catheter distal end 333.
FIGS. 20 and 21 illustrate another spraying tip wherein the
catheter distal end 333''' has a substantially closed end 336
except for a series of small openings 338. The openings 338 will
again cause fluid expelled from the catheter 310 to fan out provide
a spraying or "painting" of the entire target area. While five
openings 338 are illustrated, more or fewer openings may be
provided and may be arranged in configurations other than the
illustrated configuration.
[0048] These and other advantages of the present invention will be
apparent to those skilled in the art from the foregoing
specification. Accordingly, it will be recognized by those skilled
in the art that changes or modifications may be made to the
above-described embodiments without departing from the broad
inventive concepts of the invention. It should therefore be
understood that this invention is not limited to the particular
embodiments described herein, but is intended to include all
changes and modifications that are within the scope and spirit of
the invention as defined in the claims.
* * * * *