U.S. patent application number 11/457339 was filed with the patent office on 2006-11-02 for ureteral access sheath.
Invention is credited to Ralph V. Clayman, Gary R. Dulak.
Application Number | 20060247602 11/457339 |
Document ID | / |
Family ID | 37235428 |
Filed Date | 2006-11-02 |
United States Patent
Application |
20060247602 |
Kind Code |
A1 |
Dulak; Gary R. ; et
al. |
November 2, 2006 |
URETERAL ACCESS SHEATH
Abstract
A ureteral access sheath adapted for insertion into a urethra
includes an elongate tube extending between a proximal end and a
distal end. A handle assembly is disposed at the proximal end and
includes enlarged portions which inhibit migration of the sheath
into the urethra. The enlarged portions are shaped like the bell of
a horn with a concave, distally-facing outer surface and a convex,
proximally-facing inner surface. The inner surface functions as a
funnel while the outer surface is sized and configured to receive
adjacent fingers of a user's hand held in its natural position. In
an associated method, this shape of the handle assembly facilitates
maintaining the sheath in a stationary position during insertion
and removal of instrumentation. The handle assembly can be movable
on the tube to facilitate variation of the sheath link in situ.
Inventors: |
Dulak; Gary R.; (Valencia,
CA) ; Clayman; Ralph V.; (Irvine, CA) |
Correspondence
Address: |
APPLIED MEDICAL RESOUCES CORPORATION
22872 Avenida Empresa
Rancho Santa Margarita
CA
92688
US
|
Family ID: |
37235428 |
Appl. No.: |
11/457339 |
Filed: |
July 13, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10198030 |
Jul 17, 2002 |
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11457339 |
Jul 13, 2006 |
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09303485 |
Apr 30, 1999 |
6471684 |
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11457339 |
Jul 13, 2006 |
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Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61M 25/0662 20130101;
A61M 25/0014 20130101; A61M 25/0017 20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
1. A ureteral access sheath adapted for insertion into a urethra
having a diameter D.sub.1, the access sheath being adapted for use
by a person having a pair of adjacent fingers, the access sheath
comprising: an elongate tube having a diameter D.sub.2 and a lumen
extending between a proximal end and distal end, the diameter
D.sub.2 being smaller than the diameter D.sub.1 of the urethra,
wherein the elongate tube includes a helical spring; a first handle
disposed at the proximal end of the tube; portions of the first
handle extending radially outwardly of the tube to provide the
first handle with a diameter D.sub.3 that is greater than the
diameter D.sub.1 of the urethra, the handle portions being defined
by a first surface facing generally distally and a second surface
facing generally proximally; and a second handle disposed distally
of the first handle, the second handle including a third surface
facing generally proximally wherein the first surface and the third
surface are concave, continuous and both sized and configured to
receive the adjacent fingers of the user, wherein the first surface
is continuous with the third surface so as to define an annular
recess, wherein the second surface is convex so as to form a funnel
leading into the lumen of the tube, whereby the handle portions
inhibit distal migration of the proximal end of the tube into the
urethra.
2. The access sheath recited in claim 1 wherein the second surface
extends decreasingly radially inwardly with progressive equal
distal positions along the tube.
3. The access sheath recited in claim 2 wherein the first surface
extends decreasingly radially inwardly with progressive equal
distal positions along the tube.
4. A ureteral access sheath, comprising: an elongate tube having a
lumen extending between a proximal end and a distal end; a handle
disposed at the proximal end of the tube having a flared
configuration, a first surface facing generally distally, and a
second surface facing generally proximally and configured to funnel
instrumentation into the lumen; and a coiled spring formed around
the elongate tube and having an outer body covering the coiled
spring.
5. The ureteral access sheath of claim 4, wherein the first surface
is concave.
6. The ureteral access sheath of claim 5, wherein the second
surface is convex.
7. The ureteral access sheath of claim 4, wherein the first surface
is convex.
8. The ureteral access sheath of claim 7, wherein the second
surface is concave.
9. The ureteral access sheath of claim 4, wherein the coiled spring
provides kink resistance to the tube.
10. The ureteral access sheath of claim 4, wherein the tube
provides a smooth surface to facilitate passage of the
instrument.
11. The ureteral access sheath of claim 4, wherein the outer body
provides covering for the coils of the spring.
12. The ureteral access sheath of claim 4, wherein the
instrumentation includes an obturator comprising an elongate rod
extending between a proximal end and a distal end.
13. The ureteral access sheath of claim 12, wherein the obturator
further includes a releasable mechanism disposed at the proximal
end of the elongate rod that is removably attachable to the
handle.
14. The ureteral access sheath of claim 13, wherein the attachment
of the obturator to the sheath precludes inadvertent advancement of
the sheath in front of the obturator.
15. A ureteral access sheath, comprising: an elongate tube having a
lumen extending between a proximal end and a distal end; a handle
disposed at the proximal end of the tube, the handle extending
radially outwardly of the tube forming a funnel with an opening
leading into the lumen of the tube; a coiled spring formed around
the elongate tube and having an outer body covering the coiled
spring.
16. The ureteral access sheath of claim 15, wherein the coiled
spring provides kink resistance to the tube.
17. The ureteral access sheath of claim 15, wherein the tube
provides a smooth surface to facilitate passage of an
instrument.
18. The ureteral access sheath of claim 15, wherein the outer body
provides covering for the coils of the spring.
19. The ureteral access sheath of claim 17, wherein the
instrumentation includes an obturator comprising an elongate rod
extending between a proximal end and a distal end.
20. The ureteral access sheath of claim 19, wherein the obturator
further includes a releasable mechanism disposed at the proximal
end of the elongate rod that is removably attachable to the
handle.
21. The ureteral access sheath of claim 20, wherein the attachment
of the obturator to the sheath precludes inadvertent advancement of
the sheath in front of the obturator.
22. A ureteral access sheath, comprising: an elongate tube having a
lumen extending between a proximal end and a distal end; a handle
disposed at the proximal end of the tube, the handle extending
radially outwardly of the tube forming a funnel with an opening
leading into the lumen of the tube; a coiled spring incorporated
into the elongate tube.
23. The ureteral access sheath of claim 22, wherein the coiled
spring provides kink resistance to the tube.
24. The ureteral access sheath of claim 22, wherein the tube
provides a smooth surface to facilitate passage of an
instrument.
25. The ureteral access sheath of claim 22, wherein the outer body
provides covering for the coils of the spring.
26. The ureteral access sheath of claim 24, wherein the
instrumentation includes an obturator comprising an elongate rod
extending between a proximal end and a distal end.
27. The ureteral access sheath of claim 26, wherein the obturator
further includes a releasable mechanism disposed at the proximal
end of the elongate rod that is removably attachable to the
handle.
28. The ureteral access sheath of claim 27, wherein the attachment
of the obturator to the sheath precludes inadvertent advancement of
the sheath in front of the obturator.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 10/198,030, filed Jul. 13, 2002, which is a
Continuation-in-Part of U.S. patent application Ser. No.
09/303,485, filed Apr. 30, 1999, now U.S. Pat. No. 6,471,684,
issued Oct. 29, 2002, the disclosures of which are hereby
incorporated by reference as if set in full herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to guideways for
endoluminal access and more specifically to surgical access devices
adapted to introduce surgical instrumentation into body
conduits.
[0004] 2. Discussion of the Prior Art
[0005] Surgical access devices of the prior art typically include a
sheath having an outside diameter and an inside diameter. An
obturator or dilator is inserted into the sheath to facilitate
introduction of the sheath into the body conduit. Once the sheath
is positioned, the obturator is removed leaving a working channel
for surgical instrumentation.
[0006] Particularly in the field of urology, the sheath has been
provided in the form of an elongate tube having an axis extending
between a proximal end and a distal end. The diameter of the tube
is generally constant, except for a reduced diameter segment at the
distal end. Although the obturator has had an enlarged structure at
its proximal end, there has been no such enlargement for the
sheath. This has presented a problem as the sheath has tended to
migrate distally and disappear beneath the urethral meatus.
Representative of this art is the FLEXIBLE URETEROSCOPE SHEATH
manufactured and sold by Cook Urological Incorporated.
[0007] Access devices particularly adapted for other body conduits
have had enlargements at the proximal end, but these have not been
specifically configured to prevent migration or facilitate the
introduction of instrumentation. Representative of this art are the
"banana peel" sheaths which split axially for removal after
catheter placement.
[0008] During the introduction and removal of dilators, obturators,
and instrumentation into and out of a sheath, it is always
desirable to facilitate maintenance of the sheath in a relatively
stationary orientation. In the past, there has been no handle
structure which was sized and shaped to accommodate engagement by a
user's hand disposed in its natural position with the palm facing
the user. Nor has there been any progressive funnel structure which
would facilitate the introduction of instrumentation into the
working channel of the sheath.
SUMMARY OF THE INVENTION
[0009] These deficiencies of the prior art have been eliminated
with the present access device which includes a sheath having at
its proximal end a handle specifically adapted to inhibit migration
and facilitate use with instrumentation. The handle is formed as a
radial enlargement having a distally-facing surface and a
proximally-facing surface The distally-facing surface has a
generally concave configuration which provides a gradual
enlargement inhibiting migration of the sheath into the ureter. The
concave configuration is sized to receive adjacent fingers of a
user's hand disposed in its natural position, in order to
facilitate the stationary orientation of the sheath. The concave,
distally-facing surface is continuous around the axis of the sheath
so that the advantage of this concave configuration can be
appreciated regardless of the radial orientation of the sheath.
[0010] The proximal-facing surface has a generally convex
configuration providing for an increased funneling of an instrument
as it is inserted into the working channel of the sheath. Both the
distally-facing surface and the proximally-facing surface extend
radially inwardly with progressively equal distal positions along
the sheath. This provides the handle with the general shape of the
bell of a horn. This configuration is not only ergonomically
comfortable, but highly practical in addressing the problems of
migration, as well as instrument insertion and removal.
[0011] The handle can be provided with characteristics permitting
the handle to be moved to a preferred position along the tube of
the sheath, and then to be fixed to the tube at that preferred
location. This makes it possible to provide the sheath with any
desired length, even after it has been inserted into the body
conduit. A metal structure such as a spring can be molded into the
tube of the sheath to facilitate kink resistance.
[0012] The inner dilator can be provided with a Luerlock end,
permitting attachment of a sidearm adaptor (not shown). This allows
for installation of contrast during sheath placement without the
need to remove the guidewire.
[0013] These and other features and advantages of the invention
will become more apparent with a description of preferred
embodiments and reference to the associated drawings.
DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view illustrating a sheath of the
present invention with an obturator or dilator adapted for use with
the sheath;
[0015] FIG. 2 is a perspective view illustrating the obturator
operatively disposed within the sheath;
[0016] FIG. 3 is an axial cross-section view taken along lines 3-3
of FIG. 2 and illustrating the obturator operatively disposed
within a tube and "handle" of the sheath;
[0017] FIG. 4 is an enlarged radial cross-section view of the
handle assembly illustrated in FIG. 3;
[0018] FIG. 5 is a side-elevation view of the sheath and obturator
operatively disposed in the urethra and illustrating a preferred
configuration for the handle assembly of the sheath;
[0019] FIG. 6 is a side-elevation view similar to FIG. 5 of a
further embodiment of the handle assembly of the present
invention;
[0020] FIG. 7 is a side-elevation view partially in phantom and
exploded to illustrate components of another preferred embodiment
of the handle assembly providing for sheath length adjustment;
[0021] FIG. 8 is a side-elevation view illustrating the components
of FIG. 7 in an assembled configuration;
[0022] FIG. 9 is a radial cross-section view taken along lines 9-9
of FIG. 8;
[0023] FIG. 10 is a perspective, disassembled view of a further
embodiment of a handle assembly permitting length adjustment;
[0024] FIG. 11 is a perspective, assembled view of the components
illustrated in FIG. 10; and
[0025] FIG. 12 is a side-elevation view partially in fragment and
illustrating a spring embodiment of the tube associated with the
sheath of the present invention
DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE
INVENTION
[0026] A ureteral access sheath is illustrated in FIG. 1 and
designated generally by the reference numeral 10. In FIG. 1, the
sheath 10 is illustrated in combination with a separate, but
associated, dilator or obturator 12. The sheath 10 has the general
configuration of an elongate tube 14 having an axis 16 which
extends between a proximal end 18 and a distal end 21. A handle 23
is disposed at the proximal end 18 of the tube 14 and provides
access into a working channel 25 of the tube 14.
[0027] The obturator 12 will typically have the configuration of an
elongate rod 30 extending between a proximal end 32 and a distal
end 34. A knob 36 is disposed at the proximal end 32 and a tapered
tip 38 is formed at the distal end 34. The obturator 12 is adapted
to be inserted into the working channel 25 of the sheath 10 with
the knob 36 extending proximally of the sheath 10, and the distal
end 34 extending distally of the sheath 10. This operative position
of the obturator 12 within the sheath 10 is illustrated in the
assembled view of FIG. 2. An axial cross-section view of the
assembled combination is illustrated in FIG. 3 where the rod 30 of
the obturator 12 is more clearly shown within the working channel
25 of the sheath 10.
[0028] If desired, the releasable lock (not shown) can be provided
to removably attach the obturator 12 to the sheath 10. When locked
in place, the obturator 12 and sheath 10 can then be passed as a
single unit over the guidewire. This arrangement precludes
inadvertent advancement of the sheath 10 in front of the obturator
12, which could greatly impede proper passage of the sheath and
potentially the ureter.
[0029] The handle 23 associated with the sheath 10 is of particular
interest to the invention and is illustrated in the enlarged, axial
cross-section view of FIG. 4. From this view it can be seen that
the handle 23 has the general configuration of the bell of a horn.
The handle 23 has a distally-facing surface 41 on the outside of
the handle 23, and a proximally-facing surface 43 on the inside of
the handle 23. Both of these surfaces 41 and 43 in the preferred
embodiment are continuous and have a generally conical
configuration. In the illustrated embodiment, the distally-facing
surface 41 is generally concave, while the proximally-facing
surface 43 is generally convex.
[0030] The handle 23 can be provided with two small holes 45, 46
for passage of sutures 47 and 48, respectively. Once the sheath is
in place, the sutures 47, 48 can be clamped with hemostats (not
shown) to the surgical drapes, thereby preventing distal migration
of the sheath and loss of ureteral access. Once the
obturator/sheath combination has been advanced to the desired
position in the ureter, the obturator 12 can be unlocked from the
sheath 10 and removed. In the manner discussed in greater detail
below, these features offer particular advantages to the present
invention.
[0031] One of the purposes of the proximally-facing surface 43 is
to funnel the obturator 12 and other surgical instrumentation into
the working channel 25 of the sheath 10. With the generally conical
configuration, this proximally-facing surface functions as a funnel
with a radius which decreases with progressive distal positions
along the axis 16. Thus, as the instrumentation is moved distally,
the proximally-facing surface 43 guides the instrument along a
decreasingly decreasing radius into the working channel 25 of the
sheath 10. Providing the surface 43 with a generally convex
configuration further facilitates this funneling feature of the
invention. When the surface 43 is convex, its radius decreases at a
decreasing rate with progressively equal distal positions along the
axis 16.
[0032] The distally-facing surface 41 is intended to facilitate
engagement of the sheath 10 by a user's hand held in its most
natural state. In FIG. 5, adjacent fingers 50 and 52 of the user's
hands are illustrated schematically by the circles 50 and 52. In
the natural state, the palm of the user's hands would be facing the
user in the proximal direction, to the left in FIG. 5. The sheath
10 is adapted to be operatively positioned between the fingers 50
and 52 with the handle 23 positioned so that the distally-facing
surface 41 is in juxtaposition to the fingers 50 and 52. This fit
is facilitated by forming the surface 41 with a size and
configuration generally similar to the fingers 50 and 52, as
illustrated in FIG. 5. Thus, with the distally-facing surface 41
having a generally conical configuration, it has a radius which
decreases with progressive distal positions along the axis 16. In
an embodiment wherein the surface 41 is also concave, the radius of
the surface 41 decreases at a decreasing rate with progressively
equal distal positions along the axis 16.
[0033] In operation, as the surgical instrument, such as the
obturator 12, is inserted into the handle 23, it produces a force
F.sub.1 (illustrated by arrow 54) in the distal direction. This
force is opposed by the fingers 50 and 52, which engage the
distally-facing surface 41 and apply opposing forces F.sub.2 and
F.sub.3 (represented by arrows 56 and 58). In this manner, the
fingers 50 and 52 can maintain the sheath 10 generally stationary
even when the obturator 12 is being inserted. It will also be noted
that with the user's hand in the natural position, it tends to form
a barrier which prevents any instrumentation from extending
exteriorly beyond the handle 23 into contact with ureteral tissue
60. As shown in FIG. 5, the urethra has a first diameter. The tube
14 has a second diameter that is less than the first diameter of
the urethra while the handle 23 has a third diameter greater than
the first diameter of the urethra.
[0034] Although the embodiment of FIG. 5 is particularly adapted to
facilitate insertion of a surgical instrument, such as the
obturator 12, it will be appreciated that removal of the instrument
also creates withdrawal forces on the sheath 10. A further
embodiment of the handle, which can easily accommodate not only
insertion forces but also withdrawal forces, is illustrated in FIG.
6 In this embodiment, a handle 61 is similar to the handle 23,
except that the outer, distally-facing surface 41 is curved
distally outwardly to form a proximally-facing outer surface 63. In
this case, the two surfaces 41 and 63 form a continuous surface
which defines an annular recess sized and configured to receive the
fingers 50 and 52.
[0035] In this embodiment, insertion of the instrument, such as the
obturator 12, is resisted by the forces F.sub.2 and F.sub.3 applied
by the fingers 50 and 52, respectively, to the distally-facing
surface 43, as previously discussed with reference to FIG. 5. In a
similar manner, when the instrument such as the obturator 12 is
withdrawn, it produces a force F.sub.4 (illustrated by arrow 65)
which must be resisted in order to maintain the sheath 10
stationary. This resistance is provided in the embodiment of FIG. 6
by the pressure of the fingers 50, 52 against the proximally-facing
outer surface 63. Thus, fingers 50, 52 provide opposing forces
F.sub.5 and F.sub.6 designated by arrows 67, 70, respectively.
[0036] FIGS. 7-9 illustrated a further embodiment involving a
handle, such as the handles 23 or 61, which is movable relative to
the tube 14 of the sheath 10. This embodiment is particularly
desirable as it permits the tube 14 to be cut in situ, at the
operative site, to a preferred length. With a sheath of this type,
only a single access device need be present at the operative site.
Multiple sheaths having different lengths are not required to be
present in order to have a sheath of the desired length. As
illustrated in FIG. 7, this embodiment of the sheath 10 includes
the tube 14 which is slidingly engageable by a handle assembly 72
that includes a sleeve 74 and a funnel 76. The sleeve 74 is formed
as a cylinder 77 having an interior bore 78 and external threads
81. An elastomeric element 83 is disposed within the bore 78 and is
provided with an axial lumen 84 appropriately sized to receive the
tube 14.
[0037] The funnel 76 is formed similar to the handle 23, but
includes two concentric cylinders 85 and 87 which extend distally.
The outer cylinder 85 is provided with interior threads 90, which
are sized to receive the external threads 81 of the sleeve 74. The
inner cylinder 87 of the funnel 76 is provided with an outer
diameter less than the inner diameter of the bore 78. This inner
cylinder 87 extends to a distal surface 92.
[0038] In operation, the funnel 76 is moved axially over the sleeve
74 and the internal threads 90 are screwed onto the external
threads 81. Further rotation of the funnel 76 relative to the
sleeve 74, causes the distal surface 92 of the inner cylinder 87 to
axially compress the elastomeric element 83. This compression
causes the element 83 to expand inwardly decreasing the diameter of
its lumen 84 and thereby increasing the frictional engagement of
the handle assembly 72 relative to the tube 14.
[0039] In order to provide the sheath 10 with a desired length, the
tube 14 can be cut to a predetermined length, either before or
after mounting the handle assembly 72 on the tube 14. Axial
movement of the handle assembly 72 to a desired proximal location
on the tube 14 provides the sheath 10 with the desired length.
Operation of the handle 72 in the manner previously discussed will
fix the assembly 72 on the tube 14 at this desired location.
[0040] In another embodiment illustrated in FIG. 10, a movable
handle assembly 96 includes a funnel 98 similar to the handle 23.
It also includes a cylinder 99 which extends distally within
portions 101 which have a reduced diameter. A separate finger clamp
102 includes a cylinder 104 which has a diameter which is dependent
upon operation of finger tabs 103 and 105. When these tabs 103 and
105 are compressed, the cylinder 104 has a relatively large
diameter. When the tabs 103 and 105 are not compressed, the
cylinder 104 is biased toward a reduced diameter. This finger clamp
102 is intended to be operatively disposed over the thin portions
101 of the cylinder 99, as illustrated in FIG. 11. In this
operative position, the entire handle assembly 96 can be moved
along the tube 14 by compressing the finger tabs 103 and 105 of the
clamp 102. The tube 14 can then be cut, for example, with scissors
106, to any desired length. Compressing the finger tabs 103 and 105
will permit the handle assembly 96 to be moved to a distal
position, as illustrated in FIG. 11, where the tabs 103 and 105 can
be released to compress the thin portions 101 and maintain the
handle assembly 96 in a fixed relationship with the tube 14.
[0041] A further embodiment of the invention is illustrated in the
side-view of FIG. 12. In this embodiment, the tube 14 is formed
with an inner plastic body 110, surrounded by a metal spring coil
112, which is further covered by an outer body 114. This particular
embodiment of the tube 14 provides a high degree of kink resistance
and can be used with any of the handle assemblies previously
discussed. With this embodiment of the tube 14, the inner body 110
provides a smooth surface within the sheath 10, which facilitates
passage of instrumentation. The spring coil 112 adds kink
resistance to the tube 14, while the outer body 114 provides a
suitable covering for the coils of the spring 112.
[0042] From the foregoing description of preferred embodiments, it
will be apparent that many variations on the concept of this
invention will be contemplated by those skilled in the art. For
example, many different configurations of the tube 14 can be used
with the various handle assemblies disclosed. Furthermore, the
handle assemblies can be embodied in many different forms to
provide at least one curved outer surface which is sized and
configured to receive the fingers of a user's hand in a normal
position. The fact that this desired outer shape can be combined
with a funnel configuration at the 20 proximal end of the sheath
will add further advantages to these various embodiments.
[0043] Although exemplary embodiments of the invention have been
shown and described, many other changes, modifications, and
substitutions will now be apparent to those of ordinary skill in
the art, without necessarily departing from the spirit and scope of
this invention as set forth in the following claims.
* * * * *