Note: Descriptions are shown in the official language in which they were submitted.
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SUCTION AND IRRIGATION HANDPIECE AND TIP
Field of the Invention
This invention relates generally to medical irrigation systems and, more
particularly, to
hand-held medical irrigation devices that have a tip with suction and
irrigation channels.
Background of the Invention
Irrigation devices are in common use in a variety of non-surgical
environments, such as
nursing homes and other long-term care facilities, where they are used to
treat bed sores and
to other injuries that are accessible externally about a patient. These
devices generally comprise an
irrigation handpiece and accompanying irrigation tip that direct irrigation
liquid from an
irrigation source to an irrigation site. Effective treatment often requires
that the injured site be
irrigated several times.
Conventional irrigation and suction devices have a combination suction and
irrigation tip
1 s that can be detachably connected to a handpiece having both irrigation and
suction lumens. The
free end of the tip has a conical splash shield that, during use, is pressed
against and about the
irrigated region to confine irrigation liquid (e.g., saline) to that region. A
typical tip is shown in
U.S. Patent No. 4,692,140 (Olson). The Olson tip has an outer (suction) tube,
an inner
(irrigation) tube coaxially aligned with the suction tube, and a web (referred
to as "pegs" in
20 Olson) that supports the distal end of the irrigation tube within the
suction tube. The annular
space between the tubes provides a suction pathway for biological debris
aspirated from the
irrigation site. Aspirated biological debris is drawn through the suction
pathway to the suction
lumen in the handpiece, from which it flows through a connecting tube to a
debris collection
chamber.
25 One problem with such devices is that the biological debris ingested into
the handpiece
suction lumen (from the irrigation site) may contain infectious bacteria that
could contaminate
the handpiece. The handpiece can thus become septic and may create an
undesirable risk of
reinfection to the patient if it is reused. Accordingly, although irrigation
handpieces with
detachable tips are available, there has been a resistance to their use
because the handpieces are
3o relatively expensive and can only be used once. The preferred treatment is
to to bathe the patient
in a warm whirlpool bath instead of locally irrigating the injury with an
irrigation handpiece and
tip. This alternative treatment method is inefficient, however, since it is
time consuming and
treats both injured and uninjured parts of the patient's body.
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Another difficulty with the foregoing coaxial tip is that the suction pathway
can clog
easily with aspirated biological debris because it has a relatively small
cross-sectional dimension.
The web also appears to further obstruct debris drawn toward the annular
suction pathway since
it partially covers the open distal end of the pathway.
A flexible splash shield that is permanently fastened to the distal end of the
outer suction
tube also presents problems. More particularly, when the irrigation tip must
be positioned very
close to the irrigation site, it may be necessary to cut off the end of the
shield along one of
several circumferential ring guides. In addition to being time consuming and
cumbersome, the
structure of the tip is permanently altered. A new tip must be used to
irrigate a larger local injury
~ o site.
In addition, it is common during use for irrigation fluid and biological
debris to escape
from the splash shield because, for example, the irrigation surface may not be
smooth or the
attendant may inadvertently move the handpiece while irrigating. This can
cause the debris and
irrigation liquid to splash onto the handpiece and/or attendant, consequently
contaminating the
15 handpiece and exposing the attendant to infection.
It therefore is among the general objects of the invention to provide an
improved
suction/irrigation tip that avoids contamination of the handpiece.
Summary of the Invention
2o In accordance with one aspect of the invention, the suction lumen in a
detachable suction
and irrigation tip is configured so that aspirated fluid and debris are passed
directly to an external
suction source when the tip is used with a conventional handpiece having both
suction and
irrigation lumens. No portion of the suction lumen in the tip is in fluid
communication with the
suction lumen in the handpiece. However, the irrigation lumen in the handpiece
is in fluid
25 communication with the irrigation lumen in the tip so that irrigation can
pass through the
handpiece and tip in normal fashion.
In accordance with another aspect of the invention, the suction and irrigation
lumens in
the tip are arranged coaxially with the inner tube defining the suction lumen
and the annular
lumen between the inner and outer tubes defining the irrigation lumen. The
annular lumen
30 terminates in an annular end wall that includes a number of
circumferentially spaced outlet
apertures through which irrigation liquid is emitted. Since the cross-
sectional dimension of the
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suction lumen is greater than the radial dimension of the surrounding annular
lumen,
the risk of that lumen being clogged by debris is reduced.
In accordance with yet another aspect of the invention, a flexible splash
shield
is slidably mounted on the tip. This enables the distal end of the suction and
irngation
tubes to be positioned directly against the irrigation site without having to
cut the
shield.
In accordance with still another aspect of the invention, the tip is provided
with a protective covering having one end that is heat sealed to the tip and
another end
that is open. When the tip is connected to a handpiece, the covering is sized
to fit
loosely about the handpiece and may extend past the bottom of the handpiece.
The
covering protects the handpiece and the attendant from debris that may splash
from
the irrigation site.
It is among the objects of the invention to provide a combination suction and
irngation tip that is detachably connectable to a handpiece and in which
biological
debris aspirated through the suction lumen bypasses the handpiece.
Another object of the invention is to provide an improved combination suction
and irngation tip that may be detachably connected to an irrigation handpiece
in
which the risk of the handpiece becoming contaminated with biological debris
is
reduced.
In accordance with an aspect of the present invention, there is provided a
detachable suction tip for use with a suction handpiece, the handpiece having
a
suction lumen extending therethrough for removing irngation fluid from an
irrigation
site, and an irngation lumen extending therethrough for providing irngation
fluid to
an irngation site, the tip including a suction tube for aspirating irngation
fluid from
the irngation site, and a connector for mechanically connecting the tip to the
handpiece, wherein the suction tube has a fluid bypass path within the
detachable tip
which channels aspirated irngation fluid directly to a suction source so that
aspirated
fluid within the suction tube does not communicate with the handpiece suction
lumen;
and the connector also having a plug for sealing the suction lumen in the
handpiece
when the tip is connected to the handpiece.
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In accordance with another aspect of the present invention, there is provided
a
detachable suction and irrigation tip for use with an irrigation handpiece,
the
handpiece having a suction lumen and an irrigation lumen extending
therethrough, the
irrigation lumen directing irrigation fluid to an irrigation site, the tip
including an
irrigation tube for directing the irrigation fluid to the irrigation site, a
connector for
detachably connecting the izrigation .tube to the handpiece to provide fluid
communication therebetween wherein the connector is configured to seal the
suction
lumen in the handpiece when the tip is connected to the handpiece, and a
suction tube
for aspirating irrigation fluid from the irrigation site, the suction tube has
a fluid
bypass path within the detachable tip constructed to channel aspirated
irngation fluid
directly to a suction source so that aspirated fluid within the suction tube
does not
communicate with the handpiece.
In accordance with yet another aspect of the present invention, there is
provided a method of assembly of a surgical irrigation device that includes
providing
1 S a handpiece defining a handpiece irrigation lumen and a handpiece suction
lumen;
connecting the handpiece irrigation lumen to an irrigation fluid source;
detachably
connecting a tip to the handpiece, the tip having a tip irrigation tube in
fluid
communication with the handpiece irrigation lumen and a tip suction tube for
aspirating fluid from a surgical site further wherein a bypass fluid path is
in fluid
communication with the tip suction tube, and connects the bypass fluid path to
a
suction source.
In accordance with yet another aspect of the present invention, there is
provided an apparatus for irrigating an irrigation site comprising a handpiece
having
an irrigation lumen extending therethrough and a tip comprising an irngation
tube, a
suction tube for aspirating fluid from the irrigation site and a connector for
detachably
connecting the irngation tube to the handpiece wherein the suction tube is in
communication with a bypass fluid path contained within the tip, said bypass
fluid
path bypasses the handpiece to prevent the aspirated fluid within the suction
tube
from communicating with the interior of the handpiece.
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Brief Description of the Drawings
The foregoing and other objects and advantages of the invention will be
appreciated more fully from the following further description thereof with
reference
to the accompanying drawings wherein:
Figure 1 is a perspective view of the irngation system in accordance with the
invention;
Figure 2 is a perspective view of the suction irngation tip with the splash
shield retracted;
Figure 3 is a longitudinal cross section of the suction irrigation tip along
line
3-3 of Figure 1;
Figure 4 is a perspective view of the suction irngation tip showing the rear
and
side components of the tip;
Figure 5 is a bottom perspective view of the rear portion of the suction
irrigation tip;
Figure 6 is a front perspective view of the suction irngation tip;
Figure 7 is a perspective view of the suction irrigation tip and handpiece
with
the polymeric envelope extending just past the bottom of the handpiece; and
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Figure 8 is a perspective view of the suction irrigation tip and handpiece
with
the polymeric envelope extending to the attendant's elbow.
Description of the Illustrative Embodiment
Figure I illustrates the main components of the suction and irrigation system,
which includes a conventional handpiece 10 connected to a reservoir bag 12 by
flexible irrigation tubing 14, and a combination suction and irrigation tip 16
detachably connectable to the handpiece 10. Such a handpiece may also include
a
suction tube 19 extending into the interior of the handpiece 10 which can be
connected to a suction source 18 (e.g., wall suction) to aspirate debris. As
described in
detail below, when the inventive tip 16 is connected to the handpiece 10, a
suction
bypass is provided that diverts aspirated debris away from the interior of the
handpiece 10, thus reducing the risk of contaminating the handpiece 10.
Irrigation
fluid (e.g., saline) is provided by the bag 12, from which it is pumped
through the
handpiece 10 and tip 16, to the irrigation site.
The handpiece 10 may be a Simpulse SoloT~ suction irrigator (available from
C.R. Bard, Inc. of Murray Hill, N.J.) which has a self contained pump,
battery, and
motor, (omitted for clarity such as that described in more detail in U.S.
Patent No.
5,746,721, issued on May 5, 1998 and assigned to C.R. Bard, Inc. A suction
lumen 22
and an irrigation lumen 24, shown in phantom, extend through the entire length
of the;
handpiece. The suction lumen 22 is connectable to the suction source 18 at one
end
and terminates at a suction port 28 at the other end. The irrigation lumen 24
is
connectable to the irrigation source 12 at one end and terminates at an
irrigation port
at the other end. Both ports 28 and 30 are formed through a fitting 26 at the
distal
end of the handpiece 10.
25 Tn accordance with principles of the invention, a special tip (i.e. tip 16)
is
provided for use with the conventional handpiece 10. The proximal end of the
tip 16
is configured to detachably mate with the fitting 26. When the tip 16 is
connected to
the handpiece 10 and the handpiece 10 is energized (by squeezing a trigger 31
),
irrigation fluid passes through the irrigation port 30 and into the tip 16.
The irrigation
30 fluid is emitted in a pulsatile liquid stream from the distal end 32 of the
tip at a
pulsating frequency that is controllable by the trigger 31. However, the
suction port
28 is plugged by a plug 34 extending from the tip proximal end 36. When the
tip 16 is
not connected to the handpiece 10, a plug 38 having two projections 40, 44
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preferably is inserted into the ports 28 and 30 to prevent entry of
contaminants into the
handpiece.
The tip 16, illustrated in cross section in FIG. 3, may be made from a hard,
substantially
transparent plastic. The tip 16 includes an inner (suction) tube 46 coaxially
aligned within an
outer (irrigation) tube 48, a flexible, funnel-shaped splash shield S4, and a
connector 56. The
suction tube 46 provides a direct pathway 50 for suction from the tip distal
end 32 to a suction
source (schematically illustrated as source 18 in Figure 1 ). Aspirated debris
therefore never
enters the handpiece 10. The annular space 52 between the suction and
irrigation tubes 46 and
48 provides a pathway for irrigation fluid. The splash shield 54, slidably
mounted to the
1o irrigation tube 48, enables treatment to be confined to a localized
treatment site. The connector
S6 at the tip proximal end 36 removably connects the tip 16 to the handpiece
10.
The suction tube 46 is supported within the irrigation tube 48 at one end by
an outlet
nozzle 58, and at the other end by an elbow shaped conduit 60. The outlet
nozzle 58 is in the
form of a plurality of circumferentially spaced openings formed in an annular
end wall. The
elbow shaped conduit 60 extends into and downwardly through the connector 56,
terminating at
a tapered lower end 62 having a plurality of annular ridges 63 (figure S). The
suction tube 46 is
sealed to both the outlet nozzle 58 and elbow-shaped conduit 60 to form a
continuous suction
lumen 64 from the tip distal end 32 to the tapered lower end 62 of the elbow
60 to which the
suction tubing 20 from a suction source may be connected.
2o Although the elbow shaped conduit 60 is shown as extending from the
proximal end of
the suction tube 46, it may depend from any part of the suction tube 46. In
a.n alternative
embodiment, for example, the suction tube 46 is about half the size as it is
in the preferred
embodiment and the elbow shaped conduit 60 may connect to the suction tube 46
within the
irrigation tube 48. The tapered end 62 of the elbow shaped conduit 60 extends
through a wall of
the irrigation tube 48 for connection with the flexible suction tubing 20.
The connector 56 has an irrigation fluid chamber 66 that receives fluid from
the
handpiece irrigation port 30 through an irrigation connector 68. After the
Iluid is received in the
fluid chamber 66, the fluid chamber 66 directs it to the annular space S2,
which then directs it
through the outlet nozzle S8. An O-ring 70 may encircle the irrigation
connector 68 to seal the
3o connection between the irrigation connector 68 and the irrigation port 30
on the handpiece. A
flexible clip 72 may be molded integrally with the connector 56 for engagement
with a lip 74
formed along the underside of the handpiece fitting 26.
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As shown in figures 4 and 5, a hood 76 extends proximally from the connector
56 to
shield the suction and irrigation ports 28 and 30 from irrigation fluid and
debris that, in use, may
splash back toward the handpiece 10. The hood 76 preferably has a partially
oblong shape,
approximating the shape of the handpiece fitting 26. It extends downwardly
about the tip plug
34 and partially about the irrigation connector 68. When the tip 16 is
connected to the handpiece
10, the hood 76 covers the top portion of the fitting 26, thus further
reducing the risk of splashed
fluids contaminating the ports 28 and 30. The rounded top of the hood 76
causes fluids to drip
past the sides of the nozzle 26.
The flexible shield 54 includes a proximal collar 78 and a conical body that
diverges in a
1o distal direction to a distal rim 80. The collar 78 is slidably mounted to
the irrigation tube 48 and
has an annular gripping ridge 82 to facilitate gripping the collar 78. A
plurality of
circumferential ridges 84 (e.g., three) may be included on the inner surface
of the shield 54 to
serve as cutting guides for cutting shield 54. Vent holes 86 formed in the
side of the shield 54
prevent the shield 54 from collapsing under suction and also enable air to mix
with the debris
aspirated from the site to avoid stagnation of the debris within the shield
54. The shield 54 may
be made from a flexible, substantially clear plastic that may be shaped during
use to conform to
the shape and contour of the irrigation site.
The collar 78 may be secured to the distal end of the tip 16 by both an
annular flange 88
(shown in figures 2 and 3) and a discontinuous circumferential ridge 90 formed
on the irrigation
2o tube 48. The ridge 90 has two discontinuities 92 that enable the shield 54
to be easily forced
over the securing ridge 90. The shield 54 may be retracted proximally (FIG 2),
over the securing
ridge 90, by applying a proximal force to either the rim 54 or to the gripping
ridge on the collar
78. The irrigation tube 48 may be tapered slightly toward the tip distal end
32 to increase the
resistance to proximally retracting the shield 54. A stop ridge 94 may
circumscribe the proximal
end of the irrigation tube 48 to prevent the splash shield 54 from being
retracted into contact with
the connector 56.
The shower head nozzle 58 is fastened to the tip distal end 32 and includes an
end wall ~7
and a cylindrical wall 98 extending proximally from the end wall. The nozzle
58 serves a
number of important functions. In addition to partially securing the splash
shield 54 to the tip i 6
3o and securing the suction tube 46 coaxially within the irrigation tube 48,-
it can be configured to
emit irrigation fluid from the tip 16 in a specialized spray pattern. To that
end, the shower head
nozzle 58 has a plurality of irrigation holes 96 (e.g.. nine) longitudinally
formed through the
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cylindrical wall 98 and end wall 97, and a central suction hole 100. The
diameter of the central
suction hole 100 should have approximately the same diameter as the inner
diameter of the suction
tube 46 such as, for example, 0.1875 inches (4.81 mm). The number, shape, and
size of the
irrigation holes 96 are selected both to provide a specialized spray pattern
for the irrigation fluid
and to regulate the force with which the irngation fluid is emitted from the
tip 16. Accordingly,
the suction/irrigation tip 16 may be customized to be usable with certain
handpieces only. For
example, when irrigating an externally exposed wound (e.g., a bed sore), it is
preferred that the
irrigation fluid be emitted from the tip 16 at a force not exceeding 15 p.s.i.
(1 bar). When the tip
16 is used with the Simpulse SoIoTM suction irrigation handpiece, nine round
holes having a
diameter of 0.040 inches (1.03 mm) have produced satisfactory results.
Similarly, when used with
the Simpulse PlusT'~ suction irngation handpiece, also available from C.R.
Bard, Inc., four round
holes having a diameter of 0.040 (1.03) inches have produced satisfactory
results.
During the irrigation procedure, it therefore is important that the attendant
easily select
the tip 16 that corresponds with a specific handpiece 10. Accordingly, it is
preferred that the tip
16 have a simple identification means that quickly and easily indicates the
tip 16 that
corresponds to the handpiece 10 being used. To that end, the tip connector 56
may be color
coded to correlate with the handpiece 10. For example, the tip connector 56 to
be used with the
Simpulse SoloT'~ may be colored purple, while the tip connector 56 to be used
with the Simpulse
Plus T'~ may be colored green. As a further means for ensuring proper tip use,
the tip connector
56 may be specially shaped to mate only with the fitting 26 of the handpiece
1J with which it is
to be used. Therefore, the wrong tip 16 cannot fit into the wrong
pump/handpiece 10. To that
end, either the irrigation connector 68 or the tip plug 34 may be provided
with a ridge 101 (Fig.
4) or other irregularity, and the corresponding handpiece suction port 28 or
irrigation port 30 may
be molded to that complimentary shape. The connector 56 may only be connected
to the
corresponding port for a fluid tight fit.
Fig. 7 illustrates an arrangement by which the handpiece 10 is protected from
irrigation
fluid and other biological debris that may splash from the irngation site
during use. To that end,
the tip 16 is provided with an protective covering 102 having one end 104 that
is heat sealed to
the connector 56 and another end 106 that is open. The protective covering 102
is sized to fit
loosely about the handpiece 10. The length of the protective covering 102
preferably is long
enough to extend to the bottom end of the handpiece 10. This ensures that the
handpiece 10 will
remain protected by the protective covering 102 even though the protective
covering 102 might
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shift somewhat relative to the handpiece 10. An elastic band may be connected
about the
protective covering open end 106 to provide a secure fit about the bottom end
of the handpiece ,
10. The protective covering 102 is can be made from a thin, flexible,
substantially transparent
polymeric material, such as a low density polyethylene having a thickness of
about 0.001 inch
(.04 mm). It is dimensioned so that it will maintain a loose fit about the
handpiece 10. The
flexibility and transparent nature of the polymeric protective covering 102
enables the attendant
to effectively operate all the controls on the handpiece 10 through the
protective covering.
Fig. 8 shows a second arrangement by which both the handpiece 10 and
attendant's arm
are protected from debris that splashes from the site. To that end, the tip 16
is provided with a
long protective covering 108 having one end 110 that is heat sealed to the
connector 56 and
another end 112 that is open. The long protective covering 108 is sized to fit
loosely about the
handpiece 10 so that the attendant may operate the handpiece 10 from within
the long protective
covering 108 The length of the protective covering 108 preferably is three
times the length of
the handpiece 10 so that the open end 112 will extend approximately to the
attendant's elbow
114. This ensures that both the handpiece 10 and attendant's arm will be
protected from debris
that splashes from the site. The long protective covering 108 may be made from
a thin, flexible,
substantially transparent polymeric material, such as a low density
polyethylene having a
thickness of about 0.001 inch (.04 mm). It is dimensioned so that the
attendant's hand will easily
fit inside the protective covering 108 to operate the handpiece 10. The
flexibility and transparent
2o nature of the long protective covering 108 enables the attendant to
effectively operate all the
controls on the handpiece 10 from inside and outside the protective covering
108.
When in use, the tip 16 is connected to the handpiece 10 and the flexible
suction tubing
is connected to the tapered lower end 62 of the elbow shaped conduit 60. The
handpiece
suction tube 22 remains unused. Since the tip 16 is connected to the handpiece
10, the tip plug
34 sealingly connects to the handpiece suction port 28 and the irrigation
connector 68 connects to
the handpiece irrigation port 30. The shield 54 may be positioned at the tip
distal end 32 and the
rim 80 may positioned at the local irrigation site. If desired, either of the
flexible protective
coverings 102 or 108 may be disposed over and about the handpiece 10. The user
may then
simultaneously irrigate and aspirate the site. The attendant may retract the
shield 54 to put the
3o shower head nozzle 58 directly against, or very close proximity to, the
irrigated site. The large
cross-sectional area of the suction tube 46 reduces the possibility of
clogging. After use, the tip
16 and protective covering 102 or 108 are discarded and the two prong plug 38
is inserted into
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the suction and irrigation ports 28, 30 to ensure that the handpiece 10
remains aseptic. The
handpiece 10 may be reused at a later time by removing the two prong plug 38
and inserting a
new suction irrigation tip 16.
It should be understood that the foregoing description of the invention is
intended merely
to be illustrative thereof and that other modifications and embodiments may be
apparent to those
skilled in the art without departing from its spirit.
