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Description  |
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BACKGROUND OF THE INVENTION
The present invention relates to a system for providing fluid to a site
inside the body and in particular the present invention relates to an
irrigation tubing set system and method for providing fluid flow
continuously or for delivering a bolus of fluid for irrigating or flushing
an internal body site or organ that is accessed through a relatively small
incision, natural orifice of the body, or in conjunction with a
laparoscope, endoscope, resectoscope or similar device.
Certain medical procedures, such as cystoscopy and ureteroscopy, as well as
other urological, gynecological, and laparoscopic procedures and
surgeries, are performed inside the body through an apparatus, through a
very small incision, or through a small natural orifice of the body.
Instruments used to perform these types of surgical procedures include
resectoscopes, irrigation-aspiration cannula, laparoscopes, and so on. In
addition, certain medical diagnostic procedures are performed by accessing
an internal body site through a small incision or natural orifice and
inserting an endoscope to enable the physician to view the internal body
site.
When performing these types of surgeries or diagnostic procedures, it is
sometimes necessary for the physician to apply small volumes of a fluid,
such as water, to flush blood or tissue from the surgical area to enable
the procedure to proceed. Some surgical instruments and endoscopes,
especially those used for urological procedures, are provided with flow
channels to allow the physician to apply a flushing or irrigating fluid to
the internal body site or to expand a body cavity. This is typically done
by suspending one or more plastic bags containing the irrigating fluid on
an IV pole and connecting the bags to the inlet of the flow channel of the
surgical instrument with conventional plastic tubing. To control flow from
the bags to the instrument, a clamp may be positioned on the tubing. If
the physician desires to flush the site with water, he can loosen the
clamp. Although this arrangement may be suitable for some procedures, it
has some limitations. For example, it may be difficult to control the
fluid pressure being applied by the suspended bags to the instrument. In
addition, it may be inconvenient or awkward for the physician to adjust
the clamp to control the flow while also handling the surgical instrument.
In addition, the volume and pressure of water being delivered may be
difficult to control.
Accordingly, it is an object of the present invention to provide a system
and method that addresses or overcomes the disadvantages of the prior
methods of fluid delivery to an internal body site. Such a system may also
find application in other medical and non-medical fluid delivery systems.
SUMMARY OF THE INVENTION
To address the above concerns, the present invention provides a tubing set
for connecting a source of irrigating fluid to an intraoperative surgical
instrument having a fluid delivery passage therein. The tubing set
includes a first section having an inlet for connection to the source of
fluid, a second section having an outlet for connection to the medical
instrument, and a pump connected between the first section and the second
section. A valve is located between the inlet and the outlet and restricts
flow in a direction from the source to the surgical instrument. The tubing
set can be operated to deliver a continuous, relatively unrestricted flow
of fluid from the source of irrigating fluid to the surgical instrument or
can be operated to deliver a smaller continuous flow, such as a trickle,
by appropriate adjustment. Further, the tubing set can be used to deliver
a bolus of fluid to the surgical instrument upon operation of the pump.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a first embodiment of the present
invention, shown in relation to a source of irrigating fluid and a
surgical instrument.
FIG. 2 is a perspective view similar to that of FIG. 1 showing another
embodiment of the present invention.
FIG. 3 is a perspective view similar to that of FIG. 1 showing still
another embodiment of the present invention.
FIG. 4 is a top view of portions of the adjusting nut and rod shown in the
embodiment of FIG. 3.
FIG. 5 is a top view similar to FIG. 4 of the portions of the adjusting nut
and rod shown in another position.
FIG. 6 is a perspective view similar to that of FIG. 1 showing still
another embodiment of the present invention.
FIG. 7 is a perspective view similar to that of FIG. 1 showing yet another
embodiment of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIG. 1 there is shown a first preferred embodiment of the
present invention. The embodiment shown in FIG. 1 is a tubing set or
system 10 that is used to provide a liquid, such as sterile water or
saline, to an intraoperative instrument. The intraoperative instrument may
be used in conjunction with a procedure that accesses an internal body
site through a small surgical incision or natural orifice. These
procedures may be for diagnostic or therapeutic purposes and include in
particular cystoscopy and ureteroscopy, as well as other urological,
transurethral, gynecological and laparoscopic diagnostic procedures and
surgeries.
The tubing system 10 includes a first section of tubing 14 that defines a
first fluid passage 16. The first section of tubing 14 is preferably
composed of polyvinylcloride (PVC) tubing with an I.D. of approximately
0.20 inches and a length of approximately 8 feet, although other sizes and
materials may also be suitable. Located at one end of the tubing 14 is a
fitting 18 that provides a fluid inlet to the fluid passage 16 defined by
the first section of tubing 14. The fitting 18 provides for a suitable
connection with a source of irrigating fluid 20. According to the first
embodiment, the source of irrigating fluid is comprised of one or more
conventional bags of saline water, although alternatively the source of
fluid may be other fluids used in conjunction with medical procedures for
irrigation of surgical sites. The source of fluid 20 typically has a
fitting 22 located thereon. The fitting 18 on the tubing 14 is suitable
for making a matable connection with the fitting 22 on the bag 20. In one
embodiment, the fitting 18 on the tubing 14 may be a spike 23 suitable for
piercing a membrane in the fitting 22 of the bag 20. A spike cover 24 may
be provided to enclose the spike 23 during shipment, storage, and handling
of the tubing set 10 and is removed by the physician prior to use of the
tubing. Other types of matable fittings or adapters are also considered to
be suitable. For example, the fitting 18 on the tubing 14 may be a luer
lock-type fitting, that is matable with a corresponding type of fitting 22
on the bag 20.
Connected to the opposite end of the first section of tubing 14 is a pump
30. In this embodiment, the pump 30 is a tubular pump composed of a
resilient, hollow, flexible plastic tube defining an internal chamber or
volume 32 having an inlet 33 and an outlet 34. The internal chamber 32 of
the pump 30 is in fluid communication with the first fluid passage 16 via
the inlet 33. In this embodiment, the pump 30 fills with fluid under
pressure applied by the source of fluid 20. In the first embodiment, the
tubular pump is appropriately sized for grasping manually. Accordingly,
the tubular pump is approximately 43/4 inches in length and 7/8 inches in
diameter. The tubular pump is preferably made of PVC. A suitable tubular
pump is commercially available from Miles, Covina Calif.
Located in the first fluid flow passage 16 between the source of fluid 20
and the pump 30 is a first valve 35. The first valve 35 may be a one-way
or check valve and is oriented so that it restricts flow in the first
fluid flow passage 16 so that fluid flow is in the direction from the
source of fluid 20 toward the pump 30 and not from the pump 30 back toward
the source of fluid 20. In the first embodiment, a commercially available
check valve may be used, such as a plastic or metal ball-type valve
available from Miles, Covina, Calif. In the first embodiment, the first
valve 35 is inserted in line with the first tubing section 14 between the
distal end of the tubing 14 and the inlet 33 to the pump 30.
Alternatively, the first tubing section 14 may be formed of two parts with
the first valve 35 located between the two parts.
Connected to the outlet 34 of the tubular pump 30 is a second section of
tubing 40. The second section of tubing 40 defines a second fluid passage
42. The second section of tubing may also be composed of PVC tubing with
an I.D. of approximately 0.20 inches. The second section of tubing 40 has
a length of approximately 2 feet, although other sizes and materials may
also be suitable. Located at a distal end of the second section of tubing
40 is a second fitting 44 that provides for a fluid outlet from the second
fluid passage 42. The second fitting 44 provides for a suitable connection
with an intraoperative instrument 50 which may be a cystoscope. The
intraoperative instrument 50 has a fitting 52 located thereon. The fitting
44 at the end of the second section of tubing 40 is preferably suitable
for making a matable connection with the fitting 52 on the intraoperative
instrument 50. In one embodiment, the fitting 44 on the second section of
tubing 40 is a rotating male luer lock-type fitting and the fitting 52 on
the intraoperative instrument 50 is a female luer lock-type fitting. Other
types of matable fittings or adapters may also be used.
Located in the second fluid flow passage 42 between the pump 30 and the
intraoperative instrument 50 is a second valve 58. The second valve 58 may
be a one-way or check valve and is oriented so that it restricts flow in
the second fluid flow passage 42 so that fluid flow is in the direction
from the pump 30 toward the intraoperative instrument 50 (direction of
arrow 59) and not from the intraoperative instrument 50 back toward the
pump 30. In the first embodiment, a commercially available check valve may
be used, such as a plastic or metal ball-type available from Miles,
Covina, Calif. In the first embodiment the second valve 58 is inserted in
line with the second tubing section 40 between the distal outlet 34 of the
pump 30 and the proximal inlet to the second tubing section 40.
Alternatively, the second tubing section 40 may be formed of two parts
with the valve 58 located between the two parts.
In addition, a tubing clamp 60 is provided on the second section of tubing
40. The tubing clamp 60 may be of a conventional type that is located on
the exterior of the flexible second section of tubing 40 and is manually
operable to releasibly squeeze the exterior of the second section of
tubing 40 to restrict the flow therethrough. The clamp 60 is preferably of
the type that provides for a range of adjustment positions from fully open
to fully closed.
To use the irrigation tubing set 10 of FIG. 1 in an intraoperative
procedure, the fitting 18 of the irrigation tubing set 10 is connected to
the source of fluid 20, as shown. The source of fluid 20 is preferably
provided by suspending one or more bags of water on an IV pole 62 so that
the fluid flows by gravity through the tubing set 10. The tubing set 10 is
preferably primed by actuating the pump 30 repeatedly to expel
substantially all air from the tubing set. Then, the irrigation tubing set
10 is connected to the intraoperative instrument 50. The clamp 60 is
opened so that fluid flows through the intraoperative instrument 50. The
delivered fluid pressure is provided by the height of the water bag above
the intraoperative instrument 50. In this way, the fluid pressure is
relatively low, relatively constant and easily controlled. Because the
valve 58 permits fluid flow from the fluid source 20 toward the
intraoperative instrument 50, fluid will flow through the continuous fluid
path provided by the first section of tubing 14, the pump 30, and the
second section of tubing 40. This rate of fluid flow is a function of the
fluid pressure (i.e. which is related to the height of the fluid source
bag) and the resistance of the entire fluid path. The resistance of the
fluid path may be adjusted by manual adjustment of the clamp 60. If the
clamp 60 is fully open, fluid will flow freely through the tubing set 10
and the fluid flow can be relatively high. The clamp 60 may be adjusted to
restrict the flow through the tubing set 10 so that the flow rate is
relatively low, e.g. a trickle. The flow rate may also be adjusted by
changing the height of the hanging bags 20. Thus, the irrigation tubing
set 10 may provide for a continuous flow or trickle of fluid from the
fluid source 20 to the intraoperative instrument 50. This continuous flow
or trickle is advantageous as it helps to irrigate the surgical site and
keeps the surgical area around the tip of the intraoperative instrument
clear. Also, the trickle flow is low enough so that it does not interfere
with normal progress of the surgical procedure.
The irrigation tubing set 10 of FIG. 1 has the further advantage that it
can be used to provide a relatively large amount of water, if desired.
Although a small flow or trickle of water may be desirable on a continuous
basis, occasionally the physician may need to deliver a substantial amount
of water to flush an area. In order to provide a relatively large amount
(i.e. a bolus) of water to the surgical site, the physician can operate
the pump 30. This is readily performed in the embodiment of FIG. 1 by
manually squeezing the tubular pump 30. As mentioned above, the pump 30
becomes filled with water when the irrigation tubing set is connected to
the source of fluid 20. Upon squeezing the tubular pump, the fluid
pressure inside the pump increases. Therefore, the fluid is delivered
through the second section of tubing 40 toward the intraoperative
instrument 50 and to the surgical site. The first valve 35 prevents fluid
from flowing from the pump 30 back into the fluid source 20 when the pump
30 is squeezed. The second valve 58 allows fluid to flow from the pump 30
toward the intraoperative instrument, but prevents fluid from being back
pressured toward the fluid source, especially if the bag of water runs
out.
The embodiment of FIG. 1 may be used in conjunction with surgeries in which
the operative site is not pressurized (i.e. at ambient pressure). In
addition, the embodiment of FIG. 1 could also be used in conjunction with
surgical procedures in which the operative site is pressurized (e.g.
insufflated) provided that the relative pressures were taken into account.
Also, although the pump of FIG. 1 is described as a tubular pump, other
types of pumps may also be used such as bulb pumps, syringes, foot pedal
type pumps, piston pumps, and so on.
Referring to FIG. 2, there is shown a second embodiment of the present
invention. The second embodiment is similar in certain respects to the
first embodiment and similar components are indicated by the same numerals
incremented by 100. Components in the second embodiment may have the same
size and composition as similar components in the first embodiment, except
where noted.
In the embodiment of FIG. 2, there is an irrigation tubing set 110 having a
first section of tubing 114 that defines a first fluid passage 116. A
fitting 118, such as a spike 123, provides for a suitable connection with
a fitting 122 on a source of irrigating fluid 120. As in the first
embodiment, a spike cover 124 may be provided.
Connected to the opposite end of the first section of tubing 114 is a pump
130. In this embodiment, the pump 130 is a bulb pump. The bulb pump is
composed of a resilient, hollow, flexible plastic bulb defining an
internal chamber 132 and having an inlet 133 and an outlet 134. The
internal chamber 132 is in fluid communication with the first fluid
passage 116. The bulb pump 130 fills with fluid and assumes an expanded
size under pressure applied by the source of fluid 120. The bulb pump is
sized appropriately for grasping manually. For example, the bulb pump is
approximately 4 inches in length and 15/8 inches in diameter. A suitable
bulb pump is commercially available from Halkey-Roberts Corp. of St.
Petersburg, Fla.
Connected to the outlet 134 of the pump 130 is a second section of tubing
140 defining a second fluid passage 142. Located at a distal end of the
second section of tubing 140 is a second fitting 144 that provides for a
suitable connection with a fitting 152 on an intraoperative instrument
150. A tubing clamp 160 is located on the second section 140 of tubing.
Located in the first fluid flow passage 116 between the source of fluid 120
and the pump 130 is a first valve 135. The first valve 135 is oriented so
that it restricts flow in the first fluid flow passage 116 so that fluid
flow is in the direction from the source of fluid 120 toward the pump 130
(direction of arrow 131) and not from the pump 130 back toward the source
of fluid 120. A commercially available valve may be used, such as a welded
pillow valve available from Haemotronic, Fairfield, N.J. In this
embodiment, the first tubing section 114 is formed of two parts, 114A and
114B, with the first valve 135 located between the two parts.
The second embodiment 110 also includes a second valve 158 located in the
second fluid flow passage 142 to restrict flow in the direction from the
pump 130 toward the intraoperative instrument 150 (direction of arrow
159). In this embodiment, the second valve 158 may be identical to the
first valve 135. In this embodiment, the second tubing section 140 is
formed of two parts 140A and 140B with the second valve 158 located
between the two parts.
The second embodiment also includes an air bleed-off valve 174 located at
the inlet 133 to the pump 130.
In this embodiment of the irrigation tubing set, preparation and operation
is similar to that of the previous embodiment. The irrigation tubing set
110 is connected to the source of fluid 120 which is suspended on an IV
pole 162. The tubing set 110 is preferably primed by actuating the pump
130 repeatedly to expel substantially all air from the tubing set. The
bleed-off valve 174 may be opened at this stage to assist in expelling air
from the tubing set.
The irrigation tubing set 110 is connected to the intraoperative instrument
150 and the clamp 160 is opened. The delivered fluid pressure is provided
by the height of the water bag 120 above the intraoperative instrument
150. Like the previous embodiment, the irrigation tubing set 110 has the
advantage that it can be | | |
