CA2130566C - Method and apparatus for relieving excess insufflation pressure - Google Patents
Method and apparatus for relieving excess insufflation pressure Download PDFInfo
- Publication number
- CA2130566C CA2130566C CA002130566A CA2130566A CA2130566C CA 2130566 C CA2130566 C CA 2130566C CA 002130566 A CA002130566 A CA 002130566A CA 2130566 A CA2130566 A CA 2130566A CA 2130566 C CA2130566 C CA 2130566C
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- CA
- Canada
- Prior art keywords
- receptacle
- fluid
- body cavity
- insufflation
- gas
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
- A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3348—Pressure measurement using a water column
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Endoscopes (AREA)
- Examining Or Testing Airtightness (AREA)
Abstract
A method and apparatus for relieving insufflation pressure in a body cavity (18) in excess of a predetermined value are provided. A conduit assembly (24) extends from the body cavity (18) through the surface (61) of a fluid reservoir and has a port (63),positioned beneath the fluid surface (61). The relief pressure is selected by setting the relative positioning of the open end (63) and fluid surface (61). The apparatus avoids insufflation gas leakage problems associated with known insufflation pressure relief devices.
Description
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METHOD AND APPARATUS FOR RELIEVING
EXCESS INSUFFLATION PRESSURE
FIELD OF THE INVENTION
This invention pertains to an improved apparatus for relieving insufflation pressure in excess of a predetermined value during surgical procedures wherein a body cavity is insufflated.
BACKGRAUND OF THE INVENTION
- -Certain surgical procedures involve insufflation, i.e., introducing a gas such as certain inert gases or air into a body cavity: One such procedure is laparoscopic surgery. Laparoscopic surgery is a minimally invasive type of surgical procedure wherein surgical instruments and imaging eq~ipm~nt are inserted into a body cavity through an access cannula, thereby avoiding the need for large incisions. In such procedures, it is common to introduce a gas into he body cavity to separate a wall of the body cavity or ~ther t~a~ue from the surgical site.
Sufficient clearance is thus pr~vided °~o facilitate insertion and manipulation og the surgical instruments and view.~.ng equipment It is important to monitor the introduction of the ~n~uff~.ation gas and °the insufflation pressure in the body cavity fluxing surgery. F~r e:~ample, a reduction in 2~ patient vital signs may result if the insufflation pressure is too high. It i.s thus desirable to maintain the insufflation pr~s~ure within a range where adequate insufflation is provided substantially without affecting ~~.30JC~
'WO 93/18704 PCT/US93/UZ388 _z_ the patient's vita2 signs. Tn addition, pressurized insufflation gas may spread from the surgical site into the patient's body resulting in post~surgery pain.
Moreover, a high insufflation gas delivery rate can result in rapid depletion of the gas source, i.e., a gas canister, necessitating changing or replenishing of the source and prolonging surgery. For these and other reasons, it is useful to account for the insufflation gas and monitor the insufflation pressure.
Heretofore, the insufflation pressure has commonly been regulated by using a mechanical pressure relief valve which opens, thereby partially venting the body cavity, when the insufflation pressure reaches a predetermined limit. One such type of mechanical valve involves the use ~.5 of a biasing device such as a spring to provide a back pressure such that the valve regains closed until the insufflation pressure is sufficient tc~ overcome the back pressuxe. Thus, in theoxy, the insufflation pressure can be maintained below a desired liimit in such devices by selecting an appropriate biasing device or device setting.
However, it has been found that such mechanical pressure relief valves may leak under normal operating conditicans. It is; often desired to maintain the ;' insufflation pressure within a narrow pressure range 2~ during surgery. Fog example,'during leper~scopic surgery, surgeA~ts comm~nly insufflate the b~dy cavity to approximately 1~ mm Hg~~wever, it~is generally desired .
td keep the insufflatior~ pressure below about 16 mm Hg to ~Jf Pf . ~, . _ p ' I x ~~
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~ ~,J.~:rs." ~ . . "~x. . ,.,.. .,.r ,t , , , . ,."" .,.. .. . . . .:...,. , .~ . .,., WO 93/18704 PC.T/~JS9310238$
METHOD AND APPARATUS FOR RELIEVING
EXCESS INSUFFLATION PRESSURE
FIELD OF THE INVENTION
This invention pertains to an improved apparatus for relieving insufflation pressure in excess of a predetermined value during surgical procedures wherein a body cavity is insufflated.
BACKGRAUND OF THE INVENTION
- -Certain surgical procedures involve insufflation, i.e., introducing a gas such as certain inert gases or air into a body cavity: One such procedure is laparoscopic surgery. Laparoscopic surgery is a minimally invasive type of surgical procedure wherein surgical instruments and imaging eq~ipm~nt are inserted into a body cavity through an access cannula, thereby avoiding the need for large incisions. In such procedures, it is common to introduce a gas into he body cavity to separate a wall of the body cavity or ~ther t~a~ue from the surgical site.
Sufficient clearance is thus pr~vided °~o facilitate insertion and manipulation og the surgical instruments and view.~.ng equipment It is important to monitor the introduction of the ~n~uff~.ation gas and °the insufflation pressure in the body cavity fluxing surgery. F~r e:~ample, a reduction in 2~ patient vital signs may result if the insufflation pressure is too high. It i.s thus desirable to maintain the insufflation pr~s~ure within a range where adequate insufflation is provided substantially without affecting ~~.30JC~
'WO 93/18704 PCT/US93/UZ388 _z_ the patient's vita2 signs. Tn addition, pressurized insufflation gas may spread from the surgical site into the patient's body resulting in post~surgery pain.
Moreover, a high insufflation gas delivery rate can result in rapid depletion of the gas source, i.e., a gas canister, necessitating changing or replenishing of the source and prolonging surgery. For these and other reasons, it is useful to account for the insufflation gas and monitor the insufflation pressure.
Heretofore, the insufflation pressure has commonly been regulated by using a mechanical pressure relief valve which opens, thereby partially venting the body cavity, when the insufflation pressure reaches a predetermined limit. One such type of mechanical valve involves the use ~.5 of a biasing device such as a spring to provide a back pressure such that the valve regains closed until the insufflation pressure is sufficient tc~ overcome the back pressuxe. Thus, in theoxy, the insufflation pressure can be maintained below a desired liimit in such devices by selecting an appropriate biasing device or device setting.
However, it has been found that such mechanical pressure relief valves may leak under normal operating conditicans. It is; often desired to maintain the ;' insufflation pressure within a narrow pressure range 2~ during surgery. Fog example,'during leper~scopic surgery, surgeA~ts comm~nly insufflate the b~dy cavity to approximately 1~ mm Hg~~wever, it~is generally desired .
td keep the insufflatior~ pressure below about 16 mm Hg to ~Jf Pf . ~, . _ p ' I x ~~
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avoid over-insufflation problems such as described above.
Thus, pressure relief valves may be exposed to pressures near the selected relief pressure during surgery. Known mechanical pressure relief valves may leak as the a.nsufflation pressure approaches the relief pressure and therefore fail to provide abrupt and positive pressure relief . As a result, the surgeon ° s ability to monitor the insufflation pressure and account for the insufflation gas may be impaired. In addition, the total amount of ~.0 insufflation gas required during surgery may be increased due to the leakage. Moreover, because such mechanical pressure relief valves generally do not provide a visual indication when" the relief pressure is exceeded, the surgeon nay continue ~o introduce insufflation gas not knowing that the relief pressure has been exceeded, thereby possibly posing a ri:~k to the patient and further increasing gas usage.
Tt is a further disadvantage of known mechanical pressure relief valves that such valves utilize moving parts wha.ch may malfuhction or require maintenance.
More~ver, some known mechanical pre~sube relief valves are of relatively complicated c~nstruc~a.on: Such valves thereby increase costs, particularly when used in disposable medical applications.
~1305G6 W~ 93/1~70A ~ ' P~C:T/L1S93/023H8 ., SUMMARY OF THE INVENTION
The present invention provides a method and apparatus for relieving insufflation pressure in a body cavity in excess of a predetermined value. The invention provides abrupt and positive pressure relief and reduces leakage problems associated with prior art devices. The invention also provides a visual indication when the relief pressure is exceeded, thereby increasing safety and reducing gas usage. In addition, an apparatus constructed in accordance with the present invention does not require moving parts thereby avo~.da.nc~ maintenance and reducing the likelihood of malfunction. Moreover, the present intention provides an apparatus which is of simple construction and may be produced inexpensively. The present invention therefore lends itself to disposable ~pplicata.ons such that peat use sterilization is unnecessary and contamination concerns are reduced.
According to,~ne aspect of the present invention, an apparatus for relieving insufflation pressure in a body ;, cavity in excess of a predetermined value is provided.
The apparatus comprises ~ receptacle containing a fluid and an insufflataora gas ea~haust assembly. The exhaust assembly extends into the fluid contained in the receptacle and has a;first end positioned a predetermined distance beneath the top surface of tlae fluid contained in the receptacle such that insufflation gas is exhausted from the body cavity via the first end of the exhaust assembly whew the insufflation pressure exceeds the PC,'f/US93/02388 predetermined value. That is, the fluid exerts a back pressure on the exhaust assembly such that insufflation gas does not flow through the port unless the insufflation pressure exceeds the back pressure. Thus, the relief pressure can be selected by setting the predetermined distance between the top surface of the fluid in the receptacle and the first end of the exhaust assembly, e.g., by changing the fluid level in the receptacle or by moving the first end relative to the top surface of the fluid. The exhaust assembly can comprise a tube which is adapted for interconnection to an exhaust port from the body cavity. The exhaust assembly preferably includes a conduit which is fixed with respect to the receptacle such that the predetermined distance is set by adding or subtracting fluid from the receptacle. The receptacle can 'GOmprise a back or other rigid, or non-rigid container.
Preferably, the receptacle is at least partly transparent, i.e., the receptacle iswholly or partially comprised of transparent or translucent material. Additionally, the ~0 receptacle is preferably formed from inexpensive materials, such as certain'plastic materials, as it is desirable ~o dispose of the receptacle after use.
Calibration markings may be provided on the receptacle to assist in setting the f3uid level. The ~lu~,d surface can be exposed to the ambient atmosphere:. The fluid should be a sterile so3.ution such as sterile saline soluta.on.
p~cc~rding to another asgect of the present invention, an insufflation system is p~ovi:deds The system comprises ;..,. : ::.:.. ... . ;.: . . _ ~ ;v : ,." ~' ~ . ::';
:.. ,. ,~ ., .:~~..,. .,... .. ..
210 ~~6 ', .~
dV0 93/18704 PCI'/US93/02388 an insufflation gas source, an inlet assembly for one-way delivery of gas from the gas source to a body cavity, and an outlet assembly for one-way venting of insufflation gas from the body cavity. The outlet assembly extends from the body cavity into a fluid contained in a receptacle and includes a first end submerged a predetermined distance beneath the surface of the fluid contained in the receptacle. The fluid may comprise a sterile fluid such as sterile saline solution.
20 according to a further aspect of the present invention, a method for relieving excess insufflation pressure in a body cavity is provided. The method includes the steps of providing an insufflation gas exhaust assembly including a receptacle cantaining a fluid and an exhaust lane extending from a body cavity into the fluid, and establishing one-way insufflation gas communication from the body cavity to the receptacle via the exhaust line. The step of establishing can be acco~onplished by pressurizing the body cavity such that ~ insufflati~n gas flows therefrom and/or opening a valve or cover to allow flow through tlhe eonduit assembly.
According to a still further aspect of the present invention, a method for venting a body cavity is provided.
The method comprises the steps of setting the relative positioning between a first end of an exhaust line extending from a body cavity and the top surface of a fluid contained in a receptacle s~ that the f~.rst endl is positioned a preselected distance beneath the surface and 21305~~
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establishing one-way insufflation gas communication from the body cavity to the receptacle via the exhaust line.
Insufflation gas thus flaws from the body cavity to the first end of the exhaust line when the insufflation pressure exceeds a predeteranined value. The relative positioning between the first end and the fluid surface can be selected by changing the fluid level in a receptacle or by moving the first end of the exhaust lane.
The method can further include the step of flowing insufflation gas from a gas source to the body cavity.
BRIEF DE5CRI1~'TION OF THE DFtAjnTING~
For a more complete understanding of the present invention and for further advantages thereof, reference is now made to the following detailed description taD~~n in conjunction with the accompanying drawings, in whichs Fig. 1 is a front view of an insufflation system constructed in accordance with an embodiment of the present invention;
Fig: 2 is a front ~riew of a receptacle which can be used in the system of F'iga 1: and Fig. 3' is ~ front view of another receptacle constructed ~.n accordance with the present invention.
DETAILED D~SCRaFTION OF THE ~NVEN'~ION
Referring t~ Fag. 1, an insufflation system 25, constructed in accordance with the present invention is generally ident~.fied 'by the reference numeral 10. The .v:.~:l7fl. . . .. , .. ...., . ~ ~ . . . ...., n ~~.~oJ~~
'W~ 9311$7U4 , PCT/US93/0238R
_8_ system 10 comprises an insufflation gas source 12, a gas delivery conduit assembly 14, and a pressure relief assembly 16. A control unit 15 for controlling gas flow from the gas source 12 may be included within gas delivery conduit assembly 14.
~ The system 10 can be used in connection with any insufflation application wherein it is desired to relieve insufflation pressure in excess of a preselected value.
In the illustrated embodiment, the system 10 is depicted in a typical laparoscopic surgery setting. Tn such a setting, for example, a body cavity, generally identified by the reference numeral 18, of a patient 20 may be insufflated to provide clearance between the surgical site and the abdominal wall or other surrounding tissue, 35 thereby facilitating manipulation of surgical tools and viewing equipment.
An insufflation gas is delivered from the gas source 12 to the body cavity 18 through the gas delivery assembly 14. The gas source 12 can be a canister of a known insufflation gas, such as C02, and can be incorporated into a gas cart (not shown) or provided separately. A
valve 22 is provided to regulate the flow pf gas from the gas s~urce 12. The gas source 22 and/or control unit 15 can further include a gas flow or pressure meter and/or a gauge t~ monitor the remaining gas supply.
The gas delivery asseanbly l4 sealably engages an outlet of the gas source 12 and extends into the body cavity 1~ to deliver the insufflation gas thereto. Only ~~~o~s~
W~! 93/1f3704 PCT/U593/02388 _g_ one~way gas flow should be permitted through the gas delivery assembly 14 to avoid contamination of the gas source 12 or upstream components. The assembly 14 may comprise a single gas line or a series of gas lines. For example, the insufflation gas may be delivered to the body cavity 18 through a cannula which can also be used to provide access to the surgical site for surgical tools, viewing equipment and the like, thereby reducing the required number of incisions. Thus, the insufflation gas may be routed to the body cavity 18 through a gas l ine from the source 12, internal passageways of a surgical instrument, and a cannula. Alternatively, a separate conduit assembly dedicated to delivery of the insufflation gas may be provided, and the gas source 12, may be interconnected to an inlet port ~f an access cannula 29, as shown.
A pressure relief assembly 16 is provided to relieve insuffiatioa~ pressure in the body cavity 18 in excess of a predetermined value. The assembly 16 comprises a gas outlet conduit subassembly 24 eactending from the body cavity l8 and a fluid reservoir subassembly 32 for selectively relieving excess insufflatfon pressure. The gas outlet subassembly 24 may comprise a series of gas lines for selectively delivering insufflation gas from the body cavity l8 to the flu~:d reser~roir subassembly 32, or the gas outlet subassembly 24 may be provided by way of a single tube. In the illustrated embodiment, the gas outlet subassembly 24 comprises a length of flexible tubing 26 which sealably engages an exhaust port 28 of the access cannula 31. The tubing 26 should have a width sufficient to~accommodate flow of insufflation fluid therethrough with little resistance. For example, the tubing 26 can have an inside diameter of about 1/4-3/16 inch. The tubing 26 can be sealably attached to the cannula 31 by way of a standard LUERT"~ lock, frictional engagement, or other means. If desired, a valve or cover can be included in the gas outlet subassembly 24 to selectively close fluid communication between the body cavity 18 and the reservoir subassembly 32.
Generally, the reservoir subassembly 32, which will be described in greater detail below, comprises a fluid reservoir and an insufflation fluid passageway separated from the reservoir by a substantially fluid impermeable barrier. The insufflation fluid passageway extends through the reservoir fluid surface and has an open end a predetermined distance beneath the surface. It will thus be appreciated that the reservoir fluid will fill the insufflation fluid passageway to the level of the surface of the reservoir if the pressure in the insufflation fluid passageway is equal to the pressure exerted on the surface of the reservoir. If the pressure in the insufflation fluid passageway is, greater than the pressure on the surface of the reservoir, the level of reservoir fluid in the i.nsufflatior fluid passageway will be reduced accordingly. Thus, because insufflation pressure is communicated from the body cavity 18 to the insufflation WU 93/~~7~14 ~ ~ ~ j ~ ~ fCT/US93/02388 fluid passageway, insufflation fluid can pass from the body cavity 18, through the open end of the insufflation fluid passageway, and to the surface of the reservoir when the insufflation pressure is sufficiently greater than the pressure on the surface of the reservoir. ~.t the surface, the insufflation fluid may be vented to the ambient atmosphere or the fluid may be collected and/or filtered.
The parameters involved in determining the relief pressure of the pressure relief assembly thus include the density of the reservoir fluid, the pressure exerted on the~surface of the reservoir and the distance between tine reservoir surface and the open end of the insufflation fluid passageway. It will therefore be appreciated that many configurations of the reservoix° subassembly 32 are possible. For example, the reservoir subassembly 32 can comprise a bottle, beaker, bag or other receptacle and the reservoir surface can be exposed to the ambient atmosphere or to non-atmospheric pressure. ,A flexible bag or other inexpensive, easily disposed receptacle is preferred as it is desirable to dispose of the receptacle after use to avoid sterilisation costs and attendant risks. The insufflation fluid passageway can be an integral portion of a receptacle or may be preovid~d by way of a conduit which is moveable re~.ata.ve to such a receptacle. The distance b~etw~en the reservoir suxface and the open end of the insufflatiQn fltaa.d passageway can therefore be .
adjusted by changing the reservoir fluid level or by mooring such a moveable conduit relative to the receptacle .
~~.3056G
'VV~ 93/18704 Pt'T/US93/02388 As shown, separate cannulas 29 and 31 are provided to allow separate access to the body cavity I8 for assemblies 14 and 15 and to allow.for one-way insufflation gas flow throughout the system 10. This construction provides a number of advantages. First, since the pressure relief assembly 26 does not communicate with the gas delivery assembly 14 (other 'than via body cavity 18), accurate regulation of the insufflation pressure in the body cavity 18 is insured. It has been found that systems which attempt to regulate the insufflation pressure in a body cavity by monitoring pressure in an insufflation gas delivery line can be inaccurate due to differences between the pressure inside the body cavity and in the delivery line. Such differences result at least in part from back pressure reflected from the inlet part t~ the body cavity which is normally somewhat restricted. The present invention avoids this problem by positioning the reservoir subassembly 32 downstream from the bodgr~cavity 18 in a one-way flow system 10. The illustrated construction also lends itself to disposable, add-~an applications. That is, the pressure relief assembly 16 or portions thereof can be pravided separately and disposed of aftex use. Other advantages will be apparent to those skilled in the art.
In the emb~diment of Figs. 1 and 2, the reservoir subassembly 3~ comprises a receptacle 44 such as a bag formed from flex~.ble elastomeric material. Preferably, the receptacle 44'is at least partly transparent to allow viewing into the receptacle 44. The receptacle 44 can _ tn,, Y,."a~~1.'.:'. _ f ..h..:.' 7 r...-...;~.o.. .r ~:~
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;,..~ ., , _ , . . , l' 7, ,...,..m.ii.o , ..~~Y. ....n .. a ....... , .. ...,...,u. " . . " "; 1 ".,. ." ,.,....,. .. ~...f~~......~" . , .. ~ , e, . .....
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_~3_ conveniently be constructed by attaching two thin sheets together at portions thereof, e.g. by heat sealing, RF
bonding, adhesive bonding or other technique, to form an internal fluid retaining space 46. The illustrated receptacle 44 includes an insufflation gas conduit portion 48 and a reservoir portion 50 wherein the portions 48 and 50 are separated by a substantially fluid impermeable barrier 51. The barrier 51, which can be formed by sealing the front and back walls of the receptacle 44 together, extends downwardly from a top. edge 5B of the .
receptacle 44. A gap 54 is prov~.ded in the barrier 5l or between the barrier 42 and a bottom wall 56 of the receptacle 44 to allow fluid communication between the portions 48 and 50. PreferablyP the gas conduit portion 48 has relatively small volume as compared to the reservoir portion 50 such that a change in fluid level in the gas conr~uit 48 results in a smaller change in the fluid level in the reservoir portion 50:
lnsufflation gas is introduced into the conduit portion 48 through adapter tube 58:' The adapter tube 58, which is s~alably disposed within a peripheral seal 60 of the receptacle 44 above the fl.uid surface 61, is adapted to sealably engage tubing 26 from the body cavity 18 of the patient ~0. The adapter tube 58 and the tubing 26 may b~ interconnected by way of a lockang assembly such ay~: a Luer lock, frictional ~ngagemen~ or other means. In the ~.llustr~ted emb~dimerat, the adapter tube 58 and tubing ~6 are friction fitted so that a seal is formed between the 2~.3~~~!~
W~ 931af~704 PCT/US93/0238$
-~.4-adapter tube 58 and tubing 26 when they are mated. The illustrated receptacle 44 also includes a second tube 62 which extends through the peripheral seal 60 above the fluid surface 61 into the reservoir portion 50 of the receptacle 44. The tube 62 allows venting of the insufflation gas and can be used to add fluid to the receptacle 44.
The receptacle 44 may be adapted to be hung out of the way during surgery, thereby conserving operating theater space and reducing the likelihood of tilting or spilling of the receptacle 44 or its contents. As illustrated, the receptacle 44 is provided with a bulge 64 including a sealed opening 66 for this purpose. The receptacle 44 can thus be hung from an IV or plasma bag stand 65 or other hanger assembly. Preferably, the opening S6 is positioned apt or near a longitudinal axis 68 ; .
~of the receptacle 44 so that the axis 68 tends to orient vertically when fluid is added to the receptacle 44.
As shown in Figure 2; markings aan be provided on the receptacle 44 for use xn setting the desired relief pressure. because the relief pressure is proportional to the distance ~ between the ~pen end ~r gort 63 of the insufflation gas coa~duit portion 48 and the surface 61 of the reservoir f~.uid, the relief pressure can be set at a desired ,lwel by filling he receptacle 44 with the fluid until the fluid reaches the appropriate level. Various fluid levels and,~or associated relief pressure settings can thus be conveniently calibrated by placing markings rV0 93/18704 ~ ~ ~ ~ ? ~ ~ fCT/dJS93/0~38R
-~ 15-directly on the receptacle ~4. Calibration can be accomplished experimentally or by using known formulas, e.g., relating 1 mm Hg to a depth of the reservoir fluid.
It will be appreciated that many different reservoir fluids can be used in accordance with the present invention. However, the reservoir fluid should be a sterile fluid such as 7% sterile saline solution to reduce the likelihood of contamination in the event that the fluid enters the body cavity 18.
Referring to Fig. 3, a front view of a receptacle 70 constructed in accordance with an alternative embodiment of the present invention is shown. The receptacle 70 can comprise a battle, beaker, bag or other container.
Preferably, the receptacle 70 is at least partly transparent to allow viewing. of the reservoir fluid 72 therein and to allow viewing of bubbles rising through the fluid 72 when the predetermined rela.ef pressure is exceeded. ~n the illustrated embodiment, the receptacle 70 is formed from two sheets of clear plastic which are sealed together at peripheral portions thereof to define an internal fluid r~taa:ning space. For ease of construction, the a.llustrated receptacle 70 is formed from sheet materials which can be sealably attached together by heat seala~ag or RF welding. Alternatively, the sheets ~5 could; be attached tbgether by an adhe~~.ve or other means.
xnsufflation fluid from a body cavity i~ introduced into the rec~ptacl~ 7p by way ~f a conduit assembly including a tube 74 and a channel 76. Tlae tube 74, which 2130~GG
W~ 93/1870a ~ PCT/LJS93/02388 ~z6~
is in fluid communication with the body cavity, extends through a bottom edge 78 of the receptacle 70 and has an open end 80 within the channel 76. A seal 84 is provided in the bottom edge 78 about the tube 74 to substantially prevent leakage of reservoir fluid 72. Any suitable means may be ut~.li~ed to provide the seal 84. In the illustrated embodiment, the seal 84 comprises a widened portion wherein the sheet materials of the receptacle are heat sealed or RF welded together. Preferably, the open end 80 is positioned above the surface 82 of the reservoir fluid 7 2 to reduce the l ~.kel ihood that fluid 7 ~ wil l f l ow through the tube 74 to the body cavity.
The channel T6 extends downwardly from a top edge 86 of the receptacle 70 and has a port 88 positioned a ~:5 predetermined distance D beneath the surface 82. The channel 76 has an inside width W~ greater thin an outside width W~ of the tube 74 such that insufflation fluid can flow therebetween. It will be appreciated that the channel 76 is sealed at an upper edge 90 so that insufflation fluid flowing from the body cavity can only escape from the conduit assembly through port 88. In this re~asd, the channel 76 may comprise, for example, a tube having a sealed upper end. In tie illustrated embodiment, the channel 76 3.s formed by sealing portions of the sheet materials of the receptacle 70 together, e.g., by heat sealing or RF bonding. Preferably, the channel 76 is positioned along a vertidal centerline 92 of the receptacle 70 to reduce horizontal movement of the center WO 93/18704 ~ ~ 3 ~ j ~ ~ PCT/US93/023$8 of gravity and tilting of the receptacle 70 due to flow of reservoir fluid 72 into or out of the channel 76. The illustrated configuration has also been found to reduce or eliminate the incidence of undesired clinging of the opposing sheet materials of the receptacle 70, which clinging could obstruct the flow of insufflation fluid.
The receptacle 70 further includes at least one opening through a wall of the receptacle 70 above the surface 82 to allow introduction of reservoir fluid 72 to the receptacle 70 and escape of insufflation fluid therefrom. an the illustrated'embodiment, wherein the channel 76 is provided' by sealing the sheet materials of the receptacle 70 t~gether such that insuf~lation fluid cannot flow around the channel 76 above the surface 82, 1~ openings are provided in the receptacle 70 on both sides of the channel 76: As sha~r~rn, the openings comprise tubes ~94 sealably extending through the top edge 86 of the receptacle 70. The i~;lustrated receptacle also includes a hole ~'6 positioned on or near the centerline 92 to allow the receptacle to be hung from an IV stand or otheg hanger, hereby conserving space in the operating theater.
In addition,: the illustrated receptacle includes markings 98 on a su=face thereof to ' aid ' in setting the reservoir fluid le el.
Tn operation, an insufflation system constructed in accordance with an embodiment of the present invention can be used as full~ws. Operating room personnel can first remove a disposable bag and tuMng from protective ,~.,.,.. .. ~.:~ ... >.-:~..._. ;: ......~. _.w....<<,.....:........: .-.r_ ..:~. ...:.......: .~x...... :~ ._......: _... ..: ..:,,. .,.:..
~1~O~GG
"I~VV~ X3/18704 PCT/U593/023~8 packaging using aseptic techniques. The bag and connected tubing can then be passed outside of a sterile field, retaining a free end of the tubing in the sterile field.
~ ' 4 The bag can be hung on an IV stand or other hanger and filled with sterile saline solutis~n to the desired relief pressure as indicated by markings on the bag. The free end of the tubing can then be connected to the vent port of a cannula extending from a body cavity of a patient.
Insufflation fluid is delivered from a source to the body cavity, e.g., ~y opening valves; try provide the desired insufflation pressure. When in use, bubbles will be seen rising through the reservoir fluid whenever the set relief pressure is exceeded: After use, the tubing should be detached frog the cannula, or f3.uid communication between ~;5 the bag and'e~nnula should otherwise be closed, prior to removing the cannula from the patient. The bag and tubing, which are of simple canstruction, can be discarded after use in accordance with accepted medical procedures.
The gresent invention has a -number of advantages over 24 known insufflation systems. The gresent invention provides arc insufflation system capable of abrupt and positive gressure relief. An apparatus constructed and used in accordance with the present invention can thus function near he'selected relief pressure substantially 25 without leakage of he inshfflati~n gas. A physician's ability td monitor the insuf~lation~ pressure and account for the ia~sufflation gas is therefore enhanced. Yn addition, the likelihood of depleting the insufflation gas 2~30~~~
source during surgery is reduced thereby avoiding time consuming interruptions during surgery. The present invention also provides a visual indication, i.e., bubbles, when the relief pressure is exceeded. Moreover, the present invention provides a pressure relief apparat~a of simple construction which lends itself to disposable applications. The present invention also provides a pressure relief apparatus which can be constructed without moving parts which may malfunction or require maintenance.
Additional advantages of the present invention will be apparent to those ski~.led ira the ast.
While the present invention has been described in relation to specific embodiments thereof, additional alternative embodiments apparent to those skilled in the art in view of the present disclosure are intended to fall within the scope of the .present ~nventi,an as further defined by the.claims yet farth below.
Thus, pressure relief valves may be exposed to pressures near the selected relief pressure during surgery. Known mechanical pressure relief valves may leak as the a.nsufflation pressure approaches the relief pressure and therefore fail to provide abrupt and positive pressure relief . As a result, the surgeon ° s ability to monitor the insufflation pressure and account for the insufflation gas may be impaired. In addition, the total amount of ~.0 insufflation gas required during surgery may be increased due to the leakage. Moreover, because such mechanical pressure relief valves generally do not provide a visual indication when" the relief pressure is exceeded, the surgeon nay continue ~o introduce insufflation gas not knowing that the relief pressure has been exceeded, thereby possibly posing a ri:~k to the patient and further increasing gas usage.
Tt is a further disadvantage of known mechanical pressure relief valves that such valves utilize moving parts wha.ch may malfuhction or require maintenance.
More~ver, some known mechanical pre~sube relief valves are of relatively complicated c~nstruc~a.on: Such valves thereby increase costs, particularly when used in disposable medical applications.
~1305G6 W~ 93/1~70A ~ ' P~C:T/L1S93/023H8 ., SUMMARY OF THE INVENTION
The present invention provides a method and apparatus for relieving insufflation pressure in a body cavity in excess of a predetermined value. The invention provides abrupt and positive pressure relief and reduces leakage problems associated with prior art devices. The invention also provides a visual indication when the relief pressure is exceeded, thereby increasing safety and reducing gas usage. In addition, an apparatus constructed in accordance with the present invention does not require moving parts thereby avo~.da.nc~ maintenance and reducing the likelihood of malfunction. Moreover, the present intention provides an apparatus which is of simple construction and may be produced inexpensively. The present invention therefore lends itself to disposable ~pplicata.ons such that peat use sterilization is unnecessary and contamination concerns are reduced.
According to,~ne aspect of the present invention, an apparatus for relieving insufflation pressure in a body ;, cavity in excess of a predetermined value is provided.
The apparatus comprises ~ receptacle containing a fluid and an insufflataora gas ea~haust assembly. The exhaust assembly extends into the fluid contained in the receptacle and has a;first end positioned a predetermined distance beneath the top surface of tlae fluid contained in the receptacle such that insufflation gas is exhausted from the body cavity via the first end of the exhaust assembly whew the insufflation pressure exceeds the PC,'f/US93/02388 predetermined value. That is, the fluid exerts a back pressure on the exhaust assembly such that insufflation gas does not flow through the port unless the insufflation pressure exceeds the back pressure. Thus, the relief pressure can be selected by setting the predetermined distance between the top surface of the fluid in the receptacle and the first end of the exhaust assembly, e.g., by changing the fluid level in the receptacle or by moving the first end relative to the top surface of the fluid. The exhaust assembly can comprise a tube which is adapted for interconnection to an exhaust port from the body cavity. The exhaust assembly preferably includes a conduit which is fixed with respect to the receptacle such that the predetermined distance is set by adding or subtracting fluid from the receptacle. The receptacle can 'GOmprise a back or other rigid, or non-rigid container.
Preferably, the receptacle is at least partly transparent, i.e., the receptacle iswholly or partially comprised of transparent or translucent material. Additionally, the ~0 receptacle is preferably formed from inexpensive materials, such as certain'plastic materials, as it is desirable ~o dispose of the receptacle after use.
Calibration markings may be provided on the receptacle to assist in setting the f3uid level. The ~lu~,d surface can be exposed to the ambient atmosphere:. The fluid should be a sterile so3.ution such as sterile saline soluta.on.
p~cc~rding to another asgect of the present invention, an insufflation system is p~ovi:deds The system comprises ;..,. : ::.:.. ... . ;.: . . _ ~ ;v : ,." ~' ~ . ::';
:.. ,. ,~ ., .:~~..,. .,... .. ..
210 ~~6 ', .~
dV0 93/18704 PCI'/US93/02388 an insufflation gas source, an inlet assembly for one-way delivery of gas from the gas source to a body cavity, and an outlet assembly for one-way venting of insufflation gas from the body cavity. The outlet assembly extends from the body cavity into a fluid contained in a receptacle and includes a first end submerged a predetermined distance beneath the surface of the fluid contained in the receptacle. The fluid may comprise a sterile fluid such as sterile saline solution.
20 according to a further aspect of the present invention, a method for relieving excess insufflation pressure in a body cavity is provided. The method includes the steps of providing an insufflation gas exhaust assembly including a receptacle cantaining a fluid and an exhaust lane extending from a body cavity into the fluid, and establishing one-way insufflation gas communication from the body cavity to the receptacle via the exhaust line. The step of establishing can be acco~onplished by pressurizing the body cavity such that ~ insufflati~n gas flows therefrom and/or opening a valve or cover to allow flow through tlhe eonduit assembly.
According to a still further aspect of the present invention, a method for venting a body cavity is provided.
The method comprises the steps of setting the relative positioning between a first end of an exhaust line extending from a body cavity and the top surface of a fluid contained in a receptacle s~ that the f~.rst endl is positioned a preselected distance beneath the surface and 21305~~
wo ~~v~s~oa ~ ~crvus~3voZ3~~
establishing one-way insufflation gas communication from the body cavity to the receptacle via the exhaust line.
Insufflation gas thus flaws from the body cavity to the first end of the exhaust line when the insufflation pressure exceeds a predeteranined value. The relative positioning between the first end and the fluid surface can be selected by changing the fluid level in a receptacle or by moving the first end of the exhaust lane.
The method can further include the step of flowing insufflation gas from a gas source to the body cavity.
BRIEF DE5CRI1~'TION OF THE DFtAjnTING~
For a more complete understanding of the present invention and for further advantages thereof, reference is now made to the following detailed description taD~~n in conjunction with the accompanying drawings, in whichs Fig. 1 is a front view of an insufflation system constructed in accordance with an embodiment of the present invention;
Fig: 2 is a front ~riew of a receptacle which can be used in the system of F'iga 1: and Fig. 3' is ~ front view of another receptacle constructed ~.n accordance with the present invention.
DETAILED D~SCRaFTION OF THE ~NVEN'~ION
Referring t~ Fag. 1, an insufflation system 25, constructed in accordance with the present invention is generally ident~.fied 'by the reference numeral 10. The .v:.~:l7fl. . . .. , .. ...., . ~ ~ . . . ...., n ~~.~oJ~~
'W~ 9311$7U4 , PCT/US93/0238R
_8_ system 10 comprises an insufflation gas source 12, a gas delivery conduit assembly 14, and a pressure relief assembly 16. A control unit 15 for controlling gas flow from the gas source 12 may be included within gas delivery conduit assembly 14.
~ The system 10 can be used in connection with any insufflation application wherein it is desired to relieve insufflation pressure in excess of a preselected value.
In the illustrated embodiment, the system 10 is depicted in a typical laparoscopic surgery setting. Tn such a setting, for example, a body cavity, generally identified by the reference numeral 18, of a patient 20 may be insufflated to provide clearance between the surgical site and the abdominal wall or other surrounding tissue, 35 thereby facilitating manipulation of surgical tools and viewing equipment.
An insufflation gas is delivered from the gas source 12 to the body cavity 18 through the gas delivery assembly 14. The gas source 12 can be a canister of a known insufflation gas, such as C02, and can be incorporated into a gas cart (not shown) or provided separately. A
valve 22 is provided to regulate the flow pf gas from the gas s~urce 12. The gas source 22 and/or control unit 15 can further include a gas flow or pressure meter and/or a gauge t~ monitor the remaining gas supply.
The gas delivery asseanbly l4 sealably engages an outlet of the gas source 12 and extends into the body cavity 1~ to deliver the insufflation gas thereto. Only ~~~o~s~
W~! 93/1f3704 PCT/U593/02388 _g_ one~way gas flow should be permitted through the gas delivery assembly 14 to avoid contamination of the gas source 12 or upstream components. The assembly 14 may comprise a single gas line or a series of gas lines. For example, the insufflation gas may be delivered to the body cavity 18 through a cannula which can also be used to provide access to the surgical site for surgical tools, viewing equipment and the like, thereby reducing the required number of incisions. Thus, the insufflation gas may be routed to the body cavity 18 through a gas l ine from the source 12, internal passageways of a surgical instrument, and a cannula. Alternatively, a separate conduit assembly dedicated to delivery of the insufflation gas may be provided, and the gas source 12, may be interconnected to an inlet port ~f an access cannula 29, as shown.
A pressure relief assembly 16 is provided to relieve insuffiatioa~ pressure in the body cavity 18 in excess of a predetermined value. The assembly 16 comprises a gas outlet conduit subassembly 24 eactending from the body cavity l8 and a fluid reservoir subassembly 32 for selectively relieving excess insufflatfon pressure. The gas outlet subassembly 24 may comprise a series of gas lines for selectively delivering insufflation gas from the body cavity l8 to the flu~:d reser~roir subassembly 32, or the gas outlet subassembly 24 may be provided by way of a single tube. In the illustrated embodiment, the gas outlet subassembly 24 comprises a length of flexible tubing 26 which sealably engages an exhaust port 28 of the access cannula 31. The tubing 26 should have a width sufficient to~accommodate flow of insufflation fluid therethrough with little resistance. For example, the tubing 26 can have an inside diameter of about 1/4-3/16 inch. The tubing 26 can be sealably attached to the cannula 31 by way of a standard LUERT"~ lock, frictional engagement, or other means. If desired, a valve or cover can be included in the gas outlet subassembly 24 to selectively close fluid communication between the body cavity 18 and the reservoir subassembly 32.
Generally, the reservoir subassembly 32, which will be described in greater detail below, comprises a fluid reservoir and an insufflation fluid passageway separated from the reservoir by a substantially fluid impermeable barrier. The insufflation fluid passageway extends through the reservoir fluid surface and has an open end a predetermined distance beneath the surface. It will thus be appreciated that the reservoir fluid will fill the insufflation fluid passageway to the level of the surface of the reservoir if the pressure in the insufflation fluid passageway is equal to the pressure exerted on the surface of the reservoir. If the pressure in the insufflation fluid passageway is, greater than the pressure on the surface of the reservoir, the level of reservoir fluid in the i.nsufflatior fluid passageway will be reduced accordingly. Thus, because insufflation pressure is communicated from the body cavity 18 to the insufflation WU 93/~~7~14 ~ ~ ~ j ~ ~ fCT/US93/02388 fluid passageway, insufflation fluid can pass from the body cavity 18, through the open end of the insufflation fluid passageway, and to the surface of the reservoir when the insufflation pressure is sufficiently greater than the pressure on the surface of the reservoir. ~.t the surface, the insufflation fluid may be vented to the ambient atmosphere or the fluid may be collected and/or filtered.
The parameters involved in determining the relief pressure of the pressure relief assembly thus include the density of the reservoir fluid, the pressure exerted on the~surface of the reservoir and the distance between tine reservoir surface and the open end of the insufflation fluid passageway. It will therefore be appreciated that many configurations of the reservoix° subassembly 32 are possible. For example, the reservoir subassembly 32 can comprise a bottle, beaker, bag or other receptacle and the reservoir surface can be exposed to the ambient atmosphere or to non-atmospheric pressure. ,A flexible bag or other inexpensive, easily disposed receptacle is preferred as it is desirable to dispose of the receptacle after use to avoid sterilisation costs and attendant risks. The insufflation fluid passageway can be an integral portion of a receptacle or may be preovid~d by way of a conduit which is moveable re~.ata.ve to such a receptacle. The distance b~etw~en the reservoir suxface and the open end of the insufflatiQn fltaa.d passageway can therefore be .
adjusted by changing the reservoir fluid level or by mooring such a moveable conduit relative to the receptacle .
~~.3056G
'VV~ 93/18704 Pt'T/US93/02388 As shown, separate cannulas 29 and 31 are provided to allow separate access to the body cavity I8 for assemblies 14 and 15 and to allow.for one-way insufflation gas flow throughout the system 10. This construction provides a number of advantages. First, since the pressure relief assembly 26 does not communicate with the gas delivery assembly 14 (other 'than via body cavity 18), accurate regulation of the insufflation pressure in the body cavity 18 is insured. It has been found that systems which attempt to regulate the insufflation pressure in a body cavity by monitoring pressure in an insufflation gas delivery line can be inaccurate due to differences between the pressure inside the body cavity and in the delivery line. Such differences result at least in part from back pressure reflected from the inlet part t~ the body cavity which is normally somewhat restricted. The present invention avoids this problem by positioning the reservoir subassembly 32 downstream from the bodgr~cavity 18 in a one-way flow system 10. The illustrated construction also lends itself to disposable, add-~an applications. That is, the pressure relief assembly 16 or portions thereof can be pravided separately and disposed of aftex use. Other advantages will be apparent to those skilled in the art.
In the emb~diment of Figs. 1 and 2, the reservoir subassembly 3~ comprises a receptacle 44 such as a bag formed from flex~.ble elastomeric material. Preferably, the receptacle 44'is at least partly transparent to allow viewing into the receptacle 44. The receptacle 44 can _ tn,, Y,."a~~1.'.:'. _ f ..h..:.' 7 r...-...;~.o.. .r ~:~
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;,..~ ., , _ , . . , l' 7, ,...,..m.ii.o , ..~~Y. ....n .. a ....... , .. ...,...,u. " . . " "; 1 ".,. ." ,.,....,. .. ~...f~~......~" . , .. ~ , e, . .....
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wo ~~i~87oa ~ ~ ~ d ~ ~ 6 ~c~ius~3io2~~~
_~3_ conveniently be constructed by attaching two thin sheets together at portions thereof, e.g. by heat sealing, RF
bonding, adhesive bonding or other technique, to form an internal fluid retaining space 46. The illustrated receptacle 44 includes an insufflation gas conduit portion 48 and a reservoir portion 50 wherein the portions 48 and 50 are separated by a substantially fluid impermeable barrier 51. The barrier 51, which can be formed by sealing the front and back walls of the receptacle 44 together, extends downwardly from a top. edge 5B of the .
receptacle 44. A gap 54 is prov~.ded in the barrier 5l or between the barrier 42 and a bottom wall 56 of the receptacle 44 to allow fluid communication between the portions 48 and 50. PreferablyP the gas conduit portion 48 has relatively small volume as compared to the reservoir portion 50 such that a change in fluid level in the gas conr~uit 48 results in a smaller change in the fluid level in the reservoir portion 50:
lnsufflation gas is introduced into the conduit portion 48 through adapter tube 58:' The adapter tube 58, which is s~alably disposed within a peripheral seal 60 of the receptacle 44 above the fl.uid surface 61, is adapted to sealably engage tubing 26 from the body cavity 18 of the patient ~0. The adapter tube 58 and the tubing 26 may b~ interconnected by way of a lockang assembly such ay~: a Luer lock, frictional ~ngagemen~ or other means. In the ~.llustr~ted emb~dimerat, the adapter tube 58 and tubing ~6 are friction fitted so that a seal is formed between the 2~.3~~~!~
W~ 931af~704 PCT/US93/0238$
-~.4-adapter tube 58 and tubing 26 when they are mated. The illustrated receptacle 44 also includes a second tube 62 which extends through the peripheral seal 60 above the fluid surface 61 into the reservoir portion 50 of the receptacle 44. The tube 62 allows venting of the insufflation gas and can be used to add fluid to the receptacle 44.
The receptacle 44 may be adapted to be hung out of the way during surgery, thereby conserving operating theater space and reducing the likelihood of tilting or spilling of the receptacle 44 or its contents. As illustrated, the receptacle 44 is provided with a bulge 64 including a sealed opening 66 for this purpose. The receptacle 44 can thus be hung from an IV or plasma bag stand 65 or other hanger assembly. Preferably, the opening S6 is positioned apt or near a longitudinal axis 68 ; .
~of the receptacle 44 so that the axis 68 tends to orient vertically when fluid is added to the receptacle 44.
As shown in Figure 2; markings aan be provided on the receptacle 44 for use xn setting the desired relief pressure. because the relief pressure is proportional to the distance ~ between the ~pen end ~r gort 63 of the insufflation gas coa~duit portion 48 and the surface 61 of the reservoir f~.uid, the relief pressure can be set at a desired ,lwel by filling he receptacle 44 with the fluid until the fluid reaches the appropriate level. Various fluid levels and,~or associated relief pressure settings can thus be conveniently calibrated by placing markings rV0 93/18704 ~ ~ ~ ~ ? ~ ~ fCT/dJS93/0~38R
-~ 15-directly on the receptacle ~4. Calibration can be accomplished experimentally or by using known formulas, e.g., relating 1 mm Hg to a depth of the reservoir fluid.
It will be appreciated that many different reservoir fluids can be used in accordance with the present invention. However, the reservoir fluid should be a sterile fluid such as 7% sterile saline solution to reduce the likelihood of contamination in the event that the fluid enters the body cavity 18.
Referring to Fig. 3, a front view of a receptacle 70 constructed in accordance with an alternative embodiment of the present invention is shown. The receptacle 70 can comprise a battle, beaker, bag or other container.
Preferably, the receptacle 70 is at least partly transparent to allow viewing. of the reservoir fluid 72 therein and to allow viewing of bubbles rising through the fluid 72 when the predetermined rela.ef pressure is exceeded. ~n the illustrated embodiment, the receptacle 70 is formed from two sheets of clear plastic which are sealed together at peripheral portions thereof to define an internal fluid r~taa:ning space. For ease of construction, the a.llustrated receptacle 70 is formed from sheet materials which can be sealably attached together by heat seala~ag or RF welding. Alternatively, the sheets ~5 could; be attached tbgether by an adhe~~.ve or other means.
xnsufflation fluid from a body cavity i~ introduced into the rec~ptacl~ 7p by way ~f a conduit assembly including a tube 74 and a channel 76. Tlae tube 74, which 2130~GG
W~ 93/1870a ~ PCT/LJS93/02388 ~z6~
is in fluid communication with the body cavity, extends through a bottom edge 78 of the receptacle 70 and has an open end 80 within the channel 76. A seal 84 is provided in the bottom edge 78 about the tube 74 to substantially prevent leakage of reservoir fluid 72. Any suitable means may be ut~.li~ed to provide the seal 84. In the illustrated embodiment, the seal 84 comprises a widened portion wherein the sheet materials of the receptacle are heat sealed or RF welded together. Preferably, the open end 80 is positioned above the surface 82 of the reservoir fluid 7 2 to reduce the l ~.kel ihood that fluid 7 ~ wil l f l ow through the tube 74 to the body cavity.
The channel T6 extends downwardly from a top edge 86 of the receptacle 70 and has a port 88 positioned a ~:5 predetermined distance D beneath the surface 82. The channel 76 has an inside width W~ greater thin an outside width W~ of the tube 74 such that insufflation fluid can flow therebetween. It will be appreciated that the channel 76 is sealed at an upper edge 90 so that insufflation fluid flowing from the body cavity can only escape from the conduit assembly through port 88. In this re~asd, the channel 76 may comprise, for example, a tube having a sealed upper end. In tie illustrated embodiment, the channel 76 3.s formed by sealing portions of the sheet materials of the receptacle 70 together, e.g., by heat sealing or RF bonding. Preferably, the channel 76 is positioned along a vertidal centerline 92 of the receptacle 70 to reduce horizontal movement of the center WO 93/18704 ~ ~ 3 ~ j ~ ~ PCT/US93/023$8 of gravity and tilting of the receptacle 70 due to flow of reservoir fluid 72 into or out of the channel 76. The illustrated configuration has also been found to reduce or eliminate the incidence of undesired clinging of the opposing sheet materials of the receptacle 70, which clinging could obstruct the flow of insufflation fluid.
The receptacle 70 further includes at least one opening through a wall of the receptacle 70 above the surface 82 to allow introduction of reservoir fluid 72 to the receptacle 70 and escape of insufflation fluid therefrom. an the illustrated'embodiment, wherein the channel 76 is provided' by sealing the sheet materials of the receptacle 70 t~gether such that insuf~lation fluid cannot flow around the channel 76 above the surface 82, 1~ openings are provided in the receptacle 70 on both sides of the channel 76: As sha~r~rn, the openings comprise tubes ~94 sealably extending through the top edge 86 of the receptacle 70. The i~;lustrated receptacle also includes a hole ~'6 positioned on or near the centerline 92 to allow the receptacle to be hung from an IV stand or otheg hanger, hereby conserving space in the operating theater.
In addition,: the illustrated receptacle includes markings 98 on a su=face thereof to ' aid ' in setting the reservoir fluid le el.
Tn operation, an insufflation system constructed in accordance with an embodiment of the present invention can be used as full~ws. Operating room personnel can first remove a disposable bag and tuMng from protective ,~.,.,.. .. ~.:~ ... >.-:~..._. ;: ......~. _.w....<<,.....:........: .-.r_ ..:~. ...:.......: .~x...... :~ ._......: _... ..: ..:,,. .,.:..
~1~O~GG
"I~VV~ X3/18704 PCT/U593/023~8 packaging using aseptic techniques. The bag and connected tubing can then be passed outside of a sterile field, retaining a free end of the tubing in the sterile field.
~ ' 4 The bag can be hung on an IV stand or other hanger and filled with sterile saline solutis~n to the desired relief pressure as indicated by markings on the bag. The free end of the tubing can then be connected to the vent port of a cannula extending from a body cavity of a patient.
Insufflation fluid is delivered from a source to the body cavity, e.g., ~y opening valves; try provide the desired insufflation pressure. When in use, bubbles will be seen rising through the reservoir fluid whenever the set relief pressure is exceeded: After use, the tubing should be detached frog the cannula, or f3.uid communication between ~;5 the bag and'e~nnula should otherwise be closed, prior to removing the cannula from the patient. The bag and tubing, which are of simple canstruction, can be discarded after use in accordance with accepted medical procedures.
The gresent invention has a -number of advantages over 24 known insufflation systems. The gresent invention provides arc insufflation system capable of abrupt and positive gressure relief. An apparatus constructed and used in accordance with the present invention can thus function near he'selected relief pressure substantially 25 without leakage of he inshfflati~n gas. A physician's ability td monitor the insuf~lation~ pressure and account for the ia~sufflation gas is therefore enhanced. Yn addition, the likelihood of depleting the insufflation gas 2~30~~~
source during surgery is reduced thereby avoiding time consuming interruptions during surgery. The present invention also provides a visual indication, i.e., bubbles, when the relief pressure is exceeded. Moreover, the present invention provides a pressure relief apparat~a of simple construction which lends itself to disposable applications. The present invention also provides a pressure relief apparatus which can be constructed without moving parts which may malfunction or require maintenance.
Additional advantages of the present invention will be apparent to those ski~.led ira the ast.
While the present invention has been described in relation to specific embodiments thereof, additional alternative embodiments apparent to those skilled in the art in view of the present disclosure are intended to fall within the scope of the .present ~nventi,an as further defined by the.claims yet farth below.
Claims (27)
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:-
1. An apparatus for use in an insufflation system to relieve insufflation pressure in a body cavity in excess of a predetermined value, said insufflation system including a source of insufflation gas, an inlet conduit for one-way insufflation gas flow from said source to said body cavity, and an exhaust port for one-way insufflation gas flow away from said body cavity, said apparatus comprising:
a receptacle containing a fluid; and conduit means for allowing one-way flow of insufflation gas from said body cavity into said fluid contained in said receptacle when an insufflation pressure in said body cavity exceeds a predetermined value, said conduit means having a first end for receiving insufflation fluid from said body cavity via said exhaust port and a second end positioned a predetermined distance beneath a top surface of said fluid contained in said receptacle wherein, during use, insufflation gas is exhausted from said body cavity via said conduit means when said insufflation pressure exceeds said predetermined value.
a receptacle containing a fluid; and conduit means for allowing one-way flow of insufflation gas from said body cavity into said fluid contained in said receptacle when an insufflation pressure in said body cavity exceeds a predetermined value, said conduit means having a first end for receiving insufflation fluid from said body cavity via said exhaust port and a second end positioned a predetermined distance beneath a top surface of said fluid contained in said receptacle wherein, during use, insufflation gas is exhausted from said body cavity via said conduit means when said insufflation pressure exceeds said predetermined value.
2. The apparatus of claim 1, wherein said receptacle has an opening therein above said top surface of said fluid contained in said receptacle for passage of an insufflation gas.
3. The apparatus of claim 1, wherein said receptacle comprises a flexible bag.
4. The apparatus of claim 3, wherein said bag is adapted to be hung above said body cavity from a hanger assembly.
5. The apparatus of claim 1, wherein said receptacle is at least partly transparent.
6. The apparatus of claim 1, further comprising means for setting said predetermined distance between said top surface and said second end.
7. The apparatus of claim 6, wherein said means for setting comprises means for adjusting a level of said top surface.
8. The apparatus of claim 6, wherein said means for setting comprises an opening for adding fluid to said receptacle or for subtracting fluid therefrom.
9. The apparatus of claim 1, wherein said conduit means comprises a first conduit extending from a point above said top surface of said fluid contained in said receptacle to said second end.
10. The apparatus of claim 9, wherein said conduit means further comprises a second conduit extending upwardly from a bottom edge of said receptacle and having an open end positioned within said first conduit, wherein said second conduit has a width less than a width of the first conduit.
11. The apparatus of claim 9, wherein said first conduit comprises a compartment of said receptacle formed by sealing a portion of a front wall of said receptacle to a portion of a back wall thereof.
12. The apparatus of claim 9, wherein said first conduit is positioned substantially along a vertical centerline of said receptacle.
13. The apparatus of claim 1, wherein said receptacle comprises a first compartment and a second compartment, the compartments separated by a substantially fluid impermeable partition, communication between said first and second compartments provided by a passageway located a predetermined distance D beneath said top surface of said fluid contained in said receptacle, wherein the distance D is selected such that insufflation gas passes through said passageway when said insufflation pressure exceeds said predetermined value.
14. The apparatus of claim 1, wherein said receptacle includes calibration markings to assist in setting a level of said top surface of said fluid contained in said receptacle.
15. The apparatus of claim 1, wherein said receptacle contains a substantially sterile fluid.
16. An insufflation system, comprising:
a source of insufflation gas;
inlet means, extending from said source to a body cavity, for one-way delivery of said gas to the body cavity;
a receptacle containing a fluid; and outlet means, separate from said inlet means, extending from said body cavity to said receptacle, for one-way venting of insufflation gas from said body cavity into said receptacle when the pressure in said body cavity exceeds a predetermined value, said outlet means including a first end submerged a predetermined distance beneath a surface of said fluid contained in said receptacle.
a source of insufflation gas;
inlet means, extending from said source to a body cavity, for one-way delivery of said gas to the body cavity;
a receptacle containing a fluid; and outlet means, separate from said inlet means, extending from said body cavity to said receptacle, for one-way venting of insufflation gas from said body cavity into said receptacle when the pressure in said body cavity exceeds a predetermined value, said outlet means including a first end submerged a predetermined distance beneath a surface of said fluid contained in said receptacle.
17. The system of claim 16, wherein said receptacle contains sterile saline solution.
18. A method for relieving excess insufflation pressure in a body cavity, comprising the steps of:
providing an insufflation gas exhaust assembly including a receptacle for containing a fluid and an exhaust line having a first open end and a second end for submersion within said fluid;
attaching said first open end to an exhaust port for exhausting insufflation gas from said body cavity; and establishing one-way insufflation fluid communication from said body cavity to said receptacle via said exhaust line.
providing an insufflation gas exhaust assembly including a receptacle for containing a fluid and an exhaust line having a first open end and a second end for submersion within said fluid;
attaching said first open end to an exhaust port for exhausting insufflation gas from said body cavity; and establishing one-way insufflation fluid communication from said body cavity to said receptacle via said exhaust line.
19. The method of claim 18, wherein said step of establishing comprises pressurizing the body cavity such that insufflation fluid flows therefrom.
20. The method of claim 18, wherein said step of establishing comprises opening a valve to allow flow of insufflation fluid through said exhaust line.
21. A method for venting insufflation gas from a body cavity comprising the steps of:
setting the relative positioning between a first end of an exhaust line extending from a body cavity and the top surface of a fluid contained in a receptacle so that the first end is positioned a preselected distance beneath the surface; and connecting a second end of said exhaust line to an exhaust port for exhausting insufflation gas from said body cavity so as to establish one-way insufflation gas communication from said body cavity to said receptacle via said exhaust line.
setting the relative positioning between a first end of an exhaust line extending from a body cavity and the top surface of a fluid contained in a receptacle so that the first end is positioned a preselected distance beneath the surface; and connecting a second end of said exhaust line to an exhaust port for exhausting insufflation gas from said body cavity so as to establish one-way insufflation gas communication from said body cavity to said receptacle via said exhaust line.
22. The method of claim 21, further comprising the step of:
flowing insufflation gas from a gas source to said body cavity.
flowing insufflation gas from a gas source to said body cavity.
23. The method of claim 21, wherein said step of setting comprises adding fluid to said receptacle.
24. An apparatus for relieving insufflation pressure in a body cavity in excess of a predetermined value, comprising:
a fluid receptacle formed from flexible film material for containing a predetermined level of fluid; and conduit means for providing one-way insufflation gas communication from a body cavity to said fluid receptacle having a first end disposed at a predetermined position within said fluid receptacle and a second end detachably connectable to an exhaust port from the body cavity for receiving insufflation gas from said body cavity via said exhaust port wherein, during use, the first end is submerged within a predetermined level of fluid contained in said fluid receptacle and insufflation gas is permitted to pass from the body cavity through the conduit means and into said fluid receptacle when pressure in the body cavity exceeds a predetermined value.
a fluid receptacle formed from flexible film material for containing a predetermined level of fluid; and conduit means for providing one-way insufflation gas communication from a body cavity to said fluid receptacle having a first end disposed at a predetermined position within said fluid receptacle and a second end detachably connectable to an exhaust port from the body cavity for receiving insufflation gas from said body cavity via said exhaust port wherein, during use, the first end is submerged within a predetermined level of fluid contained in said fluid receptacle and insufflation gas is permitted to pass from the body cavity through the conduit means and into said fluid receptacle when pressure in the body cavity exceeds a predetermined value.
25. The apparatus of claim 24, wherein said fluid receptacle comprises a flexible bag.
26. The apparatus of claim 24, wherein said conduit means comprises a compartment of said fluid receptacle formed by sealing a portion of a front wall of said fluid receptacle to a portion of a backwall thereof.
27. The apparatus of claim 24, wherein said conduit means comprises flexible film material.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US85173692A | 1992-03-16 | 1992-03-16 | |
| US07/851,736 | 1992-03-16 | ||
| PCT/US1993/002388 WO1993018704A1 (en) | 1992-03-16 | 1993-03-15 | Method and apparatus for relieving excess insufflation pressure |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2130566A1 CA2130566A1 (en) | 1993-09-30 |
| CA2130566C true CA2130566C (en) | 2001-09-11 |
Family
ID=25311544
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002130566A Expired - Lifetime CA2130566C (en) | 1992-03-16 | 1993-03-15 | Method and apparatus for relieving excess insufflation pressure |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP0631488A4 (en) |
| AU (1) | AU3810593A (en) |
| CA (1) | CA2130566C (en) |
| WO (1) | WO1993018704A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2510321B (en) | 2012-11-12 | 2018-01-31 | Biosurgical S L | Agitation apparatus |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE595044C (en) * | 1932-06-03 | 1934-03-27 | Herbert Mangold Dr | Device for introducing gases into the human body |
| US3782363A (en) * | 1971-07-15 | 1974-01-01 | G Davis | Pneumo-infufflator apparatus |
| FR2326734A1 (en) * | 1975-10-04 | 1977-04-29 | Wolf Gmbh Richard | GAS INSUFFLATION APPARATUS APPLICABLE IN PARTICULAR TO THE FILLING OF A BODY CAVITY |
| US4459983A (en) * | 1979-07-24 | 1984-07-17 | Christian Beyreuther | Breathing apparatus for reanimation of newborns |
| NL8702698A (en) * | 1987-11-11 | 1989-06-01 | Leuven Res & Dev Vzw | GAS INSULFATION SYSTEM IN ENDOSCOPY AND A SURGICAL ENDOSCOPE THEREFOR. |
-
1993
- 1993-03-15 CA CA002130566A patent/CA2130566C/en not_active Expired - Lifetime
- 1993-03-15 AU AU38105/93A patent/AU3810593A/en not_active Abandoned
- 1993-03-15 WO PCT/US1993/002388 patent/WO1993018704A1/en not_active Application Discontinuation
- 1993-03-15 EP EP93907531A patent/EP0631488A4/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| WO1993018704A1 (en) | 1993-09-30 |
| AU3810593A (en) | 1993-10-21 |
| EP0631488A4 (en) | 1995-04-19 |
| CA2130566A1 (en) | 1993-09-30 |
| EP0631488A1 (en) | 1995-01-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |