United States Patent [1 1 Binard et a1.
1 1 Jan.7, 1975 1 1 INSUFFLATION DEVICE [73] Assignee: The Kendall Company, Walpole,
Mass.
[22] Filed: Oct. 27, 1972 [21] Appl. No.: 301,564
FOREIGN PATENTS OR APPLICATIONS 611,037 6/1926 France 128/184 594,678 6/1925 France 128/184 791,947 10/1935 France 128/184 Primary Examiner-Kyle L Howell [5 7] ABSTRACT A device for insufflating a patients body from a source of pressurized gas. The device includes a flexible gas reservoir having an inlet port, an outlet port, and means for indicating a preselected volume of gas in the reservoir. Means is provided for connecting the gas source to the inlet port of the reservoir for filling the reservoir with the preselected volume of gas from the gas source. The device has body penetrating means for introducing gas into the patients body, and means for pumping a selected volume of gas from the outlet port of the filled reservoir through the penetrating means and into the body.'
1 Claim, 7 Drawing Figures Patented Jan. 7, 1975 3 Sheets-Sheet 1 FIG. 2
Patented Jan. 7, 1975 3,858,572
3 Sheets-Sheet 2 Patented Jan. 7, 1975 3,858,572
3 Sheets-Sheet 3 FIG. 5 74 INSUFFLATION DEVICE BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device for insufflating a patients body.
2. Description of the Prior Art Pneumography is the use of a gas as a contrast medium for radiographic visualization of the body interstices. When insufflated into a patients body, gases separate tissues and organs in the body, and since they have lower densities than the surrounding body tissues and organs, they are delineated on X-rays and outline body organs, cavities, and intestines, to facilitate radiography. Historically, insufflation has also been utilized to dissect facial planes of tissues, such as in a tubal ligation procedure for sterilization, to inflate collapsed body structures, and for diagnostic and/or treatment of the brain (pneumoencephalography).
As a particular example of the usefulness of an insufflation procedure, an iodine based dye has been introduced into the kidneys in retrograde and intravenous pyelogram procedures to obtain X-rays of the kidneys. Although the internal structure of the kidneys is shown in the X-rays during a retrograde or intravenous pyelogram, the outline of the kidneys does not clearly appear during such a procedure, and certain problems, such as a tumor on a kidney, will not necessarily be detected through use of either of these procedures. Accordingly, a gas has been insufflated into the retroperitoneal space of the patient to separate the kidneys from the surrounding tissues and present the outline of the kidneys in sharp contrast during radiography. Moreover, it has been learned that an increasing number of patients are allergic to the dye used in retrograde and intravenous pyelograms, and the above described perirenal insufflation procedure presents a desired alternative in such a case.
It has been discovered that insufflation of the patient is best carried out through the use of carbon dioxide, due to the possible danger of gas embolism when a different gas is utilized. Since carbon dioxide is rapidly absorbed and dissolved by the body, the danger of gas embolism is minimized when carbon dioxide is used. A larger volume of carbon dioxide, relative to other gases, must be insufflated into the body due to its rapid absorption by the body and a sufficient quantity of carbon dioxide must be available for insufflation. For example, two liters of carbon dioxide is adequate for a perirenal insufflation procedure. However, it is desirable that the volume of gas insufflated into the body be known. This follows since if carbon dioxide is not used, the danger of gas embolism is present if too much gas is insufflated. If carbon dioxide is utilized for insufflation, and a given volume of gas, such as two liters, has been injected into the body without achieving the desired results, the procedure should be verified to determine whether some deficiency may be present. For example, a needle, utilized for insufflating the carbon dioxide, may havebeen incorrectly positioned in the patient, or the gas may have escaped into another part of the body.
In the past, insufflation has usually been accomplished by injecting gas from a pressurized gas source directly into the patient. The flow rate of the pressurized gas has been utilized to estimate the desired amount of gas for the insufflation, which has proven inadequate since the volume of pressurized gas introduced from the source is not readily determined by the flow rate of the gas. Also, the pressurized gas source has been connected to a syringe, and the pressurized gas is pumped by the syringe from the source into the patient. However, since the gas is under a relatively high pressure, relative to atmospheric pressure, the volume of gas at atmospheric pressure is still not known, and the pressure may force a plunger in the syringe out of the syringe during pumping.
SUMMARY OF THE INVENTION A principal feature of the present invention is the provision of a device of simplified construction for insufflating a patients body from a source of pressurized gas.
The insuffiating device of the present invention includes a flexible gas reservoir having an inlet port, an outlet port, and means for indicating a preselected volume of gas in the reservoir. Means is provided for connecting the gas source to the inlet port of the reservoir for filling the reservoir. The device has body penetrating means for introducing gas into the patients body, and means for pumping a selected volume of gas from the outlet port of the filled reservoir through the penetrating means and into the body.
A feature of the invention is that the indicating means designates when the reservoir is filled with the preselected volume of gas.
Another feature of the invention is that the indicating means may be utilized to prevent overinflation of the reservoir.
Still another feature of the invention is that the gas in the filled reservoir is retained at approximately atmospheric pressure.
Yet another feature of the invention is that the volume of insufflated gas may be determined by the pumping means.
Further features will become more fully apparent in the following description of the embodiments of this invention and from the appended claims.
DESCRIPTION OF THE DRAWINGS In the drawings:
FIG. 1 is a fragmentary perspective view, partly broken away, of the insufflating device of the present invention as connected to a source of pressurized gas;
FIG. 2 is a sectional view taken substantially as indicated along the line 2-2 of FIG. 1;
FIG. 3 is a fragmentary perspective view of the'device of FIG. 1 during filling of a reservoir in the device from the gas source;
FIG. 4 is a fragmentary plan view, taken partly in section, of the device of FIG. 1, during operation of pumping means in the device to withdraw gas from the filled reservoir;
FIG. 5 is a fragmentary elevational view on an enlarged scale, taken partly in section, of the device of FIG. 1, during operation of the pumping means to force gas through the penetrating means in the device;
FIG. 6 is a fragmentary elevational view of another embodiment of the penetrating means, and
FIG. 7 is a perspective view, partly broken away, of a package for the device of FIG. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIG. 1, there is shown a device, generally designated 10, for insufflating a patients body from a source of pressurized gas designated generally 12. The insufflating device includes aflexible gas reservoir 14, means 16 connecting thegas source 12 to thereservoir 14, body penetrating means 18 for introducing gas into the patients body, and means 20 for pumping a selected volume of gas from thereservoir 14 through the penetratingmeans 18 and into the body.
Thegas source 12 may have avalve 22 for controlling the introduction of pressurized gas from thesource 12 into theconnecting means 16. The connectingmeans 16 comprises a tube 24 which may have anipple 26 forconvenience in attaching the end of the tube remote the gas source to thereservoir 14. Any suitable means, such as asleeve 28, may be utilized to connect the other end of the tube 24 to thesource 12.
Thereservoir 14 is preferably relatively inelastic, and may be made from a flexible material, such as plastic. As shown, thereservoir 14 may be constructed from a pair offlexible sheets 30a and 30b, which are joined at their edges along aline 32,.such as by RF scaling, to form a closed bag having aninternal chamber 34.
Thereservoir 14 has apush valve 36 of a type well known to the art, which defines aninlet port 38 to the reservoir. When the valve is open communication is established between theinlet port 38 and thechamber 34 of the reservoir. Thenipple 26 of the tube 24 may be connected to theinlet port 38 of the reservoir, as indicated by the arrow in the drawing, and the valve is constructed to open when thenipple 26 is so attached to establish communication between thegas source 12 and thereservoir chamber 34. When thetube nipple 26 is removed from theinlet port 38, thevalve 36 closes to prevent passage of air out of the reservoir through the inlet port. The reservoir also has anipple 40 secured to the reservoir which defines anoutlet port 42 of the reservoir.
The reservoir includesmeans 44 for indicating when a preselected volume of gas is introduced into the reservoir from thegas source 12. As shown in FIGS. 1 and 2, a preferred form of the indicatingmeans 44 comprises aballoon 45 which is secured to the reservoir and which communicates with thechamber 34. The balloon may be secured to the reservoir by a pair ofannular members 47a and 47b, as best shown in FIG. 2. Theannular member 47b is secured to thewall 49 of the reservoir, and theannular member 47a is snugly received in the inside of themember 47b. The open end 51 of theballoon 45 is positioned over the outside of themember 47a, as shown, and themember 47a is depressed into themember 47b to secure theballoon 45 in place. The inside of theballoon 45 then communicates with the inside of the reservoir through anaperture 53 in thereservoir wall 49. The operation of the indicating means 44 is described in greater detail below.
As illustrated in FIG. 1, the pumping means 20 includes a valve assembly. 46 and a pump orsyringe 48, with thesyringe 48 being removably connected to thevalve assembly 46 for use, as indicated by the direction of the arrow in the drawing. As best shown in FIG. 5, the valve assembly has aninlet opening 50, anoutlet opening 52, and apassageway 54 which communicates with the inlet andoutlet openings 50 and 52 through valves. A first one-way valve 56, such as a flap valve, is secured in thevalve assembly 46 adjacent theinlet opening 50, such that thevalve 56 permitsthepassage of gas from the inlet opening 50 into thepassageway 54, but prevents passage of gas from thepassageway 54 to theinlet opening 50. The valve assembly also has a second one-way valve 58, such as a flap valve, adjacent theoutlet opening 52. Thesecond valve 58 permits passage of gas from thepassageway 54 to theoutlet opening 52, but prevents passage of gas from the outlet opening 52 to thepassageway 54.
Thesyringe 48 is of a well-known type, and has anouter body 60, acavity 62, aplunger 64 slidably received in thecavity 62, and atip 66 removably attached to aflange 68 in thevalve assembly 46. When thesyringe 48 is attached to thevalve assembly 46, thesyringe cavity 62 communicates with thepassageway 54 of the valve assembly, and thesyringe plunger 64 is utilized to withdraw and force gas from and into thepassageway 54.
As shown in FIGS. 1 and 4, atube 70 communicates between theoutlet port 42 of thereservoir 14 and the inlet opening 50 of thevalve assembly 46, and serves as means connecting theoutlet port 42 and theinlet opening 50. If desired, oneend 72 of thetube 70 may have anipple 74 to facilitate connection of thetube 70 to thevalve assembly 46, and theother end 76 of thetube 70 is connected to thereservoir nipple 40.
As shown in FIGS. 1 and 5, the penetratingmeans 18 may comprisehollow needles 78, or, as shown in FIG. 6, aflexible catheter 80 which may be secured to ahollow needle 82 having a relativelyshort cannula 84. The particular type of penetrating means utilized is determined by the type of insufflation procedure performed, during which the penetrating means is inserted into the patients body, and gas is introduced through the penetrating means into the body.
The type of insufflation procedure performed also determines whether one or more needles or catheters are needed for the procedure. If a single needle or catheter is utilized for the penetrating means, the penetrating means may be connected to the outlet opening 52 of thevalve assembly 46 by a tube having a sufficient length. However, if'the insufflation procedure requires a pair of needles or cathethers, or combination thereof, a Y-shapedconnector 86 may be removably attached to thevalve assembly 46, such that it communicates with theoutlet opening 52, and a pair oftubes 88a and 88b may be connected between theconnector 86 and the penetrating means 18 to establish communication between theoutlet opening 52 and the penetrating means. If desired, the end of the tubes 88a and b remote theconnector 86 may havenipples 90a and 90b, respectively, in order that the penetratingmeans 18 may be conveniently attached to the nipples, as indicated by the direction of the arrow in FIG. 1. Additionally, a pair ofclamps 92a and 92b of a well-known type are positioned on the tubes 88a and b, respectively, to selectively open and close the tubes, as desired.
In operation, the tube 24 is connected to thegas source 12 by thesleeve 28, and. thetube nipple 26 is secured to theinlet port 38 of thereservoir 14, as shown in FIG. 1, to open thevalve 36 and establish communication between the tube 24 and thereservoir chamber 34. Next, thecontrol valve 22 of thegas source 12,
which is preferably carbon dioxide to prevent the possibility of gas embolism to the patient, is opened to introduce the gas into thechamber 34. As the gas fills thechamber 34, the flexible walls of the reservoir expand and the reservoir inflates, as shown in FIG. 3. Once the reservoir is filled with a preselected volume of gas, theballoon 45 of the indicating means 44 expands to indicate that the reservoir has been filled with the desired amount of gas. The volume of gas retained in the chamber is primarily determined by the size of the chamber, and may be preselected according to the requirements of a desired insufflation procedure. For example, the filled reservoir may retain two liters of gas for a perirenal insufflation procedure.
Theballoon 45 also serves as means to prevent overinflation of the reservoir, since the balloon will burst prior to rupture of the reservoir. It is apparent that any suitable device may also be utilized to prevent overinflation of the reservoir, such as knock-out plugs.
. Once theballoon 45 has inflated, thecontrol valve 22 on the gas source is closed, and thetube nipple 26 is removed from theinlet port 38 to close thevalve 36 and prevent passage of gas from thechamber 34 through theinlet port 38. When theballoon 45 is inflated, gas in the reservoir is retained at a pressure slightly greater than atmospheric pressure, and the balloon contracts to force gas from thechamber 34 through theoutlet port 42 into the remainder of thedevice 10, thus purging air from this part of the device. When the device has undergone sufficient purging or bleeding, which may be indicated by deflation of theballoon 45, theclamps 92a and b may be used to close the tubes 88a and b and prevent further escape of gas until use of the device on the patient.
The penetrating means 18 should be properly positioned in the patient according to the particular insufflation procedure being performed, and thetube nipples 90a and b may then be connected to the penetrating means preparatory to use of the device. if theclamps 92a and b have been used to close the tubes 88a and b, they are then opened to establish communication between thevalve assembly 46 and the penetratingmeans 18.
Next, theplunger 64 of thesyringe 48 is partially retracted from the syringeouter body 60, as indicated by the direction of the arrow in FIG. 4, and gas is then withdrawn from thechamber 34 through thetube 70, thefirst valve 56, and thepassageway 54 into thesyringe cavity 62, as indicated by the direction of the arrows in the drawing. Thesecond valve 58 prevents passage of gas from the outlet opening 52 to thepassageway 54 when thesyringe plunger 64 is retracted. Thesyringe plunger 64 is then pushed into the syringeouter body 60, as indicated by the direction of the arrow in FIG. 5, and gas, previously retained in thesyringe cavity 62, is forced through thepassageway 54, thesecond valve 58, the tubes 88a and b, the penetratingmeans 18, and into the patients body, as indicated by the direction of the arrows in the drawing. When thesyringe plunger 64 is pushed into thesyringe body 60, thefirst valve 56 prevents passage of gas from thepassageway 54 to theinlet opening 50 and back to the reservoir chamber.
As shown in FIG. 1, thesyringe body 60 may be calibrated by indicia 94, and the indicia 94 may be utilized to withdraw a selected volume of gas from the reservoir chamber when thesyringe plunger 64 is retracted from thesyringe body 60, by retracting the plunger to a selected indicium 94. The selected volume of gas is then forced into the patients body when the syringe plunger is pushed into the syringe body. The total volume of gas injected into the patients body may readily be determined by counting the number of repetitive plunger strokes of the syringe. Alternatively, if the total volume of gas retained in the filled reservoir is approximately equal to the desired amount of gas to be insufflated into the patient, the pumping means 20 may be used until the reservoir has collapsed and the gas has been removed from its chamber.
As pumping of gas from the filled reservoir proceeds, the flexible walls of the reservoir slowly settle as the gas is removed from its chamber. During this time, the gas in the reservoir chamber remains at approximately atmospheric pressure since the reservoir is relatively inelastic and does not compress the gas in the chamber, other than that caused by the slight weight of the reservoir walls itself. Since the gas remains at approximately atmospheric pressure in the chamber, the volume of gas at atmospheric pressure introduced into the patient during insufflation may readily be determined and controlled by the pumping means 20. Although the pumping means has been described with use of a syringe, it is apparent that any suitable pump may be utilized which may pump gas in a manner such that the volume of gas pumped is known.
A package 94 for the insufflation device is shown in FIG. 7, which comprises abox 95, atray 96 for retaining components of the device, and acover 99 for the box, such as a lid. Thereservoir 14 of the device may have a pair offlaps 97 extending from opposing ends of the reservoir, and the reservoir may be secured in the lower part of the box by attaching theflaps 97 to opposing sides of the box by suitable means, such asstaples 98. Thecomponent tray 96 is placed in thebox 95 over thereservoir 14, and thecover 99 is closed for the packaging of the device. During use of the device, the reservoir is conveniently retained in the box and may be inflated from the gas source in this location.
The foregoing detailed description is given for clearness of understanding only, and no unnecessary limitations should be understood therefrom, as modifications will be obvious to those skilled in the art.
We claim:
1. A device for use with a source of pressurized gas for insufflating a patients body, the device comprising a gas reservoir for retaining a volume of gas at approximately atmospheric pressure, said reservoir formed from a gas impervious flexible material and including an inlet port and an outlet port;
balloon means for automatically releasing gas from said reservoir to the atmosphere when said gas reaches a predetermined pressure, thereby preventing overinflation of said reservoir;
first conduit means communicating with said inlet port and connectable to said source of pressurized gas for the filling of said reservoir;
body penetrating means for introducing gas into the patients body; and
second conduit means connecting said reservoir outlet port and said body penetrating means and including means for pumping a selected volume of gas from said reservoir to said body penetrating means.