US 3190291 A
Description (OCR text may contain errors)
June 22, 1965 F. E. B. FOLEY SELF-INFLATING BAG CATHETER Filed Oct. 8, 1962 United States Patent 3,190,291 SELF-INFLATING BAG QATHETER Frederic E. B. Foley, S41 St. Clair Ave., St. lanl, Minn. Filed Get. 8, 1962, Ser. No. 228,834 4 Claims. (1. 12d- 349) This invention relates to `a bag catheter and more particularly relates to a self-inflating bag catheter.
Inflatable ba-g catheters have been well known in the catheter art and have been in common use for at least the last twenty-five years. Such a catheter comprises essentially an elongated flexible shaft of soft rubber or the like with an inflatable sleeve or bag surrounding the shaft adjacent the distal end thereof. Ordinarily at the proximal end portion of the shaft there is provided a flexible divergent tube which communicates with .an inflating lumen or passage through the wall of the shaft into the `inflatable bag. The purpose of this divergent tube is to facilitate injection of fluid into the sleeve for inflating Isame Without disturbing the positioning of the proximal end of the main shaft. At the distal end of the catheter body forwardly, and if desired, rearwardly, of the inflatable sleeve yare one or more drainage inlet ports which open into the drainage passage or lumen provided by the tubular bore of the shaft. This drainage passage drains through the proximal end of the shaft body which is generally enlarged for interitting with a `glass tube or the like for conducting drainage fluid to a suitable container from the catheter.
These inflatable bag catheters are conventionally used .to drain urine from the human bladder. In use the catheter is introduced into the bladder through the urethra and positioned so that the drainage inlets and the inflatable bag are within the bladder. The proximal end portion of the shaft and the divergent tube remain outside of the lbody of the patient `and the catheter is positioned in place by the injection of fluid through the divergent tube Iand the inflating lumen into 4the bag whereby the bag forms a balloon retaining the catheter distal end portion within the bladder and preventing inadvertent displacement therefrom.
To inflate the bag, water is generally measured into a hypodermic syringe to a predetermined volume. The divergent tube has Ia closed end, usually in the form of a soft rubber plug. The hypodermic needle of the syringe is pushed through the plug into the bore of the tube, which bore of course constitutes Va continuation of .the inllating passage. The water from the syringe is then injected into the tube and the ybag inflated. Upon withdrawal of the needle, lthe soft rubber plug is self-sealing so that no water escapes from the tube and the bag remains inflated.
Because of the retention of the catheter in living tissue the inflating water must .be maintained -in aseptic condition. Thus, the water, syringe, needle, and such auxiliary equipment as funnel, pipette, wat-er container, etc., as may be needed for inflation must he sterilized 'and maintained in a sterile state during inflation. The resulting inflating procedure is a cumbersome operation at best and usually requires in addition to the physician an assistant to the physician.
yIn accordance with this invention a bag catheter is provided which not only contains its own inflating fluid but which is also self-inflating -and which needs no external agency either to facilitate or maintain the inflation of the bag. The catheter of this invention is a selfinflating `bag catheter which is so constructed as to maintain the .inflating fluid in a compressed, but readily expansible state, until bag inflation is required. This new catheter is so constructed that the divergent tube is eliminated and the catheter is in effect a single, unitary shaft construction with the proximal end portion of the catheter being slightly larger than lthe proximal end porions of the main shafts of the now used bag catheters.
The present invention, which ena-bles catheters to be formed as a unitary shaft with no divergent appendages facilitates both packaging and handling as well Ias eliminating the processing and molding steps heretofore necessary to form the divergent end tube. Thus, While with my invention a self-inflatable bag catheter can be constructed utilizing either divergent tube constructions or unitary shaft constructions, .a significant advantage of my invention is the production lof a self-inflating bag catheter free from any divergent :appendages without sacrificing any convenience in use of the catheter.
The self-inflating bag catheter of this invention comprises an elongated flexible tubular shaft or soft feeling rubbery material, usually natural rubber latex. T he shaft has proximal and distal ends and the main bore of the shaft constitutes a drainage passage or lumen through the length of the shaft for drainage of fluid through the shaft from the distal to the proximal ends. An inflatable bag or sleeve surrounds and has its edges peripherally`sealed to .the shaft adjacent the shaft distal end so lthat the bag is free to expand to an inflated balloon surrounding the catheter shaft. An inflating pass-age or lumen is provided through the shaft wall, parallel to the drainage passage, and opening at one end into the inflatable bag and at its other end into an enlarged chamber formed in the proximal end portion of the catheter. The Wall of this chamber Ais suitably rigidilled so that expansible inflating fluid is maintained therein in a cornpressed state without distortion of the catheter shape. Openable means is provided between the chamber and the inilating passage normally :sealing off communication therebetween which means is readily disruptable from a position externally of the catheter, allowing the compressed fluid to expand and inflate Ithe thin bag at the distal end of the catheter.
The invention will be further described with reference to the embodiments shown in the accompanying drawing wherein:
FIGURE l illustrates the self-inflating bag catheter in an uninflated state;
yFIGURE 2 is a view of the distal end portion of the catheter disclosing the catheter bag in its inflated condition;
FIGURE 3 is an enlarged cross-sectional View through the length of the proximal end portion of the shaft illustnating one construction whereby the expansible fluid is maintained in a compressed state prior to bag inflation;
FIGURE 4 is an end view of the proximal end of the catheter;
FIGURE 5 is a cross-sectional view through the shaft body taken substantially along the plane of section line 5-5 of FIGURE l;
FIGURE 6 is a v-iew of ya closure means for sealing off the passage between the fluid supply chamber and the bag inllating passage;
FIGURE 7 is a View similar to that of FIGURE 3 of the modified catheter construction; and
FIGURE 8 is an end View of the proximal end of the catheter of FIGURE 7.
It is to be understood that the illustrations of the drawing are not drawn to scale and in sorne instances may in fact be considerably exaggerated for clarity of cross-sectional details.
Referring first to the modification illustrated in FIG- URES 1-6, the intlating bag catheter of this invention is designated in its entirety by the numeral 10. The catheter comprises an elongated generally cylindrical shaft l2 terminating in a soft, blunted distal end 16 and having a relatively enlarged proximal end portion 14. In use, the catheter is inserted only to the juncture of the shoulder 3 28 between the main body of the shaftlZ and the enlarged proximal end portionrv 14.
At its distal end 16 the shaft is provided with drainage inlet ports 1S. Rearwardly ofthe inletports 1S at the distal end portion of the shaft r11,2 the inflatable sleeve 20 of the catheter is attached. As is apparent from an examination of FIGURE l, sleeve Ztl in its normal state simply envelops the shaft like a shaft-conforming band whereas in its inflated state as shown in FIGURE 2, it provides an enlarged balloon surrounding the shaft end.
The drainage inlet ports 18 communicate, as illustrated inVFIGUEVES l3--5, with the tubular bore 22 of the shaft 12 which bore serves as thedrainage lumen of the catheter. `The drainage lumen 22 is enlarged as at 23 at the proximal end portion of the catheter for the coupling therewith of any drainage attachments. The passage 274 extending parallel to the drainage passage 22 opens at-its distal end into the space between the sleeve 26 `and the shaft 12 andk it is through this passage that the inflating fluid for,Y the bag passes. This intlating passage 24 follows theshoulder 28 to termination point 30 in the proximal end` portion 14 of the shaft wherein it opens into a tubular chamber 32. A frangible closed end tube 34 normallycloses communication between passage 24 and chamber 32. Y
In the modification illustrated in FIGURES 3 and 4, the tubular wall of the chamber'32 is lined with a suitable rigidifying liner 36 which may be in the form of a simple aluminum tube or the like over which the rubber latex forming the shaft may be formed. The proximal end portion of the 4inside wall of the yrigid liner 36 is bevelled outcap is-provided with an opening 80 therein which opens against the soft rubber plug 70.
In the use `of the catheter modifications of FIGURE 7, the intlating fluid may be injected through the opening 80 and through the plug 7 t) into the chamber .64 where it is retained until the Ycap 78 is unscrewed and pulled away from the proximal endlof the shaft whereupon the closure tip 76 opens communication between'the 'chamber 64 and the inflating passageSS.
ofcourse, otherfclosuremeans and closure disrupting means other than thosel just illustrated can be usedv in the practice vof. this invention as can differing chamber. wall rigidifying means( With respect to the latter it is contemplatedthat the chamber wall can be rigidif'ied simply by embedding a vplastic or metal spirally wound coil therein. l i
The inflating fluid to be used must be one which is not toxic to the human body, which` does not unduly rpermeate the walls 'of theY inflated sleeve when the sleeve is immersed in body fluids and preferably one which is readily handleable for compression. vCertain inert iluorocarbon fluids such asthoseV ofthe Freon or Kel-F, family are suitable. A preferred fluid has been found to'k be perfluorocyclobutane C4F8, marketed under the trade name FreenvC318 by E.` I. `dulont de Nemours & Company.A This fluid is extremely inert and has been found to provide an ideal'expansible fluid forV use with natural rubber bodied wardlyas at 33 for the sealing reception therein of lasoft rubber plug 49, which closes off the entrance thereto. The frangible tube 34 may be in ythe nature of a simple glass tube, one end of which is closed as at 42, which closed end projects into the chamber 32. The open end portiion of ltube 34 frictionally seats within the inflating passage 24. Intermediate its ends the tube maybe scored as at 46. y
Once the catheter is made and the plugs 34 and-40 in place, a controlled amount of an expansible inflating fluid 'can be injected through a hypodermic needle or the like through k,the plug 40' into the chamber 32 and retained therein'in a compressed state. When the catheter is'to be used thephysician need simply flex the prox- .imal end portion 14 of the catheter whereupon the frangible tube 34 is broken and the compressed fluidY expands through the inflating passage 24 into the sleeve 20 and inflates the sleeve. f
` A modified form of catheter is illustrated in FIGURE 7 and designated in' its entirety by the numeral 48. This catheter, also comprises an elongated shaft body 5t)` through which a drainage passage 54 extends having an enlarged proximal end 56 accommodated by the enlarged proximal end portion 52 of the shaft. The wall of the shaft is provided a bag inflating passage 5S which follows the jog of the shoulder 60 of the catheter shaftVV to its proximal end 62 where it opens into a tubular chamber 64.
, The tubular; chamber `64 has the wall thereof rigidfied with a rigid liner 66 which may be in the form of a small aluminum tube or the like as in the previous modification.
The proximal end of the tube 66 projects beyond the end of the catheter and is flaredV outwardly tov form a bellshaped end. A ysoft rubber plug 70 normally closes this bell-shaped end. v
An elongated shank 72 projects through the plug ,'70
into the chamber 64 and at the end thereof terminating in the chamber lprovided with a cone-shaped tip 76 which catheters; it has a boiling point of about 21 F. which enables encapsulation in liquid'form with safety and dispatch at relatively low pressures.v This fluid does not unduly swell natural latex rubber and 'has-been found to have longi retention in vthin latex rubber balloons over long periods of time when the inflatedfballoon is immersed in urine, the normal environment 'for the inflated balloon.
From the foregoing lit will be seen that the present invention provides a greatly improved .urethal bag catheter.
1. A self-inflating bag catheter. comprising an elongated ilexible rubbery shaft for draining body tluidstherethrough, said shaft having proximal and distal ends and having aninflatable sleeve mounted thereon adjacent,l said i distal end, Vthe proximal end portion of said shaft having a chamber therein, said shaft having an inflating'passage therethrough intercoinmunicating said chamber and said normally seals off communication between chamber 64 and inflating passage 58, At the end thereof projecting through the soft rubber'plug 70 the shaft is attached to a cap 78 which may be screwed into place over the bellshaped end 68 or otherwise releasably fixed thereto. The
yinflatable sleeve, readily openable sealingmeans normally sealing off vcommunication between said chamber and said inflating passage, an expansible fluid sufficiently impermeable to the wall of said chamber for storage therein maintained within,y said chamber in a compressed state for inflation 'of said sleeve upon opening of said sealing means, and means rigidifying the shaft 'wall vforming said chamber to prevent distortion 'thereof by saidinflating fluid.
2. A self-inflating bag catheter comprising an elongated ilexible rubbery shaft for draining body fluids therethrough, said shaft having proximal and distal ends and having an inflatable sleeve mounted thereon adjacent said distal end, theproxirnal end portion of said shaft having a chamber therein, said shaft having aninilating passage therethroughV intercommuniating said chamber and said inflatable sleeve, readily openable sealing means normally sealing off communication between said chamber and said inilating passage, an expansible fluid sufficiently impermeable to theiwall ,of said chamber for storage therein maintained within lsaid chamber in a compressed state for inflation of said sleeve upon opening of said sealing means, and'means rigidifying the shaft wall forming said chamber toV prevent distortion thereof by said inflating fluid, said readily openable sealing means comprising a frangble tube having a closed end projecting into said chamber and an open end frictionally seated within saidV intlating vpassage and openable `by fractureupon flexing said shaft in the Vicinity of .the juncture of said inflating passage and said chamber.
3. A self-inflating .bag catheter comprising an elongated lexible rubbery shaft for draining body fluids therethrough, said shaft having proximal and distal ends and having an inflatable sleeve mounted thereon adjacent said distal end, the proximal end portion of said shaft having a chamber therein, said shaft having an iniating passage therethrough intel-communicating said chamber and said inflatable sleeve, readily openaole sealing means normally sealing oi communication between said chamber and said inlating passage, an expansible fluid sufliciently impermeable to the wall of said chamber for storage therein maintained Within said chamber in a compressed state for inflation of said sleeve upon opening of said sealing means, and means rigidifying the shaft Wali forming said chamber to prevent distortion thereof by said inilating huid, said readily openable sealing means comprising an elongated shank having a passage closing means at one end seating in said inflating passage, the other end of said shank projecting exteriorly of said catheter for unseating said closing means upon movement thereofaway from said inilating passage.
4. A self-inilating bag catheter comprising an elongated exible rubbery shaft for draining body fluids therethrough, said shaft having proximal and distal ends and having an inlatable sleeve mounted thereon adjacent said distal end, the proximal end portion of said shaft having a chamber therein, said shaft having an inflating passage therethrough intercommnnicating said chamber and said mils-.table sleeve, readily openable sealing means normally sealing od communication between said chamber and said inllating passage, an inert iiuorocarbon i'laid maintained within said chamber in a compressed state for inilation of said sleeve upon opening of said sealing means, and means rigidifying the shaft wall forming said chamber to prevent distortion thereof by said irilating fluid.
References Cited hy the Examiner UNTED STATES PATENTS 1,089,803 3/14 Noli 128--349 3,044,468 7/62 Birtwell 12S-649 3,049,25 8/62 Kriwkowitsch l28-325 RICHARD A. GAUDET, Primary Examiner.
GRDAN FRANKLIN, Exmnz'ner.