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Publication numberUS3699964 A
Publication typeGrant
Publication dateOct 24, 1972
Filing dateDec 28, 1970
Priority dateJul 2, 1970
Publication numberUS 3699964 A, US 3699964A, US-A-3699964, US3699964 A, US3699964A
InventorsRichard E Ericson
Original AssigneeBard Inc C R
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Closed urinary drainage and irrigation system
US 3699964 A
Images(8)
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Description  (OCR text may contain errors)

United States Patent Ericson L431 I Oct. [5,4] CLOSED URINARY DRAINAGE AND Q'I I- Il lll&LIlI I QN IRRIGATION SYSTEM Argyle Catalogue, A.-S.'Aloe C0. rec d 1960 [72] Inventor: Richard E. Ericson, Keene, N.H. Primary Examiner chafles R Rosenbaum [73] Assignee: C.R. Bard Inc., Murray Hill, NJ. A rn y-W. on Seward [22] Filed: Dec. 28, 1970 57 PP NOJ 101,976 'Aclosed system, disposable, urinary drainage and ir- Relawd U 8 Application Data rigation system having the following improvements: l. a flexible drainage tube of increased internal diame- [63] contmuauonm'pafl of ter, which is larger than the maximum internal diame- 23, 1969, abandonedter at which a continuous column of urine will form in the tube when urine flows therethrough by gravity Ffll'elgll Applmatloll pl'lol'lty Data from the bladder, to thereby prevent microorganisms July 2 1970 Canada 087040 from ascending the tube the bladder; July 3, 1970 Great Britain ..32,372/70 2. a circumferential slit extending part way around the circumference of the drainage tube located over the [52 US. Cl ..12s/275 Shank of the catheter adapter to Provide a unique yp [51 lm. Cl. ..A61f 5/44 im'gation valve for alternately irrigating the bladder [58 Field of Search ..128/214 227 275-278 and draining the bladder thwugh the drainage tube into a drainage bag in which the urine is collected without disconnecting and reconnecting the drainage 56 R f CM tube from the catheter adapter shaft and without the 1 e erences I necessity of clamping off the drainage tube between UNlTED STATES PATENTS the valve and the bag;

3. a one way ball valve and housing therefor at the end g g of the drainage tube located within the drainage bag e e s to prevent reflux while permitting free flow of urine 3,186,410 6/1965 Buono 128/275 through the flrainage tube into the g 3,262,448 7/l966 Ring et al. ..l28/2l4.4 4. a protective cap over the end of t e draw off tube 3,375,828 4/1968 Sheridan ..i28/35l for drawing urine from the drainage bag, such cap 3,416,567 12/ 1968 Von Dardel et al. .L....l28/2l4 being efiective to protect the end of the draw off tube 3,421 ,509 1 [1969 Fiore 128/349 from with contaminated Objects; and

Pannier, .II'. ...I28/2I4.4 5 a disposable yringe in the sterile i 3,473,532 10/ i969 Eisenberg 1 28/295 igating fluid i5 prepackaged and whigh is particularly 3,513,849 Vaillancourt et al ..l28/349 adapted to be used with the aforesaid irrigation valve to permit irrigation without leakage.

41 Claims, 28 Drawing Figures PATENTEDnm 24 m2 SHEET 1 0F 8 INVENTOR- RICHARD E. ERICSON ATTORNEYS PATENTED 0m 24 1912 SHEET 2 BF 8 iNvENTOR' RICHARD E. ERICSON imfilh ATTORNEYS PATENTEDHBI 24 9 3 6 99 9 64 sum 3 or 8 IN TOR RICHARD E. CSON ATTORNEYS PATENTED um 24 I972 SHEET N [If 8 INVENTOR RICHARD E. ERICSON 0 by I" 1 ATTORNEYS PATENTED IT 24 1973 3 699,964

SHEET 6 IF 8 I .90 I 1 I 205 II 202 1 68 INVENTOR,

I RICHARD E. ERICSON l W BY i, $9162., Manama ATTORNEYS PATENTEU BT I972 SHEET 7 BF 8 INVENTOR. I BY RICHARD E. ERI CSON 98/362 wowgadomfi $10M ATTORNEYS PATENTEDHBT 24 I97? 3 6 99 .964

SHEET 8 0r 8 INVENTOR. RICHARD E. ERICSON ATTORNEYS CLOSED URINARY DRAINAGE AND IRRIGATION SYSTEM CROSS REFERENCES TO RELATED APPLICATIONS the closed urinary drainage and irrigation system disclosed and shown in my copending U.S. patent application Ser. No. 669,183, filed Sept. 20, 1967, now U.S. Pat. No. 3,478,743,Nov. 18, 1969.

SUMMARY OF THE INVENTION The invention relates to the aforesaid improvements in drainage and irrigation systems, all designed to reduce the danger of retrograde infection of the urinary tract and bladder and some of which are also designed to facilitate alternating irrigation and drainage without leakage and with minimum chance of contamination.

A serious problem in urinary drainage, which involves draining the urine from the bladder into a urine collection bag or other container through a catheter and drainage tube attached by an adapter to the catheter, is the ascent of microorganisms from the bag up the drainage tube to the urethra and bladder. It has been discovered that one reason for this is because the urine often forms a continuous liquid column in the drainage tube up which the microorganisms can ascend to the catheter by swimming up the column or by being carried up the column by air bubbles.

According y, a primary object of the present invention is the solution of this problem by eliminating the aforesaid ascent of the microorganisms.

This is achieved in accordance with the present invention by enlarging the internal diameter of the drainage tube, to a diameter which is greater thanthe maximum diameter at which a continuous column of 0 urine can be formed during urine flow in the tube by gravity from the catheter.

Furthermore, by eliminating the formation of a continuous column of urine in the drainage tube, the gravity flow of the urine can be readily observed through the transparent or translucent plastic tube to better ob serve patient output.

Also, the formation of a continuous column of liquid in the drainage tubing presents problems in making accurate periodic urine output determinations with conventional drainage tubing, because it is impossible to determine at any time that a measurement is taken how much of the urine is being held up in the drainage tube. The enlarged internal diameter drainage tubing of the present invention eliminates this disadvantage.

The inside diameter of standard drainage tubing is between six thirty-seconds inch and nine thirty-seconds inch. The internal diameter of the drainage tube of the present invention is substantially greater than nine thirty-seconds inch and is preferably between eleven thirty-seconds inch and twelve thirty-seconds inch, the most preferred dimension being eleven thirty-seconds inch.

This aspect of the invention is based upon the recognition that if the internal diameter of the tubing is increased sufficiently, a point will be reached at which the formation of a liquid meniscus, which involves a surface tension phenomenon, is eliminated. Such a meniscus is formed by molecules of the liquid forming a bridge between the drainage tube walls. It is this meniscus which results in the formation of a continuous urine column in standard drainage tubing. If the opposite walls of the tubing are sufficiently far apart, cannot be formed at the normal flow rate of the urine by gravity through the catheter and adapter a meniscus cannot be formed. Accordingly, a continuous urine column cannot be formed.

Further advantages are achieved by making the plastic drainage tube highly flexible. To achieve this, the plastic is made softer and thicker (greater wall thickness) than in conventional drainage tubes. A

preferred plastic is a highly plasticized polyvinylchloride, e.g., plasticized with a phthalate plasticizer. Preferably, the plastic has a softness falling within the Durometer-Shore A range, a preferred softness being between 60 and Durometer-Shore A, and the thickness of the wall of the drainage tube is substantially greater than 0.040 inch, for example 0.055 inch. The thickness of the wall of standard drainage tubes is between 0.030 inch and 0.040 inch.

This increased softness and increased wall thickness of the drainage tube permits it to take sharp bends without occlusions, which are apt to prevent drainage or to cause the formation of a continuous column of urine even with the larger internal diameter drainage tubing.

Another problem with closed drainage and irrigation systems is that in order to connect the irrigation source with the in-dwelling catheter to alternately introduce irrigation liquid into the bladder, it is necessary to disconnect the end of the drainage tube, i.e., the catheter adapter, from the in-dwelling catheter. Upon disconnection of the drainage tube from the catheter, it is difiicult for the nurse or doctor to continue to hold it while irrigating. Consequently, it is usually placed upon the bed or upon a table and, in many cases, becomes contaminated. Furthermore, it is apt to fall on the floor to further increase the chances of contamination. Also, in disconnecting and reconnecting the drainage tube with the in-dwelling catheter, the fingers are very apt to come in contact with the end of the drainage tube or with the open end of the catheter funnel with resulting contamination. When it is remembered that during irrigation, this disconnection and reconnection is repeated alternately a number of times, it will be realized that the chances of contamination are extremely great.

In an attempt to overcome these very serious disadvantages of the aforesaid conventional disconnectreconnect arrangement, in my aforesaid copending application, I propose a catheter with a branch having a valve in it, which normally closes the branch during drainage but which can be forced open by inserting the tip of an irrigation syringe or of an irrigation adapter connected to an irrigation bottle by tubing. Although this avoids many of the disadvantages of a disconnectreconnect arrangement, it has further disadvantages as follows:

1. in order for the insertion of the tip of the syringe or adapter to open the branch valve while, at the same time, forming a seal with the branch to prevent leakage,

construction cannot be used with the many different commercially available tip designs, which is essential as a practical matter;

2. when the irrigation tip is inserted into the branch to open the valve, it tends to push contaminants, which accumulate at the valve, into the catheter and eventually into the urethra and bladder with danger of infection; upon repeated irrigations, the build up of contaminants on the inside and the outside of the valve increases with consequent'increased chance of infection, due to the lack of any self cleaning of these areas; furthermore, with such a construction, there are undercut pockets and recesses in which contaminants can easily collect; this is a disadvantage with any kind of valved irrigation branch;

3. the cross-sectional area of the portal entry is restricted by the valve construction so that blood clots and debris from the bladder and urethra are apt to plug the valve; even if they do not plug the valve, they are a source of contamination and interfere with good and proper irrigation;

4. the branch and valve contained therein add to the bulk, unbalance and instability of the catheter and drainage tube assembly and are apt to dig into the patient when he rolls over, all of which add to the discomfort of the patient;

5. with a valved branch or side arm, the drainage tube must be shut off during irrigation to prevent the irrigating fluid from flowing through the drainage tube into the drainage bag; this must be done by clamping the drainage tube; however, most hospitals will not approve of clamping the drainage tube in this manner because of the danger that the nurse might forget to unclamp the tube after the irrigation step is terminated and drainage is commenced; although this can be avoided by the use of complex one-way check valves,- these are so complicated they are impractical;

6. it is not possible to take a urine specimen directly from the catheter without disconnecting the drainage tube from the catheter.

Accordingly, it is another object of the present invention to provide a combined drainage and irrigating system in which the aforesaid disadvantages of a connect-disconnect arrangement and a valved branch are avoided.

This is achieved in accordance with the invention by providing a normally closed entry in the side of the drainage tube into which the syringe tip or irrigation adapter can be inserted to thereby provide communication between the irrigation source and the catheter while shutting off communication between the catheter and the drainage bag without disconnecting the drainage tube from the catheter. It is achieved in accordance with a preferred embodiment of the invention by providing a circumferential slit extending part way around the circumference of the drainage tube located over the shank of the catheter adapter with the unslit portion of such circumference acting as a flexible hinge about which the slit end of the tube can be flexed off the open end of the adapter shaft to expose it for irrigation by inserting into it the externally tapered tip of an irrigation syringe or an externally tapered irrigation adapter connected to a source of irrigating fluid. A

I sleeve is provided over the slit portion of the drainage tube to prevent accidental opening of the slit and also to protect against contamination of the slit.

The catheter adapter is preferably made of a material, preferably plastic, which has greater resilience and flexibility and is less brittle than conventional plastic catheter adapters so that when the externally tapered irrigation syringe tip or externally tapered irrigation adapter is inserted into the open end of the adapter shank and into engagement with such open end an excellent seal is formed between such open end and the tip or irrigation adapter without danger of cracking the catheter adapter with most tips and adapters of conventional design.

After irrigation, it is necessary only to flex the slit end of the drainage tubing about the aforesaid flexible hinge and back over the open end of the catheter adapter shaft followed by sliding the protective sleeve in place over the slit portion of the tube.

During irrigation, the slit end of the tube which has been removed from over the catheter adapter shank is held in place by the hinge portion to thereby reduce the danger of contamination thereof, as compared to the aforesaid connect-disconnect arrangement.

With this kind of an arrangement the dangers of touching either the slit end of the sleeve which is flexed off the catheter adapter shank or the open end of the catheter adapter shank are greatly reduced.

Furthermore, this arrangement provides a self cleaning effect, as compared to a valved irrigation branch, in that any contaminants which might accumulate on the aforesaid slit end of the tube or at the aforesaid open end of the catheter adapter shank during irrigation will be washed down the enlarged drainage tube into the drainage bag after the slit end of the tube has been again flexed back onto the catheter adapter shank and drainage is commenced.

Because when the irrigation tip or adapter is introduced into the exposed end of the catheter adapter shank the drainage tube is cut off from communication with either the source of irrigating fluid or the catheter, it is not necessary to clamp the drainage tube during irrigation, as is true with the use of a valved irrigation branch.

Furthermore, this slit tube arrangement is ultra simple, inexpensive, fool-proof and avoids the necessity of a bulky and uncomfortable valved irrigation branch.

Another problem which presents itself with these types of drainage systems is the danger of reflux of urine from the collection bag back through the drainage tube to the urethra. In the past it has been attempted to avoid this by applying to the end of the drainage tube which extends into the drainage bag a flutter valve made up of two flat pieces of flexible material, which are normally collapsed against each other to prevent flow of fluid into the tube but which are forced apart by the flow of urine from the catheter through the tube into the bag. Although this flutter type valve is effective to prevent reflux, the pressure necessary to open it is usually such that it sometimes tends to support a column of urine.

Accordingly, it is yet another object of the present invention to provide an improved valve arrangement at the end of the drainage tube within the drainage bag which does not have the aforesaid characteristic of a flutter valve.

This is achieved by means of a ball valve made up of (a) a housing, one end of which is secured to the end of the drainage tube and has a valve seat and the other end of which is provided with a stop and (b) a ball which is adapted to roll freely within the housing to a closed position against the valve seat and to an open position against the stop. The ball is instantaneously moved to the closed position at the commencement of any flow from the bag into the housing to instantaneously seat on the valve seat and thereby prevent reflux of urine into the drainage tube. Furthermore, the ball is instantaneously responsive to any tilting of the bag to close the valve seat. On the other hand, it is highly responsive to even a very slight flow of urine in the drainage tube to the valve seat to instantaneously roll to its open position against the aforesaid stop to allow free flow of the urine through the housing into the bag without any build up of a urine column in the drainage tube.

By making the minimum open cross-sectional flow area into, through and out of the housing greater than the maximum cross-sectional area of the drainage tubing at which a continuous column of urine is formed in the tubing, this insures against the build up of such a column due to restriction of urine flow.

Since the housing is made of a plastic which is substantially more rigid than the bag, it effectively prevents the bag panels from sticking together at the exit end of the drainage tube to thereby impede the flow of urine from the drainage tube into the bag, which may also be a cause of build up of a continuous liquid column in the drainage tube.

Furthermore, the housing prevents the inner surfaces of the bag panels, if contaminated, from coming in contact with the end of the enlarged drainage tube.

Preferably, a plurality of slots are provided in the housing for flow between the housing and bag and they are elongated and extend in the longitudinal direction of the housing. In this way, free flow is insured. Furthermore, the ball must be of a material which has a greater specific gravity than the urine and which is resistant to attack by urine, a preferred material being stainless steel. This is to prevent the ball from floating in urine insidethe housing and from corroding.

Another pr-oblem which, in some instances, has presented itself with the closed drainage system disclosed in my aforesaid copending patent application is the contamination of the end of the draw-off tubing for drawing urine out of the bag. Such draw-off tubing, as well as the draw-off tubing of conventional urinary drainage systems, is apt to become contaminated by contact with the fingers or with contaminated objects in the room.

Accordingly, it is yet another object of the present invention to overcome this problem.

This is achieved by providing a protective cap over v and around the end of the draw-off tubing. The cap comprises a housing into which the end of the draw-off tubing extends but which extends axially beyond such end of the draw-off tubing with the inner surface of the housing around the end of the draw-off tubing being substantially larger in radius than the outer surface of the end of the draw-off tubing, whereby the inner surface of the housing is spaced radially and outwardly from the outer surface of the end of the draw-off tubing located within the housing. in this way, the housing at all times protects the end of the draw-off tubing to prevent it from becoming contaminated.

Furthermore, when this cap is used with the closed drainage system disclosed in my aforesaid copending application, which has a relatively rigid stabilizing tube extending along the top of the bag, it has the further advantage that when the end of the draw-off tubing is inserted into an open end of the stabilizing tube when the tubing is not being used, as described in the aforesaid such end of the stabilizing tube is received within the housing between the housing wall and the end of the draw-off tubing to provide a seal between the stabilizing tube and the draw-off tubing.

Preferably, the protective cap is provided with an integral internal hollow tubular section, which is an extension of and functionally forms the end portion of the draw-off tubing and it is this end portion which is located within the housing and is spaced radially and inwardly from the housing wall, as aforesaid. Preferably, the external surface of the aforesaid tubular section is tapered to facilitate insertion thereof into the end of the stabilizing tube and to provide a tight sealing fit between such section and the stabilizing tube. The protective cap insures against the clamp on the drawoff tubing accidentally sliding off the end thereof.

Conventionally, irrigation with an irrigation syringe is carried out with the use of the irrigating syringe, a basin and a bottle containing the irrigating fluid. The irrigating fluid is poured into the basin and is aspirated into the bulb or piston type syringe followed by irrigation of the patient. This technique has the serious disadvantages that it is time consuming, it involves a number of manipulations and it is subject to a number of errors. In pouring the irrigating fluid from the bottle into the basin and in aspirating it from the basin into the syringe, there are multiple opportunities for contamination.

Accordingly, it is yet another object of the invention to provide an irrigating syringe and technique which will avoid these disadvantages.

This is achieved in accordance with the present invention by providing a prepackaged, plastic irrigating syringe, containing the sterile irrigating fluid, such as a saline solution, prepackaged and sealed therein. Thus, the syringe functions not only as a bulb type syringe but also as a package for the irrigating fluid. This syringe is made of a heat resistant, compressible, flexible, transparent or translucent, resilient, plastic material having a low rate of moisture vapor transmission, which is highly resistant to autoclaving conditions, particularly, heat and hot steam, and which has a reduced neck extending axially from an end thereof into an externally tapered elongated syringe tip. The tip has a cap removably secured thereover and therearound with a sealing surface of the cap urged against a complimentary sealing surface of the tip to seal the syringe. After the cap has been removed and the tip has been inserted into the exposed open end of the catheter shank, as aforesaid, the fluid can be forced out of the bottle by squeezing and compressing the side walls, aspiration into and out of the bladder being achieved by alternate and repetitive compression and release.

Preferably, the bottle is made of a copolymer of a major proportion of propylene and a minor proportion of ethylene and is of a size which will fit in the palm of the hand with the preferred maximum and minimum wall thickness, exclusive of the tip, being 0.035 inch and 0.020 inch, respectively.

The use of this prepackaged syringe reduces to a minimum the danger of contamination and the number of procedural steps required for irrigation. Also, the syringe is disposable so that once it is emptied, it is discarded with no danger of contamination due to repeated use.

Preferably, the bottle-syringe has a relatively flat or equivalent bottom so that it can be placed upright on a supporting surface without danger of spillage or tip contamination.Preferably, it is in the form of a cylinder with the tip extending from one end of the cylinder.

Further advantages and features of the invention will be apparent from the following description and accompanying drawings describing and showing preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS drainage bag (this is the normal position of the draw-off tubing) and in broken lines during draw off;

FIG. 2 is a section taken along the line 2--2 of FIG. 1;

FIG. 3 is a section taken along the line 3-3 of FIG.

FIG. 4 is an enlarged view in perspective with portions cut away of the catheter adapter and the end portion of the urinary drainage tube secured thereto of the system of FIG. 1, showing the irrigation slit for alternate irrigation and drainage and with the protective sleeve located over the irrigation slit to protect the slit and to prevent it from being opened;

FIG. 5 is a non-sectional view like FIG. 4 but with the protective sleeve slid back on the drainage tube to expose the irrigation slit;

FIG. 5A is a view like FIG. 5 in which the irrigation slit lies in a plane at an angle of about 45 to the longitudinal center line of the drainage tube rather than in a plane 90 to such center line as in FIG. 5.

FIG. 6 is a view in perspective of the irrigation arrangement of FIGS. 4 and- 5 with the protective sleeve slid off from the slit in the drainage tube to expose it and with the slit end of the drainage tube swung off from the open end of the catheter adapter shank to expose such open end for taking a sample of urine and/or for irrigation;

FIG. 6A is a view corresponding to FIG. 6 of the embodiment of FIG. 5A;

FIG. 6B is a side view of the embodiment of FIG. 5A;

FIG. 7 is a view like FIG. 6 showing the tip of an irrigation syringe inserted into the open end of the exposed catheter adapter shank end during irrigation;

FIG. 8 is a view taken along the line 8-8 of FIG. 7;

FIG. 8A is a reduced view of the irrigation arrangement of FIG. 7 with the open end of the catheter adapter shank exposed for irrigation but showing irrigation from a bottle of irrigating fluid through an irrigating tube and tapered adapter rather than from a syringe;

FIG. 9 is a section taken along the line 9-9 of FIG.

FIG. 10 is a section taken along the line 10-10 of FIG. 9;

FIG. 11 is a view like FIG. 9 showing a different construction for holding the protective sleeve in place over the slit drainage tube;

FIG. 12 is an enlarged view in perspective of the end of the drainage tube of FIG. 1 which extends into the drainage bag and with a part of the bag panel cut away to expose the ball valve located at such end of the drainage tube;

FIG. 13 is a section taken along the line 1313 of FIG. 12;

FIG. 14 is a section taken along the line 14-14 of FIG. 13;

FIG. 15 is a view in perspective of the free end of the draw-off tube of FIG. 1 together with a portion of the comer of the drainage bag and showing the protective cap over such end of the draw-off tube and the draw-off tube removed from the stabilizing tube extending along the top of the drainage bag;

FIG. 16 is a view in elevation and partially in section of the part of the closed drainage system shown in FIG. 15;

FIG. 17 is a section taken along the line 17l7 of FIG. 16;

FIG. 18 is a view partially in section of the prepackaged irrigation syringe shown in FIGS. 7 and 8;

FIG. 19 is a view in perspective of another kind of irrigating entry associated with the catheter adapter and showing the closure therefor in solid lines in open position and in broken lines in closed position;

FIG. 20 is a view like FIG. 19 with the closure open and with the tip of the irrigating syringe of FIGS. 7 and 8 inserted in the irrigating entry for irrigation;

FIG. 21 is a longitudinal view in cross-section of the embodiment shown in FIG. 20, with the closure shown in full lines in the open position and in broken lines in closed position;

FIG. 22 is a view taken along the section line 2222 in FIG. 21 with the irrigating syringe removed;

FIG. 23 is a sectional view in elevation of another kind of irrigating entry in the catheter adapter utilizing a flap valve shown in its normal position during drainage; and

FIG. 24 is a view like FIG. 23 during irrigation with the protective cap removed and with the tip of the syringe introduced into the irrigating entry to shut off communication between the catheter and the drainage tube.

DETAILED DESCRIPTION With reference to the figures, the numeral 2 represents a closed urinary drainage and irrigation system comprising a sealed, plastic urinary drainage bag 4, a urinary drainage tube 6, an end of which extends into the interior of bag 4 and the opposite end of which is provided with a catheter adapter 8, and a draw-off tube 10 extending from the bottom of the bag 4 and having a clamp 11.

The urinary drainage bag 4 is of generally the same construction as that disclosed in my copending patent application Ser. No. 669,183 now US. Pat. No. 3,748,743. It comprises a pair of thin, flat, flexible, plastic, e.g., polyvinylchloride, sheet panels 12 and 14 arranged back-to-back against each other and heat sealed together along their margins at 16 to form a flat, collapsible bag having an upper edge 18, a lower edge 20 and two side edges 22 and 24. Preferably, the front panel 12 is transparent or translucent whereas the rear panel 14 is opaque and white, and the inside surface of each of the panels is embossed with a medium tafi'eta finish to thereby make the surface rough to reduce the tendency of the panels to adhere against. each other. A pair of heat seal lines 26 and 28, extending along but spaced from the upper edge 18 of {the bag, separate the bag into a main urine collectionichamber 30 and an upper marginal pocket 32 extending along the top of the bag from side-to-side. The pocket 32 is open at its ends 34 and 36, the side edges 22 and 24 not being sealed in these areas.

Located slightlyabove the seal line 28 are a plurality of horizontally spaced, horizontal slits 38 heat sealed along their edges and extending through both panels of the bag for receiving a flexible plastic hanging strap 40 for hanging the bag to a bed rail or the like during use, all as described in the aforesaid copending application.

Snugly but removably received in the pocket 32 above slits 38 (the end portion 27 of line 26 and the branch 29 of line 28 form restrictions in the pocket) is a cylindrical, elongated, stabilizing tube 42 made of plastic, e.g., polystyrene, and open at both ends 44 and 46. The plastic of tube 42, and hence tube 42, are relatively rigid compared to the plastic bag 2. The length of the plastic, stabilizing tube 42 is about the same as the overall width of the bag proper from side to side. However, the unsealed edge 34 of the pocket 32 terminates short of the corresponding main side edge 22 of the bag, as shown, so that the stabilizing tube 42 protrudes beyond the edge 34 of the pocket, as shown, for receiving a protective cap 48 secured to the free end of the draw off tube 10, as shown. The fit between the stabilizing tube 42 and the restrictions 27 and 29 of the pocket 32 is a snug one to insure against the tube 42 accidentally sliding out of an open end of the pocket 32.

The lower edge 20 of the bag bows downwardly as shown, the lowest area 21 lying near the middle of the lower edge 20 directly below the middle slit 38.

Located in the stabilizing tube 42, opposite the end which receives the protective cap 48 of the draw-off tube is a filter 50, e.g., a wad of cotton, for filtering out microorganisms from any air which might enter the urine collection chamber 30 through the stabilizing tube 42 and the draw-off tube 10, the free end of which is removably received in the end 46 of the stabilizing tube 42 in an air-tight manner to provide communication therebetween, as will be described more fully hereinafter.

Although the open-ended stabilizing tube 42, and draw-off tube 10 provide communication between-the atmosphere and the fluid chamber 30 through the filter 50 for gas sterilization of the system and for over-flow from the bag 2, nevertheless, the wad 50 prevents-the entry of microorganisms into the system, all as described in my aforesaid copending patent application.

The hanging strap 40 is of a highly flexible, plastic, e.g., linear polyethylene and has the same shape and the same fastening button 41 for removably and adjustably fastening the ends together as the corresponding hanging strap described in the aforesaid pending patent application.

The relatively rigid stabilizing tube 42 stabilizes the bag so that it can be hung by the single strap 40 without sagging or wrinkling due to the unbalanced weight of the bag. Furthermore, it provides support for strap suspension by the strap 40 and the end 46 thereof provides a protective and convenient receptacle for the free end of the draw-off tube 10. Also the draw-off tube, when located within the end 46 of the stabilizing tube 42, as shown in FIG. 1, provides a route for gas sterilizing the system and for overflow in the event that the bag becomes too full and before the bladder becomes distended in the eventthat the bag is not emptied when it should be, all as described in my copending patent application.

The end portion of the soft, flexible, transparent or translucent plastic, e.g., polyvinylchloride, drainage tube 6 extends through the upper left side edge 24 of the bag at the thickened seal area 52 into the fluid chamber 30 in an air-right manner, as shown. Actually, the edge portions of the panels 12 and 14 at the seal area 52 are hermetically sealed around the periphery of and to a short plastic receptor tube (not shown) through which the drainage tube 6 extends and in which it is hermetically sealed. The end portion 64 of the drainage tube 6 which is located within the drainage bag 4 is provided at its end with a ball valve construction 66, shown in detail in FIGS. 12 to 14 and which will be described more fully hereinafter. The other end of drainage tube 6 is fitted tightly around the shank 54 (FIGS. 4 and 5) of the catheter adapter 8 in an air-tight manner and is provided with an irrigation entry arrangement 56 to be described in detail hereinafter.

The catheter adapter is covered by a conventional, removable, flexible, plastic (polyethylene) adapter cap (not shown) which snaps over the shoulder 57 in an airtight manner but which is removed when the system is to be used so that the rubber catheter 58 (Foley catheter in the drawings) can be attached thereto, as shown in FIGS. 4 and 6-8.

The end portion of the soft, flexible, transparent or translucent, plastic (e.g. polyvinylchloride) draw-off tube 10 extends in an air-tight manner between the panels 12 and 14 through the lower side edge 22 at the enlarged seal area 60 of the bag into the fluid chamber 30. Actually, as in the case of the drainage tube 6, the draw-off tube 10 is hermetically sealed by solvent cement within a flexible, plastic (polyvinylchloride), transparent receptor tube (not shown) which extends through the sea] area 60 with the adjacent edge portions of the panels 12 and 14 being hermetically sealed by heat around and to the periphery of the receptor tube at the seal area 60. The other end 62 (FIGS. 15-17) of draw-off tube 10 is beveled and is secured within the protective cap 48, which is removably applied over the end 46 of the stabilizing tube 42, as shown in FIG. 16, and which will be dewribed more fully hereinafter.

The improvements provided by the present invention are directed primarily to the irrigation entry arrangement 56, to the ball valve assembly 66, to the protective cap 48, to a drainage tube 6 of increased internal diameter, as will be described more fully hereinafter,

and to an improved prepackaged irrigation syringe 68 (FIGS. 7, 8 and 18) in which sterile irrigation fluid is prepackaged and which is particularly adapted for use with the irrigation entry arrangement 56 as shown in FIGS. 7 and 8 and as will be described more fully hereinafter. The aforesaid improvements will now be described in detail as follows.

THE ENLARGED INSIDE DIAMETER DRAINAGE TUBE 6 The inside diameter of the drainage tube 6 leading from the catheter adapter 8 to the drainage bag 4 is made large enough so that urine will pass by gravity from the catheter adapter through the tube and into the bag without forming a continuous column of urine.

therein, i.e., the internal diameter and cross-sectional area, respectively, of the drainage tube 6 are greater than the maximum internal diameter and cross-sectional area, respectively, at which a continuous column of urine will form in the tube 6 when urine flows therethrough from the catheter adapter by gravity.

In conventional drainage tubes, having a standard inside diameter between six thirty-seconds inch and nine thirty-seconds inch, the urine flowing by gravity from the catheter adapter through the tube into the drainage bag may form a continuous column of urine in the tube from drainage bag to catheter, up which column microorganisms may ascent to the catheter S8 and thence to the urethra by swimming up the column or by being carried up the column by air bubbles.

The formation of such a continuous urine column in the drainage tube is avoided.

This by increasing the internal diameter of the drainage tube 6 sufficiently to eliminate the formation of a liquid meniscus in the tube which involves a surface tension phenomenon as previously explained.

Urine has components which giveit adhesive characteristics and consequently the surface tension phenomenon is greater than with water so that a solid column of liquid forms more easily.

It has been found that the minimum inside diameter to prevent the formation of a urine meniscus and thereby eliminate the aforesaid surface tension phenomenon, which causes the formation of a continuous urine column, is a diameter substantially greater than nine thirty-seconds inch. Therefore, the minimum inside diameter is substantially greater than nine thirtyseconds inch and the preferred ID. is between eleven thirty-seconds inch and twelve thirty-seconds inch. If the inside diameter is made too large the tubing becomes too cumbersome.

Because a solid column of urine does not form in the enlarged tube 6, the free flowing movement of the urine through the tube can be easily observed, which is an important advantage in observing rate of flow of urine.

The tube 6 is preferably made highly flexible so that it can take relatively short bends without forming occlusions or restrictions which cause the build up of a continuous urine column. To achieve this, it is made somewhat softer and thicker (wall thickness) thanconventional drainage tubes. The tube 6 shown in the drawings is made of plasticized polyvinyl chloride, the plasticizer being a phthalate ester, e.g., diisooctyl phthalate.

The thickness of the wall of the drainage tube 6 in they drawings is 0.055 inch, whereas the thickness of the wall of standard drainage tubes is between 0.030 and 0.040 inch. The thickness of the wall of the drainage tube of the instant invention is preferably substantially greater than 0.040 inch.

The tubing 6 preferably has a softness falling within Durometer-Shore A. More preferably, the softness is between 55 and 80 (Durometer-Shore A). Tubing 6 in the drawings has a Durometer-Shore A softness of 65.

IRRIGATION ENTRY ARRANGEMENT 56 The end portion (FIGS. 4-10) of the internally enlarged flexible drainage tube 6 is fitted tightly over and around the hollow shank 54 of the catheter adapter 8 with a friction fit and has a circumferential slit 72 which extends around a major part of, but not entirely around, its circumference and which is located over the shank. This slit end portion 70 of tube 6 is normally covered by a plastic, e.g., polyethylene, protective irrigation sleeve 74 which, like adapter shank 54, is relatively rigid compared to tube 6, which is fitted snugly but slidably around such end portion 70 and which protrudes axially beyond the open end 76 of adapter shank 54 over a portion of the tube 6 located adjacent to, but not over, such shank as shown in FIG. 4.

When the relatively rigid irrigation sleeve 74 is positioned over the slit tube portion 70, as shown in FIG. 4, to cover and close slit 72, the end portion thereof over the shank 54 is received with a snug friction flt within the skirt 78, which extends integrally from the periphery of shank 54 radially outwardly and then longitudinally along the shank 54, as shown in FIG. 4. The friction fit between the skirt 78 and the end 75 of irrigation sleeve 74 prevents the sleeve 74 from being accidentally moved axially off the slit portion 70 of tube 6 to thereby accidentally expose the slit.

The radially extending portion 79 of skirt 78 is spaced a slight distance from the shoulder 57 of the adapter 8, as shown, in order to provide an annular external radiused recess 81 for receiving the end 84a of the adapter-receiving funnel 94 of rubber catheter 58, which is stretched around the shoulder 57 to hold the catheter 58 firmly on the adapter 8, as shown in FIGS. 4 and 8. The external comer 83 of the skirt 78 is radiused.

The circumferential slit 72 is exposed by sliding the protective sleeve 74 axially along the tubing and off from the shank 54 so that the end thereof clears the open end 76 of such shank, as shown in FIG. 5.

Irrigation sleeve 74 has two oppositely disposed corrugated finger pieces 82 to aid in sliding the sleeve along tube 6 off the slit portion 70 of the tube to expose the slit.

Although the friction fit between skirt 78 and the end portion 75 of the sleeve is tight enough to prevent accidental sliding of the sleeve off the slit portion 70 to expose the slit, it is not so tight as to unduly hinder such movement of the sleeve deliberately with the fingers from the slit covering position shown in FIG. 4 to the slit exposing position shown in FIG. 5 and back again. Also, although the fit between the sleeve and the end portion 70 of the tube 6 is snug, it is not so tight as to unduly hinder the aforesaid movement of the sleeve.

As aforesaid, the slit 72 extends around only a part of the circumference of the end portion 70 of tubing 6. The remaining unslit part 73 of such circumference acts as a flexible, resilient hinge for swinging the slit end 84 of the tube 70 off the open end 76 of the adapter shank 54 to thereby expose such open end 76, as shown in FIG. 6, for irrigating the bladder, as shown in FIGS. 7 and 8, by inserting the tapered neck 90 of the flexible and resilient plastic irrigation syringe bottle 68, filled with sterile irrigation fluid, into the exposed open end 76 of the shank and squeezing the irrigating fluid into the bladder through the catheter.

When irrigation is completed the tapered neck 80 is removed from the open exposed end 76 of shank 54 and the slit end 84 of the tube 6 is swung about the unslit hinge portion 73 of the tube circumference back over the open end 76 of the shank again into abutting relation with the other opposed slit end 91 of the tube, whereupon the protective sleeve 74 is slid axially back over the slit end portion 70 of the tubing 6 (over the slit 72) and over the adapter shank 54 to the position shown in FIG. 4 with the edge portion 75 thereof snugly received within the skirt 78.

The rigid protective sleeve 74 prevents accidental swinging of the slit end 84 off the open end 76 of the shank 54 of the adapter. Also, it protects the slit 72 from contamination and holds the slit ends of the tube snugly together, i.e., it prevents any parting of such slit ends.

The length of the relatively rigid sleeve 74 is such that when it is in the close position shown in FIG. 4, it extends away from the catheter a sufficient distance beyond the slit 72 and the open end 76 of the shank 54 so that flexing of the tube 6 will not disturb the slit, i.e., it isolates the slit from such flexing. The relatively rigid adapter shank, which functions as a rigid support for the slitted portion 70 of the tube, cooperates to so isolate the slit.

The slit 72 is located over the shank 54 close enough to the open end 76 of the shank to permit the slit end 84 of the tube '70 to clear such open end 76 when such slit end is swung about hinge 73 to the irrigation position shown in FIGS. 6-8 to expose such open end 76 for irrigation. x

The outside diameter of he adapter shank 54 is larger than the normal inside diameter of the drainage tube 6 to achieve a tight, liquid and air-proof seal between'the slit end 70 of the tube and the adapter shank when the sleeve 74 is in the close position shown in FIG. 4. However, the fit is not so tight that the slit end 84 of the tube 70 cannot be easily swung over the open end 76 of the catheter shank to the position shown in FIG. 6.

The sleeve 74 and slit end portion 70 of tube 6 are in the positions shown in FIG. 4 during drainage. The tight fit between the slitted tube end portion 70 and the shank 54 of the adapter and the relatively snug fit between the irrigation sleeve 74 and the tube portion 70, together with the fact that the slit ends of the tube 70 are held in snugly abutting relationship on the shank 54, insures against leakage of urine through the slit and also reduce the danger of contamination entering the system through the slit. The prevention of a continuous column of urine in the drainage tube because of the increased intemal size of such tubing also prevents such leakage since the urine falls from the open end 76 of the adapter shank 54 into the tubing 6 beyond the slit 72 and consequently does not have an opportunity to back up between the tube end portion 70 and the periphery of the adapter shank 54.

It is noted that the end of tubing 6 abuts against the internal surface of the wall 79 of skirt 78. The same is true of the end of sleeve 74 when it is in the close position shown in FIG. 4.

It is preferred to have the slit 72 in the end portion 70 of the drainage tube 6 located around the relatively rigid catheter shank, as shown, but the slit 72 can be located further down the drainage tube 6 toward the drainage bag. In such case, it is preferred to provide a relatively rigid inner sleeve fitted within such slitted portion of the tube with a tight friction fit to take the place of the adapter shank to rigidly support such slit portion with the outer, relatively rigid protective sleeve located over such slitted portion and the relatively rigid inner sleeve. In such case, the inner sleeve may be of the same dimensions as the adapter shank 54 and the position of the slit relative to the ends of such inner sleeve may be the same as the position of slit 72 relative to the shank 54in FIG. 4. However, the closer the slit is to the catheter adapter the better. If such a relatively rigid inner supporting sleeve is omitted, it is more difficult to isolate the slit from flexing of the tube 6, it is more difficult to prevent accidental parting of the slit ends and leakage through, and contamination of, the slit is more apt to occur, but if the outer protective sleeve is made long enough to effectively isolate the slit from flexing of the tube 6 and to prevent accidental parting of the slit ends, and if it fits snugly enough around the tubing to minimize leakage, such inner sleeve can be eliminated.

If desired, this same slit valve principle can be used on the catheter itself if inside and outside, relatively rigid sleeves are used.

A small piece of larger diameter, flexible plastic (polyvinylchloride) tubing 92 is sealed (by solvent or friction sealing) around the drainage tubing 6 at a point spaced from the slit 72 and from the open end 76 of shank 54, as shown in FIGS. 4 and 5, to act as a stop for the protective sleeve 74 when it is slid axially over the drainage tubing out from over the slit to the position shown in FIG. 5.

The catheter adapter 8 is novel in that it is made of a resin, such as polyvinylchloride, which has a greater resilience, flexibility and impact strength and is substantially less hard and brittle than conventional polystyrene catheter adapters, although it is still relatively rigid so that the shank 54 thereof provides an excellent non-bending and non-yieldable support for the slit portion 70 of the tube 6. Accordingly, when the tapered neck or tip of the irrigating syringe 68 is thrust firmly into the open end 76 of the adapter shank 54, an excellent liquid-tight seal is provided between the inner edge 93 of such open end 76 and the tapered tip 90 so that irrigation can be achieved without leakage and without entry of contaminants into the system and without danger of breaking the shank. This greater resilience, flexibility and yieldability of the adapter shank insures an excellent liquid-tight seal with tapered irrigation tips of a variety of sizes, including all conventional sizes.

The tapered neck 90 itself is made of a linear copolymer of ethylene and propylene so that it also has resilience and flexibility to contribute to the liquid-tight seal between it an the open end 76 of the shank 54 to thereby insure irrigation without leakage.

Since the protective sleeve 74 is also made of a plastic which, although relatively rigid, also has suffrcient resilience and flexibility (preferably the same material as the catheter shank), a tight fit can be achieved between the end portion 75 thereof and the skirt 78 while still permitting the sleeve to be slid out of the skirt without difficulty.

As can be seen in FIG. 6, a urine sample can be conveniently obtained at any time with minimum danger of contamination merely by sliding the irrigation sleeve off the slitted portion 70 of the drainage tube followed by swinging the slit end 84 off the open end 76 of the catheter adapter shank 54, as shown in FIG. 6, while the catheter is in place in the urethra and bladder of the patient, i.e., with an in-dwelling catheter.

Although in the drawings the catheter is shown secured to the catheter adapter, the system is manufactured and shipped with a protective cap (not shown) secured over the catheter adapter in an air-tight manner to provide a closed system. The cap is removed when the system is to be used and the catheter has been inserted into the patient, followed by inserting the adapter into the adapter receiving funnel 94 of the catheter, as shown in FIGS. 4 and 6-8.

Since both the adapter 8 and the irrigation sleeve 74 are molded, close tolerances can be accurately achieved between the internal annular surface of the skirt 78 and the external annular surface of the end portion 75 of such sleeve when the sleeve is located within the skirt in the position shown in FIG. 4, to

thereby insure a good snug fit therebetween to prevent accidental sliding movement of the sleeve to expose the slit 72 while permitting the sleeve to be deliberately so moved by the fingers without difficulty when so desired.

However, such skirt can be omitted as shown in FIG. 11, in which case the snug fit between the internal surface of the sleeve 74 and the external surface of the slit tube portion 70 over the shank 54 is relied on to prevent accidental sliding movement of the sleeve. Actually, in such case the external diameter of the shank and the internal diameter of the sleeve are such as to squeeze the tube portion 70 between them to insure the aforesaid snug fit between sleeve and tube. However, it is difficult to control the tolerances of plastic tubing and consequently the fit between the sleeve and tubing over the shank may be too tight, in which case movement of the sleeve becomes too difficult, or the fit may be too loose in which case the sleeve is apt to be accidentally moved to expose the slit. Accordingly, the FIGS. 4l0 embodiment with the skirt 78 is preferred although the FIG. 11 embodiment has proved successful also.

Irrigation can be carried out not only with the prepackaged irrigating syringe 68 shown in FIGS. 7 and 8 but also, with conventional irrigating syringes and, as shown in FIG. 8A, with a conventional supply 96 of irrigating fluid in a stoppered bottle 98 having a vent tube 100 and a plastic, flexible, translucent or transparent irrigation tube 102 with a molded, plastic, e.g., polyvinyl chloride, adapter 104 secured at its end, which is relatively rigid compared to the tube 102 and which is externally tapered so that when it is inserted into the exposed open end 76 of the adapter shank 54, as shown in FIG. 8A, the tapered periphery forms a liquid-tight seal with such open end by engagement with the outer end 93 of the bore 55 in the adapter shank 54in the same way that the tapered neck of the syringe 68 forms a seal with such open end in FIG.

8. A clamp 106 is provided for the irrigating tube 102.

Although in FIGS. 1-5, 6 and 7-11, the circumferentially extending irrigation slit 72 lies in a plane which is 90 to the longitudinal center axis of the irrigation tube, the circumferential slit may lie in a plane at any other angle to the longitudinal center axis of the irrigation tube, as shown in FIGS. 5A, 6A and 6B, in which the circumferentially extending irrigation slit 72A lies in a plane at an angle of 45 to the longitudinal center axis of the irrigation tube. As a matter of fact, the embodiment of FIGS. 5A, 6A and 6B is preferred since it facilitates swinging of the slit end 84A of the tube off from and onto the open end of adapter 54, reduces the chance of leakage and increases the durability of the hinge portion of the irrigation tube. Although in FIGS. 5A, 6A and 6B, the angle of the slit is 45 to the longitudinal axis of the irrigation tube, it may, as aforesaid, be at any angle to such center line which will permit swinging of the slit end 84A of the irrigation tube off from and onto the open end of the adapter. Furthermore, the slit may be curvilinear as shown by the dot-dash line 7213 in FIG. 68. Furthermore, it may have a bend in it as shown by broken line 72C in FIG. 63.

It is noted that the slit 72 and open end 76 of the catheter shank form an entry in the side of the drainage tube (the catheter adapter, as well as the catheter, may be considered part of such tube) with a proximal (i.e., closest to the patient) portion of such tube extending in one direction from such slit and open end and a distal (i.e., furtherest from the patient) portion 6 of the tubing extending in an opposite direction from such slit and open end (this is the portion which is swung off the adapter shank). It is also noted that when the tip 90 of the irrigation syringe 68 is inserted into the exposed open end 76 to provide communication between the catheter and irrigation source, communication is cut off between such proximal and distal portions so that irrigating fluid cannot flow into such distal portion of the drainage tube into the drainage bag but only into the proximal portion of the tubing and thence through the catheter. Accordingly, it is not necessary to clamp the drainage tube during irrigation. This may be referred to as a closed end to end irrigation system and it is achieved without the aforesaid disadvantages of a connect-disconnect arrangement.

Another less preferred way of achieving this is shown in FIGS. 19 to 22 in which the shank 54a of the catheter adapter 8a is extended and is provided with an obtuse angle bend 106 of about 135 to form a proximal part 108 and a distal part 110 on either side of the bend, the distal end of the distal part 110 having the end of the flexible drainage tube 6 extending thereover to secure the adapter to the drainage tube 6. Again, the adapter is really a part of the drainage tube. The top of the distal portion 110 adjacent the bend has a flat area 112 having an opening or entry 114 therein, which is located at the proximal end thereof and which is axially aligned and communicates with the bore 116 in the proximal part of the adapter. Actually, the opening 114 and its wall are continuations of the bore 116 and its wall, i.e., the curvilinear contour of the wall of bore 116 continues uninterrupted to the upper edge of the opening 114, except for the intersection therewith at 120 of the reduced diameter bore 118 of distal portion 110. Such bore 116, at its upper end, and opening 114 have a slight taper inwardly as they extend in a proximal direction. Accordingly, when the tapered irrigation tip 90 of the prepackaged irrigating syringe 68 or of any conventional irrigating syringe is inserted into the opening 114 and bore 116, as shown in FIGS. 20 and 21 to provide irrigation, such tip fits snugly in such opening and bore to thereby cover the end 120 of bore 118 to effectively cut off communication between the distal portion 110 and proximal portion 108 of the drainage tubing. Accordingly, it is not necessary to clamp the flexible drainage tube 6 distally of the opening or entry 114. The aforesaid snug fit provides a leakproof seal between the catheter adapter or drainage tube and the tip 90.

The flat 112 is provided with a pair of marginal and longitudinal overhangs 122 which form a way for sliding movement of a flat sliding closure 124 between close position over the opening 114 during drainage (full line position in FIGS. 19 and 21) and open position to expose such opening 114 for irrigation (broken line position in FIGS. 19 and 21). The closure 124 is provided with a finger piece 126 to aid in sliding the closure. The fit between the closure 124 and the way 122 is snug enough to prevent accidental movement of the closure from close position to accidentally expose the opening during drainage.

Yet another even less preferred way of obtaining end-to-end closed irrigation without a connect-disconnect arrangement is disclosed in FIGS. 23 and 24. In this case, the adapter 8b has a bend at 130 dividing the adapter into a proximal portion 132 having a bore 148 and a distal portion 134 having a bore 136 of substantially smaller diameter than bore 148 and to the free end of which the flexible drainage tube 6 is secured, as shown. The proximal portion 132 has a slight axial extension 137 over which is normally located during drainage a removable cap 138. Secured within the extension 136 is an annular sleeve 140 of a flexible, resilient and elastic material, such as rubber, the inner end of which is provided with a circular disk 142 of the same material and integrally connected to the sleeve only at a small flexible hinge area 144 but otherwise separate from the sleeve.

The normal relaxed position of the disk 142 during drainage is shown in FIG. 23, in which position the periphery of the disk 142 engages the inner wall of the bore 148 snugly around its entire circumference.

However, when the tapered tip 90 of the irrigating syringe 68 is inserted into the open extension 137 (after removal of cap 138) it forces the disk 142 to be swung around its flexible hinge 144 into the recess 145 and over the end 146 of the bore 136 in the distal portion 134 to thereby shut off communication between such distal portion and the proximal portion 132, as shown in FIG. 24.

By tapering the disk 142, as shown, a snug fit is achieved between the'tip 90 and the wall of bore 148 of 65 which the disk 142 now forms a part to provide a seal and thereby permit irrigation without leakage. Since the disk 142 is forced tightly against the end of bore 136 a seal is achieved to prevent irrigating fluid from flowing into bore 136. The open extension 137 comprises an entry in the side of the catheter adapter 8b, which is functionally part of the drainage tubing.

It maybe seen that with all of these embodiments irrigation can be carried out quite conveniently and simply without the aforesaid connect-disconnect arrangement, with its attendant dangers of contamina tion, and without requiring a clamp for the drainage tube during irrigation.

The slit tube irrigation arrangement of FIGS. 4-1 1 is exceedingly simple, fool-proof, inexpensive and convenient to use. It does not become plugged by solids in the urine and reduces danger of retrograde infection to a'minimum, particularly when coupled with the enlarged, inside diameter drainage tube and the one way ball valve assembly 66 to be hereinafter described in greater detail.

BALL VALVE ASSEMBLY 66 The one-way ball valve assembly 66 (FIGS. 12-14) within the bag 4 comprises a semi-rigid polyvinylchloride (the same material as the catheter adapter 8 and irrigation sleeve 74) hollow cylindrical ball housing 150 having at one end thereof a reduced end portion 152 around which the end of the drainage tube within the drainage bag is cemented.

The intersection of reduced end portion 152 and the housing proper forms an external shoulder 154, against which the end of tube 6 abuts, and an internal valve seat 156 formed by the intersection of the internally tapered bore 158 in reduced section 152 and the curved end portion 160 of the internal bore 168 within the enlarged portion 170 of the housing. The other open end of the housing 170 is closed by a cap 151 of the same material as the housing and cemented thereover. Housing portion 170 houses a stainless steel ball 172 and is provided with three elongated, circumferentially and equidistantly spaced longitudinal slots 174 extending to the capped end, and three circumferentially and equidistantly spaced internal, tapered longitudinal ribs 176 to decrease frictional contact of the housing with the ball.

The ribs 176 extend to the capped end of the enlarged portion 170 of the housing and, as shown in FIG. 13, they are tapered inwardly as they extend from such capped end.

The diameter of the stainless steel ball is substantially less than the diameter of the ball housing portion 170 but is, of course, substantially larger than the diameter of the valve seat 156. It is also substantially larger than the width of the slots 174.

Ball 172 is adapted to roll freely within the housing 170 between a closed position (shown in broken lines in FIG. 13), in which it f'u'mly engages the valve seat 156 to close communication between the bag 4 and the drainage tube 6 and to which it moves instantaneously in response to the commencement of even the slightest flow of urine from the bag through slots 174 into the housing 170 or in response to any tilting of the bag which might cause such commencement of flow, and an open position (shown in full lines in FIG. 13), in which it engages the flat inside wall of cap 151 to permit free and unrestricted flow of urine from tubing 6 into housing 170 and through slots 174 into the any time there is flow of urine through the drainage tube 6 to the valve seat so that the ball is in open position, the open cross-sectional area of each of the slots 174 and of the seat 156 is at least as great as the internal cross-sectional area of the enlarged drainage tube 6. Accordingly, the entire system from catheter adapter to bag has no passage having a cross-sectional area small enough to form a continuous column of urine in the tube so that the ball valve assembly 66, although effectively preventing reflux of urine from the bag into the tube 6, cooperates with the internally enlarged drainage tube to prevent the formation of a continuous column of urine in the drainage tube. It also functions to do this because of the ease with which the ball is rolled to its normal open position. Preferably, but not necessarily, the drainage tube 6 is secured in the edge 52 of the drainage bag so that the valve housing 66 is at a very slight inclination to cause the ball 172 to normally occupy its open position by gravity. This insures that the ball valve will not normally restrict the flow of urine in the slightest. Accordingly, no force is required to open the valve seat 156 so that the ball does not support the build-up of any urine column in the drainage tube, which is a disadvantage of a valve which requires any substantial force to open it.

A plurality of slots 174 are used and the diameter of the ball is made considerably smaller than the inside diameter of the housing 170 in which it rolls and the slots are elongated to insure free and unrestricted flow of liquid from the tube 6 through the housing into the bag to thereby prevent the build-up of a liquid column in the drainage tube. Actually, only one slot of the aforesaid size would be enough to prevent the formation of a continuous column of urine in the drainage tube but multiple slots provide a safety margin and also increase the sensitivity of the ball to commencement of refluxing into the housing through the slots. The greater the total slot area the better.

It is noted that when the ball is in open position (full lines in FIG. 13) it lies in front of the slots so that any slight flow inwardly through the slots instantly moves the ball to close position.

In the drawings, the spherical ball 172 is 0.375 inch in diameter, the valve seat is 0.340 inch in diameter, the inside diameter of the housing is 0.50 inch, the open length of-the slots is 0.50 inch and the width of the slots is 0. l6 inch.

The ribs 176 reduce friction between the ball and housing to a minimum to thereby insure free rolling of the ball in response to even the slightest force.

. The cap 151 functions as a stop for the ball. Any other kind of stop will do and it is not essential that the open end of the housing 170 be closed.

The polyvinylchloride housing 150, although relatively rigid has sufficient resilience and flexibility so that the ball 172 forms a good seal with the valve seat 156.

The bore 158 of reduced diameter portion 152 is tapered inwardly as it extends toward the valve seat 156 to cause the ball to be more easily moved away from the seat to open position by flow of urine through the drainage tube 6 to the seat.

The ball may be made of other materials, such as plastic, as long as it has a specific gravity substantially greater than the urine so that it will not float and so long as it is inert to the urine.

The molded housing holds apart the flexible panels 12 and 14 of bag to thereby insure against the panels sticking together at the exit of the drainage tube into the bag i.e., the housing insures that there will always be a space at the exit of the drainage tube into which the urine can freely flow. This is another reason for the plurality of circumferentially spaced slots, i.e., to insure against the bag panels covering a single slot to thereby restrict such outflow. In this respect, it is pointed out that urine is more adhesive than water and consequently is apt to cause the bag panels to adhere together. For the same reason the tendency of the urine to form a meniscus in the drainage tube 6 is greater than water.

It is noted that the outside diameter of reduced end portion 152 is larger than the inside diameter of the flexible tube 6. As aforesaid, the diameter of the opening defined by valve seat 156 is eleven thirty-seconds inch like the internal diameter of the tube 6.

If desired the enlarged housing may be slightly tapered inwardly as it extends from the cap 151 to the shoulder 154.

PROTECTIVE CAP 48 FOR DRAW-OFF-TUBING 10 The semi-rigid (relatively rigid compared to the flexible plastic draw-off-tubing 10), hollow protective cap 48 (FIGS. 15-17) is cylindrical in shape and is made of a molded polyvinyl chloride, having the same properties as the ball valve housing and the catheter adapter in that it has more resilience and flexibility as compared, for example, to polystyrene. It is made up of an enlarged diameter hollow part having an enlarged bore 191 therein and a reduced diameter hollow part 182 having a reduced diameter bore 188 within which the beveled end portion 184 of the flexible plastic draw-off-tubing 10 is snugly received in a liquid-tight and air-tight manner with the comer 186 of the beveled end 62 of the draw-off-tube 10 in engagement with the internal shoulder 186a within the bore 188.

The enlarged portion 180 has an integral internal hollow tubular tip 190 therein extending integrally,

coaxially and longitudinally thereinto from the end of portion 180 adjacent to reduced portion 182 but terminating a substantial distance from the opposite open end 181 of portion 180 so that the free end of tip 190 is located well within the portion 180, as shown in FIG. 16. The external periphery of the tip 190 is tapered and is spaced radially inwardly from the internal surface 191 of the enlarged portion 180.

The wall of the internal bore of the tip 190 is axially aligned with the wall of the bore of the draw-off-tube 10 and is of the same diameter so that when the drawoff tube 10 is located in the cap 48, as shown in FIG. 16, the tip 190 constitutes an extension of the draw-offtube 10 and may be considered as a part thereof.

The dimensions of the periphery of tip 190 and of the space 192 between such periphery and the internal surface of the portion 180 are such that when the cap 48, with the draw-off-tube 10 located therein, is placed over the end portion 194 of the stabilizing tube 42 protruding beyond the edge 34 of the pocket 32, the

tapered tip 190 is received snugly '1 'thin the end 46 of the stabilizing tube with a liquid-tight and air-tight fit and the enlarged diameter part'l80 of the cap is located around, but radially spaced from, such end of the stabilizing tube, as shown in FIG. 16. The resilience and flexibility of the tip 190 and stabilizing tube 42, together with the: external taper'of the tip, provides an excellent seal therebetween while at the same time permitting the cap'48 to be easily placed over the end of the stabilizing tube during normaluse and to be easily removed therefrom to draw urine from the bag 4.

The aforementioned close fit between tip 190 and the end of the stabilizing tube and between the drawoff-tube l and the internal surface of the reduced diameter portion 182 of the cap insures against the entry of contaminants into the system, against leakage of sterilizing gas during sterilization and against leakage of urine in the event that urine should overflow up the draw-off-tube into the stabilizing tube.

If desired, the draw-off-tube 10 can be sealed in the cap.

The open end 181 of the cap is preferably beveled, as shown.

It may be seen that when the draw-off-tube 10 is removed from the stabilizing tube, as shown in broken lines in FIG. 1, to draw off urine from the bag, the protective cap 48, i.e., the enlarged housing 180, protects the end 190 of the draw off tube 10-190 fromcon tamination by contact with contaminated objects, in cluding the fingers, while at the same time improving the seal between the draw-off-tube and stabilizing tube when the draw-off-tube is located in the stabilizing tube during drainage.

A less preferred way of obtaining generally the same effect is to eliminate the tip 190, with the end portion 184 of the flexible draw-off-tubing being inserted in the cap so that the corner 186 thereof is located in the same position as the end of tip 190 in FIG. 16. In such case, the external surface of such draw-off-tube within the enlarged portion 180 is spaced radially inwardly from the internal surface of portion 180 the same distance as the external surface of the tip 190 is spaced from such internal surface in FIG. 16 and the end'portion 184 of the draw-off-tube is received snugly within the end of the stabilizing tube.

In such case, the space between the external surface of the draw-off-tube within portion 180 and the inside surface of portion 180 may be such that the end of the stabilizing tube is snugly gripped therebetween, or the end portion 184 of the draw-off-tube 10 may be tapered and of the same size as the tip 190 to thereby cooperate with the end of the stabilizing tube in the same way.

The internal diameter of the draw-ofl-tube is a standard nine thirty-seconds inch which is smaller than the inside diameter of the drainage tube 6 although it may be of the same size or larger.

The draw-off-tube 10 is provided witha conventional external clamp 11 which is normally open during drainage when the draw-ofi-tube is in the position shown in full lines in FIG. 1.

The overflow provided by the draw'off-tube-stabilizing tube route cooperates with the other features described above to insure against retrograde infection.

The irrigation sleeve 74, ball valve housing 150 and cap 151 and protective cap 48 may be colored, e.g., yellow, to designate by color code the vital areas so far as retrograde infections is concerned. This is done in the commercial embodiment.

Also in the commercial embodiment, the stabilizer tube is colored blue and the transparent or translucent bag panel is provided with graduations to indicate the amount of urine in the bag at any time. Irrigation Bottle 68 Irrigation bottle-syringe 68 is cylindrical in shape and is made of an autoclavable, flexible, resilient and elastic copolymer of propylene and ethylene in which propylene constitutes the major constituent.

It is prepackaged with sterile irrigating fluid, e.g., water or saline solution (the syringe tip'90 and internal surface of the bottle-syringe 68 are also sterile) and is sealed by an elongated rigid cap 200 of polypropylene located over the syringe tip and threaded over the threaded base 202 of the tip 90 by cooperating internal threads 205 on the cap so that the end 204 of the tip 90 is pressed tightly against the sealing disk 206 of compressible material, e.g., rubber, to provide an air-tight and liquid-proof seal, as described in my aforesaid copending application. A whiskey seal may be used between cap and bottle at the threaded areas to make the unit tamper-proof, as described in such copending application.

The syringe-bottle 68 has sufficient rigidity to hold its shape but is sufficiently flexible, resilient, yieldable and elastic to be easily squeezed by the fingers to eject the fluid. It is elastic enough to return to its normal shape after squeezing so that the fluid can be easily aspirated out of and into the syringe and into and out of the bladder to irrigate.

The syringe tip 90 is more rigid than the syringe proper and, as aforesaid, is of such dimension that it can be inserted into the exposed open end 76 of the catheter adapter shank 54 to a point at which its periphery engages such open end to form an excellent friction fit and seal during irrigation.

The optimum thickness of the wall of the syringe proper is between 0.025 and 0.030 inch. The maximum thickness is preferably about 0.035 inch and the minimum preferably about 0.020 inch.

The syringe 68 is of a size to fit within the palm of the hand and has a flat bottom or the equivalent (e.g., centrally dished) to permit it to be placed on a supporting surface without tipping. The syringe is also provided with graduation marks.

The present invention is not only useful for drainage from, and'irrigation of, the bladder but can also be used for closed system drainage from, and closed system irrigation of, other body cavities.

It is'not intended that the invention be limited to the constructions shown and described in the accompanying drawings and the above description but only to those constructions which are claimed below and their equivalents.

I claim:

1. In a system for draining and irrigating a body cavity, tubing for transporting fluids from said body cavity, said tubing having an entry in the side thereof and comprising a distal portion extending in one direction from said entry and a proximal portion extending in an op-

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Classifications
U.S. Classification604/33, 604/325, 128/912, D24/118, 604/326, 604/323, 604/37
International ClassificationA61M39/02, A61F5/44
Cooperative ClassificationA61F5/44, Y10S128/912, A61M39/02
European ClassificationA61M39/02, A61F5/44