CA1130686A - Disposable urethral catheter assembly - Google Patents

Disposable urethral catheter assembly

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Publication number
CA1130686A
CA1130686A CA311,791A CA311791A CA1130686A CA 1130686 A CA1130686 A CA 1130686A CA 311791 A CA311791 A CA 311791A CA 1130686 A CA1130686 A CA 1130686A
Authority
CA
Canada
Prior art keywords
chamber
bag
catheter
fluid collector
collector according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA311,791A
Other languages
French (fr)
Inventor
Yeongchi Wu
Christopher A. Nowacki
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rehabilitation Institute of Chicago
Original Assignee
Rehabilitation Institute of Chicago
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rehabilitation Institute of Chicago filed Critical Rehabilitation Institute of Chicago
Priority to CA311,791A priority Critical patent/CA1130686A/en
Application granted granted Critical
Publication of CA1130686A publication Critical patent/CA1130686A/en
Expired legal-status Critical Current

Links

Abstract

Case 2956 DISPOSABLE URETHRAL CATHETER ASSEMBLY

Abstract of the Disclosure A disposable urethral catheter assembly includes a flexible bag in which are defined a number of chambers. In an upper cham-ber, a catheter is contained in a sterile environment. When the catheter is inserted into the urethra, the fluid flows into the bag and into a lower sample chamber, excess fluid being collected in the upper chamber. After catheter use, a cannula plug seals a first barrier between the upper and lower chamber and thus isolates the sample in the lower chamber. The upper chamber, its contents and the catheter are discarded, and the lower sample chamber and its contents are sent to a laboratory for analysis and culture.

Description

~ase 2~35~
1~31;~686 Background of the Invention ~ his invention relates generally to fluid collectors for use with catheters and related apparatus, and more particularly con-cerns a catheter fluid collector device which more or less auto-matically isolates a fluid sample for later laboratory study, 5 including urinalysis and culture and sensitivity tests.
, Many victims of paralysis are unable to ~7oluntarily evacu-ate their bladder~ ~hese persons must be catheterized periodically in order to remove accumulating body waste fluids.
:~ .
A number of non-surgical and semi-surgical techniques and 10 related devices have been offered to perform this catheterization.
For male patients this procedure in general involves aseptically preparing the penis, and then inserting a catheter into the urethra, while maintaining sterile technique, until the eye of the catheter reaches an~l communicates with the bladder. Urine then flows 15 through the catheter and can be directed into a collection container or dispo~al device.

If a u~ine specimen is required for medical analysis, the urine flOw from the catheter is directed into a specimen collection container until an adequate sample is collected; remaining portions 20 of the urine flow are then directed back into the disposal structure.
When the bladder has been emptied and the procedure completed, the catheter is removed and disposed of, and the specimen container is sealed and sent to a laboratory for microbiological and bio-chemical studies.
- 2 -~3~6i3~
~ t least some of these techniques and their associatea implements offer the dangers of urethra contamination during procedure preparation, catheter contamination during handling, and specimen contamination during specimen container filling, sealing and emptying. Many of the techniques and associated apparatus must be performed in a semi-sur~ical setting; they cannot be conveniently performed by the patient himself while he is alone and in a semi-private washroom or other location.
Additionally, when collector bags or receptacles are pro-vided, some catheterization apparatus permit inadvertent removalof the catheter from the collector, thus presenting the possi-bility of accidental spillage and attendant mess. Such an occurrence can cause discomfort and even humiliation to the patient.
It is accordingly the general object of the present invention to provide a urine collector which is handy and safe to use, and which more or less automatically containerizes a ~rine sample for laboratory analysis.
More speciflcally the invention seeks to provide a urine collector and catheter device which minimizes the danger of catheter contamination during catheter insertion into the urethra and which minimizes the risk of urine sample contamina-tion from outside sources. The inuention further seeks to pro-vide such a collector and catheter which more or less automati-cally segregates or defines and encapsulates or containerizes aurine sample and which can be used even by the patient himself when he is alone in a washroom or a relatively private area.
The invention in one aspect comprehends a fluid collector bag comprising, in combination, a flexible film defining two opposed bag sides, and first barrier means defining at least a first chamber capable of containing a predetermined volume of ~3~686 fluid and a second chamber capable of containing liquid in excess of the liquid deposited in the first chamber. The first barrier means also defines a restricted opening and plug means initially positioned in the first chamber co-operates with the restricted opening for selectively sealing the first chamber from the second chamber after the first chamber has been filled.
The invention in another aspect comprehends a fluid collector comprising a urethra catheter for delivering a quan-tity of liquid from a human body, and a flexible bag containing the catheter prior to catheter use. The bag includes first barrier means defining at least a first chamber capable of con-taining a predetermined volume of liquid and a second chamber capable of containing the liquid delivered from the body in ~ excess of the liquid deposited in the first chamber. The col-; lector further includes a cannula plug member for fully sealing the first chamber from the second chamber after the first chamber has been filled.
Further the invention comprehends a fluid collector com-prising a urethra catheter and an elongated flexible container having, at its top, a stiffened resilient cuff normally biased into a closed position, a pair of seal lines defining a restric-ted top chamber at the bag top. The collector has an upper chamber housin~ the urethra catheter,and a heat sealed restrictive opening defining the bottom of the upper chamber and the top of a lower chamber, and a cannula plug for closing the upper cham-ber from the lower chamber.
Other aspects and advantages of the invention will becomeapparent upon reading the following detailed description and upon reference to the drawings. Throughout the drawings, like reference numerals refer to like parts.

~,~

1~3~686 C~se 2gS~;

Brief Description of the Drawings Fig. 1 is an elevational view of the novel collector and catheter as they appear when ready for use;

Fig. 2 is an elevational view similar to Fig. 1 sho~ving the catheter and collector as they can appear when the catheter is being inserted into the urethra; - -Fig. 3 is an elevational view similar to Figs. 1 and 2 and showing the collector and catheter as they can appear when the catheter has been relatively fully Inserted and is about to deliver a quantity of fluid to the collector.

Fig. 4 is an elevational view of a collector first cha-mber which has been filled with fluid and sealed for removal to a lab-oratory for analysis;

Fi's~ ~J iS a perspective view of the collector first chamber and associated cannula plug;

Fig. 6 is a sectional view of the cannula plug taken substan-tlally in the plane of line 6-~ in Fig. 4;

Fig. 7 is an elevational view in partial section of a second embodiment of the collector bag;

Fig. 8 is an elevational view in partial section of a further embodiment of the collector bag;

~13~6~3~ Case 2g5~;

Fig. 9 is an elevational view in partial section of a collector first chamber with a modified cannula plug; and Fig. 10 is a perspective view of a collector first chamber which has been filled with fluid and with the modified cannula plug 5 in fluid delivering position.

Detailed Description . .
While the invention will be described in connection with a preferred embodiment and procedure, it will be understood that it is not intended to limit the invention to this embodiment or proce-dure, On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention and defined by the appended claims. For exampleJ this collector device and procedure can be used, with suitable minor modifications, by female as well as male patients.

~urnlng first to Fig. l, there is shown the novel collector 10 and catheter 11 embodying the present invention. ~lere the collector takes the form of a transparent flexible bag 14 made of a suitable polymeric film such as any of the appropriate polyolefins, polystyrenes or the like. The bag can be of an elongated form, as illustrated, and is defined by two folded or otherwise opposed material layer films 15 and 16 sealed at a bottom 17 and may also be sealed at the top 25a with a suitable tear seal. Such sealing of top 25a can be used in the event the collector is not packaged in a secondary sterile container or envelope. It is contemplated that the bag interior will be rendered sterile by appropriate operations during manufacture.

1~3L3'~1686 c~s~ ~35~;

rrhe catheter 11 can be considered to comprise an elongated hollow tube 1~ terminating at one end in an enlarged or bulbous discharge end 20. At an opposite tip 21, an eye or perforation 22 communicates with the hollow tube interiora as is well known in the 5 art of urethra catheters. The catheter, too, is rendered sterile during manufacturing.

After manufacturing production and prior to use, the catheter 11 is carried in a sterile environment. rrO this end, the bag 14 is provided with a closure top 25. If desired, a resilient member 10 within the closure top 25 can be biased into an open position from its normally closed position by squeezing opposite edges 26 toward each other to provide an irregular, hollow, polygonal opening and chamber 27 for accommodating the head of a male penis. rrhis top chamber 27 is at least partly defined by two upper chevrons 30 and 15 31 formed within and upon the bag, as by heat sealing narrow bands 32 and 33 of one bag side 15 against the opposlte bag side 16.

In use, the urethra orlfice and head of the penis is asepti-cized, 'rhe ~ag top 25 is then opened, thereby exposing and forming the top cll~mber 27. A suitable lubricant is added to top chamber 20 27 and the penis glans is inserted into chamber 27 until it contacts chevrons 30 and 31 thereby orienting and aligning the urethra with the opening 37. rrhe bag 14 and catheter 11 are then manipulated so as to extend the catheter 11 out from the top of the bag, as il-lustrated in ~ig. 2. In accordance with one aspect of the invention, 25 this procedure eliminates the need for directly touching the catheter 11, for the bag opening 27 is adapted tobebroughtover the penis 8Ç; ~ase 2tJ56 head. Since the interior of the opening 27 is aseptic~ catheteriza-tion procedure sterility is encouraged.

It will be noted that these upper chevrons 30 and 31 extend toward one another, but terminate at truncations 34 and 35, re-5 spectively, which define a restricted opening 37 through which thecatheter tube 19 extends. 'rO discourage inadvertent catheter re-moval in accordance with another aspect of the invention, the opening 37 is reduced in size relative to the enlarged catheter bul-bous end 20 whereby end 20 cannot be inadvertently pulled through, 10 as particularly illustrated in Fig. 3, When male patients use the novel device, the catheter can be gripped through the bag with the forefinger and thumb of one hand while the penis is held against the chevrons 30 and 31 inside the bag top cavity 27. ~he patient or user eases t}le caiheter tube 19 into the urethra orifice and into the 15 urethra itself with succeeding gripping and releasing motions, allowing the plastic bag 14 to relax into its original position after each movern~nt. In this way, the catheter is inserted into the urethra unl;il th~ catheter tube opening 22 enters the bladder and urine begins flowing into the bag. Urine flow is permitted until a 2Q substantial portion of the bladder has been evacuated. When catherization has been completed, or when the maximum acceptable volume has been received in the bag) the patient or user removes the catheter and bag in one outward motion.

In accordance with yet another aspect of the invention, a 25 urine sample of convenient volume for laboratory analysis is more or less alltomatically collected by this device and procedure, ~o C~ase 2~5~i 8~ ~

this end, two lower chevrons 40 and 41 are formed within and upon the bag, as by heat sealing the bag sides 15 and 16 to one another along outwardly diverging lines 42 and 43 respectively. A rela-tively narrow opening 45 is defined between two opposed heat sealed lines 46 and 47, and through this opening 45 a predetermined quantity of fluid can flow into a specimen reservoir, here comprising a lower or first chamber 50. When the first chamber is filled, additional fluid accumulates in a relatively upper or second chamber 51. Ihe total volume of fluid material collected can be determined with reasonable accuracy by a volumetric measurement scale marked - upon the bag when the bag is held in a vertical position, as indicated in Figs. 1 through 3.

Lying within the first chamber 50 is a cannula plug 53 formed to fit within and seal the restricted inter-chamber opening ~5, as shown in Fig. 4, thereby defining or sealing off a urine sample in-the lower or first chamber 52 for laboratory analysis.
~n a preferred embodiment, this cannula plug 53 is formed of air-entrainetl plastic or other suitably inert but lightweight material which causes the plug to float with the tip in the up position toward the openlng a~5. ~his plug 53 can be considered to include a base 55 and a trocar-like cap 56 defined by a tapered point 57. Because the plug 53, which is lighter at the tip part 56 than at the base part 55, floats, it preliminarily mo~es toward the opening 45 as the first chamber 50 is filled, thereby minimi~ing final plug insertion and chamber sealing trouble and effort.

c~ 2g~6 ~3~686 After the plug 53 has been inserted ~n the opening 45, the top or second chamber 51, the catheter 11, and other portions of the device can be discarded, in further accordance with the inven-tion. ~o do this, the entire device 10 is preferably removed to a 5 disposal area, where the fluid in the second or top chamber 51 is emptied. Ihe patient or attendant then removes the catheter 11 and top portion of the bag 14, as by tearing or cutting along a convenient sever line 60 which can be marked upon the bag; or with removal of the catheter, the patient empties the urine and seals the whole bag 10 from the opener 25 byfoldingitseveral times toward the lower por-tion 61. The lower portion 61 of the deviceJ including the filled and sealed first chamber 50, can then be transmitted to the laboratory for urine analysis and culture, sensitivity tests together with de-sired identi~ying data, such as the patient's name and any hospital 15 - room number.

In the laboratory~ a laboratory technician removes the trocar top cap portion 56 from the base 55 of the cannula plug 53, as illustrated particularly in Fig. 5. 'rhe plug base portion 55 is provided with a bore 65 which is exposed by removal of cap 56. In 20 - accordance with another aspect of the invention, urine from the specimen chamber 50 can thus be conveniently directed to analysis or test equipment. ~o insure good base-cap fit, the base 55 can be provided with an extended annular nipple 66J and a plug 67 ex-tends from the cap 56 into the nipple 66 for a con~enient but short 25 distance, as illustrated particularly in Fig. 6. After the fluid sample is dispensed and tests have been completed, the device lower portion 61 and any unused fluid can also be discarded~

~L~13 ~86 c~ase 2~35~

thereby eliminating any need to undertake costly re-sterilization procedures .

~eferring now to Fig. 7, wherein similar numerals are utilized to designate similar parts with the addition of the suffix "b". The bag 14b includes a top seal 25a and a closure top 25b plus chevrons 30b and 31b of the same general configuration in the ~irst embodiment. Each of the chevrons 30b and 31b have truncated portions 34b and 35b respectively and form an opening 37b. It was found in the use of the primary embodiment that occasionally the bulbous end 20b of the catheter 11~ could block the opening 37b and thereby prevent the flow of air out of the bag as it is being filled.
To overcome this, a pair of spaced heat sealed points 70 are pro-vided in axial spaced relation relative to opening 37b. These points 70 space the bulbous end 20b of catheter llb and permit the escape ~ , , .
1 5 of entrapped aLr from within the bag.

l'he coIlector shown in Fig. 8 is substantia~ly similar to the other embodiments with the addition of two channels 80 and 82 in the chevrons 30c and 31c, respectively. The relatively lower edges of - the truncated segments 84 and 86 are axially displaced from the lower edges of chevrons 30c and 31c. This prevents any attempts to force a catheter, not shown, into the channels 80 or 82 but rather directs such a catheter into the centrally located opening 37c for insertion into the urethra.

Figs. 9 and 10 disclose a modified plug 53d for sealing the lower or first chamber 50d. The bag 14d has a predetermined width . ., ~aC;e 2956 ~3~686 and the plug 53d has an ovcrall lcllgtll grealer thall said predetcl -mined width whereby the plug 53d cannot become inadvertently inverted when it is utilized to seal the opening 45d at the top of lower chamber 50d.

Plug 53d includes a base 55d, a through bore 65d, an ex-tended annular nipple 6Gd and a cap portion 5Gd. Plug 53d also includes a hollow lower,extension 90 having a transverse slot 92 for assisting in the evacuation of a test sample from lower chamber 50d. It should be noted that extension 90 has a diameter greater than opening 45d thereby insuring proper insertion of base 55d into opening 45d to thereby expose cap 56d for removal to permit evacuation of the test sample.
.

Claims (23)

    The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
  1. Claim 1. A fluid collector comprising a urethra catheter for delivering a quantity of liquid from a human body, and a flexible bag containing the catheter prior to catheter use, the bag including first barrier means defining at least a first chamber capable of containing a predetermined volume of liquid and a second chamber capable of containing the liquid delivered from the body in excess of the liquid deposited in the first chamber, the collector further including a cannula plug member for fully sealing the first chamber from the second chamber after the first chamber has been filled.
  2. Claim 2. A fluid collector according to Claim 1 wherein said bag is formed of a transparent flexible polymeric film.
  3. Claim 3. fluid collector according to Claim 1 wherein said first barrier means includes two opposed chevron formations formed in and on said bag.
  4. Claim 4. A fluid collector according to Claim 3 wherein said chevron formations include a chevron defining line portion of said bag heat sealed to an adjacent but opposed portion of the bag.
  5. Claim 5. A fluid collector according to Claim 4 wherein said chevrons take the form of opposed trapezoids.
  6. Claim 6. A fluid collector according to Claim 1 wherein said cannula plug member comprises a base and a trocar cap adapted to guide the cannula plug member into sealing engagement with said barrier means.
  7. Claim 7. A fluid collector according to Claim 6 wherein said cannula plug base includes pour means for retaining the trocar cap upon the base, and for pouring the liquid from said first cham-ber after cap removal.
  8. Claim 8. A fluid collector according to Claim 1 including second barrier means separating said second chamber at least partially from an adjacent portion of said bag, said second barrier means having a central passageway adapted to permit passage therethrough of at least part of said catheter.
  9. Claim 9. A fluid collector according to Claim 8 wherein said catheter is equipped with stop means preventing complete withdrawal of the catheter from the second chamber.
  10. Claim 10. A fluid collector according to Claim 8 wherein said catheter stop means comprises an enlarged catheter end for abutment against said second barrier means when withdrawal of said catheter from said chamber is attempted.
  11. Claim 11. A fluid collector comprising, in combination, a volume-calibrated internally sterile bag adapted to contain a ure-thra catheter therein, the lower portion of the bag including heat sealed chevrons forming a fluid specimen reservoir of predeter-mined volume, a cannula plug contained within said specimen reservoir for insertion between the chevrons to seal the specimen reservoir from remaining portions of the bag, the bag further in-cluding a second set of heat sealed opposed chevrons near the top of the bag defining a channel through which the catheter is extended during catheterization and further defining, at least in part, a re-stricted chamber at the bag top for accepting a male penis.
  12. Claim 12. A fluid collector comprising a urethra catheter and an elongated flexible container having, at its top, a stiffened resilient cuff normally biased into a closed position, a pair of seal lines defining a restricted top chamber at the bag top, an upper chamber housing the urethra catheter, a heat sealed restrictive opening defining the bottom of said upper chamber and the top of a lower chamber, and a cannula plug for closing the upper chamber from the lower chamber.
  13. Claim 13. A fluid collector according to Claim 12 wherein said cannula plug includes a trocar cap, and a base defining a bore, the emplaced cap sealing the bore from fluid flow therethrough.
  14. Claim 14. A fluid collector bag comprising, in combination, a flexible film defining two opposed bag sides, and first barrier means defining at least a first chamber capable of containing a predetermined volume of fluid and a second chamber capable of containing liquid in excess of the liquid deposited in the first chamber, the first barrier means also defining a restricted opening and plug means initially positioned in said first chamber co-operating with said restricted opening for selectively sealing the first chamber from the second chamber after the first chamber has been filled.
  15. Claim 15. A fluid collector bag according to Claim 14 including closure means at a bag top capable of being opened to define a chamber for accommodating the head of a male penis.
  16. Claim 16. A fluid collector according to Claim 15 wherein closure means includes a resilient member normally biased into a closed position having two sides in relative abutment and, when opened, defining a hollow polygonal opening.
  17. Claim 17. A fluid collector according to Claim 9 wherein said stop means includes at least a pair of laterally spaced abut-ments axially spaced from said second barrier means and with the space between said abutments being aligned with said second passageway and adapted to provide an air passageway for escape of entrapped air in said collector.
  18. Claim 18. A fluid collector according to Claim 11 wherein said second set of opposed chevrons includes secondary channel means adapted to permit escape of entrapped air during filling of said collector.
  19. Claim 19. A fluid collector according to Claim 18 wherein said chevrons each include at least a pair of truncated trapezoids laterally spaced from one another to form a large centrally disposed channel adapted to accept said catheter for passage therethrough and at least one secondary channel for escape of entrapped air.
  20. Claim 20. A fluid collector according to Claim 19 wherein the centrally disposed truncated trapezoids forming the centrally disposed channel have one edge facing the specimen reservoir which is axially offset from the adjacent edge of the laterally adjacent truncated trapezoid.
  21. Claim 21. A fluid collector according to Claim 13 wherein said container lower chamber has a predetermined width, said cannula plug including said base, said cap and an extension to said base have an overall length greater than said predetermined width whereby said plug cannot be inadvertently inverted in said lower chamber but rather insures positionment of said cap in said re-stricted opening.
  22. Claim 22. A fluid collector according to Claim 21 wherein said extension is diametrally larger than said restricted opening to further insure proper orientation of said plug.
  23. Claim 23. A fluid collector according to Claim 22 wherein said extension is slotted through a substantial portion of its length, said slot communicating with said bore and adapted to facilitate drainage of said lower chamber.
CA311,791A 1978-09-21 1978-09-21 Disposable urethral catheter assembly Expired CA1130686A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA311,791A CA1130686A (en) 1978-09-21 1978-09-21 Disposable urethral catheter assembly

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA311,791A CA1130686A (en) 1978-09-21 1978-09-21 Disposable urethral catheter assembly

Publications (1)

Publication Number Publication Date
CA1130686A true CA1130686A (en) 1982-08-31

Family

ID=4112411

Family Applications (1)

Application Number Title Priority Date Filing Date
CA311,791A Expired CA1130686A (en) 1978-09-21 1978-09-21 Disposable urethral catheter assembly

Country Status (1)

Country Link
CA (1) CA1130686A (en)

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