Patent ID: 12220520

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown inFIG.1one exemplary embodiment of a system10including an integrated external female catheter and suction regulator unit20constructed in accordance with one exemplary preferred embodiment of this invention for automatically removing urine from a female patient.

The details of the integrated external female catheter and suction regulator unit20will be described later. Suffice it for now to state that the unit20basically comprises an external catheter22and a suction regulator24which when assembled together form an integrated (one-piece) unit. The external catheter22portion of the unit20basically comprises a suction tube22A and a removable liquid permeable cover22B. The cover22B is disposed over and surrounding the suction tube22A. When the unit20is in use the cover22B placed against the urethra opening of a female patient to serve as a urine wicking member to receive urine which has been excreted by the patient. The suction regulator24portion of the unit20serves to provide a suitable safe regulated level of suction to the external catheter to effectively draw urine from the cover22B through a longitudinally extending slot (to be described later) in the suction tube22A into and through the suction regulator24to deliver it to a receptacle or canister12, which forms a portion of the system10.

The receptacle or canister12is of conventional construction and includes a port12A that is configured to be connected, via a section of conventional tubing14, to a suction source, e.g., a wall regulator16of the hospital's main suction line which provides suction to the suction regulator24. The wall regulator16should be set to line vacuum or the maximum available vacuum pressure if a line function is not available. The canister12includes another port12B, which is connected, via another section of conventional tubing18, to a “line suction port”24A, of the suction regulator24. The suction regulator24includes another port, which is internal and hereinafter identified as the “regulated suction port”24B, which is connected to and in fluid communication with the proximal end of a suction tube22A.

As will also be described later the suction regulator24is configured to enable flow through it from the external catheter to the canister nearing the maximum the hospital's suction line or regulator16is capable of sustaining without allowing the pressure to rise above a desired operating value, e.g., 40 mm Hg, of the suction regulator24in the event the external catheter becomes sealed against the patient. Since the suction regulator24is located between the external catheter22and the urine collecting canister or receptacle12, the regulator24will be closer to the catheter22than if it was located between the canister or receptacle12and the hospital suction line or regulator16, thereby enabling the maximum possible urine flow, but necessitates the urine flowing through the regulator. To that end, the entire unit20is intended to be a non-sterile, single-patient-use disposable unit.

Turning now toFIGS.2,3,7and8, the details of the external catheter portion22will now be described. As mentioned above it basically comprises the suction tube22A and the liquid permeable cover22B. The suction tube22A is an elongated arcuate member having a central passageway22C extending the length thereof from its proximal end22D to its distal end22E. The distal end22E is open. The proximal end22D is also open and forms the heretofore identified internal port24B (FIG.3) of the suction regulator. The proximal end of the suction tube is secured to a portion of a housing assembly (to be described later) of the suction regulator. That portion of the housing assembly constitutes a hollow housing body26. As best seen inFIGS.7and8, the suction tube22A includes a longitudinally extending slot22F extending approximately the entire length thereof from a point22G adjacent the housing body26to the distal end22E. The slot is in fluid communication with the central passageway22C of the suction tube22along the entire length of the slot. The portion of the suction tube22A that includes the slot22F constitutes a first or distal section of the suction tube, and the portion of the suction tube that is connected to the portion of the housing assembly constitutes a second or proximal section of the suction tube.

The cover22B is a cylindrical member formed of a liquid permeable material, preferably one that is absorbent and hydrophilic, e.g., a polyurethane or a PVA (polyvinyl alcohol) sponge, although it could be formed of other liquid permeable materials such as, cellulose, polyurethane, gauze, etc. As best seen inFIG.2the cover22B includes a central passageway extending from its proximal end to a point adjacent its distal end. The internal diameter of the central passageway of the cover22B is approximately the same size or slightly smaller than the external diameter of the suction tube22A so that the suction tube can be located therein, with the cover held thereon by friction, whereupon the closed distal end of the cover closes the open distal end22E of the suction tube. Moreover, the cover extends the entire length of the suction tube up to a point immediately adjacent the housing body26. Accordingly, when regulated suction produced by the suction regulator24(as will be described later) is applied at the port24B that regulated suction will appear along the length of the slot22F to draw any urine that the female patient voided into the cover from there into the slot whereupon that urine will be pulled into the passageway22C and carried by air from through that passageway to the suction regulator24. From there the urine is carried to the receptacle or canister12. In particular, with the system10as described above when suction is applied from the hospital's suction line or wall regulator16, that high level of suction is conveyed through the tubing section14, from whence it is applied to the canister or receptacle12and the associated tubing section18to the line suction port24A of the suction regulator24, whereupon it is regulated (e.g., reduced) by operation of the suction regulator to a much lower operating level, e.g., 40 mmHg. That reduced or regulated suction will appear on the suction port24B of the regulator24and from there to the external catheter22to thereby draw urine from the external catheter22back through the regulator24, and out through the tubing section18into the receptacle or canister12for collection therein.

It should be noted that for many applications the operating level is preferably approximately 40 mmHg. However, that level could be raised up to approximately 200 mmHg, since some hospitals are comfortable with higher vacuum pressures. If desired the system10may also include an overflow detector of any suitable construction to provide an indication that the amount of urine within receptacle has reached a predetermined threshold, e.g., is about to overflow, and/or to provide a signal to a controller (not shown) stop to halt the operation of the system so that no further urine is drawn into the receptacle until it can be emptied. For example, the canister12may include a shut off float valve and/or a filter at outlet12A to prevent possible contamination of the hospital's main suction.

As should be appreciated by those skilled in the art from the discussion to follow the operation of the suction regulator24ensures that a desired level of suction is applied to the external catheter22to ensure proper and safe operation of the system, i.e., to maximize the rate at which urine may be withdrawn from the catheter into the receptacle or canister without subjecting the delicate tissue of the woman at her urethra opening to injury, e.g., a hematoma, from excess suction thereat.

Turning now toFIGS.3-6, the construction of the suction regulator portion24of the unit20will now be described. To that end as can be seen the suction regulator24basically comprises a flexible diaphragm28, a piston30, a sealing disk32, a helical compression spring34, and a housing assembly38. The housing assembly38is made up of the heretofore identified housing body26and a lid or cover36. The lid or cover36and the housing body26are configured to be connected together, as will be described later and as shown inFIG.16, to form the hollow housing assembly38. That assembly encloses (houses) the other components making up the suction regulator24. The housing body26and the cover36are preferably formed of a rigid plastic, such as ABS, although other plastics can be used. The suction tube22A, being integral with the housing body26is also formed of the same material as the housing body, but could be formed of some other material. That other material may be chosen to exhibit some degree of flexibility to enhance engagement of the external catheter22with the portion of the female's body contiguous with her urethra opening

As best seen inFIGS.3-8the housing assembly38defines two internal chambers, namely, an upper chamber40and a lower chamber42, which are separated from each other by a portion of the diaphragm28. The housing body26includes a circular annular sidewall44projecting downward from a top wall46. The circular sidewall44extends about a central axis X (FIG.6) of the suction regulator. A tubular extension48extends upward from the top wall and centered on the axis X. The tubular extension forms the heretofore identified line suction port24A and includes a passageway48A extending through it. The lower end of the passageway48A is open at44B, with the portion of the top wall46contiguous with the opening48B forming a beveled or conical surface valve seat50(FIG.5). The opening44B is in fluid communication with the upper chamber40in the interior of the housing assembly38of the suction regulator24. The upper or free end of the passageway48A is open and configured so that the distal end of the tubing section18can be connected to it, whereupon the passageway extending through that tubing section will be in fluid communication with interior of the housing assembly38and with upper chamber40.

The lid or cover36is a generally cup-shaped member having a generally planar bottom wall52and a circular annular sidewall54projecting upward therefrom. The sidewall54includes a pair of diametrically opposed notches56immediately adjacent the lower edge of the sidewall. As can be seen inFIG.16the notches56are configured to receive respective diametrically opposed projecting tabs58of the housing body26to secure the lid or cover36to the housing body26and thus complete the housing assembly38. The sidewall54of the lid or cover36also includes an arcuate recess60(FIG.9) in the edge of the sidewall located midway between the notches56. The recess60serves to receive the suction tube22A when the lid or cover36is secured to the housing body26.

The diaphragm28is best seen inFIGS.14and15, and is preferably a rolling diaphragm formed of any resilient flexible material, e.g., silicone, nitrile, etc. The diaphragm includes a generally planar circular central portion62and a folded generally V-shaped or U-shaped edge portion64surrounding the central portion and terminating in a flanged generally planar thickened periphery66. A small opening or hole68is located in the center of the central portion62. The central portion62is disposed on a planar top surface of the piston30(to be described later), with the thickened periphery66of the diaphragm disposed on an annular ledge92(FIG.4) at the lower end of the sidewall44of the housing body26between that ledge and the inner surface of the bottom wall of the lid or cover36. With the lid or cover secured to the housing base26the thickened periphery66of the diaphragm28is tightly sandwiched between the ledge and the inner surface of the lid or cover. This arrangement divides the interior of the suction regulator into the heretofore identified upper chamber40and lower chamber42. In particular, the upper chamber is formed between the inner surface of the top wall46of the body member26, the contiguous inner surface of the sidewall44of the body member, the upper surface of a portion of the diaphragm28and a portion of the piston30. The lower chamber42is formed between the inner surface of bottom wall52of the lid or cover36, and the central portion62and contiguous V or U-shaped portion64of the diaphragm28.

The piston30is best seen inFIGS.10and11and basically comprises a unitary body formed of a rigid plastic, such as ABS. The body includes a central hub70whose bottom end terminates in a circular flange72. The bottom surface of the flange is planar, but includes a circular recess74in the center thereof and extending into the hub70. A plurality of ribs76extend outward radially from the hub and serve to reinforce the flange72and to center the biasing spring34about the central axis X. The top surface of the hub70includes a recess78for receipt of the sealing disk32.

The sealing disk32is fixedly secured in the recess78of the piston30and serves as a valve member to engage the valve seat50in the upper chamber40when excess suction is applied (as will be described later). The sealing disk32is formed of any suitable material, e.g., silicone rubber.

The cover or lid36includes a small opening or vent (FIGS.2,4,9and15) to the ambient atmosphere which will be referred to as the “atmospheric reference port”80. The atmospheric reference port ensures that the lower chamber42will be at the pressure of the ambient atmosphere. In particular, the port80extends through the thickness of the cover and is in fluid communication with the interior of lower chamber42to maintain that chamber at atmospheric pressure. Inasmuch as the atmospheric reference port80is located in the bottom surface of the cover36, it is susceptible to being blocked or covered by a sticker, some other object or even a portion of the female's body. To prevent such an occurrence the lid or cover is shaped to prevent blockage of the port80. In particular, the lid or cover includes a thickened portion82located adjacent the port80with an elongated shallow tripartite or T-shaped recess or slot84extending into the thickened portion. The outer edge of the atmospheric reference port80is located at the bottom of the slot84at the intersection of the slot's various three sections and is in fluid communication with each of those sections. The outer end of each of the slot sections is open. Thus, if something should be on the surface of the thickened portion82of the lid or cover disposed over the atmospheric reference port80air can still enter into that port via any open end of the T-shaped slot84.

A label (not shown) bearing indicia or information regarding the unit20may be fixedly secured within a very shallow recess96in the outer surface of the lid or cover adjacent the thickened portion82so its presence does not block the T-shaped slot84.

The biasing spring34is a helical compression spring formed of any suitable material, e.g., stainless steel. As best seen inFIGS.3-6and13, the spring is located within the upper chamber40, with the lower end of the spring in engagement with the undersurface of the flanged portion72of the piston30and surrounding a piston's central hub70and with the upper end of the spring located within an annular recess86(FIG.5) in the undersurface of the top wall46of the housing body26. The spring is under compression to bias the piston and diaphragm downward and away from the valve seat50.

As mentioned above, the suction regulator24regulates the level of suction to a desired operating value and provides the regulated suction to the external catheter (the urine wicking member)22. To that end, the regulator24is configured to limit the amount of suction applied to the external catheter to that desired value even if a level of suction greater than that predetermined value is applied to the suction regulator from the suction source (particularly if the suction source is at a much higher level, which will typically be the case if the suction source is the hospital's suction line). The predetermined or desired suction value (hereinafter referred to has the “regulator's set-point” or “regulated set-point value”) is fixed and is factory-established by the spring34and dimensions of the housing body26, the cover or lid36, the piston34and the sealing disk42. In this regard the pressure within the lower chamber42will be equal to atmospheric pressure by virtue of the communication of that chamber with the ambient atmosphere via the atmospheric reference port80. With suction applied, the pressure within the upper chamber40will be lower than the atmospheric pressure within the lower chamber42. The differential pressure between the chambers40and42will force the diaphragm28and the piston30upward toward the valve seat50. The compression spring34, however, will impart a counter force on the piston and diaphragm that opposes the differential pressure force, thereby forcing the piston upward such that the level of suction appearing at the regulated suction port24B is the desired operating value.

If the suction applied via line suction port24A is greater that the predetermined value or level the piston30and diaphragm28will move such that the sealing disk32on the piston's hub70comes into engagement with the valve seat50, thereby isolating the upper chamber40from the suction appearing on the line suction port24A. This action thereby limits the level of suction in upper chamber and hence at external catheter22to the predetermined level (operating value). If, however, the suction applied via line suction port24A is less than the predetermined operating level the piston and diaphragm will only move part of the way downward. As such the level of suction applied to the line suction port24A will equal that in the regulated suction port24B and that applied to the external catheter22.

It should be pointed out at this juncture that the suction regulator26is also configured to prevent the sealing disk32on the piston from becoming stuck for an extended period of time on the valve seat50in the event of what will be referred to hereinafter as an “over-travel situation”. In this regard, if the suction regulator24is operated in a manner such that a high level of suction is applied very rapidly, the piston may experience an over-travel situation wherein it moves upward very quickly such that the sealing disk32becomes stuck on the valve seat50. Under this condition the suction applied to the suction tube24A of the external catheter would be at a higher level than the suction regulator24was set to provide. The suction regulator could thus stay in that state for an extended/indefinite period of time, particularly if the external catheter becomes blocked, e.g., its wicking portion (the sponge cover24B) is in tight engagement with the vaginal tissue surrounding the urethral opening and not over the urethral opening itself. To prevent such an occurrence, the regulator24includes two “bleed” holes. One bleed hole is the heretofore-identified small hole68located in the center of the diaphragm28. The second bleed hole is identified by the reference number88and is located in the piston30. In particular, as best seen inFIG.11A, the cylindrical cavity74in the piston contiguous with the bottom surface of the flanged portion72includes a radially extending recess90. The bleed hole88is located in that recess and extends through the flanged portion of the piston. Since the bleed hole68in the diaphragm28is located in the center thereof, i.e., on the central axis X, it will overlie and be in fluid communication with the cylindrical cavity74in the piston. The recess90is in fluid communication with the cylindrical cavity74. Thus, the bleed hole88in the piston will be in fluid communication with the bleed hole68in the diaphragm. Since the bleed hole68in the diaphragm is in communication with the lower chamber42, that chamber will be in fluid communication with the upper chamber40via the communicating bleed holes68and88. Hence, if the sealing disk34on the piston should become stuck on the valve seat50, air which enters into the lower chamber42via the atmospheric reference port80can then pass through the bleed hole88into the cylindrical cavity74, and from there through recess90into the bleed hole88, from whence it will enter into the upper chamber40. The ingress of air into the upper chamber will decrease the vacuum within that chamber, thus enabling the spring34to move the piston30downward so that the sealing disk32is off of the valve seat50.

It must be pointed out at this juncture that the sealing disk32becoming stuck on the valve seat50may not be an issue. In such a case the diaphragm28need not include the bleed hole68, and the piston30need not include the bleed hole88and the associated recess90.

In accordance with one exemplary preferred embodiment of the suction regulator24, inner diameter of the lower chamber42is approximately 1.5 inch. The inner diameter of the upper chamber40is approximately 1.5 inch. The spring is configured to naturally apply a bias force of approximately 1.0 pound. The inner diameter of the passageway48A is approximately 0.25 inch. The opening48B located within the bounds of the valve seat50is approximately 0.22 inch. The atmospheric reference port80is approximately 0.035 inch in diameter. The bleed hole88is approximately 0.016 inch in diameter. The bleed hole68is approximately 0.062 inch in diameter. Each tubing section14and18is conventional having an internal passageway of approximately 0.25 inch in diameter, and each section is approximately six feet in length, but could be shorter or longer depending upon the application. In any case with an integrated external female catheter and suction regulator unit20sized as just described, in a system like that described during typical operation the flow rate of air into the upper chamber40via bleed holes should be in the range of approximately 3 to 10 standard cubic feet per hour (SCFH). In fact, benchtop testing suggests that one version of the system20of this invention, making use of its disposable regulator26is capable of air flow rates up to 100 SCFH as compared to the 15 SCFH rate observed with some commercially available wall regulator set to the value of 40 mmHg. The additional flow allows for increased urine capture at the interface of the actual catheter, faster drying of the catheter (which helps prevent skin breakdown and infection) and pulls the urine through the tubing into the canister30more efficiently. This is especially true if the tubing drapes down below the height of the patient and canister.

The integrated external female catheter and suction regulator unit20of this invention is designed for use with a single female patient over a prolonged period of time and after use with that patient, it is to be disposed. The cover22B is however designed to be replaced on the suction tube whenever necessary for that particular patient. To replace the cover22B, all that is required is to remove the used cover from the suction tube22A by pulling it in the distal direction and then replacing the used (soiled) cover with a fresh cover on the suction tube.

Turning now toFIG.17there is shown another and more preferred exemplary system10′ for automatically removing urine from a female patient making use of a more preferred integrated unit120having an external female catheter122and suction regulator24′ constructed in accordance with this invention and which can be used in a method of this invention.

The system10′ is identical to the system10except for the construction of the integrated unit120, and in particular the suction regulator24′ and the external female catheter122. The components of the system10′ which are common to the system10will be given the same reference numbers and the details of their construction, arrangement and operation will not be reiterated in the interest of brevity. The suction regulator24′ is identical in construction to the suction regulator24except that the regulated suction port24B terminates in a tubular connector24B′. The tubular connector24B′ is best seen inFIGS.17and18and is configured to receive the proximal end of a tubing section of the external female catheter122so that the regulated suction produced by the suction regulator is applied to the external female catheter. The external female catheter122is best seen inFIGS.17and19and basically comprises an elongated suction tube122A and a removable liquid permeable cover122B. The elongated suction tube122A is best seen inFIGS.19and20and basically comprises an assembly of an elongated flexible conduit or tubing section124, an optional cover tube126, a multi-slot end-piece128, and a section of malleable wire130.

The conduit or tube124is a section of conventional tubing formed of any suitable flexible material, e.g., flexible PVC tubing, like used in hospitals to carry fluids via suction and has a distal end124A and a proximal end124B. The proximal end124B of the tubing section124receives the tubular connector24B′ of the suction regulator24′ to thereby connect the elongated suction tube122A to the suction regulator. The distal end124A of the tubing section124receives the proximal end128A of the multi-slot end-piece128.

The removable liquid permeable cover122B is in the form of a cylindrical sponge-like body having a rounded or domed distal end. The cover122B will be described in detail later. Suffice it for now to state that that in one exemplary preferred embodiment of this invention the cover122B is approximately 5.75 inches long measured from its distal end to its proximal end and has an outside diameter of approximately 1.125 inches. The cover is mounted on the distal end portion of the elongated suction tube122A and overlies approximately the distal-most 5 inches of the elongated suction tube. In particular, the cover is mounted on and over the distal end124A of the tubing section124and on and over the cover tube126and the multi-slot end-piece128, with the proximal portion of the cover overlying approximately 0.5 inch of the tubing section124to ensure an air-tight seal.

The multi-slot end-piece128forms a first section of the elongated suction tube and is a flexible rod-like member, e.g., an extrusion of any suitable flexible material, e.g., polyurethane. In the exemplary embodiment shown the end-piece is approximately 5 inches long with an outside diameter of approximately 0.425 inch. The end-piece128has a generally circular profile in cross-section (seeFIG.21) and includes plural longitudinally extending passageways or channels132A,132B,132C and132D, which run the full length to the end-piece. The passageways are equidistantly spaced about the periphery of the end-piece and each passageway includes a narrow width, e.g., 0.1 inch, longitudinally extending slot at the surface of the periphery of the end-piece. In particular, the passageway132A includes an associated slot134A, the passageway132B includes an associated slot134B, the passageway132C includes an associated slot134C, and the passageway132D includes an associated slot134D. The proximal end of each of the passageways134A-134D is open, as is the distal end of each of those passageways. A short length, e.g., 0.5 inch, of the proximal end of the end-piece124is disposed within the distal end124A of the tubing section124. The tubing section124from the proximal end of the end-piece to the connector24B′ of the suction regulator24′ forms what can be called a second section of the suction tube122A.

The optional cover tube126is a section of heat shrinkable tubing, which is disposed over the portion of the end-piece128immediately adjacent the distal end124A of the tubing section124, thereby covering or closing off the underlying proximal portions of the slots134A-134D, but leaving approximately 40 mm of the distal end portions of the slots uncovered or exposed. Thus, when the proximal end of the end-piece128is disposed within the distal end124A of the tubing section124and the heat shrinkable cover tube126is in place, the regulated suction applied from the suction regulator to the tubing section124will be applied to the open proximal end of each of the passageways132A-132D down the length of the passageways to exit the uncovered portions of the slots134A-134D, respectively, and the open distal ends of those passageways.

It should be noted that while the exemplary embodiment shown and described above includes four passageways and four associated slots, it is contemplated that the end-piece can have any number of passageways, with associated slots, e.g., three passageways and three associated slots. The key feature being that the slots are directed in different, equidistantly spaced radial directions with respect to the central longitudinal axis of the end piece. As such irrespective of the orientation of the elongated external catheter about its central longitudinal axis with respect to the urethra opening of the patient, there will be at least one slot generally directed to the urethra opening to accept urine therefrom. Moreover, the distal end of each of the passageways134A-134D is open. Thus, when the external female catheter is disposed adjacent the urethra of the patient, and regulated suction applied to it from the suction regulator, the regulated suction is applied to the distal end portion of the cover122B, i.e., the distal portions of the slots134A-134D that are not covered by the cover tube126. That action draws urine from the patient through the distal portion of the cover122B into the exposed portions of the slots134A-134D and the open distal ends of the passageways132A-132D and from there through those passageways into the tubing section124and from there through the suction regulator24′ to the collection canister12. The use of multiple channels facilitates the removal of urine while minimizing the chance that the channels will be collapsed by portions of the patient's anatomy.

As best seen inFIGS.18and21the end-piece128includes a small diameter, e.g., 0.051 inch, central passageway136in which the malleable wire130is located. The malleable wire can be formed of any suitable material, e.g., stainless steel, aluminum, provided that it is biocompatible and can be readily bent into a desired shape and will hold that shape. With the wire130located in the passageway136and the cover122B mounted on the distal portion of the elongated suction tube122A, the end-piece128can be bent into a somewhat arcuate shape, so that the cover122B conforms closely and comfortably to the anatomy of the patient contiguous with the patient's urethra opening. Other dimensions of the end-piece128are shown inFIG.21.

Turning now toFIG.18, the details of the cover122B will now be described. In particular, as mentioned earlier the cover122B is a cylindrical member whose distal end or tip is rounded or domed and is approximately 5.75 inch in length, and with a 1.125 inch outside diameter. The cover includes a central passageway138extending from its proximal end to a point closely adjacent its distal end. The inside diameter of the passageway138is approximately 0.375 inch. The thickness of the rounded tip is approximately 0.375 inch. The passageway138is configured for receipt of the end-piece128, the optional cover tube126, and the distal end portion of the tubing section124. To that end the internal diameter of the central passageway of the cover122B is slightly smaller than the external diameter of the end-piece128so that the cover122B is held thereon by friction. With the cover in place, the closed distal end of the cover overlies the open distal ends of the passageways134A-134D of the end-piece128.

The cover is formed of a soft (e.g., somewhat compressible), liquid-permeable material, e.g., hydrophilic polyurethane foam, although it could be formed of other liquid permeable hydrophilic materials such as PVA (polyvinyl alcohol) sponge, cellulose, etc. One preferred exemplary embodiment of a hydrophilic polyurethane foam cover is a hybrid foam having a pore size of approximately 150-300 microns, and a density in the range of 16-21 grams.

As is known, hydrophilic polyurethane foam is created by mixing chemicals including water. After the foam is formed it still contains a large quantity of water, approximately 50% by weight. In many applications, polyurethane foam is provided dry. As such, polyurethane foam is often dried by heating as part of the manufacturing process.

For the female catheters of the subject invention, it is desirable to have the foam covers as hydrophilic as possible so that urine is captured effectively. The polyurethane foam is most hydrophilic when it is moist, such as is the case immediately after foam formation and without drying. As such the foam making up all of the sponge covers of this invention is not dried. Rather, it is packaged moist in a sealed package that has a very low moisture transmission rate so that it is moist at time of use. In particular commercial embodiments of this invention will be preferably packaged wet. Since it is packaged wet, the cover preferably will include an antimicrobial additive to prevent microbial growth. Any suitable commercially available anti-microbial additive can be used, e.g., isothiazolinone treatments, zinc pyrithione, thiabendazole, silver and quaternary ammonium compounds and Polyhexamethylene biguanide (PHMB) and chlorhexidine gluconate (CHG). In addition to helping with storage, the antimicrobial agent inhibits the growth of microbes during use of the system of this invention, reducing the risk of infection.

Operation of the external female catheter120is similar to the operation of the external female catheter20and is as follows. In particular, the suction regulator24′ operates in an identical manner as the suction regulator24. Thus, when regulated suction produced by the suction regulator24′ is applied connector24B′ of the port24B that regulated suction will be applied to the exposed distal portions of the slots134A-134D and the contiguous open distal ends of the passageways132A-132D, respectively, to draw any urine that the female patient voided into the cover from there into those passageways, whereupon that urine will be pulled into the interior of the tubing section124and carried by air from the suction regulator24′. From there the urine is carried to the receptacle or canister12. In particular, with the system10′ as described above when suction is applied from the hospital's suction line or wall regulator16, that high level of suction is conveyed through the tubing section14, from whence it is applied to the canister or receptacle12and the associated tubing section18to the line suction port24A of the suction regulator24, whereupon it is regulated (e.g., reduced) by operation of the suction regulator to a much lower operating level, e.g., 40 mmHg. That reduced or regulated suction will appear on the suction port24B of the regulator24′ and from there to the external catheter122to thereby draw urine from the external catheter122back through the regulator24′, and out through the tubing section18into the receptacle or canister12for collection therein.

One of the key features of the integral suction regulator and female catheter120allows, like the features of the integral suction regulator and female catheter20, is that it can be used in a system like10′ to be attached to line suction. This configuration allows for far greater airflow than conventional methods, which aids in urine capture and drying of the catheter. Moreover, the openings through which the regulated suction is applied to the cover120B is somewhat confined in that only approximately 40 mm of the slots134A-134D are exposed to provide suction to the contiguous portions of the cover122B. By decreasing the opening size of the extrusion, i.e., the exposed slots, the subject invention is able to concentrate the same amount of airflow, increasing the velocity of the air to compound the benefits of the high volume of airflow provided by the regulator. However, since the foam component is absorbent regardless of location, over-concentration of the airflow results in location-dependent capture and non-uniform drying and may leave the patient wet or result in leaks. Iterative bench-top testing has suggested providing open slots of approximately 40 mm/1.5 inch results in optimal performance, as defined by the maximum capturable urination rate before the system is overwhelmed and leaks.

As should be appreciated by those skilled in the art, when the tubing in an external catheter circuit becomes filled with urine, either due to a patient urinating a large volume at once, or a temporary occlusion along the circuit, air entrainment is no longer possible, and urine must be pulled through the tubing by the force of suction alone. In this scenario, for any section of tubing traveling along a vertical incline, gravity opposes the suction force limiting the height of any vertical incline which can be overcome. Forty mm of Hg is equivalent to the pressure exerted by approximately 21 inches of water, meaning that for any suction-based urine management system operating at 40 mm Hg no part of the system can have a vertical incline greater than 21 inches without risking failure if the external catheter circuit becomes filled with urine. Conventional external catheter systems, (which may have a tubing path of up to 20 feet between the wall regulator and the patient) present a significant possibility that some portion of the tubing path may have a 21 inch incline, so that such prior art systems are prone to that type of failure if the external catheter circuit becomes filled with urine. In contradistinction, the systems of this invention make use of tubing that is only approximately 6 inches to approximately 24 inches between the regulator and patient's urethra opening. This means that the integrated suction regulators/external catheters of the subject invention should not be prone to failure due to too much urine.

It must be pointed out at this juncture that the various components of the integrated unit20and120shown and described above are merely exemplary of various components that may be used in accordance with this invention to provide the capabilities as discussed above. Thus, various changes can be made to the integrated external female catheter and suction regulator of subject invention from the exemplary embodiments described above. For example, the use of the optional cover tube126can be omitted. In such a case the distal end124A of the tubing section124should extend to approximately 40 mm from the distal end of the end-piece128, whereupon the tubing section124itself closes off the slots in the passageways up to the last (distal) 40 mm of the end-piece. The use of the optional heat shrinkable tube section126is a preferred means for covering portions of the slots proximally of the distal-most 40 mm thereof, since heat shrinkable tubing is more economical than the material making up the tubing section124. Moreover, the end-piece124, itself, can be constructed so that the slots134A-134D do not extend the entire length of the associated passageways132A-132D, but only the distal-most 40 mm thereof. Thus, it is contemplated that the end-piece can be constructed so that only the distal-most portion, e.g., approximately 40 mm, of the passageways132-132D include slots134A-134D, so long as the remaining portion of the passageways are configured to carry suction therethrough without leakage and so long as the entire length of the end-piece along which the cover122B extends is malleable to be conformable to the anatomy of the patient.

Moreover, the suction regulators24and24′ may be constructed somewhat similarly to the suction controller300shown in FIGS. 9A and 10A of U.S. application Ser. No. 14/227,587 entitled the Gastric Sizing Systems Including Instruments And Methods Of Bariatric Surgery filed on filed on Mar. 27, 2014, now U.S. Pat. No. 10,646,625, which is assigned to the same assignee as this invention and whose disclosure is specifically incorporated by reference herein. That suction controller if used in an integrated unit20or120like the subject invention would be modified to omit the disk314and thus result in a cost saving. In the invention of that patent the disk314is provided to seal off the system when positive pressure is applied for leak testing. The integrated unit20of this invention and any other integrated units constructed in accordance with this invention will never exceed atmospheric pressure, so a disk314is unnecessary. Moreover, the suction controller300of that patent if used in an integrated unit like that of this invention will need to be sized and configured to produce the desired regulated suction value.

Various other changes can be made to systems of this invention, in addition to changes in the suction regulator24and24′. For example, some hospitals in which the subject integrated unit will be used have special regulator set-ups that allow for connection of a suction canister directly below the wall regulator. In such a case the tubing section14of the system10may be omitted. Also, it should be pointed out that the integrated units of this invention are not limited to use in hospitals, but can be used in any application providing care to a patient.

For some applications, e.g., where the medical or other facility in which the female patient is located has its own source of suction which is in the desired range for use with a female external catheter, the integrated external female catheter and suction regulator devices as shown inFIGS.1-21can be replaced by an external female catheter without an suction regulator. Thus, various external female catheters without a suction regulator integrated with the catheters are contemplated by this invention. For example,FIGS.22-29show one such exemplary embodiment of an external female catheter200constructed in accordance with this invention,FIGS.30-31show another exemplary embodiment of an external female catheter300constructed in accordance with this invention,FIGS.32-33show still another exemplary embodiment of an external female catheter400constructed in accordance with this invention,FIGS.34-37show yet another exemplary embodiment of an external female catheter500constructed in accordance with this invention, andFIG.38shows an alternative cover that can be used in the external female catheter500in lieu of the cover that is shown inFIGS.34-37.

Each of those exemplary alternative external female catheters will be described in detail hereinafter. Suffice it for now to state that each includes an elongated suction tube having a distal end portion which is enclosed within a liquid pervious cover formed of a sponge material, with the proximal end of the suction tube being configured to be coupled to a source of suction which is in the desired operating range. If desired a receptacle or canister, like that described above, can be coupled to the external female catheter to collect the urine from the external female catheter.

Turning now toFIGS.22-29, it can be seen that the external female catheter200basically comprises an elongated suction tube202and a cover204. The elongated suction tube202is itself made up of several components, to be described shortly, and has a longitudinal central axis X, a distal end206, a proximal end208, and at least a first passageway210(FIG.23) extending longitudinally therethrough from the distal end to the proximal end. The proximal end is configured to be coupled to any suitable source of suction that provides suction at a value or level of 40-200 mmHg, and most preferably at 125 mmHg. The distal end206of the suction tube202is open as will be appreciated from the discussion to follow.

The cover204is similar in many respects to the covers disclosed in the above described embodiments and is formed of a body of a soft, moist hydrophilic, e.g., polyurethane, foam. The cover has a length in the range of 4 inches to 8 inches, a longitudinal axis X and an external surface212. The external surface212comprises a proximal end surface212A, a distal end surface212B, and an arcuate lateral surface212C interposed between the proximal end surface and the distal end surface. The proximal end surface is planar, but can be arcuate or some other shape if desired. The distal end surface212B is preferably arcuate, e.g., dome shaped, but can be planar if desired. If dome shaped it has an apex212D. If planar the entire planar surface forms the apex of the distal end surface. In any case, the entire exterior surface, including the arcuate lateral surface, is uncovered so that it is completely exposed. Therefore, since the cover is formed of a body of hydrophilic foam the entire arcuate lateral surface is fluid-permeable and extends around the longitudinal axis X from the distal end surface to the proximal end surface.

The cover204includes a central cylindrical bore212E having an inside diameter of 0.42 inch centered on the central longitudinal axis X of the cover and extending from the proximal end surface212A of the cover to a point closely adjacent the apex212D. The bore212E is configured to frictionally receive the elongated suction tube202therein, whereupon the portion or section of the elongated suction tube contiguous with the distal end206is enclosed within the body of the cover. That action is accomplished by inserting the distal end206of the suction tube into the open proximal end of the bore212E at the proximal end of the cover204and moving the suction tube and cover with respect to each other until the distal end of the suction tube reaches the distal end of the bore. Once the elongated suction tube202is in its desired position within that the cover204it will be held in place by frictional engagement with the inner surface of the contiguous bore212E so that the cover will be resistant to accidental displacement on the elongated suction tube.

In accordance with one preferred embodiment of this invention the distal end of the bore212E (and hence the open distal end206of the elongated suction tube) is spaced by a distance within the range of 0.125 inch to 0.375 inch from the apex212D of the cover, with the open distal end of each of the passageways132A-132D of the suction tube being preferably located 0.25 inch from the apex212D of the cover.

The elongated suction tube202basically comprises four components, namely, a flexible tube section214, a tubular coupler216, a heat shrink tube218, and an elongated extrusion220having at least one longitudinally extending passageway and at least one associated longitudinally extending slot. The elongated extrusion220is constructed similarly to the extrusion128described above. Hence in the interest of brevity the common features of the extrusion220will be given the same reference numbers as the extrusion128and the details and operation of those features will not be reiterated. Suffice it for now to state that the heretofore identified at least one passageway210constitutes one of the passageways132A,132B,132C, or132D of the extrusion220.

The flexible tube section214, is best seen inFIGS.23,26and29, has a length, e.g., 2.5 inch and is formed of conventional flexible tubing, e.g., polyvinylchloride (PVC) tubing. The tube section if preferably transparent, but may be translucent or opaque, as desired. The tube section214has an outside diameter of 0.375 inch, and a central passageway214A having an inside diameter of 0.25 inch. The central passageway214A extends through the entire length of the tube section from its distal end to its proximal end.

The tubular coupler216, is best seen inFIGS.23,25and28, and is in the form of a short length, e.g., 2 inches, of flexible tubing, having an outside diameter of 0.5 inch, and a central passageway216A of an inside diameter of 0.35 inch. The central passageway extends through the entire length of the tubular coupler from its distal end to its proximal end. The tubular coupler214is formed of any suitable material, e.g., PVC and is preferably transparent, but can be translucent or opaque. The distal end of the flexible tube214is disposed and fixedly secured within the proximal end of the passageway216A of the tubular coupler216by cyclohexanone or some other suitable adhesive. The proximal end of the elongated extrusion220is located within the distal end of the passageway216A of the tubular coupler.

The heat shrink tube218, is best seen inFIGS.24and27, and is a tubular member formed of any suitable heat shrinkable material, e.g., adhesive lined polyolefin. The heat shrink tube is of a length of within the range of 2 inches to 4 inches and is disposed and shrunk about a distal portion of the outer surface of the tubular coupler216and a proximal and contiguous portion of the elongated extrusion220to fixedly secure those three components together and thus form the elongated suction tube202. As can be best seen inFIG.23the distal end of the heat shrink tube218terminates a distance of between 0.5 inch and 2.5 inches from the distal end of the elongated extrusion220. Accordingly the slots134A,134B,134C and134D will be open from the distal end of the extrusion to a point between 0.5 inch and 2.5 inches from the distal end, with the remainder of those slots being closed or sealed off by the heat shrink tube to form a configuration similar to that shown inFIG.19.

The cover204is configured for external disposition with respect to the female such any portion of the liquid-permeable arcuate lateral surface will be in fluid communication with the urethra opening of the female so that urine voided by the female passes into the at least a first passageway to be carried by suction therefrom out of the external catheter for collection. In particular, and in accordance with one preferred method of the use of the external female catheter200(as well as the external female catheters300,400and500, and any other external female catheter constructed in accordance with this invention) the catheter is designed so that it is oriented generally vertically between the female's legs with the distal end of the cover facing downward and so that the female's urethra opening is immediately adjacent, and preferable in contact with, a middle portion of the arcuate lateral surface212C whether the female is supine or prone. Since the entire periphery of the arcuate lateral surface is liquid permeable, the external catheter200can be oriented so that any portion of the periphery of the cover204at approximately the middle thereof can be disposed immediately adjacent and preferably in contact with the female's urethra opening. In that state urine voided by the female will enter that peripheral portion of the cover, and under the influence of gravity and the suction provided by the elongated suction tube will flow downward through the body of the cover into the elongated suction tube, from whence it will be carried for collection, and with little or no urine leakage out of the female catheter. Specifically, urine voided by the female will enter into whichever of the uncovered slots134A-134D is facing towards the female's urethra opening, and from there the urine will be carried downward by the air flow engendered by the suction into the associated passageway132A-132D, as the case may be. In addition, any urine which reaches the domed end of the cover will flow into the distal ends of the passageways132A-132D since those ends are open. The urine entering the passageways will be carried through the passageways into the central passageway216A of the tubular coupler214, from whence it will be carried into and through the central passageway214A of the flexible tubing section216. From there the urine will carried away for collection. That urine collection action may be accomplished by connecting a receptacle or canister12to the proximal end of the elongated suction tube202via any type of conduit and associated coupler (not shown).

In the interests of comfort and fit, at least the portion of suction tube which is enclosed within the cover is preferably malleable, so that it and the enclosing cover can be bent to conform to the female's anatomy. Accordingly, the external catheter200includes a malleable wire, like the wire130described above. The malleable wire130extends down the central passageway136of the elongated extrusion220. In the interest of brevity the details of the construction and operation of the malleable wire130will not be reiterated. It should be noted that while it is preferred that the portion of the external catheter encompassed by the cover be malleable, that configuration is not mandatory.

Turning now toFIGS.30and31, the external female catheter embodiment300will now be described. It basically comprises an elongated suction tube302and a liquid permeable cover304. That external female catheter300is considerably simpler in construction than the embodiment200insofar as its elongated suction tube is concerned. In particular, the elongated suction tube302of the external female catheter300is a single unitary component, i.e., a length of flexible tubing. The flexible tubing is formed of any suitable material, e.g., PVC.

The cover304of the external female catheter300is the same basic construction as the cover of the external female catheter200. Hence the common features of the cover304will be given the same reference numbers as those of the cover204, and the details of their construction and operation will not be reiterated in the interest of brevity.

The elongated suction tube302has a length within the range of 4 inch to 8 inches, an outside diameter of 0.375 inch, and a central passageway302A extending the entire length of the suction tube302from its distal end302B to its proximal end302C. The inside diameter of the central passageway is 0.25 inch.

The distal end and contiguous portion of the suction tube302is extended into and frictionally held within the cylindrical bore212E of the cover204so that the cover is resistant to accidental displacement with respect to the suction tube. That action is accomplished by inserting the distal end302B of the suction tube into the open proximal end of the bore212E at the proximal end of the cover304and moving the suction tube and cover with respect to each other until the distal end of the suction tube reaches the distal end of the bore. Once the elongated suction tube302is in its desired position within that the cover304it will be held in place by frictional engagement with the inner surface of the contiguous bore212E so that the cover will be resistant to accidental displacement on the elongated suction tube. When so located the distal end302B of the suction tube302, which is open, will be spaced by a distance in the range of 0.125 inch to 2 inches from the apex212D of the cover304, with the most preferably distance being 1.5 inches.

The use of the external female catheter300is similar to the use of the external female catheter200. In particular, the external female catheter300is disposed with respect to the female in the same manner as that of the external female catheter200. Accordingly, when the female voids, the urine exiting her urethra will enter that peripheral portion of the cover204, and under the influence of gravity and the suction at the level of 40-200 mmHg provided by the elongated suction tube will flow down the interior of the sponge body making up the cover into the open distal end302B of the elongated suction tube302, from whence it will be carried through the central passageway302A and out its open proximal end302C for collection. That urine collection action may be accomplished by connecting a receptacle or canister12to the proximal end of the elongated suction tube302via any type of conduit and associated coupler (not shown). As is the case with the external catheter200, use of the external catheter300will result in little or no urine leakage out of the female catheter.

In the interest of simplicity of construction and cost the external female catheter300does not make use of a malleable wire to provide the catheter with the ability to be conformed to the anatomy of the female user. The external female catheter400makes up for the lack of malleability of the external female catheter300, by providing that feature, but still with a construction that is simpler than that of the external female catheter200. Thus, attention is now directed toFIGS.32and33wherein the details of the construction and operation of the external female catheter400will now be described.

The external female catheter400basically comprises an elongated suction tube402, a cover404, and a malleable wire. The cover404of the external female catheter400is of similar construction to the cover204of the external female catheter200. Hence the features of the cover404that are common with the features of the cover204will be given the same reference numbers and the details of their construction and operation will not be reiterated in the interest of brevity. The cover404does have a difference from the cover204of the external female catheter200. In particular, it includes a cylindrical cavity212F located immediately distally of the bore212E. The cylindrical cavity212F is of smaller inside diameter, e.g., 0.25 inch, than the inside diameter of the bore212E. The cylindrical cavity212F is configured to facilitate the passage of urine into the open distal end of the suction tube402, as will be described shortly. The malleable wire of the external female catheter400is the same construction as the malleable wire of the embodiment200. Hence it will be given the same reference number, i.e.,130, and the details of its construction and operation will not be reiterated in the interest of brevity.

The elongated suction tube402is an elongated flexible tube formed of any suitable material, e.g., thermoplastic elastomer, having a length with the range of 4 inches to 8 inches. It includes a passageway402A extending the length of the suction tube parallel to, but slightly laterally offset from, its central longitudinal axis X. The passageway402A extends from the distal end402B of the suction tube to its proximal end402C. The inside diameter of the passageway402A is 0.2 inch. The outside diameter of the suction tube402is 0.375 inch. The suction tube402includes a second passageway402D extending down the length of the suction tube from its distal end402B to its proximal end402C. The second passageway402D is laterally offset from the passageway402A. The inside diameter of the second passageway402D is 0.062 inch and is configured to closely hold the malleable wire130therein as shown inFIG.33.

The distal end402and contiguous portion of the suction tube402is disposed and frictionally held within the cylindrical bore212E of the cover404so that the cover is resistant to accidental displacement with respect to the suction tube. That action is accomplished by inserting the distal end402B of the suction tube into the open proximal end of the bore212E at the proximal end of the cover404and moving the suction tube and cover with respect to each other until the distal end of the suction tube reaches the distal end of the bore. Once the elongated suction tube402is in its desired position within that the cover404it will be held in place by frictional engagement with the inner surface of the contiguous bore212E so that the cover will be resistant to accidental displacement on the elongated suction tube.

The use of the external female catheter400is similar to the use of the external female catheter300except that being malleable by virtue of the inclusion of the malleable wire, it can be conformed to the anatomy of the female before it is operated. In particular, the external female catheter400is disposed with respect to the female in the same manner as that of the external female catheter300, except for being bent to a shape conforming to the female's anatomy before suction is applied. Accordingly, after the catheter400has been bent and disposed between the female's legs adjacent the female's urethra opening as described above, when the female voids, the urine exiting her urethra will enter that peripheral portion212C of the cover404, and under the influence of gravity and the suction provided by the elongated suction tube will flow down the interior of the sponge body making up the cover into the cavity212F at the open distal end402B of the elongated suction tube402. The inclusion of the cavity212serves to increase the internal surface area of the foam material making up the cover at the distal end402B of the suction tube402. For example, inFIG.31the surface area of foam at the distal end302B of the suction tube302is smaller, and even though the foam is permeable, this reduces the liquid flow capacity of the external catheter300. In contrast, and due to presence of the cavity212F of the external catheter400, the surface area of foam at the distal end402B of the suction tube402is much greater, thereby providing increased overall urine flow capacity. The surface area of the cavity212beyond the distal end of the suction tube should be at least twice the cross-sectional area of the inside of the passageway402A. More preferably, it should be five times that cross-sectional area, and most preferably, ten times that cross-sectional area. Once the urine enters into the open distal end402B of the suction to it will be carried into and through the passageway402A and out its open proximal end402C for collection. That urine collection action may be accomplished by connecting a receptacle or canister12to the proximal end of the elongated suction tube402via any type of conduit and associated coupler (not shown). As is the case with the external catheters200and300, use of the external female catheter400will result in little or no urine leakage out of that catheter.

Turning now toFIGS.34-37the details of the construction and operation of the external female catheter500will now be described. The external female catheter500basically comprises an elongated suction tube502and a cover504. The elongated suction tube502is best seen inFIG.36and basically comprises a length, e.g., 72 inches, of flexible tubing506having a central passageway506A (FIG.35) extending through the entire length of the flexible tube from its distal end to its proximal end. The inside diameter of the central passageway506A is 0.25 inch. The outside diameter of the flexible tube506is 0.375 inch. A first tubular coupler508is secured to the proximal end of the flexible tube506. A second tubular coupler510is secured to the distal end of the flexible tube506. Each tubular coupler is of conventional construction like that used in the medical field to couple various medical components together by interposed tubing so that liquid or other fluids can be transported between those components. Thus, each tubular coupler has a central passageway extending through its entire length. For example, as can be seen inFIG.35, the tubular coupler includes a central passageway510A. The tubular coupler510and its contiguous portion of the flexible tubing506is configured to be disposed and frictionally held within a cylindrical bore in the cover504as will be described shortly.

The cover504is similar in construction to the cover404of the external female catheter400. Hence the features of the cover504which are common with the features of cover404will be given the same reference numbers and the details of their construction and operation will not be reiterated in the interest of brevity. The cover504does differ from the cover504in that the cover504includes a longitudinally extending slit212G. The slit212G is a planar radially extending cut that extends linearly from the proximal end212A of the cover towards the distal end of the cover, with the distal end of the slit terminating approximately 0.5 inch to approximately 3 inches from the distal end of the cover. In the exemplary embodiment shown the distal end of the slit terminates approximately 3 inches from the cover. The slit212G is in communication with the bore212E to facilitate insertion of the distal end portion of the suction tube402into the bore of the cover404. In particular, it provides access through the cover which the tubular coupler510and the contiguous portion of the flexible tube506can be inserted laterally, instead of being inserted longitudinally through the open end of the bore212E at the proximal end212A of the cover as is the case of the external female catheters200,300and400. Once laterally inserted through the slit the distal end portion of the suction tube can be moved with respect to the cover along the longitudinal axis X until the tubular coupler510is located within the distal end portion of the bore212E (its desired position). The slit212G enables the user to visualize the position of the tubular coupler with respect to the cover so that it will be at that desired position for securement thereat. In this regard, when the suction tube502is that desired position within that the cover504it will be held in place by frictional engagement of the inner surface of the bore212E with the exterior surface of the flexible tube506, and by the frictional engagement of the inner surface of the bore212with the exterior surface of the tubular coupler510.

The use of the external female catheter500is similar to the use of the external female catheter300. In particular, the external female catheter500is disposed with respect to the female in the same manner as that of the external female catheter300. Thus, after the catheter500has been placed between the female's legs adjacent the female's urethra opening as described above, when the female voids, the urine exiting her urethra will enter that peripheral portion of the cover502, and under the influence of gravity and the suction provided by the elongated suction tube will flow down the interior of the sponge body making up the cover504into the open distal end of the passageway510A in the tubular coupler510, from whence it will be carried through the central passageway506A of the flexible tube506. From there the urine will be carried through the central passageway of the tubular coupler508at the proximal end of the suction tube for collection. That urine collection action may be accomplished by connecting a receptacle or canister12to the tubular coupler508via any type of conduit or tube inserted into the open proximal end of the passageway in the tubular coupler508. As is the case with the external catheters200and300, use of the external female catheter400will result in little or no urine leakage out of that catheter.

Turning now toFIG.38there is shown an alternative cover604that can be used in the external female catheter500in lieu of the cover504. The cover604is similar in most respects to the cover504and hence its common features will be given the same reference numbers as the features of the cover504. Moreover, the details of the construction and operation of those common features will not be reiterated in the interest of brevity. The cover604is designed so that the distal portion of the suction tube502can be readily introduced into the cover axially from the open proximal end of the central bore. To that end, the cover604does not need to, and does not, include the longitudinally extending slit212G, which facilitates lateral entry. Rather, the central bore of the cover604is of a larger internal diameter than the central bore212E of the cover504so that the distal end portion of the suction tube502and its contiguous flexible tube506can be inserted axially into the open proximal end of the central bore until it is fully within the cover, like shown inFIG.35. In particular, the central bore of the alternative cover604includes bore section212H which is located contiguous with the proximal end212A of the cover604, and a bore section212I which is located contiguous with and distally of the bore section212H. The bore section212H has an inside diameter of within the range of 0.6 inch to 0.875 inch, with a preferred inside diameter of 0.7 inch. The inner diameter of the bore section212H should be larger than the largest outer diameter of the tubular coupler510, and the inner diameter of the bore section212I should be smaller than the outer diameter of that tubular coupler. The bore section212I has an internal diameter in the range of 0.375 inch to 0.55 inch, with a preferred internal diameter of 0.45 inch. The bore section is configured to frictionally receive and hold the tubular coupler510therein. In particular, the tubular coupler510and its contiguous portion of the flexible tube506is inserted into the open proximal end of the cylindrical bore section212H at the proximal end of the cover604, whereupon the suction tube502and cover604are moved with respect to each other until the distal end of the tubular coupler510reaches the distal end of the bore section212I. Once the suction tube502is in that position it will be held in place by frictional engagement of the outer surface of the tubular coupler with the inner surface of the bore section212I.

The use of the external female catheter500with the alternative cover604is identical with the use of the female catheter500having the cover504. Thus, that method of use will not be reiterated in the interest of brevity.

As should be appreciated by those skilled in the art, the fact that each of the covers of the various external catheters of this invention is fluid-permeable throughout its entirety has a distinct advantage, namely, that the particular orientation of the cover about its longitudinal axis is irrelevant. The reason is simple, namely, any portion of the cover which would wind up confronting the urethra opening of the female when the cover is in place is fluid-permeable to readily accept the urine voided by the female. Thus, the particular orientation of the cover about its central longitudinal axis is irrelevant so long as it is fluid permeable through-out its entirety and its arcuate exterior surface is completely fluid permeable over its entirety. There are other reasons why having minimal to no impermeable surfaces is advantageous. For example, an external female catheter that is half impermeable and half permeable (longitudinally) could get suctioned to the patient resulting in injury. Because of this risk, it is desirable to use less suction to minimize the chance of injury, but this could result in increased leakage of urine. Using external catheters constructed in accordance with this invention it is recommended that vacuum regulators be set to 125 mmHg, since the completely permeable cover of the subject invention will preclude this level of suction from being fully applied to the female user. Some prior art external catheters have distal ends that are impermeable. Because the distal end of the covers of the subject external female catheters of this invention are permeable, the external female catheters of this invention have the advantage that if their distal end contacts the surface on which the female user is laying they can wick up urine that might have dripped onto the surface.

It must be pointed out at this juncture that the various components of the external female catheters200,300,400and500as shown and described above are merely exemplary of various components that may be used in accordance with this invention to provide the capabilities as discussed above. Thus, various changes can be made to the those female catheters from the exemplary embodiments described above. Moreover, their method of use may be different than that described above, depending upon conditions and the desires of the medical or other personnel attending the female.

Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.