Catheterization kit

Abstract

A catheterization kit is provided for obtaining an uncontaminated specimen of urine. The kit includes a substantially closed urine collection receptacle having an aperture for inflow of urine. A catheter tube extends through the aperture, with the distal end of the catheter tube terminating within the receptacle. A yieldable stop means is provided on the catheter tube adjacent its distal end for seating the distal end within the receptacle, but permitting removal of the catheter tube from the receptacle. Sealing means are provided for sealing the aperture after a urine sample is obtained. The receptacle, the catheter tube, and the sealing means can be enclosed within a container including a gas pervious wall portion for permitting passage of a sterilizing gas into the container. A flexible wall portion adjacent the proximal end of the catheter tube permits restraint of the catheter tube while withdrawing the urine receptacle from the container without directly handling the proximal end of the catheter tube.

Description

FIELD OF THE INVENTION

The present invention relates to a catheterization kit for obtaining an uncontaminated sample of urine. More specifically, the invention relates to a female catheterization kit including a collection receptacle and a catheter tube, and also to such kits in package form.

BACKGROUND OF THE PRIOR ART

Frequently, during a medical examination of a female, it is desirable to obtain an uncontaminated sample of the patient's urine. In the past, two methods of obtaining such a sample have been commonly used. In the first procedure, the uro-genital area is scrubbed with an antiseptic soap, and then the female patient urinates into a sterile basin. Subsequently, the sample must be transferred to a smaller container. This method is messy, and not totally reliable as a means of obtaining a sterile sample.

A second method of obtaining an uncontaminated urine sample from a female patient is to open an expensive Foley catheter tray for the sole purpose of utilizing the catheter. The patient is catheterized with the large Foley catheter. This procedure can produce an uncontaminated sample, but may be very traumatic the patient due to the use of the large catheter. to the

Recently, efforts have been made to provide a disposable catheter and urine specimen bag for women. None of these disposable bag devices has, however, permitted the collection of an uncontaminated sample in the same container used for urinalysis without leakage, and avoided the need for intermediate handling of the specimen between taking the sample and running the urinalysis.

BRIEF DESCRIPTION OF THE INVENTION

The present invention provides a catheterization kit for obtaining an uncontaminated sample of urine that comprises a substantially closed urine collection receptacle having an aperture for inflow of urine. The urine collection receptacle includes a vessel having a top opening, and a rigid top member that can be placed in liquid sealing engagement with the vessel about the periphery of the opening, with the aperture extending through the top member. A catheter tube extends through the aperture, with the distal end of the tube terminating within the receptacle. Sealing means are provided for closing the aperture after a urine sample is obtained.

If the testing procedure to be followed on the urine specimen includes centrifugation, the collection vessel is selected to be a centrifuge tube. In a preferred embodiment, the sealing means is pivotally mounted on the top member adjacent the aperture and is pivoted to seal the aperture after a sample of urine is collected.

In one embodiment the sealing means is a resilient plug that is releasably attached to the distal end of the catheter tube. Removal of the catheter tube from the collection receptacle causes the plug to be compressed into sealing engagement with the aperture and thus seals the receptacle.

The catheterization kits of this invention may be conveniently packaged in a container that encloses the receptacle, the catheter tube, and the sealing means. The container includes a gas pervious wall portion for permitting passage of a sterilizing gas into the container when the container is closed. A transparent wall portion adjacent the proximal end of the catheter tube is provided for viewing the proximal end of the catheter tube, and a flexible wall portion positioned adjacent the proximal end of the catheter tube permits the application of a restraining force on the exterior of the container to hold the proximal end of the catheter tube in place. Restraint of the proximal end of the catheter while withdrawing the receptacle from the container (a) withdraws a major portion of the length of the catheter tube from the receptacle and (b) seats a yieldable stop means that is desirably provided on the distal end of the catheter tube within the receptacle.

Preferably, the container comprises a paper bottom member and a flexible transparent film member with these members being in sheet form. The bottom member and the film member are sealed together along a continuous sealing margin. The bottom member and the transparent film member have the same shape and are congruently aligned. In a preferred embodiment, the sealing margin adjacent the bottom end of the collection vessel is spaced inwardly from the perimeter of the aligned members to permit easy opening of the container adjacent the bottom of the vessel.

A yieldable stop means is desirably provided near the distal end of the catheter tube, proximally spaced from the discharge opening or openings of the catheter tube. The yieldable stop means terminates the sliding movement of the collection vessel along the catheter tube during removal of the vessel from the container, during which time the proximal end of the catheter tube is being restrained. However, the yieldable stop means are designed to be deformable, so that a strong pull on the proximal end of the catheter tube will remove the entire catheter tube from the collection vessel after collection of a urine specimen.

The present invention provides a non-traumatic and reliable system for obtaining an uncontaminated urine specimen. Indeed, a female patient is not aware that the doctor has inserted the small diameter catheter that is desirably used in the catheter kits. The catheterization kit is self-contained, that is, the sterile sample does not have to be transferred to another container. The kit lends itself to both urinalysis, as well as to sterile culture analysis since the collection vessel itself can be a centrifuge tube. For most urinalysis work, the urine has to be transferred to a centrifuge tube and spun down.

The catheter kit of this invention can be compactly and conveniently packaged in a sterile container designed in a manner that the sterile package can be opened without contaminating the proximal tip of the catheter tube. Specifically, the catheter kit is packaged with only a short portion of the catheter tube extending out of the collection vessel. The container surrounding the catheter kit is opened adjacent the bottom of the centrifuge tube. The centrifuge tube is withdrawn from the container while restraining the proximal end of the catheter tube by applying force through the flexible wall of the sterile container.

The invention consists of the novel parts, constructions, arrangements, combinations, and improvements shown and described. The accompanying drawings which are incorporated in and constitute a part of this invention, illustrate certain embodiments of the invention and, together with the description, serve to explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Of the drawings:

FIG. 1 is a partially exploded view of a presently preferred embodiment of the catheterization kit of this invention;

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

FIG. 3 is a plan view of the catheterization kit of FIG. 1 packaged in a sterile container according to one embodiment of the invention, with a portion of the container removed for ease of viewing;

FIG. 4 illustrates the procedure for removal of the catheterization kit from the container illustrated in FIG. 3;

FIG. 5 is a partially exploded view of another embodiment of the catheterization kit of this invention, with a portion of the wall of the collection vessel broken away for ease of viewing; and

FIG. 6 is a sectional view of FIG. 5 taken along the axis of the device of FIG. 5.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIGS. 1 and 2, it can be seen that a catheterization kit constructed in accordance with the teachings of this invention includes a collection vessel 10 having an opening at its top, a top member 12 that can be placed in liquid sealing engagement with vessel 10 about the periphery of the top opening of vessel 10; and a catheter tube 14. The combination of collection vessel 10 and top member 12 form a substantially closed urine collection receptacle having an aperture for inflow of urine.

In the embodiment illustrated in FIGS. 1 and 2, collection vessel 10 is a graduated centrifuge tube formed of a clear, substantially rigid plastic material such as polystyrene. Vessel 10 has an open top 16 that permits entry of urine into the vessel. A male threaded portion 18 is provided at the upper end of vessel 10 to permit top 12 to be screwed thereon.

In accordance with the invention, a rigid top member is provided that can be placed in liquid sealing engagement with the urine collection vessel about the periphery of the top opening of the vessel. An aperture for inflow of urine extends through the top member. In the embodiment illustrated in FIGS. 1 and 2, top member 12 is a rigid molded plastic member including a cap 20 and a depending cylindrical wall 26. Cap 20 includes a circular aperture 24 that extends from the inside wall surface of cap 20 to the exterior wall surface of cap 20. The inside surface of cylindrical wall 26 is female threaded to permit the insertion of male threads 18 on vessel 10, and the liquid seaing engagement of the top member 12 and collection vessel 10.

A sealing means comprising a nozzle member 22 is mounted on cap 20. A radially extending slot 28 is molded into the top of cap 20. As illustrated in FIG. 2, the top of aperture 24 terminates in slot 28. Nozzle member 22 is pivotally mounted on cap 20 by a pair of pivot arms 30 which project laterally from nozzle 22. Preferably, nozzle 22 and pivot arms 30 are formed by a single piece of integrally molded plastic. Pivot arms 30 on nozzle 22 are pressed into a pair of converging slots 32 that extend inwardly from the top of cap 20, and are seated therein. Preferably, slots 32 converge to a width that is just smaller than the diameter of pivot arms 30, and then again diverge, so that pivot arms 30 can be pressed downwardly in the slots past the point of convergence, and then cannot be easily removed from the slots.

In the embodiment illustrated in FIGS. 1 and 2, nozzle member 22 has a bore 34 that extends along the longitudinal axis of the nozzle member. The adjacent surfaces of nozzle member 22 and slot 28 are shaped to permit nozzle member 22 to rotate between a horizontal position and a vertical position as illustrated in FIG. 2. In the vertical position, bore 34 is aligned with aperture 24. In the horizontal or closed position, a sealing surface 36 on nozzle member 22 is placed in sealing contact with that portion of cap 20 that forms the top perimeter of aperture 24. Thus, bore 34 of nozzle 22 is pivotal between an open position in which the bore is in fluid flow communication with aperture 24 in cap 20, and a closed position in which the bore is not in fluid flow communication with aperture 24.

The catheterization kit of this invention includes a catheter tube 14, that is preferably of a small outside diameter, such as an 8 Fr. tube. Such a small diameter catheter tube permits the insertion of the catheter with no trauma to the patient. As illustrated in FIGS. 1 and 2, catheter tube 14 extends through bore 34 of nozzle 22 and through aperture 24 of cap 20. The distal end 38 of catheter tube 14 terminates within vessel 10. Catheter tube 14 has an outside diameter that is smaller than the inside diameter of aperture 24 and smaller than the inside diameter of bore 34, and thus is slidable along aperture 24, and bore 34. The provision of an aperture 24 that is larger than the outside diameter of catheter tube 14 may be used to vent collection vessel 10 during collection of a specimen. Preferably, however, cap 20 is not screwed down into fluid tight engagement with vessel 10 until after collection of a urine specimen to provide the venting function during collection of a sample.

A pair of inlet openings 40 are provided near the proximal end of catheter tube 14 for inflow of urine. The distal end of the catheter tube is flared, for example, by insertion onto a mandrel while subjecting the distal end of the catheter to R.F. frequencies. The distal end of catheter tube 14 is tubular and permits discharge of urine into collection vessel 10. Catheter tube 14 can be formed from continuously extruded thermoplastic tubing, such as polyvinyl chloride tubing by conventional techniques. It is desirable to use a catheter tube 14 of a sufficient durometer rating that the proximal end of the catheter tube can be easily inserted in a patient. Alternately, plasticizer can be leached from the proximal end of a more flexible catheter tube to provide a harder proximal end, for example, by insertion of the proximal end into a bath of carbon tetrachloride.

It is desirable to provide a yieldable stop means on the catheter tube proximal from the discharge opening at the distal end of the catheter tube 14. The yieldable stop means seats the distal end of catheter tube 14 within the collection receptacle as described more fully in a subsequent paragraph outlining the procedure for use of the catheterization kit. As illustrated in FIGS. 1 and 2, the yieldable stop means can comprise the flared portion 42 of catheter tube 14 adjacent distal end 38. The flared portion 42 at distal end 38 has been designed so it will not seat in air-tight relationship with aperture 24 when using a polyvinyl chloride catheter tube, thus inserting that aperture 24 will vent vessel 10 during collection of a specimen.

FIGS. 3 and 4 illustrate a compactly packaged, easily sterilizable catheterizatin kit in which the device of FIGS. 1 and 2 is packaged within a container. The container encloses collection vessel 10, top member 12, and catheter tube 14, and is formed by a paper bottom member 50 and a flexible, transparent film member 52 that forms the top of the container. Bottom member 50 and film member 52 are sealed together along a continuous margin 54 by an adhesive, or by the use of a thermoplastic film member 52 which is then fused to bottom member 50 by the application of heat.

Preferably, and as illustrated in FIG. 3, bottom member 50 and flexible member 52 are sheets having the same shape and are congruently aligned to form the container. Sealing margin 54 is desirably spaced inwardly from the perimeter of aligned members 50 and 52 adjacent the bottom end 56 of collection vessel 10. The spacing of sealing margin 54 from adjacent end 58 of film member 52 permits the film member to be grasped and the left end of film member 52 peeled from bottom member 50 as illustrated in FIG. 4. It is also preferable that sealing margin 54 have a chevron shape as illustrated in FIGS. 3 and 4 adjacent the bottom end 56 of container 10. This chevron shape permits easier peel-back of film member 52 from bottom member 50, since a smaller area of the sealing margin, formed for example by an adhesive, is being severed at any given instant during the peel-back operation.

FIGS. 5 and 6 illusrate another embodiment of the catheterization kit of this invention. The embodiment of FIGS. 5 and 6 includes a collection vessel 60, a top member 62, and a catheter tube 64, which each perform functions similar to the functions of collection vessel 10, top member 12 and catheter tube 14 as described above with relationship to the embodiment of FIGS. 1 and 2.

Collection vessel 60 differs from collection vessel 10 in having an open end 66 having an annular ridge 65 projecting about the perimeter of the top end of collection vessel 60. Neither collection vessel 60 nor cap 62 is threaded. Cap 62 has an aperture 68 extending through its top wall surface, with catheter tube 64 passing through aperture 68. Aperture 68 is slightly larger than the outside diameter of catheter tube 64.

Top member 62 has a plurality of inwardly extending ribs 63 (one rib 63 is illustrated in FIG. 6) spaced around its depending inner wall surface. These ribs are provided to insure the venting of air from the interior of collection vessel 60 during collection of a urine specimen. During collectin of a urine specimen, top member 62 is positioned on vessel 60 with ribs 63 longitudinally aligned to contact annular ridge 65 on a collection vessel 60. After collection of a urine specimen, top member 62 is pressed further down on collection vessel 60 to the position shown in FIG. 6, and ribs 63 are no longer longitudinally aligned with ridge 65. The entire outside perimeter of annular ridge 65 is in sealing contact with top member 62 as illustrated in FIG. 6.

Two inlet openings 70 are punched in the proximal end of the catheter for inflow of urine, and two outlet openings 72 are punched in the catheter tube near the distal end of the catheter. Proximal to outlet opening 72 is a yieldable stop means 74. Stop means 74 provides an indexing gauge for positioning the distal end of the catheter, when the major portion of the length of the catheter is removed from the collection vessel 60 for the taking of a sample of urine. The stop means can be provided, for example, by placing a drop of plasticizer on the outside of the catheter tube. The yieldable stop means, however, can be overcome by a strong manual pull to permit the entire catheter tube 64 to be pulled out through aperture 68 and removed from collection vessel 60.

In the embodiment of FIGS. 5 and 6, a sealing means for sealing the aperture after a urine sample is obtained is provided by a molded resilient plug 76, preferably elastomeric, which is forced into the distal end of catheter tube 64. Resilient plug 76 has a conical surface 78 that tapers from a diameter which is equal to or slightly less than the inside diameter of catheter tube 64 up to a diameter which is larger than the inside diameter of aperture 68. Thus, when catheter tube 64 is pulled through aperture 68 while removing the catheter tube from the collection vessel, plug 76 is pulled through aperture 68 until the increasing outside diameter of surface 78 seats the plug against the perimeter of aperture 68. In this position the plug 76 forms a liquid-tight seal around the perimeter of the aperture 68.

The catheterization kit of this invention can be conveniently and compactly packaged as illustrated in FIG. 3. The distal end of the catheter tube is desirably positioned adjacent the bottom end 56 of collection vessel 10. In this position, the proximal end of the catheter tube extends out from nozzle member 22 about one and one-half inches (1-1/2inches). Bottom member 50 and top member 52 are adhered together about the catheterization device to form a closed container therefor.

Subsequently, the entire package can be exposed to a sterilizing atomsphere, for example, ethylene oxide, to sterilize the catheterization kit.

The catheter tube can be extended from collection vessel 10 and the catheterization kit can be removed from the package in a convenient manner without contaminating the proximal end of the catheter tube 14. As illustrated in FIG. 4, the free end of film member 52 adjacent the bottom 56 of collection vessel 10 can be grasped and peeled back from bottom member 50. This permits insertion of the left hand, as illustrated in FIG. 4 to grasp the bottom portion of collection vessel 10. At this time, the right hand is used to restrain the proximal end of catheter tube 14 by exerting a manual grasping force through flexible film member 52.

While continuing to hold the proximal end of catheter tube 14 by exerting force through film member 52, centrifuge tube 10 is pulled out of the package, seating the yieldable seating means, the front portion of flared surface 42, in the aperture 24 of cap 20. In this position, the distal end 38 of catheter tube 14 remains within centrifuge tube 10. The catheter tube 10 extends to a length of approximately 6 inches outside of cap 20.

Subsequently, the entire unit can be removed from the container without handling the proximal end of catheter tube 14, and thus avoiding contamination of the proximal end of the catheter tube 14.

Catheter tube 14 is held at a point adjacent cap 20 and the patient is catheterized until a sample of approximately 12 cc is obtained. If the doctor's hands are not gloved, the catheter tube should be grasped at least 6 cm from the tip during the insertion. The catheter tube is removed from the patient, and held in an upright position to drain any remaining urine into collection vessel 10. Catheter tube 14 is subsequently pulled out of collection vessel 10 and discarded. Nozzle member 22 is pressed down into a horizontal position transverse of the axis of collection vessel 10 to seal aperture 24. The urine sample is now ready for laboratory processing.

Preferably, the catheterization kit is packaged with the female threads on top member 12 loosely engaging the male threads 18 on centrifuge tube 10. In this position, top member 12 is retained on centrifuge tube 10, but air is vented through the threaded connection during inflow of urine into centrifuge tube 10. After collection of a urine sample, top member 12 can be screwed down into fluid tight sealing engagement with centrifuge tube 10.

The embodiment of FIGS. 5 and 6 can be packaged in a container identical to that illustrated in FIGS. 3 and 4. The procedure for obtaining a urine specimen using the embodiment of FIGS. 5 and 6 is similar to the procedure described above. The following different procedures should be used, however, for the embodiment of FIGS. 5 and 6. Top member 62 should not be pressed tightly down onto collection vessel 60 prior to inserting the catheterization kit into the container for packaging. Instead, air should be free to flow into and out of the collection vessel 60 between the top member 62 and collection vessel 60 during the taking of a sample to insure venting of collection vessel 60.

The dissassembly of the container, and the catheterization of the patient proceed as described above. After removal of the proximal end of catheter tube 64 from the patient, top member 12 is pressed tightly down onto collection vessel 10 and assumes the position illustrated in FIG. 6.

The catheter tube 64 is rapidly pulled out of collection vessel 60 throught aperture 68 to disengage resilient plug 76 from the distal end of catheter tube 64, and to cause plug 76 to engage the perimeter of aperture 68 and thereby seal it.

the invention in its broader aspects is not limited to the specific details shown and described. Departures may be made from such details without varying from the principles of the invention and without sacrificing its chief advantages.

Claims

What is claimed is:

1. A catheterization kit for obtaining an uncontaminated sample of urine comprising:

a. a urine collection receptacle, said urine collection receptacle including a vessel having a top opening, and a rigid top member closing said top opening, said top member including liquid sealing means that engage said vessel about the periphery of said opening, and an aperture that extends through said top member, said aperture permitting flow of fluid into and out of said receptacle;

b. a catheter tube extending through said aperture of said top member, the distal end of said catheter including an opening for discharge of urine into said receptacle and terminating within said receptacle, said catheter tube slidably mounted in said aperture of said top member to permit removal of said catheter tube from said receptacle, the proximal end of said catheter terminating ouside said receptacle; and

c. aperture sealing means mounted on said top member adjacent said aperture for closing said aperture after a sample of urine is obtained and after said catheter tube is removed from said receptacle.

2. The catheterization kit of claim 1 in which said vessel is a rigid centrifuge tube that eliminates the need to transfer the sample to another container for centrifugation.

3. the catheterization kit of claim 1 including yieldable stop means on said catheter tube for seating the distal end of said catheter tube within said vessel.

4. The catheterization kit of claim 1 in which said aperture sealing means comprises a nozzle member having a bore, said nozzle member pivotally mounted on said top member and so positioned that (a) said bore of said nozzle member is pivotal between an open position in which said bore is in fluid flow communication with said aperture in said top member, and a closed position in which said bore is not in fluid flow communication with said aperture, and (b) an outside surface of said nozzle member is in sealing contact with said top member about the periphery of said aperture when said bore is out of fluid flow communication with said aperture, and said catheter tube is axially aligned and slidable within said bore for removal of said catheter tube from said receptacle.

5. The catheterization kit of claim 4 in which said catheter tube is flexible and extends from said aperture axially along the bore of said nozzle member.

6. The catheterization kit of cliam 4 in which the ouside diameter of said catheter tube positioned in the bore of said nozzle member is smaller than the inside diameter of the bore of said nozzle member to permit venting air from said centrifuge tube between said catheter tube and said bore during the drainage of urine into said centrifuge tube.

7. A catheterization kit for obtaining an uncontaminated sample of urine comprising:

a. a urine collection receptacle, said urine collection receptacle including a vessel having a top opening; and a rigid top member including liquid sealing means engaging said vessel about the periphery of said opening, and an aperture that extends through said top member and provides for fluid flow into and out of said receptacle;

b. a catheter tube extending through said aperture of said top member and slidably engaging the wall surface of said aperture, the distal end of said catheter tube terminating within said receptacle, and including an outlet opening for discharge of urine into said receptacle; and

c. aperture sealing means for sealing said aperture after a urine sample is obtained, said aperture sealing means including a resilient plug releasably attached to the distal end of said catheter tube for sealng said aperture to the distal end of said catheter tube for sealing said aperture by engaging the wall surface of said aperture when the distal end of said catheter tube is pulled through said aperture and out from said receptacle.

8. The catheterization kit of claim 7 in which said vessel is a rigid centrifuge tube.

9. The catheterization kit of claim 7 in which said plug has a conical surface, and the axis of the concial surface is aligned with the axis of said catheter tube to facilitate seating said plug in said aperture when said catheter tube is removed from said receptacle.

10. The catheterization kit of claim 7 including yieldably stop means on the catheter tube for seating the distal end of said catheter tube within said vessel.

11. The catheterization kit of claim 7, in which said yieldable stop means are further from the distal end of said catheter tube than said plug.

12. A catheterization kit for obtaining an uncontaminated sample of urine comprising:

a. a urine receptacle including a rigid centrifuge tube having a top opening, and a rigid top member closing said top opening, said top member including liquid sealing means that engage said centrifuge tube about the periphery of said opening, said top member including an aperture extending through said top memver;

b. aperture sealing means for closing said aperture after a sample of urine is obtained, said aperture sealing means including a nozzle member having a bore, said nozzle member pivotally mounted on said top member, said nozzle member being pivotal between an open position in which said bore is in fluid flow communication with said aperture in said top member, and a closed position in which said bore is not in fluid flow communication with said aperture, said nozzle member having an outside surface in sealing contact with said top member about the periphery of said apterture when said bore is in said closed position; and

c. a catheter tube having its proximal end outside said receptacle, and said catheter tube being slidably mounted in said bore and said aperture, and having its distal end terminating within said receptacle, the distal end of said catheter tube being slidable through said aperture, and said bore for removal of said catheter tube from said receptacle after a sample is obtained.

13. The catheterization kit of claim 12 in which said top member is movable between (a) a venting position in which said top member engages said centrifuge tube and permits venting of air from said collection receptacle during inflow of urine, and (b) a sealing position in which said top member is in liquid sealing engagement with said centrifuge tube about the periphery of said top opening.