Urinary catheterization assembly with vented sheath

A urinary catheter assembly is disclosed having a catheter, a sheath enclosing an insertable portion of the catheter, and one or more vents in fluid communication with the lumen of the sheath and an environment outside the sheath.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present disclosure is directed to devices and methods for catheterization of the urinary bladder. More particularly, the present invention relates to such devices and methods employing a sheathed catheter.

2. Background of the Invention

The occasional or periodic catheterization of an individual's urinary bladder is a common practice today for many persons who are in a hospital setting, a nursing home, doctor's office, rehabilitation facility or at home. For instance, a patient may be catheterized to treat such conditions as urinary retention, the inability to evacuate urine, or for the purpose of obtaining a sterile urine specimen from a patient in a doctor's office.

Generally, catheterizations may be assisted (non self-catheterizations) or unassisted (self-catheterizations). In assisted catheterizations, a nurse may perform the catheterization by employing a catheterization tray (“cath tray”), which typically includes a sterile drape, gloves, a conventional catheter, antiseptic solution, cotton balls, lubricant, forceps, underpad and a urine collection container. All of these items are typically packaged together and sterilized. However, to perform the catheterization, the nurse must open the tray and handle the various items in the tray. Although special precautions may be taken, maintaining a sterile environment during the procedure may present challenges. Further, because multiple steps are involved in the procedure, a nurse may spend a significant amount of time (e.g., 10-15 minutes) carrying out each catheterization. In addition, conventional “cath tray” procedures may be expensive or otherwise impractical for use with some individuals and situations today.

For some of the above-stated reasons, many individuals, if capable, would prefer to perform self-catheterization. For many, the level of risk and discomfort of repeated catheterizations carried out over the course of a day (e.g., at 3-6 hour intervals) are offset by the accompanying convenience, privacy or self-reliance that is achieved. Some of the major difficulties that arise in self-catheterization are problems relating to maintaining the required level of sanitation during the procedure, and the difficulty of sometimes performing the procedure under conditions of restricted space and privacy.

A variety of catheterization kits and products are currently available. For instance, U.S. Pat. No. 6,090,075 (House I) discloses a catheter assembly with a catheter introducer member for positioning catheter assembly against the urethral opening, a flexible catheter, and a flexible thin-walled sheath surrounding the catheter and partially covering the catheter introducer.

Some catheterization assemblies and kits employ hydrophilic catheters that are self-lubricating when wetted with a fluid (e.g., water) prior to use. U.S. Pat. No. 6,409,717 (Astra Aktiebolag) and U.S. Pat. No. 6,736,805 (AstraZeneca AB) describe apparatus for wetting a hydrophilic urinary catheter, having a wetting receptacle which defines a wetting fluid receiving area for receiving the catheter and a wetting fluid container having a discharge outlet movable from a closed position to an open position on application of a predetermined condition thereto to enable the wetting fluid to be discharged from the container. U.S. Pat. No. 6,634,498 (Coloplast A/S) describes certain urinary catheter assemblies including a urinary catheter having at least a part of its surface a hydrophilic surface layer intended to produce a low-friction surface character of the catheter by treatment with a liquid swelling medium during manufacture of the catheter assembly, and a catheter package having a cavity for accommodation of the catheter. The package includes a compartment having walls of a gas impermeable material that accommodates the liquid swelling medium and a pre-treated catheter for long term preservation of the low-friction surface character and provision of a ready-to-use catheter assembly.

Some catheter assemblies include a protective sheath that surrounds the catheter or a portion thereof. The sheath may serve multiple purposes. For instance, the sheath may prevent contamination of the catheter as the catheter is handled prior to and/or during use. In addition, in some hydrophilic catheters, the sheath may contain a wetting agent used to lubricate the catheter during use. Failure of the sheath may lead to various problems, such as urinary tract infections, pain, and/or difficult catheterizations.

In some instances, a flexible catheter sheath is gathered near the distal end of the catheter (e.g., end relatively away from the patient) during use to allow the catheter to advance beyond the sheath and into the patient's urethra. As the sheath is gathered, the volume within the sheath may decrease. In assemblies in which the sheath lumen is not in fluid communication with a collection receptacle or the environment outside the sheath, some fluid contained within the sheath (e.g., air, wetting agent, etc.) may become trapped and compressed, resulting in a pressure buildup within the sheath (e.g., the sheath may “balloon-up”). A slight to moderate pressure build-up within the sheath may not result in any problems; however, excessive pressure build-up within the sheath may lead to noticeable problems. For example, excessive pressure buildup within the sheath may result in forces opposing further gathering of the sheath, thereby limiting the degree to which the catheter may be advanced into the urethra. In addition, as a consequence of an excessive pressure build-up, the sheath may “balloon-up,” potentially limiting the ability of the user to adequately grasp the catheter through the sheath. This consequence may detrimentally affect the ability of the user to control and manipulate the catheter during insertion. Further, an extreme pressure build-up may cause the sheath to rupture, potentially compromising the ability of the sheath to prevent contamination of the catheter contained within. In addition, a tear or rupture in the sheath may detrimentally impact the ability of the sheath to contain a wetting agent (e.g., hydrophilic catheters), create a clean-up nuisance, and possibly result in an unexpected, abrupt movement of the catheter. In instances in which excessive pressure-build-up within the sheath could arise, it would be advantageous to have a means to relieve some of the pressure build-up within the sheath lumen.

Accordingly, there remains a need for an easy-to-use, sanitary and disposable catheterization assembly. Such an assembly would be well received it if includes a flexible sheath capable of protecting the catheter from contamination, is capable of containing a lubricant or a wetting agent in the case of a hydrophilic catheter, is capable of being gathered to advance the catheter, and is capable of deterring excessive pressure build-up within the sheath lumen when the sheath is gathered.

SUMMARY OF THE INVENTION

These and other needs in the art are addressed in one embodiment by a urinary catheter assembly. In an embodiment, the catheter assembly comprises a catheter including a first end having a urine inlet, a second end having a urine outlet, and a urethra insertable portion. In addition, the catheter assembly comprises a pliable sheath including a lumen, wherein the sheath encloses all or a portion of the insertable portion. Further, the catheter assembly comprises one or more vents in fluid communication with the lumen and an environment outside the lumen.

The foregoing has broadly outlined certain features of the embodiments described herein in order that the detailed description that follows may be better understood. Additional features will be described hereinafter. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other devices, methods, or systems for carrying out the same purposes of the embodiments disclosed herein. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, different persons may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function. The drawing figures are not necessarily to scale. Certain features of the invention may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness.

Referring toFIG. 1A, an embodiment of a vented sheathed catheter assembly100is shown. Assembly100comprises a flexible catheter10and a protective sheath40. Catheter10includes an insertable portion20(intended to be inserted into a patient's urethra) and a non-insertable portion30(not intended to be inserted into the patient). Urethra-insertable portion20commences at a catheter tip14, which contains one or more urine inlet(s)16, and ends at an insertion stop location26, adjacent non-insertable portion30.

Catheter10further comprises a tip14, a distal end32including a urine outlet34, and a through bore (not shown inFIGS. 1A-C) that permits fluid communication between inlet(s)16and a urine outlet34. When sufficiently inserted into a patient's bladder, catheter10allows urine to drain from the patient's bladder through inlet(s)16, through the central bore of catheter10, and exit catheter10at outlet34. Optionally, a urine collection bag may be pre-attached or may be attached by the user such that outlet34may be in fluid communication with the collection bag (e.g.,FIGS. 5A and 5B).

It is to be understood that “distal” and “proximal” as used herein refer to locations relative to the patient when the catheter assembly is in use. In particular, “distal” refers to locations relatively away from the patient, while “proximal” refers to positions relatively near the patient. For example, the distal end of sheathed catheter assembly100is the end of catheter assembly100relatively away from the patient (e.g., distal end32), and the proximal end of sheathed catheter assembly100is the end of catheter assembly100relatively near the patient (e.g., tip14).

In the embodiment illustrated inFIGS. 1A-C, catheter tip14initially rests inside, and is supported by, an introducer77. Introducer77slidingly engages insertable portion20of catheter10. Further, introducer77includes one or more vents50in fluid communication with lumen41and the environment outside sheath40. In the embodiment shown inFIGS. 1A-C, vents50are passageways through introducer77.

Catheter10may be any flexible catheter. Further, catheter10may comprise any suitable material including without limitation, vinyl, red rubber latex, silicone elastomer, and the like. The urethra-insertable portion20of catheter10is generally the length of catheter that may be appropriately inserted into the patient's urethra in order to perform a successful urinary catheterization. In select embodiments, the length of insertable portion20is about ⅔rdsthe length of catheter10, and the length of non-insertable portion30is about ⅓rdthe length of catheter10. The actual length of catheter10, and the length of the insertable portion20, may depend on a variety of factors including without limitation, the application of catheter10(e.g., adult or child size), the patient's physiology, or combinations thereof. As a practical matter, the length of catheter10available for insertion (e.g., insertable portion20) is decreased, at least to some extent, by the distance on catheter10required to accommodate introducer77(if provided) and sheath40when sheath40is gathered near second sheath terminus42.

Sheath40comprises a first sheath terminus44coupled to introducer77and a second sheath terminus42coupled to catheter10at attachment point12. Attachment point12is positioned between tip14and a distal end32. In other embodiments, first sheath terminus44may not be coupled to an introducer or other tip cover, but rather partially or completely enclose tip14. In certain embodiments, attachment point12is located about ⅔rdsthe length of catheter10from tip14.

In the embodiments shown inFIGS. 1A-C, second sheath terminus42is fixed to catheter10at attachment point12so as to prevent rotational and translational movement of second sheath terminus42relative to catheter10. Second sheath terminus42may be fixed to catheter10at attachment point12by any suitable means including without limitation, by a collar, by an adhesive, by heat pressing, or combinations thereof. In other embodiments, second sheath terminus42may not be fixed to catheter10(e.g.,FIG. 4A). For instance, second sheath terminus42may slidingly engage catheter10. In addition, second sheath terminus42and attachment point12are positioned at the junction of the insertable portion20and non-insertable portion30of catheter10, adjacent distal end32.

During use of assembly100, flexible sheath40may be gathered as tip14and insertable portion20are advanced through introducer77and into the patient's urethra. Thus, one skilled in the art will appreciate that, in some embodiments, less than all of catheter10protected by the sheath40may be needed for insertion into the patient. Accordingly, an insertion stop location26(where the catheter stops near the urethral opening upon establishment of urine flow) may substantially coincide with attachment point12, or it may be spaced away from attachment point12closer to the tip14.

In the embodiment ofFIGS. 1A-C, sheath40encloses all, or at least part of, the insertable portion20, thereby creating a sheath lumen41between sheath40and catheter10. Sheath40may comprise any suitable material. In select embodiments, sheath40is an elongated, flexible plastic bag. Further, sheath40and lumen41may comprise any suitable geometry including without limitation, rectangular, cylindrical, flattened, inflated, partially inflated, etc. In the embodiment shown inFIGS. 1A-C, sheath40includes a plurality of vents50ain a distal portion of sheath40. Vents50aare in fluid communication with lumen41of sheath40and the environment outside sheath40.

Together, introducer77and sheath40cooperate to enclose and protect catheter10, insertable portion20in particular, from contamination prior to and during use. In the embodiment shown inFIG. 1A, insertable portion20of catheter10is maintained in sterile condition inside introducer77and sheath40. In alternative embodiments having no introducer77or other tip cover, insertable portion20of catheter10may be enclosed entirely within sheath40and thereby maintained in sterile condition.

Still referring toFIG. 1A, during use, introducer77is aligned with the patient's urethra. In some embodiments, the proximal tip of introducer77may be inserted up to 2 cm into the patient urethra. Tip14is then pushed through introducer77to advance tip14and insertable portion20into the patient's urethra. Catheter10moves relative to introducer77as insertable portion20is advanced through introducer77. As insertable portion20is advanced into the patient's urethra, sheath40may be gathered as second sheath terminus42moves toward first sheath terminus44, giving catheter assembly100an appearance similar to that shown inFIG. 1B. By continuing to advance tip14and insertable-portion20into the patient's urethra, sheath40may continue to gather between second sheath terminus42and first sheath terminus44, giving catheter assembly100an appearance similar to that shown inFIG. 1C.

In some sheathed catheter assemblies, the process of gathering sheath40to advance insertable portion20into the patient's urethra may result in a pressure increase (e.g., a pressure build-up) in lumen41. This may particularly be a problem in sheathed catheter assemblies in which the sheath lumen is not open ended, not in fluid communication with a urine collection bag, or not in fluid communication with an environment outside the sheath. Without being limited by theory, in sheathed catheter assemblies lacking vents50or vents50a, as sheath40is gathered, the volume within lumen41may decrease. Fluid (e.g., air, wetting agent, etc.) within lumen41may become trapped and compressed within lumen41as the volume of lumen41decreases. The compression of the contents of lumen41may result in a pressure increase within lumen41relative to the environment outside assembly100(e.g., sheath40may “balloon-up” as it is gathered between second sheath terminus42and first sheath terminus44).

Slight to moderate pressure build-ups may present minor or no problems at all. However, in some cases, excessive pressure build-up within lumen41may lead to undesirable consequences. For instance, a pressure build-up in lumen41may result in a force opposing the continued advancement of insertable portion20through introducer77and into the patient's urethra. This force may act to push introducer77towards tip14. In addition, a pressure build-up within lumen41may cause sheath40to “balloon-up,” which may detrimentally impact the ability of the user to grasp the catheter enclosed by sheath40. For example, a pressure build-up in lumen41may result in some expansion (e.g., increase in the diameter) of lumen41, which may render catheter10somewhat more challenging to handle, position, and/or manipulate. Further, a very high pressure build-up within lumen41may result in a tear or rupture of sheath40. For example, if a user continues to advance insertable portion20and gather sheath40as sheath40“balloons-up,” at some point, the material comprising sheath40may rupture (e.g., “pop”) or a connection between sheath40and catheter10may fail. Either event may undesirably reduce the ability of sheath40to prevent contamination of catheter10. For example, if sheath40is torn, direct contact with insertable portion20, before insertable portion20is placed inside the patient, may be possible.

However, by including vents50in introducer77and vents50ain lumen41, pressure within lumen41may be relieved as fluid (e.g., air) compressed in lumen41may escape lumen41through vents50and vents50a. In this manner, vents50and vents50amay deter an excessive pressure build-up within lumen41as sheath40ais gathered between second sheath terminus42and first sheath terminus44as illustrated inFIGS. 1A-C. In the embodiment ofFIGS. 1A-C, vents50are passageways through introducer77and vents50aare a plurality of relatively small apertures in sheath40. In some embodiments, the plurality of vents50amay form an array or organized pattern. Further, vents50aare preferably small enough to permit fluid to escape yet still protect insertable portion20from contacting non-sterile surfaces.

FIGS. 2A-C,3A,3B,4A, and4B illustrate alternative variations of vented sheathed catheter assemblies, showing a variety of vents. Referring toFIG. 2A, a partial view of an embodiment of a sheathed catheter assembly101is shown. Assembly101comprises a flexible catheter10and a sheath40. Catheter10includes a distal end32, an insertable portion20, and a non-insertable portion30. Sheath40is coupled to a second sheath terminus42that is coupled to catheter10at attachment point12. In this embodiment, second sheath terminus42is coupled to catheter10by a collar that surrounds catheter10at attachment point12. Sheath40encloses all, or at least part of, the insertable portion20within a lumen41.

Sheath40illustrated inFIG. 2Acomprises a plurality of vents50b. Vents50bpermit fluid communication between lumen41and the environment outside sheath40. In this manner, vents50bmay deter a pressure build-up within lumen41as sheath40is gathered as illustrated inFIGS. 1A-C. For instance, when catheter10is in use and sheath40is gathered, some pressure build-up within lumen41may be relieved as fluid within lumen41is allowed to pass out of lumen41through vents50b. One or more vents50bmay be provided. Vents50bare preferably sized to adequately relieve pressure within lumen41, yet minimize and/or prevent physical contact of catheter10through sheath40.

Vents50bshown inFIG. 2Aare slits in sheath40. However, generally, vents may be any suitable geometry including without limitation, slits, holes (e.g.,FIG. 2C), perforations (FIGS. 1A-C), and the like. Further, vents50bshown inFIG. 2Aare positioned along the length of sheath40. However, generally, vents may be positioned at any suitable location including without limitation, along the entire length of sheath40(e.g.,FIG. 2A), near the distal end of sheath40(e.g.,FIGS. 2B and 2C), near the proximal end of sheath40(e.g., near first sheath terminus44), in a collar that couples sheath40to catheter10, in an introducer (e.g., introducer77), or combinations thereof.

Referring toFIG. 2B, another embodiment of a sheathed catheter assembly102is illustrated. Vents50ccomprise a plurality of slits provided in sheath40near second sheath terminus42. By locating vents50cnear second sheath terminus42, any possible contamination of catheter10through vents50cmay be localized near second sheath terminus42. Although contamination of catheter10is generally undesirable, if any contamination of catheter10is to occur, it is preferred that such contamination occur as far as possible from catheter tip end14, since more distal portions of catheter10are least likely to be inserted into a patient's urethra.

Referring toFIG. 2C, another embodiment of a sheathed catheter assembly103is illustrated. Vents50dcomprise a plurality of holes in sheath40near second sheath terminus42. Similar to the embodiment illustrated inFIG. 2B, in this embodiment, vents50dare positioned near the portion of catheter10least likely to come into contact with a patient when in use (e.g., about non-insertable portion30).

Referring toFIG. 2D, another embodiment of a sheathed catheter assembly104is illustrated. Vent50ecomprises a single hollow tubular55provided through and across sheath40. Vent50eis essentially the through bore of tubular55. Thus, vent50eis in fluid communication with lumen41of sheath40and the environment outside sheath40. Tubular55may be connected to sheath40by any suitable means including without limitation, by heat pressing, adhesive, molded as part of sheath40, or combinations thereof. In the embodiment shown inFIG. 5D, vent50eis positioned near the portion of catheter10least likely to come into contact with a patient when in use (e.g., near second sheath terminus42). In other embodiments, one or more tubular55including a vent50emay be provided in any suitable location in sheath40including without limitation, at the distal end of sheath40, along the length of sheath40, at the proximal end of sheath40, or combinations thereof. In addition, in the embodiment shown inFIG. 2D, second sheath terminus42is fixed to catheter10at attachment point12by heat pressing sheath40to catheter10.

Referring toFIG. 3A, a partial view of another embodiment of a vented sheathed catheter assembly105is shown. Assembly105comprises a flexible catheter10and a protective sheath40. Catheter10includes a distal end32, an insertable portion20, and a non-insertable portion30. Second sheath terminus42is coupled to a collar43. Collar43is coupled to catheter10at attachment point12. Sheath40encloses all, or at least part of, the insertable portion20within a lumen41.

In the embodiment illustrated inFIG. 3A, collar43is fixed to catheter10to prevent translational and rotational motion of collar43relative to catheter10. In different embodiments, collar43may not be translationally and rotationally fixed relative to catheter10.

As best seen inFIG. 3B, collar43is physically attached to catheter10. Catheter10includes a through bore11in fluid communication with urine inlets at the catheter proximal tip and in fluid communication with outlet34. Collar43comprises four vents50f. Vents50fare passages extending through collar43. In general, vents50fin collar43permit fluid communication between lumen41and the environment outside sheath40. Thus, vents50fmay permit fluid within lumen41(e.g., air) to escape lumen41. In this manner, vents50fmay deter a pressure build-up within lumen41as sheath40is drawn back towards catheter distal end32.

In other embodiments, collar43may include any suitable number of vents50f(e.g., one, two, three or more vents50). Vents50fare provided across or through collar43and spaced evenly about collar43. In other embodiments, vents50fmay not be spaced evenly about collar43. Although vents50fshown inFIG. 3Bhave a circular cross-section, in general, vents50fmay be any suitable geometry including without limitation, circular cross-section (e.g., FIG.3AC), rectangular cross-section, or combinations thereof. Further, vents50fare preferably sized to sufficiently relieve pressure within lumen41, yet minimize and/or prevent physical contact of catheter10through collar43.

Vents50fmay be provided in any suitable location of collar43. Still further, vents similar to vents50fmay be provided in a collar that couples first sheath terminus44to introducer77illustrated inFIGS. 1A-C.

Still referring toFIGS. 3A and 3B, vents50fare provide in collar43near second sheath terminus42. By locating vents50fnear second sheath terminus42and distal end32, any possible contamination of catheter10through vents50fmay be localized near the distal end of catheter10(e.g., the portion of catheter10least likely to contact the patient).

Referring toFIGS. 4A and 4B, a partial view of another embodiment of a vented sheathed catheter assembly106is shown. Second sheath terminus42is coupled to a collar43. Collar43is coupled to catheter10. A single vent50gresults from an annular gap that arises between collar43and catheter10since the inside diameter of collar43is greater than the outside diameter of catheter10. Thus, in this embodiment, collar43is not fixed to catheter10, but rather slidingly engages catheter10. Similar to the embodiment illustrated inFIGS. 3A and 3B, in this embodiment, vents50gare position near the portion of catheter10least likely to come into contact with a patient when in use (e.g., near second sheath terminus42and distal end32).

InFIGS. 1A-Cand2A-C, vents50a, b, c, anddare provide in sheath40. InFIG. 2D, a vent50eis provided across sheath40in the form of a tubular55. InFIGS. 3A,3B,4A, and4B, vents50fandgare provided in collar43(e.g. second sheath terminus42). In different embodiments, vents may be provided in any suitable location allowing pressure within sheath lumen41to be relieved. Suitable locations may include without limitation, one or more vents in a collar coupling the sheath to the catheter (e.g., collar43), one or more vents in the sheath (e.g., vents50cin sheath40shown inFIG. 2B), one or more vents in the introducer or tip cover provided in the proximal tip of the catheter, one or more vents in a collar coupling the sheath to the proximal end of the catheter, or combinations thereof.

Referring toFIG. 5A, an embodiment of a vented sheathed catheter assembly107comprises a urine collection receptacle90. Urine collection receptacle90may be removably attached, permanently attached (non-removable), or integral to assembly107. Collection receptacle90may be constructed of any suitable material. Collection receptacle90is preferably made of a flexible, water-proof material (e.g., plastic) and is sized to hold a volume of urine in the range of 700-2000 mL, preferably about 1000 mL.

Collection receptacle90comprises a terminus92and a lumen94. Distal end32of catheter10, having a urine outlet34, is positioned inside a lumen94of urine receptacle90. In this manner, urine may flow from a patient's bladder, through catheter10and out of catheter outlet34into lumen94of urine collection receptacle90. In this manner, urine may drain from outlet34into lumen94of collection receptacle90. In some embodiments, a simple opening (not shown) in terminus92may permit distal end32to pass into lumen94. In the embodiment illustrated inFIG. 5A, terminus92is coupled to collar43at a receptacle attachment point13. Receptacle attachment point13may be any suitable geometry for permitting collection of urine from catheter10. For example, receptacle attachment point13may include without limitation, a collar or band that mates with collar43to create a secure water-tight seal/attachment, a hole adapted to connect collection receptacle90to collar43, or combinations thereof.

Assembly107further comprises vents50cin sheath40. Vents50care positioned near second sheath terminus42. As discussed above, vents50cprovide a means to relieve pressure within sheath lumen41.

Depending on the location of one or more vents, lumen41of sheath40may or may not be in fluid communication with lumen94of collection receptacle90. For example, inFIG. 5A, lumen41of sheath40is not in fluid communication with lumen94of receptacle90. However, in other embodiments, lumen41of sheath40may be in fluid communication with lumen94of receptacle90. For example, a portion of sheath40may be placed within urine receptacle90such that one or more vents provided in sheath41may be positioned partially or completely within collection receptacle90. In another example, one or more vents may be provided in sheath terminus42or in a collar43that are in fluid communication with lumen94of collection receptacle90.

Referring toFIG. 5B, another embodiment of a vented sheathed catheter assembly108comprising a urine collection receptacle90is illustrated. Collection receptacle90may be removably attached, permanently attached (non-removable), or integral to assembly108. Collection receptacle90may be constructed of any suitable material. Collection receptacle90is preferably made of a flexible, water-proof material (e.g., plastic) and is sized to hold a volume of urine in the range of 700-2000 mL, preferably about 1000 mL.

Collection receptacle90comprises a terminus92comprising a mating receptacle collar45. Receptacle collar45is coupled to collar43at receptacle attachment point13. In some embodiments, receptacle attachment point13may form a water-tight seal between collar43and mating receptacle collar45. In different embodiments, no mating receptacle collar or band is provided in collection receptacle90and distal end32may simply pass through a hole provided in terminus92.

Still referring toFIG. 5B, distal end32of catheter10, including a urine outlet34, is positioned inside lumen94of collection receptacle90. In this manner, urine may flow from a patient's bladder, through catheter10and out of outlet34into lumen94.

In the embodiment shown inFIG. 5B, lumen41of sheath40is in fluid communication with lumen94of receptacle90. Vents50gprovided in collar43are in fluid communication with one or more receptacle vents51that are provided in mating receptacle collar45. This arrangement permits fluid communication between lumen41of sheath40and lumen94of collection receptacle90. In instances when lumen94of receptacle90has a substantially larger volume than lumen41of sheath40, pressure build-up within lumen41may be relieved into lumen94of collection receptacle90without significantly impacting the operation of receptacle90or assembly108.

Referring toFIG. 5C, another embodiment of a vented sheathed catheter assembly109comprising a urine collection receptacle90is illustrated. Collection receptacle90comprises a terminus92comprising a mating receptacle collar45. Collection receptacle90may be removably attached, permanently attached (non-removable), or integral to assembly109. Collection receptacle90may be constructed of any suitable material. Collection receptacle90is preferably made of a flexible, water-proof material (e.g., plastic) and is sized to hold a volume of urine in the range of 700-2000 mL, preferably about 1000 mL.

In this embodiment, second sheath terminus42is coupled to collar43, which is fixed to catheter10at attachment point12. In addition, vents50hare provided in collar43. Further, a coupling46is fixed to catheter10at an attachment point16. Attachment point16is distal to collar43and distal to attachment point12. Coupling46couples catheter10to receptacle collar45at a receptacle attachment point13. In some embodiments, receptacle attachment point13may form a water-tight seal between coupling46and mating receptacle collar45. Distal end32of catheter10, including a urine outlet34, is positioned inside lumen94of collection receptacle90. In this manner, urine may flow from a patient's bladder, through catheter10and out of outlet34into lumen94.

Vents50hare in fluid communication with lumen41of sheath40and the environment outside sheath40. However, one of ordinary skill will appreciate that in this embodiment vents50hmay relieve pressure within lumen41, but do not place lumen41in fluid communication with lumen94of collection receptacle90. Thus, fluid within lumen41of sheath40does not commingle with fluid within lumen94of collection receptacle90.

FIGS. 1A-Cshow the urethra-contacting end of assembly100(proximal end of catheter10) as including an introducer77. In the embodiment shown inFIGS. 1A-C, introducer77is similar to an O'Neil® type tip with “cross-cut” end. Embodiments of an O'Neil type tip are disclosed in U.S. Pat. No. 4,652,259, which is hereby incorporated herein by reference in its entirety. However, in general, the proximal end of catheter10may comprise any suitable configuration. The tip cover or introducer77may be similar to those that are known in the art. For example, in some embodiments, introducer77may be a introducer similar to that disclosed in House II. Further, in other embodiments, introducer77may be replaced with a catheter tip cover to keep at least the insertable portion of the catheter sterile prior to and during use. Still further, in some embodiments, no catheter tip cover is provided and sheath40may completely or partially enclose insertable portion20of catheter10. Some alternative configurations for the proximal end of catheter10are disclosed in House I, House II, and House III.

Further, in some embodiments, a lubricant or a wetting agent may be included inside the sheath40, introducer77, or other catheter tip cover. Such a lubricant or wetting agent may serve to lubricate catheter10prior to insertion into the patient's urethra. House I and House II disclose catheter tips and sheaths capable of providing a lubricant or wetting agent to catheter10.

In addition, distal end32of catheter10may comprise any suitable geometry. Examples of suitable geometries include without limitation, flared or increased diameter distal end32(e.g.,FIG. 1A), uniform diameter distal end32(e.g.,FIG. 5A), decreasing diameter distal end32, or combinations thereof. Further, in each figure disclosed herein, distal end32of catheter10extends outside sheath40. However, in other embodiments, part or all of non-insertable portion30, including distal end32, may be enclosed by sheath40.

InFIGS. 1A-C,2A-D,3A,3B,4A,4B,5A-C of the present disclosure, second sheath terminus42is positioned near the junction of the insertable portion20and non-insertable portion30of catheter10, adjacent distal end32. However, in general, second sheath terminus42may be positioned at any suitable location. For instance, in some embodiments, second sheath terminus42may be coupled to distal end32or positioned closer to tip14. Still further, in some embodiments, second sheath terminus42may be fixed to catheter10at attachment point12, while in other embodiments, second sheath terminus42may not be fixed to catheter10.

In light of the present disclosure, one of skill in the art would appreciate that some components of the sheathed catheter assembly could comprise any of a variety of configurations and appearances, as for instance, similar to those disclosed in U.S. Pat. No. 6,090,075 (House I), U.S. App. No. 60/708,893 (House II), and U.S. application Ser. No. 11/326,699 (House III). Further, some of the embodiments disclosed therein include possible variations in the configuration of urine collection receptacle90.

Catheterization Kit

Referring toFIG. 6, a representative catheterization kit (“cath kit”)70that is particularly useful for patient catheterizations includes a sheathed catheter assembly72, representative of those shown and described above as sheathed catheter assemblies100-109. For example, vented sheathed catheter assembly72may include an introducer77, catheter10, and sheath40. Sheath40may be attached to introducer77, if present, and coupled to catheter10near the distal end of catheter10. Further, assembly72may include one or more vent(s) (not shown) capable of relieving pressure within the lumen of sheath40.

In addition to sheathed catheter assembly72, the kit preferably also contains a packet of antiseptic swabs79(e.g., swabs, cotton balls, or the like saturated with Betadine, Povidone-Iodine or other suitable antiseptic), disposable gloves80, small urine specimen bottle (with cap)78, and a tray71that holds these supplies and also serves as a urine collection container and has a capacity in the range of 700-2000 mL, preferably about 1000 mL. Preferably, a fenestrated drape is also included in the kit. A gauze pad may also be included in the kit as a convenient wipe at the end of the procedure. The kit components are protected by a sanitary wrapper or cover82. All kit components are preferably disposable.

Absent from the present kit, however, are the customary liquid antiseptic packet, cotton balls, tray for cotton balls, forceps, and packet containing lubricating jelly. In some embodiments, the fenestrated drape is also omitted from the kit without compromising sterile technique. The conventional waterproof absorbent pad is also unnecessary, as it was often included in the past primarily to provide a sterile field for placement of the sterile jelly. Preferably, with use of kit70, the lubricant is provided within sheathed catheter assembly72. For example, a sufficient amount of sterile lubricant may be present inside the sheath lumen, or inside an introducer. Alternatively, the catheter may be a lubricated hydrophilic type as is known in the art, in which case the lumen and/or an introducer of the catheter assembly may contain an aqueous wetting agent. A drawback of conventional apparatus and methods is that touching the catheter to any surface outside of the sterile field, as when lubricating jelly is applied, for instance, increases the risk of contamination and urinary tract infection. In contrast, with the present kit, if the sheathed catheter touches anything outside the sterile field, the insertable portion of the catheter remains sterile. Another potential problem associated with conventional catheterization kits and procedures is that, if a glove touches anything outside the sterile field and then touches the catheter, the catheter becomes contaminated. If a sheathed catheter assembly is employed instead, then even if a glove becomes contaminated, the catheter nevertheless remains sterile inside the protective sheath. Thus, the risk of infection and patient morbidity may be reduced or eliminated with use of the new sheathed catheter assembly72, catheterization kit70, and catheterization procedure.

The above-mentioned items omitted from conventional catheterization trays are not needed for carrying out a streamlined catheterization procedure with the above-described sheathed catheter assembly72and maintaining sterile technique.

Catheterization Procedure

Embodiments of vented sheathed catheter assemblies100-109may be used alone or as part of catheterization kit70. Referring toFIGS. 1A-C, and using assembly100in this exemplary explanation, vented sheathed catheter assembly100is preferably employed as follows: the user grasps introducer77and/or catheter10through the soft, flexible sheath40near the tip14of the catheter to align introducer77and tip14with the patient's urethra. In the case introducer77is an O'Neil® type tip, the projection of introducer77may be inserted about 1 to 2 cm into the urethra (or until the perpendicular flange prevents further insertion). Further, in the case where no introducer77is provided, if necessary, first sheath terminus44may be opened to allow the catheter tip14to emerge.

Tip14is advanced through introducer77, if provided, and into the patient's urethra. As tip14and insertable portion20are advanced, a portion of sheath40gathers between first sheath terminus44and second sheath terminus42, giving the catheter assembly an appearance similar to that shown inFIG. 1B. By appropriately repositioning the user's grasp on catheter10through sheath40, and continuing to gently urge insertable portion20into the urethra and toward the bladder, the sheath40is caused to continue gathering, giving the catheter assembly an appearance similar to that shown inFIG. 1C. Any build-up of pressure within lumen41of sheath40due to gathering of sheath40is relieved through vents50and/or vents50a, thereby deterring some of the undesirable aspects of pressure build-up.

Referring toFIG. 6, when a vented sheathed catheterization assembly (e.g., vented sheathed catheterization assembly100) is included as part of the catheterization kit70, catheterization kit70is preferably employed as follows: After opening the sanitary wrapper82, the nurse dons the gloves80and places the fenestrated drape, if provided, around the patient's genitalia. The packet79containing the antiseptic swabs is opened and the urethral area around the urethral opening is cleansed using the antiseptic swabs. Following proper sanitation, the insertable portion20of the vented sheathed catheter assembly is advanced into the patient similar to as described above in reference toFIGS. 1A-C.

When the catheter tip enters the patient's bladder a sufficient distance to commence draining of accumulated urine (e.g., about 1 cm), further insertion ceases.

Prior to commencement of urine drainage, the distal end32is placed in fluid communication with tray71so that urine can drain into tray71while preventing catheter10from contacting the collected urine. Alternatively, any other suitable urine receptacle may be used instead of the disposable tray71provided as part of kit70.

After commencement of urine flow, outlet34of catheter10may be directed briefly into the specimen container78, to collect a sterile specimen, as needed. Upon completion of urine evacuation, catheter10is withdrawn from the urethra and disposed of along with the other components of the kit. If desired, the catheter may be retracted into the sheath prior to disposal. The entire catheterization process can usually be accomplished by a nurse while maintaining sterile technique throughout the procedure.

The disclosed catheterization kit70and simplified procedure offers a way to simplify and streamline patient catheterization procedures without compromising sterile technique. Every item that the new kit70eliminates from the customary catheterization setup will decrease the number of procedural steps, and also reduces the amount of nursing time needed. Fewer steps also reduces the patient's risk for urinary tract infection, and decreases inconvenience for the patient. Kit70is intended to substantially reduce nursing time required to carry out a catheterization procedure.

In the manner described, embodiments of the present invention are intended to offer the potential to improve the convenience and sterility desirable for catheterization procedures. Some embodiments are designed to deter pressure build-up within the lumen of a protective sheath surrounding the catheter. By deterring pressure build-up within the sheath lumen, forces within the lumen which may otherwise operate against retraction of the sheath are reduced. In addition, by reducing pressure build-up within the sheath lumen, the potential for ruptures or tears in the sheath lumen may be reduced, thereby enhancing the ability of the sheath to maintain a sterile catheter. Further, by reducing pressure build-up within the sheath lumen, changes in the bulkiness/geometry of the catheter assembly, which may otherwise render the assembly more difficult to handle, position, and manipulate, may be lessened.

The disclosures of all patents, patent applications, and publications cited herein are hereby incorporated herein by reference in their entirety, to the extent that they provide exemplary, procedural, or other details supplementary to those set forth herein. Further, the discussion of a reference in this disclosure is not an admission that it is prior art to the present invention, especially any reference that may have a publication date after the priority date of this application.