Urinary Catheter and Bag Package System

Abstract

The fluid collection system includes an outer package that houses the catheter assembly during shipping and storage and can be converted into a fluid collection container during use. The catheter can be stored in the package to protect the device and any lubricious coating disposed thereon during shipping and storage. During use, the catheter can be removed from the package and the package can be converted into a fluid collection container by connecting the proximal end of the catheter to an inlet in the package. The catheter can be inserted into a patient's body to drain fluid from the body. The fluid can then be collected in the fluid collection container. Advantageously, the catheter can be easily removed from the collection container so that the collection container can be emptied and / or discarded separately.

Description

Summary of the Invention

[0001] Briefly summarized, embodiments of the present invention are directed to a liquid collection system including an outer package that houses a catheter assembly during shipping and storage and can be converted into a liquid collection container during use. The catheter can be stored in the package to protect the device and any lubricious coating disposed thereon during shipping and storage. During use, the catheter can be removed from the package and the package can be converted into a liquid collection container by connecting the proximal end of the catheter to an inlet in the package. The catheter can be inserted into a patient's body to drain liquid from the body. The liquid can then be collected in the liquid collection container. Advantageously, the catheter can be easily removed from the collection container so that the collection container can be emptied and / or discarded separately.

[0002] Disclosed herein is a liquid collection system transitionable between a storage state and a drainage state, the system comprising: an outer package defining an internal cavity and including an inlet in fluid communication with the internal cavity; and a catheter assembly having a distal portion disposed within the internal cavity in the storage state. The catheter assembly includes: a catheter body defining a catheter lumen and including an eyelet disposed at its distal tip to provide fluid communication with the catheter lumen; a hub coupled to a proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen, the hub engaging the inlet in the storage state; and a collapsible sheath extending distally from the hub and coaxially over the catheter body.

[0003] In some embodiments, the hub is removably secured to the inlet in the storage state by an interference fit, press fit, snap fit, or threaded engagement. In some embodiments, when the liquid collection system is in a stored state, the proximal end of the hub extends from the inlet.

[0004] In some embodiments, the liquid collection system further includes an abutment disposed distal to the outlet and configured to abut a portion of the inlet to prevent the outlet from engaging the inlet in a storage state.

[0005] In some embodiments, the catheter assembly is configured to be removed from the internal cavity and an outlet located at the proximal end of the hub is coupled to the inlet, thereby transitioning the system to a drainage state.

[0006] In some embodiments, the hub outlet engages the inlet in the discharged state by one of an interference fit, a press fit, a snap fit, a threaded engagement, a bayonet engagement, or a luer lock.

[0007] In some embodiments, the liquid collection system further comprises a loop coupled to the bottom edge of the outer package and configured to engage the inlet in the storage state. In some embodiments, the catheter assembly is configured to drain fluid from the patient's bladder and the outer package is configured to collect the fluid within the interior cavity.

[0008] In some embodiments, the liquid collection system further includes a cap configured to removably engage the inlet and cover one or both of the inlet and the hub outlet.

[0009] In some embodiments, the cap is configured to form a fluid-tight seal with the inlet when engaged with the inlet. In some embodiments, the liquid collection system further includes a handle coupled to the distal end of the sheath and slidably engaged with the catheter body, the handle configured to guide the distal tip of the catheter body into the urethra and to collapse the sheath as the distal tip is advanced distally.

[0010] In some embodiments, the distal tip of the handle is configured to engage the outlet of the hub to form a loop around the sheath and store the catheter body within the sheath. Also disclosed is a method of using the fluid evacuation system. The method includes providing the fluid evacuation system in a storage state. The fluid evacuation system includes an outer package defining an internal packaging cavity and including an inlet, and a catheter assembly having a distal portion disposed within the internal cavity. The catheter assembly includes a catheter body defining a catheter lumen, a hub coupled to a proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen, and a collapsible sheath extending distally from the hub and coaxially over the catheter body. The method also includes grasping the proximal end of the hub, with the distal portion of the hub removably secured to the inlet, removing the catheter assembly from the internal cavity, and coupling the proximal end of the hub to the inlet, thereby placing the catheter lumen in fluid communication with the internal cavity and transitioning the fluid evacuation system to a draining state.

[0011] In some embodiments, the hub is removably secured to the inlet in the storage state by an interference fit, press fit, snap fit, or threaded engagement. In some embodiments, when the fluid ejection system is in a stored state, the proximal end of the hub extends from the inlet.

[0012] In some embodiments, the method further includes preventing the proximal end of the hub from engaging the inlet in a storage state by abutting an abutment located distal to the proximal end of the hub against a portion of the inlet.

[0013] In some embodiments, the method further includes engaging the proximal end of the hub with the inlet in the discharged state by one of an interference fit, a press fit, a snap fit, a threaded engagement, a bayonet engagement, or a luer lock.

[0014] In some embodiments, the method further includes maintaining the outer package in a folded state in the storage state by connecting a loop attached to a bottom edge of the outer package opposite the entrance with the entrance.

[0015] In some embodiments, the method further includes expelling liquid from the catheter body into an interior cavity of the outer package. In some embodiments, the method further includes covering one or both of the inlet and the proximal end of the hub by removably engaging a cap with the inlet.

[0016] In some embodiments, the method further includes forming a fluid-tight seal between the cap and the inlet when the cap is engaged with the inlet. In some embodiments, the method further includes urging the handle proximally toward the hub, thereby collapsing the sheath between the handle and the hub and advancing the distal tip of the catheter body distal to the handle, the handle being coupled to the distal end of the sheath.

[0017] In some embodiments, the method further includes retracting a portion of the catheter body through the handle and into the sheath by sliding the handle distally from the hub, and coupling a distal tip of the handle with the proximal end of the hub to form a loop in the sheath and store the catheter body within the sheath.

[0018] Also disclosed is a method of manufacturing a liquid collection system capable of transitioning between a storage state and a drainage state. The method includes forming an outer package defining an internal cavity and including an inlet in fluid communication with the internal cavity, and forming a catheter assembly. The catheter assembly has a catheter body defining a catheter lumen and including an eyelet disposed at a distal tip to provide fluid communication with the catheter lumen, a hub coupled to the proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen, and a collapsible sheath extending distally from the hub and coaxially over the catheter body. The method also includes disposing a distal portion of the catheter assembly within the internal cavity, engaging the hub with the inlet such that the proximal end of the hub extends from the inlet, and covering one or both of the inlet and the proximal end of the hub with a cap.

[0019] In some embodiments, forming the outer package includes defining an interior cavity by joining a first sheet of flexible material to a second sheet of flexible material along their edges using one of adhesive, bonding, welding, or ultrasonic welding.

[0020] In some embodiments, the inlet is formed as a separate structure and secured between a first sheet of flexible material and a second sheet of flexible material to provide fluid communication with the interior cavity.

[0021] In some embodiments, the hub is removably secured to the inlet by an interference fit, press fit, snap fit, or threaded engagement. In some embodiments, the method further includes preventing the proximal end of the hub from entering the inlet by abutting an abutment located distal to the proximal end of the hub against a portion of the inlet.

[0022] In some embodiments, the method further includes maintaining the outer package in a folded state by engaging a loop coupled to a bottom edge of the outer package with an entrance coupled to a top edge of the outer package.

[0023] In some embodiments, the method further includes maintaining the catheter assembly within a sterile environment defined by the cap and outer packaging by forming a fluid-tight seal between the cap and the inlet.

[0024] Also disclosed is a method of transitioning a liquid collection system from a storage state to a drainage state, the method including disengaging a cap from an inlet of an outer package, disengaging a hub of a catheter assembly from the inlet, removing the catheter assembly from an interior cavity defined by the outer package, and coupling a proximal end of the hub to the inlet, thereby placing a lumen of the catheter assembly in fluid communication with the interior cavity.

[0025] In some embodiments, the method further includes disengaging a loop connected to a bottom edge of the outer package opposite the inlet located on the top edge of the outer package from the inlet, and unfolding the outer package.

[0026] In some embodiments, the outlet of the hub extends from the inlet in the storage state and is disposed within the inlet in the discharge state. In some embodiments, the outer package and the cap cooperate to maintain the catheter assembly in a sterile environment when the fluid collection system is in storage.

[0027] In some embodiments, the catheter assembly includes a catheter body defining a lumen, a hub coupled to the proximal end of the catheter body, an outlet of the hub in fluid communication with the lumen, and a collapsible sheath extending coaxially over the catheter body.

[0028] Also disclosed is a method of storing a liquid collection system, the method including draining liquid from a lumen of a catheter body of a catheter assembly into an interior cavity defined by an outer package, disengaging an outlet of a hub of the catheter assembly from an inlet of the outer package, and coupling a cap to the inlet to form a fluid-tight seal therebetween.

[0029] In some embodiments, the method further includes enclosing the catheter body within a sheath by sliding the catheter body distally through the handle, the sheath extending coaxially over the catheter body between the hub and the handle.

[0030] In some embodiments, the method further includes coupling a distal end of the handle to a proximal end of the hub to form a loop and secure the catheter body within the sheath.

[0031] In some embodiments, the method further comprises disengaging the cap from the inlet and emptying the liquid from the interior cavity of the outer package. A more particular description of the present disclosure will be given by reference to specific embodiments thereof which are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0032] [Figure 1A] 1 shows a perspective view of an outer package of a liquid collection system according to an embodiment disclosed herein. [Figure 1B] 1 shows a perspective view of a catheter assembly of a liquid collection system according to an embodiment disclosed herein. [Figure 2A]1 shows an enlarged detail view of a catheter assembly engaged with an inlet of an outer package in a storage state according to an embodiment disclosed herein. [Figure 2B] 1 shows an enlarged detail view of a catheter assembly removed from its outer packaging according to an embodiment disclosed herein. [Figure 2C] 1 shows an enlarged detailed view of the proximal end of the catheter assembly coupled to the inlet of the outer package in the vented state, according to an embodiment disclosed herein. [Figure 3A] 1 illustrates a method of transitioning a liquid dispensing system from a storage state to a dispensing state according to embodiments disclosed herein. [Figure 3B] 1 illustrates a method of transitioning a liquid dispensing system from a storage state to a dispensing state according to embodiments disclosed herein. [Figure 3C] 1 illustrates a method of transitioning a liquid dispensing system from a storage state to a dispensing state according to embodiments disclosed herein. [Figure 3D] 1 illustrates a method of transitioning a liquid dispensing system from a storage state to a dispensing state according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0033] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other numerous embodiments disclosed herein. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are not limiting and are not necessarily drawn to scale.

[0034] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed location, orientation, or direction. Instead, such designations are used to reflect, for example, a relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Additionally, as used in this specification, including the claims, the words "including," "has," and "having" shall have the same meaning as the word "comprising."

[0035] In the following description, the terms "or" and "and / or" as used herein should be interpreted as being inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of A, B, C, A and B, A and C, B and C, A, B and C." Exceptions to this definition occur only where combinations of elements, components, features, steps or acts are in some way inherently mutually exclusive.

[0036] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. Although the proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0037] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes a length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is used with the patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0038] To aid in the description of the embodiments described herein, a longitudinal axis extends generally parallel to the axial length of the catheter, a transverse axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and transverse axes.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A and 1B illustrate an exemplary fluid collection system (“system”) 100 configured to drain fluid from a patient's body. System 100 may generally include an outer package 110 (FIG. 1A) and a catheter assembly 130 (FIG. 1B), and may be transitionable between a storage state (FIG. 3A) and a drainage state (FIG. 3D). Exemplary fluids drained by drainage system 100 may include blood, urine, ascites, pus, etc. In one embodiment, system 100 may be configured to drain urine from a patient's bladder.

[0040] 1A, the outer package 110 may generally include a container body 112 defining a length (l) and a width (w). The body 112 may be formed of a flexible or rigid material, such as a plastic, polymer, thermoplastic, composite, or the like. As shown, the body 112 is formed from two sheets of flexible material joined along their edges using adhesive, bonding, welding, ultrasonic welding, or the like, to define an interior cavity 114. The outer package 110 may further include an inlet 116 that provides fluid communication with the interior cavity 114 of the body 112.

[0041] In one embodiment, the inlet 116 may include a cap 118 configured to engage with the inlet 116 to prevent fluid communication. Optionally, the cap 118 may be tethered to the inlet 116 or the body 112. The cap 118 may engage with the inlet 116 via a snap fit, an interference fit, a press fit, a bayonet fit, a luer lock, a threaded connection, or a similar suitable engagement method. In one embodiment, one or both of the inlet 116 and the cap 118 may be formed of the same material as the body 112. In one embodiment, one or both of the inlet 116 and the cap 118 may be formed of a different material than the body 112 and may exhibit different mechanical properties. In one embodiment, one or both of the inlet 116 and the cap 118 may be formed of a material that is relatively rigid relative to the body 112.

[0042] In one embodiment, the outer package 110 may further include a loop 120 or similar structure coupled to or integrally formed with an edge of the body 112. For example, as shown in FIG. 3B, the loop 120 may be coupled to the bottom edge of the body 112, opposite the inlet 116, which is coupled to the top edge. The loop 120 may engage one or both of the inlet 116 and the cap 118 to secure the outer package in a folded configuration (FIGS. 1A, 3A). Advantageously, the folded configuration may maintain the system 110 in a more compact shape during transportation and storage.

[0043] As shown in FIG. 1B , the catheter assembly 130 of the system 100 may include a catheter body 132 extending longitudinally and defining a lumen 134. The catheter body 132 may extend between a distal end 136 and a proximal end 138. The distal end 136 may include an eyelet 142 providing fluid communication with the lumen 134. In one embodiment, the distal tip 136 may be configured for insertion into the urethra to access and drain fluids from a patient's bladder. The proximal end 138 of the catheter body 132 may be supported by a hub 140 defining a hub lumen 144. The hub lumen 144 may be in fluid communication with the catheter body lumen 134 and extend to a hub outlet at the proximal end 148. In one embodiment, the catheter body 132 may include a lubricious coating, an antimicrobial coating, or a similar coating, or a combination thereof, applied to at least a portion of its exterior surface.

[0044] The catheter assembly 130 may further include a foldable sheath 150 formed from a thin, gas-impermeable film or similar material and extending annularly around the catheter body 132. The proximal end of the sheath 150 may be coupled to the distal end of the hub 140 and may extend coaxially over the catheter body 132 to the distal end 136. Advantageously, the sheath 150 can protect the catheter body 132 during shipping and storage. The sheath 150 can prevent direct contact that could contaminate the portion of the catheter body 132 inserted into the patient. Additionally, the sheath 150 can protect the coating and prevent the coating from drying out. In use, the sheath 150 can be configured to fold when the catheter body 132 is inserted into a patient.

[0045] In one embodiment, the catheter assembly 130 may include a handle 160 disposed distally and defining a channel 164. The distal end of the sheath 150 may be coupled to the proximal end of the handle 160. In one embodiment, one or both of the hub 140 and the handle 160 may be formed of a plastic, polymer, elastomer, rubber, silicone rubber, or the like. In one embodiment, one or both of the hub 140 and the handle 160 may include a gripping surface disposed on an outer surface. The gripping surface may include ridges, grooves, or similar textured surfaces or additional materials configured to provide an improved grip for a user. Additionally, the gripping surfaces of the hub 140 and / or the handle 160 may indicate to a user the appropriate location for grasping and manipulating the catheter assembly 130.

[0046] In one embodiment, the handle channel 164 may include a valve 162 or frangible seal extending therethrough and configured to control the flow of fluid therethrough during shipping and storage. Advantageously, one or more of the sheath 150, the handle 160, and the valve 162 cooperate to contain the catheter body 132 and any coatings disposed thereon in a sealed and / or sterile environment, preventing drying of the catheter body 132 and coatings. Additionally, the valve 162 may reduce exposure of the catheter body 132 to pathogens or contaminants. During use, the distal tip 136 of the catheter body 132 may be biased through the valve 162, which may separate the distal tip 136 and extend distally of the handle 160. In one embodiment, the inner diameter of the channel 164 may be equal to or slightly larger than the outer diameter of the catheter body 132. In one embodiment, the catheter body 132 may be slidably engaged with the channel 164 .

[0047] 2A-2C show further details of the hub 140 and inlet 116 of the system 100. When the system 100 is in a storage state, the distal portion of the catheter assembly 130 may be disposed within the cavity 114 of the body 112 with a portion of the outer surface of the hub 140 engaging the inner surface of the inlet 116 via an interference fit, press fit, snap fit, bayonet fit, luer lock, or threaded engagement. In one embodiment, a portion of the outer surface of the hub 140 may define a tapered profile to facilitate engaging the inlet 116 via one of an interference fit, press fit, or luer lock.

[0048] 2A shows an enlarged detailed view of the hub 140 engaged with the inlet 116, with the distal portion of the catheter assembly 130 positioned within the cavity 114 of the body 112. In one embodiment, the inlet 116 may be formed from a relatively rigid material, such as a plastic, polymer, thermoplastic, or composite material. In one embodiment, the hub 140 may be formed from a relatively flexible material relative to the inlet 116, such as a plastic, polymer, elastomer, rubber, silicone rubber, or composite material.

[0049] In one embodiment, the hub 140 may include an abutment 146, such as an annular ring or similar structure, configured to abut a surface of the inlet 116 and prevent a proximal end 148 of the hub 140 from entering the inlet 116. Thus, as shown in FIG. 2A , a proximal portion of the hub 140 disposed proximal to the abutment 146 may extend from the inlet 116 when the hub 140 is engaged with the inlet 116 in a storage state. In one embodiment, the hub 140 may engage with the inlet 116 to form a seal therebetween and prevent the flow of liquid between the outer surface of the hub 140 and the inner surface of the inlet 116. Advantageously, the sealing engagement between the hub 140 and the inlet 116 may mitigate the introduction of pathogens or contaminants into the internal cavity 114 while the system 100 is in a storage state.

[0050] In one embodiment, the cap 118 may engage the inlet 116 by one of an interference fit, a press fit, a snap fit, a bayonet engagement, a luer lock, or a threaded engagement, and may cover one or both of the inlet 116 and the proximal end 148 of the hub 140 extending therefrom. Advantageously, the cap 118 may provide a seal that prevents contaminants from contacting the catheter assembly 130 or the interior cavity 114 of the package 110 while the system 100 is in storage.

[0051] As shown in FIGS. 2A-2C, during use, a user can disengage the hub 140 from the inlet 116 by disengaging the cap 118 and grasping the proximal portion of the hub 140 (FIG. 2B). The user can then remove the catheter assembly 130 from the internal cavity 114. As shown in FIG. 2C, the user can then transition the system 110 from the storage state to the discharge state by inverting the catheter assembly 110 and engaging the proximal end 148 of the hub 140 with the inner surface of the inlet 116. The proximal end 148 of the hub 140 can engage with the inlet 116 via one of an interference fit, a press fit, a snap fit, a bayonet engagement, a luer lock, or a threaded engagement.

[0052] 3A-3D illustrate an exemplary method of use of the fluid evacuation system 100. As shown in FIG. 3A, the system 100 may be provided in a folded storage state with the catheter assembly 130 disposed within the internal cavity 114 and the hub 140 engaged with the inlet 116 and covered by the cap 118. Optionally, a loop 120 may engage the inlet 116 to maintain the body 112 in the folded storage state. Advantageously, in the storage state, the entire catheter assembly 130 is maintained within the sterile environment of the internal cavity 114. Thus, the body 112 can serve as the outer packaging 110 for the system 100. This can prevent the catheter assembly 130, and in particular any lubricious coating, from drying out during transport or storage. Furthermore, the catheter assembly 130 is protected from any dust or contaminants during transport or storage. Furthermore, the loop structure 120 can reduce the overall profile of the system 100 in the storage state by maintaining the outer packaging 110 in the folded state.

[0053] As shown in FIGS. 3A-3B, a user can expose the proximal end 148 of the hub 140 by disengaging the cap 118 from the inlet 116. The user can then unfold the body 112 by disengaging the loop 120 from the inlet 116 (FIG. 3B). As shown in FIGS. 2B and 3C, a user can grasp the proximal end 148 of the hub 140 extending from the inlet 116 and disengage the hub 140 from the inlet 116. The catheter assembly 130 can then be completely removed from the interior cavity 114 of the outer package 110. The user can then invert the catheter assembly 110 and engage the outlet at the proximal end 148 of the hub 140 with the inlet 116. In one embodiment, the outer surface of the proximal end of the hub 140 can be engaged with the inner surface of the inlet 116, such as by threading.

[0054] In one embodiment, the user can then position the catheter body 132 by grasping the handle 160 and aligning the distal tip 136 of the catheter body 132 with the target location, e.g., the urethra. The user can then slide the handle 160 proximally relative to the distal tip 136. The sheath 150 collapses, allowing the distal tip 136 to break a seal or slide distally of the handle 160 across a valve 162 located within the channel 164 and enter the urethra. In one embodiment, the user can urge the catheter body 132 through the channel 164 of the handle 160 by supporting the hub 140 and urging the hub 140 distally. Advantageously, the sheath 150 can maintain the catheter body 132 and any lubricious coating thereon in a sterile environment, even during placement of the catheter body 132. The user can then access the bladder by advancing the hub 140 toward the handle 160 and advancing the catheter body 132 through the urethra. Once the eyelet 142 accesses the bladder, fluid can flow proximally through the lumen 134 of the catheter body 132. Advantageously, the handle 160, sheath 150, and hub 140 can mitigate direct contact by enclosing the catheter body 132, or the portion that enters the patient's body, in a sterile environment. This can prevent the introduction of pathogens or similar pathogens that can cause catheter-associated urinary tract infections (CAUTIs).

[0055] In one embodiment, a user may place the catheter body 132 in the patient's body before connecting the hub 140 to the inlet 116. In one embodiment, a user may connect the hub 140 to the inlet 116 before placing the catheter body 132 in the patient's body. As shown in FIG. 3D , the system 100 can then transition to a draining state to drain fluid from the bladder through the catheter body lumen 134 and into the interior cavity 114 of the body 112. Thus, in the draining state, the outer package 110 can become a fluid collection container. In one embodiment, once fluid has drained from the bladder, a user can remove the catheter body 132 from the urethra by urging the hub 140 distally away from the handle 160. Thus, the catheter body 132 can be withdrawn through the handle channel 164 and retracted into the sheath 150.

[0056] In one embodiment, once the liquid is dispensed, the user can remove the hub 140 from the inlet 116 and re-engage the cap 118 with the inlet 116, creating a fluid-tight seal therebetween. Advantageously, the outer package 110 can contain and store liquid within the interior cavity 114 until the liquid and / or package 110 can be disposed of in a discreet manner. Because the cap 118 forms a fluid-tight seal with the inlet, the outer package 110 containing the liquid can be stored or preserved without spilling the liquid. For example, the outer package 110 can be set aside or placed in a pocket or bag until the liquid and / or package 110 can be disposed of in a discreet manner. In one embodiment, the sealed package 110 containing the liquid can be disposed of all together. Alternatively, the cap 118 can be removed to empty the liquid from the cavity 114, and the body 112 can optionally be folded or rolled up for disposal.

[0057] In one embodiment, a user can retract the catheter body 132 into the sheath 150 by urging the hub 140 away from the handle 160. In one embodiment, the distal tip of the handle 160 engages with an outlet at the proximal end 148 of the hub 140 by one of a snap fit, an interference fit, a press fit, a bayonet fit, a luer lock, a threaded engagement, or a similar suitable engagement. The handle 160, the hub 140, and the sheath 150 can thus create a loop that contains the catheter body 132 and any liquid therein in a sealed environment. Advantageously, the looped catheter assembly 130 can also be set aside or placed in a pocket or bag until the catheter assembly 130 can be disposed of discreetly, or stored until properly cleaned for reuse.

[0058] Although some specific embodiments have been disclosed herein, and the specific embodiments have been disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these adaptations and / or modifications as well. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A liquid collection system capable of transitioning between a storage state and a discharge state, comprising: an outer package defining an interior cavity and including an inlet in fluid communication with said interior cavity; a catheter assembly having a distal portion disposed within the internal cavity in the storage state, a catheter body defining a catheter lumen and including an eyelet disposed at a distal tip for providing fluid communication with the catheter lumen; a hub coupled to a proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen, the hub engaging the inlet in the storage state; a collapsible sheath extending distally from the hub and coaxially over the catheter body.

2. The liquid collection system of claim 1 , wherein the hub is removably secured to the inlet in the storage state by an interference fit, press fit, snap fit, or threaded engagement.

3. The liquid collection system of claim 1 or 2, wherein a proximal end of the hub extends from the inlet when the liquid collection system is in the storage state.

4. 4. The liquid collection system of claim 1, further comprising an abutment disposed distally of the outlet and configured to abut a portion of the inlet to prevent the outlet from engaging the inlet in the storage state.

5. 5. The liquid collection system of claim 1, wherein the catheter assembly is configured to be removed from the internal cavity and the outlet located at the proximal end of the hub is coupled to the inlet, thereby transitioning the system to the draining state.

6. 6. A liquid collection system according to any one of claims 1 to 5, wherein the hub outlet, in the discharged state, engages with the inlet by one of an interference fit, a press fit, a snap fit, a threaded engagement, a bayonet engagement, or a luer lock.

7. The liquid collection system of any one of claims 1 to 6, further comprising a loop connected to a bottom edge of the outer package and configured to engage the inlet in the storage state.

8. 8. The liquid collection system of claim 1, wherein the catheter assembly is configured to drain liquid from a patient's bladder and the outer package is configured to collect the liquid within the internal cavity.

9. The liquid collection system of any one of claims 1 to 8, further comprising a cap configured to removably engage the inlet and cover one or both of the inlet and the hub outlet.

10. The liquid collection system of claim 9 , wherein the cap is configured to form a fluid-tight seal with the inlet when engaged with the inlet.

11. 11. The liquid collection system of claim 1, further comprising a handle coupled to a distal end of the sheath and slidably engaged with the catheter body, the handle configured to guide the distal tip of the catheter body into the urethra and to collapse the sheath as the distal tip is advanced distally.

12. The fluid collection system of claim 11 , wherein the distal tip of the handle is configured to engage the outlet of the hub to form the sheath into a loop and store the catheter body within the sheath.

13. 1. A method of using a liquid discharge system, comprising: Providing the liquid discharge system in a storage state, the liquid discharge system comprising: an outer package defining an interior cavity and including an inlet; a catheter assembly having a distal portion disposed within the internal cavity, the catheter assembly comprising: a catheter body defining a catheter lumen; a hub coupled to the proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen; providing the fluid drainage system in a storage state, the fluid drainage system including a collapsible sheath extending distally from the hub and coaxially over the catheter body; grasping a proximal end of the hub so that a distal portion of the hub is removably secured to the inlet; removing the catheter assembly from the internal cavity; placing the catheter lumen in fluid communication with the internal cavity by coupling the proximal end of the hub with the inlet, thereby transitioning the fluid drainage system to a draining state.

14. The method of claim 13 , wherein the hub is removably secured to the inlet in the storage state by an interference fit, press fit, snap fit, or threaded engagement.

15. The method of claim 13 or 14, wherein the proximal end of the hub extends from the inlet when the liquid ejection system is in the storage state.

16. 16. The method of claim 13, further comprising abutting a portion of the inlet with an abutment located distally of the proximal end of the hub to prevent the proximal end of the hub from engaging the inlet in the storage state.

17. 17. The method of any one of claims 13 to 16, further comprising engaging the proximal end of the hub with the inlet in the ejected state by one of an interference fit, a press fit, a snap fit, a threaded engagement, a bayonet engagement, or a luer lock.

18. 18. The method of any one of claims 13 to 17, further comprising maintaining the outer package in a folded state in the storage state by connecting a loop attached to a bottom edge of the outer package opposite the entrance with the entrance.

19. The method of any one of claims 13 to 18, further comprising draining liquid from the catheter body into the interior cavity of the outer package.

20. The method of any one of claims 13 to 19, further comprising covering one or both of the inlet and the proximal end of the hub by removably engaging a cap with the inlet.

21. 21. The method of claim 20, further comprising forming a fluid-tight seal between the cap and the inlet when the cap is engaged with the inlet.

22. 22. The method of any one of claims 13 to 21, further comprising: urging a handle proximally toward the hub to collapse the sheath between the handle and the hub and advance a distal tip of the catheter body distal to the handle, the handle being coupled to a distal end of the sheath.

23. 23. The method of claim 22, further comprising: retracting a portion of the catheter body through the handle and into the sheath by sliding the handle distally from the hub; and coupling a distal tip of the handle with a proximal end of the hub to form a loop around the sheath and retract the catheter body within the sheath.

24. 1. A method of manufacturing a liquid collection system capable of transitioning between a storage state and a discharge state, comprising: forming an outer package defining an interior cavity and including an inlet in fluid communication with said interior cavity; forming a catheter assembly, the catheter assembly comprising: a catheter body defining a catheter lumen and including an eyelet disposed at a distal tip for providing fluid communication with the catheter lumen; a hub coupled to the proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen; forming a catheter assembly having a collapsible sheath extending distally from the hub and coaxially over the catheter body; placing a distal portion of the catheter assembly within the internal cavity; engaging the hub with the inlet such that a proximal end of the hub extends from the inlet; and covering one or both of the inlet and the proximal end of the hub with a cap.

25. 25. The method of claim 24, wherein forming the outer package comprises joining a first sheet of flexible material to a second sheet of flexible material along their edges using one of adhesive, bonding, welding, or ultrasonic welding to define the interior cavity.

26. 26. The method of claim 25, wherein the inlet is formed as a separate structure and secured between the first sheet of flexible material and the second sheet of flexible material to provide fluid communication with the interior cavity.

27. A method according to any one of claims 24 to 26, wherein the hub is removably secured to the inlet by an interference fit, press fit, snap fit or threaded engagement.

28. 28. The method of any one of claims 24 to 27, further comprising preventing the proximal end of the hub from entering the inlet by abutting an abutment located distally of the proximal end of the hub against a portion of the inlet.

29. 29. The method of any one of claims 24 to 28, further comprising maintaining the outer package in a folded state by engaging a loop connected to a bottom edge of the outer package with the inlet connected to a top edge of the outer package.

30. 30. The method of any one of claims 24 to 29, further comprising maintaining the catheter assembly within a sterile environment defined by the cap and the outer package by forming a fluid-tight seal between the cap and the inlet.

31. 1. A method of transitioning a liquid collection system from a storage state to a discharge state, comprising: disengaging a cap from the opening of the outer package; disengaging a hub of a catheter assembly from the inlet; removing the catheter assembly from an interior cavity defined by the outer package; and placing a lumen of the catheter assembly in fluid communication with the internal cavity by coupling a proximal end of the hub to the inlet.

32. 32. The method of claim 31, further comprising disengaging a loop connected to a bottom edge of the outer package opposite the inlet located on a top edge of the outer package from the inlet; and unfolding the outer package.

33. 33. The method of claim 31 or 32, wherein the outlet of the hub extends from the inlet in the storage state and is disposed within the inlet in the discharge state.

34. The method of any one of claims 31 to 33, wherein the outer package and the cap cooperate to maintain the catheter assembly in a sterile environment when the liquid collection system is in the storage state.

35. 34. The method of any one of claims 31 to 33, wherein the catheter assembly includes a catheter body defining the lumen, the hub coupled to a proximal end of the catheter body, the outlet of the hub in fluid communication with the lumen, and a collapsible sheath extending coaxially over the catheter body.

36. 1. A method of storing a liquid collection system, comprising: Draining liquid from a lumen of a catheter body of the catheter assembly into an interior cavity defined by an outer package; disengaging an outlet of the hub of the catheter assembly from an inlet of the outer package; and coupling a cap to the inlet thereby forming a fluid-tight seal therebetween.

37. 37. The method of claim 36, further comprising enclosing the catheter body in a sheath by sliding the catheter body distally through a handle, the sheath extending coaxially over the catheter body between the hub and the handle.

38. 37. The method of claim 36, further comprising coupling a distal end of the handle to a proximal end of the hub to form a loop and secure the catheter body within a sheath.

39. 39. The method of any one of claims 36 to 38, further comprising disengaging the cap from the inlet and emptying the liquid from the internal cavity of the outer package.

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