Catheter and bag packaging system

Abstract

Disclosed herein are fluid collection systems that include an overpackage that accommodates a conduit assembly during shipping and storage and that can be converted to a fluid collection container during use. During shipping and storage, the catheter may be stored within a package to protect the device and any lubricious coating disposed thereon. During use, the catheter may be removed from the package, and the proximal end of the catheter may be coupled to the inlet of the package, and the package converted into a fluid collection container. The catheter may be inserted into a patient's body to drain fluid from the patient's body. The fluid may then be collected within the fluid collection container. Advantageously, the conduit may be easily detached from the collection container to allow discrete emptying and / or disposal of the collection container.

Description

Summary of the Invention

[0001] Briefly summarized, embodiments of the present invention relate to a fluid collection system including an outer package that houses a catheter assembly during transportation and storage and can be converted into a fluid collection container during use. During transportation and storage, the catheter can be stored within the package to protect the device and any lubricious coating disposed thereon. During use, the catheter can be removed from the package, and the proximal end of the catheter can be coupled to the inlet of the package, and the package can be converted into a fluid collection container. The catheter can be inserted into a patient's body to drain fluid from the patient's body. Then, the fluid can be collected within the fluid collection container. Advantageously, the catheter can be easily detached from the collection container to allow discrete emptying and / or disposal of the collection container.

[0002] Disclosed herein is a fluid collection system capable of transitioning between a storage state and a drainage state, the system including: an outer package that defines an internal chamber and includes an inlet in fluid communication with the internal chamber; a catheter assembly having a distal portion disposed within the internal chamber in the storage state, the catheter assembly including: a catheter body that defines a catheter lumen and includes an aperture disposed at a distal end to provide fluid communication with the catheter lumen; a bushing that is coupled to the proximal end of the catheter body and defines an outlet in fluid communication with the catheter lumen, the bushing being engaged with the inlet in the storage state; and a collapsible sheath that extends distally from the bushing and extends coaxially over the catheter body.

[0003] In some embodiments, the bushing is releasably secured within the inlet in an interference fit, press fit, snap fit, or threaded engagement in the storage state.

[0004] In some embodiments, when the fluid collection system is in the storage state, the proximal end of the bushing extends from the inlet.

[0005] In some embodiments, the fluid collection system further includes a stop member disposed distally of the outlet and configured to abut against a portion of the inlet to prevent the outlet from engaging the inlet in the storage state.

[0006] In some embodiments, the catheter assembly is configured to be removed from the internal chamber, and the outlet disposed at the proximal end of the bushing is coupled to the inlet to convert the system into the drainage state.

[0007] In some embodiments, the bushing outlet engages the inlet in one of an interference fit, press fit, snap fit, threaded, bayonet, or luer lock engagement in the drainage state.

[0008] In some embodiments, the fluid collection system further includes a ring coupled to the bottom edge of the outer package and configured to engage the inlet in the storage state.

[0009] In some embodiments, the catheter assembly is configured to drain fluid from a patient's bladder, and the outer package is configured to collect the fluid within an internal chamber.

[0010] In some embodiments, the fluid collection system further includes a cap configured to releasably engage the inlet and cover one or both of the inlet and the bushing outlet.

[0011] In some embodiments, the cap is configured to form a fluid-tight seal with the inlet when engaged therewith.

[0012] In some embodiments, the fluid collection system further includes a handle coupled to the distal end of the sheath and slidably engaged with the catheter body, the handle being configured to guide the distal end of the catheter body into the urethra and collapse the sheath as the distal end is advanced distally.

[0013] In some embodiments, the distal end of the handle is configured to engage the outlet of the bushing to form the sheath into a loop and receive the catheter body therein.

[0014] Also disclosed herein is a method of using a fluid drainage system, comprising: providing a fluid drainage system in a storage state, the fluid drainage system having: an outer package that defines an internal chamber and includes an inlet; a catheter assembly, a distal portion of which is disposed within the internal chamber, the catheter assembly including: a catheter body that defines a catheter lumen; a bushing coupled to the proximal end of the catheter body and defining an outlet in fluid communication with the catheter lumen; a collapsible sheath extending distally from the bushing and coaxially over the catheter body; grasping the proximal end of the bushing, the distal portion of which is releasably secured within the inlet; removing the catheter assembly from the internal chamber; and coupling the proximal end of the bushing to the inlet to place the catheter lumen in fluid communication with the internal chamber and convert the fluid drainage system to a drainage state.

[0015] In some embodiments, the bushing is releasably secured within the inlet by an interference fit, a press fit, a snap fit, or a threaded engagement in the storage state.

[0016] In some embodiments, the proximal end of the bushing extends from the inlet when the fluid drainage system is in the storage state.

[0017] In some embodiments, the method further includes abutting a stop disposed distal to the proximal end of the needle sleeve against a portion of the inlet to prevent the proximal end of the bushing from engaging the inlet in the storage state.

[0018] In some embodiments, the method further includes coupling the proximal end of the bushing to the inlet in the drainage state by one of an interference fit, a press fit, a snap fit, a threaded, bayonet, or Luer lock engagement.

[0019] In some embodiments, the method further includes coupling a loop attached to the bottom edge of the outer package opposite the inlet to the inlet in a stored state to secure the outer package in a folded state.

[0020] In some embodiments, the method further includes introducing fluid from the catheter body into the inner chamber of the outer package.

[0021] In some embodiments, the method further includes releasably engaging a cap with the inlet to cover one or both of the inlet and the proximal end of the bushing.

[0022] 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.

[0023] In some embodiments, the method further includes pushing the handle proximally toward the bushing to collapse the sheath between the handle and the bushing and to advance the distal end of the catheter body distally toward the handle, the handle being coupled to the distal end of the sheath.

[0024] In some embodiments, the method further includes sliding the handle distally from the bushing to withdraw a portion of the catheter body through the handle and into the sheath, and coupling the distal end of the handle to the proximal end of the bushing to form the sheath into a loop and to receive the catheter body therein.

[0025] Also disclosed herein is a method of manufacturing a fluid collection system capable of transitioning between a stored state and a drainage state, the method comprising: forming an outer package that defines an inner chamber and includes an inlet in fluid communication with the inner chamber; forming a catheter assembly having: a catheter body that defines a catheter lumen and includes an aperture disposed at a distal end to provide fluid communication with the catheter lumen; a bushing that is coupled to the proximal end of the catheter body and defines an outlet in fluid communication with the catheter lumen; and a collapsible sheath that extends distally from the bushing and extends coaxially over the catheter body; placing a distal portion of the catheter assembly within the inner chamber; engaging the bushing with the inlet such that the proximal end of the bushing extends from the inlet; and closing one or both of the inlet and the proximal end of the bushing with a cap.

[0026] In some embodiments, forming the outer package includes joining a first sheet of flexible material to a second sheet of flexible material along an edge of the first sheet of flexible material using an adhesive, bonding, welding, or ultrasonic welding to define the inner chamber.

[0027] In some embodiments, 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 inner chamber.

[0028] In some embodiments, the bushing is releasably secured within the inlet by an interference fit, press fit, snap fit, or threaded engagement.

[0029] In some embodiments, the method further includes causing an abutment disposed distally of the proximal end of the needle sleeve to abut against a portion of the inlet to prevent the proximal end of the sleeve from entering the inlet.

[0030] In some embodiments, the method further includes engaging a ring coupled to the bottom edge of the outer package with an inlet coupled to the top edge of the outer package to hold the outer package in a folded state.

[0031] In some embodiments, the method further includes forming a fluid-tight seal between the cap and the inlet to secure the catheter assembly within a sterile environment defined by the cap and the outer package.

[0032] Also disclosed herein is a method of converting a fluid collection system from a storage state to a drainage state, including: disengaging the cap from the inlet of the outer package; disengaging the sleeve of the catheter assembly from the inlet; removing the catheter assembly from the internal chamber defined by the outer package; and coupling the proximal end of the sleeve to the inlet to place the inner lumen of the catheter assembly in fluid communication with the internal chamber.

[0033] In some embodiments, the method further includes: disengaging the ring from the inlet, the ring being coupled to the bottom edge of the outer package and opposite the inlet disposed at the top edge of the outer package; and unfolding the outer package.

[0034] In some embodiments, the outlet of the sleeve extends from the inlet in the storage state and is disposed within the inlet in the drainage state.

[0035] In some embodiments, when the fluid collection system is in the storage state, the outer package and the cap cooperate to maintain the catheter assembly within a sterile environment.

[0036] In some embodiments, the catheter assembly includes a catheter body defining an inner lumen, a sleeve coupled to the proximal end of the catheter body, an outlet of the sleeve in fluid communication with the inner lumen, and a collapsible sheath extending coaxially over the catheter body.

[0037] Also disclosed herein is a method of storing a fluid collection system, including: draining fluid from the inner lumen of the catheter body of the catheter assembly into an internal chamber defined by the outer package; disengaging the outlet of the sleeve of the catheter assembly from the inlet of the outer package; and coupling the cap to the inlet to form a fluid-tight seal therebetween.

[0038] In some embodiments, the method further includes sliding the catheter body distally through a handle to enclose the catheter body within a sheath that extends coaxially over the catheter body between the sleeve and the handle.

[0039] In some embodiments, the method further includes coupling the distal end of the handle to the proximal end of the sleeve to form a ring and securing the catheter body within the sheath.

[0040] In some embodiments, the method further includes disengaging the cap from the inlet and draining fluid from the inner chamber of the outer package. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] A more particular description of the disclosure will be presented by reference to specific embodiments of the disclosure shown in the drawings. It should be understood that these drawings only depict typical embodiments of the invention and thus should not be considered as limiting the scope of the invention. The exemplary embodiments of the invention will be described and explained with additional particularity and detail by using the drawings, wherein:

[0042] Figure 1A A perspective view of the outer package of a fluid collection system according to an embodiment disclosed herein is shown.

[0043] Figure 1B A perspective view of a catheter assembly of a fluid collection system according to an embodiment disclosed herein is shown.

[0044] Figure 2A A close-up detail of a catheter assembly engaged with the inlet of the outer package in a storage state according to an embodiment disclosed herein is shown.

[0045] Figure 2B A close-up detail of a catheter assembly removed from the outer package according to an embodiment disclosed herein is shown.

[0046] Figure 2C A close-up detail of the proximal end of a catheter assembly coupled to the inlet of the outer package in a draining state according to an embodiment disclosed herein is shown.

[0047] Figures 3A to 3D A method of converting a fluid drainage system from a storage state to a draining state according to an embodiment disclosed herein is shown. DETAILED DESCRIPTION

[0048] Before disclosing some specific embodiments 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 may have features that can be easily separated from the specific embodiments, and these features can optionally be combined with or replace the features of any of the many other embodiments disclosed herein. It should be understood that the drawings are schematic and schematic representations of exemplary embodiments of the invention and are neither restrictive nor necessarily drawn to scale.

[0049] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing 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 in a group of features or steps and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Additionally, as used herein (including in the claims), the words "comprising", "having", and "containing" shall have the same meaning as the word "including".

[0050] In the following description, the term "or" and "and / or" as used herein shall be interpreted as inclusive or meaning any one or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B, and C". An exception to this definition occurs only when the combination of elements, components, functions, steps, or acts is inherently mutually exclusive in some way.

[0051] Relative to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter as disclosed herein includes a part of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal end portion or distal length of the catheter.

[0052] Relative to "distal", for example, the "distal portion" or "distal end portion" of a catheter as disclosed herein includes the part of the catheter that is intended to be placed near or within a patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be placed near or within a patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be placed near or within a patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter; however, 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 otherwise indicates, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0053] To assist in describing the embodiments described herein, a longitudinal axis extends generally parallel to the axial length of the catheter. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal axis and the lateral axis.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0055] Figures 1A to 1B An exemplary fluid collection system ("system") 100 configured to drain fluid from a patient's body is shown. System 100 generally may include an outer package 110 ( Figure 1A ) and a catheter assembly 130 ( Figure 1B ), and may be capable of transitioning between a storage state ( Figure 3A ) and a drainage state ( Figure 3D ). Exemplary fluids that may be drained by drainage system 100 may include blood, urine, peritoneal fluid, pus, and the like. In one embodiment, system 100 may be configured to drain urine from a patient's bladder.

[0056] As Figure 1A shown, outer package 110 generally may include a container body 112 that defines a length (l) and a width (w). Body 112 may be formed of a flexible material or a rigid material, such as plastic, polymer, thermoplastic, composite material, and the like. As shown, body 112 is formed of two flexible sheets that are joined along their edges using adhesive, bonding, welding, ultrasonic welding, or the like to define an internal chamber 114. Outer package 110 may also include an inlet 116 that provides fluid communication with the internal chamber 114 of body 112.

[0057] In one embodiment, the inlet 116 may include a cap 118 configured to engage the inlet 116 and prevent fluid communication therethrough. Optionally, the cap 118 may be tethered to the inlet 116 or the body 112. The cap 118 may engage the inlet 116 by a snap fit, interference fit, press fit, bayonet fit, luer lock, threaded engagement, or similar suitable engagement. 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 material different from the body 112, thereby exhibiting different mechanical properties. In one embodiment, one or both of the inlet 116 and the cap 118 may be formed of a material relatively rigid with respect to the body 112.

[0058] In one embodiment, the outer package 110 may further include a ring 120 or similar structure coupled to or integrally formed with an edge of the body 112. For example, as Figure 3B shown, the ring 120 may be coupled to the bottom edge of the body 112 opposite the inlet 116 (which is coupled to the top edge). The ring 120 may engage one or both of the inlet 116 and the cap 118 to secure the outer package in a folded configuration ( Figure 1A , Figure 3A ). Advantageously, the folded configuration may maintain the system 110 in a more compact profile during transportation and storage.

[0059] As Figure 1B shown, the catheter assembly 130 of the system 100 may include a catheter body 132 that extends longitudinally and defines 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 aperture 142 that provides fluid communication with the lumen 134. In one embodiment, the distal tip 136 may be configured to be inserted into the urethra to access the patient's bladder and drain fluid therefrom. The proximal end 138 of the catheter body 132 may be supported by a bushing 140 that defines a bushing lumen 144. The bushing lumen 144 is in fluid communication with the catheter body lumen 134 and may extend to a bushing outlet at the proximal end 148. In one embodiment, the catheter body 132 may include a lubricating coating, an antibacterial coating, or a similar coating or a combination thereof disposed on at least a portion of its outer surface.

[0060] The catheter assembly 130 may also include a collapsible sheath 150 formed of a thin air-impermeable membrane or similar material and extending circumferentially around the catheter body 132. The proximal end of the sheath 150 may be coupled to the distal end of the bushing 140 and may extend coaxially over the catheter body 132 to its distal end 136. Advantageously, the sheath 150 may protect the catheter body 132 during transportation and storage. The sheath 150 may prevent direct touch contact, which may contaminate the portion of the catheter body 132 that will be inserted into the patient's body. Additionally, the sheath 150 may protect the coating and prevent the coating from drying out. In use, the sheath 150 may be configured to collapse as the catheter body 132 is inserted into the patient's body.

[0061] 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 bushing 140 and the handle 160 may be formed of plastic, polymer, elastomer, rubber, silicone, etc. In one embodiment, one or both of the bushing 140 and the handle 160 may include a gripping surface disposed on its outer surface, including ridges, grooves, or similar textured surfaces or additional materials configured to provide an improved grip to the user. Additionally, the gripping surfaces of the bushing 140 and / or the handle 160 may indicate to the user the proper locations for gripping and manipulating the catheter assembly 130.

[0062] In one embodiment, the handle channel 164 may include a valve 162 or frangible seal that extends across the channel 164 and is configured to control fluid flow through the channel 164 during transportation and storage. Advantageously, one or more of the sheath 150, the handle 160, and the valve 162 may cooperate to enclose the catheter body 132 and any coating disposed thereon within a sealed and / or sterile environment, thereby preventing the catheter body 132 and the coating from drying out. Additionally, the valve 162 may reduce the exposure of the catheter body 132 to pathogens or contaminants. During use, the distal end 136 of the catheter body 132 may be pushed through the valve 162, which may separate the distal end 136 and allow it to extend distally into 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.

[0063] Figures 2A to 2CFurther details of the bushing 140 and the inlet 116 of the system 100 are shown. When the system 100 is in a storage state, the distal portion of the catheter assembly 130 can be disposed within the cavity 114 of the body 112, where a portion of the outer surface of the bushing 140 engages the inner surface of the inlet 116 by interference fit, press fit, snap fit, bayonet fit, Luer lock, or threaded engagement. In one embodiment, a portion of the outer surface of the bushing 140 can define a tapered outer profile to facilitate engagement of the inlet 116 by one of interference fit, press fit, or Luer lock engagement.

[0064] Figure 2A Close-up details of the bushing 140 engaged with the inlet 116 are shown, where the distal portion of the catheter assembly 130 is disposed within the cavity 114 of the body 112. In one embodiment, the inlet 116 can be formed of a relatively rigid material, such as plastic, polymer, thermoplastic, composite material, etc. In one embodiment, the bushing 140 can be formed of a material that is relatively compliant with respect to the inlet 116, such as plastic, polymer, elastomer, rubber, silicone rubber, composite material, etc.

[0065] In one embodiment, the bushing 140 can include an abutment 146, such as an annular ring, or a similar structure configured to abut against the surface of the inlet 116 and prevent the proximal end 148 of the bushing 140 from entering the inlet 116. Thus, as Figure 2A shown, when the bushing 140 is engaged with the inlet 116 in the storage state, the proximal portion of the bushing 140 disposed proximal to the abutment 146 can extend from the inlet 116. In one embodiment, the bushing 140 can engage the inlet 116 to form a seal therebetween and prevent fluid flow between the outer surface of the bushing 140 and the inner surface of the inlet 116. Advantageously, the sealed engagement between the bushing 140 and the inlet 116 can reduce the introduction of pathogens or contaminants into the internal chamber 114 when the system 100 is in a storage state.

[0066] In one embodiment, the cap 118 can engage the inlet 118 by one of interference fit, press fit, snap fit, bayonet, Luer lock, or threaded engagement, and can cover one or both of the inlet 116 and the proximal end 148 of the bushing 140 extending therefrom. Advantageously, when the system 100 is in a storage state, the cap 118 can provide a seal to prevent contaminants from contacting the catheter assembly 130 or the internal chamber 114 of the package 110.

[0067] In use, as Figures 2A to 2C shown, the user can disengage the cap 118 and grasp the proximal portion of the bushing 140 to disengage the bushing 140 from the inlet 116 ( Figure 2B ). Then, the user can remove the catheter assembly 130 from the internal chamber 114. AsFigure 2C As shown, the user can then flip the catheter assembly 110 and engage the proximal end 148 of the bushing 140 with the inner surface of the inlet 116 to transition the system 110 from a storage state to a drainage state. The proximal end 148 of the bushing 140 can engage the inlet 116 by way of an interference fit, press fit, snap fit, bayonet, luer lock, or threaded engagement.

[0068] Figures 3A to 3D An exemplary method of using the fluid drainage system 100 is shown. As Figure 3A shown, the system 100 can be provided in a folded storage state, where the catheter assembly 130 is disposed within the inner chamber 114, the bushing 140 is engaged with the inlet 116 and covered by the cap 118. Optionally, the ring 120 can engage the inlet 116 to maintain the body 112 in a folded storage state. Advantageously, in the storage state, the entire catheter assembly 130 is secured within the sterile environment of the inner chamber 114. Thus, the body 112 can serve as the outer package 110 of the system 100. This can prevent the catheter assembly 130 (especially any lubricious coating) from drying out during transportation or storage. Additionally, during transportation or storage, the catheter assembly 130 is protected from any dust or contaminants. Further, the ring structure 120 can maintain the outer package 110 in a folded state, thereby reducing the overall profile of the system 100 in the storage state.

[0069] As Figures 3A to 3B shown, the user can disengage the cap 118 from the inlet 118, thereby exposing the proximal end 148 of the bushing 140. The user can then disengage the ring 120 from the inlet 116 and unfold the body 112 ( Figure 3B ). As Figure 2B and Figure 3C shown, the user can grasp the proximal end 148 of the bushing 140 extending from the inlet 116 and disengage the bushing 140 from the inlet 116. The catheter assembly 130 can then be completely removed from the inner chamber 114 of the outer package 110. The user can then flip the catheter assembly 110, and the outlet at the proximal end 148 of the bushing 140 can be engaged with the inlet 116. In one embodiment, the outer surface of the proximal end of the bushing 140 can engage the inner surface of the inlet 116, such as by threaded engagement.

[0070] In one embodiment, the user can then place the catheter body 132 by grasping the handle 160 and aligning the distal end 136 of the catheter body 132 with a target location (e.g., the urethra). The user can then slide the handle 160 proximally relative to the distal end 136. The sheath 150 can collapse to allow the distal end 136 to slide distally towards the handle 160, thereby breaking the seal or traversing the valve 162 disposed within the passage 164 and entering the urethra. In one embodiment, the user can support the bushing 140 and push the bushing 140 distally to push the catheter body 132 through the passage 164 of the handle 160. Advantageously, the sheath 150 can maintain the catheter body 132 and any lubricious coating disposed thereon within a sterile environment, even during placement of the catheter body 132. The user can then advance the bushing 140 towards the handle 160 to advance the catheter body 132 through the urethra and into the bladder. When the aperture 142 enters the bladder, fluid can flow proximally through the lumen 134 of the catheter body 132. Advantageously, the handle 160, the sheath 150, and the bushing 140 can contain the catheter body 132 or the portion to be inserted into the patient's body within a sterile environment and reduce direct touch contact. This can prevent the introduction of pathogens or similar catheter-associated urinary tract infection (CAUTI) inciting agents.

[0071] In one embodiment, the user can place the catheter body 132 within the patient's body before coupling the bushing 140 to the inlet 116. In one embodiment, the user can couple the bushing 140 to the inlet 116 before placing the catheter body 132 within the patient's body. As Figure 3D shown, the system 100 then transitions to a drainage state, and fluid can be drained from the bladder through the catheter body lumen 134 and into the internal chamber 114 of the body 112. Thus, in the drainage state, the outer package 110 can become a fluid collection container. In one embodiment, once fluid has been drained from the bladder, the user can remove the catheter body 132 from the urethra by pushing the bushing 140 distally away from the handle 160. Thus, the catheter body 132 is withdrawn through the handle passage 164 and can be contained within the sheath 150.

[0072] In one embodiment, once the fluid has been drained, the user can detach the bushing 140 from the inlet 116 and can re-engage the cap 118 with the inlet 116, thereby creating a fluid-tight seal therebetween. Advantageously, the outer package 110 can contain and store the fluid within the internal chamber 114 until the fluid and / or the package 110 can be disposed of carefully. Since the cap 118 forms a fluid-tight seal within the inlet, the outer package 110 containing the fluid can be placed or stored without any fluid spillage. For example, the outer package 110 can be placed on a surface or placed in a pocket or bag until the fluid and / or the package 110 can be disposed of carefully. In one embodiment, the sealed package 110 containing the fluid can be disposed of together. Alternatively, the cap 118 can be removed and the fluid can be drained from the chamber 114, and optionally, the body 112 can be folded or rolled up and disposed of.

[0073] In one embodiment, the user can retract the catheter body 132 into the sheath 150 by pushing the bushing 140 away from the handle 160. In one embodiment, the distal end of the handle 160 engages the outlet at the proximal end 148 of the bushing 140 in one of a snap fit, interference fit, press fit, bayonet fit, Luer lock, threaded engagement or similar suitable engagement. Thus, the handle 160, the bushing 140 and the sheath 150 can form a ring that houses the catheter body 132 and any fluid therein within a sealed environment. Advantageously, the annular catheter assembly 130 can also be placed on a surface or placed in a pocket or bag until the catheter assembly 130 can be disposed of or stored carefully until the catheter assembly is properly cleaned for reuse.

[0074] Although some specific embodiments have been disclosed herein and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can be envisioned by those of ordinary skill in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Thus, changes can be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A fluid collection system capable of switching between a storage state and a drainage state, the system comprising: An outer package that defines an internal chamber and includes an inlet that is in fluid communication with the internal chamber; A catheter assembly having a distal portion disposed within the internal chamber in the storage state, the catheter assembly comprising: A catheter body that defines a catheter lumen and includes an eyelet disposed at a distal end to provide fluid communication with the catheter lumen; A bushing that is coupled to the proximal end of the catheter body and defines an outlet that is in fluid communication with the catheter lumen, the bushing being engaged with the inlet in the storage state; and A collapsible sheath that extends distally from the bushing and extends coaxially over the catheter body.

2. The fluid collection system according to claim 1, wherein the bushing is releasably fixed within the inlet in the storage state by an interference fit, a press fit, a snap fit, or a threaded engagement.

3. The fluid collection system according to claim 1 or 2, wherein when the fluid collection system is in the storage state, the proximal end of the bushing extends from the inlet.

4. The fluid collection system according to any one of claims 1 to 3, further comprising a abutment member that is disposed distally of the outlet and is configured to abut against a portion of the inlet to prevent the outlet from engaging the inlet in the storage state.

5. The fluid collection system according to any one of claims 1 to 4, wherein the catheter assembly is configured to be removed from the internal chamber, and the outlet disposed at the proximal end of the bushing is coupled to the inlet to convert the system to the drainage state.

6. The fluid collection system according to any one of claims 1 to 5, wherein the bushing outlet engages the inlet in the drainage state by one of an interference fit, a press fit, a snap fit, a threaded, bayonet, or luer lock engagement.

7. The fluid collection system according to any one of claims 1 to 6, further comprising a ring that is coupled to the bottom edge of the outer package and is configured to engage the inlet in the storage state.

8. The fluid collection system according to any one of claims 1 to 7, wherein the catheter assembly is configured to drain fluid from a patient's bladder, and the outer package is configured to collect the fluid within the internal chamber.

9. The fluid collection system according to any one of claims 1 to 8, further comprising a cap that is configured to releasably engage the inlet and cover one or both of the inlet and the bushing outlet.

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

11. The fluid collection system according to any one of claims 1 to 10, further comprising a handle that is coupled to the distal end of the sheath and is slidably engaged with the catheter body, the handle being configured to guide the distal end of the catheter body into the urethra and collapse the sheath as the distal end is advanced distally.

12. The fluid collection system according to claim 11, wherein a distal end of the handle is configured to engage the outlet of the bushing to form the sheath into a loop and receive the catheter body therein.

13. A method of using a fluid drainage system, comprising: providing the fluid drainage system in a storage state, the fluid drainage system comprising: an outer package that defines an internal chamber and includes an inlet; a catheter assembly, a distal portion of which is disposed within the internal chamber, the catheter assembly comprising: a catheter body that defines a catheter lumen; a bushing that is coupled to a proximal end of the catheter body and defines an outlet in fluid communication with the catheter lumen; and a collapsible sheath that extends distally from the bushing and extends coaxially over the catheter body; grasping a proximal end of the bushing, a distal portion of the bushing being releasably fixed within the inlet; removing the catheter assembly from the internal chamber; and coupling the proximal end of the bushing to the inlet to place the catheter lumen in fluid communication with the internal chamber and convert the fluid drainage system to the drainage state.

14. The method according to claim 13, wherein the bushing is releasably fixed within the inlet in an interference fit, press fit, snap fit, or threaded engagement in the storage state.

15. The method according to claim 13 or 14, wherein when the fluid drainage system is in the storage state, the proximal end of the bushing extends from the inlet.

16. The method according to any one of claims 13 to 15, further comprising: causing an abutment disposed distally of the proximal end of the bushing to abut against a portion of the inlet to prevent the proximal end of the bushing from engaging the inlet in the storage state.

17. The method according to any one of claims 13 to 16, further comprising: engaging the proximal end of the bushing with the inlet in an interference fit, press fit, snap fit, thread, bayonet, or Luer lock engagement in the drainage state.

18. The method according to any one of claims 13 to 17, further comprising: coupling a loop attached to a bottom edge of the outer package opposite the inlet to the inlet in the storage state to hold the outer package in a folded state.

19. The method according to any one of claims 13 to 18, further comprising: draining fluid from the catheter body into the internal chamber of the outer package.

20. The method according to any one of claims 13 to 19, further comprising: releasably engaging a cap with the inlet to cover one or both of the inlet and the proximal end of the bushing.

21. The method according to claim 20 further comprises: forming a fluid-tight seal between the cap and the inlet when the cap is engaged with the inlet.

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

23. The method according to claim 22 further comprises: sliding the handle distally from the bushing to withdraw a portion of the catheter body through the handle and into the sheath and coupling a distal end of the handle to the proximal end of the bushing to form the sheath into a loop and receive the catheter body therein.

24. A method of manufacturing a fluid collection system capable of being converted between a storage state and a drainage state, the method comprising: Form an outer package that defines an internal chamber and includes an inlet in fluid communication with the internal chamber; Form a catheter assembly that includes: A catheter body that defines a catheter lumen and includes an aperture disposed at a distal end to provide fluid communication with the catheter lumen; A bushing that is coupled to a proximal end of the catheter body and defines an outlet in fluid communication with the catheter lumen; and A collapsible sheath that extends distally from the bushing and extends coaxially over the catheter body; Place a distal portion of the catheter assembly within the internal chamber; Engage the bushing with the inlet such that a proximal end of the bushing extends from the inlet; and Seal one or both of the inlet and the proximal end of the bushing with a cap.

25. The method according to claim 24, wherein forming the outer package comprises: Use one of adhesive bonding, gluing, welding, or ultrasonic welding to join a first flexible material sheet to a second flexible material sheet along an edge to define the internal chamber.

26. The method according to claim 25, wherein the inlet is formed as a separate structure and fixed between the first flexible material sheet and the second flexible material sheet to provide fluid communication with the internal chamber.

27. The method according to any one of claims 24 to 26, wherein the bushing is releasably fixed within the inlet by an interference fit, a press fit, a snap fit, or a threaded engagement.

28. The method according to any one of claims 24 to 27, further comprising: Cause an abutment disposed distally of the proximal end of the bushing to abut against a portion of the inlet to prevent the proximal end of the bushing from entering the inlet.

29. The method according to any one of claims 24 to 28, further comprising: Engage a ring coupled to a bottom edge of the outer package with the inlet coupled to a top edge of the outer package to fix the outer package in a folded state.

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

31. A method of converting a fluid collection system from a storage state to a drainage state, comprising: Disengage a cap from an inlet of an outer package; Disengage a bushing of a catheter assembly from the inlet; Remove the catheter assembly from an internal chamber defined by the outer package; And Couple a proximal end of the bushing to the inlet to place the lumen of the catheter assembly in fluid communication with the internal chamber.

32. The method according to claim 31 further comprises: Disengage a ring from the inlet, the ring being coupled to a bottom edge of the outer package and opposite the inlet disposed at a top edge of the outer package; And unfold the outer package.

33. The method according to claim 31 or 32, wherein an outlet of the bushing extends from the inlet in the storage state and is disposed within the inlet in the drainage state.

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

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

36. A method of storing a fluid collection system, comprising: diverting fluid from the lumen of the catheter body of the catheter assembly into an internal chamber defined by an outer package; disengaging the outlet of the bushing of the catheter assembly from the inlet of the outer package; and coupling a cap to the inlet to form a fluid-tight seal therebetween.

37. The method according to claim 36, further comprising: sliding the catheter body distally through a handle to enclose the catheter body within a sheath that extends coaxially between the bushing and the handle over the catheter body.

38. The method according to claim 36 further comprises: coupling a distal end of the handle to a proximal end of the bushing to form a loop and to secure the catheter body within the sheath.

39. The method according to any one of claims 36 to 38, further comprising: disengaging the cap from the inlet and evacuating the fluid from the internal chamber of the outer package.

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