WO2024196960A1

WO2024196960A1 - Fluid collection apparatus with accessory housing

Info

Publication number: WO2024196960A1
Application number: PCT/US2024/020596
Authority: WO
Inventors: Landon Duval
Original assignee: UR24Technology Inc
Current assignee: UR24Technology Inc
Priority date: 2023-03-21
Filing date: 2024-03-19
Publication date: 2024-09-26
Anticipated expiration: 2025-09-21

Abstract

A fluid collector apparatus comprising an accessory housing having a communication channel, the accessory housing configured to be releasably coupled to a vented housing and configured to be coupled to a proximal end of a collection tube to couple the collection tube to the vented housing. The accessory housing can be structured to include a first cavity configured to receive the proximal end of the collection tube therein. The accessory housing can be further structured to include a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity. In some embodiments, the third cavity is configured to receive a portion of the vented housing therein.

Description

FLUID COLLECTION APPARATUS WITH ACCESSORY HOUSING PRIORITY AND RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/491,397 filed on March 21, 2023. The above-listed disclosure is incorporated herein by reference in its entirety. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.

TECHNICAL FIELD

[0002] The present disclosure relates to devices and methods for the collection of body fluids including urine, and more particularly to an accessory housing having a communication channel.

BACKGROUND

[0003] Urinary collection and analysis for medical reasons may be managed with absorbent diapers, in-dwelling urinary catheters and/or external, non-invasive urine collection devices. However, diapers are associated with a high rate of skin breakdown and decubitus ulcer formation while indwelling urinary catheters are a leading cause of urinary tract infections. In addition, urinary catheters can increase the risk of urinary tract infections and may be difficult to attach for use, difficult to detach when desired, and difficult to re-attach when needed again. External non-invasive urine collection devices can be cumbersome and ineffective for attaching to a male, female, or infant urethra when a patient is mobile. In addition, accurate and speedy placement of a urinary catheterization to ensure adequate urinary drainage while preventing leakage of urine can be challenging for healthcare providers. Accordingly, there has been a great demand for non-invasive external incontinence devices for collecting human urine without exposing the body to continuous urine contact. Therefore, it would be advantageous to have a fluid collector apparatus comprising an accessory housing that is designed to connect multiple parts in a timely manner and to tightly seal the parts to minimize involuntary leakage of urine.

SUMMARY

[0004] Embodiments of systems, methods, and devices (apparatus) for collecting body fluids are described and illustrated herein. [0005] One innovation includes an accessory housing that is configured to rclcasably couple to a fluid collection apparatus. The accessory housing can be coupled to a collection tube configured to collect urine from a patient’s urethra. Another innovation is a method of providing a fluid collection apparatus to collect fluid from a patient, such methods can include using a fluid collection apparatus disclosed herein, connecting a discharge tube of a fluid collection device to a vacuum source, and connecting a collection tube coupled to an accessory housing, which is coupled to a vented housing, to a patient to collect urine or another body fluid. Such methods can include connecting the accessory housing to the vented housing. Such methods can also include connecting the collection tube to the accessory housing.

[0006] Another innovation includes a fluid collector apparatus having an accessory housing having a communication channel, the accessory housing configured to be releasably coupled to a vented housing and configured to be coupled to a proximal end of a collection tube to couple the collection tube to the vented housing. In some embodiments, the accessory housing includes a first cavity configured to receive the proximal end of the collection tube therein. In some embodiments, the accessory housing can include a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein the third cavity is configured to receive a portion of the vented housing therein. In some embodiments, the accessory housing includes a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein the vented housing is configured to receive a portion of the accessory housing therein such that the third cavity is adjacent to a cavity for receiving urine in the vented housing. In some embodiments, the fluid collection apparatus further comprises a fastener having a proximal end and a distal, wherein the proximal end of the fastener can be structured to fit into the second cavity for coupling the fastener to the accessory housing, and the distal end of the fastener can be structured to fit into a cavity of the proximal end of the collection tube when the collection tube is positioned in the first cavity of the accessory housing such that a portion of the proximal end of the collection tube is between the distal end of the fastener and an interior surface of the accessory housing.

[0007] Embodiments of a fluid collection apparatus can include one or more other features. In some embodiments, the fluid collection apparatus further comprises a fastener having a proximal end and a distal end, wherein the proximal end of the fastener is structured to fit into the second cavity for coupling the fastener to the accessory housing. In some embodiments, the distal end of the fastener has a cross-sectional diameter that is larger than a cross-scctional diameter of the proximal end of the fastener. In some embodiments, the proximal end of the fastener is flange-shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the proximal end of the fastener. In some embodiments, the distal end of the fastener is flange- shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the distal end of the fastener. In some embodiments, the accessory housing has a distal end that couples to the collection tube. In some embodiments, the accessory housing has a proximal end that couples to the vented housing. In some embodiments, the distal end of the accessory housing has a greater cross-sectional diameter than the proximal end of the accessory housing.

[0008] In some embodiments of a fluid collection apparatus, the vented housing includes a proximal end and a distal end, the housing having a first aperture on the proximal end and a second aperture on the distal end, and wherein the fluid collection apparatus further includes a baseplate positioned inside the vented housing, the baseplate including a distal side, a proximal side opposite the distal side, a circumferential side surface between the distal side and the proximal side, a main aperture extending through a portion of the baseplate, and a valve aperture extending through a portion of the baseplate; a discharge tube having a distal end and a proximal end, the proximal end extending into the vented housing through the second aperture and coupled to the baseplate; and a valve positioned in the vented housing and mounted in the valve aperture, the valve configured to allow air to flow from inside of the vented housing through the valve and into an interior volume defined in part by the proximal side of the baseplate. In some embodiments, the fluid collection apparatus further includes a sealing material positioned between the side surface of the baseplate and an inside surface of the vented housing. In some embodiments, the valve is configured to allow air to flow from inside of the vented housing through the valve and into an interior volume of a front housing, the interior volume in communication with the collection tube cavity when the pressure differential between the air pressure in the rear housing and the air pressure in the interior volume is above a certain level such that suction is maintained in the collection tube. In some embodiments, the baseplate circumference is circular-shaped. In some embodiments, the main aperture is in a center portion of the baseplate. In some embodiments, the proximal end of the discharge tube extends into the main aperture and at least partially through the baseplate. In some embodiments, the fluid collection apparatus further includes an O-ring positioned around the proximal end of the discharge tube coupling the discharge tube to the distal side of the baseplate. In some embodiments, the fluid collection apparatus further includes a sensor positioned in a chamber of the housing, the sensor configured to transmit a signal, indicative of fluid in the housing, to a processing system. In some embodiments, the sensor is configured to detect moisture, sugar, blood, sodium chloride, protein, or calcium.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The features and advantages of the embodiments described herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only certain embodiments in accordance with the disclosure and are not to be considered limiting of its scope. In the drawings, similar reference numbers or symbols typically identify similar components, unless context dictates otherwise. In some instances, the drawings may not be drawn to scale.

[0010] Figure 1 illustrates a perspective view of an example of an embodiment of a fluid collection apparatus.

[0011] Figure 2 illustrates a perspective view of an example of another embodiment of a fluid collection apparatus.

[0012] Figure 3 illustrates an exploded view illustrating certain components of the fluid collection apparatus shown in Figure 1.

[0013] Figure 4 illustrates a side elevation view of an example of an embodiment of an accessory housing coupled to a collection tube and a front housing.

[0014] Figure 5 illustrates a cross-sectional side elevation view of the example of the embodiment of the accessory housing, collection tube, and front housing illustrated in Figure 4.

[0015] Figure 6 illustrates a prospective view of the embodiment of the accessory housing coupled to the collection tube and the front housing illustrated in Figure 4.

[0016] Figure 7 illustrates a prospective view of the cross-sectional view of the embodiment of the accessory housing coupled to the collection tube and the front housing illustrated in Figure 4. [0017] Figure 8A illustrates a cross-sectional view of an example of an embodiment of a front housing.

[0018] Figure 8B illustrates an example of another embodiment of a front housing.

[0019] Figure 9A illustrates a cross-sectional view of an example of an embodiment of an accessory housing.

[0020] Figure 9B illustrates a cross-sectional view of an example of another embodiment of an accessory housing.

[0021] Figure 10 illustrates a cross-sectional view of an example of an embodiment of a fastener that couples the collection tube to an accessory housing.

[0022] Figure 11A illustrates an example of an embodiment of a front housing, accessory housing, and fastener coupled together.

[0023] Figure 11B illustrates an example of another embodiment of a front housing, accessory housing, and fastener coupled together.

[0024] Figure 12A illustrates an example of certain dimensions of a front housing, accessory housing, and fastener coupled together that can be used in an external catheter device for a male patient.

[0025] Figure 12B illustrates an example of another embodiment of a front housing, accessory housing, and fastener coupled together that can be used in an external catheter device for a male patient.

[0026] Figure 13 A illustrates an example of certain dimensions of the front housing that can be used in an external catheter device for a male patient, illustrated in Figure 12A.

[0027] Figure 13B illustrates an example of another embodiment of certain dimensions of the front housing that can be used in an external catheter device for a male patient, illustrated in Figure 12B.

[0028] Figure 14A illustrates an example of certain dimensions of the accessory housing that can be used in an external catheter device for a male patient, illustrated in Figure 12A.

[0029] Figure 14B illustrates an example of another embodiment of certain dimensions of the accessory housing that can be used in an external catheter device for a male patient, illustrated in Figure 12B. [0030] Figure 15 illustrates an example of certain dimensions of a fastener that can be used in an external catheter device for a male patient.

[0031] Figure 16A illustrates an example of certain dimensions of a front housing that can be used in an external catheter device for an infant patient or a female patient.

[0032] Figure 16B illustrates an example of another embodiment of certain dimensions of a front housing that can be used in an external catheter device for an infant patient or a female patient.

[0033] Figure 17A illustrates an example of certain dimensions of an accessory housing that can be used in an external catheter device for an infant patient or a female patient.

[0034] Figure 17B illustrates an example of another embodiment of certain dimensions of an accessory housing that can be used in an external catheter device for an infant patient or a female patient.

[0035] Figure 18 illustrates an example of certain dimensions of a fastener that can be used in an external catheter device for an infant patient or a female patient.

DETAILED DESCRIPTION

[0036] Embodiments of systems, methods, and apparatus for collecting body fluids each can have several aspects (features), no single aspect of which is solely responsible for its desirable attributes. Without limiting the scope of the claims that follow, some of the aspects are described below. Various features of the embodiments described below may be included on an apparatus to collect body fluids from a subject (e.g., a human or an animal). While the disclosure is written in the context of fluid collection for a human subject, the methods and apparatus disclosed herein can also be used on an animal. The drawings referred to illustrate various features that can be included in various implementations of examples of a fluid collection apparatus (or device) that is positioned external to a subject’s body (sometimes referred to herein simply as the/an “apparatus” for ease of reference). In some examples, for clarity of illustration, not all of the features of a particular fluid collection apparatus are necessarily included in a particular figure. Various illustrated or described implementations of a fluid collection apparatus can also have additional features, including features that are illustrated or described elsewhere herein. Illustrations in the drawing sheets presented herein are examples only and should not be taken as limiting. [0037] The embodiments of a fluid collection apparatus disclosed herein address many of problems in current fluid collection apparatus. Many patients, male and female, have a need for non-invasive external incontinence devices for collecting human urine without exposing the body to continuous urine contact. There is also a need for an external incontinence device which can be applied with a consistent spatial orientation to allow leak-free use, especially for females. Preparing an external incontinence device for use by a male or female patient can include various assembly steps, which can be time-consuming and may be difficult to perform quickly. For example, some external incontinence devices may require manually coupling a urine discharge tube to the external incontinence device to form a leak-proof connection, and coupling a urine intake tube to the external incontinence device to form a leakproof connection, and some external incontinence devices require manually coupling a urethra interface tube (or receiver) to the external incontinence device - all of which are time consuming. Furthermore, such operations can be difficult to perform while wearing gloves. In addition, different patients (e.g., male/female) may also have different needs for configurations of the external incontinence device, which can increase the variety of external incontinence devices for each of the patient’s needs. Therefore, there is a need for an easier to configure an external incontinence device to prepare it for immediate patient use. In addition, there is a need to minimize the number of different external incontinence devices and components that are kept on-hand. The disclosed fluid collection apparatus designed to be leak free, comfortable to wear, lightweight, and easily attached and detached to a patient. The fluid collection apparatus may be disposable. The fluid collection apparatus may be formed of transparent or translucent materials such that urine discharged into the apparatus is visible to a healthcare provider and/or a patient. The fluid collection apparatus may be provided fully assembled in a sterilized pouch so that it is ready for immediate use. The fluid collection apparatus may be provided in a “male version” or a “female version,” each version configured to fit any patient. If a special fitting is required, for example for a female version of the apparatus, a urethra tube can be designed to be incorporated into the apparatus without having to change any other components.

[0038] The fluid collection apparatus can be worn at times when urination is expected or desired and may be disconnected and removed from, and reconnected to an individual at will. The fluid collection apparatus may generally include a collection tube, a vented housing (having a variety of components therein), an accessory housing, and a discharge tube. The collection tube is a flexible deformable material (e.g., silicone). The collection tube may be adapted to conform to a desired size and shape by a urethra tube, which is inserted into the proximal end of the collection tube. That is, the collection tube may deform to the shape, size, and angle of an exterior surface of the urethra tube inserted into the collection tube.

[0039] In an example of a fluid collection apparatus for a male patient, the collection tube (being deformable) can be adapted for engagement with a male urethra by receiving an individual’s penis. A urethra tube, inserted in the collection tube, may be used to resize or re-shape the collection for a more desirable fit. A urethra tube inserted into the collection tube can also provide the collection tube additional internal support. For example, a cylindrical urethra tube inserted into the proximal end of the collection tube and positioned near the baseplate can provide internal support to the collection tube such that it does not collapse when suction is applied to the discharge tube, and a corresponding vacuum is produced in the “chamber” surrounded by the baseplate (sealing the distal end of the collection tube) and the sides of the collection tube on the proximal side of the baseplate. In some embodiments, the male urethra tube is from *4” - 5” long. For example, in some embodiments, the male urethra tube may have a length of Yi”, 1” 1.5”, 2”, 2.5”, 3”. 3.5”, 4”, 4.5”, or 5” (+/- *4”). In some embodiments, two or more male urethra tubes may be inserted into the collection tube to provide internal support to the collection tube and/or to change the size or shape the collection tube.

[0040] In an example of a collection apparatus for a female patient, a urethra tube inserted into the proximal end of the collection tube can adapt the collection tube (e.g., change the shape and/or size of the collection tube) to engage a female urethra for improved sealing of the collection tube with the patient. The urethra tube may have a flared end that is larger on the proximal end than the distal end, the flared end allowing a better fit/engagement with a female urethra. The urethra tube may also have an angled portion allowing a better fit/engagement with a female urethra. For example, the urethra tube may have a first portion that has first longitudinal axis and a second portion that has a second longitudinal axis, the first longitudinal axis and the second longitudinal axis aligned at an angle, for example, an angle of between about 0° to about 90°. In some embodiments, such an angle may be in the range of about 5° to about 25°, for example, about 15°. Adapting the collection tube by inserting the urethra tube into the collection tube advantageously allows the same collection tube (same part/componcnt) to be configured for use with male or female patients, thus minimizing the number of different collection tubes (e.g., sizes, shapes, angles, etc.) that need to be kept in stock (e.g., one collection tube can be used for many or all patients).

[0041] The collection tube and the discharge tube are coupled to the vented housing such that urine collected in the collection tube can flow into the discharge tube. In various embodiments, the discharge tube may typically be of 8’, 10’, or 12’ in length to allow connection to a urine collection container. A discharge tube may be of any suitable length, for example, between about 2” and 20’ (or more) based on the use of the fluid collection system and the needs of the patient. An example of a vented housing is illustrated and described herein. However, in other embodiments, the vented housing can have other shapes and designs and provide the same function. The vented housing can include one, or a plurality of vents, that allow air to enter the housing. The vents can be of any shape, size, and arrangement that allow air to enter the housing and inhibit or prevent unwanted things (e.g., material, fingers, debris, and the like) from entering the vented housing. The discharge tube may be an integral tube that extends into a portion of the vented housing and is coupled to the baseplate. Alternatively, the discharge tube may include two or more components that are coupled together. For example, a discharge tube may include a first component (e.g., an interconnection device) having a proximal portion that is coupled to the baseplate and a distal portion that extends partially or fully out of the vented housing, and may include a second component (e.g., tubing) that is connected to the distal portion of the first component.

[0042] The collection tube may extend into a proximal end of the vented housing and be coupled to a baseplate. The baseplate may be disc-shaped, having a curved perimeter edge (or side) such that the perimeter is circular, oval, or curved. The baseplate includes a main aperture through which urine can flow from the collector tube to the discharge tube. The collection tube may be coupled to the side of the baseplate by positioning (inserting) the baseplate inside of the end of the collection tube. The discharge tube may be coupled to a center portion of the baseplate such that urine that flows through the main aperture flows into the discharge tube.

[0043] The vented housing further includes a front housing having a proximal end and a distal end. The front housing and the collection tube are coupled by an accessory housing having a proximal end and a distal end. The accessory housing can be used to quickly and easily (c.g., within seconds) couple or dc-couplc a collection tube to a fluid collection apparatus in a manner that is not a permanent attachment of the components. In various embodiments, an accessory housing can be used to couple a collection tube configured to interact with a male’s urethra to the fluid collection apparatus or to couple a collection tube configured to interact with a female’s urethra to the fluid collection apparatus. In use, in some embodiments, the accessory housing can be provided with a male or female configured collection tube attached to it, and then the accessory housing can be easily attached to the fluid collection apparatus. Use of an accessory housing and/or fitting allows a healthcare provider to easily change from using an external catheter to an in-dwelling catheter, or an in-dwelling catheter to an external catheter without having to change the fluid collection apparatus.

[0044] The embodiments of an accessory housing, and the fluid collection apparatus the accessory housing can be coupled to, address many problems in the current fluid collection apparatus. When the fluid collection apparatus is used, a healthcare provider can select to use one of the collection tubes or select to use an in-dwelling catheter, each coupled to an accessory housing, and then couple the distal end of the desired first, second, or third accessory housing to the proximal end of the front housing of the fluid collection apparatus several accessory housing. Having such a versatile accessory housing allows for a wide range of functionalities, while also saving time and healthcare resources.

[0045] The following is a list of certain components that are described and illustrated in this disclosure in reference to the above-listed figures. Other components, or aspects of these components, may not be included in the list but are disclosed in the figures and description. Accordingly, any aspect illustrated in the figures, whether-or-not called out separately herein, can form a portion of various embodiments and may provide basis for claim limitation relating to such aspects, with or without additional description. The components include:

1 fluid collection apparatus

2 fluid collection apparatus

5 distal side/end

6 proximal side/end

10 vented housing rear housing distal end rear housing proximal end rear housing vent(s)

1 st aperture rear housing coupling real- housing coupling front housing

2nd aperture real' housing exterior surface rear housing front housing distal end front housing (coupled to collection tube via accessory housing) proximal end front housing (coupled to baseplate and rear housing)

1 st aperture proximal end front housing

2nd aperture distal end front housing grommet baseplate valve(s) main aperture valve aperture

O-ring(s) valve first end (proximal end) valve second end (distal end) discharge tube distal end discharge tube proximal end discharge tube coupler sleeve ring collection tube distal end collection tube proximal end collection tube (interacts with patient) stretched fluid tube collection tube cavity a first coupling structure front housing, on/near proximal endb second coupling structure front housing, on/near proximal end urethra interface (urethra tube) distal end accessory housing proximal end accessory housing accessory housing a threads of accessory housing b recess of accessory housing fastener center portion fastener (waist) distal end fastener proximal end fastener aperture through fastener coupling structure inside collection tube (e.g., ridges) first portion collection tube distal end second portion collection tube distal end third portion collection tube distal end 2a 1^st cavity of accessory housing 2b side surface of 1^st cavity of accessory housing 2c top surface of 1^st cavity accessory housing 2d ledge of 1^st cavity accessory housing 3 proximal end of 2^nd cavity of accessory housing 4 2^nd cavity of accessory housing 5 distal end of 2^nd cavity of accessory housing 6a first corresponding cavity of accessory housing 6b second corresponding cavity of accessory housing 8 1^st aperture 0 2^nd aperture 2 communication channel (or opening) 144 opening between 1 ^st cavity and 2^nd cavity or accessory housing

146 tapered surface

150 accessory housing cavity

[0046] The fluid collection apparatus can be embodied in a slim, compact, and aesthetically pleasing design to facilitate being worn and used in a variety of situations. The compact and aesthetically pleasing design of the apparatus also can advantageously reduce a patient’s stress level of having to use such a device. An example of such a fluid collection apparatus for collecting urine from a female subject is shown in Figure 1, which illustrates a perspective view of embodiments of a fluid collection apparatus with an accessory housing 89. As illustrated in Figure 1, the fluid collection apparatus 1 includes a vented housing 10 having a front housing 22 and a rear housing 12. A distal portion 23 of the front housing 22 and a proximal portion of the rear housing 12 may be coupled together to form an integral vented housing 10. The rear housing 12 may have a curved exterior surface 21 and include one or more vents (holes) 15 that extend through the surface of rear housing 12, allowing air to flow from outside of the rear housing 12 to a cavity inside of the rear housing 12. Various configurations of the rear housing 12 can have differently -shaped curved exterior surfaces (e.g., circular, oval, etc.), and the vents 15 can also have various shapes in various configurations. The front housing 22 may have a curved surface and may have a smaller diameter at a proximal portion where the collection tube 62 enters the front housing 22 and a larger diameter where the front housing 22 is coupled to the rear housing 12. Various configurations of the front housing 22 can have differently-shaped curved surfaces.

[0047] The fluid collection apparatus 1 also includes a discharge tube 55 (or interconnection tube) that has a distal end that extends for a length outside of the venter housing 10, and a proximal end that extends through a grommet 30, into the interior of the vented housing 10, and is coupled to a baseplate 40 (Figure 3). The grommet 30 is positioned in an aperture at the distal end of the vented housing 10. A portion of the grommet 30 can extend into the interior of the rear housing 12 and a portion of the grommet extending outside of the rear housing 12.

[0048] In some embodiments, a coupling portion 19 of the front housing 22 may fit inside a coupling portion 18 of the rear housing 12. That way, the front housing 22 and the rear housing 12 may be structured to be releasably coupled together. The front housing 22 includes a proximal end 24 and a distal end 23 and the coupling portion 19 of the front housing 22 may be attached to the distal end 23 of the front housing. In some embodiments, the rear housing 12 and the front housing 22 may be coupled without either of the coupling portion 18 of the rear housing 12 or the coupling portion 19 of the front housing 22, or neither of them.

[0049] In some embodiments, the proximal end 24 of the front housing 22 and a distal end 87 of the accessory housing 89 are coupled together. In some embodiments, a proximal end 88 of the accessory housing 89 and a distal end 63 of the collection tube 62 are coupled together. For example, the accessory housing 22 may couple or de-couple the collection tube 62 quickly (i.e. within a second) to the fluid collection apparatus in a manner that is not a permanent attachment of the components. In various embodiments, an accessory housing can be used to couple a collection tube configured to interact with a male’s urethra to the fluid collection apparatus, or to couple a collection tube configured to interact with a female’s urethra to the fluid collection apparatus. As illustrated in Figure 3, a urethra tube 70 is inserted into a proximal end 64 of the collection tube 62. The shape of the proximal end 64 of the collection tube 62 can change as the collection tube 62 conforms to the shape of the urethra tube 70. In some embodiments, a stretched fluid tube 66 is attached to the proximal end 64 of the collection tube 62, allowing to attach and detach a urethra tube 70. For example, in Figure 1 , the collection tube 62 attached to the stretch fluid tube 66 is shaped for interfacing with a female patient. In some embodiments, the proximal end 64 of the collection tube 62 is attached to the urethra tube 70 without the stretch fluid tube 66. For example, in Figure 2 the collection tube 62 without a stretch fluid tube 66 is shaped for interfacing with a male.

[0050] The embodiments of an accessory housing, and the fluid collection apparatus the accessory housing can be coupled to, address many problems in the current fluid collection apparatus. The accessory housing can also be used with other fluid collection systems. Advantages of using the accessory housing include that it allows releasably coupling of multiple components to a housing of a fluid collection apparatus. For example, a first accessory housing 89 can be coupled to a collection tube 62 configured to connect with a female urethra. A second accessory housing 89 can be coupled to a collection tube 62 configured to connect to a male urethra. A third accessory housing 89 can be coupled to a fitting that is configured to connect to one or more in-dwelling catheters. When the fluid collection apparatus is used, a healthcare provider can select to use one of the collection tubes 62 or select to use an in-dwelling catheter, each coupled to an accessory housing 89, and then couple the distal end of the desired first, second, or third accessory housing 89 to the proximal end of the front housing 22 of the fluid collection apparatus. In some embodiments, a fluid collection apparatus can be packaged as a kit that includes a fluid collection apparatus and one or more of the first, second, and/or third accessory housings. That way, before, during, or after a medical procedure, a healthcare provider can change from one of the first, second, or third accessory housings to another of the first, second, or third accessory housings, and switch back and forth as needed. In another example, the fluid collection components can also include a fitting and one or more in-dwelling catheters, and a healthcare provider can decide to use either an internal catheter or an external catheter, or a combination of internal and external catheters. Use of an accessory housing and/or fitting allows a healthcare provider to easily change from using an external catheter to an in-dwelling catheter, or an in-dwelling catheter to an external catheter without having to change the fluid collection apparatus.

[0051] An example of such a fluid collection apparatus for collecting urine from a male subject is shown in Figure 2, which illustrates a perspective view of the embodiments of a fluid collection apparatus with an accessory housing 89. In this example embodiment, the urethra tube 70 (not shown here) attached to the proximal end 64 of the collection tube 62 can be shaped for interfacing with a male. In some embodiments, the urethra tube 70 may be sized for a tight connection around a patient’s penis. In some embodiments, the urethra tube 70 may be comprised of a transparent soft elastomeric material such as a silicone gel. In some embodiments, the urethra tube 70 may include a plurality of ribs within the urethra tube 70 that provide improved gripping around the penis, allowing the penis to be secured within the urethra tube 70 as a suction produced in the collection tube by an attached vacuum pump.

[0052] Figure 3 is an exploded view illustrating another view of certain components of an example of the fluid collection apparatus 1 for collecting urine from a female subject as shown and described above in Figure 1. In Figure 3, the proximal end 6 of the fluid collection apparatus 1 is oriented on the right-hand side, and the distal end 5 is oriented on the left-hand side. As illustrated, the vented housing 10 includes vents 15 in the exterior surface 21 of the rear housing 12. The rear housing 12 has a proximal end 13 and a distal end 14. The rear housing 12 has a first aperture 16 and a second aperture 20. Grommet 30 is positioned in the first aperture 16, a portion of the grommet 30 extending into the interior of the rear housing 12 and a portion of the grommet extending outside of the rear housing 12. In some embodiments, the rear housing 12 may have a curved exterior surface 21 and include one or more vents 15 that extend through the surface of the rear housing 12 that allow air to flow from outside of the rear housing 12 to a cavity inside of the rear housing 12, and then the air can flow through one of the valves 46 into a volume defined by a baseplate 40, the front housing 22 and the collection tube 62. The valves 46 are configured to allow air to enter the collection tube 62 (e.g., when the pressure differential between the air pressure in the rear housing 12 and the air pressure in the collection tube is above a certain level) such that suction is maintained in the collection tube within a desired range. In an example, such a negative pressure (compared to ambient pressure) of about 3 to 18 inches of Hg is maintained in the collection tube.

[0053] The valves 46 extend through the valve apertures 48 that extend between a distal side and a proximal side of the baseplate 40. In an example, the valve apertures 48 may be aligned to form pathways that go straight through the baseplate 40 and may be aligned normal (or nearly normal) to a plane in which the baseplate 40 is aligned. In the illustrated embodiment, the valve apertures 48 are aligned to form openings in the baseplate 40 that are at a non-normal angle to the plane in which the baseplate 40 is aligned. In certain embodiments, the fluid collection apparatus 1 may have at least 1 valve and/or less than 5. The embodiment in Figure 3 includes three valves 46. The valve apertures 48 are generally aligned to be angled inward. Each valve 46 includes a first end 51 and a second end 52. The first end 51 may extend through a valve aperture 48 and protrude from the baseplate 40 on the proximal side of the baseplate 40. The second end 52 is positioned in the rear housing 12. In this example, a proximal end 57 of the discharge tube 55 extends through the main aperture 47 and may be coupled to the baseplate 40 by an O-ring 50 positioned around the proximal end 57. Some embodiments may include more than one O-ring 50 (e.g., two O-rings). The O-ring 50 can inhibit or prevent the proximal end from being pulled back through the baseplate 40. In some embodiments, a coupler 58 may include a sleeve 59 that fits around a portion of the discharge tube 55 and may be used to couple the discharge tube 55 to the baseplate 40. For example, by connecting to a protrusion (not shown) that extends from the distal side of the baseplate 40. In some embodiments, a ring structure 60 may be used to attach the sleeve 59 to the discharge tube 55. The ring structure 60 may also limit the extent the discharge tube 55, or the coupler portion 58, extends through the baseplate 40.

[0054] As illustrated, the distal end 87 of the accessory housing 89 is coupled to the proximal end 24 of the front housing 22. In some examples, the accessory housing 89 is coupled to the front housing 22 using threads. In some examples, the accessory housing 89 is coupled to the front housing using corresponding structures that have a snap-fit connection. The distal end 63 of the collection tube 62 is coupled to, and extends out of, the accessory housing 89. In some examples, a urethra tube 70, inserted into the collection tube 62, changes the shape of the proximal end of the collection tube 62 as the collection tube 62 conforms to the exterior shape of the urethra tube 70. For example, the urethra tube 70 may be shaped for interfacing with a female patient as illustrated in Figure 3. In certain embodiments, the urethra tube 70 may be shaped for interfacing with a male patient.

[0055] Figure 4 illustrates a side elevation view of an example of an embodiment of an accessory housing 89, shown here coupled to a collection tube 62 and a portion of a fluid collection apparatus, in this example, through a front housing 22 of a fluid collection apparatus. In an example, the front housing 22 is coupled to a rear housing 12 of fluid collection apparatus 1. The accessory housing 89 includes a distal end 87 and a proximal end 88. In some embodiments, the distal end 87 of the accessory housing 89 may have a smaller diameter than the proximal end 88 of the accessory housing 89. In some embodiments, the distal end 87 of the accessory housing 89 may have a larger diameter than the proximal end 88 of the accessory housing 89. In some embodiments, the diameter of the distal end 87 of the accessory housing 89 may be the same as the proximal end 88 of the accessory housing 89.

[0056] Figure 5 illustrates a cross-sectional side elevation view of the example of an accessory housing, collection tube, and front housing illustrated in Figure 4. As illustrated, the fluid collection apparatus further comprises a fastener 91 having a distal end 93 and a proximal end 94. In some embodiments, the proximal end of the fastener 94 of the fastener 91 has a cross-sectional diameter that is larger than a cross-sectional diameter of the distal end 93 of the fastener 91. In some embodiments, the distal end of the fastener is flange-shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the distal end of the fastener. In some embodiments, the proximal end of the fastener is flange- shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the proximal end of the fastener. In some embodiments, the fastener 91 may include an aperture 95 that extends between the distal end 93 of the fastener 91 and the proximal end 94 of the fastener 91. In some embodiments, the fastener 91 can be used to couple the collection tube 62 to the accessory housing 89. In this example embodiment, the distal end 93 of the fastener 91 can be structured to fit into a cavity 150 of the accessory housing 89 for coupling the fastener 91 to the accessory housing 89. In some embodiments, the collection tube 62 includes a cavity 68 that extends inside the length of the collection tube 62. In this example embodiment, the proximal end 94 of the fastener 91 can be structured to fit into the cavity 68 of the collection tube 62 when the collection tube 62 is positioned in the cavity 150 of the accessory housing 91 such that a portion of the distal end of the collection tube is between the proximal end 94 of the fastener 91 and an interior surface of the accessory housing.

[0057] Figure 6 illustrates a perspective view of the embodiment of an accessory housing 89 coupled to a collection tube 62 and a front housing 22 illustrated in Figure 4. In some embodiments, the accessory housing 89 includes a first aperture 138 on the distal end 87 and a second aperture 140 on the proximal end 88. The collection tube 62 extends through the first aperture 138 and is coupled to the accessory housing 89. A portion of the front housing 22 extends through the second aperture 140 and is coupled to the accessory housing 89.

[0058] Figure 7 illustrates a prospective view of the cross-sectional view of the embodiment of an accessory housing 89 coupled to a collection tube 62 and a front housing 22 illustrated in Figure 4. As illustrated, in order to couple the distal end 63 of the collection tube 62 to the accessory housing 89, the proximal end 94 of the fastener 91 can be inserted into the distal end 63 of the collection tube 62 such that a first portion 97 of the collection tube 62 extends around the proximal end 94 of the fastener 91 to nearly the distal end 93 of the accessory housing 91 and is adjacent to the waist 92 off the accessory housing. In some embodiments, a second portion 98 of the collection tube 62 is adjacent to the proximal end 94 of the fastener 91 between the distal end 63 of the collection tube 62 and an inside surface of the accessory housing 89. In some embodiments, a third portion 99 of the collection tube 62 is adjacent to the proximal end 94 of the fastener 91 such that the flange-shaped proximal end 94 is between the first portion 97 and the third portion 99 of the collection tube 62. [0059] Figures 8A-8B illustrate a cross-sectional view of various embodiments of a front housing 22. In some embodiments, the front housing 22 may have a curved surface, and may have a smaller diameter at the proximal end 24 where the front housing 22 is coupled to the accessory housing 89, and a larger diameter at the distal end 23 where the front housing 22 is coupled to the rear housing 12. Various configurations of the front housing 22 can have differently-shaped curved surfaces (e.g., circular, oval, etc.). In some embodiments, the front housing 22 can be releasably coupled together by a coupling structure 69 on a proximal portion of the front housing 22 and a corresponding cavity 136 on a distal portion of the accessory housing 89 (Figures 8A-9B). In an example in Figure 8A, coupling cavity 152a near the proximal end 24 of the front housing 22 can be a male-threaded structure threaded along corresponding circumferential coupling edges that are mated together to couple the accessory housing 89 to the front housing 22 to releasably lock them together. In some embodiments, near a proximal portion of the front housing 22 comprises one or more protrusions 69a shaped based on the coupling cavity 152a. For example, the coupling cavity 152a in Figure 8 A is an oblique male-threaded structure, and one or more protrusions 69a on each side of the proximal end 24 of the front housing 22 correspond to this structure.

[0060] In some embodiments, a corresponding cavity 136a of the accessory housing 89 can be a female-threaded coupling structure (Figure 9A) comprising threads 90a (or indentations) corresponding to the male-threaded structure in Figure 8A. The front housing 22 can be threaded onto the corresponding cavity 136a of the accessory housing 89 for coupling. Coupling the coupling cavity 152a with protrusions 69a onto the corresponding cavity 136a of the accessory housing 89 allows the accessory housing 89 to be quickly and easily connected and disconnected from the fluid collection apparatus. In some embodiments, the accessory housing 89 can have zero protrusion.

[0061] In other embodiments, the accessory housing 89 and the front housing 22 can include other corresponding coupling structures. For example, as illustrated in Figure 8B, the front housing 22 has a second example embodiment of a coupling structure 69b without threaded structures but has one or more scallop-shaped protrusions on each side. In some embodiments, the second coupling structure 69b can be sized to fit into a recess 90b in Figure 9B, allowing the front housing 22 to “snap-fit” onto the accessory housing 89 in 9B. In some embodiments, the accessory housing 89 includes a tapered surface 146 such that a portion of the tapered surface 146 tapers inward as it extends from the distal end of the accessory housing 88 to the recess 90b of the accessory housing 89. In some embodiments, the tapered surface 146 does not taper inward but instead extends aligned with the angle of an external surface of the accessory housing 89. In some embodiments, the tapered surface 146 tapers inward at an angle A of between about 0 degrees and about 20 degrees. For example, in some embodiments, the tapered surface 146 tapers inward at an angle A of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 degrees, plus or minus 0.5 degrees. In some embodiments, the tapered surface 146 tapers inward at an angle A of between about 5 degrees and about 11 degrees. In some embodiments, the tapered surface 146 tapers inward at an angle A of between about 7 degrees and about 9 degrees. In this example, the tapered surface 146 allows a user to easily push the front housing 22 straight onto the accessory housing 89. This embodiment may provide a quick and easy connection and disconnection from the fluid collection apparatus. In addition, this embodiment may provide a tight seal to prevent leakage of a patient’s urine as it flows from the patient into the proximal end 64 of the collection into the front housing 22.

[0062] In Figures 9A-9B, the accessory housing 89 includes a communication channel (or opening) 142 that extends between the first aperture 138 and the second aperture 140 in Figure 6. When the collection tube 62 and front housing 22 are coupled to the accessory housing 89, a continuous cavity is formed through the collection tube 62, through the fastener 91, through the accessory housing 89, into the front housing 22 (i.e., from the proximal end 62 collection tube to inside the front housing 22) which allows urine to flow from a patient into the proximal end 64 of the collection into the front housing 22. In some embodiments, the accessory housing 89 can include a first cavity 132 and a second cavity 134. The first cavity 132 has a side surface 132a comprising an inner wall. The side surface 132a extends inward toward an opening of the first cavity 144. The first cavity 132 also has a top surface 132c that forms the opening 144. The opening 144 is configured to connect the first cavity 132a and a second cavity of the accessory housing 134. In some embodiments, the opening of the first cavity 144 is coupled to a proximal end 133 of the second cavity 134. In some embodiments, the second cavity 134 is coupled to a distal end 135 of the second cavity 134 in order to access the corresponding cavity 136. In some embodiments, the top surface 132c and the side surface 132b can be separate components or any variation of components. In some embodiments, the first cavity 132a has an inner projection of the side surface 132b in a proximal portion that has a diameter (D2) that is narrower than the diameter of the first cavity (DI ). The outward project of the side surface provides an overhang that engages a ledge, 132d.

[0063] In some embodiments, and as illustrated in Figures 10, 15, and 18, the fastener 91 includes a flange-shaped proximal end 94 and a flanged- shaped distal end 93, which are connected by a center portion (waist) 92 of the fastener 91. The flange-shaped proximal end 94 has a cross-section diameter that is larger than the cross-sectional diameter of the waist 92 and the flange-shaped distal end 93. The flange-shaped distal end 93 has a crosssection diameter that is larger than the cross-sectional diameter of the waist 92. In this embodiment, the flanged- shaped proximal end 94 also has a cross-sectional diameter that is greater than the cross-sectional diameter of the flanged- shaped distal end 93.

[0064] Figure 10 illustrates a cross-sectional view of the example of the embodiment of the fastener 91 that couples the collection tube to the accessory housing illustrated in Figure 4 to further illustrate its structure. The fastener 91 includes an aperture 95 that extends through the fastener 91. After the fastener 91 is coupled to the collection tube 62 such that the proximal end 94 of the fastener 91 extends from the collection tube 62, the proximal end 94 of the fastener 91 and the distal end 63 of the collection tube 62 can be inserted through the first aperture 138 and into the first cavity 132. The proximal end 94 of the fastener 91 can further be inserted through the opening 144 from the first cavity into the second cavity 134. The cross-sectional diameter of the opening 144 can be smaller than the cross-sectional diameter of proximal end 94 of the fastener, such that when the proximal end 94 of the fastener 91 is inserted into the second cavity 134, the fastener 91 is held in place in the second cavity 134. In some embodiments, the proximal end 94 of the fastener 91 can be tilted slightly to allow it to be placed in the second cavity 134. In other embodiments, the portion of the accessory housing 89 around the opening 144 and/or the proximal end 94 of the fastener 91 is generally rigid but flexible enough to allow the proximal end 94 of the fastener 91 to be inserted through the opening 144 into the second cavity 134, such that the fastener 91 “snaps” into place. While the Figures illustrate a preferred embodiment of a structure for coupling the collection tube 62 into the accessory housing, other structures can also be used.

[0065] Figure 11A illustrates a cross-sectional view of the example of the embodiment of the front housing, accessory housing, and fastener coupled together. When the distal end 93 of the fastener 91 is positioned in the second cavity 134 of the accessory housing 89 (for example, as illustrated in Figure 9B), the aperture 95 forms part of the communication channel 142 that allows urine or another collected fluid to flow from the collection tube 62 through the accessory housing 89 and fastener 91, and into the front housing 22, where it can then can flow through a discharge tube into a collection container. Figure 11B illustrates another cross-sectional view of the example of the embodiment of the front housing, accessory housing, and fastener coupled together (without threads).

[0066] Figures 12-15 illustrate various dimensions of embodiments of a front housing 22, an accessory housing 89, and a fastener 91 that can be used as part of a fluid collection apparatus/external catheter device for a male patient. Figures 12A-12B illustrate examples of an assembled front housing 22, accessory housing 89, and a fastener 91 coupled together. In these examples, the overall length (LI) of the coupled together front housing 22, accessory housing 89, and a fastener 91 is about 2.63”. In some embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 1.25” and about 4.0”. In some embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 1.5” and about 3.75”. In some embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 1.75” and about 3.5”. In other embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 2.0” and about 3.25”. In some embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 2.25” and about 3.0”. In some embodiments, LI of the coupled together housing 22, accessory housing 89, and a fastener 91 can be between about 2.5” and about 2.75”. In some embodiments, the overall length (LI) can be, or about, 1.2, 1.3,

1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4,

3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 inches, plus or minus 0.25.

[0067] Figures 13A-13B illustrate example embodiments of a front housing 22, an accessory housing 89, and a fastener 91 that can be used as part of a fluid collection apparatus/external catheter device for a male patient. In other example embodiments, Figures 16A-16B illustrate a cross-sectional of a front housing 22 of a fluid collection apparatus that can be used in an external catheter device for an infant patient or a female patient. In these examples, the length (L2) of the front housing 22 is about 1.93”. In some embodiments, L2 of the front housing 22 can be between about 0.53” and about 3.33”. In some embodiments, L2 of the front housing 22 can be between about 1.03” and about 2.83”. In some embodiments, L2 of the front housing 22 can be between about 1.53” and about 2.33”. In some embodiments, the length of the front housing 22 (L2) can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, or 3.4 inches, plus or minus 0.05.

[0068] In some embodiments, the width (Wl) of the front housing 22 of Figures 12A-12B and the front housing 22 of Figures 16A-16B is about 2.25”. In some embodiments, Wl of the front housing 22 can be between about 0.50” and about 4.0”. In some embodiments, W 1 of the front housing 22 can be between about 0.75” and about 3.75”. In some embodiments, Wl of the front housing 22 can be between about 1.0” and about 3.5”. In some embodiments, Wl of the front housing 22 can be between about 1.25” and about 3.25”. In some embodiments, Wl of the front housing 22 can be between about 1.50” and about 3.0”. In some embodiments, Wl of the front housing 22 can be between about 1.75” and about 2.75”. In some embodiments, Wl of the front housing 22 can be between about 1.5” and about 2.5”. In some embodiments, the width of the front housing 22 (Wl) can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2,

1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3,

3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 inches plus or minus 0.25.

[0069] Figures 14A-14B illustrate the cross-sectional of the accessory housing 89 of Figures 12A-12B that can be used as part of a fluid collection apparatus/external catheter device for a male patient. In other example embodiments, Figures 17A-17B illustrate the cross-sectional of the accessory housing 89 of a fluid collection apparatus that can be used in an external catheter device for an infant patient or a female patient. In these examples, the length (L3) of the accessory housing 89 is about 1.12”. In some embodiments, L3 of the accessory housing 89 can be between about 0.5” and about 1.74”. In some embodiments, L3 of the accessory housing 89 can be between about 0.75” and about 1.49”. In some embodiments, L3 of the accessory housing 89 can be between about 1.0” and about 1.24”. In some embodiments, the length of the accessory housing 89 (L3) can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, or 1.7 inches, plus or minus 0.05.

[0070] In some embodiments, the width (W2) of the accessory housing 89 in Figures 14A-14B is about 1.79”. In some embodiments, W2 of the accessory housing 89 can be between about 0.50” and about 3.08”. In some embodiments, W2 of the accessory housing 89 can be between about 0.75” and about 2.83”. In some embodiments, W2 of the accessory housing 89 can be between about 1.0” and about 2.58”. In some embodiments, W2 of the accessory housing 89 can be between about 1.25” and about 2.33”. In some embodiments, W2 of the accessory housing 89 can be between about 1.5” and about 2.08”. In some embodiments, W2 of the accessory housing 89 can be between about 1.75” and about 1.83”. In some embodiments, the width (W2) of the accessory housing 89 can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 inches, plus or minus 0.25.

[0071] Figure 15 illustrates the cross-sectional of the fastener 91 of Figures 12A- 12B that can be used as part of a fluid collection apparatus/external catheter device for a male patient. In this example, the length (L4) of the fastener 91 in Figure 15 is about 0.45”. In some embodiments, L4 of the fastener 91 can be between about 0.10” and about 0.8”. In some embodiments, L4 of the fastener 91 can be between about 0.35” and about 0.55”. In some embodiments, the length of the fastener 91 (L4) can be, or about, 0.1, 0.2, 0.3, 0.4, 0.5, or 0.6 inches, plus or minus 0.25.

[0072] In this example, the width (W3) of the fastener 91 in Figure 15 is about 1.13”. In some embodiments, W3 of the fastener 91 can be between about 0.5” and about 1.76”. In some embodiments, W3 of the fastener 91 can be between about 0.75” and about 1.51”. In some embodiments, W3 of the fastener 91 can be between about 1.0” and about 1.26”. In some embodiments, the width (W3) of the fastener 91 can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, or 1.8 inches, plus or minus 0.25.

[0073] These dimensions are examples of some preferred embodiments. In other examples, these dimensions may be different so long as the same utility is achieved. In other examples: the length (L2) of the front housing may be between about 0.5” and about 5”; the width (Wl) of the front housing may be between about 0.5” and about 4”; the length (L3) of the accessory housing may be between about 0.5” and about 3”; the width (W2) of the accessory housing may be between about 0.5” and about 3”; and the width (W3) of the fastener is between about 0.5” and about 2”, and the length (L4) of the fastener is between about 0.3” and about 1.5”. [0074] In other examples, Figures 16A-18 illustrate examples of certain dimensions of a front housing 22, accessory housing 89, and a fastener 91 that can be used in an external catheter device for an infant patient or a female patient.

[0075] Figures 17A-17B illustrate the cross-sectional of the accessory housing 89 of a fluid collection apparatus that can be used in an external catheter device for an infant patient or a female patient. In these examples, the width (W4) of the accessory housing 89 of a fluid collection apparatus that can be used in an external catheter device for an infant patient, or a female patient is about 1.55”. In some embodiments, W4 of the accessory housing 89 can be between about 0.5” and about 2.6”. In some embodiments, W4 of the accessory housing 89 can be between about 0.75” and about 2.35”. In some embodiments, W4 of the accessory housing 89 can be between about 1.0” and about 2.1”. In some embodiments, W4 of the accessory housing 89 can be between about 1.25” and about 1.85”. In some embodiments, W2 of the accessory housing 89 can be between about 1.5” and about 1.6”. In some embodiments, the width (W4) of the accessory housing 89 can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, or 2.6 inches, plus or minus 0.25.

[0076] Figure 18 illustrates the cross-sectional of the fastener 91 of Figures 12A- 12B. In this example, the length (L4) of the fastener 91 is about 0.45”. In some embodiments, L4 of the fastener 91 can be between about 0.10” and about 0.8”. In some embodiments, L4 of the fastener 91 can be between about 0.35” and about 0.55”. In some embodiments, the length (L4) of the fastener 91 can be, or about, 0.1, 0.2, 0.3, 0.4, 0.5, or 0.6 inches, plus or minus 0.25.

[0077] In this example, the width (W5) of the fastener 91 in Figure 18 is about 1.01”. In some embodiments, W5 of the fastener 91 can be between about 0.5” and about 1.52”. In some embodiments, W5 of the fastener 91 can be between about 0.75” and about 1.27”. In some embodiments, W5 of the fastener 91 can be between about 1.0” and about 1.02”. In some embodiments, the width (W5) of the fastener 91 can be, or about, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, or 1.6 inches, plus or minus 0.25.

[0078] The foregoing description details certain embodiments of the systems, devices, and methods disclosed herein. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems, devices, and methods can be practiced in many ways. In this description, embodiments are described as a plurality of individual parts, and methods as a plurality of individual steps and this is solely for the sake of illustration. Accordingly, it is contemplated that some additional parts or steps may be added, some parts or steps may be changed or omitted, and the order of the parts or steps may be re-arranged while maintaining the sense and understanding of the apparatus and methods as claimed.

[0079] As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the technology with which that terminology is associated. Conditional language such as, among others, “can,” “could,” “might” or “may,” unless specifically stated otherwise, are otherwise understood within the context as used in general to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or arc to be performed in any particular embodiment.

[0080] Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.

[0081] Disjunctive language such as the phrase “at least one of X, Y, or Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and/or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.

[0082] The phrase “based on” does not mean “based only on,” unless expressly specified otherwise. In other words, the phrase “based on” describes both “based only on” and “based at least on.” Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices.

[0083] It will be appreciated by those skilled in the art that various modifications and changes may be made without departing from the scope of the described technology. Such modifications and changes are intended to fall within the scope of the embodiments. It will also be appreciated by those of skill in the art that parts included in one embodiment arc interchangeable with other embodiments; one or more parts from a depicted embodiment can be included with other depicted embodiments in any combination. For example, any of the various components described herein and/or depicted in the figures may be combined, interchanged or excluded from other embodiments.

[0084] The above description also discloses methods and materials of the present application. The devices and methods of a fluid collection apparatus described herein may be susceptible to modifications in the methods and materials, as well as alterations in the fabrication methods and equipment. Such modifications will become apparent to those skilled in the ail from a consideration of this disclosure or practice of the invention disclosed herein. Consequently, it is not intended that this invention be limited to the specific embodiments disclosed herein, but that it covers all modifications and alternatives coming within the true scope and spirit of the invention as embodied in the attached claims. Applicant reserves the right to submit claims directed to combinations and sub-combinations of the disclosed inventions that are believed to be novel and non-obvious. Inventions embodied in other combinations and sub-combinations of features, functions, elements and/or properties may be claimed through amendment of those claims or presentation of new claims in the present application or in a related application. Such amended or new claims, whether they are directed to the same invention or a different invention and whether they are different, broader, narrower, or equal in scope to the original claims, are to be considered within the subject matter of the inventions described herein.

Example Embodiments

[0085] Embodiment I. A fluid collector apparatus comprising an accessory housing having a communication channel, the accessory housing configured to be releasably coupled to a vented housing and configured to be coupled to a proximal end of a collection tube to couple the collection tube to the vented housing.

[0086] Embodiment 2. The fluid collection apparatus of claim 1, wherein the accessory housing includes a first cavity configured to receive the proximal end of the collection tube therein. [0087] Embodiment 3. The fluid collection apparatus of claim 2, wherein the accessory housing includes a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein the third cavity is configured to receive a portion of the vented housing therein.

[0088] Embodiment 4. The fluid collection apparatus of claim 2, wherein the accessory housing includes a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein vented housing is configured to receive a portion of the accessory housing therein such that the third cavity is adjacent to a cavity for receiving urine in the vented housing.

[0089] Embodiment 5. The fluid collection apparatus of either claim 2 or claim 3, further comprising a fastener having a proximal end and a distal end, wherein the proximal end of the fastener is structured to fit into the second cavity for coupling the fastener to the accessory housing, and the distal end of the fastener is structured to fit into a cavity of the proximal end of the collection tube when the collection tube is positioned in the first cavity of the accessory housing such that a portion of the proximal end of the collection tube is between the distal end of the fastener and an interior surface of the accessory housing.

[0090] Embodiment 6. The fluid collection apparatus of claim 2, further comprising a fastener having a proximal end and a distal end, wherein the proximal end of the fastener is structured to fit into the second cavity for coupling the fastener to the accessory housing.

[0091] Embodiment 7. The fluid collection apparatus of claim 6, wherein the distal end of the fastener has a cross-sectional diameter that is larger than a cross-sectional diameter of the proximal end of the fastener.

[0092] Embodiment 8. The fluid collection apparatus of claim 6, wherein the proximal end of the fastener is flange-shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the proximal end of the fastener.

[0093] Embodiment 9. The fluid collection apparatus of claim 6, wherein the distal end of the fastener is flange-shaped, the fastener having a waist that has a smaller cross- sectional diameter than a cross-sectional diameter of the distal end of the fastener.

[0094] Embodiment 10. The fluid collection apparatus of claim 1, wherein the accessory housing has a distal end that couples to the collection tube. [0095] Embodiment 11. The fluid collection apparatus of claim 10, wherein the accessory housing has a proximal end that couples to the vented housing.

[0096] Embodiment 12. The fluid collection apparatus of claim 11, wherein the distal end of the accessory housing has a greater cross-sectional diameter than the proximal end of the accessory housing.

[0097] Embodiment 13. The fluid collection apparatus of claim 1, wherein the vented housing includes a proximal end and a distal end, the housing having a first aperture on the proximal end and a second aperture on the distal end, and wherein the fluid collection apparatus further includes a baseplate positioned inside the vented housing, the baseplate having a distal side,

[0098] a proximal side opposite the distal side, a circumferential side surface between the distal side and the proximal side, a main aperture extending through a portion of the baseplate, and a valve aperture extending through a portion of the baseplate; a discharge tube having a distal end and a proximal end, the proximal end extending into the vented housing through the second aperture and coupled to the baseplate; and a valve positioned in the vented housing and mounted in the valve aperture, the valve configured to allow air to flow from inside of the vented housing through the valve and into an interior volume defined in part by the proximal side of the baseplate.

[0099] Embodiment 14. The fluid collection apparatus of claim 13, further comprising a sealing material positioned between the side surface of the baseplate and an inside surface of the vented housing.

[0100] Embodiment 15. The apparatus of claim 13, wherein the valve is configured to allow air to flow from inside of the vented housing through the valve and into an interior volume of a front housing, the interior volume in communication with the collection tube cavity when the pressure differential between the air pressure in the rear housing and the air pressure in the interior volume is above a certain level such that suction is maintained in the collection tube.

[0101] Embodiment 16. The apparatus of claim 13, wherein the baseplate circumference is circular-shaped.

[0102] Embodiment 17. The apparatus of claim 13, wherein the main aperture is in a center portion of the baseplate. [0103] Embodiment 18. The apparatus of claim 13, wherein the proximal end of the discharge tube extends into the main aperture and at least partially through the baseplate.

[0104] Embodiment 19. The apparatus of claim 18, further comprising an O-ring positioned around the proximal end of the discharge tube coupling the discharge tube to the distal side of the baseplate.

[0105] Embodiment 20. The apparatus of claim 13, further comprising a sensor positioned in a chamber of the housing, the sensor configured to transmit a signal, indicative of fluid in the housing, to a processing system.

[0106] Embodiment 21. The apparatus of claim 20, wherein the sensor is configured to detect moisture, sugar, blood, sodium chloride, protein, or calcium.

Claims

WHAT IS CLAIMED IS:

1. A fluid collector apparatus comprising an accessory housing having a communication channel, the accessory housing configured to be releasably coupled to a vented housing and configured to be coupled to a proximal end of a collection tube to couple the collection tube to the vented housing.

2. The fluid collection apparatus of claim 1, wherein the accessory housing includes a first cavity configured to receive the proximal end of the collection tube therein.

3. The fluid collection apparatus of claim 2, wherein the accessory housing includes a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein the third cavity is configured to receive a portion of the vented housing therein.

4. The fluid collection apparatus of claim 2, wherein the accessory housing includes a second cavity and a third cavity, the second cavity positioned between the first cavity and the second cavity, wherein vented housing is configured to receive a portion of the accessory housing therein such that the third cavity is adjacent to a cavity for receiving urine in the vented housing.

5. The fluid collection apparatus of either claim 2 or claim 3, further comprising a fastener having a proximal end and a distal end, wherein the proximal end of the fastener is structured to fit into the second cavity for coupling the fastener to the accessory housing, and the distal end of the fastener is structured to fit into a cavity of the proximal end of the collection tube when the collection tube is positioned in the first cavity of the accessory housing such that a portion of the proximal end of the collection tube is between the distal end of the fastener and an interior surface of the accessory housing.

6. The fluid collection apparatus of claim 2, further comprising a fastener having a proximal end and a distal end, wherein the proximal end of the fastener is structured to fit into the second cavity for coupling the fastener to the accessory housing.

7. The fluid collection apparatus of claim 6, wherein the distal end of the fastener has a cross-sectional diameter that is larger than a cross-sectional diameter of the proximal end of the fastener.

8. The fluid collection apparatus of claim 6, wherein the proximal end of the fastener is flange- shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the proximal end of the fastener.

9. The fluid collection apparatus of claim 6, wherein the distal end of the fastener is flange- shaped, the fastener having a waist that has a smaller cross-sectional diameter than a cross-sectional diameter of the distal end of the fastener.

10. The fluid collection apparatus of claim 1, wherein the accessory housing has a distal end that couples to the collection tube.

11. The fluid collection apparatus of claim 10, wherein the accessory housing has a proximal end that couples to the vented housing.

12. The fluid collection apparatus of claim 11, wherein the distal end of the accessory housing has a greater cross-sectional diameter than the proximal end of the accessory housing.

13. The fluid collection apparatus of claim 1, wherein the vented housing includes a proximal end and a distal end, the housing having a first aperture on the proximal end and a second aperture on the distal end, and wherein the fluid collection apparatus further includes: a baseplate positioned inside the vented housing, the baseplate having a distal side, a proximal side opposite the distal side, a circumferential side surface between the distal side and the proximal side, a main aperture extending through a portion of the baseplate, and a valve aperture extending through a portion of the baseplate; a discharge tube having a distal end and a proximal end, the proximal end extending into the vented housing through the second aperture and coupled to the baseplate; and a valve positioned in the vented housing and mounted in the valve aperture, the valve configured to allow air to flow from inside of the vented housing through the valve and into an interior volume defined in part by the proximal side of the baseplate.

14. The fluid collection apparatus of claim 13, further comprising a sealing material positioned between the side surface of the baseplate and an inside surface of the vented housing.

15. The apparatus of claim 13, wherein the valve is configured to allow air to flow from inside of the vented housing through the valve and into an interior volume of a front housing, the interior volume in communication with the collection tube cavity when the pressure differential between the air pressure in the rear housing and the air pressure in the interior volume is above a certain level such that suction is maintained in the collection tube.

16. The apparatus of claim 13, wherein the baseplate circumference is circular-shaped.

17. The apparatus of claim 13, wherein the main aperture is in a center portion of the baseplate.

18. The apparatus of claim 13, wherein the proximal end of the discharge tube extends into the main aperture and at least partially through the baseplate.

19. The apparatus of claim 18, further comprising an O-ring positioned around the proximal end of the discharge tube coupling the discharge tube to the distal side of the baseplate.

20. The apparatus of claim 13, further comprising a sensor positioned in a chamber of the housing, the sensor configured to transmit a signal, indicative of fluid in the housing, to a processing system.

21. The apparatus of claim 20, wherein the sensor is configured to detect moisture, sugar, blood, sodium chloride, protein, or calcium.