Ostomy Output Transfer System

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority of Provisional Patent Application 63/672,300, filed on Jul. 17, 2024. The disclosure of this priority application is incorporated by reference herein, for all purposes.

BACKGROUND OF THE INVENTION

Ostomates need to empty their ostomy bag quite frequently. Many people choose to empty it into a toilet. This typically requires kneeling or crouching in front of the toilet, which can be physically uncomfortable or difficult (e.g., for people with mobility issues or back pain), and un-sanitary.

SUMMARY OF THE INVENTION

The invention solves these problems with a system that is configured to hold a funnel over the open toilet bowl. The funnel has a drain that extends into or close to the bowl. The funnel is designed such that it can be coupled to a source of running water such as a nearby sink or the toilet water input. The water runs down along the interior of the funnel, to wash the waste down and out of the funnel and into the toilet.

The funnel can be held in its operative position by a support or stand so that it doesn't need to be held or even touched by the ostomate. The support can be coupled directly to the toilet, or it can be free-standing on, or coupled directly to, the floor near the toilet, or it can be supported on a wall or another structure that is close to the toilet. The water inlet can be a flexible hose with an end fitting that allows it to be fluidly coupled to a nearby faucet (e.g., a bathroom sink faucet) or it can be fluidly coupled to the water inlet of the toilet.

There are many funnel designs that can accomplish the desired flow of water down the interior of the funnel. For example, the funnel could have interior and exterior walls that are at least partially spaced apart to hold the water in the opening or channel defined between the walls. The channel has an outlet at the top of the interior wall. Water flows through the channel, over the lip at the outlet, down the interior wall(s) of the funnel and out and into the toilet. Waste emptied into the funnel is carried out by the water. A valve can be included to control the water flow. There can also be a second smaller hose with a spray feature that can be used to clean the funnel, the ostomy bag, or anything else nearby. The water flow in the cleaning/spray hose can also be controlled by a valve. The spray hose can be held in place using a clip coupled to the funnel.

This disclosure in some examples features an ostomy output transfer system which in its most basic example includes a support structure configured to mount to a toilet or stand or be mounted on the floor, a wall, or another structure near a toilet. There is a funnel held by the support structure, where the funnel has an interior wall. A water source conveys water into the funnel such that the water runs down the interior wall of the funnel There is a drain from the funnel that is configured to be positioned by the support structure over the bowl of the toilet, to drain ostomy bag contents and water from the funnel into the toilet.

In some examples the support structure comprises a support arm that carries the funnel on its distal end. In an example the support arm is pivotably coupled to the toilet (or to a wall or to the floor) such that its distal end can be repositioned relative to the toilet, such that it is over the toilet bowl, or not. In an example the drain comprises a drain hose configured to be coupled to the funnel outlet.

In some examples the funnel has an exterior wall that is at least partially spaced from the interior wall, to define a channel that is configured to carry the water. In an example the water is conveyed into the channel of the funnel. In an example the water is conveyed into the lower portion of the channel. In an example the channel comprises raised features to cause the water to swirl as it passes through the channel and into the funnel. In an example the funnel comprises a channel outlet proximate the open top of the funnel, to convey water onto the funnel interior wall at or near the top of the interior wall.

In some examples the water source comprises an inlet hose that is configured to be fluidly coupled to a faucet (e.g., the faucet of a nearby sink) or to the toilet water inlet. In an example the ostomy output transfer system also includes a cleaning spray hose fluidly coupled to the inlet hose, to allow the user to spray down at least the interior of the funnel. In an example the ostomy output transfer system also has a user-operable valve that is operable to direct inlet water to the funnel or to the spray hose. In an example the ostomy output transfer system also has a clip at the top of the funnel for removably holding the spray hose. In an example there is also a middle support structure or housing near the bottom of the funnel, and the inlet water enters the funnel through the middle housing.

In some examples the support structure comprises a structure that is configured to be mounted to a wall proximate the toilet. In some examples the support structure comprises a structure that is configured to be mounted to a floor proximate the toilet. In some examples the support structure comprises a structure that is configured to be mounted to the toilet.

BRIEF DESCRIPTION OF DRAWINGS

One non-limiting exemplary embodiment of the ostomy output transfer system is shown in FIGS. 1-4.

FIG. 1 includes a top perspective view of the system,

FIG. 2 is an exploded view of the system,

FIG. 3 is a front view of the system in place over a toilet and ready for use,

FIG. 4 is a view like FIG. 3 and illustrating an ostomy pouch ready to be emptied into the funnel

FIG. 5A is a front view of a particular design of the funnel,

FIG. 5B is a cross-sectional view taken along line A-A of FIG. 5A,

FIG. 5C illustrates interior hidden features of the funnel of FIGS. 5A and 5B in phantom,

FIG. 6 is a view similar to FIG. 1 illustrating a different (wall) mounting option,

FIG. 7 is a view similar to FIG. 1 illustrating another different (floor) mounting option.

DETAILED DESCRIPTION OF THE INVENTION

Following is a list of at least some of the part numbers in the drawings.

FIGS. 1-4:

• • 10—Ostomy Output Transfer System
  • 11—support structure
  • 12—Funnel
  • 13—body of support structure
  • 14—Middle Housing/support structure
  • 15—hinge/pivot pin
  • 16—Support Arm
  • 17—hinge/pivot pin retaining nut
  • 18—Drain Hose
  • 19—support arm receiving structure
  • 20—Water Valve
  • 21—Pipe Fitting
  • 22—Cleaning/Spray Hose
  • 23—end of support arm receiving structure
  • 24—Spray Mechanism
  • 26—Water Inlet Hose
  • 27—clip
  • 28—Pipe Connector
  • 30—Pipe Connector
  • 32—Ostomy Bag
  • 34—Pipe Fitting Receiving Port
  • 44—sink faucet
  • 45—funnel support structure
  • 100—toilet
  • 102—toilet bowl
  • 104—toilet tank

FIGS. 5A-5C:

• • 12—Funnel
  • 52—Funnel Lip
  • 54—Interior Channel
  • 56—Interior Wall
  • 58—Exterior Wall
  • 60—Holes in Funnel Lip
  • 62—funnel exit opening
  • 64—Funnel Top Opening
  • 66—Internal Raised Swirl

FIG. 6:

• • 10a—Ostomy Output Transfer System version 2
  • 110—wall mount structure
  • 112—support structure receiving structure
  • 114—wall interface plate (to be mounted to a wall)

FIG. 7:

• • 10b—Ostomy Output Transfer System version 3
  • 120—floor mount structure
  • 122—support structure stand
  • 124—floor interface structure

Ostomy Output Transfer System 10, FIGS. 1-4, includes support structure 11 that is configured to hold funnel 12. Funnel 12 does not require any particular shape as long as it has a top waste inlet opening and a lower exit opening. Support structure 11 includes body 13 and support arm receiving structure 19 that receives end 23 of support arm 16 such that arm 16 can pivot relative to structure 11 via pivot/hinge pin 15 and retaining nut 17.

Funnel 12 is removably held or supported by funnel support structure 45 located at the distal end of arm 16, such that funnel 12 can be positioned relative to the toilet bowl. Middle housing/support structure 14 of funnel 12 is large enough to sit on or clip into funnel support structure 45. Drain tube or pipe 18 can be removably fluidly connected to the outlet opening of funnel 12, to direct water and waste into the toilet bowl.

Water is provided such that it flows down the interior of the funnel. Water is provided via hose 26 that can be fluidly coupled to a water source (such as bathroom sink faucet 44, FIG. 3). Valve 20 can be operated to direct water to the funnel via pipe fitting receiving port 34, or to spray hose 22 via pipe connector 28. Spray mechanism 24 can be carried at the end of spray hose 22, and can be held in place on the funnel via clip 27.

Ostomy bag 32, FIG. 4, can be emptied into funnel 12, and the contents washed down the funnel and into the toilet bowl. When the user has finished emptying (and cleaning) the bag, optionally funnel and/or tube 18 can be removed and arm 16 can be pivoted away from the toilet bowl, to leave the toilet open for other uses.

One non-limiting example of a funnel design is shown in FIGS. 5A-5C. Funnel 12 includes top opening 64, lip 52, holes 60 in the lip, and funnel exit opening 62. Interior wall 56 is spaced from exterior wall 58 to define an intermediate space or channel 54 through which water can flow. Raised curved features or swirls 66 (FIG. 5C) can be included to impart a swirling motion to the water as it flows through the channel, so that is swirls down the interior wall and so may better wash down the wall.

FIG. 6 is a view similar to FIG. 1 illustrating a different (wall) mounting option, where Ostomy Output Transfer System version 2, 10a, is configured to be mounted to a wall close to the toilet, using wall mount structure 110 with support structure receiving structure 112 and wall interface plate 114 (to be mounted to a wall). Support structure 13 is pivotable couple to structure 112, as shown.

FIG. 7 is a view similar to FIG. 1 illustrating another different (floor) mounting option, where Ostomy Output Transfer System version 3 (10b) includes floor mount structure 120 configured to be mounted to or to free-stand on the floor near the toilet. Support structure stand 122 holds support structure 13 and is supported by floor interface structure 124 that is configured to be bolted or attached to, or simply stand on, the floor.

Following includes further descriptions of aspects of the subject ostomy output transfer system (also called herein the “OsmoFlo”™ device). These include: OsmoFlo Instructions for Use (IFU); Mounting Options for OsmoFlo Support Arm: OsmoFlo Alternative Design & Manufacturing Options; and Alternative Design & Manufacturing Options. The following describe non-limiting details of some embodiments, such as materials, manufacturing approaches, and different mounts/stands.

OsmoFlo Instructions for Use (IFU): Objective: To provide ostomates with clear, step-by-step instructions on how to use the OsmoFlo device for safe, hygienic, and efficient emptying and cleaning of their ostomy pouch.

Before You Begin:

• • 1. Familiarize Yourself: Read this entire IFU carefully before using the OsmoFlo device for the first time.
  • 2. Preparation: Ensure the OsmoFlo device is properly assembled and securely mounted beside the toilet tank (see separate Mounting Instructions).
  • 3. Hygiene: Wash your hands thoroughly with soap and water.
  • 4. Supplies: Gather any necessary supplies, such as toilet paper or wipes.

Using the OsmoFlo Device:

1. Positioning:

• • Gently slide the OsmoFlo device from its resting position beside the toilet tank.
  • Position the device over the toilet bowl, ensuring it is stable and secure.
  • If needed, adjust the height or angle of the device using the adjustment mechanisms (refer to the Mounting Instructions for details).

2. User Positioning:

• • Sit or stand comfortably beside the toilet, facing the OsmoFlo device.
  • Ensure you have easy access to the device's opening and the cleaning hose.

3. Activate Water Flow:

• • Locate Water Control: Find the designated button, lever, or valve that controls the water flow to the OsmoFlo device.
  • Turn On Water: Activate the water control to initiate a gentle stream of water into the device.
  • Adjust Flow (if applicable): If your OsmoFlo model allows, adjust the water flow rate to your preference.

4. Emptying the Pouch:

• • Open the Pouch: Carefully open the end of your ostomy pouch as you normally would.
  • Direct the Output: Hold the open end of the pouch over the funnel-shaped opening at the top of the OsmoFlo device.
  • Empty: Allow the ostomy output to flow into the OsmoFlo device. The device will guide the output directly into the toilet bowl.
  • Complete Emptying: Ensure all output has emptied from the pouch. Gently squeeze or massage the pouch if necessary.

5. Cleaning:

• • Rinse the Pouch: Pick up the cleaning hose (attached to the OsmoFlo device) and direct a gentle stream of water into the opening of the ostomy pouch.
  • Thorough Cleaning: Rinse the inside of the pouch thoroughly, ensuring all residue is removed.
  • Clean the Device: If any ostomy output has splattered onto the OsmoFlo device, use the cleaning hose to rinse it off as well.

6. Finishing Up:

• • Close the Pouch: Securely close the end of your ostomy pouch as you normally would.
  • Return the Device: Gently slide the OsmoFlo device back to its resting position beside the toilet tank.
  • Hygiene: Wash your hands thoroughly with soap and water.

Important Safety Information:

• • Intended Use: The OsmoFlo device is intended for single-person use only.
  • Cleaning: Clean the OsmoFlo device after each use with a mild detergent and water. Do not use harsh chemicals or abrasive cleaners.
  • Maintenance: Refer to the separate Maintenance Instructions for details on how to maintain and care for your OsmoFlo device.
  • Warnings:
    • Do not use the OsmoFlo device if it is damaged or malfunctioning.
    • If you experience any discomfort or irritation while using the device, discontinue use and consult your healthcare provider.

Troubleshooting:

• • If the device does not drain properly:
    • Check for any clogs or obstructions in the funnel or tubing.
    • Ensure the device is properly positioned over the toilet bowl.
  • If you experience leaks:
    • Make sure all connections are tight and secure.
  • If you experience odor:
    • Ensure the odor control mechanism (e.g., charcoal filter) is properly installed and functioning.
    • Replace the odor control component if necessary (refer to the Maintenance Instructions).
      By following these detailed instructions, you can safely and effectively use the OsmoFlo device to manage your ostomy care routine. If you have any questions or concerns, please consult your healthcare provider.

Mounting Options for OsmoFlo Support Arm. Objective: To provide a secure and stable mounting solution for the OsmoFlo device that is compatible with a wide range of standard toilets, leveraging existing toilet bolts for ease of installation and minimal modification to the bathroom environment.

Option 1: Toilet Tank Bolt Attachment

• • 1. Identification: Locate the two bolts that secure the toilet tank to the toilet bowl. These are typically located at the rear of the tank, near the base.
  • 2. Assessment: Ensure that the existing bolts have sufficient excess length protruding beyond the nut that secures the tank. The support arm attachment will require approximately 1-2 inches of excess thread.
  • 3. Preparation: If necessary, loosen the tank bolts slightly to create enough space to accommodate the support arm bracket.
  • 4. Bracket Installation: The OsmoFlo support arm will include a specially designed bracket with a hole. Slide the bracket onto the excess bolt thread and align it with the desired position for the support arm.
  • 5. Secure Bracket: Use a nut (provided with the OsmoFlo kit) to securely tighten the bracket onto the bolt. Ensure the bracket is firmly in place and does not wobble.
  • 6. Arm Attachment: Attach the OsmoFlo support arm to the bracket using the provided screws or fasteners.

Option 2: Toilet Base Bolt Attachment

• • 1. Identification: Locate the two bolts that secure the toilet to the floor. These are usually concealed by plastic caps, which can be easily removed.
  • 2. Assessment: Similar to Option 1, ensure there is sufficient excess thread length on the base bolts.
  • 3. Preparation: If needed, slightly loosen the base bolts to create space for the support arm bracket.
  • 4. Bracket Installation: Slide the bracket (same as in Option 1) onto the excess bolt thread and align it with the desired position for the support arm.
  • 5. Secure Bracket: Tighten the nut onto the bolt, ensuring the bracket is secure and stable.
  • 6. Arm Attachment: Attach the OsmoFlo support arm to the bracket.

Important Considerations:

• • Bolt Compatibility: Ensure the hole in the support arm bracket is compatible with the thread size of the existing toilet bolts (typically ¼ inch or 5/16 inch).
  • Weight Capacity: Design the support arm and bracket with sufficient strength and stability to support the weight of the OsmoFlo device when filled with waste.
  • Tool-Free Installation: If possible, design the bracket and arm attachment mechanism to allow for tool-free installation, making it easier for users and caregivers to set up the device.
  • Adjustability: Incorporate adjustability into the support arm design to accommodate different toilet heights and user preferences.

Additional Notes:

• • The proposed mounting mechanism leverages existing standard hardware found in most toilets, minimizing the need for modifications to the bathroom.
  • The design can be adapted to fit various bolt sizes and configurations.
  • This mounting approach is intended to be simple, secure, and user-friendly.
    Conclusion: The OsmoFlo support arm can be mounted using either the toilet tank bolts or the toilet base bolts. Both options involve identifying the bolts, assessing the excess thread length, preparing the area if needed, installing the bracket onto the excess bolt thread, securing the bracket with a nut, and attaching the support arm to the bracket.

OsmoFlo: Alternative Design & Manufacturing Options. Introduction: The OsmoFlo Ostomy Management System presents a novel approach to ostomy care, and its design and production offer various avenues for innovation and optimization. This document outlines a range of alternative approaches for consideration, highlighting their potential benefits and drawbacks.

Design Options

1. Freestanding Design:

• • Instead of mounting directly to a toilet, the OsmoFlo could be freestanding with a base or stand. This increases placement flexibility and eliminates the need for toilet compatibility.

2. Multiple Water Source Connections:

• • Offer adapters for both toilet water lines (using a T/Y connector) and faucets (with threaded or snap-on connectors) to accommodate different bathroom setups.

Development Options

1. Modular System:

• • Develop a base model with core functionality and offer modular additions for customization (e.g., two-piece tray with magnetic connectors, enhanced odor control filters).

2. Waterless System:

• • Explore a version that utilizes only superhydrophobic coatings for waste repulsion, eliminating the need for a water source. This would increase portability but might require more frequent cleaning.

Manufacturing Options

• • Core Components:
    • Housing: Injection molding (high volume, precision), thermoforming (larger parts, cost-effective), or casting (for complex geometries or specific materials).
    • Valves: Injection molding (high volume, precision), CNC machining (lower volumes, complex geometries), or casting (for complex internal structures or specific materials).
    • Connectors: Primarily injection molding for precision and consistency.
    • Clips/Fasteners: Injection molding for cost-effectiveness and high volumes.
    • Tubing/Seals/Gaskets: Extrusion is the most efficient method for producing continuous profiles.
  • Alternative Manufacturing:
    • 3D Printing: Suitable for low-volume production, custom-fit components, and rapid prototyping (testing different materials quickly).

Material Options

• • Skin-Contact Layer:
    • Platinum-Cured Silicone: Highest biocompatibility, but more expensive.
    • TPEs: Good balance of flexibility, biocompatibility, and cost.
  • Structural Components:
    • Thermoset Polyurethane: Excellent durability, but less flexible.
    • Polypropylene: Cost-effective and offers good chemical resistance.
  • Tubing/Catheters:
    • TPU: Highly flexible and biocompatible.
    • Medical-Grade Polymers: Consider other options like PVC or silicone depending on specific requirements.
  • Seals/Gaskets:
    • Silicones: Excellent for sealing and chemical resistance.
    • TPEs: Can be formulated for specific sealing applications.

Hydrophobic Coating Options:

• • Fluoropolymers (e.g., Teflon): High performance, but may be costly. Best for internal components.
  • Nano-Coatings: Consider for antimicrobial properties on internal or external surfaces.
  • Plasma Treatments: Suitable for simpler geometries and external components.
  • Silicone-Based Coatings: A cost-effective option for internal components where moderate hydrophobicity is sufficient.

Advanced Technology Options:

• • Sensor Integration: Output volume, leak detection, or stoma health sensors.
  • Wireless Connectivity: Data transmission to mobile apps for tracking and analysis.
  • Automated Features: Motion sensors, servos for automated movements, temperature control.
  • Mobile App Integration: User profiles, distance detection, personalized settings.
    Conclusion: This document presents a range of options to explore in the development of the OsmoFlo device. The final choices will depend on a careful balance of factors like cost, performance, regulatory requirements, and user preferences. By considering these alternatives, HygieneStream can further refine the OsmoFlo design and manufacturing approach to create a product that best serves the needs of ostomates.

Alternative Design & Manufacturing Options:

Alternative Design Options:

Freestanding Design:

Instead of mounting directly to a toilet, the system could be freestanding with a base or stand.

Multiple Water Source Connections:

Offer adapters for both toilet water lines (using a T/Y connector) and faucets (with threaded or snap-on connectors).

Modular Additions for Base Model;

• • 1. Two-piece tray
    • a. Rubber edging
    • b. Magnets to hold the tray pieces together
  • 2. Cleaning hose with Spray mechanism

Sold Separately;

• • 1. Deodorizing and neutralizing charcoal ring

Variations;

• • 1. Waterless Ostomy Output Transfer System using more resilient hydrophobic coatings.
  • 2. Ostomy Output Transfer System Kids is a significantly smaller replica of the original Ostomy Output Transfer System roughly 50% smaller for the Funnel, Drain hose, Support arm and Cleaning hose.
  • 3. Simplistic portable Ostomy Output Transfer System on a belt with a pocket for wipes and a pocket for a small water bottle.
  • 4. Advanced portable Ostomy Output Transfer System on a belt with a pocket for wipes and a hose with a rubber end to connect to a faucet, or the end of the hose can be a pipe fitting that attaches to the threads on the opening of a faucet.
  • 5. Ostomy Output Disposal System is a replica of the Ostomy Output Transfer System with the main difference being a receptacle replaces the drain hose and a one-way valve to prevent odors from escaping, allowing for multiple emptyings without the need of direct access to a toilet for output disposal.
  • 6. Advanced versions with the ability to analyze, monitor, detect, capture data for pattern recognition and prediction, integration to IoT, provide data to medical professionals and patients. Possible analysis of;
    • a. Novel Chemicals
    • b. Quantity
    • c. Viscosity
    • d. Spectroscopy
  • 7. Automated systems
    • a. Motion sensor (wave it out/away)
    • b. Servos for movement
    • c. Temperature control
    • a. Integrate with mobile device application to include, but not limited to, user profiles, distance detection, save preferred placement, water temperature etc.

Alternative Manufacturing Options:

• • Injection Molding
  • CNC Machining
  • 3D Printing
  • Thermoforming
  • Casting
  • Extrusion

Ostomy Output Transfer System Parts and Manufacturing Options:

• • Housing: Injection Molding, Thermoforming, Casting
  • Valves: Injection Molding, CNC Machining, Casting
  • Connectors: Injection Molding
  • Clips/Fasteners: Injection Molding
  • Metal Parts: CNC Machining, Casting
  • Complex Geometries: CNC Machining, 3D Printing.
  • Low-Volume Parts: CNC Machining, 3D Printing
  • Custom-Fit Components: 3D Printing.
  • Housing Covers: Thermoforming
  • Trays or Reservoirs: Thermoforming
  • Certain Cosmetic Parts: Thermoforming
  • Valve Bodies: Casting
  • Tubing: Extrusion
  • Seals and Gaskets: Extrusion
  • Other Profiles: Extrusion

Alternative Material Options:

• • Silicones
    • Platinum-Cured Silicone
    • Peroxide-Cured Silicone
  • Polyurethanes
    • Thermoplastic Polyurethane (TPU)
    • Thermoset Polyurethane
  • Medical-Grade Polymers
    • Polyethylene
    • Polypropylene
    • Copolymers
  • Thermoplastic Elastomers (TPEs)

Alternative Material Options by Part:

• • Skin Contact Layer:
    • Platinum-Cured Silicone:
    • TPE:
  • Structural Components:
    • Thermoset Polyurethane:
    • Polypropylene:
  • Tubing/Catheters:
    • Thermoplastic Polyurethane (TPU):
    • Medical-Grade Polymers:
  • Seals/Gaskets:
    • Silicones:
    • TPE:

Potential Hydrophobic Coating Options:

• • Teflon-like (Fluoropolymers): Internal components
  • Nano-Coatings: Internal or External use, based on antimicrobial needs.
  • Plasma Treatments: External parts and Simpler device geometries.
  • Silicone-Based Coatings: Internal components where moderate hydrophobicity is acceptable.

Other design options are contemplated and are within the scope of the present invention. For example, there are many ways that water could be provided such that it floods the interior of the funnel. For example, the funnel could be solid and there could be a water channel at the top of the channel with openings to release the water (almost like the bowl of a typical porcelain toilet). The openings could be angled holes that released the water at an angle so it swirled down the funnel, to better clean the funnel surface. Or the openings could be configured as small spray heads.

As another alternative, the spray nozzle could be the only source of water to the funnel. For example, the spray nozzle could be held in place by the clip at a location and angle such that it sprayed water onto the funnel. Once the bag had been emptied the nozzle could then be removed from the clip and the user could spray down any parts of the funnel that needed to be cleaned.

Having described above several aspects of at least one example, it is to be appreciated that various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure and are intended to be within the scope of the invention. Accordingly, the foregoing description and drawings are by way of example only, and the scope of the invention should be determined from proper construction of the appended claims, and their equivalents.