Simple sample stool collection, containment, and specimen disbursement system

A stool collection, containment, and specimen disbursement system for facilitating easier stool collection while protecting the samples from bio-contamination and providing easier functionality for patients, diagnostic centers, and labs.

BACKGROUND

Stool collection ordered by physicians for the purposes of a variety of lab tests and assays can be a tedious, messy and possibly lead to bio-contamination of the sample. The sample collection typically requires the patient to defecate into a large plastic collection bowl that sits on top of the toilet bowl. After the primary sample is deposited into the collection bowl, the patient is required to wear plastic gloves and use a tongue depressor to collect measured samples from the collection bowl and distribute these samples into a variety (5-10) of containers and assay tubes dedicated for each test. After distributing the measure samples into the various collection jars and tubes, the patient is then required to refrigerate and/or freeze the samples to limit containment of the samples. This is laborious, distasteful process that often goes uncompleted due to the nature of the collection. Patient compliance suffers as a result and many tests may not be performed as a result. This collection process is typically done at home which further increases patient non-compliance.

Accordingly a need exists to change this dynamic. There is a need for a collection methodology that facilitates easier collection, protect sample from bio-contamination and provide easier functionality for patients, diagnostic centers and labs.

SUMMARY

This need is met by a novel device concept for collection of stool samples for diagnostic testing. It is designed to facilitate easier collection, containment, protection of sample from bio-contamination and to provide easier functionality for patients, diagnostic centers and labs. It includes a variety of features that enable distributing, re-sealing and extracting specific sample quantities.

The need can be met by a stool collection, containment, and specimen disbursement system including at least: a polymeric toilet seat cover that can fit over a variety of toilet seats; an elastic band that secures the toilet seat cover to the toilet seat; a polymeric funnel that extends from the toilet seat cover into the toilet bowl and is connected to the inside of a polymeric collection bag by means of perforated tear lines on either side of the collection bag; an opening in the polymeric funnel large enough to allow urine to bypass the collection bag and flow directly into the toilet bowl; a looped handle connected to the perforated tear lines and used to tear the funnel away from the collection bag; a primary seal with adhesive at the opening of the containment bag with an attached primary pull seal tab that allows the removal of an adhesive cover sheet; a larger secondary seal with adhesive positioned outside of the funnel along the outside of the collection bag with a removable adhesive cover sheet; and a variable flow rate nozzle on one side of the collection bag.

DETAILED DESCRIPTION

Referring toFIG. 1the proposed solution includes a thin polymeric toilet seat cover2to fit a variety of toilet seats. The toilet seat cover2is secured by an elastic band1. The band can be produced from any number of elastomeric polymer or rubber materials. A polymeric funnel4extends from the toilet seat cover and connects to the inside of a polymeric collection bag5. The seat cover extends into the toilet bowl and transitions into the funnel. The seat cover is sufficiently wide and long to cover the toilet seat. It may be made of a light plastic material that is lightweight, biodegradable and strong enough to accommodate the physical demands of the funnel, which can be made of the same material (i.e the funnel being an extension of the toilet seat). The seat cover/funnel may be made of a material that is flushable.

The funnel4is an extension of the seat cover2, which helps funnel the specimen into the collection bag5. It is attached to the inside of collection bag5. It may be made from the same material as the seat cover and be of sufficient strength to hold the collection bag above the water line when full. The collection bag connects to the funnel from the opening on the top edge of the bag. The bag hangs horizontally so as not to reach water level (Average water line is 6″-7″). The collection bag “in-situ” may be approximately 5″-6″ wide and 4″-5″ tall. The collection bag may be constructed out of non-latex, PVC type or similar material similar to IV bags. The plastic should also be sufficiently smooth and/or have a surface conducive to channeling the specimen into the collection bag as smoothly, cleanly and expeditiously as possible. This could include a silicone-type coating. The seat cover/funnel should be made of a material that is flushable if environmentally feasible and appropriate. The opening of the collection bag is large enough to accommodate the funnel4and sample collection: approximately 3″ wide. After use it can be easily sealed by both a primary and secondary seal system as will be explained below. As an alternate a combination of the primary seal tab7and tear line pull handle9might be integrated into one handle to perform both “functions” at the same time. Thereby, separating the funnel from the collection bag and exposing the primary seal with one pull from a single handle.

The proposed stool containment, collection, and specimen disbursement system has multiple layers of sealing capability to facilitate easier collection, protect sample from bio-contamination and provide easier functionality for patients, diagnostic centers and labs. It includes a variety of features that enable distributing, re-sealing and extracting specific sample quantities when and as needed.

A perforated tear line8serves as the primary connection between the funnel4and the collection bag5. This perforated tear line connects funnel4to both inside walls of the collection bag. The tear lines can be also seen inFIG. 2. The perforations should be sufficiently strong to remain intact and keep the collection bag elevated above the water line during and after sample collection; approximately 1.25 lbs max weight. The collection bag connects to the funnel from the opening on the top edge of the bag. The bag hangs horizontally so as not to reach water level (Average water line is 6″-7″). The collection bag is constructed out of non-latex, PVC material similar to IV bags. The collection bag has a re-sealable, variable flow rate nozzle11on one side of the bag. The collection bag “in-situ” should be approximately 5″-6″ wide and 4″-5″ tall. After sample collection, the funnel is separated from the collection bag via a pull handle9, aided by the perforations on the tear line. The pull handle9connected to one side of the tear line8of sufficient strength to separate the funnel from the collection bag5.

A primary adhesive seal with peel off backing seals the opening of the collection bag5after sample collection and funnel removal via tear line handle9. It is secured by the patient to create a primary seal at the top opening of the collection bag in order to prevent leaking or spillage. The primary adhesive seal is exposed via primary seal tab7and sealed after the funnel4has been detached from the collection bag. The adhesive backing should be easily reachable and removable from outside the bag opening using a pull-tab. This tab7connects to one side of the adhesive backing6. The seal should be up to 4″ inches wide by 1″ inch tall which should be sufficient to securely close the entire opening14of the collection bag after funnel removal. The seal is about ½″ longer than the opening on both sides for better adhesion and spill prevention.

The primary seal tab7is a small tab of sufficient size and strength to remove the primary seal backing6from the adhesive strip on the primary seal. The tab should be easily reachable from outside the funnel4and collection bag opening14.

A perforated tear line8serves as the primary connection between the funnel4and the collection bag5. Perforated tear line8should connect the funnel to both inside walls of the collection bag. The perforations should be sufficiently strong to remain intact and keep the collection bag elevated above the water line during and after sample collection; approximately 1.25 lbs max weight. After sample collection, the funnel is separated from the collection bag via a pull handle9, aided by the perforations on the tear line. The pull handle9connected to one side of the tear line8of sufficient strength to separate the funnel from the collection bag5.

The opening14of collection bag5is large enough to accommodate the funnel4and sample collection. It is sealed by both primary6and secondary10adhesive seals.

A funnel urine opening3, shown inFIG. 2has an opening large enough to enable urine to directly flow into the toilet bowl during the specimen collection process and avoid contamination of the stool specimen. The opening will be sufficiently large to accommodate both male and female anatomy.

In use and after sample collection, the patient/user can then lift the complete system from the toilet. The funnel is then separated from the collection bag via a pull handle9. The patient/user can grab pull handle and pull upward with enough force to then separate the entire funnel, including elastic band1and seat cover2. A clean separation is aided by the perforations on the tear line.

Once the polymeric funnel, elastic band, and polymeric seat cover have been removed closing seal6can then quickly complete the primary seal. This is done by the patient pulling on primary pull seal tab7, which strips off the adhesive seal cover sheet, exposing the adhesive layer of the primary seal, and covers the opening into the collection bag to provide the primary seal. The primary seal with adhesive then seals the opening of the collection bag and is secured by the patient to create a primary seal that prevents leaks or spillage. The primary adhesive seal is exposed and sealed after the funnel has been detached from the collection bag. The adhesive backing is easily reachable and removable from outside the bag opening after the funnel has been removed. This could be a looped or flat tab that connects to seal6to enable the adhesive backing to be removed. The seal should be up to 3 inches wide by 1 inch tall which should be sufficient to securely close the entire opening of the collection bag after funnel removal.

Referring back toFIG. 1, the dotted line10designates a larger secondary adhesive seal and label flap that in this side view lies along the outside of collection bag5and is therefore not visible in this drawing. That secondary adhesive seal and label flap also has a peel off backing that when removed exposes the adhesive so that the larger secondary adhesive seal and label flap can be draped over the top of the collection bag to ensure an airtight seal and bio-containment.

The collection bag5may accommodate a label that includes patient information and a list of requested tests and assays. This label area could be on the larger secondary adhesive seal and label flap10. A custom label can be supplied using a pre-populated label template. The label could have check boxes next to each requested test in order to verify completion.

FIG. 1also shows is a re-sealable, variable flow rate nozzle11on one side of collection bag5. The nozzle is re-sealable using a snap cap13and twist-to-open valve with ridges for sure grip. The twist valve also provides variable flow-rate for specimen distribution. The valve can be twisted to close completely and re-capped for storage or use at another time.

The valve extends into collection bag5approximately two inches via a plastic spindle that connects directly to a round edged (non-perforating) fanned tip12. As the nozzle is twisted to open and adjust the flow rate, the inside fanned-tip rotates accordingly. This enables higher flow rates for more dense or hardened samples.

FIG. 3Is a close-up/exploded view of primary seal with adhesive strip being exposed via pull-tab7. As pull-tab7is pulled the perforated funnel is detached along the tear line8from the collection bag via pull-handle. Once the funnel, elastic band, and seat cover have been removed closing the primary seal6can then quickly do the first level of sealing and containment. This is done by the patient (or lab technician) pulling on primary pull seal tab7, which strips off the adhesive seal cover sheet, exposing the adhesive layer of the primary seal6, and covers the opening into the collection bag to provide the primary seal. The primary seal6with adhesive then seals the opening of the collection bag and is secured by the patient to create a primary seal and prevent spillage.

After the primary seal is in place the secondary seal10(with its own adhesive) is then draped over the primary seal to ensure an airtight seal and bio-containment.

Although certain embodiments and their advantages have been described herein in detail, it should be understood that various changes, substitutions and alterations could be made without departing from the coverage as defined by the appended claims. Moreover, the potential applications of the disclosed techniques is not intended to be limited to the particular embodiments of the processes, machines, manufactures, means, methods and steps described herein. As a person of ordinary skill in the art will readily appreciate from this disclosure, other processes, machines, manufactures, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufactures, means, methods or steps.