DEVICE FOR COLLECTION OF EXCESS FLUIDS FROM AN ENDOSCOPE

A device to safely collect any fluid discharged through the biopsy cap into another container without contaminating the surrounding environment. A device that can be attached to an endoscope in order to collect any fluid discharged through an external opening of an endoscope's internal channel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and medical instruments provided for and relating to inspection of internal cavities. Particularly, the present invention relates to endoscopes which can be introduced into a person's body to inspect internal cavities or lumens.

2. Description of the Prior Art

Modern endoscopes typically comprise a flexible tube with one or more internal channels that can be used to inject into or aspirated from the body air or fluids. Small instruments can also be passed into the body through one of these channels. Most modern endoscopes (e.g., side-viewing scopes, gastroscopes, and colonoscopes) feature a combined suction/instrument channel connected by a Y-shape connector internally near the handle portion of the instrument. A soft rubber seal, commonly known as a biopsy cap, is typically placed on top of the instrument insertion opening to maintain a negative pressure within the suction/instrument channel as well as to minimize overspill of fluids through the instrument insertion opening.

U.S. patent application Ser. No. 12/467,726, by Kaye, discloses a device for use with an endoscope. The body defines a vessel for collecting fluid that may otherwise escape through the port or valve of the endoscope.

SUMMARY OF THE INVENTION

Advantages and Differences of Invention Over Known Prior Art

Unfortunately, with current assemblies, the overspill of fluids from the instrument insertion opening through the biopsy cap remains a common occurrence in practice. This is especially common during procedures that require repeated passages of instruments leading to a loss of integrity of the biopsy cap. Additionally, this may also occur during procedures that utilize air insufflations resulting in a positive pressure gradient that forces fluids to escape from the biopsy cap.

As a term of art, ‘overspill of fluids’ is a polite way to describe the occurrence, however, this phrase does not refer to the spilling of water, or other sanitary fluids. Instead, this phrase refers to fluids such as bile, blood, liquid stool, or other bodily secretions. Being spilled during testing, these fluids may understandably contain known or unknown pathogens. As a result, any overspill of fluids is problematic for many reasons beyond the mess that is created by fluid escaping the biopsy cap. During a procedure the risks presented by an overspill of fluids are increased. Specifically, an overspill of fluids at this time not only leads to contamination of the procedure area but also poses significant health risks to the endoscope operator.

Therefore, there exists a need for a device to safely collect any fluid discharged through the biopsy cap into another container without contaminating the surrounding environment. The present invention seeks to address this need and fulfills other goals and objectives as well. One embodiment of the present invention relates to a device that can be attached to an endoscope in order to collect any fluid discharged through an external opening of an endoscope's internal channel.

It is an object of the present invention to provide a fluid container for collecting fluids discharged from an endoscope. The endoscope usually has at least one instrument and at least one instrument channel. The fluid container has a front wall, a rear wall, a bottom wall, and side walls. The front wall, rear wall, bottom wall, and side walls are waterproof and define an interior portion of the fluid container.

The fluid container also has an expandable collection section which is also defined by the front wall, rear wall, bottom wall, and side walls. The expandable collection section is capable of expanding such that the fluid container can alter shape from a first configuration to a second configuration.

The fluid container also has at least two openings. The first opening is provided to facilitate insertion of the at least one instrument into the fluid container. The first opening is usually located on the front wall of the fluid container.

The second opening is provided to facilitate egression of the at least one instrument inserted through the first opening to now exit the fluid container. Because the second opening is adapted to fit over the at least one instrument channel of the endoscope, this enables the second opening to facilitate egression of the at least one instrument into the at least one instrument channel of the endoscope.

It is an object of the present invention to provide the fluid container with walls which are substantially transparent so that the interior portion can be visualized from outside the fluid container.

It is another object of the present invention to provide the fluid container with a marker located around the first opening. This marker should be capable of providing a visual and tactile target to help a user identify the orifice of the first opening.

It is a further object of the present invention to provide the fluid container with a spill-proof seal which can cover the orifice of the first opening to facilitate reduction of overspill of fluids through this first opening.

It is yet another object of the invention to provide the fluid container with a self-adhesive band around the second opening as a means for attaching the apparatus to an endoscope. The fluid container may also have an integrated rubber seal around the second opening to connect the fluid container to the instrument channel on an endoscope. The fluid container may also have a third opening, which permits fluids collected within the fluid container to be removed, the third opening located adjacent the bottom wall of the fluid container.

The fluid container may also have a third opening and a water-tight sealing mechanism, such as a zipper, connected to the third opening. The zipper would be capable of facilitating the third opening in opening and securely closing repeatedly. The fluid container may also have the front wall, rear wall, bottom wall, and side walls made of waterproof materials such as plastic, silicone, rubber, or cellulose.

The present invention achieves these and other objectives by providing a fluid container for collecting fluids discharged from an endoscope. The endoscope has at least one instrument and at least one instrument channel. The fluid container has at least one folded waterproof wall defining an interior portion of the fluid container.

The fluid container has an instrument insertion opening which is adapted to facilitate insertion of the at least one instrument therethrough into the fluid container, the instrument insertion opening which is located on an exterior facing portion of the water-proof wall of the fluid container;

The fluid container has an endoscope attachment aperture which is adapted to be fitted over the at least one instrument channel of the endoscope. The endoscope attachment aperture is adapted to facilitate egression of the at least one instrument, inserted through the first opening, to exit the fluid container and enter the at least one instrument channel of the endoscope.

The fluid container has an expandable collection section which is capable of collecting the fluids discharged from the at least one instrument channel of the endoscope. The fluid container also has a first packing configuration having a first volume, and a second collecting configuration having a second volume. The first volume of the first packing configuration is less than the second volume of the second collecting configuration. The second volume of the second collecting configuration may be at least five times larger than the first volume of the first packing configuration.

DETAILED DESCRIPTION OF THE INVENTION

To promote an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitations of the scope of the invention are thereby intended. Such alterations and further modifications in the illustrated device, and such further applications of the principles of the inventions as illustrated herein being contemplated as would normally occur to one skilled in the art of which the invention relates.

One embodiment of the invention is illustrated inFIG. 1throughFIG. 2. In each of the embodiments discussed, a fluid container20according to the present invention has three main components: a spill-proof instrument insertion opening40, an endoscope attachment aperture60, and a collection section30. As can be seen inFIG. 2, the spill-proof instrument insertion opening40is located on the front wall21of the fluid container20and the endoscope attachment aperture60is located on the back wall22(opposite the front wall21) of the fluid container20. The fluid collection section30is the void defined by the walls of the fluid container20and extends between the front and back walls21,22.

Rather than designing a fluid container20as an immutable shape incapable of adaptable configurations like the prior art, the present invention is capable of at least three configurations. These alternative adapting configurations facilitate easy storage, maneuverability, and portability. Specifically, these configurations enable the fluid container to be collapsible so that the device can be easily stored flat when folded.

In order to easily facilitate folding, storing, and unfolding from a first folded configuration (FIG. 1A) to at least a second use configuration (FIG. 1D), the expandable collection section34has a foldable portion35generally comprised of portions of the side walls23,24, angled side walls27, and the bottom wall26.

Fluid container20can be manufactured from plastic, silicone, or any other flexible and water-proof materials. The thickness of the material may be between 0.25 mm and 5 mm, preferably at least between 0.5 mm and 3 mm, and typically between 0.5 mm and 1 mm.

For clarity, the present invention is depicted in the accompanying drawings as if the material was completely opaque so as to distinguish between elements present in different positions. Ideally however, the material of the fluid container20comprising the front, back, left, right, top and bottom walls21,22,23,24,25,26,27should be clear, semi-transparent, or fully transparent material38so that the amount of fluid content12can be easily visualized from an outside perspective. When transparent material is employed, internal components, such as are visible inFIGS. 1B and 1C, are also fully visible from an external perspective.

Also, while the terms front, side, rear, back and top are used to refer to the water-proof walls of the container20, these terms are used solely for ease of discussion. Indeed, in this embodiment, the walls are entirely integral with one another, formed from a single sheet of thin layer of medical grade plastic sheeting by folding along multiple edges and sealing along two edges.

Fluid Collection Sections30

While the invention places no limitations on the holding size of fluid container20, the collection section30should be large enough to hold the anticipated amount of fluid, but not so large so as to interfere with the normal operation of the endoscope.

While many various shapes for the fluid container20are possible, most embodiments have an expandable collection section34which has an expanding triangular prism shape. In these circumstances, the portion above the expandable collection section34also usually has an upper triangular prism shape. The height of the upper triangular prism39is the height 31H of the upper portion31plus the height 32H of the biopsy section32plus the height 33H of the main section33minus the height 34H of the expanding collection section34.

In the second and first configurations, the height 20h of the container20may be between 30 mm and 200 mm, and typically around 150 mm. The height 31H of the upper section31may be between 20 mm and 80 mm, preferably at least between 50 mm and 60 mm, and typically around 55 mm. The height 32H of the biopsy section32may be between 2 mm and 12 mm, preferably at least between 5 mm and 10 mm, and typically around 8 mm.

The height 33H of the main section33may be between 20 mm and 90 mm, preferably at least between 40 mm and 70 mm, and typically around 60 mm. The height 34H of the collection section34may be between 10 mm and 80 mm, preferably at least between 20 mm and 60 mm, and typically around 40 mm.

Generally, the height 32H (and corresponding volume) of the biopsy section32will be less than the height 31H (and corresponding volume) of the upper section31. The height 31H (and corresponding volume) of the upper section31will generally be less than the height 33H (and corresponding volume) of the main section33.

The depth of the container20alters between the first configuration (FIG. 1A) and the second configuration (FIG. 1D). Specifically, in the first configuration, the depth of the container20is typically about 5 mm. In the second configuration, the depth of the container20varies between 5 mm along the top of the upper section31and expanding to 80 mm at the widest portion of the collection section34.

Specifically, in the second configuration, the depth 31d of the upper section31may expand from 2 mm to 50 mm, preferably at least from 4 mm to 40 mm, and typically from 5 mm to 20 mm. The depth 32d of the biopsy section32may expand from 10 mm to 50 mm, preferably around from 15 mm to 40 mm, and typically from 20 mm to 30 mm. The depth 33d of the main section33may expand from 20 mm to 70 mm, preferably around from 25 mm to 60 mm, and typically from 30 mm to 55 mm. At its greatest depth 34d, the collection section34may be between from 60 mm to 100 mm, preferably at least between 60 mm to 80 mm, and typically around 70 mm.

In the first configuration, the fluid container20is a simple rectangle plus two matching triangles, so volume of the fluid container20may be calculated simply from V1=((W39*H39*D39)+2*(½*W34*H34*D34))=(width*height*depth). For a fluid container20with measurements of 20W=70 mm, 20D1=1 mm and 20H=160 mm, then the volume V1=11.2 mL.

In the second configuration, the volume of the lower collection section34in the second use configuration will generally be greater than the volume of the remainder of the container20regardless of a ratio of height 34h in correlation with height 33h, or stated mathematically, V34>(V30−V34) or V34>V39.

The significantly larger volume size in the second configuration is possible due to the altered shape in the second configuration. The volume of the entire fluid container20may be determined by finding the volume of the two triangular prism shapes defining the fluid container. However, as previously stated, to ensure that no fluids are lost, it is preferable that only the portion of the fluid container20below the insertion opening40is considered viable for fluid collection. Mathematically then, the volume of the container in the second configuration can be determined from:

For a container20with measurements 20W=70 mm, 20H−31H−32H=120 mm, 20D=70, 33H−34H=40, 31H+32H=25, 26D=70, and then V2=(½*70*120*70)+(½*70*40*70)−(½*70*25*70)=331 mL. Overall, the main section33(including the collection section34) of a fluid container20in the second configuration may contain between 100 cc to 450 cc, or preferably between 150 cc to 400 cc, while 250 cc to 350 cc in size should be adequate for a typical application.

Returning then to our example, it is possible to compare the volume of the container20in the first configuration, V1, to the volume of the container20in the second configuration, V2, where V1=56 mL and V2=331 mL, V2=1V1*6). For this embodiment then, the volume of the container20in the second configuration, V2, is more than 5 times the volume of the container20in the first configuration, V1. For other embodiments the volume of the container20in the second configuration, V2, is at least 4 times the volume of the container20in the first configuration, V1. In yet further embodiments, the volume of the container20in the second configuration, V2, is between 2 to 10 times the volume of the container20in the first configuration, V1

Spill-proof instrument insertion opening40is affixed to a front side of the fluid container20, such that the orifice of the opening is positioned right above the biopsy cap67when the device is properly attached to an endoscope10, as illustrated inFIG. 2.FIG. 3illustrates an enlarged view of one embodiment of spill-proof instrument insertion opening40. The instrument insertion opening40is composed of an outer ring42and an inner fenestrated membrane41.

The instrument insertion opening40is adapted to facilitate insertion of the endoscope instrument (or tool) through the opening40into the fluid container20. To facilitate this, directionality, the instrument insertion opening40is located on an exterior facing portion of the water-proof wall of the fluid container20.

The outer ring42can be manufactured from rubber, foam, or any other semi-flexible and water-resistant materials. The purpose of outer ring42is to maintain the integrity of inner fenestrated membrane41. In embodiments having a transparent wall38, the visually distinct coloring of the outer ring42also provides a visual and tactile target to help an endoscope operator locate the inner fenestrated membrane41easily and efficiently during a procedure. The inner diameter43of outer ring42should match the size of a typical biopsy cap, may be between 5 mm and 20 mm, preferably at least between 8 mm and 12 mm, and typically around 10 mm. The outer diameter44of outer ring42may be between 10 mm and 40 mm, preferably at least between 15 mm and 30 mm, and typically around 20 mm.

The inner fenestrated membranes41acts as flexible valve walls which engage the side walls of the endoscope instrument to reduce fluid back flow. The insertion opening40may contain one or more layers of fenestration membrane in order to provide adequate spillage resistance. Indeed, in the embodiment shown inFIG. 3, a second layer of fenestration membranes is present with a fenestration pattern43that is at an angle to the first layer of fenestration membrane as shown inFIG. 1. Specifically, the fenestration patterns inFIG. 1are vertical and horizontal, while the fenestration patterns43of the additional layer of membranes41inFIG. 3are rotated at 45 degrees with respect to the first layer.

The fenestration patterns43of both the first and second layer of membranes41extend from the inner diameter44of the outer circle42until reaching an internal axis45. The fenestration patterns43shown here causing portions of the membranes41to have a cuneate, triangular, wedge or petal shape. These membranes41can be manufactured from the same material as fluid container20or any other flexible and water-proof materials.

As illustrated inFIG. 2, in some embodiments, the spill-proof instrument insertion opening40is not attached to the biopsy cap. A small gap43exists between spill-proof instrument insertion opening40and the biopsy cap7. This separation43facilitates in reducing or abolishing the capillary effect that would otherwise occur due to the small internal diameter of the suction instrument channel and facilitates easier intentional draining of the fluids12into fluid container20when desired.FIG. 5shows an alternative embodiment of the fluid container20of the present invention having an alternative position for the spill proof instrument insertion opening40.

Endoscope attachment aperture60is affixed to the back side of fluid container20opposite from spill-proof instrument insertion opening40, as illustrated inFIG. 2. Endoscope attachment aperture60provides an orifice61through which the instrument insertion opening40of an endoscope10and the biopsy channel7are connected to fluid container20. It also serves as an attachment point to help secure the fluid container20around the handle of an endoscope10.

Specifically, the endoscope attachment aperture60is adapted to fit over the instrument channel7of the endoscope10. The endoscope attachment aperture60facilitates egression of the endoscope instrument, previously inserted through the first opening, to exit the fluid container20and enter the instrument channel7of the endoscope10.

FIG. 4provides a view of one embodiment of endoscope attachment aperture60. In this embodiment, the endoscope attachment aperture60has two strips of adhesive62,63which are aligned next to each other. These strips62,63extend lengthwise from a top end adjacent the top25of the container20, to a bottom end adjacent the bottom26of the container20.

In this embodiment, each strip62,63is folded horizontally from side to side, usually along a midway point67, such that wings64,65extend outwardly from the folding point67. These wings64,65are extensions that run along the external sides of the biopsy cap (inside the fluid container20) and can form a water-tight seal opposite the instrument insertion opening of an endoscope, as illustrated inFIG. 2.

The height of the orifice61may be between 5 mm and 70 mm, preferably at least between 10 mm and 40 mm, and typically around 25 mm.

Additional Embodiments

Other embodiments of the invention are illustrated inFIGS. 5-18. However, as the principle elements of these additional embodiments remain constant and similar to the previously discussed elements of the present invention, there is no need to repeat the discussion of these identical elements.

In the embodiment shown inFIGS. 6 and 7, the fluid container20has a spill-proof instrument insertion opening40on the front of fluid container20and an integrated biopsy cap67on the opposite rear side of fluid container20. The construction of fluid container20and spill-proof instrument insertion opening40in this preferred embodiment is the same as discussed above.

Integrated biopsy cap67represents a soft rubber seal similar to that used for any commercially available biopsy cap. However, in the present embodiment, the integrated biopsy cap67is permanently bonded to fluid container20, such that the integrated biopsy cap67can be properly aligned to spill-proof instrument insertion opening40, as illustrated inFIG. 6.

Another embodiment of the invention is illustrated inFIG. 7. In this embodiment, a resealing drainage opening50is provided along the bottom wall26to correspond with the expandable collection section34of the fluid container20. This resealable drainage opening50allows fluid collected in fluid container20to be emptied without removing the fluid container20from an endoscope. Resealing drainage opening50can be opened and closed repeatedly throughout the lifetime of the container20. The resealing drainage opening50in this embodiment may be constructed based on a zipper, zip-seal, slider, or any other water-tight closure mechanisms.

Further Illustrations of Expanding Collection Section34

Yet another embodiment of the present invention is shown inFIGS. 8-18. Again, as the principal elements of this additional embodiments remain constant and similar to the previously discussed elements of the present invention, the discussions of those similar element(s) are expounded upon here. Later, attention is directed towards those aspects of the invention which slightly differ.

Various viewpoints of this embodiment in the first folded configuration are shown inFIGS. 8-11 and 13.FIGS. 12 and 14-18illustrate various viewpoints of this embodiment in the second and third use configurations. As before, the expandable collection section34is defined by foldable portion35which in turn is generally comprised of portions of the side walls23,24, and the bottom wall26.

In this embodiment, as before, the bottom wall26is folded inwards perpendicularly between the corners29when in the folded configuration.FIGS. 8-11 and 13illustrate this, withFIG. 10specifically showing the cross-sectional view illustrating how the bottom wall is folded inwards between corners29.

Note that when viewed from the front, the front wall21is an irregular hexagon in both configurations. However, as shown inFIGS. 13-15, when viewed from either of the sides, the shape changes from an extremely narrow rectangular shape (FIG. 13) to a first partially unfolded configuration in an arrowhead shape (FIG. 14) to a very bottom-heavy pyramidal (triangular) shape (FIG. 15).

As before, the overall volume increases significantly from the first configuration to the second configuration. This increase in volume is facilitated during manufacture by providing two seams along opposing perpendicular axes. That is, in the folded first packing configuration, a first seam corresponding to the top wall25extends along the x-axis (FIG. 11). In the second use configuration, a second seam corresponding to the bottom wall26extends along the y-axis (FIG. 12).

Spill Proof Instrument Insertion Opening40

In this embodiment, the outer ring42of the spill proof instrument insertion opening40is a colored and textured structure which provides additional protection and barrier against spilling while also providing additional support for the opening40. The outer ring42in this embodiment is made from a foam material that is about 1 to 2 mm thick. The fenestration pattern43is similar, but the diameter is smaller, so that the inner diameter44of the outer ring is also smaller, about 5 mm.

The endoscope attachment aperture60of this embodiment is defined by a semi-circular, almost tear-drop shaped orifice61instead of a vertically extending rectangular slit as above. An upper portion of the aperture60is partially encompassed by an adjacent, but not abutting, arcuate brace68. The brace68is made of a foam material that is about 1 to 2 mm thick an reduces the likelihood of fluid leakage around the endoscope attachment aperture60.

Similar or identical in construction to the outer ring42of the spill proof instrument insertion opening40, the brace68reduces spillage which might otherwise occur. However, instead of comprising a columnar portion, the arcuate brace68forms only about 70% of a circular circumference about the perimeter of the upper portion of the aperture60. The brace68has a thickness which is equal to the thickness of the outer ring42so that these two components nest within each other when the container20is in the first folded configuration. The entire thickness of the container20in the first folded configuration then (FIG. 9) is not greater than 3 mm, and indeed is usually between 1-2 mm.

The wider shape of the outer facing portion of the orifice66along the upper portion facilitates engagement with wider endoscope instrument insertion portions7(seeFIG. 11). The endoscope attachment aperture60also has a single large exterior adhesive strip62positioned along the back wall22. This adhesive strip62has no vertically extending wings64, however, it does have a larger surface area overall. When in the packing configuration as inFIG. 8, an adhesive cover69may be provided for transporting. This adhesive cover69may be provided without a matching orifice66in order to provide a sanitary seal for the fluid container20as a whole. However, it is also envisioned that a separate sanitary packaging could be provided for this purpose.

LIST OF REFERENCED ELEMENTS

The following reference numbers are adhered to within the specification to refer to those referenced elements within the drawings of the present application.

CONCLUSION