Patent Description:
Endoscopes and other elongated medical instruments are relatively expensive products because they are typically configured for multiple uses. These instruments include one or more cannulas or lumens, through which surgical implements and other devices are passed during a surgical procedure. During use, a cannula may be exposed to bodily fluids and other materials that can accumulate on an inner surface of the lumen. If the accumulated material is not thoroughly cleaned from the inner surface prior to disinfection and sterilization, surgical debris can be passed to another patient, leading to infection or other complications. It is thus critical to properly clean the interior surfaces of endoscopes and similar surgical instruments. However, these medical devices can include long, narrow, tortuous lumens, which are often difficult to access and clean properly.

Another challenge includes properly determining when a cannulated device has been properly cleaned. Lumens of such device are difficult or impossible to inspect visually. Standard cleaning protocols can be followed but these do not always result in a properly cleaned device. Consequently, improved testing methods and devices are required to ensure an elongated medical instrument is properly cleaned.

Various techniques and devices have been previously proposed for cleaning cannulated instruments. The simplest procedure involves immersing the devices in solutions containing a detergent. Other applications use a small flexible brush, much like the conventional bottle brush having bristles locked between twisted wires. Such brushes are not entirely effective as they do not always evenly contact all the inner surfaces of a lumen. In addition, the bristles can scratch or damage the interior surfaces of the endoscopes and leave hardened deposits behind.

One possible solution to this problem is disclosed by U. Patent Application Publication No. <CIT>, which describes a hydrophilic polyurethane coating deposited on the bristles of a conventional endoscopic cleaning brush. Another solution is disclosed by <CIT>, which describes a wiping member configured to uniformly distribute the contaminates on the internal wall of the lumen and treating the resulting film with an enzyme. Yet another solution is disclosed by <CIT>, which describes both a brush and a swab attached to a shaft for cleaning lumens. Another cleaning system uses a polyurethane foam immersed in an enzymatic cleaning solution, as described in commonly assigned <CIT>. However, none of these devices always provide perfect cleaning of medical instructions, necessitating testing cleaning effectiveness.

One method for testing the cleanliness of an instrument following a cleaning protocol includes passing a test swab through the "cleaned" cannula and analyzing the test swab for any biological debris or bioburden. One test of bioburden relies on the presence of adenosine triphosphate (ATP). ATP is a molecule found in and around living cells, and can provide a direct measure of biological concentration. However, current systems and methods cannot test for ATP where biological cells are contained within a biofilm.

A biofilm is produced by a complex and coordinated network of microbes having increased resistance to detergents and antibiotics. Microbes within the network form an organic polymer matrix, producing a sticky mucous coating, or slime. The matrix provides structural support for cellular communities formed within the network. Channels may distribute nutrients within the network, allowing the communities to grow in a more isolated environment.

Biofilms can include a variety of microbes, including aerobic and anaerobic bacteria, algae, protozoa, and fungi. The bacteria in a biofilm can have significantly different properties from free-floating bacteria due to the complex matrix structure. For example, microbial cells within the matrix may have unique gene expression. This may allow synergistic interactions within the complex network.

<CIT> discloses a method for determining degree of pollution of a narrow human medical device. The method involves inserting or removing a clean swab of a wire into a cavity of a medical device. The clean swab is introduced into a transparent test vessel using a holder fixed at an end of the wire for detection of adenosine triphosphate (ATP) or adenosine monophosphate (AMP). The clean swab is left in the test container for predetermined time. The test container is introduced into the measuring device for luminescence measurement.

Current devices and methods are not able to consistently extract ATP from biological cells contained within a protective biofilm. Consequently, current devices and methods may underreport the true level of cleanliness of a medical instrument if the testing relies upon ATP analysis. The present disclosure provides improved devices and methods for testing the cleanliness of cannulated medical instruments.

One aspect of the present invention provides a method testing a cleanliness of a cannula of a medical instrument using a testing device, wherein the testing device comprises a guiding member having a rounded first end and a second end releasably coupled to a sponge element containing a dried extractant. The method steps include wetting the sponge element in at least one of sterile water and ATP-free water to activate the dried extractant and inserting the first end of the guiding member into a proximal end of the cannula. The guiding member is then pushed into the cannula to pass the first end of the guiding member through the cannula until the first end of the guiding member exits a distal end of the cannula. The guiding member is then pulled out of the distal end of the cannula and an inner surface of the cannula is contacted with the activated extractant to lyse a cell located on the inner surface of the cannula; pulling the second end of the guiding member and the sponge element out of the distal end of the cannula; detaching the sponge element from the guiding member; introducing the sponge element into a test swab tube; and exposing the sponge element to a reagent in the test swab tube.

Further aspects of the present disclosure are the subject of the dependent claims.

Additional objects and advantages of the present disclosure will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and together with the description, serve to explain the principles of the present disclosure.

Reference will now be made in detail to the present embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings.

The present disclosure is described herein with reference to an illustrative embodiment for a particular application, such as, for example, testing the cleaning of a medical instrument. It is understood that the embodiments described herein are not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and substitution of equivalents that all fall with the scope of the present disclosure. Accordingly, the present disclosure is not limited by the foregoing or following descriptions.

<FIG> shows a schematic diagram of a device <NUM> for cleaning a cannula of a medical instrument, according to an exemplary embodiment. The medical instrument can be a flexible or rigid scope, for example, an endoscope, a flexible fiberoptic, a laparoscopic instrument, a tracheostomy tube, a proctoscope, a bronchoscope, orthopedic instruments, part of an instrument or any medical device with a cannula or a lumen. The medical instrument can be articulated or non-articulated. A cannula of a medical instrument can vary in length and shape. For example, the length of a cannula can range from about <NUM> to about <NUM>. While the cross-sectional geometry of a cannula can vary, they are generally circular, oval, or have an arcuate shape.

Device <NUM> can comprise an elongated flexible guiding member <NUM> having a first end <NUM> and a second end <NUM>. Guiding member <NUM> can be flexible along its longitudinal length and configured to follow and flex based on the geometry of a cannula of the medical instrument being cleaned. Guiding member <NUM> can be made of flexible polypropylene, polyoxmethylene, or other flexible polymers or plastics. The diameter of guiding member <NUM> can range between <NUM> to <NUM>.

Device <NUM> can further comprise a plurality of cleaning elements <NUM> attached to guiding member <NUM>. For example, plurality of cleaning elements <NUM> can be located between first end <NUM> and second end <NUM>. In some embodiments, plurality of cleaning elements <NUM> can comprise a foam element <NUM> and a bristle element <NUM>. In other embodiments, plurality of cleaning elements <NUM> can be located at one end of guiding member <NUM> or at some other locations along guiding member <NUM>.

As shown in <FIG>, foam element <NUM> can comprise a foam structure <NUM>. Foam structure <NUM> can comprise a hydrophobic medical grade polyurethane foam that forms a backbone for an open cell foam. A coating of hydrophilic medical grade polyurethane can be formed on the hydrophobic backbone. Foam structure <NUM> can have a high porosity resulting in a plurality of pores <NUM>. Plurality of pores <NUM> can vary in size and shape.

Foam structure <NUM> can be generally cylindrical or another suitable shape. The cross-sectional diameter of foam element <NUM> can be approximately equal to or greater than the inner diameter of the cannula being cleaned. A cross-sectional diameter <NUM> of foam element <NUM> can be between about <NUM> to about <NUM>. Cross-sectional diameter <NUM> of foam element <NUM> can be selected based on the dimension of the cannula being cleaned. For example, cross-sectional diameter <NUM> can be greater than the cross-sectional diameter of the cannula being cleaned, but not so much greater that foam element <NUM> is unable to compress and fit within the cannula. A length <NUM> of foam element <NUM> can range between about <NUM> to about <NUM> inches.

In various other embodiments, the cross-sectional diameter of foam element <NUM> can vary along length <NUM> of foam element <NUM>. For example, in <FIG>, a cross-sectional diameter <NUM> decreases moving away from second end <NUM>. In contrast, in <FIG> a cross-sectional diameter <NUM> remains substantially constant over a length <NUM> of foam element <NUM>. In <FIG>, a cross-sectional diameter <NUM> varies along a length <NUM> of foam element <NUM> creating a wave like element. Additional embodiments of foam element <NUM> are contemplated. For example, <FIG> illustrates an additional embodiment of foam element <NUM> wherein foam element <NUM> includes multiple foam sections spaced apart creating a plurality of cavities <NUM> between each section. Cavities <NUM> can act as collection chambers for bioburden, reducing the amount of bioburden collected on the exterior surface of foam element <NUM>. In other embodiments, it is contemplated that surface features (e.g., helical slots, protrusions, dimples, ridges, etc.) can be used to enhance bioburden removal.

Foam element <NUM> can be attached to guiding member <NUM> using an adhesive material, for example, an epoxy or glue, as would be apparent to those of ordinary skill in the art. In another embodiment, foam element <NUM> can be attached to guiding member <NUM> using a heat bonding method that can eliminate the need for an adhesive material. The adhesive or heat bonding method used can be configured to ensure that foam element <NUM> will not disconnect from guiding member <NUM> during use.

<FIG> illustrates an enlarged view of bristle element <NUM>. Bristle element <NUM> can be located in the region of first end <NUM>. Bristle element <NUM> can be comprised of a plurality of bristles <NUM> secured between a plurality of twisted metal wires <NUM> protruding from guiding member <NUM>. Bristles <NUM> can be made of nylon. It is contemplated that other methods apparent to those of ordinary skill in the art for securing bristles to a brush or a support member are contemplated.

Bristles <NUM> can extend out laterally from twisted metal wires <NUM> forming a generally cylindrical shape. Bristles <NUM> in addition to extending out laterally can be angled toward first end <NUM> or away from first end <NUM>. The diameter of the generally cylindrical shape bristle element <NUM> can be about <NUM> to about <NUM>. The cross-sectional diameter of bristle element <NUM> can correspond to the cross-sectional diameter of foam element <NUM> and can be selected based on the dimension of the cannula being cleaned. It is contemplated that the cross-sectional diameter of bristle element <NUM> can be less than, equal to, or greater than the diameter of the foam element <NUM>. The length of bristle element <NUM> can range between about <NUM> to about <NUM> inches. In various embodiments, varying the length of bristles <NUM> can create ridges or a helical pattern along the exterior of bristle element <NUM>.

Device <NUM> can further comprise a bulb <NUM> at first end <NUM> of device <NUM>. Bulb <NUM> can include a rounded protrusion covering the end of metal wires <NUM>. Bulb <NUM> can be made of rubber, plastic or polymer, for example, polypropylene. In operation, bulb <NUM> can be configured to slide freely over edges and rough surfaces to allow for easy insertion and guiding through the cannula being cleaned.

In various other embodiments (not shown), device <NUM> can include additional cleaning elements beyond just foam element <NUM> and bristle element <NUM> described above. For example, device <NUM> can comprise a plurality of bristle elements <NUM> extending along guiding member <NUM> spaced at different intervals. Alternatively, device <NUM> can comprise a plurality of foam elements <NUM> extending along guiding member <NUM> spaced at different intervals. In yet another embodiment, device <NUM> can comprise a plurality of both foam elements <NUM> and bristle elements <NUM>.

In addition to varying the number of cleaning elements, the location of the cleaning elements can also vary. For example, foam element <NUM> can be located in the region of first end <NUM> and bristle element <NUM> can be located in the region of second end <NUM>. In yet another embodiment, both foam element <NUM> and bristle element <NUM> can be located in the region of either first end <NUM> or second end <NUM>.

Device <NUM> can also include one or more different types of cleaning elements. For example, as shown in <FIG>, device <NUM> can include a squeegee element <NUM> in addition to foam element <NUM> and bristle element <NUM>. As shown in <FIG>, squeegee <NUM> can comprise at least one of a wiping member <NUM> attached to guiding member <NUM> located between first end <NUM> and second end <NUM>. Two adjacent wiping members <NUM> can be spaced apart while coupled by a separating member <NUM>.

It is also contemplated that device <NUM> could include only foam element <NUM> and squeegee element <NUM>, and not bristle element <NUM>. Other various embodiments of device <NUM> could include various other numbers or combinations of various types of cleaning elements.

The cross-sectional shape of wiping members <NUM> can be configured to correspond to the shape of a cannula being cleaned. A cross-sectional diameter <NUM> of wiping members <NUM> can be equal to or less than the diameter of a cannula being cleaned. In other embodiments, diameter <NUM> for each wiping member can be different, such that the diameter <NUM> decreases moving toward first end <NUM>. Wiping members <NUM> can be configured to contact the inner surface of the cannula being cleaned and sweep material dislodged by bristle element <NUM>. Squeegee element <NUM> and wiping members <NUM> can be flexible or rigid and formed of polyurethane, polypropylene, or other polymer or plastic.

Device <NUM> as described above with regard to the various embodiments can be characterized as a mechanical cleaning device. However, in order to enhance the cleaning effectiveness of device <NUM> the mechanical cleaning can be combined with chemical cleaning. According to an exemplary embodiment, one or more of cleaning elements <NUM> can be combined with a cleaning solution <NUM>. For example, cleaning solution <NUM> can be an enzymatic cleaner of the type configured to degrade, disperse, or dissolve biological contaminant. These can include ENDOZIME® AW Triple Plus® with A. or ENDOZIME® Bio-Clean (Ruhof Corp. Other enzymatic cleaners configured to disperse and dissolve biological contaminant (e.g., bioburden) can be used. Cleaning solution <NUM> can take the form of a liquid, gel, foam, solid, paste, or spray cleaner and may be applied to foam element <NUM>.

According to various embodiments, as shown in <FIG>, device <NUM> can comprise foam element <NUM> containing cleaning solution <NUM>. In one embodiment, foam element <NUM> can be immersed in cleaning solution <NUM> and used immediately for cleaning a medical instrument. In an alternate embodiment, foam element <NUM> can be immersed in cleaning solution <NUM> and then passed through a dryer, of known construction, wherein excess water is removed without destruction of the enzymes. For example, foam element <NUM> can be dipped in cleaning solution <NUM> for between about <NUM> second and <NUM> seconds and then removed to dry. Following drying, device <NUM> can be packaged or stored until shipment to the end user. Device <NUM> can be individually packaged in an ATP-free environment or sterile packaged. Before use, device <NUM> can be removed from its package and foam element <NUM> immersed in sterile or ATP-free water to activate cleaning solution <NUM>.

Device <NUM> as described above can be utilized as an instrument for cleaning a cannula of a medical instrument. <FIG> shows a flow chart <NUM> illustrating the method of cleaning a cannula of a medical instrument using device <NUM>.

Device <NUM> can be provided in a package (e.g., single use package) that identifies the dimensions of foam element <NUM> and bristle element <NUM> in order to allow the end user to select the correct device <NUM> size based on a cannula being cleaned. In an alternate embodiment, instead of the package identifying the dimensions of foam element <NUM> and bristle element <NUM>, the package can identify the dimensions of the target cannula.

In yet another embodiment, guiding member <NUM> can be color coded based on the dimension of cleaning elements <NUM>. For example, yellow can indicate foam element <NUM> has about a <NUM> cross-sectional diameter, red can indicate foam element <NUM> has about a <NUM> cross-sectional diameter, and purple can indicate foal element <NUM> has about a <NUM> cross-sectional diameter. It is contemplated that additional colors and diameters can be used.

After the user removes device <NUM> from the package, the user can immerse foam element <NUM>, which can be combined with cleaning solution <NUM>, in clean water to reactivate cleaning solution <NUM>. In an alternate embodiment, as described above, foam element <NUM> can be immersed in cleaning solution <NUM> immediately prior to use.

Next, the user can insert first end <NUM> into the proximal end of a cannula of a medical instrument. The user can then feed guiding member <NUM> through the cannula. If there is some resistance from bioburden lodged in the cannula, the user can move device <NUM> back and forth until the path is clear. The user can then continue feeding device <NUM> through the cannula.

The user can continue to feed guiding member <NUM> until bulb <NUM> exits from the distal end of the cannula. Once bulb <NUM> exits from the distal end, the user can reorient the medical instrument being cleaned and begin pulling on device <NUM>, drawing device <NUM> through the cannula from the distal end instead of pushing it through from the proximal end.

Bristle element <NUM> moving through the cannula first can dislodge and break up large pieces of bioburden and carry out many of the pieces. Subsequently, foam element <NUM> can carry out the remainder of the pieces using the flat face of foam element <NUM> as a plowing surface. In addition, foam element <NUM> can also contact the interior surface of the cannula and mechanically and chemically cleaning the surface. The user can continue to pull device <NUM> until foam element <NUM> exits the distal end of the cannula. It can be advantageous to not pull device <NUM> back through the proximal end because bioburden may be redeposited within the cannula. In addition, the user can rotate guiding member <NUM> while pushing and pulling in order to cause rotation within the cannula to enhance cleaning.

Once device <NUM> is completely removed from the cannula, device <NUM> can be thoroughly rinsed to remove all signs of bioburden. Particularly, foam element <NUM> and bristle element <NUM> can be thoroughly rinsed.

The user can then repeat the above process one or more times until there is substantially no visible debris left on foam element <NUM> following removal from the cannula.

Device <NUM> can be configured for single use. Once a cannula is cleaned, device <NUM> can be disposed of according to proper procedure. In alternate embodiments, device <NUM> can be cleaned, sanitized and stored for later reuse.

Following a pre-cleaning, partial cleaning, or allegedly complete cleaning of the medical instrument or a portion of the medical instrument, a test can be performed to determine the cleanliness of one or more cannulas or lumens within the medical instrument. Accordingly, <FIG> shows a schematic diagram of a testing device <NUM> configured for testing the cleanliness of a cannula or lumen of a medical instrument as described above. Testing device <NUM> can include one or more features of device <NUM> previously described. For example, testing device <NUM> could include one or more of foam element <NUM>, bristle element <NUM>, squeegee element <NUM>, or other type of cleaning element.

Testing device <NUM> can comprise an elongated flexible guiding member <NUM> having a first end <NUM> and a second end <NUM>. Guiding member <NUM> can be flexible along its longitudinal length and configured to follow and flex based on the geometry of a cannula of the medical instrument being tested. Guiding member <NUM> can be made of flexible polypropylene, polyoxmethylene, or other flexible polymers or plastics. The diameter of guiding member <NUM> can range between <NUM> to <NUM>.

Testing device <NUM> can further comprise a sponge element <NUM> attached to coupling member <NUM>. Sponge element <NUM> can be attached using an adhesive material, for example, an epoxy or glue, as would be apparent to those of ordinary skill in the art. In another embodiment, sponge element <NUM> can be attached using a heat bonding method to eliminate the need for an adhesive material. The adhesive or heat bonding method used can be configured to ensure that sponge element <NUM> will not disconnect from coupling member <NUM> during use, avoiding dislodgment within the cannula during testing. Sponge element <NUM> can include one or more features of foam element <NUM> described above.

As shown in <FIG>, sponge element <NUM> can comprise a foam structure <NUM>. Foam structure <NUM> can comprise a hydrophobic medical grade polyurethane foam that forms a backbone for an open cell foam. A coating of hydrophilic medical grade polyurethane can be formed on the hydrophobic backbone. Hydrophilic polyurethanes are water-loving and absorb liquids to a greater degree than hydrophobic polyurethane. However, the physical strength and tensile strength of hydrophilic materials is less than that of hydrophobic materials. Therefore, the composite material used as the foam structure <NUM> provides benefits of both materials. Foam structure <NUM> can have a high porosity resulting in a plurality of pores <NUM>. Plurality of pores <NUM> can vary in size and shape.

Foam structure <NUM> can be generally cylindrical or another suitable shape. A cross-sectional diameter <NUM> of sponge element <NUM> can be between about <NUM> to about <NUM>. Cross-sectional diameter <NUM> of sponge element <NUM> can be approximately equal to or greater than the inner dimension of the cannula being cleaned. Cross-sectional diameter <NUM> of sponge element <NUM> can be selected based on the dimension of the cannula being tested. For example, cross-sectional diameter <NUM> can be greater than the cross-sectional diameter of the cannula being cleaned, but not so much greater that sponge element <NUM> is unable to compress and fit within the cannula. A length <NUM> of sponge element <NUM> can range between about <NUM> inches to about <NUM> inches. As described above for foam element <NUM>, sponge element <NUM> can be provided in various configurations.

As shown in <FIG>, sponge element <NUM> can be impregnated with an extractant <NUM>. Sponge element <NUM> can either be immersed in extractant <NUM> immediately prior to use or extractant <NUM> can be dried onto sponge element <NUM> and activated immediately prior to use. In some embodiments, sponge element <NUM> can be configured to absorb and retain water to activate extractant <NUM> in less than about <NUM>. In some embodiments, sterile water or ATP-free water can be used to activate extractant <NUM>.

Extractant <NUM> can comprise a detergent-based preservative and extractant configured to open biological cells and release ATP. For example, intracellular ATP can be released to enhance detection of biological cells contained within a biofilm. For example, extractant <NUM> can comprise Triton X-<NUM>, a quaternary-based detergent, tricholoacetic acid, and protocatechuic acid. In addition, extractant <NUM> can further comprise a buffering solution. The immersion of sponge element <NUM> in extractant <NUM> can also act as a pretreatment of sponge element <NUM>, removing latent ATP.

Traditionally, swabbing a cannula collects mostly extracellular ATP because intracellular ATP remaining within cells in a biofilm may not be detected. By not lysing biological cells within the biofilm, prior devices for testing cleanliness using ATP analysis may have provided inaccurate results. Collecting and testing for only the extracellular ATP is not always accurate because these protocols fail to detect biological cells present in the biofilm. To mitigate these problems with prior art devices and methods, the present disclosure provides extractant <NUM> to lyse the biofilm's cells. Releasing intracellular ATP allows for its collection and subsequent analysis using the devices and methods described herein.

In an alternate embodiment, as described above for foam element <NUM>, testing device <NUM> can comprise a plurality of sponge elements <NUM> or other cleaning elements. A sponge element located nearest first end <NUM> can contain extractant <NUM>, while other sponge elements may not contain extractant. Such a configuration of sponge elements can provide more time for extractant <NUM> to react with any bioburden present in the cannula before the other sponge elements pass over the bioburden and collect it. Various other configurations of elements associated with testing device <NUM> are also contemplated, where some may include extractant <NUM> and some may not.

Coupling member <NUM> can be configured to uncouple sponge element <NUM> from guiding member <NUM> following the swabbing of a cannula. Coupling member <NUM> can include a reduced cross-sectional area configured to preferentially detach. Coupling member <NUM> could also include a region configured for detachment using another device. For example, coupling member <NUM> could be configured to be cut, snapped, or severed using scissors, blade, forceps, or other similar device.

To facilitate uncoupling, coupling member <NUM> can further comprise a crease <NUM>. Crease <NUM> can be located be located less than about <NUM> inches from sponge element <NUM>. Crease <NUM> can be configured to snap with repeated bending. Alternatively, crease <NUM> can also be configured to indicate the location where coupling member <NUM> should be cut to provide a suitable size for subsequent analysis. In other embodiments, crease <NUM> can take the form of an indicia, perforated edge, indentation, reduced cross-sectional area, protrusion, or similar structure. Coupling member <NUM> could be color coded to distinguish guiding member <NUM>.

As shown in <FIG>, coupling member <NUM> can include a release mechanism <NUM>. Release mechanism <NUM> can include a latch, clip, hook, loop, or other type of detachment mechanism. In some embodiments, coupling member <NUM> or element <NUM> can be flexible to pass through a cannula. As such, release mechanism can have an outer dimension of less than about <NUM>.

Sponge element <NUM> can be analyzed using various devices or systems. Uncoupling sponge element <NUM> from guiding member <NUM> can facilitate analysis of sponge element <NUM>. For example, sponge element <NUM> can be analyzed for ATP using the ATP Complete® hand held device test kit (Ruhof Corp. According to an exemplary embodiment, <FIG>, shows parts of a device test kit <NUM>. Device test kit <NUM> can comprise a test swab tube <NUM>, a test swab <NUM>, and a testing device <NUM>. Testing device <NUM> can be hand-held.

Test swab tube <NUM> can be a generally cylindrical container sealed at the bottom with an opening at the top. Test swab tube <NUM> can be configured to receive sponge element <NUM>.

Test swab <NUM> can be a cap container configured to be releasably coupled to test swab tube <NUM>. Test swab <NUM> can include a reagent <NUM> within an upper portion <NUM> of test swab <NUM>. Reagent <NUM> can include a solution containing liquid-stable luciferase/luciferin. Other types of solid, liquid, or gaseous forms of reagent <NUM> could be used to detect ATP or another type of bioburden indicator.

Test swab <NUM> can be configured to be snapped when coupled to test swab tube <NUM> causing reagent <NUM> to release into test swab tube <NUM>. Test swab <NUM> can further comprise a swabbing member <NUM> configured to swab a surface or provide force to maintain an item (such as an uncoupled sponge element) within test swab tube <NUM>.

Device <NUM> can include a cover <NUM> configured to open and expose an aperture configured to receive test swab tube <NUM>. Device <NUM> can be configured to analyze the amount of contamination with the test swab tube <NUM>. For example, device <NUM> can detect the amount of ATP collected by sponge element <NUM> and output a numerical value. A higher numerical value can indicate a higher level of contamination.

In other embodiments, it is contemplated that sponge element <NUM> may be used in conjunction with other measurement devices. For example, sponge element <NUM> can be used with a protein or a ninydrin measurement device.

Testing device <NUM> as described above can be utilized as an instrument for testing the cleanliness of a cannula of a medical instrument. <FIG> shows a flow chart <NUM> illustrating the method of testing the cleanliness of the cannula of a medical instrument using testing device <NUM>, according to an exemplary embodiment. Similar to device <NUM>, testing device <NUM> can be provided in a package (e.g., single use package) that identifies the dimensions of sponge element <NUM> or cannula in order to allow the user to select the correct size of testing device <NUM>, based on the size of the cannula to be cleaned.

After the user removes testing device <NUM> from the package, the user can immerse sponge element <NUM> (containing extractant <NUM>) in sterile or ATP-free water to activate extractant <NUM>. In an alternate embodiment, as described above, sponge element <NUM> can be immersed in extractant <NUM> immediately prior to use.

Next the user can insert first end <NUM> of guiding member <NUM> into the proximal end of the cannula of the medical instrument being tested. The user can then push guiding member <NUM> through the cannula until first end <NUM> exits the distal end of the cannula. The medical instrument can be repositioned and guiding member <NUM> pulled through the cannula. Pulling can continue until sponge element <NUM> approaches the proximal end of the cannula. Once sponge element <NUM> approaches the proximal end, the user can carefully pull on guiding member <NUM> to ensure sponge element <NUM> is properly inserted into the cannula.

Once sponge element <NUM> is in the cannula, the user can continue to pull on guiding member <NUM>. As a result, sponge element <NUM> can be pulled through the cannula causing foam structure <NUM> immersed in extractant <NUM> to contact an inner surface of the cannula. Extractant <NUM> can cause living biological cells in the cannula to open and release intracellular ATP. Sponge element <NUM> can function to collect at least intracellular ATP, along with any additional bioburden present. Testing device <NUM> and sponge element <NUM> can also collect protein and ninhydrin for analysis.

The user can pull on guiding member <NUM> at a steady speed. Pulling on guiding member too rapidly can reduce the time extractant <NUM> has to react with the biological cells. As a result, the amount of intracellular ATP collected may be reduced. Therefore, the user can pull at a speed of between about <NUM> and about <NUM> inches/second.

The user can continue to pull guiding member <NUM> until sponge element <NUM> exits the distal end of the cannula. Once testing device <NUM> is completely removed from the cannula, sponge element <NUM> can be uncoupled from guiding member <NUM>. Sponge element <NUM> can be uncoupled from guiding member <NUM> using coupling member <NUM>. For example, coupling member <NUM> can be cut or crease <NUM> bent back and forth until it snaps.

Uncoupled sponge element <NUM> can be placed in test swab tube <NUM>, as shown in <FIG>. The user can then place test swab <NUM> on top of test swab tube <NUM> and couple the two together. Next, the user can snap test swab <NUM> causing reagent <NUM> to flow down into test swab tube <NUM>. Squeezing upper portion <NUM> can expedite the release of reagent <NUM>. The user can then gently shake test swab <NUM> and test swab tube <NUM> for about <NUM> to about <NUM> seconds.

Care should be taken to avoid contacting sponge element <NUM> with any surface that may contain ATP. For example, sponge element <NUM> may be placed within test swab tube <NUM> and then uncoupled from guide member <NUM>. Alternatively, sponge element <NUM> can be detached from guide member <NUM> and then placed within test swab tube <NUM> if sufficient care is taken to ensure the uncoupled sponge element is not exposed to an additional source of ATP.

Following shaking, the user can open cover <NUM> and insert test swab <NUM> and test swab tube <NUM> into the opening in device <NUM>. After insertion, the user can close the cover and initiate the measurement reading.

Device <NUM> can be configured to analyze test swab tube <NUM> to produce a signal associated with a level of cleanliness of the cannula. For example, device <NUM> can output a numerical value representative of the amount of ATP. The amount of ATP can include extracellular ATP, intracellular ATP, combinations of both types of ATP, or other sources of ATP contained within a biofilm.

A numerical value associated with a representation of the signal can be provided in relative light units (RLU). Depending on numerical value, additional cleaning can be recommended. For example, a RLU reading of <NUM> to about <NUM> can indicate low contamination level and therefore additional cleaning may not be recommended. In contrast, a RLU reading of about <NUM> or higher can indicate a high contamination level and therefore additional cleaning may be recommended.

In various embodiments, detection devices can be utilized that detect the amount of protein, ninhydrin, intracellular ATP, combinations of these or other indicators of bioburden.

As shown in <FIG>, device <NUM> and testing device <NUM> can be combined to form a kit <NUM> for cleaning and testing the cleanliness of the cannula of a medical instrument. Kit <NUM> can comprise at least one device <NUM> having a cleaning element <NUM> containing a cleaning solution <NUM> and at least one testing device <NUM> having a sponge element <NUM> containing an extractant <NUM>. The size of both devices can correspond to the same size cannula. In addition, kit <NUM> can comprise additional aliquots of cleaning solution <NUM> and extractant <NUM>. In other embodiments, cleaning solution <NUM> and extractant <NUM> can be provided in separate containers as a kit that can be configured to be used with a variety of cleaning and testing devices for cannulated medical instruments.

In other embodiments, one or more different types of kits <NUM> can be provided. For example, kit <NUM> could include testing device <NUM> and test swab tube <NUM>. In other embodiments, kit <NUM> could include test swab <NUM>, reagent <NUM>, testing device <NUM>, or other various combinations of the components described above.

Claim 1:
A method of testing a cleanliness of a cannula of a medical instrument using a testing device (<NUM>), wherein the testing device (<NUM>) comprises a guiding member (<NUM>) having a rounded first end (<NUM>) and a second end (<NUM>) releasably coupled to a sponge element containing a dried extractant, the steps comprising:
wetting the sponge element in at least one of sterile water and ATP-free water to activate the dried extractant;
inserting the first end (<NUM>) of the guiding member (<NUM>) into a proximal end of the cannula;
pushing the guiding member (<NUM>) into the cannula to pass the first end (<NUM>) of the guiding member (<NUM>) through the cannula until the first end (<NUM>) of the guiding member (<NUM>) exits a distal end of the cannula;
pulling at least part of the guiding member (<NUM>) out of the distal end of the cannula;
contacting an inner surface of the cannula with the activated extractant to lyse a cell located on the inner surface of the cannula;
pulling the second end (<NUM>) of the guiding member (<NUM>) and the sponge element out of the distal end of the cannula;
detaching the sponge element from the guiding member (<NUM>);
introducing the sponge element into a test swab tube; and
exposing the sponge element to a reagent in the test swab tube.