Unit dose package for cleaning surgical instruments

Abstract

In some embodiments, the present disclosure relates to a unit dose pack for forming a bath for cleaning a medical device. The unit dose package may include at least a first chamber containing an enzymatic detergent composition comprising one or more enzymes, the first chamber being formed from at least one first sheet comprising a water-soluble film, and the at least one first sheet enclosing the enzymatic detergent composition, where when immersed in water, the at least one first sheet has a water-soluble film in which the at least one first sheet has a water-soluble film in which the at least one first sheet has a water-soluble film in which the at least one first sheet has a water-soluble film in which the at least one second sheet has a water-soluble film in which the at least one second sheet has a water-soluble film. The enzymatic detergent composition is released from the first chamber into water. In other embodiments, the present disclosure relates to methods of cleaning a medical device using at least one such unit dose package. In some embodiments, the medical device is an endoscope.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 343,956, filed on May 19, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to unit dose packages that can be used to clean and sterilize surgical instruments, such as endoscopes and the like. Background Art

[0003] An endoscope is an elongated cylindrical instrument that may be rigid or flexible and that incorporates an optical system or video system and a light source. An endoscope is constructed so that one end can be inserted into a body cavity or surgical incision to a depth that allows an external observer to view surfaces at or near the internal insertion end of the endoscope.

[0004] During surgery, reusable endoscopes are exposed to biological material from the patient, such as mucus, saliva, feces, blood, tissue, etc. After the endoscopic procedure is completed, the endoscope must be cleaned and disinfected / sterilized before use on another patient. For this reason, used endoscopes undergo a pre-cleaning process (called "reprocessing") prior to disinfection or sterilization. Disinfection or sterilization of instruments that have not been thoroughly pre-cleaned may result in infection in the patient.

[0005] Conventionally, during reprocessing, detergent is metered into a sink or receptacle where it is mixed with fill water and the endoscope is immersed in this water bath. Sometimes, standard sized reprocessing tanks are used, which results in more consistent fill levels, but the available equipment at a reprocessing facility may not be consistent. Additionally, the fill water dilutes the detergent, which introduces variables based on the quality of the water entering the building, which may affect the effectiveness of the detergent solution in cleaning the endoscope.

[0006] Detergent dosing is another aspect of reprocessing endoscopes. Insufficient detergent dosing may result in inadequate cleaning. Excessive detergent dosing may result in prolonged rinsing phases or residues inside the endoscope, which may compromise effective clinical outcomes. Therefore, proper dilution of detergent during reprocessing is important for efficient, economical cleaning and good cleaning results.

[0007] Current dosing methods include hand pumps and constant dosing pumps. However, the results of these dosing methods vary. Dosing pumps require maintenance and calibration, and proper dosing with hand pumps is heavily dependent on the user. In addition, the user may use less accurate measurements, which is associated with the possibility of under-dosing or over-dosing of detergent.

[0008] A more robust solution is needed to produce a more manageable detergent dosing while potentially addressing other factors to maintain detergent effectiveness. Summary of the invention

[0009] In some embodiments, the present disclosure relates to a unit dose package for forming a bath for cleaning medical devices. The unit dose package may include at least a first chamber, the first chamber containing an enzymatic detergent composition comprising one or more enzymes, the first chamber being formed by at least one first sheet comprising a water-soluble film, and the at least one first sheet encapsulating the enzymatic detergent composition, wherein upon immersion in water, the enzymatic detergent composition is released from the first chamber into the water.

[0010] In some embodiments, the enzymatic detergent composition can be a liquid composition, a gel composition, a powder composition, or a combination thereof.

[0011] In some embodiments, which may be used in combination with any of the above embodiments, the combination comprises a protease and / or an amylase.

[0012] In some embodiments that may be used in combination with any of the above embodiments, the water-soluble film is a water-soluble polymer film.

[0013] In some embodiments that may be used in combination with any of the above embodiments, the first sheet further comprises a water-resistant barrier layer disposed between the water-soluble film and the enzymatic detergent composition. In some of these embodiments, the water-resistant barrier layer is thin enough that after the water-soluble film dissolves when immersed in water, the water-resistant barrier layer tears under mild agitation, thereby releasing the enzymatic detergent composition.

[0014] In some embodiments that may be used in combination with any of the above embodiments, the unit dose package further comprises a second chamber, the second chamber being separate from the first chamber and comprising a water treatment composition, the second chamber being formed by at least one second sheet comprising a water soluble film, and the at least one second sheet encapsulating the water treatment composition.

[0015] In some of these embodiments, the at least one first sheet and the at least one second sheet are identical, and the enzymatic detergent composition and the water treatment composition are released substantially simultaneously when immersed in water.

[0016] In some of these embodiments, the at least one first sheet and the at least one second sheet are different, and the water treatment composition is released before the enzymatic detergent composition when immersed in water. For example, the thickness of the water-soluble film in the at least one first sheet is greater than the thickness of the water-soluble film in the at least one second sheet, and / or the water solubility of the water-soluble film in the at least one second sheet is greater than the water solubility of the water-soluble film in the at least one first sheet.

[0017] In some embodiments that may be used in combination with the above embodiments, the water treatment composition is selected from a disinfectant, an anti-disinfectant, a water softener, a water hardener, or a pH adjuster.

[0018] In some embodiments that can be used in combination with the above embodiments, the unit dose package further comprises a third chamber, the third chamber being separate from the first chamber and the second chamber, wherein the third chamber comprises an additional treatment composition, the third chamber is formed by at least one third sheet comprising a water soluble film, and wherein the at least one third sheet encapsulates the additional treatment composition. In some of these embodiments, the water treatment composition is a water disinfectant composition, and the additional treatment composition is an anti-disinfectant composition. Upon immersion in water, the water treatment composition is released before the additional treatment composition, and the additional treatment composition is released before the enzymatic detergent composition is released.

[0019] In some embodiments, the present disclosure is directed to a unit-dose package for forming a bath for cleaning medical devices, the unit-dose package comprising (a) a first chamber comprising an enzymatic detergent composition and (b) a second chamber separated from the first chamber and comprising a water treatment composition, the enzymatic detergent composition comprising a protease and an amylase, the first chamber being formed by at least one first sheet comprising a water-soluble polymer film, and the at least one first sheet encapsulating the enzymatic detergent composition, and the second chamber being formed by at least one second sheet comprising a water-soluble polymer film, and the at least one second sheet encapsulating the water treatment composition.

[0020] In some embodiments, at least one first sheet and at least one second sheet are different and the water treatment composition is released before the enzymatic detergent composition when immersed in water.

[0021] In some of these embodiments, the thickness of the water-soluble polymer film in the at least one first sheet is greater than the thickness of the water-soluble polymer film in the at least one second sheet.

[0022] In other embodiments, the present disclosure is directed to a method for cleaning a medical device, comprising (a) forming a bath by filling a water tank with a predetermined volume of fill water and adding at least one unit dose package according to any of the above embodiments to the fill water, and (b) cleaning the medical device by immersing the medical device in the bath.

[0023] In some embodiments, the medical device is an endoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate schematically various exemplary embodiments and, together with the description, serve to explain the principles of the present invention.

[0025] Figure 1 schematically depicts a unit dose package according to one embodiment of the present disclosure;

[0026] Figure 2 schematically depicts a unit dose package according to another embodiment of the present disclosure;

[0027] Figure 3 schematically depicts a unit dose package according to yet another embodiment of the present disclosure; and

[0028] Figure 4 A unit dose package according to yet another embodiment of the present disclosure is schematically depicted. DETAILED DESCRIPTION

[0029] The present disclosure relates to the delivery of enzymatic detergents in the form of standardized unit dose packages, which may also be referred to as clips or pouches. The unit dose packages are used to form baths for cleaning surgical instruments, including endoscopes, such as colonoscopes, duodenoscopes, and bronchoscopes, among others. As a specific example, colonoscopes are used for diagnosis and surgery of the human colon. The colon insertion portion of the instrument is approximately 2 meters long and has one or more hollow passages or lumens. These lumens run the length of the endoscope. The lumens allow gas to be injected into the colon to expand the organ, they allow liquid to be injected for irrigation or lens cleaning, they allow liquid to be aspirated, and they allow long flexible instruments to be inserted to allow biopsies and hemostasis.

[0030] In the present disclosure, a cleaning bath can be formed by adding one or more standardized unit dose packages to fill water in a cleaning sink having a standardized volume to form a bath. By filling the sink to a predetermined level and by adding the correct number of unit dose packages (e.g., one, two, three, four, etc., depending on the sink volume and desired concentration), it can be ensured that the user has applied the appropriate dose of detergent to the bath.

[0031] Reference now Figure 1 Schematic diagram of the present disclosure, the unit dose package 100 includes at least a first chamber 110 containing an enzymatic detergent composition. In various embodiments, the first chamber is formed by at least one first sheet 120, which includes a water-soluble film and encapsulates the enzymatic detergent composition. After being immersed in water, the enzymatic detergent composition is generally released from the first chamber into the water within 4 minutes or less, preferably 2 minutes or less.

[0032] Enzymatic detergent compositions contain one or more enzymes and typically contain additional ingredients as discussed further below. Enzymatic detergent compositions can be in the form of liquids, gels, powders, liquid-gel mixtures, liquid-powder mixtures or gel-powder mixtures, among other possible forms.

[0033] In various embodiments, reference is now made to Figure 2 , the unit dose package 100 of the present disclosure further includes a second chamber 210, which is separated from the first chamber 110 and contains a water treatment composition. In some of these embodiments, the second chamber is formed by at least one second sheet 220, which includes a water-soluble film and encapsulates the water treatment composition. At least one second sheet 220 and at least one first sheet 120 can be the same or different, for example, depending on the desired release time.

[0034] The water treatment composition may contain, for example, disinfectants, anti-disinfectants, water softeners, water hardeners, enzyme catalysts, or other water treatment ingredients that support the cleaning function of the enzymatic detergent composition. Like the enzymatic detergent composition, the water treatment composition may be in the form of a liquid, gel, powder, a liquid-gel mixture, a liquid-powder mixture, or a gel-powder mixture, among other possible forms.

[0035] In some embodiments, the water treatment composition will depend on the geographic destination of the unit dose package. For example, where the geographic destination has hard water, the water treatment composition may include a water softener, where the geographic destination has soft water, the water treatment composition may include a water hardening agent, where the geographic destination has water with a high chlorine content, the water treatment composition may include a dechlorinating agent, where the geographic destination has water with a high pH or low pH, the water treatment composition may include a pH adjusting agent, where the geographic destination has water with a high salinity, the water treatment composition may include a salinity reducing agent, and / or where the geographic destination has water with elevated ammonia or organic amines, the water treatment composition may include an agent to remove or neutralize ammonia or organic amines.

[0036] In some embodiments, where the unit dose package includes a second chamber containing a water treatment composition separate from a first chamber containing an enzymatic detergent composition, the water treatment composition can be released from the second chamber of the unit dose package before releasing the enzymatic detergent composition from the first chamber of the unit dose package.

[0037] In some embodiments, reference is now made to Figure 3 , the unit dose package 100 of the present disclosure further includes a third chamber 310, which is separated from the first chamber 110 and the second chamber 210 and contains an additional treatment composition. In these embodiments, the third chamber is formed by at least one third sheet 320, which includes a water-soluble film and encapsulates the additional treatment composition. At least one first sheet 120, at least one second sheet 220, and at least one third sheet 220 can be the same or different, for example, depending on the desired release time.

[0038] The additional treatment composition may include, for example, disinfectants, anti-disinfectants, water softeners, water hardeners, dechlorinators, pH adjusters, salinity reducers, and / or agents for removing or neutralizing ammonia or organic amines, among other ingredients. Like the enzymatic detergent composition and the water treatment composition, the additional treatment composition may be in the form of a liquid, gel, powder, a liquid-gel mixture, a liquid-powder mixture, or a gel-powder mixture, among other possible forms.

[0039] In some embodiments, after immersion in water, the water treatment composition is released from the second chamber before the additional treatment composition is released from the third chamber, and the additional treatment composition is released from the third chamber before the enzymatic detergent composition is released from the first chamber. In a specific embodiment, the water treatment composition can be a disinfectant (such as a chlorinating agent) and the additional treatment composition can be an anti-disinfectant (such as a dechlorinating agent).

[0040] The water-soluble film used in the unit dose package of the present disclosure (i.e., the water-soluble film that can be present in the first sheet, the second sheet, the third sheet, etc.) can be formed using any suitable water-soluble film-forming material. In some embodiments, the water-soluble film is a water-soluble polymer film. In some embodiments, the water-soluble polymer film can include one or more of the following: polyvinyl ether (PVE), polyvinyl alcohol, polyvinyl pyrrolidine, polyalkylene oxide (e.g., polyethylene oxide), polyacrylamide, polycarboxylic acid (e.g., polyacrylic acid, polymethacrylic acid) and salts thereof, polyvinyl acetate, polyamino acid and salts thereof, polyamide, polyanhydride, polysaccharide (including natural gum) and film-forming cellulose polymer (e.g., cellulose ether, cellulose ester, cellulose amide, methylcellulose and hydroxypropyl methylcellulose), and the aforementioned copolymers.

[0041] In addition to the water-soluble film, in some embodiments, the first sheet, the second sheet, the third sheet, etc. may include a waterproof barrier layer disposed between the water-soluble polymer film and the encapsulated composition (e.g., an enzymatic detergent composition, a water treatment composition, an additional treatment composition, etc.).

[0042] One implementation of this structure is Figure 4 As shown in the schematic diagram, Figure 4 A unit dose package 100 is shown having a first chamber 110 containing an enzymatic detergent composition, wherein the first chamber 110 is formed from at least one first sheet material including a water soluble film 120s encapsulating the enzymatic detergent composition and a water resistant barrier layer 120b.

[0043] Examples of such water-resistant barriers include various water-insoluble polymers, including silicones or other natural rubbers, as well as hydrophobic coatings and the like.

[0044] The thickness of the waterproof barrier layer can be very thin, so that when the water-soluble polymer film dissolves, even under mild stirring, the waterproof barrier layer is immediately torn, releasing the enzymatic detergent composition. For example, the thickness of the water-soluble polymer film can be at least 10 times, at least 25 times, at least 50 times, at least 100 times or more than the thickness of the waterproof barrier layer.

[0045] In some embodiments, at least one layer (e.g., a water-soluble polymer film layer) of a sheet encapsulating a composition described herein (e.g., an enzymatic detergent composition, a water treatment composition, an additional treatment composition, etc.) may comprise a thermoplastic polymer such that the composition may be encapsulated by a thermal process (such as a heat sealing process, among other possibilities).

[0046] In a multi-chamber embodiment (e.g., an embodiment with two chambers, three chambers, etc.), the chambers can have the same volume. In a multi-chamber embodiment, the chambers can have different volumes. For example, the volume of the first chamber can be 1.25 times to 1.5 times to 2 times to 5 times (or more) the volume of the second chamber. Alternatively, the volume of the first chamber can be 0.75 times to 0.5 times to 0.2 times (or less) the volume of the second chamber. Similarly, the volume of the second chamber can be 1.25 times to 1.5 times to 2 times to 5 times (or more) the volume of the third chamber. Alternatively, the volume of the second chamber can be 0.75 times to 0.5 times to 0.2 times (or less) the volume of the third chamber.

[0047] In multi-chamber embodiments, the encapsulated compositions (eg, encapsulated enzymatic detergent compositions, encapsulated water treatment compositions, encapsulated additional treatment compositions, etc.) can be the same color or can be different colors.

[0048] When it is desired to release all compositions (eg, enzymatic detergent composition, water treatment composition, additional treatment composition, etc.) at once, the sheets encapsulating the compositions (eg, first sheet, second sheet, third sheet, etc.) may be the same.

[0049] In multi-chamber embodiments, when it is desired to stagger the release of compositions (eg, enzymatic detergent compositions, water treatment compositions, additional treatment compositions, etc.), the sheets encapsulating the compositions will be different.

[0050] In some of these embodiments, the sheets can be formed using the same water-soluble film material; however, the thickness of the water-soluble film can vary, with thinner water-soluble films being used for earlier release and thicker water-soluble films being used for later release.

[0051] In some embodiments of these embodiments, the sheet can be formed using different water-soluble film materials. For example, a water-soluble film containing a polymer with higher water solubility can be used for earlier release, while a water-soluble film containing a polymer with lower water solubility can be used for later release. As another example, because a higher molecular weight polymer generally has a lower water solubility than a lower molecular weight polymer of the same composition, a water-soluble film containing a lower molecular weight polymer can be used for earlier release, while a water-soluble film containing a higher molecular weight polymer can be used for later release.

[0052] A range of enzymatic detergent compositions can be used in conjunction with the unit dose packages of the present disclosure. The enzymatic detergent compositions comprise one or more enzymes. Beneficial enzymes include amylases, proteases, cellulases, lipases, and combinations thereof.

[0053] Any suitable amylase or mixture of amylases from any source can be used in the enzymatic detergent composition. For example, the amylase can be derived from a plant, an animal or a microorganism (e.g., a yeast, a mold or a bacterium). Beneficial amylases include, but are not limited to, those derived from Bacillus, such as B. licheniformis, B. amyloliquefaciens, B. subtilis or B. stearothermophilus. The amylase can be purified or a component of a microbial extract, and can be a wild type or variant (chemical or recombinant).

[0054] Any suitable protease or mixture of proteases from any source may be used in the enzymatic detergent composition. For example, the protease may be derived from plants, animals or microorganisms (e.g., yeast, mold or bacteria). Beneficial proteases include, but are not limited to, enzymes derived from Bacillus subtilis, Bacillus licheniformis and Streptomyces griseus. The protease may be purified or a component of a microbial extract and may be wild type or variant (chemical or recombinant).

[0055] Any suitable cellulase or mixture of cellulases from any source may be used in the enzymatic detergent composition. The cellulase may be derived from plants, animals or microorganisms (e.g., fungi or bacteria). The cellulase may be purified or a component of a microbial extract, and may be wild type or variant (chemical or recombinant).

[0056] Any suitable lipase or mixture of lipases from any source may be used in the enzymatic detergent composition. The lipase may be derived from plants, animals or microorganisms (e.g., fungi or bacteria). The lipase may be purified or a component of a microbial extract, and may be wild-type or variant (chemical or recombinant).

[0057] In addition to the foregoing, the enzymatic detergent composition may also comprise additional enzymes. The additional enzymes may include, but are not limited to, cutinases, peroxidases, glucanases, or mixtures thereof.

[0058] In addition to one or more enzymes, the enzymatic detergent composition may also contain many other ingredients, including one or more of the following: stabilizers, such as polyols (e.g., C3-C8 polyols, such as glycerol, etc.); preservatives, such as isothiazolinones (e.g., methylisothiazolinone, benzisothiazolinone, etc.); buffers and / or alkalinity sources; corrosion inhibitors; surfactants; defoaming agents; dyes; fragrances; water conditioners; and combinations thereof.

[0059] In a multi-chamber embodiment, the water treatment composition and the additional treatment composition may include a variety of ingredients selected from, for example, one or more disinfectants (e.g., chlorine, chloramines), one or more anti-disinfectants (e.g., sodium thiosulfate or sodium bisulfate), one or more water softeners (e.g., polycarboxylic acid polymers), phosphates, chelating agents (e.g., citric acid, EDTA, sodium phytate, tetrasodium glutamate diacetate, or trisodium ethylenediamine disuccinate), one or more water hardeners (including calcium and magnesium salts), one or more acidifiers (e.g., citric acid, fumaric acid, hydrochloric acid, lactic acid, malic acid, nitric acid, phosphoric acid, propionic acid, sodium dihydrogen phosphate, sulfuric acid, or tartaric acid) and / or one or more alkalizers (e.g., ammonium carbonate, diethanolamine, monoethanolamine, potassium hydroxide, sodium bicarbonate, sodium borate, sodium carbonate, sodium hydroxide, or triethanolamine), etc.

[0060] Although the term "endoscope" has been used above, it will be understood that a variety of devices including but not limited to duodenoscopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, sheaths, catheters, or any other suitable delivery devices or medical devices may be used in conjunction with the present disclosure.

Claims

1. A unit dose package for forming a bath for cleaning medical devices, the unit dose package comprising at least a first chamber, the first chamber containing an enzymatic detergent composition comprising one or more enzymes, the first chamber being formed by at least one first sheet comprising a water soluble film, and the at least one first sheet encapsulating the enzymatic detergent composition, wherein upon immersion in water, the enzymatic detergent composition is released from the first chamber into the water.

2. The unit dose package of claim 1, wherein the enzymatic detergent composition is a liquid composition, a gel composition, a powder composition, or a combination thereof.

3. The unit dose package according to any one of claims 1-2, wherein the enzymatic detergent composition comprises a protease and / or an amylase.

4. The unit dose package according to any one of claims 1 to 3, wherein the water soluble film is a water soluble polymer film.

5. The unit dose package of any one of claims 1-4, wherein the first sheet further comprises a water resistant barrier layer disposed between the water soluble film and the enzymatic detergent composition.

6. The unit dose package of claim 5, wherein the water resistant barrier is thin enough so that after the water soluble film is dissolved by immersion in water, the water resistant barrier tears under agitation, thereby releasing the enzymatic detergent composition.

7. The unit dose package according to any one of claims 1-6, further comprising a second chamber, the second chamber being separated from the first chamber and comprising a water treatment composition, the second chamber being formed by at least one second sheet comprising a water-soluble film, the at least one second sheet encapsulating the water treatment composition.

8. The unit dose package of claim 7, (a) wherein the at least one first sheet and the at least one second sheet are identical and wherein upon immersion in water, the enzymatic detergent composition and the water treatment composition are released substantially simultaneously, or (b) wherein the at least one first sheet and the at least one second sheet are different and wherein upon immersion in water, the water treatment composition is released prior to the enzymatic detergent composition.

9. The unit-dose package according to claim 8, wherein the thickness of the water-soluble film in the at least one first sheet is greater than the thickness of the water-soluble film in the at least one second sheet, and / or wherein the water solubility of the water-soluble film in the at least one second sheet is greater than the water solubility of the water-soluble film in the at least one first sheet.

10. The unit dose package of any one of claims 7-9, wherein the water treatment composition is selected from a disinfectant, an anti-disinfectant, a water softener, a water hardener, or a pH adjuster.

11. The unit-dose package according to any one of claims 7-10, further comprising a third chamber, the third chamber being separated from the first chamber and the second chamber, wherein the third chamber comprises an additional treatment composition, the third chamber being formed by at least one third sheet comprising a water-soluble film, the at least one third sheet encapsulating the additional treatment composition.

12. The unit dose package of claim 11, wherein the water treatment composition is a water disinfectant composition, wherein the additional treatment composition is an anti-disinfectant composition, and wherein upon immersion in water, the water treatment composition is released before the additional treatment composition, and the additional treatment composition is released before the enzymatic detergent composition is released.

13. A unit dose package for forming a bath for cleaning medical devices, the unit dose package comprising: (a) a first chamber comprising an enzymatic detergent composition comprising a protease and an amylase, the first chamber being formed by at least one first sheet comprising a water-soluble polymer film, the at least one first sheet encapsulating the enzymatic detergent composition; and (b) a second chamber separated from the first chamber and comprising a water treatment composition, the second chamber being formed by at least one second sheet comprising a water-soluble polymer film, the at least one second sheet encapsulating the water treatment composition.

14. The unit dose package of claim 13, wherein the at least one first sheet and the at least one second sheet are different, and wherein upon immersion in water, the water treatment composition is released before the enzymatic detergent composition.

15. A method of cleaning a medical device, comprising (a) forming a bath by filling a water tank with a predetermined volume of fill water and adding at least one unit dose package according to claims 1-14 to the fill water, and (b) cleaning the medical device by immersing the medical device in the bath.

Images