Method and system for monitoring waste streams to increase efficiency of surgical irrigation procedures - Patents.com

Abstract

A method and system for monitoring waste streams in a surgical procedure is provided. The method includes providing irrigation fluid to a surgical area. The method may also include removing irrigation fluid and medical waste from the surgical area via an aspiration line to generate a fluid flow in the aspiration line. The method may also include monitoring the fluid flow based on a lateral flow test to generate a result. The method may also include providing feedback to a user based on the result.

Description

[Technical field]

[0001] Aspects of the present disclosure are directed to methods and systems for monitoring waste streams to increase the efficiency of surgical irrigation procedures. In particular, aspects of the present disclosure are directed to using lateral flow testing to determine the presence of target substances in the waste streams, thereby increasing the efficiency of surgical irrigation procedures. [Background technology]

[0002] Irrigation of the surgical cavity, otherwise used interchangeably herein as irrigation, is performed during most surgical procedures as part of an effort to minimize the presence of debris and / or microorganisms that may adversely affect patient outcome. The ability to minimize debris and / or microorganisms can contribute to reducing and / or eliminating complications such as infections that can have devastating effects on a patient's recovery.

[0003] Despite the importance of the irrigation process, there are no standard techniques for surgeons to distinguish when the surgical cavity is sufficiently cleansed and ready to close. Surgeons are left to rely solely on experience and the appearance of the surgical cavity to determine when the irrigation process is complete. There is a large degree of variability in these techniques, thereby reducing the overall effectiveness of the irrigation process.

[0004] For example, conventional techniques require the surgeon to visually assess and rely on experience to know when sufficient irrigation has occurred. This technique has a wide variability based on the following factors: 1) it relies on having a clear field of view of the surgical cavity; 2) it has limited sensitivity based on the use of visual inspection; and 3) it has variability from surgeon to surgeon based on non-specific or quantifiable requirements for "knowing" the desired appearance of a clean surgical cavity.

[0005] Thus, there is a need in the art to provide the surgeon with a guide for determining when the surgical cavity has been effectively cleaned and when continued cleaning is no longer required to remove debris and / or microorganisms, i.e., when an acceptable level of decontamination has been achieved. More specifically, there is a need in the art to provide criteria that the surgeon can rely on to determine when irrigation can be considered complete and the wound can be closed. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Serial No. 17 / 152,565 Summary of the Invention

[0007] The following presents a simplified summary of one or more aspects of the disclosure to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects, and is not intended to identify key or critical elements of all aspects or to delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects of the disclosure in a simplified form as a prelude to the more detailed description that is presented later.

[0008] According to some aspects, the present disclosure is directed to a method and system for monitoring waste streams in a surgical procedure. The method includes providing irrigation fluid to a surgical area. The method may also include removing irrigation fluid and medical waste from the surgical area via an aspiration line to generate a fluid flow in the aspiration line. The method may also include monitoring the fluid flow based on a lateral flow test to generate a result. The method may also include providing feedback to a user based on the result.

[0009] According to some aspects, the present disclosure is directed to a method and system for performing irrigation. The method includes providing irrigation fluid to a surgical field. The method also includes removing irrigation fluid and medical waste in the surgical field via at least one suction line to generate a fluid flow in the suction line. The method also includes analyzing the fluid flow to generate a result. The method also includes generating a feedback signal based on the result. The method also includes if the feedback signal indicates a negative result, irrigation is complete and the surgical field is closed, and if the feedback signal indicates a positive result, irrigation is not complete and the method for performing irrigation is repeated.

[0010] To the accomplishment of the foregoing and related ends, the one or more aspects of the disclosure comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail certain illustrative features of the one or more aspects. These features are indicative, however, of only a few of the various ways in which the principles of the various aspects can be employed, and the description is intended to include all such aspects and their equivalents. [Brief description of the drawings]

[0011] The novel features believed to be characteristic of the aspects described herein are set forth in the appended claims. In the following description, like parts are labeled with the same respective numerals throughout the specification and drawings. The drawing figures are not necessarily drawn to scale, and certain figures may be shown in exaggerated or generalized form for the benefit of clarity and conciseness. However, the disclosure itself, as well as preferred modes of use, further objects, and advances thereof, will be best understood by reference to the following detailed description of exemplary embodiments, when read in conjunction with the accompanying drawings. [Figure 1] FIG. 1 illustrates a portion of an example system according to an aspect of the present disclosure. [Diagram 2]FIG. 2 illustrates another portion of an example system according to an aspect of the present disclosure. [Diagram 3] 1 illustrates an example suction monitoring assembly according to aspects of the present disclosure. [Figure 4] FIG. 1 illustrates an example apparatus for measuring an amount of a substance in a perfusion system, according to an aspect of the present disclosure. [Diagram 5] 1 is a flow diagram illustrating an example method for monitoring a waste stream according to an aspect of the present disclosure. [Figure 6] FIG. 1 depicts an example system diagram of various hardware components and other features for use in accordance with aspects of the present disclosure. [Figure 7] FIG. 1 is a block diagram of various example system components for use in accordance with aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The following contains definitions of selected terms used herein. The definitions include various examples and / or forms of components that fall within the scope of the term and that can be used to implement. These examples are not intended to be limiting.

[0013] The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details intended to provide a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

[0014] Certain aspects of the particular system are now presented with reference to various example systems and methods. These systems and methods are described in the following detailed description and illustrated in the accompanying drawings by various blocks, modules, components, circuits, steps, processes, algorithms, etc. (collectively referred to as "elements"). These elements may be implemented using electronic hardware, computer software, or any combination thereof. Whether such elements are implemented as hardware or software depends on the particular application and design constraints imposed on the overall system.

[0015] As used herein, the term "irrigation fluid" refers to a fluid suitable for the irrigation processes described herein. As used herein, "irrigation" refers to the irrigation of a body cavity, a surgical cavity, and / or an external wound.

[0016] According to some embodiments, the cleaning fluid may include a disinfectant solution. As used herein, "disinfectant solution" refers to a solution that includes at least a solvent and one or more disinfectants. According to some embodiments, the disinfectant solution includes an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent includes at least a majority of water. It should be understood that in some examples, the solvent may include or consist of water. According to some embodiments, the disinfectant solution includes an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent includes at least a majority of alcohol. It should be understood that in some examples, the solvent may include or consist of one or more alcohols. Non-limiting examples of alcohols include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof.

[0017] In one non-limiting example, the disinfectant may include a cationic molecule (i.e., a molecule having a positive charge), such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from a biguanide). According to some embodiments, the disinfectant may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from a bis-(dihydropyridinyl)-decane). According to some embodiments, the disinfectant may include an octenidine salt and / or a chlorhexidine salt. According to some embodiments, the disinfectant may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.

[0018] Additionally or alternatively, the disinfectant may include iodine. According to some embodiments, the iodine may be provided as an iodine complex, such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethyleneoxypolypropyleneoxy-iodine, undecoylinium-chloride-iodine, iodine povacrilex, and combinations thereof.

[0019] Additionally or alternatively, the disinfectant may include an oxidant (i.e., an oxidizing agent). Non-limiting examples of oxidants according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.

[0020] Additionally or alternatively, the disinfectant may include an antibiotic, which according to some embodiments may be bacitracin, vancomycin, gentamicin, ansef, clindamycin, and polymyxin, and combinations thereof.

[0021] Additionally or alternatively, the disinfectant may include Bactisure and XPerience, which according to some embodiments may be (1) sodium citrate (~30 g / L), citric acid (~32 g / L), and sodium lauryl sulfate (~1 g / L), and (2) sodium acetate (~30 g / L), acetic acid (~50 g / L), and benzalkonium chloride (~1 g / L) and ethanol (~100 g / L), and (3) combinations thereof.

[0022] A disinfectant may have sufficient antimicrobial activity to provide an acceptable log reduction of microorganisms within a period of time. As used herein, it should be understood that the term "microorganism" may refer to any microorganism that is to be killed and / or removed as a result of cleaning. Exemplary microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0023] Exemplary bacteria include, but are not limited to, Streptococcus spp. (e.g., Streptococcus mutans, Streptococcus pyogenes, Burkholderia salivarius, Burkholderia sanguis, etc.), Staphylococcus spp. (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Burkholderia haemolyticus, Burkholderia hominis, Burkholderia simulans, Burkholderia saprophyticus, etc.), Enterococcus spp. (e.g., Enzyme faecalis, Enzyme faecium, and Enzyme hirae, etc.), Bacteroides fragilis, Cutibacterium acnes (formerly Propionibacterium acnes), Clostridium difficile (spores and vegetative cells), Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Klebsiella spp. (e.g., K. aerogenes, K. pneumoniae, etc.), Acinetobacter baumannii, Malacoccus luteus, Haemophilus influenzae, and Serratia marcescens, both drug-resistant and drug-susceptible.

[0024] Exemplary fungi include, but are not limited to, drug-resistant and drug-susceptible Aspergillus brasiliensis, Candida species (C. albicans, C. auris, C. dubliniensis, C. glabrata, C. guilliermondii, C. kefir (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis), Epidermophyton inguinale, Microsporum species (e.g., M. gypseum, M. canis, etc.), and Trichophyton mentagrophytes.

[0025] Exemplary viruses include, but are not limited to, cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus types 1 (HSV-1) and 2 (HSV-2), influenza virus, parainfluenza virus, norovirus, and coronavirus, which contain DNA and RNA genomes that are single-stranded or double-stranded, with sense or antisense orientation, and protein coats (capsids) with or without a lipid envelope.

[0026] Exemplary bacteria include Streptococcus, Staphylococcus, Enterococcus, Pseudomonas, Streptococcus mutans, Streptococcus pyogenes (group A beta-hemolytic streptococci), Bordetella salivarius, Bordetella sanguis, Staphylococcus aureus, Staphylococcus epidermidis, Bordetella haemolyticus, Bordetella hominis, Bordetella simulans, Bordetella saprophyticus, Methicillin / oxacillin-resistant (MRSA / ORSA) and Methicillin / oxacillin-susceptible Staphylococci (MSSA / OSSA), Enterococci (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hirae), Vancomycin-resistant Enterococci (VRE) and Vancomycin-susceptible Enterococci (VSE), These include, but are not limited to, Bacteroides fragilis, Propionibacterium acnes, Propionibacterium acidophilus, Clostridium difficile (spores and vegetative cells), Selenomonas spp., Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella pneumoniae, Klebsiella aerogenes, K. pneumoniae multidrug resistant (MDR), Acinetobacter baumannii, A. baumannii MDR, Achromobacter xylosoxidans, Micrococcus luteus, Ralstonia picketii, Haemophilus influenzae, and Serratia marcescens.

[0027] Exemplary fungi include, but are not limited to, Aspergillus, Candida, Aspergillus niger, Candida albicans, C. auris, C. dubliniensis, C. glabrata (formerly Torulopsis glabrata), C. guilliermondii, C. keffiyeh (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis, Epidermophyton inguinale, Microsporum gypseum, M. canis, and T. mentagrophytes.

[0028] Exemplary viruses include, but are not limited to, those that have a lipid component in their coat or have an outer envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus types 1 (HSV-1) and 2 (HSV-2), influenza virus, parainfluenza virus, variola virus (smallpox virus), vaccinia, norovirus, and coronavirus.

[0029] Exemplary debris includes, but is not limited to, bone fragments, tissue, blood, bile, pus, mucus, feces, cartilage, fat, urine, environmental contaminants (ie, dirt, non-sterile fluids, hair, etc.).

[0030] Exemplary non-endogenous proteins include, but are not limited to, proteins derived from feces, gut flora, bacteria, and fungi.

[0031] According to some embodiments, the period of time may be a period of about 5 minutes or less, optionally about 4 minutes or less, optionally about 3 minutes or less, optionally about 2 minutes or less, and optionally about 1 minute or less.

[0032] According to some embodiments, the period of time may be about 120 seconds or less, optionally about 105 seconds or less, optionally about 90 seconds or less, optionally about 75 seconds or less, optionally about 60 seconds or less, optionally about 45 seconds or less, optionally about 30 seconds or less, and optionally about 15 seconds or less.

[0033] It should be understood that an "acceptable log reduction" can be microorganism-dependent. For example, as described herein, an acceptable log reduction can refer to an acceptable log reduction of one microorganism present on a surface (e.g., present in a body cavity or at an external wound site), a combination of two or more microorganisms present on a surface, or all microorganisms present on a surface.

[0034] According to some embodiments, an acceptable log reduction is at least about 1.0, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally at least about 2.1, optionally at least about 2.2, optionally at least about 2.3, optionally at least about 2.4, optionally at least about 2.5, optionally at least about 2.6, optionally at least about 2.7, optionally at least about 2.8, optionally at least about 2.9, optionally at least about 3.0, optionally at least about 3.1, optionally at least about 3.2, optionally at least about 3.3, optionally at least about 3.4, optionally at least about 3.5, optionally at least about 3.6, optionally at least about 3.7, optionally at least about 3.8, optionally at least about 3.9, optionally at least about 4.0, optionally at least about 4.1, optionally at least about 4.2, optionally at least about 4.3, optionally at least about 4.4, optionally at least about 4.5, optionally at least about 4.6, optionally at least about 4.7, optionally at least about 4.8, optionally at least about 4.9, and optionally at least about 5.0.

[0035] According to some embodiments, the disinfectant may be present in the disinfecting solution at a concentration sufficient to provide an acceptable log reduction of microorganisms over a period of time as described herein. According to some embodiments, the disinfectant may be present in the disinfecting solution at a concentration of about 0.001 to 5% w / v, optionally about 0.001 to 2.5% w / v, optionally about 0.001 to 1% w / v, optionally about 0.001 to 0.1% w / v, optionally about 0.001 to 0.01% w / v, optionally about 0.01 to 5% w / v, optionally about 0.01 to 2.5% w / v, optionally about 0.01 to 2% w / v, optionally about 0.01 to 1.5% w / v, optionally about 0.01 to 1% w / v, and optionally about 0.5% w / v.

[0036] According to some embodiments, the disinfectant may be present in the disinfecting solution at a concentration of about 0.1 to 0.9% w / v, optionally about 0.2 to 0.8% w / v, optionally about 0.3 to 0.7% w / v, and optionally about 0.4 to 0.6% w / v.

[0037] According to some embodiments, the disinfectant may be present in the disinfecting solution at a concentration of about 0.1 to 10% w / v, optionally about 0.2 to 1% w / v, optionally about 0.3 to 1% w / v, and optionally about 0.4 to 1% w / v.

[0038] It should be understood that, according to some embodiments, the cleaning fluid is not necessarily a disinfectant solution as described herein, but may be any medically acceptable fluid configured to perform the cleaning process as described herein. In one non-limiting example, the cleaning fluid may include saline. The saline may include water and sodium chloride in a medically acceptable concentration, such as about 0.1 to 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0039] According to some embodiments, the cleaning fluid may also contain radioisotopes, or in other words, radioactive elements, such as Fluorine-18, Gallium-67, Krypton-81m, Rubidium-82, Nitrogen-13, Technetium-99m, Indium-111, Iodine-123, Xenon-133, and Thallium-201.

[0040] According to some embodiments, the cleaning fluid may be a cleaning fluid as described in US Pat. No. 6,399,633, which is incorporated herein by reference in its entirety.

[0041] In accordance with the present disclosure, as described below, the device includes a body configured to contain a cleaning fluid as described herein. It should be understood that as used herein, "dispensing" (also referred to as "discharging") can refer to transferring the cleaning fluid to an application member in fluid communication with the body and / or transferring the cleaning fluid from the application member to a surface.

[0042] According to some embodiments, the body may comprise a body material that is compatible with the cleaning fluid contained therein, i.e., a material that does not chemically or physically react with the cleaning fluid or that does not otherwise render the cleaning fluid unsuitable for medical use.

[0043] According to one aspect of the present disclosure, the fluid lines may include semi-flexible conduits, flexible conduits, or rigid conduits. Additionally, the fluid lines may be transparent and visually see-through.

[0044] According to one aspect, the present disclosure does not require a line of sight to determine when an adequate amount of irrigation of the surgical cavity is complete. By monitoring the flow of irrigation fluid waste, the present disclosure can detect the presence of microorganisms and / or debris being removed from the surgical cavity at any location that contacts the irrigation fluid. This eliminates the limitation of only being able to evaluate visual areas and greatly facilitates monitoring of debris and / or microorganisms for other organs or tissues that may not be visually present.

[0045] According to another aspect, the present disclosure has a significantly higher sensitivity compared to conventional techniques that rely on visual inspection. Whereas conventional techniques rely on human vision (and therefore may not be sufficient to detect materials that are not discernible to the human eye (i.e., submicron particles, microorganisms, etc.)), the present disclosure uses analytical techniques and other detection methodologies that provide a significantly higher sensitivity compared to the human eye. The present disclosure eliminates the limited sensitivity to the assessment, thereby significantly improving the effectiveness of the assessment when the surgical cavity is adequately cleaned.

[0046] Additionally, according to another aspect, the present disclosure does not require the use of subjective methodology from conventional techniques, but instead has a quantifiable, non-subjective methodology for assessing irrigation of a surgical cavity. By utilizing a non-subjective methodology, the present disclosure eliminates limitations associated with surgeon-to-surgeon and patient-to-patient variability that hinders conventional techniques. Another advantage is that the non-subjective methodology does not require any specific training and / or experience by the surgeon, thereby further increasing reproducibility in determining when a surgical cavity is sufficiently irrigated.

[0047] The systems and methods can monitor fluid lines for substances such as microorganisms, debris, non-endogenous proteins, bone fragments, blood, bile, pus, feces, urine, environmental contaminants, microbial and fungal proteins, and / or other aspects, as described below.

[0048] 1 and 2 (as described below) together constitute a preferred irrigation system. FIG. 1 illustrates a portion of an example irrigation system for use in a surgical procedure, according to one embodiment of the present disclosure. As illustrated in FIG. 1, application member 100 may include a connecting portion 101 and an ejection portion 102. Connection portion 101 may be configured to connect application member 100 to a body 106, as described herein. Ejection portion 102 may include one or more ejection openings 103 configured to dispense a fluid (e.g., antiseptic solution, etc.) onto a surface, such as a surgical site, during a cleaning process. It should be understood that ejection portion 102 may include a conduit 104, which may be a semi-flexible conduit, a flexible conduit, or a rigid conduit.

[0049] 1, the application member 100 may further include a dispensing aid 105 as described herein, such as a pump. The dispensing aid may be a mechanical pump. Additionally or alternatively, the dispensing aid may be an electric pump.

[0050] It should be appreciated that the application member 100 having the dispensing assist device 105 described herein can dispense cleaning fluid (e.g., disinfectant solution, etc.) from the body 106 upon actuation of the dispensing assist device 105 (e.g., actuation of a pump described herein). Additionally or alternatively, the dispensing assist device 105 can function to dispense fluid from the body 106 in conjunction with gravity. For example, FIG. 1 illustrates an example body 106, i.e., a body configured such that at least a portion of the cleaning fluid contained therein is dispensed by gravity when provided in a particular orientation. It should be appreciated that the dispensing assist device advantageously allows a user to control the force of the dispensed cleaning fluid flow, the fluid flow rate, and / or the fluid flow pattern (e.g., pulsed or constant, etc.).

[0051] Although the example shown in FIG. 1 shows a discharge portion having one discharge opening, it should be understood that the discharge portion may include two, three, four, or more discharge openings. Each of the discharge openings may be the same size as one or more of the other discharge openings, or may be a different size than one or more of the other discharge openings. Additionally or alternatively, each of the discharge openings may have the same shape as one or more of the other discharge openings, or may have a different shape than one or more of the other discharge openings. The shape and / or size of the one or more discharge openings may be selected to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. According to some embodiments, the shape and / or size of the one or more discharge openings may be adjustable such that the dispensed fluid flow force, fluid flow rate, and / or fluid flow pattern may be adjustable.

[0052] 1 shows one example of an outlet portion of an irrigation system used in a surgical procedure, however, any conventional irrigation system outlet portion can be used. Additionally or alternatively, the body 106 can be made of a deformable material, such as plastic, which allows irrigation fluid to be expelled by applying a compressive force to the body.

[0053] FIG. 2 illustrates a portion of an example irrigation system for use in a surgical procedure according to one embodiment of the present disclosure. Illustrated in FIG. 2 is a medical aspiration system 200. As illustrated in FIG. 2, for example, the medical aspiration system 200 can include an aspiration monitoring assembly 202. The aspiration monitoring assembly 202 is described in detail below according to FIGS. 3 and 4. According to one embodiment of the present disclosure, the aspiration monitoring assembly 202 and / or its components can be disposable. The aspiration monitoring assembly 202 can include multiple lines 204 and 206. In one embodiment of the present disclosure, the aspiration line 206 is in and the line 204 is out. The lines 204 and 206 can be configured to facilitate fluid communication between a fluid line external to the aspiration monitoring assembly 202 and a fluid line internal to the aspiration monitoring assembly 202.

[0054] According to one aspect of the present disclosure, the medical aspiration system 200 includes a first aspiration line 206a. The medical aspiration system 200 may include a second aspiration line 206b in one aspect of the present disclosure. The aspiration monitoring assembly 202 may be configured to utilize the first and second aspiration lines 206a, 206b simultaneously and / or independently.

[0055] According to one aspect of the present disclosure, the medical suction system 200 may include a vacuum source 208. According to one aspect of the present disclosure, the vacuum source 208 is a hospital vacuum source. According to one aspect of the present disclosure, the vacuum source 208 is a pump. Many variations are possible as known to those skilled in the art. According to one aspect of the present disclosure, the vacuum source 208 is fluidly connected to the suction monitoring assembly 202 via a first vacuum line 210a. According to one aspect of the present disclosure, a second vacuum line 210b connects the vacuum source 208 to the suction monitoring assembly 202. The medical suction system 200 may be configured to utilize the first and second vacuum lines 210a, 210b simultaneously and / or independently.

[0056] According to one aspect of the present disclosure, the medical aspiration system 200 includes a waste tank 212. The waste tank 212 can be configured to store medical waste, which may include one or more substances selected from blood, tissue, bone, other bodily fluids and / or other debris, microorganisms, non-endogenous proteins, and / or dispensed irrigation fluid (i.e., irrigation fluid that has come into contact with the surgical area that may or may not contain additional substances based on the condition of the irrigation). According to one aspect of the present disclosure, the waste tank 212 is fluidly connected to a waste line 214 or other disposal line. The waste tank 212 can be connected to the suction monitoring assembly 202 via the waste line 214.

[0057] The suction monitoring assembly 202 can monitor one or more substances in medical waste removed from a body cavity, a surgical cavity, and / or an external wound during a surgical procedure. The same reference numbers are used for FIG. 2 as illustrated with reference to FIG. 3. In one embodiment of the present disclosure, the suction monitoring assembly 202 may include sampling devices 302a and 302b, which are connected in-line with corresponding first and second suction lines 206a and 206b, respectively. The sampling devices 302 are described in detail below with reference to FIG. 4. The sampling devices 302a and 302b are connected to fluid lines 306a and 306b, respectively.

[0058] Additionally, according to another aspect, the suction monitoring assembly 202 may include sampling ports 304a and 304b that are connected in-line with the corresponding first and second suction lines 206a and 206b, respectively. The sampling ports 304 are described in more detail below with reference to FIG. 4. The sampling ports 304a and 304b are connected to fluid lines 308a and 308b, respectively.

[0059] In one aspect of the present disclosure, a user, such as a surgeon, may be able to determine when perfusion is complete by monitoring the fluid passing through the first suction line 206a and the second suction line 206b continuously via a sampling device. In another aspect of the present disclosure, the fluid may be monitored in parallel with the fluid lines 306 and / or 308. The fluid lines 306 and / or 308 may be of different sized inner diameters to allow for different flow rates. For example, if a smaller path is used for one fluid line, the fluid may flow at a slower rate, which may help facilitate the selection of measurement techniques described below. In another aspect of the present disclosure, the fluid may be monitored via the sampling port 304 to allow a sample of the fluid to be obtained at a specific time and tested at a location remote from the perfusion system.

[0060] According to one aspect of the present disclosure, the fluid will be monitored for specific substances to determine if the irrigation and / or irrigation is complete. The substances to be monitored in the surgical irrigation waste may vary depending on the type of surgery and / or the patient's risk factors. For example, the substances to be monitored may be more general substances (i.e., any substances not in the irrigation and / or irrigation fluid solution itself) or more specific substances (i.e., the specific substances or microorganisms listed above) depending on the risk factors associated with the surgical procedure.

[0061] In another aspect of the disclosure, the material to be monitored may also be influenced by factors such as traumatic versus non-traumatic (traumatic surgery may have less control and greater variability in the material that may be present in the surgical cavity), risk to the surgery (possibility of inadvertently cutting the bowel during a surgical procedure, or detection of anastomotic leaks in colorectal surgery).

[0062] In one aspect of the present disclosure, the irrigation system can provide feedback to the user indicating that irrigation should continue or that irrigation is complete. In one aspect of the present disclosure, a visual indication, e.g., light 310, can be provided to the user indicating whether irrigation should continue or is complete. For example, if continuous monitoring is being performed by the irrigation system, the light 310 can provide immediate feedback to the surgeon regarding the effectiveness of irrigating and / or cleaning the surgical cavity. As described below in connection with FIG. 4, the intensity and / or color of the light can be related to the amount of material measured. For example, the light 310 can be red indicating that further irrigation and / or cleaning of the cavity may be necessary based on the sample device 302. This type of real-time output can also provide assistance in determining areas of the surgical cavity that may require further cleaning. For example, if the surgeon is rinsing a particular area of ​​the wound and immediately removing the waste stream, the real-time indication can provide guidance as to whether that particular area requires further irrigation.

[0063] According to another aspect of the present disclosure, the perfusion system can provide an audible indication to the user, such as, for example, through speaker 312. The audible indication thereby avoids the need for the surgeon and / or user to see a visual indication. In one aspect of the present disclosure, the pitch, volume and / or frequency of the sound of the audible indication can be related to the amount of material measured by the perfusion system.

[0064] 3, although two suction lines 206 are illustrated, any number of suction lines may be implemented, e.g., 1, 2, 3, 4, etc. Additionally, although both a sampling port 304 and a sampling device 302 are illustrated, any number or variation of sampling ports or sampling devices may be implemented, e.g., 1, 2, 3, 4, etc. For example, a single suction line may be implemented that includes a single sampling device 302 and no sampling ports. In another example, two sampling devices 302a may be included on a single suction line 206a. Any combination and / or variation may be implemented based on the sampling and / or measurement procedures described below.

[0065] FIG. 4 illustrates an exemplary device for detecting the presence and / or measuring the amount of a substance in a perfusion system according to one embodiment of the present disclosure, specifically illustrating a lateral flow test. The lateral flow test may be performed to detect the presence and / or measure the amount of a substance in the perfusion fluid waste stream, as described below. In one embodiment of the present disclosure, the lateral flow test may be located within the sampling device 302 for continuous monitoring and to provide feedback to the user. In another embodiment of the present disclosure, the lateral flow test may be located outside and away from the perfusion system, where the lateral flow test is provided with a sample obtained via the sampling port 304.

[0066] According to one aspect of the present disclosure, the test strip may be generally referred to as a lateral flow test strip, and the specific structure and detection principle of the test strip are known to those skilled in the art. A typical test strip includes a specimen collection area (also called sample pad), a marker area (also called conjugate pad) membrane, a detection area including a test area and a control area, and an absorbent area (also called wick), where the specimen collection area includes a specimen receiving pad, the marker area includes a marking pad, and the absorbent area may include an absorbent pad, and the detection area includes the necessary chemicals that can detect the presence of the substance to be detected (commonly called analyte), such as immunological reagents or enzymatic chemical reagents. A commonly used test strip is a nitrocellulose filter membrane strip, i.e., the detection area includes a nitrocellulose filter membrane, and specific binding molecules are immobilized on the nitrocellulose filter membrane to indicate the test result; it may also be a cellulose acetate membrane or a nylon membrane, etc. The detection area may also include a test area and a control area downstream, and generally, the control area and the test area appear in the form of horizontal lines called test lines or control lines. Other indicators, such as circles or squares, may be used. The test strips may be conventional reagent strips or other types of reagent strips that detect by capillary action. Furthermore, the test strips generally contain dry chemical reagent components, such as immobilized antibodies or any other reagents, and when encountering a liquid, the liquid flows along the reagent strip under capillary action, and the dry reagent components are dissolved in the liquid during the flow process and react with the dry reagents in the next area, thus performing the required detection. The liquid flows according to the capillary action.

[0067] In one aspect of the disclosure, the use of lateral flow testing may be used to determine the presence and / or amount of a target substance. As described above, this testing methodology works by adding the solution to be analyzed to one side of the cartridge / device / test strip. In one aspect of the disclosure, the solution is provided via the suction line from the wash procedure. The solution then travels across the cartridge via capillary action and interacts with various substrates that provide a visual indication of the presence of the target substance. In one embodiment, the test strip is loaded with a conjugated antibody that will bind to the analyte. If the analyte is present, binding to the antibody will occur. As the antibody / analyte complex continues to travel through the test strip, the complex can bind to additional reagents that provide a visual indication or symbol of the presence of the analyte.

[0068] In one embodiment of the present disclosure, the lateral flow test can provide a binary outcome, for example, "yes" for the presence of a target substance during rinsing or "no" for the absence of the target substance. In another embodiment of the present disclosure, the lateral flow test can compare the results to one or more thresholds, thereby providing a specific outcome based on the type of target substance being tested. For example, if the presence of any of the specific target substances is harmful to the patient during rinsing, a binary outcome can be implemented by the system. In another example, if the presence of a specific target substance is only harmful at a discrete level at a specific location on the patient, different thresholds can be implemented by the system during rinsing. In other words, if level 1 substance X is not harmful in the patient's arm during rinsing, but level 2 is harmful, the same cartridge / device / test strip can provide a level 1 or level 2 indication to the user to determine whether rinsing should be continued or completed. In another embodiment of the present disclosure, the lateral flow test can also provide a quantification of the target substance based on a comparison of thresholds. For example, the comparison of thresholds can provide a range. If the first threshold is met by the lateral flow test, then more than X amount of target substance is present. Additionally, if the second threshold is not met by the lateral flow test, less than Y amount of target material is present, etc. In other words, the user can determine the range of target material present in the wash based on multiple thresholds. For example, more than X amount but less than Y amount of target material is present in the wash, as described above. In other words, lateral flow is a highly sensitive test that detects at ppb levels for specific analytes. Based on the target material in the surgical site and waste stream, lateral flow thresholds can be established, as described above.

[0069] According to one aspect of the present disclosure, the use of this methodology for monitoring perfusion fluid offers many advantages over current techniques. First, the use of conjugated antibodies can allow for a very specific indication of the presence of a target substance, which may be part of a specific microorganism or a non-endogenous protein. In addition, this methodology can allow for a very low limit of detection, thereby allowing the presence of a target substance at low CFU / mL amounts to be accurately identified. This methodology can also provide a very rapid response, thereby providing the user or surgeon with near real-time information regarding the perfusion of the surgical cavity.

[0070] According to another aspect of the disclosure, this testing methodology can be incorporated for measurement of the waste perfusate flow at a particular time (i.e., the test strip may be contacted with the waste perfusate flow via the sampling device 302 or sampling port 304). This test can be used at different times during the perfusion process to monitor the progress of the perfusion in removing microorganisms, debris, or other material from the surgical cavity.

[0071] In addition, lateral flow test strips can be assembled to provide measurements at discrete intervals. Through the use of a multi-channel cartridge, perfusion fluid can be added to individual channels at discrete time intervals, thereby providing the surgeon with an indication of the presence of target substances throughout the perfusion process. For example, different test strips for testing different substances (e.g., analytes) in the waste stream can be placed in different sampling devices 302. In another example, a single lateral flow test strip can be placed in a single sampling device 302 or through a sampling port 304, but can also be designed to perform multiple tests at the same or different times.

[0072] As noted above, the detection agents (e.g., antibodies or chemical detectors) used in this testing methodology may be modified based on the particular surgical procedure and risk factors for the patient. For example, the presence of Propionibacterium acnes may be a significant risk factor during implant surgery, and thus the detection agent may be designed to specifically bind to this microorganism.

[0073] 5, therein is illustrated a flow diagram showing an example method 500 for measuring an amount of a substance in a perfusion system, according to one embodiment of the present disclosure. For example, method 500 may be performed in conjunction with the perfusion system described above with respect to FIGS. 1-4.

[0074] At block 502, the method may include providing an irrigation fluid to the surgical area. As described above, the irrigation fluid may be a lavage fluid. This fluid may be provided to the surgical area via the system described above with respect to FIG.

[0075] At block 504, the method may include removing irrigation fluid and medical waste materials in the surgical area. These irrigation fluid and medical waste materials mixed together can create a fluid flow. As described above, the fluid flow is monitored to determine when the surgeon's cleaning or irrigation is complete.

[0076] At block 506, the method may further include monitoring the fluid flow based on a detection test for an analyte, such as a lateral flow test, to generate a result. For example, the test may be configured to test for a specific substance based on the type of procedure being performed, such as described above. In one aspect of the disclosure, the result may be a negative or positive indication. For example, if the test shows a positive result, the result indicates that the area needs further cleaning. In another example, if the test shows a negative result, the result indicates that the area has completed cleaning and the wound can be closed.

[0077] At block 508, the method may include providing feedback to a user based on the results. For example, the test may provide an indication to communicate a positive or negative result. In another example, the test may trigger an alert, such as a light or an audible noise as described above, to communicate the result to the user.

[0078] In block A, the user may decide, based on the results generated, whether further cleaning is required or whether the wound can be closed.

[0079] Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof, and may be implemented in one or more computer systems or other processing systems. In one aspect, the present disclosure is directed to one or more computer systems capable of performing the functions described herein. An example of such a computer system 600 is shown in FIG.

[0080] In one aspect of the present disclosure, the suction monitoring assembly 202 may have a computer system, such as computer system 600, capable of processing and generating results of the monitoring, as described above. For example, the computer system may generate results from the outcome of the sampling devices 302a and 302b and / or the sampling ports 304a and 304b. The computer system 600 may further compare the results to a threshold and generate an output signal based on the comparison. For example, the lateral flow test strips may be measured / observed / screened using spectroscopy. The spectroscopy may convert the results into a numerical value by measuring / observing / screening the intensity of a visual display. The results may then be communicated along the computer system. The output signal may also be implemented to trigger an alert to the user, as described above. For example, a light may be illuminated and / or a sound may be generated based on the output signal. The user may then determine that the irrigation is complete and close the patient, or determine that the irrigation is not complete and continue irrigating the patient. In other words, if the flush is not complete for the patient, the system will alert the user, and the process can repeat itself until the system determines that the flush is complete and alerts the user.

[0081] 6 presents an example system diagram of various hardware components and other features for use according to one embodiment of the present disclosure. Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof, and may be implemented in one or more computer systems or other processing systems. In one example variant, the embodiments described herein may be directed to one or more computer systems capable of performing the functions described herein. An example of such a computer system 600 is shown in FIG.

[0082] Computer system 600 includes one or more processors, such as processor 604. Processor 604 is connected to a communications infrastructure 606 (e.g., a communications bus, crossover bar, or network, etc.). In one example, a perfusion system may include processor 604. Various software aspects are described in terms of this example computer system. After reading this description, it will become apparent to one skilled in the relevant art or arts how to implement aspects described herein using other computer systems and / or architectures.

[0083] Computer system 600 may include a display interface 602 that transfers graphics, text, and other data from a communications infrastructure 606 (or from a frame buffer, not shown) for display on a display unit 630. Computer system 600 also includes a main memory 608, preferably random access memory (RAM), and may also include a secondary memory 610. The secondary memory 610 may include a hard disk drive 612 and / or a removable storage drive 614, which may represent, for example, a floppy disk drive, a magnetic tape drive, an optical disk drive, or the like. The removable storage drive 614 reads from and / or writes to a removable storage unit 618 in a well-known manner. The removable storage unit 618 represents a floppy disk, magnetic tape, optical disk, or the like that is read from and written to by the removable storage drive 614. As will be appreciated, the removable storage unit 618 includes a computer usable storage medium having stored thereon computer software and / or data.

[0084] In alternative embodiments, secondary memory 610 may include other similar devices that allow computer programs or other instructions to be loaded into computer system 600. Such devices may include, for example, removable storage units 622 and interfaces 620. Examples of such devices may include program cartridges and cartridge interfaces (such as those found in video game devices), removable memory chips (such as erasable programmable read-only memories (EPROMs) or programmable read-only memories (PROMs)) and associated sockets, as well as other removable storage units 622 and interfaces 620 that allow software and data to be transferred from the removable storage units 622 to the computer system 600.

[0085] Computer system 600 may also include a communications interface 624. Communications interface 624 allows software and data to be transferred between computer system 600 and external devices. Examples of communications interface 624 may include a modem, a network interface (such as an Ethernet card), a communications port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, and the like. The software and data transferred via communications interface 624 is in the form of signals 628, which may be electronic, electromagnetic, optical, or other signals capable of being received by communications interface 624. These signals 628 are provided to communications interface 624 over a communications path (e.g., channel) 626. This path 626 carries signals 628 and may be implemented using wire or cable, fiber optics, telephone lines, cellular links, radio frequency (RF) links, and / or other communications channels. In this specification, the terms "computer program medium" and "computer usable medium" are used generally to refer to media such as removable storage drive 680, a hard disk installed in hard disk drive 670, and signals 628. These computer program products provide software to computer system 600. Aspects described herein may be directed to such computer program products.

[0086] Computer programs (also referred to as computer control logic) are stored in main memory 608 and / or secondary memory 610. Computer programs may also be received via communications interface 624. Such computer programs, when executed, enable computer system 600 to perform various features in accordance with aspects described herein. In particular, computer programs, when executed, enable processor 604 to perform such features. Such computer programs thus represent controllers of computer system 600.

[0087] In variations in which the aspects described herein are implemented using software, the software may be stored in a computer program product and loaded into the computer system 600 using the removable storage drive 614, the hard disk drive 612, or the communications interface 620. As described herein, the control logic (software), when executed by the processor 604, causes the processor 604 to perform functions according to the aspects described herein. In another variation, the aspects are implemented primarily in hardware, for example using hardware components such as application specific integrated circuits (ASICs). The implementation of hardware state machines to perform the functions described herein will be apparent to those skilled in the relevant art or arts.

[0088] In yet another example variation, aspects described herein are implemented using a combination of both hardware and software.

[0089] FIG. 7 is a block diagram of various example system components, according to one aspect. FIG. 7 illustrates a communication system 700 that can be used in accordance with various aspects described herein. The communication system 700 includes one or more accessors 760, 762 (also interchangeably referred to herein as one or more "users") and one or more terminals 742, 766. For example, the terminals 742, 766 may include a perfusion system or related systems, etc. In one aspect, data for use according to aspects described herein is entered and / or accessed, for example, by an assistant 760, 762 via a terminal 742, 766, such as a personal computer (PC), minicomputer, mainframe computer, microcomputer, telephone device, or wireless device such as a personal digital assistant ("PDA") or handheld wireless device, which is coupled, for example, via a network 744, such as the Internet or an intranet, and couplings 745, 746, 764 to a server 743, such as a PC, minicomputer, mainframe computer, microcomputer, or other device having a processor and a repository for data and / or a connection to a repository for data. The couplings 745, 746, 1464 include, for example, wired, wireless, or fiber optic links. In another exemplary variation, the methods and systems according to aspects described herein operate in a stand-alone environment, such as on a single terminal.

[0090] For example, in one aspect of the disclosure, the results generated by the system as described above can be sent or communicated to a remote server via a wired or wireless connection. For example, the perfusion system can send a quantitative number of target substances, a threshold comparison outcome, or any results of the irrigation process to the remote server. The remote server may include a patient's electronic medical record system (EMR). In another aspect of the disclosure, the remote server may be accessed by a mobile device or may actively contact the mobile device. For example, the mobile device can access the remote server with the results via a dedicated application or website loaded on the mobile device. In another example, the remote server can push or contact the mobile device via, for example, a text message, email, or push notification.

[0091] Aspects discussed herein may also be described and implemented with respect to computer-readable storage media that store computer-executable instructions. Computer-readable storage media include computer storage media and communication media, such as flash memory drives, digital versatile disks (DVDs), compact disks (CDs), floppy disks, and tape cassettes. Computer-readable storage media may include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information, such as computer-readable instructions, data structures, modules, or other data.

[0092] It will be appreciated that various implementations of the disclosed and other features and functions, or alternatives or variations thereof, may be desirably combined into many other different systems or applications, and various presently unforeseen or unanticipated substitutions, modifications, changes, or improvements may subsequently be made by those skilled in the art, which are also intended to be encompassed by the appended claims.

Claims

1. (a) providing irrigation fluid to a surgical area; (b) removing the irrigation fluid and medical waste in the surgical area via at least one suction line to generate a fluid flow within the at least one suction line; (c) analysing said fluid stream via a lateral flow test to generate a result based on predefined criteria; (d) generating a feedback signal based on the results, the feedback signal indicating whether cleaning has reached the predetermined criteria; and (e) based on the feedback signal, (1) if the predetermined criterion has not been reached, repeating steps (a) through (d) until the cleaning process reaches the predetermined criterion, or (2) if the predetermined criterion has been reached, terminating the cleaning process. A method of performing cleaning, comprising:

2. The method of claim 1 , wherein the lateral flow test is configured to test for a target substance contained within the fluid stream.

3. The method of claim 2 , wherein the target material comprises at least one of a microorganism, debris, or a non-endogenous protein.

4. 10. The method of claim 1, wherein the lateral flow test is performed in-line in the at least one aspiration line.

5. 5. The method of claim 4, wherein the lateral flow test is performed continuously on the fluid stream.

6. 5. The method of claim 4, wherein the lateral flow test is performed at least once on the fluid stream, and optionally periodically thereafter.

7. The method of claim 1 , wherein the feedback signal triggers a visual indication to a user.

8. The method of claim 7 , wherein the visual indicator is a light source.

9. The method of claim 7, wherein the visual indication is a symbol in the lateral flow test.

10. 10. The method of claim 1, wherein the lateral flow test is performed remotely by obtaining a sample from the fluid stream.

11. A system for performing the steps of claim 1.

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