Method and system for monitoring waste flow to improve efficiency of surgical irrigation process

Abstract

A method and system for monitoring waste flow during a surgical procedure. The method includes providing an irrigation fluid to the surgical field. The method may also include removing irrigation fluid and medical waste of the surgical field through the aspiration line to create a fluid flow in the aspiration line. The method may also monitor the fluid flow according to the lateral flow test to generate a result. The method may also include providing feedback to the user according to the result.

Description

Technical Field

[0001] Various aspects of the present disclosure relate to methods and systems for monitoring waste streams to improve the efficiency of surgical flushing procedures. Specifically, various aspects of the present disclosure relate to using lateral flow testing to determine the presence of target substances in waste streams, thereby improving the efficiency of surgical flushing procedures. Background Art

[0002] During most surgical procedures, the surgical cavity is "irrigated" (used interchangeably herein with "lavage") in order to minimize the presence of debris and / or microorganisms that could adversely affect the patient's surgical outcome. The ability to minimize debris and / or microorganisms helps to reduce and / or eliminate complications such as infection that could be disastrous to the patient's recovery.

[0003] Despite the importance of the irrigation process, there are no standard practices for surgeons to distinguish when the surgical cavity has been adequately irrigated and the wound is ready for closure. Surgeons are left to rely on experience and the appearance of the surgical cavity to determine when the irrigation process is complete. These practices are full of variability, which reduces the overall effectiveness of the irrigation process.

[0004] For example, traditional techniques require surgeons to visually assess and rely on experience to determine when adequate irrigation has been performed. This practice is highly variable due to the following factors: 1) reliance on clear line of sight to the surgical cavity; 2) limited sensitivity based on visual inspection; and 3) variability between surgeons due to the unclear or unquantifiable requirement of "knowing" what a clean surgical cavity should look like.

[0005] Therefore, there is a need in the art to provide the surgeon with an indication of when the surgical cavity has been effectively cleaned and when continued irrigation to remove debris and / or microorganisms is no longer necessary, i.e., when an acceptable level of decontamination has been achieved. More specifically, there is a need in the art for a standard that the surgeon can rely on to determine when irrigation can be considered complete and the wound can be closed. Summary of the invention

[0006] The following is a simplified summary of one or more aspects of the present disclosure to provide a basic understanding of these aspects. This summary is not an extensive overview of all contemplated aspects, and is neither intended to identify the key or important elements of all aspects, nor to delimit the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects of the present disclosure in a simplified form as a prelude to a more detailed description later.

[0007] According to some aspects, the present disclosure relates to methods and systems for monitoring waste flow during a surgical procedure. The method includes providing a flushing fluid to a surgical area. The method may also include removing the flushing fluid and medical waste from the surgical area through an aspiration line to generate a fluid flow in the aspiration line. The method may also include monitoring the fluid flow to generate a result based on a lateral flow test. The method may also include providing feedback to a user based on the result.

[0008] According to some aspects, the present disclosure relates to methods and systems for performing lavage. The method includes providing lavage fluid to a surgical area. The method also includes removing lavage fluid and medical waste from the surgical area through 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 when the feedback signal indicates a negative result, lavage is completed and the surgical area is closed; when the feedback signal indicates a positive result, lavage is not completed and the lavage method is repeated.

[0009] To achieve the above and related purposes, one or more aspects of the present disclosure include the features fully described below and particularly pointed out in the claims. The following description and drawings set forth in detail certain illustrative features of one or more aspects. However, these features are indicative of only a few of the various ways in which the principles of the various aspects can be employed, and the present description is intended to include all such aspects and their equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The novel features believed to characterize the various aspects described herein are set forth in the appended claims. In the following description, similar parts are labeled with the same numerals throughout the specification and drawings, respectively. The drawings are not necessarily drawn to scale, and certain drawings may be shown in exaggerated or generalized form for the sake of clarity and conciseness. However, the disclosure itself, as well as its preferred mode of use, further objects and improvements thereof, will be best understood by reading the following detailed description of exemplary embodiments in conjunction with the accompanying drawings, in which:

[0011] Figure 1 A portion of an example system according to various aspects of the present disclosure is shown;

[0012] Figure 2 Another portion of an example system according to various aspects of the present disclosure is shown;

[0013] Figure 3 An example puff monitoring assembly according to various aspects of the present disclosure is shown;

[0014] Figure 4 An example apparatus for measuring the amount of material in a flushing system according to various aspects of the present disclosure is shown;

[0015] Figure 5is a flow chart of an example method for monitoring a waste stream according to various aspects of the present disclosure;

[0016] Figure 6 An example system diagram illustrating various hardware components and other features used in accordance with various aspects of the present disclosure; and

[0017] Figure 7 is a block diagram of various example system components used in accordance with various aspects of the present disclosure. DETAILED DESCRIPTION

[0018] The following includes definitions of selected terms used herein. These definitions include various examples and / or forms of components that can be used for implementation within the scope of the terms. These examples are not limiting.

[0019] The following detailed description in conjunction with the accompanying drawings is intended to illustrate various configurations and is not intended to represent the only configuration for implementing the concepts described herein. In order to provide a comprehensive understanding of the various concepts, the detailed description includes specific details. However, it will be apparent to those skilled in the art that these concepts can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring these concepts.

[0020] Several aspects of certain systems will now be described with reference to various example systems and methods. These systems and methods will be described in the detailed description below and illustrated in the accompanying drawings by various blocks, modules, components, circuits, steps, processes, algorithms, etc. (collectively referred to as "elements"). These elements can be implemented using electronic hardware, computer software, or any combination thereof. Whether these elements are implemented in the form of hardware or software depends on the specific application and the design constraints on the overall system.

[0021] As used herein, the term "irrigation fluid" refers to a fluid suitable for use in the irrigating procedures described herein. As used herein, "irrigation" refers to the flushing of a body cavity, surgical cavity, and / or external wound.

[0022] According to certain aspects, the irrigation fluid may include a disinfectant solution. As used herein, a "disinfectant solution" refers to a solution comprising at least a solvent and one or more disinfectants. According to certain aspects, the disinfectant solution includes an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent comprises 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 aspects, the disinfectant solution includes an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent comprises 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, isopropanol, n-propanol, and combinations thereof.

[0023] In one non-limiting example, the disinfectant may include a cationic molecule (i.e., a molecule having a positive charge), for example, a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from biguanide). According to some aspects, the disinfectant may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some aspects, the disinfectant may include an octenidine salt and / or a chlorhexidine salt. According to some aspects, the disinfectant may include Alexidine, octenidine hydrochloride, chlorhexidine gluconate, and combinations thereof.

[0024] Additionally or alternatively, the disinfectant may include iodine. According to some aspects, the iodine may be provided in the form of an iodine complex, such as povidone iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyoxyethylene polyoxypropylene-iodine, enchloridium iodine, iodine polymers, and combinations thereof.

[0025] Additionally or alternatively, the disinfectant may include an oxidant (ie, an oxidizing medium). Non-limiting examples of oxidants according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.

[0026] Additionally or alternatively, the disinfectant may include an antibiotic. According to some aspects, the antibiotic may be bacitracin, vancomycin, gentamicin, cefazolin, clindamycin and polymyxin, and combinations thereof.

[0027] Additionally or alternatively, the disinfectant may also include Bactisure and XPerience. According to some aspects, Bactisure and XPerience 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), benzalkonium chloride (~1 g / L) and ethanol (~100 g / L), and (3) combinations thereof.

[0028] The disinfectant may have an antimicrobial activity sufficient to provide an acceptable log reduction of microorganisms over a certain period of time. It should be understood that, as used herein, the term "microorganism" may refer to any microorganism that is killed and / or removed by irrigation. Exemplary microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0029] Exemplary bacteria include, but are not limited to, drug-resistant and drug-sensitive Streptococci (e.g., Streptococcus mutans, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus sanguinis), Staphylococci (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus spp., Staphylococcus saprophyticus), Enterococci (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hilaris), Bacteroides fragilis, Propionibacterium acnes (formerly Propionibacterium acnes), Clostridium difficile (spores and vegetative cells), Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Klebsiella (e.g., Klebsiella aerogenes, Klebsiella pneumoniae), Acinetobacter baumannii, Micrococcus luteus, Haemophilus influenzae, and Serratia marcescens.

[0030] Exemplary fungi include, but are not limited to, resistant and drug-sensitive Aspergillus brasiliensis, Candida species (Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata, Candida guillermonida, Candida kefir (pretropical Candida), Candida krusei, Candida lusutsuga, Candida tropicalis), Epidermophyton floccosum, Microsporum species (e.g., Microsporum gypseum, Microsporum canis), and Trichophyton mentagrophytes.

[0031] Exemplary viruses include, but are not limited to, DNA and RNA genomes that are single-stranded or double-stranded, in sense or antisense orientation, with or without a lipid envelope and a protein coat (capsid), such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), influenza virus, parainfluenza virus, norovirus, and coronavirus.

[0032] Exemplary bacteria include, but are not limited to, Streptococci, Staphylococci, Enterococci, Pseudomonas, Streptococcus mutans, Streptococcus pyogenes (Group A β-hemolytic Streptococci), Streptococcus salivarius, Streptococcus sanguinis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus saprophyticus, methicillin / oxacillin-resistant Staphylococci (MRSA / ORSA) and methicillin / oxacillin-sensitive Staphylococci (MSSA / OSSA), Enterococci (such as Enterococcus faecalis, Enterococcus faecium and Enterococcus hilaris), Vancomycin-susceptible enterococci (VRE) and vancomycin-susceptible enterococci (VSE), Bacteroides fragilis, Propionibacterium acnes, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, Klebsiella pneumoniae, multidrug-resistant (MDR) Klebsiella pneumoniae, Acinetobacter baumannii, multidrug-resistant Acinetobacter baumannii, Achromobacter xylosoxidans, Micrococcus luteus, Ralstonia pickeri, Haemophilus influenzae, and Serratia marcescens.

[0033] Exemplary fungi include, but are not limited to, Aspergillus, Candida, Aspergillus niger, Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata (formerly Torulopsis glabrata), Candida guillermonii, Candida kefir (formerly Candida tropicalis), Candida krusei, Candida lusutsuga, Candida tropicalis, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis, and Trichophyton mentagrophytes.

[0034] Exemplary viruses include, but are not limited to, viruses having a lipid component in their outer shell or having an outer envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), influenza virus, parainfluenza virus, smallpox virus (pox virus), vaccinia virus, norovirus, and coronavirus.

[0035] Exemplary debris include, but are not limited to, bone fragments, tissue, blood, bile, pus, mucus, feces, cartilage, fat, urine, environmental contaminants (ie, dirt, non-sterile fluids, hair, etc.).

[0036] Exemplary non-endogenous proteins include, but are not limited to, feces, intestinal microbiota, proteins from microbes and fungi.

[0037] According to some aspects, the certain time period may be a time period of no more than about five minutes, optionally no more than about four minutes, optionally no more than about three minutes, optionally no more than about two minutes, and optionally no more than about one minute.

[0038] According to some aspects, the above-mentioned certain time period may not exceed about 120 seconds, optionally not exceed about 105 seconds, optionally not exceed about 90 seconds, optionally not exceed about 75 seconds, optionally not exceed about 60 seconds, optionally not exceed about 45 seconds, optionally not exceed about 30 seconds, and optionally not exceed about 15 seconds.

[0039] It should be understood that an "acceptable log reduction" may depend on the microorganism. For example, an acceptable log reduction as described herein may refer to an acceptable log reduction of one type of microorganism present on a surface (e.g., present in a body cavity or external wound), a combination of two or more types of microorganisms present on a surface, or all microorganisms present on a surface.

[0040] According to some aspects, an acceptable log reduction may be 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.

[0041] According to some aspects, the disinfectant may be present in the disinfecting solution at a concentration sufficient to provide an acceptable log reduction of microorganisms over a certain period of time as described herein. According to some aspects, the disinfectant may be present in the disinfecting solution at a concentration between about 0.001% w / v and 5% w / v, optionally between about 0.001% w / v and 2.5% w / v, optionally between about 0.001% w / v and 1% w / v, optionally between about 0.001% w / v and 0.1% w / v, optionally between about 0.001% w / v and 0.01% w / v, optionally between about 0.01% w / v and 5% w / v, optionally between about 0.01% w / v and 2.5% w / v, optionally between about 0.01% w / v and 2% w / v, optionally between about 0.01% w / v and 1.5% w / v, optionally between about 0.01% w / v and 1% w / v, and optionally about 0.5% w / v.

[0042] According to some aspects, the disinfectant may be present in the disinfecting solution at a concentration between about 0.1% w / v and 0.9% w / v, optionally between about 0.2% w / v and 0.8% w / v, optionally between about 0.3% w / v and 0.7% w / v, and optionally between about 0.4% w / v and 0.6% w / v.

[0043] According to some aspects, the disinfectant may be present in the disinfecting solution at a concentration between about 0.1% w / v and 10% w / v, optionally between about 0.2% w / v and 1% w / v, optionally between about 0.3% w / v and 1% w / v, and optionally between about 0.4% w / v and 1% w / v.

[0044] According to some aspects, the irrigation fluid need not be a disinfecting solution as described herein, and may be any medically acceptable fluid configured to perform an irrigation process as described herein. In one non-limiting example, the irrigation fluid may include a saline solution. The saline solution may include water and sodium chloride at a medically acceptable concentration, such as between about 0.1% and 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0045] According to some aspects, the irrigation fluid may also contain radioactive isotopes, in other words, isotopes that are radioactive, such as fluorine-18, gallium-67, krypton-81m, rubidium-82, nitrogen-13, technetium-99m, indium-111, iodine-123, xenon-133, and thallium-201.

[0046] According to some aspects, the irrigation fluid can be an irrigation fluid as described in US Application SN 17 / 152,565, which is incorporated herein by reference in its entirety.

[0047] The device according to the present disclosure, as described below, includes a body configured to contain an irrigation fluid as described herein. It should be understood that, as used herein, "dispensing" (alternatively referred to as "discharging") can refer to delivering the irrigation fluid to an application component in fluid communication with the body, and / or can refer to delivering the irrigation fluid from the application component to a surface.

[0048] According to some aspects, the body can include a body material that is compatible with the irrigation fluid contained therein, ie, a material that does not chemically or physically react with the irrigation fluid or otherwise render the irrigation fluid unsuitable for medical use.

[0049] According to one aspect of the present disclosure, the fluid line may include a semi-flexible conduit, a flexible conduit, or a rigid conduit. In addition, the fluid line may be transparent and can be visually seen through.

[0050] According to one aspect, the present disclosure eliminates the need for line of sight to determine when the proper amount of flushing of the surgical cavity has been completed. By monitoring the flushing solution waste stream, the present disclosure will be able to detect the presence of microorganisms and / or debris removed from the surgical cavity at any location that comes into contact with the flushing solution. This eliminates the limitation of only being able to evaluate those visible areas, and also greatly facilitates the monitoring of debris and / or microorganisms of other organs or tissues that may not be visible.

[0051] According to another aspect, the present disclosure has extremely high sensitivity compared to traditional practices that rely on visual inspection. Traditional methods rely on human vision (and therefore may be inadequate to detect substances that cannot be discerned by the human eye (i.e., submicron particles, microorganisms, etc.)), while the analytical techniques and other detection methods used by the present disclosure have higher sensitivity than the human eye. When the surgical cavity has been fully flushed, the present disclosure eliminates the limited sensitivity of the assessment, thereby greatly improving the effectiveness of the assessment.

[0052] Furthermore, according to another aspect, the present disclosure does not require the use of subjective methods in traditional practice, but rather utilizes a quantifiable, non-subjective method to assess the flushing of the surgical cavity. By using a non-subjective method, the present disclosure eliminates limitations associated with surgeon-to-surgeon and patient-to-patient variability that have hampered traditional practice. Another advantage is that the non-subjective method does not require the surgeon to receive any specific training and / or have any specific experience, thereby further improving the repeatability of determining when the surgical cavity has been adequately flushed.

[0053] The systems and methods described below can monitor substances in fluid lines, such as microorganisms, debris, non-endogenous proteins, bone fragments, blood, bile, pus, feces, urine, environmental contaminants, proteins from microorganisms and fungi, and / or other aspects.

[0054] Figure 1 and Figure 2 (described below) together form the preferred flushing system. Figure 1 An example portion of an irrigation system for use during a surgical procedure according to one aspect of the present disclosure is shown. Figure 1 As shown, the application member 100 may include a connection portion 101 and a discharge portion 102. As described herein, the connection portion 101 may be configured to connect the application member 100 to the body 106. The discharge portion 102 may include one or more discharge holes 103 for discharging a fluid (e.g., a disinfectant solution) to a surface (e.g., a surgical site) during an irrigation process. It should be understood that the discharge portion 102 may include a conduit 104, which may be a semi-flexible conduit, a flexible conduit, or a rigid conduit.

[0055] like Figure 1 As shown, the application component 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.

[0056] It should be understood that the applicator component 100 with the dispensing aid 105 as described herein can dispense irrigation fluid (e.g., disinfectant) from the body 106 when the dispensing aid 105 is actuated (e.g., when the pump as described herein is actuated). Additionally or alternatively, the dispensing aid 105 can be used to dispense fluid from the body 106 in conjunction with gravity. For example, Figure 1 An exemplary body 106 is shown, i.e., a body that is configured such that when it is positioned in a certain orientation, at least a portion of the irrigation fluid contained therein is dispensed by gravity. It should be appreciated that the dispensing assist device will advantageously allow a user to control the fluid flow force, fluid flow rate, and / or fluid flow pattern (e.g., pulsed or constant) of the irrigation fluid being dispensed.

[0057] although Figure 1 The example shown in shows a discharge portion with one discharge hole, but it should be understood that the discharge portion may include two, three, four or more discharge holes. Each discharge hole may have the same size or a different size as one or more of the other discharge holes. Additionally or alternatively, each discharge hole may have the same shape or a different shape as one or more of the other discharge holes. The shape and / or size of the one or more discharge ports may be selected to provide a certain fluid flow force, fluid flow rate and / or fluid flow pattern. According to some aspects, the shape and / or size of the one or more discharge holes may be adjustable so that the fluid flow force, fluid flow rate and / or fluid flow pattern of the distributed fluid may be adjustable.

[0058] although Figure 1 The example shown in shows an example of a discharge portion of an irrigation system used during a surgical procedure, but any conventional discharge portion of an irrigation system can be used. Additionally or alternatively, the body 106 can be made of a deformable material such as plastic, which allows the irrigation fluid to be discharged by applying a compressive force to the body.

[0059] Figure 2 An example portion of an irrigation system for use during a surgical procedure is shown in accordance with one aspect of the present disclosure. Figure 2 Shown is a medical suction system 200. Figure 2 As shown, for example, the medical suction system 200 may include a suction monitoring component 202. Figure 3 and Figure 4The suction monitoring assembly 202 is described in detail. According to one aspect of the present disclosure, the suction monitoring assembly 202 and / or its components can be disposable. The suction monitoring assembly 202 can include a plurality of lines 204 and 206. In one aspect of the present disclosure, the suction line 206 is a suction line and the line 204 is a suction line. The lines 204 and 206 can be configured to facilitate fluid communication between a fluid line external to the suction monitoring assembly 202 and a fluid line internal to the suction monitoring assembly 202.

[0060] According to one aspect of the present disclosure, the medical suction system 200 includes a first suction line 206a. In one aspect of the present disclosure, the medical suction system 200 may include a second suction line 206b. The suction monitoring assembly 202 may be configured to use the first suction line 206a and the second suction line 206b simultaneously and / or separately.

[0061] 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. As known to those skilled in the art, there may be many variations. 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 can be configured to use the first vacuum line 210a and the second vacuum line 210b simultaneously and / or separately.

[0062] According to one aspect of the present disclosure, the medical suction system 200 includes a waste bin 212. The waste bin 212 can be configured to store medical waste, which can include one or more substances selected from blood, tissue, bone, other body fluids and / or other debris, microorganisms, non-endogenous proteins and / or distributed irrigation fluid (i.e., irrigation fluid that has been in contact with the surgical field, which may or may not contain additional substances depending on the state of irrigation). According to one aspect of the present disclosure, the waste bin 212 is connected to a waste line 214 or other processing line fluid. The waste bin 212 can be connected to the suction monitoring assembly 202 via the waste line 214.

[0063] The suction monitoring component 202 can monitor one or more substances in medical waste removed from a body cavity, surgical cavity, and / or external wound during a surgical procedure. Figure 3 The reference numerals shown are also used for Figure 2In one aspect of the present disclosure, the suction monitoring assembly 202 may include a sampling device 302a and a sampling device 302b, and the sampling device 302a and the sampling device 302b are respectively connected in series to the corresponding first suction pipeline 206a and the second suction pipeline 206b. Figure 4 The sampling device 302 is described in detail. The sampling devices 302a and 302b are connected to the fluid lines 306a and 306b, respectively.

[0064] In addition, according to another aspect, the suction monitoring assembly 202 may include sampling ports 304a and 304b, which are connected in series to the corresponding first suction line 206a and second suction line 206b, respectively. Figure 4 The sampling port 304 is described in detail. The sampling ports 304a and 304b are connected to the fluid lines 308a and 308b, respectively.

[0065] In one aspect of the present disclosure, a user (e.g., a surgeon) can continuously monitor the fluid passing through the first suction line 206a and the second suction line 206b by a sampling device to determine when flushing is completed. In another aspect of the present disclosure, the fluid can be monitored in parallel with the fluid line 306 and / or the fluid line 308. The inner diameter size of the fluid line 306 and / or the fluid line 308 can be different to achieve different flow rates. For example, if the path of a fluid line is smaller, the fluid will flow at a lower flow rate and may help select a measurement technique, as described below. In another aspect of the present disclosure, the fluid can be monitored by the sampling port 304 so that a sample of the fluid is obtained at a specific time and tested away from the flushing system.

[0066] According to one aspect of the present disclosure, specific substances in the fluid are monitored to determine whether flushing and / or lavage is complete. The substances to be monitored in the surgical flushing waste can vary depending on the type of surgery and / or patient risk factors. For example, the substances to be monitored can be more general (i.e., any substance that is not in the flushing and / or lavage fluid itself) or more specific (i.e., specific substances or microorganisms as described above), depending on the risk factors associated with the surgical procedure.

[0067] In another aspect of the present disclosure, the substances to be monitored may also be affected by factors such as trauma versus non-traumatic (traumatic surgery may have poorer control and greater variability over substances that may be present in the surgical cavity), surgical risks (the intestine may be inadvertently cut during surgery or anastomotic leaks may be detected in colorectal surgery).

[0068] In one aspect of the present disclosure, the irrigation system can provide feedback to the user indicating that irrigation should continue or that irrigation has been completed. In one aspect of the present disclosure, a visual indication, such as a light 310, can be provided to the user indicating whether irrigation should continue or has been completed. For example, if the irrigation system is continuously monitoring, the light 310 can provide the surgeon with immediate feedback on the effectiveness of irrigation and / or the cleaning of the surgical cavity. As described below in conjunction with Figure 4 As described, the intensity and / or color of the light can be associated with the amount of substance measured. For example, the light 310 can be red, indicating that the cavity may need more flushing and / or cleaning according to the sampling device 302. This type of real-time output can also help determine the area of ​​the surgical cavity that may need additional cleaning. For example, if the surgeon is cleaning a specific area of ​​the wound and immediately clearing the waste stream, the real-time indication can provide guidance for whether the specific area needs further flushing.

[0069] According to another aspect of the present disclosure, the irrigation system can provide an audible indication to the user, for example, a speaker 312. Thus, the audible indication does not require the surgeon and / or user to view 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 associated with the amount of substance measured by the irrigation system.

[0070] See also Figure 3 Although two suction lines 206 are shown in the figure, any number of suction lines can be implemented, for example, the number of suction lines is 1, 2, 3, 4, etc. In addition, although the sampling port 304 and the sampling device 302 are shown in the figure, any number or variation of the sampling port or the sampling device can be implemented, for example, the number of the sampling port or the sampling device is 1, 2, 3, 4, etc. For example, a single suction line can be implemented, which includes a separate sampling device 302 and does not include a sampling port. In another example, two sampling devices 302a can be included on a single suction line 206a. Any combination and / or variation can be implemented based on the sampling process and / or measurement process described below.

[0071] Figure 4 An exemplary device for detecting the presence of a substance in a flushing system and / or for measuring the amount of a substance in a flushing system is shown according to one aspect of the present disclosure, specifically for a lateral flow test. As described below, a lateral flow test can be used to detect the presence of a substance in a flushing liquid waste stream and / or to measure the amount of a substance in a flushing liquid waste stream. In one aspect of the present disclosure, the lateral flow test can be located within a sampling device 302 for continuous monitoring and to provide feedback to a user. In another aspect of the present disclosure, the lateral flow test can be located outside of the flushing system and away from the flushing system, wherein the lateral flow test is provided with a sample obtained through a sampling port 304.

[0072] According to one aspect of the present disclosure, the test strip can be generally referred to as a lateral flow test strip, and the specific structure and detection principle of the test strip are well known to those of ordinary skill in the art. The common test strip includes a specimen collection area (also referred to as a sample pad), a labeling area (also referred to as a binding pad), a detection area including a membrane, a test area and a control area, and a water absorption area (also referred to as a wick), wherein the specimen collection area includes a specimen receiving pad, the labeling area includes a labeling pad, the water absorption area may include a water absorption pad, and the detection area includes necessary chemicals that can detect the presence of a substance to be detected (commonly referred to as an analyte), for example, an immunoreagent or an enzyme chemical reagent. The commonly used test strip is a nitrocellulose filter strip, that is, the detection area includes a nitrocellulose filter membrane, and a specific binding molecule is fixed on the nitrocellulose filter membrane to display the test result; it can also be a cellulose acetate membrane or a nylon membrane, etc. In addition, the detection area can also include a downstream test area and a control area, and generally, the control area and the test area appear in the form of horizontal lines, which are referred to as test lines or control lines. Other indications can also be used, such as round, square, etc. The test strip is a traditional reagent strip, or it can be other types of reagent strips that are detected by capillary action. In addition, the test strip usually includes dry chemical reagent components, such as fixed antibodies or any other reagents, and when encountering a liquid, the liquid flows along the test strip under capillary action, and the dry reagent components are dissolved in the liquid during the flow and react with the dry reagent in the next area of ​​the area, thereby performing the necessary detection. The liquid flows by capillary action.

[0073] In one aspect of the present disclosure, a lateral flow test can be used to determine the presence and / or quantity of a target substance. As described above, the principle of this test method is to add a solution to be analyzed to one side of the test kit / device / test strip. In one aspect of the present disclosure, the solution is provided by a suction line from a lavage process. Subsequently, the solution flows through the test kit by capillary action and interacts with various substrates that provide visual indications of the presence of the target substance. In one embodiment, the test strip is loaded with a conjugated antibody that binds to the analyte. If the analyte is present, it will bind to the antibody. As the conjugate of the antibody and the analyte continues to migrate on the test strip, the conjugate can be combined with additional reagents that provide visual indications or symbols of the presence of the analyte.

[0074] In one aspect of the present disclosure, a lateral flow test can provide a binary conclusion, for example, "yes" indicates that the target substance is present during the lavage process, and "no" indicates that the target substance is not present during the lavage process. In another aspect of the present disclosure, the lateral flow test can compare the result with a threshold (or multiple thresholds) to provide a specific conclusion based on the type of target substance being tested. For example, if a specific target substance that is harmful to the patient is present during the lavage process, the system will produce a binary conclusion. In another example, if the presence of a specific target substance is only harmful at a specific level at a specific location of the patient, the system can implement different thresholds during the lavage process. In other words, if the X substance at level 1 is not harmful to the patient's arm during the lavage process, but the X substance at level 2 is harmful, the same kit / device / test strip can provide the user with an indication of level 1 or level 2 to determine whether the lavage should continue or has been completed. In another aspect of the present disclosure, the lateral flow test can also provide quantification of the target substance based on the comparison of multiple thresholds. For example, the comparison of multiple thresholds can provide a range. If the lateral flow test meets the first threshold, there is more than X amount of the target substance. Additionally, if the lateral flow test does not meet a second threshold, then less than Y amount of the target substance is present, and so on. In other words, the user can determine a range of target substances present during the lavage process based on multiple thresholds. For example, as described above, more than X amount but less than Y amount of the target substance is present during the lavage process. In other words, lateral flow is a sensitive test that can detect certain analytes at ppb levels. Depending on the target substance in the surgical site and the waste stream, the lateral flow thresholds described above can be determined.

[0075] According to one aspect of the present disclosure, the use of this method of monitoring flushing solutions has many advantages over current practices. First, the use of conjugated antibodies enables a very unique indication of the presence of a target substance. The target substance can be part of a specific microorganism or a non-endogenous protein. In addition, this method is able to achieve very low detection limits, so the presence of low CFU / mL amounts of the target substance can be accurately identified. This method can also provide a very rapid response, thereby providing the user or surgeon with near real-time information about the flushing of the surgical cavity.

[0076] According to another aspect of the present disclosure, such a test method can be used to measure the flow of flushing solution waste at a specific time (i.e., the test strip can be in contact with the flow of flushing solution waste via the sampling device 302 or the sampling port 304). This test can be used at different times during the flushing process to monitor the progress of the flushing in clearing microorganisms, debris, or other material from the surgical cavity.

[0077] In addition, the lateral flow test strips can be configured to provide measurements at discrete intervals. Through the use of a multi-channel kit, flushing solutions can be added to each channel at discrete time intervals, thereby providing the surgeon with an indication of the presence of the target substance throughout the flushing 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 located in a single sampling device 302 or through a sampling port 304, but is designed to perform multiple tests at the same or different times.

[0078] As described above, the detection substance (e.g., antibody or chemical detector) used in the test method can be modified according to the specific surgical procedure and the patient's risk factors. For example, in implant surgery, the presence of Propionibacterium acnes may be a significant risk factor, so the detection substance can be designed to specifically bind to this microorganism.

[0079] See also Figure 5 , which shows a flow chart of an example method 500 for measuring the amount of a substance in a flushing system according to one aspect of the present disclosure. Figures 1 to 4 The flushing system is used to perform method 500.

[0080] At block 502, the method may include providing a flushing fluid to the surgical area. As described above, the flushing fluid may be an irrigation fluid. Figure 1 The system described provides fluid to a surgical field.

[0081] At block 504, the method may include removing irrigation fluid and medical waste from the surgical area. These irrigation fluids and medical waste are mixed together to produce a fluid stream. As described above, the fluid stream is monitored to determine when the surgeon's irrigation or flushing is complete.

[0082] At block 506, the method may further include monitoring the fluid flow according to a detection test (e.g., a lateral flow test) for the analyte to generate a result. For example, the test can be configured to test for a specific substance based on the type of procedure performed, such as described above. In one aspect of the present disclosure, the result can be a negative indication or a positive indication. For example, if the test indicates a positive result, the result indicates that the area needs further irrigation. In another example, if the test indicates a negative result, the result indicates that the area has been irrigated and the wound can be closed.

[0083] At block 508, the method may include providing feedback to the user based on the results. For example, the test may provide an indication of conveying a positive or negative result. In another example, the test may trigger a reminder, such as a light or audible noise as described above, to convey the result to the user.

[0084] At Block A, the user will determine whether further irrigation or closure of the wound is required based on the results generated.

[0085] Various 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 implementing the functionality described herein. An example of such a computer system 600 is shown in FIG. Figure 6 Shown in.

[0086] In one aspect of the present disclosure, the suction monitoring component 202 may include a computer system, such as a computer system 600, which is capable of processing and generating monitoring results, as described above. For example, the computer system may generate results based on the conclusions of the sampling devices 302a and 302b and / or the sampling ports 304a and 304b. The computer system 600 may further compare the result with a threshold value and generate an output signal based on the comparison. For example, a lateral flow test strip may be measured / observed / checked using spectroscopy. Spectroscopy may convert the result into a numerical value by measuring / observing / checking the intensity of a visual indicator. The result may then be transmitted to the computer system. As described above, the output signal may further be used to trigger a reminder to the user. For example, a light may be turned on and / or a sound may be emitted based on the output signal. The user may then determine that the lavage has been completed and the patient may be sutured, or that the lavage is not completed and the patient may continue to be lavaged. In other words, if the patient's lavage is not completed, the system may remind the user, and the process may be repeated until the system determines that the lavage is completed and reminds the user.

[0087] Figure 6 An example system diagram of various hardware components and other functions used according to one aspect of the present disclosure is presented. Various 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 variation, various aspects 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. Figure 6 Shown in.

[0088] Computer system 600 includes one or more processors, such as processor 604. Processor 604 is connected to a communication infrastructure 606 (e.g., a communication bus, a jumper, or a network). In one example, a flushing system may include processor 604. Various software aspects are described based on this example computer system. After reading this description, it will become apparent to those familiar with the relevant technology how to implement various aspects described herein using other computer systems and / or architectures.

[0089] The computer system 600 may include a display interface 602 for forwarding graphics, text, and other data from the communication infrastructure 606 (or a frame buffer not shown) for display on a display unit 630. The computer system 600 also includes a main memory 608, preferably a random access memory (RAM), and may also include a secondary memory 610. The secondary memory 610 may include, for example, a hard disk drive 612 and / or a removable storage drive 614, in the form of a floppy disk drive, a magnetic tape drive, an optical disk drive, etc. 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 is in the form of a floppy disk, a magnetic tape, an optical disk, etc., which is read and written to by the removable storage drive 614. It will be appreciated that the removable storage unit 618 includes a computer usable storage medium having computer software and / or data stored therein.

[0090] In alternative aspects, the secondary memory 610 may include other similar devices that allow computer programs or other instructions to be loaded into the computer system 600. Such devices may include, for example, a removable storage unit 622 and an interface 620. Examples thereof may include a program cartridge and cartridge interface (such as in a video game device), a removable storage chip (such as an erasable programmable read-only memory (EPROM) or a programmable read-only memory (PROM)) and an associated socket, and other removable storage units 622 and interfaces 620 that allow software and data to be transferred from the removable storage unit 622 to the computer system 600.

[0091] The computer system 600 may also include a communication interface 624. The communication interface 624 allows software and data to be transmitted between the computer system 600 and external devices. Examples of the communication interface 624 may include a modem, a network interface (such as an Ethernet card), a communication port, a personal computer memory card international association (PCMCIA) slot and card, etc. The software and data transmitted through the communication interface 624 are in the form of signals 628, which may be electronic signals, electromagnetic signals, optical signals, or other signals that can be received by the communication interface 624. These signals 628 are provided to the communication interface 624 through a communication path (such as a channel) 626. The path 626 carries the signal 628 and can be implemented using wires or cables, optical fibers, telephone lines, cellular links, radio frequency (RF) links, and / or other communication channels. In this article, the terms "computer program medium" and "computer usable medium" are generally used to refer to media such as removable storage drives 680, hard disks installed in hard disk drives 670, and signals 628. These computer program products provide software for the computer system 600. Various aspects described herein may be directed to such computer program products.

[0092] Computer programs (also referred to as computer control logic) are stored in the main memory 608 and / or the secondary memory 610. The computer programs may also be received via the communication interface 624. These computer programs, when executed, enable the computer system 600 to perform various functions in accordance with various aspects described herein. In particular, the computer programs, when executed, enable the processor 604 to perform these functions. Thus, these computer programs represent controllers of the computer system 600.

[0093] In a variation where software is used to implement the various aspects described herein, the software can 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 communication interface 620. When the control logic (software) is executed by the processor 604, the processor 604 is caused to perform functions according to the various aspects described herein as described herein. In another variation, the various aspects are primarily implemented in hardware, for example using hardware components such as application specific integrated circuits (ASICs). It will be apparent to those familiar with the relevant technology how to implement a hardware state machine to perform the functions described herein.

[0094] In another example variation, various aspects described herein are implemented by a combination of hardware and software.

[0095] Figure 7 is a block diagram of various example system components according to one aspect. Figure 7 A communication system 700 is shown 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 can include a flushing system or related system and / or similar system. In one aspect, data used in accordance with various aspects described herein is input and / or accessed, for example, by accessors 760, 762 via terminals 742, 766 (such as personal computers (PCs), minicomputers, mainframe computers, microcomputers, telephone devices, or wireless devices, such as personal digital assistants ("PDAs") or handheld wireless devices), which are coupled to servers 743 (such as personal computers, minicomputers, mainframe computers, microcomputers, or other devices having processors and data storage repositories and / or devices connected to data storage repositories) through networks 744 (such as the Internet or intranets) and connections 745, 746, 764. Connections 745, 746, 764 include, for example, wired, wireless, or fiber optic links. In another example variation, methods and systems according to aspects described herein are executed in a standalone environment, such as on a single terminal.

[0096] For example, in one aspect of the present disclosure, the results generated by the system as described above can be transmitted or communicated to a remote server via a wired or wireless connection. For example, the flushing system can transmit a quantitative amount of a target substance, a threshold comparison result, or any result of an lavage process to a remote server. The remote server may include an electronic medical record system (EMR) of the patient. In another aspect of the present disclosure, the remote server can be accessed by a mobile device, or the remote server can actively contact the mobile device. For example, the mobile device can access the remote server containing the results through a website or a dedicated application loaded on the mobile device. In another example, the remote server can push or contact the mobile device through, for example, text messages, emails, or push notifications.

[0097] Various aspects discussed herein may also be described and implemented in the context of computer-readable storage media storing computer-executable instructions. Computer-readable storage media include computer storage media and communication media. For example, flash drives, digital versatile disks (DVDs), compact disks (CDs), floppy disks, and magnetic tape cassettes. Computer-readable storage media may include volatile and non-volatile, removable and non-removable media that may use any method or technology to store information (e.g., computer-readable instructions, data structures, modules, or other data).

[0098] It is understood that the various implementations of the above and other features and functions, or their alternatives or variations, can be combined into many other different systems or applications as needed. In addition, those skilled in the art can also make various currently unforeseen or unexpected substitutions, modifications, variations or improvements, which are also included in the following claims.

Claims

1. A method for performing lavage, comprising the following steps: (a) providing irrigation fluid to the surgical area; (b) removing the irrigation fluid and medical waste from the surgical area through at least one suction line to create a fluid flow in the at least one suction line; (c) analyzing the fluid flow by a lateral flow test to generate a result according to a predetermined standard; (d) generating a feedback signal based on the result, wherein the feedback signal indicates whether the irrigation has reached the predetermined standard; and (e) based on the feedback signal, (1) if the predetermined standard has not been met, repeating steps (a) to (d) until the irrigation has met the predetermined standard, or (2) if the predetermined standard has been met, ending the irrigation process.

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

3. The method according to claim 2, wherein: The target substance includes at least one of microorganisms, debris or non-endogenous proteins.

4. The method according to claim 1, wherein: The lateral flow test is performed serially on the at least one aspiration line.

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

6. The method according to claim 4, wherein: The lateral flow test is performed at least once and, if necessary, periodically thereafter on the fluid flow.

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

8. The method according to claim 7, wherein: The visual indication is a light source.

9. The method according to claim 7, wherein: The visual indication is a symbol relating to the lateral flow test.

10. The method according to 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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