Sample collection device and system for diagnostic screening

Abstract

Devices and systems for sample screening inside portions of a body and related methods of screening are provided. In an example, the device includes a lavage tube fluidically couplable at a proximal end to a lavage fluid reservoir; a lavage and sample collection tube fluidically couplable at a proximal end to a lavage collection reservoir; and a tip shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject. In an example, the tip defines one or more lavage apertures fluidically coupled to a distal end of the lavage tube and shaped and sized to allow passage of a lavage fluid therethrough; and one or more sample collection apertures coupled to a distal end of the lavage and sample collection tube and shaped to allow passage of a sample comprising cells therethrough.

Description

SAMPLE COLLECTION DEVICE AND SYSTEM FOR DIAGNOSTIC SCREENINGCROSS-REFERENCE(S) TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 749180, filed January 24, 2025, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] Gastric cancer affects more than 1 million people each year. High-risk populations include Eastern Europe, Central South America, Alaskan Natives, and East Asia, where the latter represents 60% of global gastric cancer cases. Gastric cancer has a good prognosis in its early stages, but as time progresses and the cancer develops, it worsens. With early detection, patients have the opportunity to treat their cancer before it progresses to the later stages and ideally, can undergo easier treatments. Currently, risk for gastric cancer is monitored based upon the known risk factors — age, family history, diet, genetics, chronic gastritis, and H. pylori infection. Typically, chronic inflammation of stomach tissue leads to intestinal metaplasia, a precancerous change in the mucosal lining of the stomach with intestinal epithelium. In order to detect gastric cancer at an early stage, people at risk for intestinal metaplasia and gastric cancer undergo a screening test called gastrointestinal endoscopy and biopsy, an invasive and costly procedure. Those people found to have intestinal metaplasia are then followed in surveillance programs to monitor the metaplasia for progression towards cancer.

[0003] There is presently a need for a non-endoscopic and non-invasive device capable of detecting, for example, intestinal metaplasia in high-risk people.SUMMARY

[0004] To address these and related challenges and needs, the present disclosure provides a device, such as a portable gastric cancer screening device, that is less invasive and more cost efficient than current gastric cancer detection systems and methods, that can comprehensively sample cells and increase accessibility for at-risk populations.

[0005] In embodiments, the device is a powered fluidic device comprising tubular extensions that slip into the stomach trans-nasally or orally for the collection of tissue fragments, cells, cell fragments (proteins and DNA), microorganisms, and blood for diseasediagnosis and prognosis. In embodiments, the device produces one or more jets of pressurized water or saline that are pulsed or continuous for periods of time to dislodge these diagnostic biologicals from the stomach lining. These diagnostic biologicals then accumulate in the water or saline temporarily in the stomach. Collection of these diagnostic biologicals occurs when the wash is obtained from the stomach using the tubing apparatus. Optical sensing of the wash can determine amounts of cells and tissue by optical scattering of the wash, and blood by optical absorption measurements. Maximum thresholds can be set to provide a safety limit on fluid pressure and / or flow (pulse) rate, while a minimum threshold may be set for the same parameters for achieving adequate amounts of diagnostic biologicals to make a disease diagnosis. Chemical additives (e.g., demucus / mucolytic chemicals, such as acetylcysteine (NAC)) to the fluid can reduce bubbles and increase biological releases, while fluidic filtering can provide cleaner optical signals for blood measurement and concentrate diagnostic biologicals. These optical measurements and fluidic pressure and flow volumes calculations from sensors can be used for real-time feedback control for safety and performance of the procedures. Control parameters can adjust the gage pressures of the pumps that apply positive and negative pressures to the fluid, flow and pulse rates, and total volume of fluid used in the procedure. Fluidic power can also steer and / or rotate one or more of the jets, tubing, and nozzles to comprehensively sample from the entire stomach lining.

[0006] Accordingly, in an aspect, the present disclosure provides a device for harvesting cells from a portion of the body. In an embodiment, the device comprising a lavage tube fluidically couplable at a proximal end to a lavage fluid reservoir; a lavage and sample collection tube fluidically couplable at a proximal end to a lavage collection reservoir; and a tip shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject, wherein the tip defines: one or more lavage apertures fluidically coupled to a distal end of the lavage tube and shaped and sized to allow passage of a lavage fluid therethrough; and one or more sample collection apertures coupled to a distal end of the lavage and sample collection tube and shaped to allow passage of a sample comprising cells therethrough.

[0007] In an embodiment, the tip is shaped and sized to pass through the nasal cavity of the subject.

[0008] In an embodiment, the tip is shaped and sized to pass through the oral cavity of the subject

[0009] In an embodiment, the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0010] In an embodiment, the one or more lavage apertures are disposed in the cylindrical surface.

[0011] In an embodiment, wherein the one or more lavage apertures are disposed at a proximal end of the cylindrical surface.

[0012] In an embodiment, the tip is configured to rotate when the lavage fluid passes through the one or more lavage apertures.

[0013] In an embodiment, the one or more sample collection apertures are disposed at a distal panel of the two panels.

[0014] In an embodiment, a length of the tip is in a range of about 10 mm to about 30 mm.

[0015] In an embodiment, a width of the tip is in a range of about 1 mm to about 8 mm.

[0016] In an embodiment, the lavage tube and the lavage and sample collection tube are arranged coaxially.

[0017] In another aspect, the present disclosure provides a system comprising a device according to any embodiment described herein.

[0018] Accordingly, in an embodiment, the present disclosure provides a system comprising a device of according to any embodiment of the present disclosure; a lavage fluid reservoir coupled to the proximal end of the lavage tube; a lavage collection reservoir coupled to the proximal end of the lavage and sample collection tube; and a pump configured to pump a lavage fluid from the lavage fluid reservoir through the lavage tube and to pump a sample through the lavage and sample collection tube to the lavage collection reservoir.

[0019] In an embodiment, the system further comprises a controller operatively coupled to the pump, the controller comprising logic that, when executed, causes the system to perform operations comprising: pumping, with the pump, the lavage fluid from the lavage fluid reservoir through the lavage tube and the one or more lavage apertures; and pumping, with the pump, the sample through the one or more sample collection apertures and through the lavage and sample collection tube and into the lavage collection reservoir.

[0020] In an embodiment, pumping, with the pump, the lavage fluid through the lavage tube and the one or more lavage apertures comprises pulsatile pumping.

[0021] In an embodiment, pumping, with the pump, the sample through the one or more sample collection apertures and the lavage and sample collection tube comprises pumping the sample through the lavage and sample collection tube periodically.

[0022] In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 5 pounds per square inch (psi) to about 160 psi.

[0023] In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 30 mL / minute per lavage aperture to about 700 mL / minute per lavage aperture.

[0024] In an embodiment, the system further comprises a light source configured to emit light onto the lavage tube and the lavage and sample collection tube; and a photodetector positioned to receive the light passed through the lavage tube and the lavage and sample collection tube.

[0025] In an embodiment, the photodetector is configured to generate a lavage signal based on a portion of the light passed through the lavage tube and a sample signal based on a portion of the light passed through the lavage and sample collection tube; and wherein the controller, operatively coupled to the photodetector, further comprises logic that, when executed, causes the system to perform operations including pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal.

[0026] In an embodiment, pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal comprises increasing pressure of the lavage fluid up to a pressure when the sample signal reaches a predetermined threshold.

[0027] In an embodiment, a portion of the lavage tube positioned to receive the light and a portion of the lavage and sample collection tube positioned to receive the light are generally flattened.

[0028] In an embodiment, the system further comprises one or more filters shaped to filter objects from the sample.

[0029] In an embodiment, the one or more filters comprises a first filter comprising apertures having a smallest size in a range of about 70 microns to about 200 microns, and a second filter comprising apertures having a smallest size of about 10 microns to about 30 microns.

[0030] In another aspect, the present disclosure provides a method of collecting a sample, the method comprising pumping, with a pump, a lavage fluid from a lavage fluid reservoir through a lavage tube and one or more lavage apertures disposed in a tip fluidically coupled to a distal end of the lavage tube; and pumping, with the pump, the sample through one or more sample collection apertures disposed in the tip and through a lavage and sample collection tube and into a lavage collection reservoir.

[0031] In an embodiment, the tip is shaped and sized to pass through a nasal cavity of a subject or an oral cavity of a subject.

[0032] In an embodiment, the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0033] In an embodiment, the one or more lavage apertures are disposed in the cylindrical surface.

[0034] In an embodiment, the one or more lavage apertures are disposed at a proximal end and a distal end of the cylindrical surface.

[0035] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.DESCRIPTION OF THE DRAWINGS

[0036] The foregoing aspects and many of the attendant advantages of the subj ect matter of the present disclosure will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

[0037] FIGURES 1A and IB illustrate age-standardized (A) incidence and (B) death rates (%) of stomach cancer per 100,000 population, 2019;

[0038] FIGURE 2 provides a comparison of functional characteristics and capabilities of devices and systems according to embodiments of the present disclosure to existing devices;

[0039] FIGURE 3 is a schematic illustration of a system according to an embodiment of the present disclosure, and an image of cytological sample from a pig stomach;

[0040] FIGURES 4A-4H provide illustrations of a device according to embodiments of the present disclosure;

[0041] FIGURES 5A-5I provide illustrations of a device according to embodiments of the present disclosure;

[0042] FIGURES 6A-6H provide illustrations of a device according to embodiments of the present disclosure;

[0043] FIGURES 7A-7H provide illustrations of a device according to embodiments of the present disclosure;

[0044] FIGURES 8A-8F provide illustrations of a device according to embodiments of the present disclosure;

[0045] FIGURE 9A is an image of a container with oatmeal disposed on an inner surface of the container;

[0046] FIGURE 9B is an image of the container after being sprayed by a device according to embodiments of the present disclosure;

[0047] FIGURE 10 is a schematic illustration of a system according to embodiments of the present disclosure;

[0048] FIGURE 11 is a sub-assembly of a system according to embodiments of the present disclosure; and

[0049] FIGURE 12 is a block diagram of a method according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0050] In various aspects, the present disclosure provides devices and systems for sample screening inside portions of a body and related methods of screening, as described further herein.

[0051] In the following description numerous specific details are set forth to provide a thorough understanding of the embodiments. One skilled in the relevant art will recognize, however, that the techniques described herein can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring certain aspects.

[0052] Some portions of the detailed description that follow are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means usedby those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of steps leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like.

[0053] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the following discussion, it is appreciated that throughout the description, discussions utilizing terms such as "selecting", "identifying", "capturing", "adjusting", "analyzing", "determining", "estimating", "generating", "comparing", "modifying", "receiving", "providing", "displaying", "interpolating", "outputting", or the like refer to the actions and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (e.g., electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such as information storage, transmission, or display devices.

[0054] The algorithms presented herein are not inherently related to any particular computer or other apparatus. Various general -purpose systems can be used with programs in accordance with the teachings herein, or it can prove convenient to construct a more specialized apparatus to perform the required method steps. The required structure for a variety of these systems will appear from the description below. In addition, embodiments of the present disclosure are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages can be used to implement the teachings of the disclosure as described herein.

[0055] Reference throughout this specification to "one embodiment," "an embodiment," "some embodiments," and "certain embodiments" means that a particular feature, structure, or characteristic described in connection with the embodiment(s) is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," "in some embodiments," or "incertain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0056] Gastric cancer affects more than 1 million people each year. It is the fifth most common cancer and the third most fatal - costing a total of $3,171 billion for US patients in 2017. As shown in FIGURES 1 A and IB, high risk populations include Eastern Europe, Central South America, Alaskan Natives, and East Asia, where the latter represents 60% of global gastric cancer cases. In 2020, there were approximately 127,211 cases of gastric cancer in the US alone, and in 2023, it was estimated that greater than 23,000 new cases would arise.

[0057] Gastric cancer has a good prognosis in its early stages, but as time progresses and the cancer develops, it worsens. With early detection, patients have the opportunity to treat their cancer before it progresses to the later stages and ideally, can undergo easier treatments. Currently, risk for gastric cancer is monitored based upon the known risk factors — age, family history, diet, genetics, chronic gastritis, and H. pylori infection. Typically, chronic inflammation of stomach tissue leads to intestinal metaplasia, a precancerous change in the mucosal lining of the stomach with intestinal epithelium. In order to detect gastric cancer at an early stage, people at risk for intestinal metaplasia and gastric cancer undergo a screening test called gastrointestinal endoscopy and biopsy, an invasive and costly procedure. Those people found to have intestinal metaplasia are then followed in surveillance programs to monitor the metaplasia for progression towards cancer. A non-endoscopic (and less invasive) device that could detect intestinal metaplasia in high-risk people would be a major advance and address an unmet need in clinical medicine.

[0058] Patients at risk of gastric cancer are suffering from high cost, inaccessible screening, and diagnostic procedures. Often heavy sedation is used with invasive procedures, which increases the cost and complexity of the endoscopic procedure that created burdens of missing a day of work and having another person take them home to rest. From the devices, systems, and methods of the present disclosure, such at-risk patents gain access to an affordable, portable device allowing them to receive adequate healthcare. Patients who may not have been able to receive screening will gain this ability.

[0059] Medical personnel who are typically responsible for gastric cancer screening procedures are often burdened with time-expensive procedures. In addition,performing endoscopy with biopsy requires teams of people to be present to give proper care. Doctors are looking for a portable, accessible, efficient device that can sample epithelial cells for sampling and diagnostic purposes.

[0060] Hospitals and insurance companies, like patients, are burdened with the cost of traditional diagnostic and screening procedures, and for care of patients. Devices, systems, and methods according to embodiments of the present disclosure provide cost relief for these organizations by providing a cheaper diagnostic procedure. In addition, the devices, systems, and methods according to embodiments of the present disclosure allow for earlier detection, and thus, less extensive care. Like doctors, hospitals are burdened with deaths from gastric cancer. With increased accessibility and earlier detection, deaths associated with gastric cancer are expected to decrease.

[0061] Traditionally, gastric cancer is diagnosed using biopsy via endoscopy, a procedure which utilizes a camera for imaging and guidance and small forceps to collect biopsy samples to be sent off for analysis. Another approach for gastric cancer screening is magnetic controlled capsule endoscopy, which consists of a guidance magnet robot, a computer workstation, an endoscopic capsule, a capsule locator, and a data recorder. Using the magnetic capsule, images are captured around the stomach and the capsule is excreted. However, these approaches pose limitations, including high costs and low accessibility, as well as the need for a biopsy to be taken from the stomach in order to make a definitive diagnosis. Additionally, endoscopies are invasive, decreasing accessibility for many at-risk populations. Serum biomarkers are an accessible alternative used to diagnose gastric cancer, but are relatively inaccurate (insensitive), invasive, and inaccessible for the most important early cancer and pre-cancerous stages. The limitations of each existing device are summarized in FIGURE 2.

[0062] None of the current screening and diagnostic practices achieve all of the checkpoints labeled in FIGURE 2.

[0063] In summary, the existing solutions are expensive, invasive, inefficient, inaccurate, insensitive, and / or not easily portable, which decreases accessibility for various populations and thus, are not attainable options for the majority of individuals globally who are at risk for gastric cancer. Gastrointestinal doctors involved within the industry have stressed the need for a low-cost, easily accessible device for populations who may not have access to advanced facilities — such as an endoscopic suite — or for patients who are unwilling or unable to undergo endoscopy.DEVICES

[0064] To address these and related unmet needs, the present disclosure provides a device for harvesting cells from a portion of the body. In embodiments, the device comprises a lavage tube fluidically couplable at a proximal end to a lavage fluid reservoir; a lavage and sample collection tube fluidically couplable at a proximal end to a lavage collection reservoir; and a tip shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject, wherein the tip defines: one or more lavage apertures fluidically coupled to a distal end of the lavage tube and shaped and sized to allow passage of a lavage fluid therethrough; and one or more sample collection apertures coupled to a distal end of the lavage and sample collection tube and shaped to allow passage of a sample comprising cells therethrough.

[0065] The devices of the present disclosure provide a number of advantageous characteristics and capabilities, some of which will now be described.

[0066] In various embodiments, the devices of the present disclosure are configured to and otherwise suitable to collect samples from various locations within the body, such as within the stomach. In embodiments, the devices of the present disclosure are able to collect epithelial cells and tissue fragments from the stomach lining.

[0067] In various embodiments, the devices of the present disclosure are accessible for high-risk populations. In embodiments, the device, system, and method of the present disclosure are configured to increase accessibility, reaching populations who may not otherwise have access to adequate gastric cancer screening techniques. Therefore, the device is easily tolerated without heavy sedation (or anesthesia) and can operate in a time efficient manner. In certain embodiments, the device, therefore, does not require advanced healthcare facilities or extensive medical personnel for appropriate use and deployment.

[0068] In various embodiments, the devices of the present disclosure are configured for effective retrieval of stomach cell samples to be sent off for analysis. After sampling, the sampling devices according to embodiments of the present disclosure are able to retain cell samples without loss so that they can be sent off for laboratory analysis. The devices, systems, and methods of the present disclosure use effective suction of the solution containing cells and other biological materials, ensuring that enough cells are retrieved from the stomach that reliable laboratory testing can be performed.

[0069] In various embodiments, the devices of the present disclosure are configured for easy removal of device from the patient's stomach through the esophagus. The devices, systems, and methods of the present disclosure allow for easy removal of the catheter once cell sampling is completed. This ensures that the device is safe and comfortable for use by being small enough that removal is tolerated without heavy sedation.

[0070] In various embodiments, the devices and systems according to embodiments of the present disclosure comprise a dual-fluid flushing and suction structures and capabilities. Accordingly, in embodiments, attached to a non-dissolvable pill capsule, there are at least two catheters — one for vacuum suction and one for fluid flushing. The catheters are configured to be attached to one or more pumps to facilitate the movement of fluid into and out of the stomach. Once a portion of the device is swallowed or passed intranasally, water or saline is pumped into the stomach through the flushing catheter, which defines holes, such as at the bottom of a circumferential surface for fluid to flow out at various angles. This fluid hits the stomach at a pressure sufficient to remove cells from the stomach lining, such as diagnostically valuable samples including one or more of tissue fragments, isolated cells, cell fragments, and micro-organisms like H. pylori. The vacuum catheter via vacuum pump is then used to suction the water and any diagnostic fluids like blood out into a collection container. The collected fluidic sample can also be condensed to a smaller biologic specimen for mailing or easy / efficient transport for analysis. So, like the device itself, the specimen can be less than 5 lbs for portability.

[0071] The devices and systems according to embodiments of the present disclosure are relatively low cost for manufacture and customer use. For example, in embodiments, the devices, systems, and methods of the present disclosure are manufacturable at a relatively low price in comparison to current competitors, such as conventional upper endoscopy with biopsy. This increases accessibility for at-risk populations of gastric cancer.

[0072] By using affordable materials such as medical grade silicone and plastics, the cost of manufacturing is low (< $50). By eliminating the need for large teams of hospital staff, large suits, high sedation, and other resources needed for traditional gastric cancer detection methods, the overall cost of the procedure is low (< $750).

[0073] The device, systems, and methods of the present disclosure are easily portable. In embodiments, the overall small size of the device (< 5 lbs) allows easy shipment and storage.

[0074] By contrast, a conventional endoscopy suite is not easily accessible, such as for most at-risk populations who may be far from urban centers. The devices, systems, and methods of the present disclosure allow for gastric screening tests to be done anywhere and increase accessibility of the diagnostic sampling.

[0075] An easily portable device allows patients from more regions, even rural regions, to be able to undergo the procedure and allows doctors from more regions to perform it.

[0076] The devices, systems, and methods of the present disclosure are able to sample cells in many or all parts of the stomach.

[0077] In embodiments, radial arrangement of waterjets in the catheter allows fluid force to hit a large amount of stomach lining surface area, creating a comprehensive cell sample with the goal of > 90% of stomach surface area.

[0078] While gastric cancer often begins growing in the lower parts of the stomach, it is important to have a comprehensive cell sampling device in order to ensure accuracy of negative results. The primary regions for stomach cell sampling include the cardia, the antrum, the angelus, the area of greater curvature, and the area of less curvature.

[0079] The device, systems, and methods of the present disclosure are comfortable for use.

[0080] Doctors and potential patients have expressed concerns about discomfort in the procedure, so it is important to ensure that the devices, systems, and methods according to embodiments of the present disclosure are comfortable enough not to dissuade users. Also, conventional endoscopy is uncomfortable and often results in a sore throat post-procedure, so a quick and comfortable procedure is desirable.

[0081] The device collects a sufficient amount of fluid cell sample for effective cytological analysis. In embodiments, the system is configured to filter the collected fluidic sample and, thus, concentrates the sample including any cells into smaller containers for easy transport (mailing) to in vitro diagnostic labs, which can perform flow cytometry and conventional cytometry for making a diagnosis.

[0082] In embodiments, the small size of the device (such as having a 6mm diameter) allows for ease of swallowing.

[0083] In embodiments, the low force / pressure applied to the inside of the stomach by the fluid jets reduces or eliminates discomfort during cell sampling while maintaining the ability to collect cells.

[0084] In embodiments, the thin catheters (such as having a 0.5 cm outer diameter) allow for high tolerability after swallowing. As the catheters are smaller in diameter than typical nasogastric tubes, significant discomfort is not anticipated.

[0085] Accordingly, compared with existing devices and solutions, the devices, systems, and methods according to embodiments of the present disclosure offer reduced cost, more portability, more comprehensive sampling, and higher patient comfort. Traditional methods, such as endoscopy with biopsy are significantly higher cost and less portable, due to the high sedation and the large facilities and resources required. The devices, systems, and methods of the present disclosure provide a more comprehensive assay, as the arrangement of fluid jets allows cell collection from the entire stomach, while traditional methods only take small samples from up to twelve locations. Because the devices, systems, and methods of the present disclosure require little to no sedation, this promotes patient comfort as long hospital stays will not be required and the procedure requires significantly less time than the traditional procedure.

[0086] In an embodiment, the tip is shaped and sized to pass through the nasal cavity of the subject.

[0087] In an embodiment, the tip is shaped and sized to pass through the oral cavity of the subject

[0088] In an embodiment, the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0089] In an embodiment, the one or more lavage apertures are disposed in the cylindrical surface.

[0090] In an embodiment, wherein the one or more lavage apertures are disposed at a proximal end of the cylindrical surface.

[0091] In an embodiment, the tip is configured to rotate when the lavage fluid passes through the one or more lavage apertures. The waterjets can impart momentum on the tip of the device so the location and orientation of the nozzles can assist in displacing and rotating the tip. The fluidic flow and sequence can be switched to a back and forth movement and rotation. In the capsule and possibly the tube tip, a spiral shape of the tubeor differential friction of the straight tube can impart differential forces that result in movement, bending, or rotation that scales with fluid flow and velocity.

[0092] In an embodiment, the one or more sample collection apertures are disposed at a distal panel of the two panels.

[0093] In an embodiment, a length of the tip is in a range of about 10 mm to about 30 mm.

[0094] In an embodiment, a width of the tip is in a range of about 1 mm to about 8 mm.

[0095] In an embodiment, the lavage tube and the lavage and sample collection tube are arranged coaxially.

[0096] Specific embodiments of devices according to embodiments of the present disclosure will now be described with reference to particular FIGURES.

[0097] FIGURES 4A-4H provide illustrations of a device 400 according to embodiments of the present disclosure. FIGURE 4A is a transparent perspective view of a device 400 according to embodiments of the present disclosure. FIGURE 4B is another perspective view of the device 400. FIGURE 4C is a top-down plan view of the device 400. FIGURES 4D-4F are various side views of the device 400. FIGURE 4G is a bottom up plan view of the device 400. FIGURE 4H is a cross-section view of the device 400.

[0098] As shown, the device 400 comprises a lavage tube 404 fluidically couplable at a proximal end 462 to a lavage fluid reservoir; a lavage and sample collection tube 408 fluidically couplable at a proximal end 464 to a lavage collection reservoir; and a tip 412 shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject.

[0099] The present disclosure refers to proximal portions of the devices and systems of the present disclosure. As used herein, in embodiments, "proximal" can refer to a portion of the device or system toward a user and away from a portion of a body into which the device or system or portion thereof is inserted. Likewise, the present disclosure refers to distal portions of the device or systems of the present disclosure. As used herein, in embodiments, "distal" can refer to portions of the devices or systems closer or adjacent to the portion of the body into which the device or system or portions thereof is inserted.

[0100] Referring again to FIGURES 4A-4H, the tip 412 is shown to define one or more lavage apertures 414 fluidically coupled to a distal end 416 of the lavage tube 404 and shaped and sized to allow passage of a lavage fluid therethrough. In operation, lavagefluid, such as water or saline, is pumped through the one or more lavage apertures 414, such as to displace cells or other biological material from a portion of a subject into which the device 400 is placed.

[0101] The tip 412 is also shown to define one or more sample collection apertures 418 coupled to a distal end 420 of the lavage and sample collection tube 408 and shaped to allow passage of a sample comprising cells therethrough. In operation, a sample fluid, such as comprising displaced cells of the subject, is pumped through the one or more sample collection apertures 418.

[0102] In the illustrated embodiment, the tip 412 is sized and shaped to pass through the oral cavity of the subject. In an embodiment, a length of the tip 412 is in a range of about 10 mm to about 30 mm.

[0103] The tip 412 is also shown to define a lavage conduit 458 coupled to the lavage tube 404, such as to convey lavage fluid within the tip 412 and out of the one or more lavage apertures 414. The tip 412 further defines a sample conduit 460 shaped to convey sample fluid from the one or more sample collection apertures 418 and to the lavage and sample collection tube 408.

[0104] As shown, the tip 412 defines a cylindrical shape comprising a cylindrical surface 422 and two panels. In the illustrated embodiment, a proximal panel 424 of the two panels is shaped to receive the lavage tube 404 and the lavage and sample collection tube 408. Here, the one or more lavage apertures 414 are disposed in the cylindrical surface 422. In the illustrated embodiment, the one or more lavage apertures 414 are disposed at a proximal end 428 of the cylindrical surface 422. As shown, the lavage apertures 414 are radially disposed about the tip 412, such as to disperse lavage fluid in a variety of directions in the portion of the body.

[0105] The one or more sample collection apertures 418 are disposed at a distal panel 426 of the two panels. As also shown, the tip 412 defines several protrusions 456 protruding from a surface of the distal panel 426. Such protrusions 456 ensure that the one or more sample collection apertures 418 are not directly in contact with a tissue surface of the subject, such as a portion of stomach tissue, that might clog or otherwise occlude the one or more sample collection apertures 418.

[0106] In an embodiment, the tip 412 has a height of about 18 mm and a diameter of about 7 mm. In an embodiment, the protrusions 456 have a height of about 3 mm and a diameter of about 2.5 mm.

[0107] In an embodiment, the device is configured to rotate when lavage fluid passes through the one or more lavage apertures. In this regard, attention is directed to FIGURES 5A-5I, in which a device 500 according to embodiments of the present disclosure is illustrated. FIGURE 5A is a transparent perspective view of a device 500 according to embodiments of the present disclosure. FIGURE 5B is another perspective view of the device 500. FIGURE 5C is a top-down plan view of the device 500. FIGURES 5D-5F are various side views of the device 500. FIGURE 5G is a bottom-up plan view of the device 500. FIGURE 5H is a cross-section view of the device 500. FIGURE 51 is another cross-section view of the device 500.

[0108] In embodiments, device 500 comprises one or more components or features analogous to those of device 400. In this regard, like elements will be described with like numerals except in the 5XX series.

[0109] As shown, the device 500 comprises a lavage tube 504 fluidically couplable at a proximal end 562 to a lavage fluid reservoir; a lavage and sample collection tube 508 fluidically couplable at a proximal end 564 to a lavage collection reservoir; and a tip 512 shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject. In the illustrated embodiment, the tip 512 is shown to define one or more lavage apertures 514 fluidically coupled to a distal end 516 of the lavage tube 504 and shaped and sized to allow passage of a lavage fluid therethrough; and one or more sample collection apertures 518 coupled to a distal end 520 of the lavage and sample collection tube 508 and shaped to allow passage of a sample comprising cells therethrough.

[0110] As shown, the one or more lavage apertures 514 are shown disposed in a cylindrical surface 522 of the tip 512, shown here in a proximal end 528 of the cylindrical surface 522. In particular, as shown, the one or more lavage apertures 514 are shown to define a path in the cylindrical surface 522 that is not orthogonal to and does not intersect with a rotational axis 566 of the cylindrical surface 522 of the tip 512. In this regard, as lavage fluid exits through the one or more lavage apertures 514, the device 500 rotates, such as about the rotational axis 566. As the device 500 rotates, lavage fluid is deposited on many surfaces in the portion of the subject, thereby releasing cells from tissue of the subject into the sample fluid. Such a wide sampling of the portion of the subject ensures that many portions of the subject can be assayed in the sample fluid.[OHl] As also shown, the lavage tube 504 and the lavage and sample collection tube 508 are arranged coaxially. Such a coaxial arrangement of lavage tube 504 and lavageand sample collection tube 508 allows for the tip 512 to rotate more easily, such as without twisting the lavage tube 504 and the lavage and sample collection tube 508, compared to a side-by-side arrangement of tubes, such as illustrated in FIGURES 4A-4H. In such coaxial or dual lumen embodiments, tubing can be spun from outside the body within an outer sheath so there is little friction to the body of the subject.

[0112] In the illustrated embodiment, the tip 512 is shown to include protrusions 556 protruding from a distal panel 526 of the tip 512.

[0113] In an embodiment, the tip 512 has a height about 18 mm and a diameter of about 8 mm.

[0114] In embodiments, the devices of the present disclosure comprise tips comprising one or more inserts, such as metal inserts, defining the one or more lavage apertures. In this regard, attention is directed to FIGURES 6A-6H in which a device 600 according to embodiments of the present disclosure is illustrated. FIGURE 6A is a transparent perspective view of the device 600. FIGURE 6B is another perspective view of the device 600. FIGURE 6C is a top-down plan view of the device 600. FIGURES 6D-6F are various side views of the device 600. FIGURE 6G is a bottom-up plan view of the device 600. FIGURE 6H is a cross-section view of the device 600.

[0115] In embodiments, device 600 comprises one or more components or features analogous to those of devices 400 and 500. In this regard, like elements will be described with like numerals except in the 6XX series.

[0116] As shown, the device 600 comprises a lavage tube 604 fluidically couplable at a proximal end 662 to a lavage fluid reservoir; a lavage and sample collection tube 608 fluidically couplable at a proximal end 664 to a lavage collection reservoir; and a tip 612 shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject. In the illustrated embodiment, the tip 612 defines one or more lavage apertures 614 fluidically coupled to a distal end 616 of the lavage tube 604 and shaped and sized to allow passage of a lavage fluid therethrough.

[0117] In the illustrated embodiment, the tip 612 comprises two panels 624 and 626, wherein a proximal panel 624 of the two panels is shaped to receive the lavage tube 604 and the lavage and sample collection tube 608, and the distal panel 626 defines the one or more sample collection apertures 618.

[0118] As also shown, the one or more lavage apertures 614 are disposed in solid inserts, such as copper inserts. In the illustrated embodiment, the one or more lavageapertures 614 are coupled to a lavage conduit 658, such as shaped and positioned to receive lavage fluid from the lavage tube 604, which is then passed through the one or more lavage apertures 614.

[0119] The device 600 is also shown to include one or more sample collection apertures 618 coupled to a distal end 620 of the lavage and sample collection tube 608 and shaped to allow passage of a sample comprising cells therethrough. As also shown, the tip 612 defines a sample conduit 660 coupled to the lavage and sample collection tube 608 on one end and to the one or more sample collection apertures 618 to allow passage of sample fluid therebetween.

[0120] The tip 612 defines a cylindrical shape comprising a cylindrical surface 622 and two panels, wherein a panel of the two panels is shaped to receive the lavage tube 604 and the lavage and sample collection tube 608. The tip 612 is shown to include protrusions 656 protruding from a distal panel 626 of the tip 612. As discussed further herein with respect to FIGURES 4A-4H, such protrusions 656 limit or prevent occlusion of the one or more sample collection apertures 618.

[0121] In an embodiment, the tip 612 has an outer diameter of about 8 mm and a height of about 18 mm. In an embodiment, the protrusions 656 have a diameter of about 2.5 mm and a height of about 3.5 mm.

[0122] In an embodiment, the tip is shaped and sized to pass through the nasal cavity of the subject. In this regard, attention is now directed to FIGURES 7A-7H in which a device 700 according to embodiments of the present disclosure is illustrated. FIGURE 7A is a transparent perspective view of the device 700. FIGURE 7B is another perspective view of the device 700. FIGURE 7C is a top-down plan view of the device 700. FIGURES 7D-7F are various side views of the device 700. FIGURE 7G is a bottom-up plan view of the device 700. FIGURE 7H is a cross-section view of the device 700.

[0123] In embodiments, device 700 comprises one or more components or features analogous to those of devices 400, 500, and 600. In this regard, like elements will be described with like numerals except in the 7XX series.

[0124] In the illustrated embodiment, the device 700 is shown to comprise a lavage tube 704 fluidically couplable at a proximal end 762 to a lavage fluid reservoir; a lavage and sample collection tube 708 fluidically couplable at a proximal end 764 to a lavage collection reservoir; and a tip 712 shaped and sized to pass through a nasal cavity of a subject.

[0125] In an embodiment, a width of the tip 712 is in a range of about 1 mm to about 8 mm.

[0126] As also shown, the tip 712 defines one or more lavage apertures 714 fluidically coupled to a distal end 716 of the lavage tube 704 and shaped and sized to allow passage of a lavage fluid therethrough. Here, the tip 712 defines a cylindrical shape comprising a cylindrical surface 722. Here, the one or more lavage apertures 714 are disposed in the cylindrical surface 722, and the one or more lavage apertures 714 are disposed at a proximal end 728 of the cylindrical surface 722.

[0127] The tip 712 is shown to further define one or more sample collection apertures 718 coupled to a distal end 720 of the lavage and sample collection tube 708 and shaped to allow passage of a sample comprising cells therethrough. As shown, the one or more sample collection apertures 718 are disposed at a distal panel 726 of the two panels, from which protrusions 756 protrude.

[0128] As shown, the sample collection aperture is set in among the protrusions 756 at the distal end and three lavage apertures 714. Lavage aperture diameters, in embodiments, are in a range of about 0.5 mm to about 0.7 mm, but can be varied for specific applications.

[0129] Outer diameter of the tip 712, in embodiments, is less than 5.6 mm for adult trans nasal applications, but can be varied according to specific applications.

[0130] Further, the lavage tube 704 and the lavage and sample collection tube 708 are arranged coaxially, such as to allow rotation of the tip 712 during operation, in particular with lavage fluid passing through the one or more lavage apertures 714.

[0131] As shown, the tip 712 defines a lavage conduit 758 to allow passage of lavage fluid.

[0132] FIGURES 8A-8F provide illustrations of a device 800 according to embodiments of the present disclosure. FIGURE 8A is a transparent perspective view of the device 800. FIGURE 8B is another perspective view of the device 800. FIGURE 8C is a top-down plan view of the device 800. FIGURE 8D is a side view of the device 800. FIGURE 8E is a bottom-up plan view of the device 800. FIGURE 8F is a cross-section view of the device 800.

[0133] In embodiments, device 800 comprises one or more components or features analogous to those of devices 400, 500, 600, and 700. In this regard, like elements will be described with like numerals except in the 8XX series.

[0134] As shown, the device 800 includes a lavage tube 804 fluidically couplable at a proximal end 862 to a lavage fluid reservoir and / or lavage collection reservoir; and a tip 812 shaped and sized to pass through a nasal cavity of a subject.

[0135] In the illustrated embodiment, the lavage apertures 814 are shown fluidically coupled to a distal end 816 of the lavage tube 804 and shaped and sized to allow passage of a lavage fluid therethrough. In this regard, lavage fluid can be emitted from the tip 812, such as to dislodge tissues, cells, etc. from a portion of the subject, such as the sinuses. As shown, the lavage apertures 814 are oriented and distributed on the tip 812 to emit lavage fluid in several directions, such as to impinge on various portions of the portion of the subject.

[0136] As shown, the device 800 includes a single tube, here the lavage tube 804. A sample can be obtained through the lavage apertures 814 and the lavage tube 804.

[0137] In an embodiment, the tip 812 has a height of about 16.8 mm and a diameter of about 5 mm.SYSTEM

[0138] In another aspect, the present disclosure provides a system comprising a device according to any embodiment described herein.

[0139] Accordingly, in an embodiment, the present disclosure provides a system comprising a device according to any embodiment of the present disclosure; a lavage fluid reservoir coupled to the proximal end of the lavage tube; a lavage collection reservoir coupled to the proximal end of the lavage and sample collection tube; and a pump configured to pump a lavage fluid from the lavage fluid reservoir through the lavage tube and to pump a sample through the lavage and sample collection tube to the lavage collection reservoir.

[0140] In an embodiment, the system further comprises a controller operatively coupled to the pump, the controller comprising logic that, when executed, causes the system to perform operations comprising: pumping, with the pump, the lavage fluid from the lavage fluid reservoir through the lavage tube and the one or more lavage apertures; and pumping, with the pump, the sample through the one or more sample collection apertures and through the lavage and sample collection tube and into the lavage collection reservoir.

[0141] In an embodiment, pumping, with the pump, the lavage fluid through the lavage tube and the one or more lavage apertures comprises pulsatile pumping.

[0142] In an embodiment, pumping, with the pump, the sample through the one or more sample collection apertures and the lavage and sample collection tube comprises pumping the sample through the lavage and sample collection tube periodically.

[0143] In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 5 pounds per square inch (psi) to about 160 psi. In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 10 pounds per square inch (psi) to about 120 psi. In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 20 pounds per square inch (psi) to about 100 psi. In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 50 pounds per square inch (psi) to about 80 psi.

[0144] In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 30 mL / minute per lavage aperture to about 700 mL / minute per lavage aperture. In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 40 mL / minute per lavage aperture to about 600 mL / minute per lavage aperture. In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 50 mL / minute per lavage aperture to about 400 mL / minute per lavage aperture. In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 60 mL / minute per lavage aperture to about 300 mL / minute per lavage aperture.

[0145] In an embodiment, the system further comprises a light source configured to emit light onto the lavage tube and the lavage and sample collection tube; and a photodetector positioned to receive the light passed through the lavage tube and the lavage and sample collection tube.

[0146] In an embodiment, the photodetector is configured to generate a lavage signal based on a portion of the light passed through the lavage tube and a sample signal based on a portion of the light passed through the lavage and sample collection tube; and wherein the controller, operatively coupled to the photodetector, further comprises logic that, when executed, causes the system to perform operations including pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal.

[0147] In an embodiment, pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal comprises increasing pressure of the lavage fluid up to a pressure when the sample signal reaches a predetermined threshold.

[0148] In an embodiment, a portion of the lavage tube positioned to receive the light and a portion of the lavage and sample collection tube positioned to receive the light are generally flattened.

[0149] In an embodiment, the system further comprises one or more filters shaped to filter objects from the sample.

[0150] In an embodiment, the one or more filters comprise a first filter comprising apertures having a smallest size in a range of about 70 microns to about 200 microns, and a second filter comprising apertures having a smallest size of about 10 microns to about 30 microns.

[0151] A system 302 according to embodiment of the present disclosure is illustrated in FIGURE 3. As shown, the system 302 includes a device 300 including a tip 312; a lavage tube 304 fluidically couplable at a proximal end to a lavage fluid reservoir; and a lavage and sample collection tube 308 fluidically couplable at a proximal end to a lavage collection reservoir. In embodiments, the device 300 is an example of the devices 400, 500, 600, 700, or 800 discussed further herein with respect to FIGURES 4A-4H, SA-51, 6A-6H, 7A-7H, and 8A-8F, respectively.

[0152] As also shown, the system 302 includes pumps and reservoirs, such as disposeable pumps and reservoirs coupled to the device 300. In specific embodiments, the system 302 includes a lavage fluid reservoir coupled to the proximal end of the lavage tube; a lavage collection reservoir coupled to the proximal end of the lavage and sample collection tube 308; and a pump configured to pump a lavage fluid from the lavage fluid reservoir through the lavage tube and to pump a sample through the lavage and sample collection tube 308 to the lavage collection reservoir.

[0153] Provided in the bottom of FIGURE 3 is an image from conventional cytology of a stained tissue fragment (left arrow) and a smaller cell (right arrow) released from a portion of a body using and collected by a system according to embodiments of the present disclosure, such as is described further herein with respect to Example 1.

[0154] In the illustrated embodiment, the tip 312, coupled with the lavage tube 304 and the lavage and sample collection tube 308, is disposed in the stomach of a subject. As also shown, the device 300 is emitting a lavage fluid from the tip 312, such as to dislodge cells and other biological materials from the lining of the stomach, for collection by the lavage and sample collection tube 308 through the tip 312.

[0155] FIGURE 10 is a schematic illustration of another system 302 according to embodiments of the present disclosure. In embodiments, the system 1002 comprises one or more components of a device according to embodiments of the present disclosure such as the devices 400, 500, 600, 700, or 800 discussed further herein with respect to FIGURES 4A-4H, 5A-5I, 6A-6H, 7A-7H, and 8A-8F, respectively. In embodiments, the system is an example of the system 302 discussed further herein with respect to FIGURE 3.

[0156] System 1002 is shown in FIGURE 10 to include a series of boxes connected by arrows or lines. As will be described, the boxes represent different functional regions, units, or modules, of system 1002. The boxes, as well as the term "unit" or "module" are used for convenience, as each functional unit or module may be a single component (such as a machine, piece of equipment, apparatus, and so forth), or part of a larger component that also incorporates one or more other functional units / modules, or may represent multiple components that cooperate to perform the function(s) of the unit, and so forth. Various functional units and components of system 1002 may be co-located, such as within a single facility, or located remotely from each other. The system 1002 may be any suitable scale, from lab scale to industrial / commercial. The arrows generally represent the direction of the material or product produced or processed by the various functional units, and, accordingly, may also represent any suitable means of conveying the material from one unit to another (such as conduits, conveyors, pipes, mailing a sample for in vitro diagnosis, etc.), and / or other pieces of processing or handling equipment. The lines generally represent operative coupling, such as through a wired connection to exchange signals therebetween. While wired connections may be shown, it will be understood that wireless operative coupling is possible and within the scope of the present disclosure.

[0157] As shown, the system 1002 includes a lavage tube 1004 fluidically couplable at a proximal end to a lavage fluid reservoir 1006; and a lavage and sample collection tube 1008 fluidically couplable at a proximal end to a lavage collection reservoir 1010.

[0158] In embodiments, the system 1002 comprises a tip 1012 shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject. As described elsewhere herein, in embodiments, the tip 1012 can define one or more lavage apertures fluidically coupled to a distal end of the lavage tube 1004 and shaped and sized to allow passage of a lavage fluid therethrough; and one or more sample collection apertures coupled to a distal end of the lavage and sample collection tube 1008 and shaped to allowpassage of a sample comprising cells therethrough. In this regard, the system, through the tip 1012, is configured to both provide a lavage fluid to a portion of the body, such as the stomach and / or sinuses, and collect a sample from the portion of the body.

[0159] In the illustrated embodiment, the system comprises one or more pumps. In the illustrated embodiment, the system comprises a suction pump 1046 and a vacuum regulator 1054 collectively configured to deliver a sample into the lavage collection reservoir 1010 from the lavage and sample collection tube 1008 and tip 1012. Such sample fluid flow can be regulated by mechanical pressure gauge 1052.

[0160] The system is shown to further include a positive pressure diaphragm pump 1048 configured to urge lavage fluid from the lavage fluid reservoir 1006. Fluid flow of the lavage fluid can be regulated by the various precision flow control valves 1050.

[0161] The system is further shown to include a controller 1032 operatively coupled to various components of the system, such as to choreograph their operation. As described further herein, the controller 1032 is operatively coupled to various system components, such as to exchange signals therebetween and to choreograph their operation. While a single controller 1032 is illustrated in and described with respect to FIG. 10, it will be understood that the controller 1032 can include one or multiple processors and / or can be part of a distributed system. In this regard, the controller 1032 can be physically part of and / or coupled to the system. Likewise, in an embodiment, the controller 1032 is not part of or coupled to the system and is, in this embodiment, physically remote from the system, but nevertheless operatively coupled to one or more components of the system.

[0162] In an embodiment, the controller 1032 can be configured to, in response to one or more signals from other system components, modulate one or more parameters of the system. Various logic modules of the controller 1032 may be implemented in software / firmware executed on a general -purpose microprocessor, in hardware (e.g., application specific integrated circuit), or a combination of both.

[0163] In an embodiment, the controller 1032 includes at least one processor and a computer-readable medium having computer-executable instructions stored thereon that, in response to execution by the at least one processor, cause the controller 1032 to perform operations, such as to perform all or portions of methods according to embodiments of the present disclosure, such as method 1200 discussed further herein with respect to FIGURE 12.

[0164] In an embodiment, the controller 1032 comprising logic that, when executed, causes the system to perform operations comprising pumping, with the pump, the lavage fluid from the lavage fluid reservoir 1006 through the lavage tube and the one or more lavage apertures; and pumping, with the pump, the sample through the one or more sample collection apertures and through the lavage and sample collection tube 1008 and into the lavage collection reservoir 1010.

[0165] In an embodiment, pumping, with the pump, the lavage fluid through the lavage tube and the one or more lavage apertures comprises pulsatile pumping. Such pulsatile pumping, such as coupled with curved lavage apertures or lavage apertures oriented non-orthogonally with respect to a rotational axis of a tip 1012 (see FIGURES SA-51) can result in rotation of the tip 1012, particularly when paired with coaxial orientation of the lavage tube 1004 and the lavage and sample collection tube 1008.

[0166] In an embodiment, pumping, with the pump, the sample through the one or more sample collection apertures and the lavage and sample collection tube 1008 comprises pumping the sample through the lavage and sample collection tube 1008 periodically.

[0167] In an embodiment, the pump pumps the lavage fluid at a pressure in a range of about 5 pounds per square inch (psi) to about 160 psi.

[0168] In an embodiment, the pump pumps the lavage fluid at a flow rate in a range of about 30 mL / minute per lavage aperture to about 700 mL / minute per lavage aperture.

[0169] In an embodiment, the systems of the present disclosure are configured to colorimetrically or otherwise optically, such as through light scattering measurements, compare lavage fluids entering the body of a subject and sample fluids exiting the body of the subject, such as for use in adjusting operational parameters of the system. In this regard, attention is directed to FIGURE 11 in which a sub-assembly of a system 1102 according to embodiments of the present disclosure is illustrated.

[0170] In embodiments, system 1102 comprises one or more components or features analogous to those of system 1002. In this regard, like elements will be described with like numerals except in the 11XX series.

[0171] As shown, the sub-assembly of the system 1102 comprises a lavage tube 1104 fluidically couplable at a proximal end to a lavage fluid reservoir; and a lavage and sample collection tube 1108 fluidically couplable at a proximal end to a lavage collectionreservoir. In embodiments, the lavage tube 1104 and lavage and sample collection tube 1108 are couplable and / or coupled to a tip of a device, as discussed elsewhere herein, such as to provide lavage fluid and collect a sample.

[0172] As lavage fluid is provided onto a portion of the subject, biological material is displaced from the portion of the subject. In particular embodiments, blood escapes from the subject into the lavage fluid in the portion of the subject. Such blood in the sample, particularly in the sample captured in the lavage and sample collection tube 1108, is indicative of successful capture of biological material in the sample. Accordingly, a colorimetric or scattering comparison of the lavage fluid and the sample, particularly at wavelengths of light indicative or consistent with biological material in the sample, can provide indicia of successful capture of biological material in the sample. Such indicia of successful (or unsuccessful) capture of biological can be used to tune operational parameters (particularly lavage fluid pressure) of the system 1102.

[0173] In this regard, the system 1102 is shown to include a light source 1134 configured to emit light onto the lavage tube 1104 and the lavage and sample collection tube 1108; and a photodetector 1136 positioned to receive the light passed through the lavage tube 1104 and the lavage and sample collection tube 1108. The system 1102 is further shown to include diffuser 1138, configured to diffuse light from the light source 1134, and a slit mask 1140 shaped and positioned to allow only a portion of the light from the light source 1134 onto the lavage tube 1104 and the lavage and sample collection tube 1108.

[0174] In an embodiment, the photodetector 1136 is configured to generate a lavage signal based on a portion of the light passed through the lavage tube 1104 and a sample signal based on a portion of the light passed through the lavage and sample collection tube 1108. In an embodiment, a controller (not shown, see FIGURE 10), operatively coupled to the photodetector 1136, further comprises logic that, when executed, causes the system 1102 to perform operations including pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal. In an embodiment, pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal comprises increasing pressure of the lavage fluid up to a pressure when the sample signal reaches a predetermined threshold.

[0175] The light source 1134 can be a white light source that comprises separate red, green, and blue LEDs within one module. In one embodiment the emission intensityof these three spectral bands can be electronically controlled separately for producing photodetector signals of sufficient signal to noise ratio for rapid robust measurements.

[0176] Since CMOS color sensitivity can be low <450 nm, in an embodiment, a blue LED centered around -416 nm can be used as the light source 1134. In an embodiment, the photodetector 1136 comprises a color CMOS pixel-array sensor comprising red, green, and blue light filtration configured to generate full color measures of the light transmission. In addition, in embodiments, the spatial arrangement of colored pixels is used to spatially separate light traveling straight thought the tube and light highly scattered. Since CMOS color sensitivity can be low <450 nm, in an embodiment, a blue LED centered around -416 nm is used as augmenting the light source 1134.

[0177] In this regard, the system 1102 can be configured to detect light transmission through tube using the photodetector 1136 and, for example with bandpass filter at -400-450 nm (not shown).

[0178] In an embodiment, the signal is normalized by dividing the blue photodiode signal IB with red light transmission signal IR using an LED centered around -680 nm (low visible light absorbance by blood) and by illuminating a photodiode with bandpass filter at -650-700 nm.

[0179] In an embodiment, white light LED or red / green LED sources on the same LED chip is used to illuminate two tubes with the optional diffuser 1138 and spectral filter for spectral ranges, such as about 530-550 nm or about 500-600 nm (CMOS-G) and about 630-700 nm or about 580-900 nm (CMOS-R).

[0180] In an embodiment, the CMOS-G signal is normalized with CMOS-R signal to create a signal IG / IR that is immune to changes in transmission due to scattering of light, such as from air bubbles in the wash, and not from light absorption from blood.

[0181] In an embodiment, both the lavage tube 1104 and the lavage and sample collection tube 1108 are illuminated and light transmitted is being detected by the same CMOS sensor. In alternative embodiments, matching LEDs and CMOS sensors for each tube are used.

[0182] In an embodiment, the lavage tube 1104 and the lavage and sample collection tube 1108 or portions 1142 thereof may be flattened for more uniform pathlength of light or a square cross-section of optically clear tubing is used.

[0183] By measuring both the water / saline going in to the portion of the body and comparing to the wash coming back out of the of the portion of the body, the difference inphotodetector signals can be highly sensitive and be calibrated against known standards, such as according to the following formulae:

[0184] IB / IR (in)-lB / lR(out) divided by lB / lR(in)+lB / lR(out)

[0185] where IB and IG are the photodetector or pixel signal values in the blue and green spectrum respectively, or

[0186] IG / IR (in)-Io / lR(out) divided by lG / lR(in)+Io / lR(out),

[0187] where IG and IR are the photodetector or pixel signal values in the blue and red spectrum respectively.

[0188] In an embodiment, the fluidic pump to generate the flow rate and / or pressure of the input water or saline can be controlled in real time using an analog electronics and / or digital microprocessor which maintains the blood level at negligible levels or an optimal value for more efficient cell scavenging from the stomach.

[0189] In an embodiment, a manual shut-off value is included, and the photodetector 1136 can also display the real-time image of the fluid in the tubes so a human observer can verify the fluid flow for proper operation and any blood for added safety.

[0190] As shown, a portion of the lavage tube 1104 positioned to receive the light and a portion of the lavage and sample collection tube 1108 positioned to receive the light are generally flattened. Such flattening of the lavage tube 1104 and lavage and sample collection tube 1108 provides more accurate measurements of the fluids therein, due at least in part to the more uniform pathlength.

[0191] In embodiments, the systems of the present disclosure comprise one or more filters shaped to filter objects from the sample. In an embodiment, the one or more filters comprises a first filter comprising apertures having a smallest size in a range of about 70 microns to about 200 microns, such as in a range of about 70 microns to about 1100 microns, and a second filter comprising apertures having a smallest size of about 10 microns to about 30 microns for human cells and down to 0.5 microns for bacteria, such a Helicobacter pylori (H. pylori). Such filters can be configured to concentrate cells from the sample.

[0192] In an embodiment, the collected lavage fluid comprises stomach fluid, blood, cells (from human, micro-organisms, and food remnants. In an embodiment, cells are collected in the filter, which can then be further analyzed.METHODS

[0193] In another aspect, the present disclosure provides a method of collecting a sample, the method comprising pumping, with a pump, a lavage fluid from a lavage fluid reservoir through a lavage tube and one or more lavage apertures disposed in a tip fluidically coupled to a distal end of the lavage tube; and pumping, with the pump, the sample through one or more sample collection apertures disposed in the tip and through a lavage and sample collection tube and into a lavage collection reservoir.

[0194] In an embodiment, the tip is shaped and sized to pass through a nasal cavity of a subject or an oral cavity of a subject.

[0195] In an embodiment, the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0196] In an embodiment, the one or more lavage apertures are disposed in the cylindrical surface.

[0197] In an embodiment, the one or more lavage apertures are disposed at a proximal end and a distal end of the cylindrical surface.

[0198] An example of a method according to embodiments of the present disclosure will now be described with respect to FIGURE 12. FIGURE 12 is a block diagram of a method 1200 according to embodiments of the present disclosure.

[0199] In embodiments, method 1200 can be performed using a device and / or system according to any embodiment or aspect of the present disclosure. In an embodiment, method 1200 can be performed using devices 400, 500, 600, 700, or 800 discussed further herein with respect to FIGURES 4A-4H, 5 A-5I, 6A-6H, 7A-7H, and BASF, respectively. In an embodiment, method 1200 can be performed using systems 302, 1002, and 1102, discussed further herein with respect to FIGURES 3, 10, and 11.

[0200] The order in which some or all of the process blocks appear in process 1200 should not be deemed limiting. Rather, one of ordinary skill in the art having the benefit of the present disclosure will understand that some of the process blocks may be executed in a variety of orders not illustrated, or even in parallel.

[0201] In the illustrated embodiment, method 1200 begins with process block 1201 which comprises pumping, with a pump, a lavage fluid from a lavage fluid reservoir through a lavage tube and one or more lavage apertures disposed in a tip fluidically coupledto a distal end of the lavage tube. In an embodiment, such pumping is pulsatile (process block 1203) or periodic.

[0202] In the illustrated embodiment, process block 1201 is followed by process block 1205, which comprises pumping, with the pump, the sample through one or more sample collection apertures disposed in the tip and through a lavage and sample collection tube and into a lavage collection reservoir.

[0203] In an embodiment, process block 1205 is followed by process block 1207, which comprises emitting light on to the lavage tube and the lavage and sample collection tube, such as described further herein with respect to FIGURE 11. In an embodiment, process block 1207 is optional.

[0204] In an embodiment, process block 1207 is followed by process block 1209, which comprises generating a lavage signal based on a portion of the light passed through the lavage tube and a sample signal based on a portion of the light passed through the lavage and sample collection tube. In an embodiment, process block 1209 is optional.

[0205] In an embodiment, process block 1209 is followed by process block 1211, which comprises comparing the lavage signal and the sample signal, such as discussed further herein with respect to FIGURE 11.

[0206] As shown, following process block 1211, the method 1200 can return to process block 1201. In this regard, in an embodiment, method 1200 can include pumping, with the pump, the lavage fluid based on the comparison of the lavage signal and the sample signal, as generated in process block 1211.

[0207] Method 1200 can also terminate, such as when a sufficiently large sample has been collected, such as in process block 1205.

[0208] The processes explained above are described in terms of computer software and hardware. The techniques described may constitute machine-executable instructions embodied within a tangible or non-transitory machine (e.g., computer) readable storage medium, that when executed by a machine will cause the machine to perform the operations described. Additionally, the processes may be embodied within hardware, such as an application specific integrated circuit ("ASIC") or otherwise.

[0209] A tangible machine-readable storage medium includes any mechanism that provides (i.e., stores) information in a non-transitory form accessible by a machine (e.g., a computer, network device, personal digital assistant, manufacturing tool, any device with a set of one or more processors, etc.). For example, a machine-readable storagemedium includes recordable / non-recordable media (e.g., read only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, etc.).EXAMPLES EXAMPLE 1 : EVALUATION OF DEVICE WITH PORCINE STOMACH

[0210] The present Example describes testing a device and system according to embodiments of the present disclosure.

[0211] Experimental Design: Ex -Vivo Testing w / Porcine Stomach:

[0212] Lab counter was with plastic wrap and clear surrounding areas (counter, floor, etc).

[0213] At least 300mL of PBS / Saline solution in was placed in waterpik.

[0214] 50 mL of saline was flushed through catheter to prime the system.

[0215] A pig stomach was placed in a beaker and the catheter end was inserted into stomach. If stomach is cut into multiple sections, the beaker was lined with sections of stomach tissue.

[0216] Four rounds of 250 mL of fluid were used for each stomach.

[0217] The waterpik was filled with at least 250 mL of saline solution and catheter end is positioned so that water stream will hit tissue. Waterpik was turned on to maximum setting until all 250 mL of saline has been used. Waterpik was turned off and catheter end was submerged in the saline.

[0218] Vacuum pump was turned on until most or all of the 250 mL of saline was collected, making sure the end was submerged the entire time. The vacuum pump was turned off and the collected saline solution was placed in container and refrigerated.

[0219] These steps were repeated in triplicate.EXAMPLE 2: BIOLOGICAL SAMPLE DISPLACEMENT TESTING

[0220] Capsule Design

[0221] This version of capsule tested has a dimension of 7mm OD x 18mm basic height printed using Cardon 3D UMA90 material, along with 3 suction protectors (2.5mm diameter, 3.5mm tall) oriented around the suction hole at the bottom of the capsule. There are 3 copper (Grade T2 in China, equivalent to grade Cl 1000 in the U.S.) inserts (2.1mm thick, 6mm tall, 2.5mm width, 0.5mm diameter hole size), and two polyurethane tube (3mm O.D. x 1.8mm I.D. for positive pressure, 1.25mm ID x 2.5mm OD for suction), all insertsand tubes are bonded onto the capsule using medical grade USP Class VI cyanoacrylate adhesive.

[0222] The suction tubing was connected onto a glass collection bottle using idex flangeless fitting, and the positive pressure tubing is connected to a 14 Gauge lure needle fitting using medical grade USP Class VI cyanoacrylate adhesive.

[0223] Fluidic System Design & Experiment Setup

[0224] A schematic diagram of the fluidic system is provided in FIGURE 10. The fluid and collection reservoir were beakers and bottles found in the lab. The major system components included a positive pressure pump (McMaster-Carr 8080K42), a suction pump (Old KNF pump found in lab), a clean fluid reservoir (6000mL flask), a collection reservoir (1000 mL glass bottle), a mechanical pressure gauge (McMaster-Carr 3850K2), and two precision flow adjustment valves (McMaster-Carr 5513N11).

[0225] Experiment Procedure

[0226] The pickle jar's wall was pasted with two packs of microwaved Quaker Oatmeal being room temperature naturally dried for 48 hours to simulate tissues covering stomach lining, and a piece of foam found in lab was cut to 20mm diameter with a hole punched for the capsule to pass through to simulate the lower esophagus sphincter (per feeling, the oatmeal was more sticky compared to previous experiment conducted on 09 / 10 / 2025).

[0227] The experiment was conducted by placing the capsule into the pickle jar, enabling power supply to the pump (diagram 4), and adjusting the needle valves until the mechanical pressure gauge displayed 50psi for approximately 43 seconds. Then, the pressure was increased to 75 psi for approximately 16 seconds to observe the effect. Then, the tubes were moved slowly up and down, with a little bit of random rotation for the jets to cover more clean area. The positive pressure pump was powered off after power washing for approximately 1 minute, and then the capsule is placed in the washed off fluid (diagram 5) and the suction pump is powered on for approximately 1 minute while the tubes were rotated outside the pickle jar. The capsule is then pulled out from the pickle jar by pulling the tubes.

[0228] Results

[0229] During and after this experiment, it was observed that most of the oatmeal (85-90%) was washed off the pickle jar wall, and the suction did not get clogged by large particles. As shown in FIGURES 9A and 9B, the oatmeal covered much of the surfaceprior to spraying with the device (see FIGURE 9A), whereas after spraying much of the oatmeal has been dislodged from the surface of the jar (see FIGURE 9B)

[0230] It was also observed that it may be possible to remove the oatmeal from the pickle jar at 50psi pressure, but 75psi was used to greatly speed up the process.

[0231] To further increase mass, and reduce manufacturing cost and complexity, a one-piece copper insert can be used. Other embodiments can include a stronger suction pump and a larger fluid collection jar. For both suction and positive pressure tubing, a Shore 50A hardness silicone tubing, or a Shore 70A customed thin polyurethane tubing can be used for increased tolerability.

[0232] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0233] In the detailed description herein, references to "one embodiment", "an embodiment", "an example embodiment", "one or more embodiments, "some embodiments", etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments. Thus, it will be appreciated that embodiments of the present disclosure may employ any combination of features described herein. All such combinations or sub-combinations of features are within the scope of the present disclosure.

[0234] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0235] As used in the specification and in the claims, the term "comprising" may include the embodiments "consisting of' and "consisting essentially of." The terms "comprise(s)," "include(s)," "having," "has," "can," "contain(s)," and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named ingredients / steps and permit the presence of other ingredients / steps. However, such description should be construed as also describing compositions or processes as "consisting of and "consisting essentially of' the enumerated ingredients / steps, which allows the presence of only the named ingredients / steps, along with any impurities that might result therefrom, and excludes other ingredients / steps.

[0236] As used herein, approximating language may be applied to modify any quantitative representation that may vary without resulting in a change in the basic function to which it is related. As used herein, the terms "substantially, "about", and "at or about" mean that the amount or value in question can be the value designated some other value approximately or about the same. It is generally understood, as used herein, that it is the nominal value indicated ±10% variation unless otherwise indicated or inferred. For example, "about 10%" may indicate a range of 9% to 11%, and "about 1" may mean from 0.9-1.1. Other meanings of "about" may be apparent from the context, such as rounding off, so, for example "about 1" may also mean from 0.5 to 1.4. The term is intended to convey that similar values promote equivalent results or effects recited in the claims. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but can be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such. It is understood that where "about" is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise. For example, the expression "from about 2 to about 4" also discloses the range "from 2 to 4."

[0237] Unless indicated to the contrary, the numerical values should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ from the stated value by less than the experimental error of conventional measurement technique of the type described in the present application to determine the value.

[0238] All ranges disclosed herein are inclusive of the recited endpoint and independently of the endpoints (e.g., "between 2 grams and 10 grams, and all the intermediate values includes 2 grams, 10 grams, and all intermediate values"). The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value; they are sufficiently imprecise to include values approximating these ranges and / or values. All ranges are combinable.

[0239] Embodiments disclosed herein may utilize circuitry in order to implement technologies and methodologies described herein, operatively connect two or more components, generate information, determine operation conditions, control an appliance, device, or method, and / or the like. Circuitry of any type can be used. In an embodiment, circuitry includes, among other things, one or more computing devices such as a processor (e.g., a microprocessor), a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or the like, or any combinations thereof, and can include discrete digital or analog circuit elements or electronics, or combinations thereof.

[0240] An embodiment includes one or more data stores that, for example, store instructions or data. Non-limiting examples of one or more data stores include volatile memory (e.g., Random Access memory (RAM), Dynamic Random Access memory (DRAM), or the like), non-volatile memory (e.g., Read-Only memory (ROM), Electrically Erasable Programmable Read-Only memory (EEPROM), Compact Disc Read-Only memory (CD-ROM), or the like), persistent memory, or the like. Further non-limiting examples of one or more data stores include Erasable Programmable Read-Only memory (EPROM), flash memory, or the like. The one or more data stores can be connected to, for example, one or more computing devices by one or more instructions, data, or power buses.

[0241] In an embodiment, circuitry includes a computer-readable media drive or memory slot configured to accept signal-bearing medium (e.g., computer-readable memory media, computer-readable recording media, or the like). In an embodiment, a program for causing a system to execute any of the disclosed methods can be stored on, for example, a computer-readable recording medium (CRMM), a signal -bearing medium, or the like. Nonlimiting examples of signal-bearing media include a recordable type medium such as any form of flash memory, magnetic tape, floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), Blu-Ray Disc, a digital tape, a computer memory, or the like, as well as transmission type medium such as a digital and / or an analog communicationmedium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., transmitter, receiver, transceiver, transmission logic, reception logic, etc.). Further non-limiting examples of signal-bearing media include, but are not limited to, DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, Video Compact Discs, Super Video Discs, flash memory, magnetic tape, magneto-optic disk, MINIDISC, non-volatile memory card, EEPROM, optical disk, optical storage, RAM, ROM, system memory, web server, or the like.

[0242] The above description of illustrated embodiments of the disclosure, including what is described in the Abstract, is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. While specific embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize.

[0243] These modifications can be made to the disclosure in light of the above detailed description. The terms used in the following claims should not be construed to limit the disclosure to the specific embodiments disclosed in the specification. Rather, the scope of the disclosure is to be determined entirely by the following claims, which are to be construed in accordance with established doctrines of claim interpretation.

[0244] While illustrative embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.NON-LIMITING EMBODIMENTS

[0245] While general features of the disclosure are described and shown and particular features of the disclosure are set forth in the claims, the following non-limiting embodiments relate to features, and combinations of features, that are explicitly envisioned as being part of the disclosure. The following non-limiting embodiments contain elements that are modular and can be combined with each other in any number, order, or combination to form a new non-limiting embodiment, which can itself be further combined with other non-limiting embodiments.

[0246] 1. A device for harvesting cells from a portion of the body, the device comprising:

[0247] a lavage tube fluidically couplable at a proximal end to a lavage fluid reservoir;

[0248] a lavage and sample collection tube fluidically couplable at a proximal end to a lavage collection reservoir; and

[0249] a tip shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject,

[0250] wherein the tip defines:

[0251] one or more lavage apertures fluidically coupled to a distal end of the lavage tube and shaped and sized to allow passage of a lavage fluid therethrough; and

[0252] one or more sample collection apertures coupled to a distal end of the lavage and sample collection tube and shaped to allow passage of a sample comprising cells therethrough.

[0253] 2. The device of Embodiment 1, wherein the tip is shaped and sized to pass through the nasal cavity of the subject.

[0254] 3. The device of Embodiments 1 or 2, wherein the tip is shaped and sized to pass through the oral cavity of the subject

[0255] 4. The device of any of Embodiments 1-3, wherein the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0256] 5. The device of Embodiment 4, wherein the one or more lavage apertures are disposed in the cylindrical surface.

[0257] 6. The device of Embodiment 4, wherein the one or more lavage apertures are disposed at a proximal end of the cylindrical surface.

[0258] 7. The device of Embodiment 4, wherein the tip is configured to rotate when the lavage fluid passes through the one or more lavage apertures.

[0259] 8. The device of Embodiment 4, wherein the one or more sample collection apertures are disposed at a distal panel of the two panels.

[0260] 9. The device of any of Embodiments 1-8, wherein a length of the tip is in a range of about 10 mm to about 30 mm.

[0261] 10. The device of any of Embodiments 1-9, wherein a width of the tip is in a range of about 1 mm to about 8 mm.

[0262] 11. The device of any of Embodiments 1-10, wherein the lavage tube and the lavage and sample collection tube are arranged coaxially.

[0263] 12. A system comprising:

[0264] the device of any of any of Embodiments 1-11;

[0265] a lavage fluid reservoir coupled to the proximal end of the lavage tube;

[0266] a lavage collection reservoir coupled to the proximal end of the lavage and sample collection tube; and

[0267] a pump configured to pump a lavage fluid from the lavage fluid reservoir through the lavage tube and to pump a sample through the lavage and sample collection tube to the lavage collection reservoir.

[0268] 13. The system of Embodiment 12, further comprising a controller operatively coupled to the pump, the controller comprising logic that, when executed, causes the system to perform operations comprising:

[0269] pumping, with the pump, the lavage fluid from the lavage fluid reservoir through the lavage tube and the one or more lavage apertures; and

[0270] pumping, with the pump, the sample through the one or more sample collection apertures and through the lavage and sample collection tube and into the lavage collection reservoir.

[0271] 14. The system of Embodiment 13, wherein pumping, with the pump, the lavage fluid through the lavage tube and the one or more lavage apertures comprises pulsatile pumping.

[0272] 15. The system of Embodiment 13, wherein pumping, with the pump, the sample through the one or more sample collection apertures and the lavage and sample collection tube comprises pumping the sample through the lavage and sample collection tube periodically.

[0273] 16. The system of Embodiment 13, wherein the pump pumps the lavage fluid at a pressure in a range of about 5 pounds per square inch (psi) to about 160 psi.

[0274] 17. The system of Embodiment 13, wherein the pump pumps the lavage fluid at a flow rate in a range of about 30 mL / minute per lavage aperture to about 700 mL / minute per lavage aperture.

[0275] 18. The system of Embodiment 13, further comprising:

[0276] a light source configured to emit light onto the lavage tube and the lavage and sample collection tube; and

[0277] a photodetector positioned to receive the light passed through the lavage tube and the lavage and sample collection tube.

[0278] 19. The system of Embodiment 18, wherein the photodetector is configured to generate a lavage signal based on a portion of the light passed through the lavage tube and a sample signal based on a portion of the light passed through the lavage and sample collection tube; and

[0279] wherein the controller, operatively coupled to the photodetector, further comprises logic that, when executed, causes the system to perform operations including pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal.

[0280] 20. The system of Embodiment 19, wherein pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal comprises increasing pressure of the lavage fluid up to a pressure when the sample signal reaches a predetermined threshold.

[0281] 21. The system of Embodiment 19, wherein a portion of the lavage tube positioned to receive the light and a portion of the lavage and sample collection tube positioned to receive the light are generally flattened.

[0282] 22. The system of any of Embodiments 12-21, further comprising one or more filters shaped to filter objects from the sample.

[0283] 23. The system of Embodiment 23, wherein the one or more filters comprises a first filter comprising apertures having a smallest size in a range of about 70 microns to about 200 microns, and a second filter comprising apertures having a smallest size of about 10 microns to about 30 microns.

[0284] 24. A method of collecting a sample from a subject, the method comprising:

[0285] pumping, with a pump, a lavage fluid from a lavage fluid reservoir through a lavage tube and one or more lavage apertures disposed in a tip fluidically coupled to a distal end of the lavage tube; and

[0286] pumping, with the pump, the sample through one or more sample collection apertures disposed in the tip and through a lavage and sample collection tube and into a lavage collection reservoir,

[0287] wherein the tip shaped and sized to pass through a nasal cavity of the subject or an oral cavity of the subject.

[0288] 25. The method of Embodiment 24, the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

[0289] 26. The method of Embodiment 25, wherein the one or more lavage apertures are disposed in the cylindrical surface.

[0290] 27. The method of Embodiment 25, wherein the one or more lavage apertures are disposed at a proximal end and a distal end of the cylindrical surface.

Claims

CLAIMSThe embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A device for harvesting cells from a portion of the body, the device comprising:a lavage tube fluidically couplable at a proximal end to a lavage fluid reservoir; a lavage and sample collection tube fluidically couplable at a proximal end to a lavage collection reservoir; anda tip shaped and sized to pass through a nasal cavity of a subject or an oral cavity of the subject,wherein the tip defines:one or more lavage apertures fluidically coupled to a distal end of the lavage tube and shaped and sized to allow passage of a lavage fluid therethrough; andone or more sample collection apertures coupled to a distal end of the lavage and sample collection tube and shaped to allow passage of a sample comprising cells therethrough.

2. The device of Claim 1, wherein the tip is shaped and sized to pass through the nasal cavity of the subject.

3. The device of Claim 1, wherein the tip is shaped and sized to pass through the oral cavity of the subj ect4. The device of Claim 1, wherein the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

5. The device of Claim 4, wherein the one or more lavage apertures are disposed in the cylindrical surface.

6. The device of Claim 4, wherein the one or more lavage apertures are disposed at a proximal end of the cylindrical surface.

7. The device of Claim 4, wherein the tip is configured to rotate when the lavage fluid passes through the one or more lavage apertures.

8. The device of Claim 7, wherein the one or more lavage apertures define a path that is non-orthogonal to a rotational axis of the tip.

9. The device of Claim 4, wherein the one or more sample collection apertures are disposed at a distal panel of the two panels.

10. The device of Claim 1, wherein a length of the tip is in a range of about 10 mm to about 30 mm.

11. The device of Claim 1, wherein a width of the tip is in a range of about 1 mm to about 8 mm.

12. The device of Claim 1, wherein the lavage tube and the lavage and sample collection tube are arranged coaxially.

13. The device of Claim 1, wherein the tip further comprises one or more protrusions extending from a surface adjacent to the one or more sample collection apertures.

14. A system comprising:the device of Claim 1;a lavage fluid reservoir coupled to the proximal end of the lavage tube;a lavage collection reservoir coupled to the proximal end of the lavage and sample collection tube; anda pump configured to pump a lavage fluid from the lavage fluid reservoir through the lavage tube and to pump a sample through the lavage and sample collection tube to the lavage collection reservoir.

15. The system of Claim 14, further comprising a controller operatively coupled to the pump, the controller comprising logic that, when executed, causes the system to perform operations comprising:pumping, with the pump, the lavage fluid from the lavage fluid reservoir through the lavage tube and the one or more lavage apertures; andpumping, with the pump, the sample through the one or more sample collection apertures and through the lavage and sample collection tube and into the lavage collection reservoir.

16. The system of Claim 15, wherein pumping, with the pump, the lavage fluid through the lavage tube and the one or more lavage apertures comprises pulsatile pumping.

17. The system of Claim 15, wherein pumping, with the pump, the sample through the one or more sample collection apertures and the lavage and sample collection tube comprises pumping the sample through the lavage and sample collection tube periodically.

18. The system of Claim 15, wherein the pump pumps the lavage fluid at a pressure in a range of about 5 pounds per square inch (psi) to about 160 psi.

19. The system of Claim 15, wherein the pump pumps the lavage fluid at a flow rate in a range of about 30 mL / minute per lavage aperture to about 700 mL / minute per lavage aperture.

20. The system of Claim 15, further comprising:a light source configured to emit light onto the lavage tube and the lavage and sample collection tube; anda photodetector positioned to receive the light passed through the lavage tube and the lavage and sample collection tube.

21. The system of Claim 20, wherein the photodetector is configured to generate a lavage signal based on a portion of the light passed through the lavage tube and a sample signal based on a portion of the light passed through the lavage and sample collection tube; andwherein the controller, operatively coupled to the photodetector, further comprises logic that, when executed, causes the system to perform operations including pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal.

22. The system of Claim 21, wherein pumping, with the pump, the lavage fluid based on a comparison of the lavage signal and the sample signal comprises increasingpressure of the lavage fluid up to a pressure when the sample signal reaches a predetermined threshold.

23. The system of Claim 21, wherein a portion of the lavage tube positioned to receive the light and a portion of the lavage and sample collection tube positioned to receive the light are generally flattened.

24. The system of Claim 14, further comprising one or more filters shaped to filter objects from the sample.

25. The system of Claim 24, wherein the one or more filters comprises a first filter comprising apertures having a smallest size in a range of about 70 microns to about 200 microns, and a second filter comprising apertures having a smallest size of about 10 microns to about 30 microns.

26. The system of Claim 14, wherein the lavage fluid comprises a mucolytic agent.

27. A method of collecting a sample from a subject, the method comprising: pumping, with a pump, a lavage fluid from a lavage fluid reservoir through a lavage tube and one or more lavage apertures disposed in a tip fluidically coupled to a distal end of the lavage tube; andpumping, with the pump, the sample through one or more sample collection apertures disposed in the tip and through a lavage and sample collection tube and into a lavage collection reservoir,wherein the tip shaped and sized to pass through a nasal cavity of the subject or an oral cavity of the subject.

28. The method of Claim 27, wherein the tip defines a cylindrical shape comprising a cylindrical surface and two panels, wherein a panel of the two panels is shaped to receive the lavage tube and the lavage and sample collection tube.

29. The method of Claim 28, wherein the one or more lavage apertures are disposed in the cylindrical surface.

30. The method of Claim 28, wherein the one or more lavage apertures are disposed at a proximal end and a distal end of the cylindrical surface.

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