The present disclosure generally relates to a device and method for aspiration tools including but not limited to a catheter used in endoscopic intervention. More specifically, current device and method relates to a novel catheter that can aspirate small amount of liquid in an uncontaminated fashion with an outer sheath.
Current procedures for collecting of fluid aspirations involve positioning an endoscope in a hollow organ such as small bowel. A sterile catheter is then advanced through the working port of the endoscope, and suction is applied to collect approximately 2 ml of intestinal fluid.
The aspirate is then transferred immediately to aerobic and/or anaerobic sterile tubes for microbiologic analysis.
However, there are two key challenges associated with this workflow, specifically: (1) inadequate fluid collection—the ability to collect more than 2 ml of luminal fluid contents within the small intestine is often challenging due to fluid availability; and (2) contamination—liquid is transferred to the catheter from the oral cavity, esophagus, and stomach. For example, bacterial counts in the oral cavity are approximately 10{circumflex over ( )}9 CFU/ml, and intestinal aspirates are typically less than 10{circumflex over ( )}3 CFU/ml, a contamination rate of just 0.001% could potentially result in a misdiagnosis of Small Intestinal Bacterial or Fungal Overgrowth. Current workflows attempt to address this through sample collection and/or flushing techniques, but there still exists an inherent problem with the device design is present.
As such, obtaining a true sterile sample via an endoscopic device is currently extremely difficult, if not impossible. The endoscopes and their suction channels are constantly being contaminated throughout the procedure. For example, by the time a gastroscope reaches the duodenum, the endoscope is contaminated by the oral, nasopharyngeal, esophageal and gastric microflora.
Therefore, there is a need for device and method for efficient collection of liquid in vivo in a sterile environment.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, compositions and methods that are meant to be exemplary and illustrative, not limiting in scope.
In an aspect of the present disclosure, an endoscopic device is disclosed. The endoscopic disclosure includes an outer sheath having a proximal end and a distal end, the distal end coupled to a handle; a suction tube inside the outer sheath; and a cap on the proximal end of the outer sheath, positioned to seal the proximal end of the outer sheath, wherein the outer sheath includes a sterile appliance wherein the cap is structured to open responsive to a force applied through the suction tube. The cap may include a plastic, a glucose, or any other material that is nontoxic (or dissolvable) in the body. The force may include air pressure, water pressure, sterile gases, or a force exerted by a guidewire that is configured to deploy through middle of the suction tube. The suction tube may include at least one hole for carrying out aspiration or suction at a target site in vivo. The outer sheath may include a metal coil.
In an embodiment of the present disclosure, the endoscopic device may further include a guidewire that is configured to go through an internal cavity of the suction tube; and an inflatable balloon that is stored near the proximal end of the outer sheath and is configured to deploy outside the outer sheath by a force exerted by the guidewire that is configured to deploy through middle of the suction tube.
In an embodiment of the present disclosure, the endoscopic device may further include a guidewire that is configured to go through an internal cavity of the suction tube; and an elliptical basket that is stored near the proximal end of the outer sheath and is configured to deploy outside the outer sheath by a force exerted by the guidewire that is configured to deploy through middle of the suction tube. The handle may be configured to be connected to a syringe full of an inert gas in order to remove the cap through gas pressure.
In an embodiment of the present disclosure, the endoscopic device may further include a suction tube having a proximal end and a distal end, the distal end coupled to a handle, wherein the suction tube comprises at least one capillary tube.
In an aspect of the present disclosure, a method for using the endoscopic device is disclosed. The method includes: inserting the endoscopic device into a body cavity during an endoscopic surgical procedure; removing the cap; deploying the suction tube; and carrying out aspiration via the suction tube in order to collect a sample from a patient's body.
In another aspect of the present disclosure, a computer readable storage medium tangibly embodying a computer readable program code having computer readable instructions is disclosed. The computer readable instructions, when implemented, cause a computer to carry out the steps of a method as described herein.
Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.
The disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting implementations and examples that are described and/or illustrated in the accompanying drawings, and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one implementation may be employed with other implementations as any person skilled in the art would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the implementations of the disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the disclosure may be practiced and to further enable those of skill in the art to practice the implementations of the disclosure. Accordingly, the examples and implementations herein should not be construed as limiting the scope of the disclosure.
Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. Unless explicitly stated otherwise, or apparent from context, the terms and phrases below do not exclude the meaning that the term or phrase has acquired in the art to which it pertains. 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 to which this invention belongs. It should be understood that this invention is not limited to the particular methodology, protocols, and reagents, etc., described herein and as such can vary. The definitions and terminology used herein are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims.
As used herein the term “comprising” or “comprises” is used in reference to compositions, methods, and respective component(s) thereof, that are useful to an embodiment, yet open to the inclusion of unspecified elements, whether useful or not. It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). Although the open-ended term “comprising,” as a synonym of terms such as including, containing, or having, is used herein to describe and claim the invention, the present invention, or embodiments thereof, may alternatively be described using alternative terms such as “consisting of” or “consisting essentially of.” Unless stated otherwise, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment of the application (especially in the context of claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. The abbreviation, “e.g.” is derived from the Latin exempli gratia, and is used herein to indicate a non-limiting example. Thus, the abbreviation “e.g.” is synonymous with the term “for example.” No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.
The terms “patient” and “subject” are used interchangeably herein. These terms are intended to include all animal subjects, including mammals. Human patients/subjects are intended to be within the scope of the patients/subjects treated using the various embodiments of the inventive systems, apparatuses and methods described herein.
A term “wireless transmitter,” as used in this disclosure, means at least one of microwave, Infrared or RF module or a cellular/wireless modem and is configured to transmit data.
The term “coupled” means at least either a direct electrical connection between the connected items or an indirect connection through one or more passive or active intermediary devices. The term “circuit” means at least either a single component or a multiplicity of components, either active and/or passive, that are coupled together to provide a desired function. The term “signal” as used herein may include any meanings as may be understood by those of ordinary skill in the art, including at least an electric or magnetic representation of current, voltage, charge, temperature, data or a state of one or more memory locations as expressed on one or more transmission mediums, and generally capable of being transmitted, received, stored, compared, combined or otherwise manipulated in any equivalent manner.
Terms such as “providing,” “processing,” “supplying,” “determining,” “calculating” or the like may refer at least to an action of a computer system, computer program, signal processor, logic or alternative analog or digital electronic device that may be transformative of signals represented as physical quantities, whether automatically or manually initiated.
A “computer,” as used in this disclosure, means any machine, device, circuit, component, or module, or any system of machines, devices, circuits, components, modules, or the like, which are capable of manipulating data according to one or more instructions, such as, for example, without limitation, a processor, a microprocessor, a central processing unit, a general purpose computer, a cloud, a super computer, a personal computer, a laptop computer, a palmtop computer, a mobile device, a tablet computer, a notebook computer, a desktop computer, a workstation computer, a server, or the like, or an array of processors, microprocessors, central processing units, general purpose computers, super computers, personal computers, laptop computers, palmtop computers, mobile devices, tablet computers, notebook computers, desktop computers, workstation computers, servers, or the like.
A “server,” as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer to perform services for connected clients as part of a client-server architecture. The at least one server application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients. The server may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction. The server may include a plurality of computers configured, with the at least one application being divided among the computers depending upon the workload. For example, under light loading, the at least one application can run on a single computer. However, under heavy loading, multiple computers may be required to run the at least one application. The server, or any if its computers, may also be used as a workstation.
A “database,” as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer. The database may include a structured collection of records or data organized according to a database model, such as, for example, but not limited to at least one of a relational model, a hierarchical model, a network model or the like. The database may include a database management system application (DBMS) as is known in the art. The at least one application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients. The database may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction.
A “communications network,” as used in this disclosure, means a wired and/or wireless medium that conveys data or information between at least two points. The wired or wireless medium may include, for example, a metallic conductor link, a radio frequency (RF) communication link, an Infrared (IR) communication link, telecommunications networks, an optical communication link, internet (wireless and wired) or the like, without limitation. The RF communication link may include, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G, 4G, 5G or future cellular standards, Bluetooth, Bluetooth Low Energy, NFC, ultrasound, induction, laser (or similar optical transmission) and the like.
A “computer-readable storage medium,” as used in this disclosure, means any medium that participates in providing data (for example, instructions) which may be read by a computer. Such a medium may take many forms, including non-volatile media, volatile media, and transmission media. Non-volatile media may include, for example, optical or magnetic disks, flash memory, and other persistent memory. Volatile media may include dynamic random access memory (DRAM). Transmission media may include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor. Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read. The computer-readable medium may include a “Cloud,” which includes a distribution of files across multiple (e.g., thousands of) memory caches on multiple (e.g., thousands of) computers.
Various forms of computer readable media may be involved in carrying sequences of instructions to a computer. For example, sequences of instruction (i) may be delivered from a RAM to a processor, (ii) may be carried over a wireless transmission medium, and/or (iii) may be formatted according to numerous formats, standards or protocols, including, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G or 4G cellular standards, Bluetooth, or the like.
A “network,” as used in this disclosure means, but is not limited to, for example, at least one of a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a personal area network (PAN), a campus area network, a corporate area network, a global area network (GAN), a broadband area network (BAN), a cellular network, the Internet, the cloud network, or the like, or any combination of the foregoing, any of which may be configured to communicate data via a wireless and/or a wired communication medium. These networks may run a variety of protocols not limited to TCP/IP, IRC, SSL, TLS, UDP, or HTTP.
The at least one endoscopic device 10, the monitor computer 40, the hosted server 50, and the database 61 may each include a computer-readable medium including a computer program that may be executed to carry out the processes disclosed herein. The computer-readable medium may include a code section or code segment for performing each step disclosed herein.
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As disclosed herein, the present invention provides a unique multilayered tip and a handle design of a catheter that can suction the contents in a completely sterile and even anaerobic fashion. It addresses following problems that are encountered during in vivo endoscopic procedure: (1) inability to confidently identify the pathogens (as oppose to contaminant bacteria, fungus and viruses) in diseases such as small intestinal bacterial/fungal overgrowth, infectious enteritis, infectious cystitis and nephritis, respiratory tract infections (e.g. ventilator associated pneumonia), sinusitis, cholangitis and pancreatitis; (2) inability to accurately identify anaerobic pathogens due to exposure to open air; (3) inability to accurately develop microbiome banks due to poor current techniques; and (4) inability to confirm the eradication of infection. Furthermore, by utilizing capillary tubes, the current invention provides an ability to suction even small amount of liquid in a sterile environment and with (or without) an outer sheath.
It is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.
Various embodiments of the invention are described above in the Detailed Description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the purview of this description are intended to be included therein as well. Unless specifically noted, it is the intention of the inventors that the words and phrases in the specification and claims be given the ordinary and accustomed meanings to those of ordinary skill in the applicable art(s).
The foregoing description of various embodiments of the invention known to the applicant at this time of filing the application has been presented and is intended for the purposes of illustration and description. The present description is not intended to be exhaustive nor limit the invention to the precise form disclosed and many modifications and variations are possible in the light of the above teachings. The embodiments described serve to explain the principles of the invention and its practical application and to enable others skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out the invention.
While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from this invention and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of this invention.
This application is a continuation of U.S. patent application Ser. No. 16/489,388, filed Aug. 28, 2019, which is the national phase of International Application No. PCT/US2018/019240, filed Feb. 22, 2018 which designated the U.S. and that International Application was published under PCT Article 21(2) in English. This application also claims priority to U.S. Provisional Patent Application No. 62/464,833, filed Feb. 28, 2017, the contents of which are incorporated herein by reference in their entirety.
Number | Date | Country | |
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62464833 | Feb 2017 | US |
Number | Date | Country | |
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Parent | 16489388 | Aug 2019 | US |
Child | 18235945 | US |