Connector with integrated non-return check valve for extension tubing and urology collection systems

A connector-with-integrated-check-valve for minimizing microbial migration to catheter-tubing is formed from three parts: a connector-for-catheter-tubing that is hollow and with an internal valve seat; an elastomer gate (sometimes with disc and stem); and a connector-for-extension-tubing that is hollow and with support-surfaces. When one end of the connector-for-catheter-tubing is attached to one end of the connector-for-extension-tubing, a pocket is formed where the seat is disposed opposite and facing the support-surfaces; the gate is disposed within this pocket; such that when the gate contacts this seat due to urine backflow (reflux), the connector-with-integrated-check-valve is closed to such urine backflow; and where a remaining end of the connector-for-catheter-tubing is attachable to catheter-tubing; and where a remaining end of the connector-for-extension-tubing is attachable to the extension-tubing, such that there is a continuous urine flow path from the catheter-tubing, to the connector-with-integrated-check-valve when open, and to the extension-tubing.

STATEMENT REGARDING FEDERAL SPONSORSHIP

No part of this invention was a result of any federally sponsored research.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to urinary tubing and more specifically to flexible urinary tubing, such as extension tubing, which may comprise various means for minimizing microbial migration in a direction opposite of intended flow. Additionally, a system and a method for forming an anti-reflux extension tubing system with respect to urinary tubing connected to a catheter and urine container are described and disclosed.

COPYRIGHT AND TRADEMARK NOTICE

BACKGROUND OF THE INVENTION

One in five patients admitted to hospitals receive an indwelling urinary catheter (hereinafter, “catheter”). When a patient receives a catheter, and the longer the catheter is placed inside the body, the more likely the patient will develop a urinary tract infection (UTI). Hospital-associated infections (HAIs) are infections acquired during the course of receiving treatment for other conditions within a hospital setting. In the United States according to the Centers for Disease Control and Prevention (CDC) more than four million patients develop HAIs in the United States each year with about 99,000 of such cases resulting in death.

UTIs may be caused by microbes (e.g. bacteria) entering the body through the catheter. The distribution of microbes among patients with hospital-acquired urinary tract-related bloodstream infections may include:enterococcus, candida, E. coli, klebsiella, staphylococcus, and the like. According to the ICHP, the urinary tract is the most common site of HAIs and accounts for more than 64% of catherized patients in acute-care hospitals. In 2014, the CDC released a HAI Progress Report stating that among five categories of HAIs, only catheter-associated urinary tract infections (CAUTI) had an increase of incidents. Due to the increase of CAUTIs, the Centers for Medicare and Medicaid Services (CMS) will not allow hospitals to be reimbursed for treating a hospital-acquired CAUTI because nosocomial CAUTIs and are believed to be “reasonably preventable.” The cost of treating UTIs could cost U.S. hospitals between $1.6 billion and $7.39 billion annually in lost Medicare reimbursements since treating each CAUTI incident may cost between US$600 to US$2,800 to treat.

Microbes may travel intraluminally in the urinary system at least two ways: (1) suspended and floating microbial cells within the urine (i.e., bacteriuria) where there is backflow (reflux) of infected urine; and (2) by biofilm migration (i.e., colonies of microbial cells that may form layers and attach themselves to surfaces) that may ascend up through the inside of urinary tubing surfaces and into the catheter and potentially enter the patient's body. Research currently suggests that preventing urine backflow (reflux) from entering the catheter and/or incorporating a hurdle or barrier that prevents biofilms from ascending through the urinary collection system would help to mitigate the number of UTIs. Currently, the number of patients developing bacteriuria or UTIs after two and three days is 10% to 30%; while after one week or longer is near 90%, and; long-term catheterization (of one month or more) results in near 100% of patients with bacteriuria or UTIs. Although not all CAUTIs may be prevented, it is believed by the medical community that a substantial number of CAUTIs may be avoided by the proper management of indwelling and external catheters. CMS developed a list of recommendations and guidelines to help reduce UTIs and CAUTIs. One of these recommendations included preventing backflow (reflux) of urine which could contain bacteriuria or other microbes. Furthermore, prevention may be the best way to manage nosocomial UTI, as opposed to focusing on expensive treatment and medicine, which may or may not be effective, as many microbes are becoming increasingly less sensitive and more resistant to antibiotics.

A first and second anti-reflux barrier (e.g., one or more check-valves and/or one or more clamps) within a urinary system (e.g., comprising extension tubing and one or more check-valves) may be beneficial by denying microbes various routes of entry into the patient. If such a system is breached (e.g., by inappropriate opening), then microbes may enter the extension tubing and catheter and travel up into the urethra or body wall of the patient and infect the patient.

To date (circa 2014), the inventor is not aware of any prior art that specifically addresses a device or component that forms an anti-reflux extension tubing system or where such a device or component may prevent urine backflow (reflux) of urine located within urinary extension tubing that connects the urinary indwelling and/or external catheter to the urine bag, or where such a device or component may prevent biofilm migration. Reference should also be made that there are no commercial products currently available that specifically addresses prevention of urine backflow in urinary collection systems, such as the extension tubing, by placing a check-valve inside the urinary extension tubing or within a connector of the extension tubing.

Rather, unrelated prior art consists of inventions for closed-system and anti-reflux system are irrigation connectors, intravenous syringe ports, closed adapters for enteral formula delivery, and needleless IV access ports for small bore luers—i.e., none of this prior art deals with urinary systems.

For example, some such prior art include: preventing backflow for blood and urine specimens (i.e., not urinary collection system) and maintaining a closed-system for irrigation; and of using check-valves in feeding tubes. Such prior art does not incorporate any anti-reflux check-valve within the primary urinary extension tubing running from the indwelling catheter to the urine bag.

Additionally, the prior art may include a check-valve located within a urine bag. This prior art may prevent urine backflow (reflux) from the urine bag into the extension tubing. However, the urine collection system between the urine bag and the patient is vulnerable and presently has no barrier against urine backflow. If there is no anti-reflux valve (i.e., check-valve) present before the catheter to prevent urine backflow, then microbes in the urine may travel from the urine in tubing into the catheter leading to a CAUTI.

There is a need in the art for satisfactorily addressing and reducing the high percentage of UTIs and CAUTIs that occur with current indwelling and/or external urinary catheter use.

It is to these ends that the present invention has been developed.

BRIEF SUMMARY OF THE INVENTION

To minimize the limitations in the prior art, and to minimize other limitations that will be apparent upon reading and understanding the present specification, the present invention may describe a connector-with-integrated-check-valve for minimizing microbial migration to catheter-tubing as well as a system for minimizing microbial migration to the catheter-tubing.

In some embodiments, the connector-with-integrated-check-valve for minimizing microbial migration to catheter-tubing may be formed from three parts: a connector-for-catheter-tubing that is hollow and with an internal valve seat; an elastomer disc shaped gate; and a connector-for-extension-tubing that is hollow and with support-surfaces. When one end of the connector-for-catheter-tubing is attached to one end of the connector-for-extension-tubing, a pocket is formed where the seat is disposed opposite and facing the support-surfaces; the gate is disposed within this pocket; such that when the gate contacts this seat due to urine backflow (reflux), the connector-with-integrated-check-valve is closed to such urine backflow; and where a remaining end of the connector-for-catheter-tubing is attachable to catheter-tubing; and where a remaining end of the connector-for-extension-tubing is attachable to the extension-tubing, such that there is a continuous urine flow path from the catheter-tubing, to the connector-with-integrated-check-valve when open, and to the extension-tubing.

It is an objective of the present invention to provide urinary extension tubing and/or a connector-with-integrated-check-valve that may be capable of minimizing microbial migration in a direction opposite of intended flow, by utilizing the various means discussed herein, specifically in the DETAILED DESCRIPTION OF THE INVENTION section of this specification.

It is another objective of the present invention to provide urinary extension tubing that may be capable of minimizing urine backflow (reflux) from the intended flow of urine within the urinary extension tubing and preventing backflow into a catheter.

It is another objective of the present invention to provide urinary extension tubing that may comprise at least one check-valve positioned within the urinary tubing or within a connector attached to the extension tubing, i.e., a connector-with-integrated-check-valve.

It is another objective of the present invention to provide urinary extension tubing that may comprise at least one biofilm abater positioned within the urinary tubing to minimize biofilm migration across the at least one biofilm abater. See the DETAILED DESCRIPTION OF THE INVENTION section for a discussion of biofilm abaters.

It is another objective of the present invention to provide urinary extension tubing and/or a connector-with-integrated-check-valve, that may comprise at least one wettable region (e.g., a region of urinary tubing inside diameter) treated with an antimicrobial coating lining at least some portions the luminal walls (interior walls) of the urinary tubing to minimize biofilm migration across the at least one wettable region treated with the antimicrobial coating.

It is another objective of the present invention to provide urinary extension tubing that may comprise various connectors, both with and without check-valves, where such connectors may be positioned within the urinary tubing, at the first terminal end, and/or the second terminal end, wherein such connectors (and/or tubing) may be treated (e.g., by coating) with an antimicrobial coating to mitigate against biofilm migration across such connectors treated with the antimicrobial coating.

It is another objective of the present invention to provide a method or series of methods for forming and maintaining an anti-reflux extension tubing system with respect to urinary extension tubing connected to a catheter.

It is yet another objective of the present invention to provide systems for forming and maintaining an anti-reflux extension tubing system with respect to urinary tubing connected to a catheter.

These and other advantages and features of the present invention are described herein with specificity so as to make the present invention understandable to one of ordinary skill in the art, both with respect to how to practice the present invention and how to make the present invention.

REFERENCE NUMERAL SCHEDULE

601check-valve pushed into place embodiment601

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments of urinary tubing configured to minimize microbial migration in a direction opposite of intended flow are described and disclosed. A system and a method for forming and maintaining a closed-system with respect to urinary tubing connected to a catheter are also described and disclosed.

Before turning to a discussion of the invention's various structures, disclosures regarding various definitions and functional objectives of the inventive structures are disclosed. “Intended flow,” “microbe, “microbial,” “antimicrobial,” “system,” “closed-system,” and “tubing” are all defined below and in turn.

An example of “intended flow” may be a flow of urine beginning from a patient's urethra (or bladder or kidney) and flowing into and through a urinary catheter (through an inside diameter), then into urinary tubing (through an inside diameter), and finally into a urine bag (e.g., leg or bed). Such intended flow is generally accomplished by the catheter being placed within the patient's urethra (or bladder or kidney), followed by the urinary tubing connected to an exit port of the catheter, and then with the urine bag connected at a remaining terminal end of the urinary tubing, and where the intended flow may be accomplished by each subsequent component being placed below the immediately prior component, i.e., to facilitate flow downhill. Intended flow of urine may be in a same direction of flow as desired-direction770. Any urine flow opposite of this intended flow direction is known as “backflow” or “reflux.” And a primary objective of this invention is to mitigate against microbes migrating in the direction opposite of the intended flow. For example, one way to minimize undesirable microbe migration, may be to prevent or mitigate against fluid (e.g., urine) backflow (reflux), since such fluid may be carrying microbes.

However, regardless of fluid flow, microbes may migrate against the direction of intended flow by forming a biofilm on a surface of the inside of urinary tubing and then said biofilm growing (migrating) in the direction opposite of intended flow. Such surface growth of microbes may generally be facilitated by the microbes attaching to a wettable surface and then growing on the wettable surface. Thus, a second way to minimize undesirable microbe migration may be to inhibit the growth of microbes on such surfaces of the tubing, especially wettable surfaces of the tubing. Another way to minimize microbe migration into the catheter may be to block growth of microbes. Additionally, a fourth way to minimize undesirable microbe migration may be to inhibit attachment of microbes on certain surfaces of the tubing.

Note, in this specification, “microbes” and “microbial” refers to a variety of micro-organisms which may comprise: bacteria, fungi (e.g., yeast), viruses, protozoans, and the like. Microbes may be floating freely and/or suspended within a fluid, including fluid flowing within tubing. Microbes attached to a surface may form a colony comprising many individual microbial cells, i.e., a biofilm. The term, “biofilm” refers to at least one microbial cell that has attached itself to a surface, i.e., a biofilm may be a microbial colony of many microbial cells attached to a surface.

The term, “antimicrobial” as used in this specification may refer to minimizing microbe migration in a direction opposite of intended flow. Functionally, this invention may provide for at least three mechanisms to this desired objective of providing an antimicrobial tubing and system, where those three mechanisms may be: (1) minimizing fluid backflow (reflux); (2) minimizing microbe growth; (3) preventing microbe growth into the catheter; and (4) minimizing microbe attachment to surfaces, particularly to wettable surfaces. As used in this specification, the term “mitigate” may be synonymous with “abate” and may include and encompasses the terms “prevent” and “inhibit.”

In some embodiments, a “system” as used in this specification may comprise: a length of urinary extension tubing and at least one connector-with-integrated-check-valve that is connected to the length of urinary extension tubing. In some embodiments, a system may comprise: a catheter, a length of urinary extension tubing, and at least one connector-with-integrated-check-valve that is connected to the length of urinary extension tubing. In some embodiments, a system may comprise: a catheter, a length of urinary tubing, and a urine bag. In embodiments, a system may comprise: a patient, a catheter, and a length of urinary tubing. In embodiments, a system may comprise: a patient, a catheter, a length of urinary tubing, and a urine bag. In some of the above systems, the system may further comprise at least one connector-with-integrated-check-valve that is connected to the length of urinary extension tubing. In some of the above systems, the urinary extension tubing may further comprise some additional structures (e.g., check-valves), some with various antimicrobial structures and functions, as further disclosed and discussed below. In some embodiments, the system may be an anti-reflux extension tubing system.

This invention may comprise various embodiments of such tubing (e.g., urinary tubing as disclosed herein). This invention may also comprise the various systems, wherein such systems may comprise the tubing and the catheter. In other words, the urinary tubing as the invention may not comprise the catheter; but, the system as the invention may comprise the catheter in some embodiments.

With respect to the catheter, such catheters may comprise both indwelling and external catheters. Indwelling catheters may comprise Foley (i.e., inserted into the urethra), suprapubic (inserted into abdomen or bladder), and nephrostomy (e.g., inserted in one or both kidneys). External catheters may comprise condom catheters and female external collection systems.

With respect to the catheter, a connection between the catheter and the extension tubing may be located at the catheter's “exit port.” Such an exit port may also be referred to as a “drainage port.”

A “closed-system” may refer to how the system may be formed and maintained isolated, i.e., kept physically separated, from components outside of the system. It may be desirable to maintain such systems as closed to help prevent infection, including urine backflow (reflux), from microbes entering the system and making their way into a patient.

A closed-system may be formed by maintaining the following connected components, with at least three points of connections (or points of being sealed from outside influence): (1) a catheter properly connected to a patient's urethra (or bladder or kidney); (2) a proper connection between the catheter's exit port and a terminal end of urinary extension tubing (e.g., a first terminal end); and (3) the remaining terminal end (e.g., second terminal end) of the urinary tubing being connected to a urine bag, or otherwise being sealed (e.g., taped, capped off or clamped shut). Each of these three points of connection may be a source of breach to render an otherwise closed-system into an open system. For example, if the catheter becomes disengaged from the patient's urethra, the system may then be open and microbes may then enter into the human body through the urethra. Another example: if the catheter exit port becomes disengaged from a terminal end of tubing (e.g., a first terminal end), then microbes may enter the catheter into what may now be an open system. This connection of catheter and extension tubing may be taped to avoid unintended disconnect. With respect to the remaining terminal end of tubing (e.g., second terminal end), when such a terminal end is properly connected to a urine bag, and the other two connections are in place, then the system may be closed and no urine backflow (reflux) can enter the tubing due to the check valve (anti-reflux) in the urine bag. But unless some additional step or mechanism is utilized when the urine bag is disengaged from the urinary extension tubing, for example, to replace the urine bag, the system may be open and microbes may then enter the system through the second terminal end of the urinary extension tubing because the remaining terminal end of tubing (e.g., second terminal end) is now open to the external environment since the means of prevention of urine backflow (reflux) is located inside the urine bag that has been removed. This invention, in its various embodiments, may provide structure to maintain the system as closed even when the tubing is disconnected from the urine bag, such as, but not limited to use of a clamp or a second check-valve (that may be closed in its default operational configuration) inside of the urinary extension tubing.

“Tubing” as used in this specification may have several different meanings. Functionally, tubing may be a conduit for transporting a material from one point to another point. For example, that material may be a fluid, such as urine. Structurally, tubing in a traditional sense may comprise an elongated hollow member (e.g., a cylinder) with at least one length (with at least two terminal ends), an outside diameter, an inside diameter, and a wall thickness (defined by the difference in outside and inside diameters). The length of tubing may generally be linear, but could form other shapes, such as a “Y” shape.

Tubing in this invention may further comprise additional structure such as: various connectors, both with and without check-valves; various check-valves, both with and without connectors; biofilm abaters; and antimicrobials coatings: of tubing surfaces, of connectors, and of check-valves. Tubing as used in this specification may be flexible tubing, i.e., as opposed to rigid tubing. Tubing as used in this specification may be medical grade tubing. Medical tubing may be sub-divided into urinary tubing, specifically extension tubing (e.g., extension-tubing9930), for the transport of urine from a catheter to a urine bag. Tubing as used herein may be described as flexible urinary tubing or flexible urinary extension tubing (e.g., extension-tubing9930). Tubing may run from an exit port of the catheter directly to the urine bag, i.e., a primary length of tubing. Tubing as used herein may be described as flexible indwelling catheter tubing (e.g., catheter-tubing9920). The length of tubing may vary to accommodate a leg bag or longer to accommodate the distance between the catheter (or patient) and a bed bag. However, the length of tubing may be predetermined.

In various embodiments, tubing may be substantially constructed of various polymers. The polymers may be suitable for tubing extrusion, injection molding, ultrasonic bonding, solvent bonding, heat welding, and/or chemical adhesives. For example, tubing in the traditional sense of an elongated hollow member with an outside and inside diameter may be efficiently manufactured by extrusion into various lengths. Whereas, tubing in the traditional sense may also be injection molded, but where such a means of manufacture may be more expensive and with limited available lengths compared to extrusion methods of manufacture. Additional, structural components of the tubing (e.g., connectors with or without check-valves, check-valves with or without connectors, biofilm abaters, and coupling sleeves) may be substantially constructed using injection molding.

Such polymers may comprise: urethane (including polyurethanes), rubber (with or without latex), polyvinyl chloride (PVC), silicone, polyethylene (low density and high density), nylon, fluropolymers, polypropylene, acrylonitrile-butadiene styrene (ABS), polycarbonate, acrylic, and/or the like. PVC may be the most common material of construction for flexible medical urinary extension tubing.

With respect to use of “substantially constructed of” in the above materials discussion, such phrasing may be used because various embodiments of tubing may also include some additional non-polymer materials. For example, in various embodiments there may be antimicrobial coatings to certain regions of the tubing, to connectors, to check-valves and/or to biofilm abaters. There may be rigid to semi-rigid plastics used in the check-valves. There may some metal (e.g., stainless steel) used in some components, for example, some check-valves may employ springs made of metal. Biofilm abaters may be constructed of entirely of silver (or silver alloy) or coated with silver (or silver alloy). In some embodiments, adhesives tapes (as a type of coupling sleeve) may also be a component of the tubing. Some solvents may be used for solvent bonding and chemical adhesives may also be utilized in assembly.

Polymer formulations may also comprise other ingredients which increase the cured polymers antimicrobial properties, for example and without limiting the scope of the present invention, including silver within the polymer formulation.

More than one type of polymer may be used within a given embodiment of tubing. For example, and without limiting the scope of the present invention, in various embodiments, the elongated member of the tubing may be substantially constructed of PVC, while a connector, with or without check-valve, may be substantially constructed of HDPE (high density polyethylene) or polycarbonate.

With respect to materials of construction because the tubing may be medical grade tubing, the choice of materials may be limited to polymers which may be manufactured aseptically (e.g., in clean rooms) and then subsequently sterilized without the tubing significantly degrading. Common sterilization methods include steam sterilization via autoclaves, gamma irradiation, ultraviolet exposure, and ethylene oxide (EtO) gas exposure. Gamma irradiation tends to render materials more brittle and steam sterilization may leave behind water vapor which condenses and may facilitate microbial contamination subsequent to the sterilization. Each of the above listed polymers may have various formulations that when cured may appropriately be sterilized by each of these sterilization methods.

Choice of materials may also be limited to polymers which may be field sterilized or sanitized by exposure to various chemicals, such as alcohol (e.g., isopropyl alcohol), bleach, and peroxides. (Field sterilization or sanitization may be sterilization or sanitization done by the user of the product, such as a medical practitioner, as opposed to sterilization that occurs as a step in the manufacturing process.)

Note, with respect to the materials of construction, it is not desired nor intended to thereby unnecessarily limit the present invention by reason of such restricted disclosure.

Now turning to a general discussion of tubing structure, which is further detailed in the discussion of the various figures. In various embodiments, the tubing may comprise a first terminal end and a second terminal end, such that the first terminal end may be disposed opposite of the second terminal end, e.g. located at longitudinal opposing ends. Tubing may be bounded by the first terminal end and the second terminal end.

In some embodiments, the tubing may comprise a wettable region, which may comprise a surface which is wetted when a fluid flows within the tubing. For example, and without limiting the scope of the present invention, common wettable regions may comprise the interior surfaces of the tubing which may comprise an inside diameter of the tubing along a corresponding length of the tubing. Additional wettable regions of the tubing may comprise various interior surfaces of various connectors, with and without check-valves, as well as check-valves without connectors.

An outside diameter of the tubing is generally not a wettable region nor a wettable surface. However, the outside diameter regions immediately proximal of the first terminal end and the second terminal end may be physically so close to wettable regions of the tubing, that such outside diameter regions may also be ideal candidate regions for treating with an antimicrobial coating.

In some embodiments, the tubing (e.g., extension tubing) may comprise a means for minimizing microbial migration in a direction opposite of intended flow. The means for minimizing microbial migration in the direction opposite of intended flow may be selected from one or more of the group comprising: (1) at least one check-valve; (2) at least one biofilm abater; (3) and the wettable region treated with an antimicrobial coating. For example, and without limiting the scope of the present invention, the tubing may comprise one check-valve which has been treated with an antimicrobial coating (or one check-valve with no antimicrobial coating). Any combination of these three means may be located within the tubing and/or at one or both of the terminal ends (first terminal end and second terminal end). Each of these three antimicrobial means for minimizing microbial migration in a direction opposite of intended flow is briefly discussed below.

Check-valves as used in this specification refer to devices which may be intended to allow fluid flow in only one direction. Check-valves may accomplish this function using a variety of means well known in the art, such as utilizing springs with balls, flaps (diaphragms), one-way gates (swing and/or tilt), duckbills, and the like. A given check-valve may generally have at least one inlet and at least one outlet, where the inlet and the outlet are generally points of connection to the check-valve. Check-valves may be in an open configuration when no back pressure is applied to the check-valve, permitting flow in the desired direction. Check-valve locations in some embodiments may be positioned at either terminal end of the tubing, both terminal ends of the tubing, or in between the two terminal ends of the tubing.

For example, a check-valve used in urinary tubing, as described and disclosed in this specification, permits urine flow in the desired direction when the upstream urine pressure exceeds the check-valve's resting state and opens the check-valve. Upstream urine pressure may be created naturally from the patient urinating, or may arise by virtue of a static head, i.e. the height of urine in tubing (and catheter) upstream of a check-valve, where the greater the height of urine, the greater the urine pressure (greater the static head of urine pressure). Such upstream urine pressure created by a static head of urine is with respect to a gravitational pull, i.e. urine like all liquid fluids flows downhill. If the exit end of urinary tubing is raised above the entry point of urinary tubing, any urine within the urinary tubing may be encouraged to flow backwards, against the intended flow, because by raising the exit end above the entry end greater downstream urine pressure has been created by a static head of urine. A check-valve in proper place (e.g., not installed backwards) within the tubing may prevent such backflow (reflux) because the check-valve may be designed to be closed when the downstream pressure exceeds the upstream pressure. In some embodiments, such a check-valve may be normally closed, only opening for normal urine flow in the direction of intended flow.

Note, the locational identifiers of “downstream” and “upstream” may be in reference to the direction of intended flow, i.e., intended flow flows from the upstream to the downstream. Such locational identifies may also be in reference to some third point in between the upstream and downstream locations, such as a check-valve.

Now turning to another antimicrobial means for minimizing microbial migration in a direction opposite of intended flow, the use of a biofilm abater within the tubing. As used in this specification, the biofilm abater is a device which may prevent or minimize biofilm movement (migration or growth) in the direction opposite of intended flow. Because biofilm movement (e.g., migration or growth) occurs more readily on wettable regions within the tubing, particularly regions which are currently wet, then the biofilm abater may be located within the tubing so as to prevent or minimize biofilm movement in the direction opposite of intended flow.

In some embodiments, biofilm abaters may circumscribe an inside diameter of the tubing. Whereas, in some embodiments, biofilm abaters may circumscribe an outside diameter of the tubing.

Biofilm abaters may operate in several ways, which are not mutually exclusive. First, the biofilm abater may inhibit microbe growth. Secondly, the biofilm abater may inhibit microbe attachment to a surface (generally a wettable surface). Inhibiting growth may involve interfering with a microbe's cellular processes, such as cellular replication or cell-wall development. While inhibiting attachment may involve creating a surface substrate that is molecularly too slippery for a microbe to attach to. Thirdly, biofilm abater may be a closed check-valve when urine is not flowing, thereby providing a physical barrier preventing biofilm from entering the catheter through the check-valve.

In some mechanisms of operation, growth inhibiting or attachment inhibiting, the biofilm abater may take on the structural and geometric properties of a ring fitted snuggly within the tubing. The biofilm abater may comprise a ring. The ring may comprise an outside diameter that may be in direct physical contact with the tubing's inside diameter, such that the tubing's inside diameter frictionally grips the ring's outside diameter. Such a ring structure may also comprise an inside diameter, configured to permit fluid flow. This point of direct physical contact between the ring and the tubing may also be such that no fluid is permitted to flow between the ring's outside diameter and the tubing's inside diameter. All fluid flow may be directed through the inside diameter of the ring.

Such a ring may inhibit biofilm growth on the wettable surfaces of the ring, such as the ring's inside diameter, by the ring's wettable surfaces comprising an antimicrobial property that inhibits growth. For example, in various embodiments, the ring may be made entirely of silver (or a silver alloy) or the ring may be coated with silver (or silver alloy). Silver, in both metallic form (and alloys) and silver salt forms, is well known within the art of comprising antimicrobial properties which inhibit microbial growth and may actually kill microbes. The biofilm abater which may comprise the ring, may have a predetermined measureable length and width, wherein the ring may comprise silver or a silver coating may inhibit biofilm migration across the inside diameter of such a ring. Such a ring may be entirely constructed of metallic silver or various external surfaces of the ring may be coated with silver. Such antimicrobial properties are not limited to silver and silver coatings.

Such a ring structure may inhibit biofilm attachment to the wettable surfaces of the ring, such as the ring's inside diameter, by the ring's wettable surfaces comprising an antimicrobial property that inhibits attachment. In various embodiment, the ring's wettable surfaces, such as the ring's inside diameter may be coated with a material providing anti-attachment properties. Anti-attachment may be accomplished by forming a surface that is molecularly smooth (molecularly slippery), such that there is no molecular geometry for microbes to attach to. For example, surfaces may be treated with a Teflon® coating, which is known to result in a slippery surface that reduces microbe attachment. Other chemicals may also be used to treat surfaces yielding a molecularly smooth surface that microbes find difficult to attach to. Such coating treatments may be applied to materials of construction typical for tubing, various connectors, and check-valves, such as silicone, PVC (polyvinylchloride), PU (polyurethane), and the like.

In various embodiments, a biofilm abater may comprise a ring, which may comprise a molecularly smooth coating of the ring's wettable surfaces, which may then inhibit biofilm migration across the inside diameter of such a ring because the microbes find difficulty in attaching to such coated regions. In various embodiments, the ring's outside diameter may not be treated with the molecularly smooth coating, as such a coating may interfere with the tubing's inside diameter frictionally gripping the ring's outside diameter.

Now turning to the third antimicrobial means for minimizing microbial migration in a direction opposite of intended flow, which may be regions of the tubing which may comprise an antimicrobial coating, where such regions are predominantly wettable regions. Such coated regions of tubing may function in an equivalent manner as the biofilm abater embodiments discussed above, but instead of coating a separate component like the biofilm abater's ring, here a region or all of the tubing material of construction may be coated with one of the antimicrobial coatings. As noted above the antimicrobial coatings may either inhibit biofilm growth across the treated region or the antimicrobial coating may inhibit attachment to the coated region. Or the antimicrobial treated region may comprise both functions. For example, in various embodiments, the coated region may comprise a silver coating which may inhibit biofilm growth across the coated region. Whereas, in other embodiments, the coated region may comprise a molecularly smooth coating which may inhibit biofilm attachment to the coated region and thus inhibit biofilm migration across the coated region.

Coated regions may comprise a given length of the tubing's inside diameter, such that the coated region completely circumscribes the tubing's inside diameter for that given length, thus presenting a uniform barrier to biofilm migration (movement). Wettable treated regions may also comprise various interior surfaces of various connectors, with and without check-valves, as well as check-valves without connectors. For example, and without limiting the scope of the present invention, in various embodiments a check-valve's interior wettable surfaces may be coated with the antimicrobial coating.

In various embodiments, a coated region may comprise a region of outside diameter tubing that is immediately proximal of the first terminal end and/or of the second terminal end, as such outside diameter regions although are generally non-wettable regions, they are regions which are nevertheless prone to contaminating urinary tubing due to their close proximity and access to inside diameter wettable regions of the tubing. Such a distance of “immediately proximal” may be up to and including 8 inches from either terminal end (first terminal and/or second terminal end). In some embodiments, an entirety of the tubing may be coated with the antimicrobial material.

In some embodiments, the tubing material of construction itself, i.e., not just the surface regions, may have antimicrobial ingredients added into the materials formulation to yield a cured material that exhibits antimicrobial properties.

Each of these means for minimizing microbial migration in the direction opposite of intended flow may be located within the tubing at various locations along the tubing's length, at the tubing's first terminal end, or at the tubing's second terminal end.

In the following discussion that addresses a number of embodiments and applications of the present invention, reference is made to the accompanying figures (drawings) that form a part thereof, where depictions are made, by way of illustration, of specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and changes may be made without departing from the scope of the invention.

TheFIG. 1series of figures includesFIG. 1A,FIG. 1B, andFIG. 1C. TheFIG. 1series of figures may serve two functions: (1) to place the tubing invention into context of being connected to a catheter at one end and a urine bag at an opposing end; and (2) to depict the inventive system, wherein the system may comprise the inventive tubing, as well as a catheter.

FIG. 1Adepicts a tubing100connected at one end to a catheter9915and at the other end to a urine leg bag9901a, shown from a frontal view. Catheter9915as shown may be properly connected to patient9910, i.e., by proper partial insertion into patient9910's urethra, i.e., catheter9915may be an indwelling catheter, such as a Foley catheter.FIG. 1Bdepicts tubing100connected at one end to catheter9915and at the other end to a urine bed bag9901b, shown from a longitudinal side view. Here catheter9915may be properly connected to patient9910that is lying down or otherwise occupying a bed.FIG. 1Cdepicts an embodiment200of tubing100connected at one terminal end, a first terminal end101to catheter9915, and at the other terminal end, a second terminal end102to urine bag9901, shown from a top view.

FIG. 2depicts embodiment200of tubing100comprising a connector integrated with check-valve205, where first terminal end101of tubing100may be connected to an exit port9917of catheter9915via connector integrated with check-valve205, shown from a top view.

Note inFIG. 2the entire catheter9915and the entire tubing100may be depicted; while patient9910and urine bag9901are not depicted. Whereas, inFIG. 2A, andFIG. 2Bthe focus may be depicting the connection where tubing100may be connected to catheter9915, which may utilize connector integrated with check-valve205to connect exit port9917to first terminal end101of tubing100.

In terms of tubing100overall length, such an overall length may be short to accommodate use with leg bag9901a. For example, and without limiting the scope of the present invention, such an overall length of tubing100may be from two inches to seven inches; or longer or shorter in other embodiments. In other embodiments, overall length may be twenty-four inches or longer to accommodate use with bed bag9901b.

FIG. 2Adepicts embodiment200of tubing100, shown from a close up longitudinal cross-sectional view of the connection.FIG. 2Bdepicts embodiment201of tubing100with an addition of tape206bwrapping around the connection between catheter9915and tubing100, shown from a longitudinal cross-sectional view.

First general structure which may be common to both embodiment200and201is discussed, followed by additional structure of embodiment201. Embodiment200of tubing100may comprise: first terminal end101, second terminal end102, and connector integrated with check-valve205. First terminal end101may longitudinally oppose second terminal102. Connector integrated with check-valve205may be a single article of manufacture. Connector integrated with check-valve205may be located at first terminal end101and may be configured to connect tubing100to catheter9915. The connection between catheter9915and tubing100may be formed by connecting first terminal end101to catheter exit port9917via connector with check-valve205(wherein that connector and check-valve are integral with respect to each other). Connector with check-valve205may comprise two opposing ends, where one end may be sized to frictionally and removably couple with an inside diameter of first terminal end101and where the other end may likewise be sized to frictionally and removably couple with an inside diameter of exit port9917. And the check-valve component of connector integrated with check-valve205may be located internally within connector integrated with check-valve205, and may prevent urine backflow (reflux), which then serves as one example of a means for minimizing microbial migration in a direction opposite of intended flow.

In various embodiments, there may be more than one connector as a component of tubing100. Additional such connectors may or may not include a check-valve. In various embodiments, there may be other means for minimizing microbial migration in a direction opposite of intended flow. For example, there may be more than one check-valve. The means for minimizing microbial migration in the direction opposite of intended flow may be selected from one or more of the group comprising at least one check-valve (205,308, and605), at least one biofilm abater613, and a region treated with an antimicrobial coating (e.g., such as region622). The region of tubing100may comprise a surface which may be wetted by fluid flowing within tubing100, such as urine flowing downstream. Such means for minimizing microbial migration in the direction opposite of intended flow may be located in tubing100, at first terminal end101, or at second terminal end102. See theFIG. 6Fdiscussion below for an embodiment including at least two check-valves (205and605). Biofilm abaters613are discussed in theFIG. 6B,FIG. 6C, andFIG. 6Ddiscussions. And see theFIG. 6Ediscussion below for an embodiment including wettable region treated with an antimicrobial coating.

As depicted inFIG. 2B, embodiment201of tubing100may comprise the additional component of tape206b. Connector integrated with check-valve205while connected to first terminal end101may comprise a length of tape206bwrapped around the connection between the first terminal end101and the exit port9917to prevent the connection from becoming disengaged which the minimizes ingress of contaminants, such as microbes, into tubing100. Securing the connection with tape206bfacilitates maintaining a closed-system. In various embodiments, when tape206bhas been wrapped around the connection, tape206bmay circumscribe a portion of terminal end101and a portion of exit port9917.

In various embodiments, tape206bmay comprise a bonding means for tape206bgripping outside surfaces of exit port9917and first terminal end101. For example, such a bonding means may be formed by at least one side of tape206bhaving an adhesive property.

Tape206bmay be a sub-category of the broader category referred to as a “coupling sleeves”206within this specification. That is, coupling sleeve206may comprise tape206b. See the discussion of theFIG. 4andFIG. 5series of figures for further details regarding coupling sleeve206.

In various embodiments, tape206bmay comprise a color on a side facing a viewer, where the purpose of such a color may be to warn a medical practitioner that terminal end101should not be disengaged from exit port9917, while catheter9915may be inserted into patient9910's urethra without some precaution taken to prevent opening of the closed-system. For example, and without limiting the scope of the present invention, such a color might be a bright orange, yellow, or red; and may have a written warning on the tape. Product literature and media (e.g., product inserts, white papers, website media, etc.) may include instructions as to the warning not to disengage such colored tape206b. Tape206bmay serve at least two functions: (1) to prevent opening of an otherwise closed-system; and (2) to warn against breaching an otherwise closed-system.

Now turning to theFIG. 3series of figures. TheFIG. 3series of figures may be generally the same as theFIG. 2series of figures, with the exception that connector integrated with check-valve205may be replaced with a connector307and a check-valve308.FIG. 3Adepicts embodiment300of tubing100which may comprise connector307coupled to non-integral check-valve308, where first terminal end101of tubing100may be connected to exit port9917of catheter9915via connector307, wherein connector307may be coupled to non-integral check-valve308, shown from a longitudinal cross-sectional view.

In embodiment300(and301), tubing100may comprise at least one connector307coupled to check-valve308, where connector307and check-valve308may be separate articles of manufacture which may be coupled together in tubing100. Connector307with coupled check-valve308may be connected to first terminal end101and may be configured to connect first terminal end101to exit port9917of catheter9915.

In various embodiments, such a coupling of connector307to check-valve308may be permanent. Whereas, in other embodiments, such a coupling may be removable, i.e., after coupling, check-valve308may be disengaged from connector307.

Various means may be used to couple connector307to non-integral check-valve308. Connector307may frictionally hold check-valve308. Check-valve308may be snapped into connector307. Connector307may be solvent bonded to check-valve308, when both components are constructed of appropriate polymers which may be solvent bonded together. Connector307may be ultrasonically welded to check-valve308. Connector307may be glued to check-valve308using an appropriate adhesive (e.g., via a medical grade cyanoacrylate).

FIG. 3Bdepicts a similar embodiment shown inFIG. 2B, with the inclusion of tape206bwrapping around the connection.FIG. 3Bdepicts embodiment301of tubing100with an addition of tape206bwrapping the connection between catheter9915and tubing100, shown from a longitudinal cross-sectional view.

TheFIG. 4andFIG. 5series of figures may introduce tubing embodiments (400,401,500, and501) where a single length of tubing100may be cut into two smaller pieces of tubing and then joined back together via a connector with a check-valve to form a single length of tubing100. Such embodiments (400,401,500, and501) may then provide for the means for minimizing microbial migration in a direction opposite of intended flow to be located within tubing100; as opposed to locating the means for minimizing microbial migration in a direction opposite of intended flow at either first terminal end101(e.g. as shown in theFIG. 2andFIG. 3series of figures) and/or at second terminal end102.

Such embodiments (400,401,500, and501) may not be mutually exclusive with locating the means for minimizing microbial migration in a direction opposite of intended flow at either first terminal end101and/or second terminal end102. Embodiments (400,401,500, and501) may also comprise other means for minimizing microbial migration in a direction opposite of intended flow which may be located at either first terminal end101and/or second terminal end102.

FIG. 4depicts embodiment400of tubing100where tubing100may be sub-divided at a joint into two smaller tubes (409and410) such that connector integrated with check-valve205may be inserted between the two smaller tubes (409and410) to join the two smaller tubes (409and410), which then form a complete length of tubing100, shown from a top view.

In embodiment400, tubing100may comprise: first tube409, second tube410, a joint, and connector integrated with check-valve205. First tube409may comprise first terminal end101and a third terminal end411. First terminal end101longitudinally opposes third terminal end411. Second tube410may comprise second terminal end102and a fourth terminal end412. Second terminal end102may longitudinally oppose fourth terminal end412. As noted above, first terminal end101may longitudinally oppose second terminal end102. The joint may be made between first tube409and second tube410to form tubing100by using connector integrated with check-valve205to connect third terminal end411to fourth terminal end412.

As used in this specification, “joint” refers to joining first tube409to second tube410; while “connection” may refer to connecting tubing100to catheter9915or to connecting tubing100to urine bag9901.

In terms of tubing400, the single length may be short to accommodate use with leg bag9901a. For example, and without limiting the scope of the present invention, single length of tubing100may be from about two inches to seven inches. In some embodiments, the single length may be about twenty-four inches or longer to accommodate use with bed bag9901b. In some embodiments, the single length may be less than about one inch to a desired length to accommodate attachment to various types of bags. Wherein “about” in this paragraph may be plus or minus 0.25 of an inch.

FIG. 4Adepicts embodiment400of tubing100, shown from a longitudinal cross-sectional view focusing on the joint between first tube409and second tube410that may be formed by connector integrated with check-valve205connecting third terminal end411to fourth terminal end412.

FIG. 4Bdepicts embodiment401of tubing100where the joint may be circumscribed by coupling sleeve206, shown from a longitudinal cross-sectional view. Tubing100may comprise coupling sleeve206which may circumscribe the joint between third terminal end411and fourth terminal end412. Coupling sleeve206may be configured to grip the joint, such that coupling sleeve206translation along tubing100may be minimized, i.e., coupling sleeve206may not freely slide along the longitude of tubing100. In some embodiments, such gripping may be accomplished by coupling sleeve206comprising geometry to frictionally grip tubing100. For example, coupling sleeve206may comprise an inside diameter which may be sized to be substantially the same as outside diameter104of tubing100, such that there may be friction between coupling sleeve206and tubing100when tubing100may be inserted into the inside diameter of coupling sleeve206. In other embodiments, coupling sleeve206may grip the joint by the bonding means. The bonding means may be selected from one or more of the group comprising heat welding, ultrasonic welding, solvent bonding, chemical adhesives (including adhesive tape), and the like. Coupling sleeve206may be bonded to outside diameter104of tubing100in a region proximal to each side of the joint to prevent the joint from becoming disengaged which minimizes ingress of contaminants, such as microbes, into tubing100.

Coupling sleeve206may comprise a length of tape206bwrapped around the joint to prevent the joint from becoming disengaged which minimizes ingress of contaminants, such as microbes, into the tubing100. Tape206bmay comprise a color, e.g., a bright color as in red, to serve as a warning to a viewer, such as a medical practitioner, that the joint should not be opened and disengaged.

Now turning to theFIG. 5series of figures. TheFIG. 5series of figures may be generally the same as theFIG. 4series of figures, with the exception that connector integrated with check-valve205may be replaced with connector307and check-valve308.

FIG. 5Adepicts embodiment500of tubing100where tubing100may be sub-divided at the joint into two smaller tubes (409and410) such that connector307with non-integral check-valve308may be inserted between the two smaller tubes (409and410) to join the two smaller tubes (409and410), which then may form tubing100, shown from a longitudinal cross-sectional view.

The details regarding the coupling of connector307to check-valve308were first discussed above under theFIG. 3Adiscussion and that discussion may apply here for embodiment500depicted inFIG. 5Aand of embodiment501depicted inFIG. 5B.

FIG. 5Bdepicts embodiment501of tubing100ofFIG. 5A, where the joint may be circumscribed by coupling sleeve206, shown from a longitudinal cross-sectional view. The details regarding coupling sleeve206were discussed above under theFIG. 4Bdiscussion and that discussion may apply here for embodiment501.

Now turning to theFIG. 6series of tubing100embodiments. TheFIG. 6series of figures addresses at least seven distinct embodiments, which may be combined into various embodiments, also within the scope of the present invention.

FIG. 6Adepicts embodiment601of tubing100where check-valve605may have been inserted into tubing100by pushing the check-valve into a desired location, shown from a longitudinal cross-sectional view.

In embodiment601, tubing100may comprise check-valve605. Check-valve605may be assembled into tubing100by pushing check-valve605inside tubing100to a desired location along a length of tubing100such that tubing100may frictionally grip check-valve605to maintain the desired location, while also forming a complete seal between a periphery of check-valve605(e.g., an outside diameter of check-valve605) and inside of tubing100(e.g., an inside diameter103of tubing100) where the check-valve605may be positioned. Check-valve605may comprise an outside diameter, as part of check-valve605's periphery, which may be substantially similar to inside diameter103of tubing100, such that check-valve605may not translate (slide) within tubing100unless a force may be applied to overcome the frictional gripping force. The nature of such frictional gripping may be to form a seal between the outside diameter of check-valve605with inside diameter103of tubing100, such that fluid flowing through tubing100may not pass between the outside diameter of check-valve605and inside diameter103of tubing100. Such a complete seal may also be formed with the aid of one or more o-rings (or gaskets) circumscribing outside diameter of check-valve605.

In various embodiments, tubing100may first be heated to increase its pliability and to expand tubing100, then subsequently check-valve605may be pushed inside tubing100to the desired location. Upon tubing100cooling, tubing100may contract and increase frictional gripping between tubing100and check-valve605.

In some embodiments, check-valve605may also be positionally fixed within tubing100by ultrasonically welding, solvent bonding, and by use of chemical adhesives.

While only one check-valve605may be depicted inFIG. 6A, such a method of positioning check-valves within tubing100may be used to place a plurality of check-valves (such as check-valve605) within tubing100.

Notes regarding check-valve605and check-valve308: Check-valve308may refer to a check-valve that may be configured to couple with connector307. Check-valve605may not necessarily include such a further limitation.

In embodiment602, tubing100may comprise one or more biofilm abater613. Each biofilm abater613may comprise a ring. The ring may have structure which comprises an inside diameter, outside diameter613a, and a thickness which may be defined by the difference between outside diameter613aand the inside diameter. Outside diameter613amay be configured to fit within inside diameter103of tubing100. Outside diameter613amay be frictionally held in place in a desired location within inside diameter103of tubing100. Such frictional gripping may be accomplished by outside diameter613abeing substantially similar, in terms of dimension, to inside diameter103of tubing100. The ring of biofilm abater613may be in a desired conformation within tubing100, such that a plane of outside diameter613amay be perpendicular to a longitude of the tubing100. The ring of biofilm abater613may comprise a longitude, wherein the longitude of the ring of biofilm abater613may be parallel to the longitude of tubing100. The longitude of tubing100may include a length, and the longitude of the ring of biofilm abater613may also include a length, wherein the length of tubing100may be greater than the length of the ring of biofilm abater613.

The ring of biofilm abater613may include surface areas covering the external surfaces of the ring. The ring of biofilm abater613may comprise an antimicrobial coating, covering surface areas of the ring. In various embodiments, the wettable surface areas of the ring of biofilm abater613may be coated with the antimicrobial coating. Outside diameter613amay not be coated with the antimicrobial coating. In some embodiments, biofilm abater613may butt against a connector and/or check-valve.

As noted above in the general discussion of biofilm abaters preceding the figures discussion, such an antimicrobial coating may prevent microbial biofilms from growing across the surface areas of the ring which have treated with such an antimicrobial coating by inhibiting microbial growth or by inhibiting microbial attachment. For example, and without limiting the scope of the present invention, such an antimicrobial coating may comprise silver (or a silver alloy) to inhibit growth. Antimicrobial properties may be achieved where the entire ring of biofilm abater613may be constructed of silver, a silver alloy, or another abating material. In other embodiments, such an antimicrobial coating may comprise a molecularly smooth chemical coating yielding a molecularly smooth surface which may reduce the ability of microbes to attached to the coated region.

FIG. 6Ddepicts embodiment603of tubing100with check-valve605and with biofilm abater613inserted into tubing100upstream of check-valve605, shown from a longitudinal cross-sectional view.FIG. 6Din comparison toFIG. 6BandFIG. 6C, includes an additional component of check-valve605. The reason for such a spatial relationship may be as follows: an intended function of check-valve605may be to prevent urine backflow (reflux) which may then prevent microbes free floating and/or in suspension in urine from travelling towards patient9910using tubing100as a conduit; however, such a check-valve may not prevent biofilm growth migration (movement) towards patient9901; and so biofilm abater613may be installed upstream of check-valve605to abate biofilm migration.

In other embodiments, such check-valves (e.g.,205,307, and605) may comprise both the backflow prevention function and biofilm migration prevent function by the check-valve having its wettable surfaces coated with the antimicrobial coating or means to be closed when urine is not flowing through the check valve.

FIG. 6Edepicts embodiment621of tubing100where inside surface region622of tubing100may comprise the antimicrobial coating, and where inside surface region622may be upstream of check-valve605, shown from a longitudinal cross-sectional view. Embodiment621depicted inFIG. 6Emay be similar to embodiment603depicted inFIG. 6D, except here inFIG. 6Ebiofilm abater613may be replaced with inside surface region622.

Inside surface region622may be a region of antimicrobial coating. Inside surface region622may be an example of the wetted region treated with the antimicrobial coating. As a wetted region treated with the antimicrobial coating, there may be a reduced likelihood of a microbial biofilm migrating across the wetted region treated with the antimicrobial coating. Inside surface region622may comprise geometry of circumscribing inside diameter103of tubing100for a sub-length622athat may be less than a total length of the tubing100. In some embodiments, sub-length622amay be a substantially similar length as the total length of the tubing100. Inside surface region622may be located upstream of check-valve605.

In various embodiments, the wetted region treated with the antimicrobial coating may be selected from one or more of the group comprising at least one connector (e.g.,307), at least one check-valve (e.g.,205,308, and/or605), at least one biofilm abater613, and/or inside surface region622of tubing100. For example, and without limiting the scope of the present invention, any of the check-valves (205,308,605) depicted in the various figures may have been treated with the antimicrobial coating, particularly on the wettable surfaces. Likewise, any of the connectors (205and307) depicted in the various figures may have been treated with the antimicrobial coating, particularly on the wettable surfaces.

Note while more than one connector with or without check-valve, check-valve with or without connector, biofilm abater613, and inside surface region622may be employed in various embodiments, there is a practical limitation to the number of such components which may be employed in any given embodiment. Such a numerical limitation arises in part because tubing100in any given application must have a finite total length, which is generally the length necessary to run from catheter9915to urine bag9901, including some length for slack and ease of patient9910movement. Such a numerical limitation may arise in the case of check-valves because each additional check-valve may increase the necessary fluid pressure to flow through all check-valves installed in serial fashion and the fluid pressure itself may a maximum pressure created by patient9910urinating and/or by any static head of urine within catheter9915and tubing100. As the number of check-valves increases the greater the required pressure is needed to flow through a serial installment of check-valves.

FIG. 6Fdepicts embodiment651of tubing100where there are two check-valves (205and605) inserted into tubing100, in serial fashion (i.e., one upstream and one downstream with respect to each other), shown from a longitudinal cross-sectional view. Connector integrated with check-valve205may be used to connect first terminal end101to exit port9917of catheter9915. Check-valve605may be inserted and pushed into the desired location within tubing100. In various embodiments, either one or both check-valves may also comprise the antimicrobial coating, particularly on wettable surfaces.

FIG. 6Gdepicts embodiment631of tubing100which may comprise sampling port632, shown from a longitudinal cross-sectional view. In embodiment631, tubing100may comprise sampling port632. Sampling port632may be located a linear distance633from second terminal end102. Sampling port632may be configured to receive a syringe for the purpose of a taking a sample of fluid from within tubing100. For example, and without limiting the scope of the present invention, a medical practitioner might take a urine sample from sampling port632in order to determine the microbial load present within the urine or for various other purposes.

In various embodiments, sampling port632may be located closer to second terminal102than to first terminal end101. Linear distance633may be 0.25 to 7.00 inches in some embodiments and other distances in other embodiments. Such a location may serve two purposes. First by placing sampling port632closer to second terminal end102(and farther from first terminal end101), there may be less interference with patient9910's comfort when urine samples are withdrawn from tubing100, as movement of tubing100at the second terminal end102may be less likely to be communicated up tubing100to catheter9915. Secondly, taking urine samples from tubing100may constitute a technical, albeit intermittent, breach of what may have otherwise been a closed-system. Withdrawing urine samples from tubing100may increase the likelihood of introducing unwanted contaminants, such as microbes, into tubing100. Placing sampling port632farther away from catheter9915and patient9910, there may be a greater likelihood of minimizing any such contaminant reaching catheter9915or patient9910.

FIG. 6Hdepicts embodiment641of tubing100which may comprise a graphical indicator642, which may indicate which end of tubing100may be detached from urine bag9901, shown from a longitudinal cross-sectional view. Second terminal end102may comprise graphical indicator642to indicate which end of tubing100may be removably coupled to urine bag9901. In various embodiments, graphical indicator642may be located a proximal distance from the connection of second terminal end102and urine bag9901, such as from 0.125 to 7.000 inches from this connection, i.e. graphical indicator642may be located relatively close to this connection. In other embodiments, different dimensions for the proximal distance may be employed. Second terminal end102may be defined by a region which encompasses this connection and graphical indicator642. Graphical indicator642may be located closer to this connection than to first terminal end101.

In various embodiments, graphical indicator642may comprise tape, such as an adhesive tape, which may be wrapped around tubing100in the vicinity of second terminal end102. In such embodiments, the tape does not necessarily have to wrap the connection itself, as the intent of such tape may not be to prevent disengagement of the connection, but rather to indicate that such an end may be appropriately and safely disengaged and still maintain a closed-system.

In various embodiments, graphical indicator642may be a color whereby such a color choice may indicate to a viewer, such as a medical practitioner, that this end of tubing100may be opened and disengaged from urine bag9901, as long as proper steps are taken to minimize ingress of contaminants, such as microbes, into tubing100. For example, and without limiting the scope of the present invention, such a color might be green. Such a color choice may also be explained in various product literature, such as product inserts and media which may be found online instructing proper use of tubing100.

Having discussed and disclosed the inventive tubing in its various embodiments, this disclosure now turns to discussing the inventive systems which may comprise the inventive tubing as discussed above.

A system for forming and maintaining a closed-system with respect to tubing100connected to catheter9915may comprise: tubing100, a second connector (e.g.,307or205), and catheter9915. The entirety of componentry as depicted inFIG. 4may depict such a system.

Tubing100may comprise: first terminal end101, second terminal end102, first tube409, second tube410, and a first connector with check-valve (e.g.,205or307coupled with308). First tube409may comprise first terminal end101and third terminal end411. First terminal end101may longitudinally oppose third terminal end411. Second tube410may comprise second terminal end102and fourth terminal end412. Second terminal end102may longitudinally opposes fourth terminal end412. The first connector may comprise a check-valve. Such a check-valve may either be connector integrated with check-valve205or connector307that has been coupled to check-valve308. The first connector with check-valve may be used to connect third terminal end411to fourth terminal end412, forming a joint between third terminal end411and fourth terminal end412. First terminal end101may longitudinally oppose second terminal end102.

In some embodiments, tubing100of the system may comprise coupling sleeve206. Coupling sleeve206may circumscribe the joint. Coupling sleeve206may be configured to prevent third terminal end411from becoming disengaged from fourth terminal end412. As noted above, coupling sleeve206may grip the joint (exterior of the joint) by the bonding means. Coupling sleeve206may comprise tape206b. Tape206bmay be an adhesive tape. Tape206bmay be a bright color, such as red.

Catheter9915may comprise exit port9917. A second connector may be used to connect first terminal end101to exit port9917such that second terminal end102remains available to removably couple to urine bag9901.

The second connector may or may not comprise a check-valve. When the second connector has no check-valve, the second connector may be connector307. When the second connector comprises a check-valve, the second connector may be connector integrated with check-valve205or the second connector may be connector307coupled to check-valve308.

In various embodiments the various check-valves of the system may or may not comprise the antimicrobial coating. In various embodiments the system may comprise one or more biofilm abaters613located within tubing100, and generally with at least one biofilm abater613located upstream of the first connector with check-valve. In various embodiments, the system may also comprise one or more inside surface region622's, and generally with at least one inside surface region622located upstream of the first connector with check-valve. In various embodiments, the system may also comprise urine bag9901.

When urine bag9901may be removed from second terminal end102, the system may still be deemed closed from upstream of the first connector with check-valve that may be located within tubing100; while open from downstream of the first connector with check-valve. In order to maintain the system closed from near second terminal end102, when urine bag9901may be removed, additional componentry (e.g., a clamp or a cap) and various methods may be employed to close second terminal end102.

Having discussed and disclosed various inventive tubing embodiments and inventive systems, this disclosure now turns to various methods for forming and maintaining a closed-system with respect to tubing100connected to catheter9915.

A method for forming and maintaining a closed-system with respect to tubing100connected to catheter9915may comprise the steps:Step1: Cutting a segment of urinary tubing100for a purpose of connecting the segment of urinary tubing100to catheter9915and to a urine bag9901.Step2: Forming a first connection between the segment of urinary tubing100and catheter9915by connecting first terminal end101of the segment of urinary tubing to exit port9917of catheter9915using a first connector. (Note, the first connector here in methods context is not the first connector discussed above in the systems discussion; rather the first connector here in the methods context is more akin to the second connector of systems discussion.)Step3: Wrapping the first connection with a first piece of tape206bto prevent the first connection from becoming disengaged which minimizes ingress of contaminants, such as microbes, into the closed-system. This step may be optional, yet the step may be important.

Second terminal end102of the segment of urinary tubing100may be available for connection to urine bag9901. Second terminal end102of the segment of urinary tubing100may be removably connected to urine bag9901. Also with respect to Step3, as discussed above, tape206bmay be colored, such as red, to indicate to a viewer to not disengage first terminal end101from exit port9917unless it may be time for catheter removal or other steps are taken to maintain the system as closed.

In various embodiments there may an additional step which precedes Step2, wherein before making the first connection, exit port9917, first terminal end101, and the first connector are sterilized by treating each component with a sterilizing material. Such treating may be immersing the component within the sterilizing material. Or treating may be wiping the component down with the sterilizing material. The sterilizing material may comprise a liquid, foam, or towel wetted with the liquid or foam. The liquid or the foam may be various alcohols (e.g., isopropyl), bleach, peroxides, betadine, and the like.

The first connector may comprise a check-valve. The first connector may either comprise a check-valve such that the first connector and the check-valve are integral being a single article of manufacture, i.e., first connector may be connector integrated with check-valve205. Or, the first connector may comprise a non-integral check-valve which is coupled to the first connector, i.e., first connector may be connector307coupled to check-valve308.

The method for forming and maintaining a closed-system with respect to tubing100connected to catheter9915may comprise the following additional steps:Step A: Cutting the segment of urinary tubing100into first tube409and second tube410. First tube409may comprise first terminal end101and third terminal end411. First terminal end101may longitudinally oppose third terminal end411. Second tube410may comprise second terminal end102and fourth terminal end412. Second terminal end102may longitudinally oppose fourth terminal end412.Step B: Forming a second connection between first tube409and second tube410by using a second connector to connect third terminal end411to fourth terminal end412. (Note, the second connector here in methods context is not the second connector discussed above in the systems discussion; rather the second connector here in the methods context is more akin to the first connector of systems discussion.)

In various embodiments, Step A and Step B may proceed Step2. In various embodiments, before making the second connection in Step B, third terminal end411, fourth terminal end412, and the second connector may be sterilized by treating each of the components with the sterilizing material.

In various embodiments, the second connection may comprise the step of securing the second connection with coupling sleeve206. Coupling sleeve206may circumscribe the joint between third terminal end411and fourth terminal end412. Coupling sleeve206may be configured to prevent third terminal end411from becoming disengaged from fourth terminal end412which may minimize ingress of contaminants, such as microbes, into the closed-system.

The step of securing coupling sleeve206to the joint may involve wrapping tape206baround the joint, i.e., coupling sleeve206may comprise tape206b, which may be an adhesive tape. Tape206bmay be colored, such as red, to indicate to a viewer that the second connection should not be opened unless intended to open the system.

Alternatively, the step of securing coupling sleeve206to the joint may involve the step of bonding coupling sleeve206to outside diameter104of tubing100in a region proximal to each side of the joint to prevent the second connection from becoming disengaged. Such bonding may be accomplished by the bonding means, e.g., of ultrasonic welding, solvent bonding, use of chemical adhesives, and the like.

The second connector may comprise a check-valve. The second connector may either comprise a check-valve such that the second connector and the check-valve are integral being a single article of manufacture, i.e., second connector may be connector integrated with check-valve205. Or, the second connector may comprise a non-integral check-valve which may be coupled to the second connector, i.e., the second connector may be connector307coupled to check-valve308.

The method for forming and maintaining a closed-system with respect to tubing100connected to catheter9915may comprise the following additional steps:Step4: Attach graphical indicator642to outside diameter of tubing104at the proximal distance from second terminal end102. SeeFIG. 6Hand the above discussion of graphical indicator642. In some embodiments, graphical indicator642may be green colored adhesive tape. In some embodiments, Step4may be optional.Step5: When urine bag9901may be changed by removing urine bag9901and replacing urine bag9901with a new urine bag, the segment of urinary tubing100may be clamped shut with a clamp prior to removal of urine bag9901. The clamp may remain in place until the new urine bag may be attached to second terminal end102at which point the clamp may be removed. It may be desirable to clamp shut tubing100as near as possible to second terminal end102without interfering with the mechanics of removing and attaching urine bag9901. In some embodiments, Step5may be optional.

In various methods, the clamping step may be replaced with a capping step. When urine bag9901may be changed by removing urine bag9901and replacing urine bag9901with a new urine bag, second terminal end102may be capped shut with a cap, preferably a sterile cap, prior to removal of urine bag9901. The cap may remain in place until the new urine bag may be attached to second terminal end102at which point the cap may be removed.

FIG. 7Athrough and includingFIG. 7Kmay at least depict an embodiment of a connector-with-integrated-check-valve700or may depict components of connector-with-integrated-check-valve700. In some embodiments, connector-with-integrated-check-valve700may be a dual ended connector with an integral check-valve disposed between the opposing tubing connection regions; wherein that integral check-valve may prevent urine reflux (backflow). The dual connector aspect may allow for connecting one end of connector-with-integrated-check-valve700to catheter-tubing9920and the remaining other connector end to extension-tubing9930. In some embodiments, catheter-tubing9920may be the exit tubing portion of catheter9915. In some embodiments, extension-tubing9930may then lead to urine bag9901, such as, but not limited to, leg urine bag9901aor bed urine bag9901b.

FIG. 7Amay depict a perspective and longitudinal cross-sectional view of connector-with-integrated-check-valve700that may be attached to catheter-tubing9920at one end and attached to extension-tubing9930at the other end of connector-with-integrated-check-valve700.FIG. 7Bmay also depict connector-with-integrated-check-valve700, but shown in an exploded, perspective, and longitudinal cross-sectional view.FIG. 7Cmay also depict connector-with-integrated-check-valve700, but shown in an exploded and a perspective view (not cross-sectional).

DiscussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-with-integrated-check-valve700may comprise three parts that may be assembled together. In some embodiments these three parts may be connector-for-catheter-tubing710, connector-for-extension-tubing730, and a gate750.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-catheter-tubing710may be removably attachable to catheter-tubing9920at a first-barb-region712of connector-for-catheter-tubing710. In some embodiments, connector-for-catheter-tubing710may be a first-elongate-member. In some embodiments, connector-for-catheter-tubing710may comprise a first-hollow-core714for passage of urine. In some embodiments, disposed opposite of first-barb-region712may be a mating-end716of connector-for-catheter-tubing710.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-catheter-tubing710may be rigid or semi-rigid. In such embodiments, connector-for-catheter-tubing710may be injection molded and/or 3D printed from one or more thermoformed plastics. In such embodiments, connector-for-catheter-tubing710may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like. In such embodiments, connector-for-catheter-tubing710may be colored, such as, but not limited to, white.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-catheter-tubing710may be an elongate member (e.g., the first-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-catheter-tubing710. Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, first-barb-region712may be tiered. In some embodiments, first-barb-region712may be tiered hose-barbs.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-catheter-tubing710may comprise a central-flange720. In some embodiments, central-flange720may be is externally located and annular. In some embodiments, central-flange720may be located between first-barb-region712and mating-end716. In some embodiments, central-flange720may help to facilitate disassembly of catheter-tubing9920from first-barb-region712of connector-for-catheter-tubing710; e.g., by the user grabbing central-flange720in one hand and grabbing catheter-tubing9920in the other hand and pulling apart.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-extension-tubing730may be attachable to extension-tubing9930at a second-barb-region732of connector-for-extension-tubing730. In some embodiments, connector-for-extension-tubing730may be a second-elongate-member. In some embodiments, connector-for-extension-tubing730may comprise a second-hollow-core734for passage of the urine. In some embodiments, disposed opposite of second-barb-region732may be a complimentary-mating-end736. In some embodiments, mating-end716(of connector-for-catheter-tubing710) may be attached to complimentary-mating-end736(of connector-for-extension-tubing730).

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-extension-tubing730may be rigid or semi-rigid. In such embodiments, connector-for-extension-tubing730may be injection molded and/or 3D printed from one or more thermoformed plastics. In such embodiments, connector-for-extension-tubing730may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-extension-tubing730may be an elongate member (e.g., the second-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-extension-tubing730.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-extension-tubing730may comprise a flange738. In some embodiments, flange738may be externally located and annular. In some embodiments flange738may be located away from second-barb-region732.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, gate750may be comprise one or more of the following properties: may be a circular disc; may be disc shaped; may be substantially disc shaped; may be a solid member; may be flexible; may be elastomeric; may be constructed from silicone; may be constructed from rubber; may be radially symmetrical; and/or the like. In some embodiments, gate750may be a circular shaped disc, that may be elastomeric, and flexible.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, when the connector-for-catheter-tubing710may be attached to the connector-for-extension-tubing730(e.g., via a union of mating-end716to complimentary-mating-end736), with the gate750disposed between portions of connector-for-catheter-tubing710and portions of connector-for-extension-tubing730; then connector-with-integrated-check-valve700may be formed from the connector-for-catheter-tubing710, the connector-for-extension-tubing730, and the gate750.

Continuing discussingFIG. 7A,FIG. 7B, andFIG. 7C, in some embodiments, connector-with-integrated-check-valve700may permits urine flow is a desired-direction770from connector-for-catheter-tubing710towards connector-for-extension-tubing730. Whereas, in some embodiments, connector-with-integrated-check-valve700may close and prevent backflow (reflux) of the urine in a direction from connector-for-extension-tubing730towards connector-for-catheter-tubing710when the urine exerts backflow pressure against gate750, which may push gate750against a seat718that may be located within connector-for-catheter-tubing710. In some embodiments, seat718may be structure of connector-for-catheter-tubing710located on or in first-hollow-core714. In some embodiments, seat718may be an internal annular shelf located in first-hollow-core714. In some embodiments, seat718may stop movement of gate750. In some embodiments, seat718may form a seal with proximate portions of gate750when connector-with-integrated-check-valve700may be in the closed configuration.

FIG. 7DandFIG. 7Emay depict connector-with-integrated-check-valve700in an open configuration.FIG. 7Dmay depict connector-with-integrated-check-valve700, shown in a longitudinal cross-sectional view.FIG. 7Emay be a close up view of connector-with-integrated-check-valve700shown inFIG. 7D. In the open configuration, gate750may not be touching seat718.

DiscussingFIG. 7E,FIG. 7B, andFIG. 7C, in some embodiments, connector-for-extension-tubing730may comprise catch-arms740. In some embodiments, connector-for-extension-tubing730may comprise from two, three, four, five, or six catch-arms740. In some embodiments, connector-for-extension-tubing730may comprise four catch-arms740. In some embodiments, catch-arms740may be arranged radially with respect to a center of connector-for-extension-tubing730(see e.g.,FIG. 7J). In some embodiments, a given catch-arm740may be a structural protrusion into a portion of the second-hollow-core734that may allow urine flow through second-hollow-core734but wherein the catch-arms740may be sized in relation to gate750to prevent the gate750from passing through a region of second-hollow-core734that is closest to second-barb-region732. In some embodiments, catch-arms740may stop movement of gate750in desired-direction770from passing into or beyond second-barb-region732. In some embodiments, catch-arms740may act as guides for some movement of gate750.

DiscussingFIG. 7E,FIG. 7B, andFIG. 7C, in some embodiments, each catch-arm740may comprise a support-surface742. See also,FIG. 7JandFIG. 7K. In some embodiments, support-surface742may be located closer to complimentary-mating-end736than to second-barb-region732. In some embodiments, support-surface742may be disposed opposite from seat718and facing the seat718. In some embodiments, disposed between seat718and support-surface742may be a pocket752that may house gate750. See e.g.,FIG. 7Efor pocket752. In some embodiments, support-surface742may contact portions of gate750when the urine is flowing in desired-direction770. In some embodiments, when the urine is flowing desired-direction770this direction of flow may create pressure upon gate750, wherein this may push gate750against support-surfaces742, which may be open configuration shown inFIG. 7Eand inFIG. 7D. Urine may flow around the arm structures of catch-arms740through first-hollow-core714.

DiscussingFIG. 7E,FIG. 7B, andFIG. 7C, in some embodiments, gate750may float within pocket752of connector-with-integrated-check-valve700. SeeFIG. 7Efor pocket752. In some embodiments, pocket752may be longitudinally bounded by seat718at one end of pocket752and by support-surfaces742at a remaining end of pocket752. In some embodiments, support-surfaces742may be disposed opposite of seat718and may face seat718. In some embodiments, support-surfaces742may be supportive surfaces of catch-arms740. In some embodiments, catch-arms740may permit the urine flow through second-hollow-core734but may not permit passage of gate750into portions of second-hollow-core734. In some embodiments, gate750may translate in pocket752, between the open configuration and the closed configuration.

FIG. 7FandFIG. 7Gmay depict connector-with-integrated-check-valve700in the closed configuration.FIG. 7Fmay depict connector-with-integrated-check-valve700, shown in a longitudinal cross-sectional view.FIG. 7Gmay be a close up view of connector-with-integrated-check-valve700shown inFIG. 7F. In the closed configuration, gate750may be touching seat718. In the closed configurations, portions of gate750closest to seat718may be physically touching portions of seat718.

FIG. 7Hmay depict connector-with-integrated-check-valve700, shown in a perspective view, an assembled perspective view; wherein connector-with-integrated-check-valve700may be attached to catheter-tubing9920and attached to extension-tubing9930.

FIG. 7Imay show an outlet perspective view of connector-for-catheter-tubing710, which may be a component of connector-with-integrated-check-valve700. In some embodiments,FIG. 7Imay depict a system for minimizing microbial migration to catheter-tubing. In some embodiments, this system may comprise extension-tubing9930of a predetermined length and connector-with-integrated-check-valve700attached to that predetermined length of extension-tubing9930.

FIG. 7Jmay show an inlet view of connector-for-extension-tubing730, which may be a component of connector-with-integrated-check-valve700.FIG. 7Kmay depict an inlet perspective view of the connector-for-extension-tubing730. In some embodiments, a distance between opposing posts746may be receiving-distance744. SeeFIG. 7Jfor receiving-distance744. In some embodiments, gate750may comprise a gate-outside-diameter754which may be an outside diameter of gate750. SeeFIG. 7Cfor gate-outside-diameter754. In some embodiments, gate-outside-diameter754may be less than receiving-distance744; and in this relationship, portions of catch-arms740(e.g., spaced posts746) may help to guide movement of gate750within pocket752.

In some embodiments, mating-end716(of connector-for-catheter-tubing710) may be a protruding annular ring that may protrude in a direction away from the first-barb-region712. See e.g.,FIG. 7I,FIG. 7B,FIG. 7E, andFIG. 7G. In some embodiments, complimentary-mating-end736may be a ring shaped receiving channel sized to receive the protruding annular ring of mating-end716. For complimentary-mating-end736seeFIG. 7J,FIG. 7K,FIG. 7B,FIG. 7E, andFIG. 7G. In some embodiments, this ring shaped receiving channel of complimentary-mating-end736may be located in flange738. See e.g.,FIG. 7B. In some embodiments, attachment between mating-end716and complimentary-mating-end736may be by one or more of: ultrasonic welding, heat welding, solvent bonding, chemical adhesive, snap fit, friction fit, press fit, and/or the like.

FIG. 8Amay depict a perspective and longitudinal cross-sectional view of an embodiment of a connector-with-integrated-check-valve800. Functionally, connector-with-integrated-check-valve800may differ from connector-with-integrated-check-valve700, in that the check-valve aspect of connector-with-integrated-check-valve800may be typically closed unless normal urine flow in desired-direction770opens the check-valve. Whereas, the check-valve aspect of connector-with-integrated-check-valve700may be normally open unless there is urine backflow (reflux) to close the integral check-valve. In some embodiments, such function of connect-or-with-integrated-check-valve800may be achieved by use of a spring (e.g., a biasing spring), closing-spring845, in the pocket, pocket852. This closing-spring845may always be pressing against gate750.

DiscussingFIG. 8A, in some embodiments, connector-with-integrated-check-valve800may comprise four parts, that of: connector-for-catheter-tubing710, gate750, connector-for-extension-tubing830, and closing-spring845. Structurally and functionally, gate750may be as discussed above for gate750in connector-with-integrated-check-valve700. Structurally and functionally, connector-for-catheter-tubing710may be as discussed above for connector-for-catheter-tubing710in connector-with-integrated-check-valve700; with the exception that now connector-for-catheter-tubing710is attached to connector-for-extension-tubing830and not connector-for-extension-tubing730.

Continuing discussingFIG. 8A, in some embodiments, connector-for-extension-tubing830may be attachable to extension-tubing9930at a second-barb-region832of connector-for-extension-tubing830. In some embodiments, connector-for-extension-tubing830may be a second-elongate-member. In some embodiments, connector-for-extension-tubing830may comprise a second-hollow-core834for passage of the urine. In some embodiments, disposed opposite of second-barb-region832may be a complimentary-mating-end836. In some embodiments, mating-end716(of connector-for-catheter-tubing710) may be attached to complimentary-mating-end836(of connector-for-extension-tubing830).

Continuing discussingFIG. 8A, in some embodiments, connector-for-extension-tubing830may be rigid or semi-rigid. In such embodiments, connector-for-extension-tubing830may be injection molded and/or 3D printed from one or more thermoformed plastics. In such embodiments, connector-for-extension-tubing830may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like.

Continuing discussingFIG. 8A, in some embodiments, connector-for-extension-tubing830may be an elongate member (e.g., the second-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-extension-tubing830.

In some embodiments, connector-for-extension-tubing830may comprise posts846, just as connector-for-extension-tubing730may comprise posts746. See e.g.,FIG. 8AandFIG. 8B. Posts846may serve substantially similar functions as posts746. Posts846may be structurally similar to posts746.

Continuing discussingFIG. 8A, in some embodiments, connector-for-extension-tubing830may comprise a flange838. In some embodiments, flange838may be externally located and annular. In some embodiments flange838may be located away from second-barb-region832.

Continuing discussingFIG. 8A, in some embodiments, about mid-way along second-hollow-core834, inside of connector-for-extension-tubing830, may be spring-stops840; wherein “about” in this context may be plus or minus 25% of the length of connector-for-extension-tubing830. In some embodiments, spring-stops840may be protrusions into second-hollow-core834, that do not prevent urine flow. In some embodiments, disposed between spring-stops840and seat718(of connector-for-catheter-tubing710), may be pocket852. In some embodiments, closing-spring845and gate750may be located within pocket852. In some embodiments, closing-spring845may be touching portions of spring-stops840and touching portions of gate750. In some embodiments, gate750may be removably touching seat718and touching an end of closing-spring845. In some embodiments, when there is normal urine flow in desired-direction770, such normal urine pressure may press against gate750, which in turn may then press against closing-spring desired-direction770, which opens this integral check-valve and allows normal urine flow into extension-tubing9930. When such normal urine flow ceases, then closing-spring845may then close gate750against seat718, to close this integral check-valve.

FIG. 8Bmay depict an exploded perspective view of the connector-with-integrated-check-valve800. InFIG. 8B, flow-gap847between posts846may be seen, wherein this gap may permit flow into and through connector-for-extension-tubing830when gate750is not pressed against seat718(or seat818), this would flow in desired-direction770.

FIG. 8Cmay depict a longitudinal cross-sectional view of an embodiment of a connector-with-integrated-check-valve800, but with some modification from connector-with-integrated-check-valve800shown inFIG. 8Aand inFIG. 8B. Detail-Region8D may be shown inFIG. 8C. In connector-with-integrated-check-valve800ofFIG. 8C, gate850may replace gate750and seat818may replace seat718.

FIG. 8Dmay depict an enlarged view of Detail-Region8D.FIG. 8Dmay show that seat818of connector-for-catheter-tubing710and seat-mating-surface851of gate850may be shaped complimentary to each other, in a cone and/or dome fashion, sealing fluid flow in the closed direction of flow opposite of desired-direction770. Which may occur in the absence of normal urine flow from the patient, when closing-spring845may be pressing portions (such as seat-mating-surface851) of gate850against seat818of connector-for-catheter-tubing710.

FIG. 9Amay depict a perspective and longitudinal cross-sectional view of an embodiment of a connector-with-integrated-check-valve900.FIG. 9Bmay depict connector-with-integrated-check-valve900, but shown in an exploded and a perspective view. Functionally, connector-with-integrated-check-valve900may differ from connector-with-integrated-check-valve700, in that the check-valve aspect of connector-with-integrated-check-valve900may be typically closed unless normal urine flow in desired-direction770opens the check-valve. Whereas, the check-valve aspect of connector-with-integrated-check-valve700may be normally open unless there is urine backflow (reflux) to close the integral check-valve. In some embodiments, such function of connector-with-integrated-check-valve900may be achieved by use of a hinge gate, i.e., a flapper gate, as in gate950, in the pocket, pocket940.

DiscussingFIG. 9AandFIG. 9B, in some embodiments, connector-with-integrated-check-valve800may comprise three parts, that of: connector-for-catheter-tubing710, gate950, and connector-for-extension-tubing930. Structurally and functionally, gate950may be as discussed above for gate750in connector-with-integrated-check-valve700; except gate950may comprise additional structure, that of hinge956. In some embodiments, gate950may be a substantially circular shaped disc, with the extension of hinge956, that may be elastomeric, and flexible. Structurally and functionally, connector-for-catheter-tubing710may be as discussed above for connector-for-catheter-tubing710in connector-with-integrated-check-valve700; with the exception that now connector-for-catheter-tubing710is attached to connector-for-extension-tubing930and not connector-for-extension-tubing730.

DiscussingFIG. 9AandFIG. 9B, in some embodiments, connector-for-extension-tubing930may be attachable to extension-tubing9930at a second-barb-region932of connector-for-extension-tubing930. In some embodiments, connector-for-extension-tubing930may be a second-elongate-member. In some embodiments, connector-for-extension-tubing930may comprise a second-hollow-core934for passage of the urine. In some embodiments, disposed opposite of second-barb-region932may be a complimentary-mating-end936. In some embodiments, mating-end716(of connector-for-catheter-tubing710) may be attached to complimentary-mating-end936(of connector-for-extension-tubing930).

DiscussingFIG. 9AandFIG. 9B, in some embodiments, connector-for-extension-tubing930may be rigid or semi-rigid. In such embodiments, connector-for-extension-tubing930may be injection molded and/or 3D printed from one or more thermoformed plastics. In such embodiments, connector-for-extension-tubing930may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like.

DiscussingFIG. 9AandFIG. 9B, in some embodiments, connector-for-extension-tubing930may be an elongate member (e.g., the second-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-extension-tubing930.

DiscussingFIG. 9AandFIG. 9B, in some embodiments, connector-for-extension-tubing930may comprise a flange938. In some embodiments, flange938may be externally located and annular. In some embodiments flange938may be located away from second-barb-region932.

DiscussingFIG. 9AandFIG. 9B, in some embodiments, proximate to complimentary-mating-end936, inside of connector-for-extension-tubing930, may be stop942; wherein “proximate” in this context may be plus or minus 25% of the length of connector-for-extension-tubing930. In some embodiments, stop942may be a narrowing of an inside diameter of second-hollow-core934, that does not prevent urine flow, but that is narrower than gate-outside-diameter954of gate950, which may prevent passage of gate950into portions of second-hollow-core934. In some embodiments, disposed between stop942and seat718(of connector-for-catheter-tubing710), may be pocket940. In some embodiments, gate950may be located within pocket852. In some embodiments, gate950may be removably touching seat718. In some embodiments, pocket940may be a hollow cylinder. In some embodiments at a distal end of pocket940may be a notch, a hinge-receiver944for receiving hinge956of gate950. In some embodiments, around a perimeter of gate950may be an extending tab, that of hinge956. In some embodiments, this tab of hinge956may fit into the notch of hinge-receiver944. In this way, gate950may removably rest against seat718when where there is no urine flow; and when there is urine flow in desired-direction770, then such urine pressure against gate950may cause portions of gate950to bend towards stop942and to stop at stop942, allowing urine to flow to extension-tubing9930through portions of second-hollow-core934.

FIG. 10Athrough and includingFIG. 10Fmay at least depict an embodiment of a connector-with-integrated-check-valve1000or may depict components of connector-with-integrated-check-valve1000. In some embodiments, connector-with-integrated-check-valve1000may be a dual ended connector with an integral check-valve disposed between the opposing tubing connection regions; wherein that integral check-valve may prevent (or minimize) urine reflux (backflow). The dual connector aspect may allow for connecting one end of connector-with-integrated-check-valve1000to catheter-tubing9920and the remaining other connector end to extension-tubing9930. In some embodiments, catheter-tubing9920may be the exit tubing portion of catheter9915. In some embodiments, extension-tubing9930may then lead to urine bag9901, such as, but not limited to, leg urine bag9901aor bed urine bag9901b.

FIG. 10Amay depict a perspective view of connector-with-integrated-check-valve1000.FIG. 10Bmay also depict connector-with-integrated-check-valve1000, but shown from a connector end of connector-for-extension-tubing1030.FIG. 10Bmay include a sectional line of10C-10C.FIG. 10Cmay also depict connector-with-integrated-check-valve1000, but shown from a longitudinal cross-sectional view along sectional line10C-10C.FIG. 10Cmay include a sectional line of10DC-10D.FIG. 10Cmay include detail region10F which may be shown as an enlarged view inFIG. 10F.FIG. 10Dmay also depict connector-with-integrated-check-valve1000, but shown from a transverse-width cross-sectional view along sectional line10D-10D.FIG. 10Emay be a perspective of connector-for-extension-tubing1030and showing gate1050disposed and floating within posts1046.FIG. 10Fmay be the enlarged cross-sectional view of region10F fromFIG. 10C.

DiscussingFIG. 10C, in some embodiments, connector-with-integrated-check-valve1000may comprise three parts that may be assembled together. In some embodiments these three parts may be connector-for-catheter-tubing1010, connector-for-extension-tubing1030, and a gate1050.

Continuing discussingFIG. 10C, in some embodiments, connector-for-catheter-tubing1010may be removably attachable to catheter-tubing9920at a first-barb-region1012of connector-for-catheter-tubing1010. In some embodiments, connector-for-catheter-tubing1010may be a first-elongate-member. In some embodiments, connector-for-catheter-tubing1010may comprise a first-hollow-core1014for passage of urine. In some embodiments, disposed opposite of first-barb-region1012may be a mating-end1016of connector-for-catheter-tubing1010. See alsoFIG. 10F.

Continuing discussingFIG. 10C, in some embodiments, connector-for-catheter-tubing1010may be rigid or semi-rigid. In some embodiments, connector-for-catheter-tubing1010may be injection molded and/or 3D printed from one or more thermoformed plastics. In some embodiments, connector-for-catheter-tubing1010may be opaque. In some embodiments, connector-for-catheter-tubing1010may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like. In such embodiments, connector-for-catheter-tubing1010may be colored, such as, but not limited to, white. See alsoFIG. 10A.

Continuing discussingFIG. 10C, in some embodiments, connector-for-catheter-tubing1010may be an elongate member (e.g., the first-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-catheter-tubing1010. See alsoFIG. 10A.

Continuing discussingFIG. 10C, in some embodiments, connector-for-catheter-tubing1010may comprise a central-flange1020. In some embodiments, central-flange1020may be is externally located and annular. In some embodiments, central-flange1020may be located between first-barb-region1012and mating-end1016. In some embodiments, central-flange1020may help to facilitate disassembly of catheter-tubing9920from first-barb-region1012of connector-for-catheter-tubing1010; e.g., by the user grabbing central-flange1020in one hand and grabbing catheter-tubing9920in the other hand and pulling apart. See alsoFIG. 10F.

In some embodiments, abutting surfaces of central-flange1020and flange1038may fuse and/or melt together from sonic welding processes or other fusing or the like process. See e.g.,FIG. 10F.

Continuing discussingFIG. 10C, in some embodiments, connector-for-extension-tubing1030may be attachable to extension-tubing9930at a second-barb-region1032of connector-for-extension-tubing1030. In some embodiments, connector-for-extension-tubing1030may be a second-elongate-member. In some embodiments, connector-for-extension-tubing1030may comprise a second-hollow-core1034for passage of the urine. In some embodiments, disposed opposite of second-barb-region1032may be a complimentary-mating-end1036. In some embodiments, mating-end1016(of connector-for-catheter-tubing1010) may be attached to complimentary-mating-end1036(of connector-for-extension-tubing1030). See also,FIG. 10EandFIG. 10F.

In some embodiments, abutting surfaces of mating-end1016and complimentary-mating-end1036may fuse and/or melt together from sonic welding processes or other fusing or the like process. See e.g.,FIG. 10F.

Continuing discussingFIG. 10C, in some embodiments, connector-for-extension-tubing1030may be rigid or semi-rigid. In some embodiments, connector-for-extension-tubing1030may be injection molded and/or 3D printed from one or more thermoformed plastics. In some embodiments, connector-for-extension-tubing1030may be opaque. In some embodiments, connector-for-extension-tubing1030may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like. See also,FIG. 10AandFIG. 10E.

Continuing discussingFIG. 10C, in some embodiments, connector-for-extension-tubing1030may be an elongate member (e.g., the second-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-extension-tubing1030. See also,FIG. 10AandFIG. 10E.

Continuing discussingFIG. 10C, in some embodiments, connector-for-extension-tubing1030may comprise a flange1038. In some embodiments, flange1038may be externally located and annular. In some embodiments flange1038may be located away from second-barb-region1032. See also,FIG. 10A,FIG. 10E, andFIG. 10F.

Continuing discussingFIG. 10AthroughFIG. 10F, in some embodiments, when the connector-for-catheter-tubing1010may be attached to the connector-for-extension-tubing1030(e.g., via a union of mating-end1016to complimentary-mating-end1036), with the gate1050disposed between portions of connector-for-catheter-tubing1010and portions of connector-for-extension-tubing1030; then connector-with-integrated-check-valve1000may be formed from the connector-for-catheter-tubing1010, the connector-for-extension-tubing1030, and the gate1050.

Continuing discussingFIG. 10C, in some embodiments, connector-for-extension-tubing1030may comprise catch-arms1040. In some embodiments, connector-for-extension-tubing1030may comprise from two, three, four, five, or six catch-arms1040. In some embodiments, connector-for-extension-tubing1030may comprise four catch-arms1040. In some embodiments, catch-arms1040may be arranged radially with respect to a center of connector-for-extension-tubing1030(see e.g.,FIG. 10B). In some embodiments, a given catch-arm1040may be a structural protrusion into a portion of the second-hollow-core1034that may allow urine flow through second-hollow-core1034but wherein the catch-arms1040may be sized in relation to gate1050to prevent the gate1050from passing through a region of second-hollow-core1034that is closest to second-barb-region1032. In some embodiments, catch-arms1040may stop movement of gate1050in desired-direction770from passing into or beyond second-barb-region1032. In some embodiments, catch-arms1040may act as guides for some movement of gate1050. In some embodiments, catch-arms1040may act as guides for some movement of a stem-portion1153of gate1050. See alsoFIG. 10BandFIG. 10Ffor catch-arms1040. See e.g.,FIG. 11Astem-portion1153of gate1050. In some embodiments, stem-portion1153may assist with preventing gate1050from becoming misaligned in pocket1052. See e.g.,FIG. 10F.

Continuing discussingFIG. 10C, in some embodiments, each catch-arm1040may comprise a post1046. In some embodiments, post1046may protrude as a distal portion of each catch-arm1040. In some embodiments, posts1046may be sized and/or spaced so as to guide translational movement of disc-portion1151of gate1050. In some embodiments, catch-arms1040may be sized and/or spaced so as to guide translational movement of stem-portion1153of gate1050. See also,FIG. 10D,FIG. 10E, andFIG. 10Ffor post1046. See e.g.,FIG. 11Afor disc-portion1151and stem-portion1153.

DiscussingFIG. 10F, in some embodiments, connector-with-integrated-check-valve1000may permit urine flow is a desired-direction770from connector-for-catheter-tubing1010towards connector-for-extension-tubing1030. Whereas, in some embodiments, connector-with-integrated-check-valve1000may close and prevent backflow (reflux) of the urine in a direction from connector-for-extension-tubing1030towards connector-for-catheter-tubing1010when the urine exerts backflow pressure against gate1050, which may push gate1050against a seat1018that may be located within connector-for-catheter-tubing1010. In some embodiments, seat1018may be structure of connector-for-catheter-tubing1010located on or in first-hollow-core1014. In some embodiments, seat1018may be an internal annular shelf located in first-hollow-core1014. In some embodiments, seat1018may stop movement of gate1050. In some embodiments, seat1018may form a seal with proximate portions of gate1050when connector-with-integrated-check-valve1000may be in the closed configuration. In some embodiments, these proximate portions of gate1050that may removably seal against seat1018may be designated sealing-surface1155shown inFIG. 11A. That is, in some embodiments, when gate1050may be under pressure that is opposite of desired-direction770, sealing-surface1155may removably butt up against seat1018, sealing off urine flow in the direction opposite of desired-direction770. Note,FIG. 10Fmay depict connector-with-integrated-check-valve1000in an open configuration (i.e., with seat1018not touching sealing-surface1155).

Continuing discussingFIG. 10F, in some embodiments, each catch-arm1040may comprise a support-surface1042. In some embodiments, support-surface1042may be located closer to complimentary-mating-end1036than to second-barb-region1032. In some embodiments, support-surface1042may be disposed opposite from seat1018and facing the seat1018, when connector-with-integrated-check-valve1000may be in its assembled configuration (e.g., as shown inFIG. 10A). In some embodiments, disposed between seat1018and support-surface1042may be a pocket1052that may house gate1050. See e.g.,FIG. 10Ffor pocket1052. In some embodiments, support-surface1042may contact portions of gate1050when the urine is flowing in desired-direction770. In some embodiments, when the urine is flowing desired-direction770this direction of flow may create pressure upon gate1050, wherein this may push gate1050against support-surfaces1042, which may be open configuration shown inFIG. 10Cand inFIG. 10F. Urine may flow around void spacing between the arm structures of posts1046(see e.g.,FIG. 10E).

Continuing discussingFIG. 10F, in some embodiments, gate1050may float within pocket1052of connector-with-integrated-check-valve1000. SeeFIG. 10FEfor pocket1052. In some embodiments, pocket1052may be longitudinally bounded by seat1018at one end of pocket1052and by support-surfaces1042at a remaining end of pocket1052. In some embodiments, support-surfaces1042may be disposed opposite of seat1018and may face seat1018, when connector-with-integrated-check-valve1000may be in its assembled configuration (e.g., as shown inFIG. 10A). In some embodiments, support-surfaces1042may be supportive surfaces of catch-arms1040. In some embodiments, catch-arms1040may permit the urine flow through second-hollow-core1034but may not permit passage of gate1050into portions of second-hollow-core1034. In some embodiments, gate1050may translate in pocket1052(e.g., back and forth movement), between the open configuration and the closed configuration.

In the closed configuration, sealing-surfaces1155of gate1050may be touching seat1018. In the closed configurations, portions of gate1050closest to seat1018may be physically touching portions of seat1018.

FIG. 10Dmay also depict connector-with-integrated-check-valve1000, but shown in a transverse-width cross-sectional view along sectional line10D-10D. In some embodiments, a distance between opposing posts1046may be receiving-distance1044. SeeFIG. 10Dfor receiving-distance1044. In some embodiments, gate1050may comprise a gate-disc-outside-diameter1154which may be a largest outside diameter of gate1050. SeeFIG. 11Aand/orFIG. 11Dfor gate-outside-diameter1154. In some embodiments, gate-disc-outside-diameter1154may be less than receiving-distance1044; and in this relationship, portions of catch-arms1040(e.g., spaced posts1046) may help to guide movement of disc-portion1151of gate1050within pocket1052. See also,FIG. 10F.

In some embodiments, mating-end1016(of connector-for-catheter-tubing1010) may be a protruding annular ring that may protrude in a direction away from the first-barb-region1012. See e.g.,FIG. 10CandFIG. 10FG. In some embodiments, complimentary-mating-end1036may be a ring shaped receiving channel sized to receive the protruding annular ring of mating-end1016. For complimentary-mating-end1036seeFIG. 10EandFIG. 10F. In some embodiments, this ring shaped receiving channel of complimentary-mating-end1036may be located in flange1038. See e.g.,FIG. 10EandFIG. 10F. In some embodiments, attachment between mating-end1016and complimentary-mating-end1036may be by one or more of: ultrasonic welding, heat welding, solvent bonding, chemical adhesive, snap fit, friction fit, press fit, and/or the like.

Gate1050may be shown by itself inFIG. 11AthroughFIG. 11D.FIG. 11Amay be a perspective view of gate1050.FIG. 11Bmay be an opposing perspective view of gate1050with respect toFIG. 11A.FIG. 11Cmay be a stem view of gate1050.FIG. 11Cmay include a sectional line11D-11D.FIG. 11Dmay be a longitudinal cross-sectional view of gate1050through sectional line11D-11D.

DiscussingFIG. 11AthroughFIG. 11D, in some embodiments, gate1050may comprise two main attached regions that are integral to each other, disc-portion1151and stem-portion1153. In some embodiments, disc-portion1151may be a circular disc; may be disc shaped; and/or may be substantially disc shaped. In some embodiments, disc-portion1151may float within pocket1052(see e.g.,FIG. 10F). In some embodiments, stem-portion1153may be substantially an elongate-member. In some embodiments, stem-portion1153may be substantially a cylindrical member. In some embodiments, stem-portion1153may extend (protrude) from a center of disc-portion1151. In some embodiments, stem-portion1153may extend (protrude) from a bottom center of disc-portion1151. In some embodiments, stem-portion1153may extend (protrude) from a center of disc-portion1151, with respect to desired-direction770. In some embodiments, disc-portion1151may comprise a substantially planar and flat portion, which may further comprise sealing-surfaces1155; wherein sealing-surfaces1155may removably seal to seat1018when there may be pressure opposite of desired-direction770. In some embodiments, stem-portion1153may extend (protrude) from a center of disc-portion1151that may be opposite of this substantially planar and flat portion that may have sealing-surfaces1155. In some embodiments, both disc-portion1151and stem-portion1153may have concentric radial symmetry about an imaginary shared longitudinal central axis. In some embodiments, both disc-portion1151and stem-portion1153may each have their own diameters, gate-disc-outside-diameter1154and stem-diameter1157, respectively. In some embodiments, gate-disc-outside-diameter1154may be larger than stem-diameter1157. See e.g.,FIG. 11AthroughFIG. 11D.

In some embodiments, stem-portion1153, which may guide gate1050, may be of different, but fixed and predetermined, lengths and/or diameters. In some embodiments, stem-diameter1157may be substantially the same as gate-disc-outside-diameter1154, in which case support-surfaces1042(vanes) may be absent. In such embodiments, sidewalls of the stem-portion1153could have one or more windows to allow fluid flow in the open direction (see e.g.,FIG. 12B).

DiscussingFIG. 11B, in some embodiments, disc-portion1151may comprise a region of annular-disc-concavity1161; which may be opposing the substantially planar and flat portion that may have sealing-surfaces1155(see e.g.,FIG. 11B). In some embodiments, annular-disc-concavity1161may help catch urine exerting pressure in the opposite direction of desired-direction770, and thus helping to assist in pushing sealing-surfaces1155against seat1018. Similarly, a distal (terminal) end of stem-portion1153may comprise stem-cavity1159; which may be a hollow space protruding into stem-portion1153; and thus, helping to assist in pushing sealing-surfaces1155against seat1018when urine may be exerting pressure in the opposite direction of desired-direction770. See e.g.,FIG. 11B.

In some embodiments, annular-disc-concavity1161may also facilitate injection molding of this gate1050, e.g., by assisting with wall thickness continuity.

In some embodiments, gate1050may be one or more of the following properties: may be a solid member; may be flexible; may be elastomeric; may be constructed from silicone; may be constructed from rubber; may be radially symmetrical; and/or the like. In some embodiments, gate1050may be substantially elastomeric and flexible.

In some embodiments, connector-for-extension-tubing1030and connector-for-extension-tubing730may be substantially identical exteriorly when connector-with-integrated-check-valve1000may be in its assembled configuration. In some embodiments, connector-for-extension-tubing1030and connector-for-extension-tubing730may be serve substantially identical functions and/or purposes.

In some embodiments, gate750and gate1050may be serve substantially identical functions and/or purposes.

Systems for minimizing microbial migration to catheter-tubing may be some embodiments of the present invention. In some embodiments, this system may comprise connector-with-integrated-check-valve1000. In some embodiments, this system may comprise connector-for-catheter-tubing1010, connector-for-extension-tubing1030, and gate1050. In some embodiments, this system may further comprise extension-tubing9930of a predetermined length and connector-with-integrated-check-valve1000attached to that predetermined length of extension-tubing9930. In some embodiments, this system may further comprise catheter-tubing9920.

FIG. 12Athrough and includingFIG. 12Cmay at least depict an embodiment of a connector-with-integrated-check-valve1200or may depict components of connector-with-integrated-check-valve1200. In some embodiments, connector-with-integrated-check-valve1200may be a dual ended connector with an integral check-valve disposed between the opposing tubing connection regions; wherein that integral check-valve may prevent (or minimize) urine reflux (backflow). The dual connector aspect may allow for connecting one end of connector-with-integrated-check-valve1200to catheter-tubing9920and the remaining other connector end to extension-tubing9930. In some embodiments, catheter-tubing9920may be the exit tubing portion of catheter9915. In some embodiments, extension-tubing9930may then lead to urine bag9901, such as, but not limited to, leg urine bag9901aor bed urine bag9901b.

FIG. 12Amay depict a perspective view of connector-with-integrated-check-valve1200in its assembled configuration.FIG. 12Bmay also depict connector-with-integrated-check-valve1200, but shown from an exploded perspective view.FIG. 12Cmay also depict connector-with-integrated-check-valve1200, but shown from a longitudinal cross-sectional view.

DiscussingFIG. 12A,FIG. 12B, andFIG. 12C, in some embodiments, connector-with-integrated-check-valve1200may comprise three parts that may be assembled together. In some embodiments these three parts may be connector-for-catheter-tubing1210, connector-for-extension-tubing1230, and a gate1250.

Continuing discussingFIG. 12C, in some embodiments, connector-for-catheter-tubing1210may be removably attachable to catheter-tubing9920at a first-barb-region1212of connector-for-catheter-tubing1210. In some embodiments, connector-for-catheter-tubing1210may be a first-elongate-member. In some embodiments, connector-for-catheter-tubing1210may comprise a first-hollow-core1214for passage of urine. In some embodiments, disposed opposite of first-barb-region1212may be a mating-end1216of connector-for-catheter-tubing1210. In some embodiments, mating-end1216may complimentary mate with complimentary-mating-end1236of connector-for-extension-tubing1230.

Continuing discussingFIG. 12C, in some embodiments, connector-for-catheter-tubing1210may be rigid or semi-rigid. In such embodiments, connector-for-catheter-tubing1210may be injection molded and/or 3D printed from one or more thermoformed plastics. In such embodiments, connector-for-catheter-tubing1210may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like. In such embodiments, connector-for-catheter-tubing1210may be colored, such as, but not limited to, white. See alsoFIG. 12AandFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-catheter-tubing1210may be an elongate member (e.g., the first-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-catheter-tubing1210. See alsoFIG. 12AandFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-catheter-tubing1210may comprise a central-flange1220. In some embodiments, central-flange1220may be is externally located and annular. In some embodiments, central-flange1220may be located between first-barb-region1212and mating-end1216. In some embodiments, central-flange1220may help to facilitate disassembly of catheter-tubing9920from first-barb-region1212of connector-for-catheter-tubing1210; e.g., by the user grabbing central-flange1220in one hand and grabbing catheter-tubing9920in the other hand and pulling apart. See alsoFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-extension-tubing1230may be attachable to extension-tubing9930at a second-barb-region1232of connector-for-extension-tubing1230. In some embodiments, connector-for-extension-tubing1230may be a second-elongate-member. In some embodiments, connector-for-extension-tubing1230may comprise a second-hollow-core1234for passage of the urine. In some embodiments, disposed opposite of second-barb-region1232may be a complimentary-mating-end1236. In some embodiments, mating-end1216(of connector-for-catheter-tubing1210) may be attached to complimentary-mating-end1236(of connector-for-extension-tubing1230). See also,FIG. 12AandFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-extension-tubing1230may be rigid or semi-rigid. In some embodiments, connector-for-extension-tubing1230may be injection molded and/or 3D printed from one or more thermoformed plastics. In some embodiments, connector-for-extension-tubing1230may be opaque. In some embodiments, connector-for-extension-tubing1230may be transparent or substantially transparent, which may aid in facilitating visual inspections for defects, biofilms, and the like. See alsoFIG. 12AandFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-extension-tubing1230may be an elongate member (e.g., the second-elongate-member) that may be radially symmetrical with respect to a longitudinal central axis of connector-for-extension-tubing1230. See alsoFIG. 12AandFIG. 12B.

Continuing discussingFIG. 12C, in some embodiments, connector-for-extension-tubing1230may comprise a flange1238. In some embodiments, flange1238may be externally located and annular. In some embodiments flange1238may be located away from second-barb-region1232. See alsoFIG. 12AandFIG. 12B.

Continuing discussingFIG. 12AthroughFIG. 12C, in some embodiments, when the connector-for-catheter-tubing1210may be attached to the connector-for-extension-tubing1230(e.g., via a union of mating-end1216to complimentary-mating-end1236), with the gate1250disposed between portions of connector-for-catheter-tubing1210and portions of connector-for-extension-tubing1230; then connector-with-integrated-check-valve1200may be formed from the connector-for-catheter-tubing1210, the connector-for-extension-tubing1230, and the gate1250.

Continuing discussingFIG. 12C, in some embodiments, connector-with-integrated-check-valve1200may permits urine flow is a desired-direction770from connector-for-catheter-tubing1210towards connector-for-extension-tubing1230. Whereas, in some embodiments, connector-with-integrated-check-valve1200may close and prevent backflow (reflux) of the urine in a direction from connector-for-extension-tubing1230towards connector-for-catheter-tubing1210when the urine exerts backflow pressure against gate1250, which may push gate1250against a seat1218that may be located within connector-for-catheter-tubing1210. In some embodiments, seat1218may be structure of connector-for-catheter-tubing1210located on or in first-hollow-core1214. In some embodiments, seat1218may be an internal annular shelf located in first-hollow-core1214. In some embodiments, seat1218may stop movement of gate1250. In some embodiments, seat1218may form a seal with proximate portions of gate1250when connector-with-integrated-check-valve1200may be in the closed configuration. In some embodiments, these proximate portions of gate1250that may removably seal against seat1218may be portions of flat-surface1253of gate1250. That is, in some embodiments, when gate1250may be under pressure that is opposite of desired-direction770, the portions of flat-surface1253of gate1250may removably butt up against seat1218, sealing off urine flow in the direction opposite of desired-direction770. In some embodiments, closing-spring1245may provide this pressure that is opposite of desired-direction770. Note,FIG. 12Cmay depict connector-with-integrated-check-valve1200in a closed configuration (i.e., with seat1218touching the portions of flat-surface1253of gate1250).

Continuing discussingFIG. 12C, in some embodiments, connector-for-extension-tubing1230may comprise two or more spring-stops1240(projections). In some embodiments, these two or more spring-stops1240may be located (disposed) between second-hollow-core1234and pocket1252. In some embodiments, these two or more spring-stops1240may be protrusions extending at least partially into a hollow core of connector-for-extension-tubing1230. In some embodiments, the two or more spring-stops1240may prevent closing-spring1245from passing into second-hollow-core1234. In some embodiments, the two or more spring-stops1240may provide a rigid to semi-rigid structure for closing-spring1245to push against. In some embodiments, the two or more spring-stops1240may be disposed between complimentary-mating-end1236and second-hollow-core1234. In some embodiments, the two or more spring-stops1240may be disposed between flange1238and second-barb-region1232. In some embodiments, the two or more spring-stops1240may be disposed opposite from seat1218and facing the seat1218, when connector-with-integrated-check-valve1200may be in its assembled configuration (e.g., as shown inFIG. 12A). In some embodiments, disposed between seat1218and the two or more spring-stops1240may be a pocket1252that may house gate1250(and pocket1252may house closing-spring1245). In some embodiments, pocket1252may be a substantially hollow cylinder with opposing openings at each end of pocket1252. See e.g.,FIG. 12Cfor pocket1252.

Continuing discussingFIG. 12C, in some embodiments, gate1250may be disposed within pocket1252of connector-with-integrated-check-valve1200. In some embodiments, closing-spring1245may be disposed within pocket1252. SeeFIG. 12Cfor pocket1252. In some embodiments, pocket1252may be longitudinally bounded by seat1218at one end of pocket1252and by the two or more spring-stops1240at a remaining end of pocket1252.

In the closed configuration of connector-with-integrated-check-valve1200, the portions of flat-surface1253of gate1250may be touching seat1218. In the closed configuration, portions of gate1250closest to seat1218may be physically touching portions of seat1218. See e.g.,FIG. 12C.

In some embodiments, mating-end1216(of connector-for-catheter-tubing1210) may be a protruding annular ring that may protrude in a direction away from the first-barb-region1212. See e.g.,FIG. 12C. In some embodiments, complimentary-mating-end1236may be a ring shaped receiving channel sized to receive the protruding annular ring of mating-end1216. For complimentary-mating-end1236seeFIG. 12C. In some embodiments, this ring shaped receiving channel of complimentary-mating-end1236may be located in flange1238. See e.g.,FIG. 12C. In some embodiments, attachment between mating-end1216and complimentary-mating-end1236may be by one or more of: ultrasonic welding, heat welding, solvent bonding, chemical adhesive, snap fit, friction fit, press fit, and/or the like.

In some embodiments, gate1250may be a hollow substantially cylindrical member that may be capped at one end and open at its opposing end, i.e., gate1250may be substantially barrel shaped, wherein such a barrel is closed at one end and open at the opposing end. In some embodiments, this capped end may be flat-surface1253; wherein portions of flat-surface1253may butt up against seat1218to removable sealing of fluid flow. In some embodiments, this hollow portion of gate1250may be gate-spring-receiving-cavity1255. In some embodiments, proximate to flat-surface1253may be one or more hole(s)-for-fluid1251. In some embodiments, the one or more hole(s)-for-fluid1251may be hole(s) through a cylindrical side wall of gate1250. In some embodiments, the cylindrical side walls of gate1250may be mesh with a plurality of holes. In some embodiments, gate-spring-receiving-cavity1255may receive at least portions of closing-spring1245. In some embodiments, closing-spring1245may push against gate1250. In some embodiments, closing-spring1245may be a helical coil spring. In some embodiments, closing-spring1245may press against gate1250causing gate1250to removably seal by butting against seat1218. In some embodiments, such a closed configuration may be the natural and/or default status for connector-with-integrated-check-valve1200. In some embodiments, when the patient urinates, the urine pressure may exceed the spring strength for closing-spring1245, compressing closing-spring1245, and opening this check-valve for urine flow in desired-direction770. See e.g.,FIG. 12BandFIG. 12C.

In some embodiments of connector-with-integrated-check-valve1200, when a closing-spring1245may be used, closing-spring1245may stop against spring-stop1240(projections) at one of pocket1252and may stop against flat-surface1253of substantially barrel shaped gate1250towards the opposing end of pocket1252. See e.g.,FIG. 12C.

In some embodiments of connector-with-integrated-check-valve1200no closing-spring1245is required.

In some embodiments, gate1250may be one or more of the following properties: may be a solid member; may be flexible; may be elastomeric; may be constructed from silicone; may be constructed from rubber; may be radially symmetrical; and/or the like. In some embodiments, gate1250may be substantially elastomeric and flexible.

In some embodiments, connector-for-catheter-tubing1210and connector-for-catheter-tubing710may be substantially identical. In some embodiments, connector-for-catheter-tubing1210and connector-for-catheter-tubing710may be serve substantially identical functions and/or purposes.

In some embodiments, connector-for-extension-tubing1230and connector-for-extension-tubing730may be substantially identical exteriorly when connector-with-integrated-check-valve1200may be in its assembled configuration. In some embodiments, connector-for-extension-tubing1230and connector-for-extension-tubing730may be serve substantially identical functions and/or purposes.

In some embodiments, gate750and gate1250may be serve substantially identical functions and/or purposes.

In some embodiments, gates (e.g.,750,950,1050, and/or1250) may be manufactured in various predetermined and different colors, wherein such colors may designate specific manufacturing lots.

Note, in some embodiments any of the “connector-with-integrated-check-valve” (e.g.,700,800,900,1000, or1200) disclosed herein could be inserted into a given section of extension-tubing (e.g., by cutting that section of extension-tubing), in which case the given connector-for-catheter-tubing (e.g.,710,1010, and/or1210) would be removably connected to extension-tubing, rather than catheter-tubing.

Note, in some embodiments, the major flat portion of a given gate (e.g.,750,950,1050, and/or1250) may be instead cone shaped, dome shaped, or both, fitting partially into the flow orifice for removable sealing against the given seat (e.g.,718,1018, and/or1218). Note, in some embodiments, the flow orifice geometry or portion thereof (e.g., seat718,1018, and/or1218) may be complimentary shaped as in cone shaped or dome shaped, for removably sealing against the given gate.

Note, in some embodiments any of the “connector-with-integrated-check-valve” (e.g.,700,800,900,1000, or1200) disclosed herein may be fitted with a given biasing spring (see e.g., closing-springs845and/or1245) so that the default setting for the given check-valve may be closed, opening when receiving urine flow pressure in direct of desired-direction770. Such a biasing spring could be anchored with suitably configured ribs and/or vanes.

Systems for minimizing microbial migration to catheter-tubing may be some embodiments of the present invention. In some embodiments, this system may comprise connector-with-integrated-check-valve1200. In some embodiments, this system may comprise connector-for-catheter-tubing1210, connector-for-extension-tubing1230, and gate1250. In some embodiments, this system may further comprise extension-tubing9930of a predetermined length and connector-with-integrated-check-valve1200attached to that predetermined length of extension-tubing9930. In some embodiments, this system may further comprise catheter-tubing9920.

In some embodiments, attachment between mating-end (e.g.,716,1016, or1216) and complimentary-mating-end (e.g.,736,836,936,1036, or1236) may be by one or more of: ultrasonic welding, heat welding, solvent bonding, chemical adhesive, snap fit, friction fit, press fit, and/or the like. In some embodiments, such attachment may be intended to be permanent. In some embodiments, such attachment may be intended to be removable.

In some embodiments, at least some of internal wettable surfaces of connector-with-integrated-check-valve (e.g.,700,800,900,1000, or1200) may be coated with an antimicrobial coating. In some embodiments, at least some of internal wettable surfaces of connector-with-integrated-check-valve (e.g.,700,800,900,1000, or1200) may be treated with an antimicrobial product. Such antimicrobial coatings and/or treatments may help to prevent or minimize microbial colonization of the internal wettable surfaces. Such antimicrobial coatings and/or treatments may help to prevent or minimize biofilm adhesion to the internal wettable surfaces.

Note, in some embodiments, if a clamp is positioned around extension-tubing9930, and if said clamp is closed preventing any air into extension-tubing9930above the clamp, and prior to disengaging extension-tubing9930from the urine collection device (e.g., urine bag9901), use of such a clamp would maintain a closed-system above the clamp which would also include a closed-system with respect to catheter9915.

A tubing for minimizing undesirable microbial migration, as well as a system and method for forming and maintaining a closed-system of urinary tubing have been described. A connector-with-integrated-check-valve has also been described. The foregoing description of the various embodiments of the invention has been presented for the purposes of illustration and disclosure. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching without departing from the spirit of the invention.