Patent Application
20240181237
This document pertains generally, but not by way of limitation, to coupling and decoupling a tubing system within a housing which is resistant to touch contamination.
Peritonitis remains a significant challenge in the management of end stage kidney disease patients on peritoneal dialysis contributing significantly to morbidity and mortality. Bacteria colonizing on skin or mucous membranes are complications that can lead to infections. One approach includes patient training but nevertheless, many patients stop adhering to these trainings after a short time, thus making this strategy unreliable.
The present inventors have recognized, among other things, that a problem to be solved can include touch contamination. A high risk of touch contamination is associated with connecting and disconnecting the peritoneal catheter with the machine. It requires washing hands, wearing a face mask, cleaning the transfer set, removing caps from both the disposable set and patient transfer set, then connecting the disposable set to the patient transfer set without contaminating either end. Maintaining sterility is critical and in the event of a break in aseptic technique, some medical care facilities automatically require a three-day course of intraperitoneal antibiotics.
The present subject matter includes a solution to the problem of touch contamination. One example includes a housing having an interior environment configured to avoid touch contamination. The housing includes a first portion, such as a cover portion, which is configured to rotate independently of a second portion, such as a cavity portion. The first portion and the second portion have alignment positions that include, in one example, a first position for removal of a first cap from a fitting, a second position to connect with a corresponding coupling to enable fluid transfer, and a third position for attachment of a replacement, or second, cap on the fitting. A configuration of engagement features, such as a key and a keyway, and such as a cleat and a lug, allow for controlled movement of the system components in a manner that reduces contamination and allows for dialysis.
Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
An example of the present subject matter includes a housing coupled to tube 40. A fitting, coupled to transfer set 20, in lieu of cap 30, allows for coupling to the housing in a manner that reduces the incidence of touch contamination.
At 205, method 200 includes aligning a transfer set connector with a decapper. The transfer set connector, sometimes called a fitting, is coupled to the housing by a receiver port in a portion of the housing. The portions of the housing are aligned in a manner to position the fitting with the decapper within the housing. The decapper can include a cleat that engages with a feature of a first cap already affixed to the fitting. The fitting can be manipulated, by rotation, by urging forward, or by some other motion, to engage the decapper and the cap on the fitting. Further manipulation of the fitting, such as denoted at 210, will remove the first cap from the fitting and expose a lumen of the fitting.
At 215, the housing is manipulated to bring the fitting into alignment with a fluid coupler within the housing. The lumen of the fitting, having been exposed by removal of the first cap, is brought into fluid connection with the fluid coupler. The fitting can be manipulated by rotation, by urging forward, or by other manipulation, to engage with the fluid coupler, as shown at 220.
While the fitting and the fluid coupler are joined, the dialysis routine is performed. When the dialysis is finished, then the present subject matter can again be manipulated to disengage from the fluid coupling, as shown at 225.
Following dialysis, the present subject matter is manipulated to install a replacement cap on the fitting of the transfer set. At 230, the housing is manipulated to align the fitting with the second cap. The second cap is carried within the interior of the housing. At 235, the fitting is manipulated to engage with the second cap. At 240, the fitting, along with the second cap, is extracted from the housing.
A first cap is disposed at a lower end of fitting 315 in the illustration. First cap includes radially projecting lugs 330, shown here to be positioned in alignment with keys 335 and in alignment with through keyways 340.
Fitting 315 includes insertion limiter 25. Insertion limiter 25 includes a flange that provides a stop to limit insertion depth of fitting 315 into receiver port 325. In addition, insertion limiter 25 includes a contoured perimeter feature to facilitate rotation and manipulation of fitting 315 relative to receiver port 325. Tube 20 is coupled to fitting 315 as shown. In one example, tube 20 is coupled to fitting 315 by a hose barb. Tube 45 is coupled to a connector affixed to cavity portion 320 of housing 300.
Cap 540 includes radially-projecting lugs 330. In addition, cap 540 includes gasket 530. In one example, gasket 530 includes an elastic O-ring. In addition, cap 540 includes elastic O-ring 510.
Cap 540 is configured to couple with fitting 315 by means of lug 520 engaged with keyway 355. When fully engaged with keyway 355, lugs 520 are bottomed in the contoured keyway and lugs 330 are positioned to aligned with keys 335 of fitting 315. Cap 540 precludes touch contamination of an end of fitting 315.
Decapper stud 910 is disposed within cavity portion 320 at a first alignment position. Cavity portion 320 includes fluid coupler 930 disposed at a second alignment position. Fluid coupler 930 is configured to engage with fitting 315 and provide a fluid-tight coupling between a lumen of fluid coupler 930 and a lumen of fitting 315. The lumen of fitting 315 is fluidly coupled to a lumen of tube 20 and thus provides a fluid-tight coupling between tube 20 and tube 40.
Cavity portion 320 includes second cap 940 disposed at a third alignment position. Second cap 940 is configured to engage with fitting 315 and provide a touch contamination free coupling. Second cap 940 is disposed proximate second cap cleats 950. Cleats 950 provides positive engagement of fitting 315 and second cap 940. As with cap 540, second cap 940 includes an elastic O-ring to provide a touch contamination free coupling. In the figure, cover portion 310 is omitted for clarity.
Cavity portion 320 and cover portion (not shown) are coupled in a manner to allow independent rotation of one relative to the other. In addition, spring plunger 960, disposed on an interior of cavity portion 320, is configured as a spring mounted plunger and when the plunger engages with a corresponding structure of the cover portion, provides a detent by which the first, second, and third alignment positions are defined. When the cover portion is set in the first alignment position, fitting 315 is aligned with decapper 910, and when in the second alignment position, fitting 315 is aligned with fluid coupler 930, and when in the third alignment position, fitting 315 is aligned with second cap 940.
Axis 10 passes through a center of cover portion 310 and the figure shows a standoff boss for engagement with a corresponding feature of cavity portion (not shown) for coupling and independent rotation of the portions of the housing.
The figure also illustrates contoured track 1030 on the underside of cover portion 310. Spring plunger 960 (
The components described herein can be manufactured of a variety of materials. For example, the housing can be fabricated of a polymer using a molding process or manufactured of metal in a machining or casting operation. In one example, selected components are fabricated using an additive manufacturing technology.
Manufacturing can include forming a housing having a cavity portion and a cover portion. The functional elements described in this document can be configured as illustrated or can be configured differently. For example, the figures illustrate contoured track disposed on an interior end wall of the housing and the spring plunger is configured to exert a detent force in a direction parallel with the center axis of the housing. In other configurations, a contoured track is disposed on a different surface. For example, a contoured track can be provided on an interior sidewall of the housing and a spring plunger can exert a detent force in an outward radial direction. As another example, a contoured track can be provided on an external surface of a center post aligned with the center axis and a spring plunger can be configured to exert a detent force in an inward radial direction.
The first portion and the second portion of the housing can be configured in a manner that differs from that illustrated herein. For example, the cover portion can include a cavity, or the housing can be fabricated of two covers and a center section. In one example, the housing portions are configured for rotary motion with one portion configured to move independent of another portion.
In some examples, the fractional turn fasteners, including a cleat and a stud or a cleat and a Ing, are replaced with a combination of helical threads on an external cylindrical surface and an internal cylindrical surface.
One example of the present subject matter includes a system comprising a housing configured for rotary motion. The housing includes a cavity portion and a cover portion. The cover portion can be configured for rotary motion relative to the cavity portion. The cover portion can include a receiver port configured to engage with a fitting configured for coupling to an end of a first tube. The receiver port and the fitting can have an insertion limiter and have a key and a corresponding keyway. The insertion limiter is configured to limit a longitudinal engagement depth of the fitting relative to the receiver port. The key and keyway are configured to allow first limited rotation of the fitting relative to the receiver port for a first depth of insertion and are configured to allow second limited rotation of the fitting relative to the receiver port for a second depth of insertion. At a first alignment position of the cavity portion relative to the cover portion, the receiver port is aligned with a first retention cleat. In addition, keyway 340 in receiver port 325 is aligned with fitting 315 so the cap lugs are aligned for engagement with retention cleats 920. The retention cleat can include fractional turn fastener configured to engage with a corresponding lug or stud. The first cap can be coupled to the fitting. The lug and the first retention cleat are configured to disengage the first cap from the fitting with rotation and longitudinal movement of the fitting relative to the receiver port. At a second alignment position of the cavity portion relative to the cover portion, the receiver port is aligned with a fluid coupler. The fluid coupler is configured to engage with the fitting and provide a fluid-tight coupling between a lumen of the fitting and a lumen of the fluid coupler. At a third alignment position of the cavity portion relative to the cover portion, the fitting is aligned with a second cap. The second cap is configured to engage with the lumen of the fitting and provide a leak resistant closure of the lumen of the fitting.
In one example, at least one of the cavity portion and the cover portion includes at least one of a knurled surface, a textured surface, or a rotation flange configured to enable band-manipulation of the cavity portion relative to the cover portion.
In one example, the fitting includes a hose barb coupling to engage with the first tube.
In one example, the fitting includes a plurality of keys.
In one example, the fitting includes an internal keyway configured to receive a lug of the first cap.
In one example, the insertion limiter includes a flange on the fitting.
In one example, the fitting includes at least one of a knurled surface, a textured surface, or a rotation flange configured to enable hand-manipulation of the fitting relative to the housing.
In one example, the lumen of the fitting is configured as a cylindrical bore.
In one example, the first cap includes an elastic O-ring.
In one example, the first cap includes a portion configured to engage with the lumen of the fitting.
In one example, the receiver port is disposed eccentric to an axis of rotation of the cover portion.
In one example, the receiver port includes a plurality of keyways, wherein at least one keyway is blind.
In one example, the receiver port includes a ramped cam configured to allow limited withdrawal of the fitting relative to the cover portion.
In one example, the fluid coupler includes an elastic O-ring.
In one example, the second cap includes an elastic O-ring.
In one example, the second cap includes a bayonet lug configured to engage with the fitting.
In one example, the housing includes a guide having a detent corresponding to the first alignment position, the second alignment position, or the third alignment position.
In one example, the guide includes a track configured to allow one-way rotation of the cover portion relative to the cavity portion.
One example includes a method. The method can include forming a housing having a first portion and a second portion in which the first portion has a receiver port configured to receive a fitting and to receive a first cap coupled to the fitting. The fitting has a fitting lumen. The first portion and the second portion are configured for independent rotation and having a first alignment position, a second alignment position, and a third alignment position, wherein the first alignment position, the second alignment position, and the third alignment positions are different. The method includes forming a first cleat on the housing to engage with a first lug of the first cap corresponding to the first alignment position. The first cleat and the first lug are configured to selectively engage and are also configured to decouple the first cap and the fitting with a first movement of the fitting relative to the receiver port. The method includes forming a fluid coupling on the housing corresponding to the second alignment position. The fluid coupling has a coupling lumen configured to engage with the fitting lumen. The method includes coupling a second cap to the housing corresponding to the third position. The second cap has a second lug configured to selectively engage with a second cleat of the housing. The second cap is configured to disengage from the housing with a second movement of the fitting relative to the receiver port.
In one example, the method of forming the housing having the second portion includes forming a track configured to engage a follower coupled to the first portion. The follower can include a spring plunger having, for example, a coil spring and a retained post or spherical element. The track has a detent corresponding to at least one of the first alignment position, the second alignment position, and the third alignment position.
In one example, the method includes forming a mechanical stop associated with the track. The mechanical stop is configured to allow rotation of the first portion relative to the second portion in a first direction and preclude rotation of the first portion relative to the second portion in a second direction.
In one example, the method of forming the housing having the first portion includes forming an alignment keyway on the receiver port. The alignment keyway is configured to engage an alignment key of the fitting.
The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A.” and “A and B.” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first.” “second,” and “third.” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, it an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18007706 | Dec 2022 | US |
| Child | 18447145 | US |
