Patent Application
20230398344
Novel aspects of the present disclosure relate to the field of medical devices. More particularly, and not by way of limitation, the present disclosure is directed to a single use cap for connectors.
Needleless connectors (NCs) are transitional interfaces that permit the exchange of fluids between containers, fluid transfer devices, and/or fluid conduits. NCs were designed primarily for use in the medical field to prevent needlestick injuries to medical care professionals. The NCs are typically attached to the ends of vascular catheters or other tubular structures, such as branched intravenous (IV) lines, to facilitate access for infusion and aspiration without the need for needles.
NCs generally have a housing that define a fluid pathway between a distal end to a proximal end. For some NCs, the proximal end is configured to engage with a fluid distribution line, such as a catheter or IV, and the distal end is exposed to the environment and configured to engage with fluid transfer device, such as a syringe, or fluid sources, such as a vial. For other NCs, the proximal end is configured to engage with a fluid source, such as a vial, and the distal end is exposed to the environment and configured to engage with a fluid transfer device. The fluid pathway, which extends axially through the NC, is typically sealed by a movable septum at the distal end to prevent entry of pathogens or contaminants into the NC. The pathogens or contaminants could then proceed into the fluid distribution line before entering into the patient's body, causing infection. Alternatively, the pathogens or contaminants could proceed into the fluid source, which would result in contamination. Disinfection of the septum before attaching the fluid source to the NC is crucial for reducing the rate of preventable infections in medical care facilities.
Novel aspects of the present disclosure are directed to a sealing device for sealing an opening of an apparatus. In a non-limiting embodiment, the apparatus can be a needleless connector (NC). The sealing device has a head that defines a cavity and a neck that defines a passage disposed between the cavity at a first end of the neck and an aperture at a second end of the neck. The aperture is configured to collapse and expand, having a first diameter in a collapsed configuration and a second diameter in an expanded configuration. The interior surface of the neck includes an engagement interface that is configured to releasably engage with a spacer. When the engagement interface is engaged with the spacer, the neck is in the expanded configuration.
Novel aspects of the present disclosure are also directed to a method of manufacturing a sealing device for sealing an opening. The method includes the step of forming the frame of the sealing device. The sealing device includes a head that defines a cavity and a neck that defines a passage disposed between the cavity at a first end of the neck and an aperture at a second end of the neck. The aperture has a first diameter when the neck is in a collapsed configuration and a second diameter when the neck is in an expanded configuration. The second diameter is larger than the first diameter. An interior surface of the neck includes an engagement interface configured to releasably engage a spacer that maintains the neck in the expanded configuration. The method further includes the step of forming a boundary layer coupled to the frame. The boundary layer encloses the cavity and the neck and defines the aperture at the second end of the neck. The method further includes the step of inserting a spacer into the passage of the neck to engage the engagement interface to cause the neck to transition from the collapsed configuration to the expanded configuration.
Novel aspects of the present disclosure are also directed to a method of using a sealing device configured to seal an opening of an apparatus. The method includes the step of obtaining the sealing device with a neck in an expanded configuration. The sealing device also includes a head that defines a cavity. The neck defines a passage disposed between the cavity at a first end of the neck and an aperture at a second end of the neck. The sealing device further includes a spacer releasably engaged to an engagement interface on an interior surface of the neck to maintain the neck in the expanded configuration. The aperture has a first diameter when the neck is in a collapsed configuration and a second diameter when the neck is in the expanded configuration, the second diameter being greater than the first diameter. The method further includes the steps of aligning the aperture of the sealing device with the opening of the apparatus so that the aperture and the opening are substantially coaxial, providing an insertion force to introduce an end portion of the apparatus housing the opening into the passage of neck, and maintaining the insertion force until the end portion of the apparatus is disposed within the cavity.
Other aspects, embodiments and features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying figures. In the figures, each identical, or substantially similar component that is illustrated in various figures is represented by a single numeral or notation. For purposes of clarity, not every component is labeled in every figure. Nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention.
The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will be best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying figures, wherein:
Needleless connectors have been identified as a cause of catheter-related bloodstream infection (CRBSI). Inadequate disinfection of NCs allows pathogens to enter a patient's bloodstream, resulting in an expensive and time-consuming road to recovery. The average costs for treating CBRSI is about $48,000, with an increase in the length of stay (LoS) at the hospital by about 7 days. Patients suffering from CBRSI are 5 times more likely to be readmitted to the hospital and experience a 10% increase in mortality rate.
To combat CBRSI, specific disinfection guidelines have been implemented. For example, the current guidelines for engaging needleless connectors (NCs) are as follows: for every engagement, scrub the surface of the NC with an alcohol wipe for 30 seconds, allow the NC to dry for 20 seconds, and then cap the NC when not engaged. In another example, the current guidelines for intravenous (IV) line access with a regular cap are as follows: remove cap, disinfect the exposed surfaces of the needleless connector, connect syringe with saline to check patency, disconnect the syringe, clean the needleless connector again, connect syringe or IV set with medication and deliver, disconnect the syringe or IV, clean the needleless connector again, connect syringe with saline to flush, and disconnect and place a new cap on the needleless connector.
These current disinfection guidelines are complex. Compliance with these guidelines can vary due to subjective interpretation of the steps and due to events occurring within specific medical settings. For example, the manual disinfection with the alcohol wipe can include multiple steps over multiple interfaces. Time constraints are sometimes not followed. Additionally, single-use caps are sometimes reused, particularly when replacement caps are not available. Sometimes caps are improperly attached or not used at all. Even conventional single-use disinfection caps that purport to eliminate the need to disinfect the NC prior to use suffer from user error. For example, some medical care providers continue to disinfect the NC because they do not know if it was previously attached correctly, or if it was removed and reused. Thus, novel aspects of the present disclosure recognize the need for a sealing device that prevents contamination of the NC during storage, disinfects the NC prior to use, and self-modifies to prevent reuse.
While the various embodiments described in this disclosure depict use of the sealing device with needleless connectors, the illustrative use should be deemed exemplary and non-limiting. The sealing devices described herein can be applied equally to connector heads, fittings, or other openings for vessels and fluid conduits in the medical field, as well as in non-medical industries.
The NC 100 includes a housing 102 having a distal end 104 and a proximal end 106. The NC 100 defines a fluid pathway between the distal end 104 and the proximal end 106, coinciding with the axis 108. A tail 110 at the proximal end 106 is configured to engage with a tube (not shown). In this example in
To prevent the ingress of pathogens into the attached tube via the NC 100, the fluid pathway can be sealed by a movable septum 114 that is partially exposed at distal end 104 of the NC. In one embodiment, the movable septum 114 is an exposed surface of a compressible valve housed within the housing 102. When the compressible valve is exposed to a compression force, the septum 114 disengages from the distal end 104 of the NC 100 to expose an opening that allows fluid to pass from a fluid dispenser through the NC 100 and into the attached tube. The compression force is generally applied to the septum 114 by attachment of a fluid transfer device or fluid source to the head 112 of the NC 100, causing the fluid transfer device or fluid source to engage with the septum 114, unsealing the septum 114 from the distal end 104 of the NC 100.
Referring to
The NC 200 includes a housing 202 having a distal end 204 and a proximal end 206. The NC 200 defines a fluid pathway between the distal end 204 and the proximal end 206, coinciding with the axis 208. A tail 210 at the proximal end 206 of the NC 200 is configured to be engaged with a fluid conduit, such as an IV (not shown), or fluid source, such as a container (not shown). A head 212 projects outwardly from the housing 202 at the distal end 204 and is configured to be removably engaged with a receiving end of a fluid transfer device (not shown), such as a syringe. In this example in
To prevent the ingress of pathogens into the attached tube via the NC 200, the fluid pathway can be sealed by a movable septum 214 that is partially exposed at distal end 204 of the NC. In one embodiment, the movable septum 214 is an exposed surface of a compressible valve housed within the housing 202. When the compressible valve is exposed to a compression force, the septum 214 disengages from the distal end 204 of the NC 200 to expose an opening that allows fluid to pass from a fluid dispenser through the NC 200 and into the attached tube. The compression force is generally applied to the septum 214 by attachment of a fluid transfer device to the head 212 of the NC 200, causing the fluid transfer device or fluid source to engage with the septum 214, unsealing the septum 214 from the distal end 204 of the NC 200.
Referring to
The interior surface of the neck 306 includes an engagement interface 312 that is configured to releasably engage with a spacer 314 to maintain the spacer 314 within the neck 306. With the spacer 314 in the neck 306, the sealing device 300 can assume the expanded configuration depicted in
The sealing device 300 may further comprise a disinfectant applicator 317 disposed within the cavity 304 and configured to apply a disinfectant 319 to the hub of a NC. In the sealing device 300 depicted in
The sealing device 300 includes a frame 318 that comprises an annular region 320 that at least partially encircles the cavity 304 of the head 302, and a solid crown 326. The frame 318 further comprises a set of arms 322 that are flexibly coupled with the annular region 320 and extend toward the second end of the neck 306. The set of arms 322 provide a compressive force directed radially inward so that the sealing device 300 can assume the collapsed configuration in the absence of spacer 314 inserted within the neck. The flexibility of the set of arms 322 allows the neck 306 to expand sufficiently to receive the hub of a NC.
The sealing device 300 further includes a boundary layer 324 coupled to the frame 320 that encloses the head 302 and the neck 306. The boundary layer 324 defines the aperture 310 at the second end of the neck 306. In the depicted embodiment, the frame 320 encircles the boundary layer 324, but in other embodiments, the frame 320 can be encircled by the boundary layer 324 or the frame 320 can be integrated within the boundary layer 324. The boundary layer may comprise an elastic material. For example, the boundary layer may comprise an overmolded thermoplastic elastomer such as but not limited to styrenic block copolymers, olefinic thermoplastic elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyester, thermoplastic polyamides, or any other thermoplastic elastomer known in the art.
Referring to
With continued reference to
With reference to
With continued reference to
Referring to
With reference to
The interior surface of the neck 406 includes an engagement interface 412 that is configured to releasably engage with a spacer 414 to maintain the spacer 414 within the neck 406. With the spacer 414 in the neck 406, the sealing device 400 can assume the expanded configuration. In this illustrative embodiment, the engagement interface 412 is an annulus that projects radially inward. In another embodiment, the engagement interface 412 can be a recessed annulus or a set of recessed slots configured to receive a corresponding engagement feature of the spacer 414.
The sealing device 400 includes a frame 418 that comprises an annular region 420 that at least partially encircles the cavity 404 of the head 402. The frame 418 further comprises a set of arms 422 that are flexibly coupled with the annular region 420 and extend toward the second end of the neck 406. The set of arms 422 provide a compressive force directed radially inward so that the sealing device 400 can assume the collapsed configuration in the absence of spacer 414 inserted within the neck 406. The flexibility of the set of arms 422 allows the neck 306 to expand sufficiently to receive the hub of a NC.
The sealing device 400 further includes a boundary layer 424 coupled to the frame 420 that encloses the head 402 and the neck 406. The boundary layer 424 defines the aperture 410 at the second end of the neck 406. In the depicted embodiment, the annular region 420 encircles a circumferential portion of the head 402, with the boundary layer 424 exposed at the crown 426.
The sealing device 400 may further comprise a disinfectant applicator 417 disposed within the cavity 404 and configured to apply a disinfectant 419 to the hub of a NC. In the sealing device 400 depicted in
With continued reference to
In accordance with any of the embodiments described herein, the frame and/or boundary layer may comprise a material having a polymer, a metal, an alloy, or any combination thereof. In some embodiments, the frame comprises a material having a larger elastic modulus than the boundary layer (i.e., the frame is more rigid than the boundary layer). An advantage of the frame comprising a rigid material is that the arms allow for the expansion and contraction of the neck.
With continued reference to
With continued reference to
Although embodiments of the invention have been described with reference to several elements, any element described in the embodiments described herein are exemplary and can be omitted, substituted, added, combined, or rearranged as applicable to form new embodiments. A skilled person, upon reading the present specification, would recognize that such additional embodiments are effectively disclosed herein. For example, where this disclosure describes characteristics, structure, size, shape, arrangement, or composition for an element or process for making or using an element or combination of elements, the characteristics, structure, size, shape, arrangement, or composition can also be incorporated into any other element or combination of elements, or process for making or using an element or combination of elements described herein to provide additional embodiments.
Additionally, where an embodiment is described herein as comprising some element or group of elements, additional embodiments can consist essentially of or consist of the element or group of elements. Also, although the open-ended term “comprises” is generally used herein, additional embodiments can be formed by substituting the terms “consisting essentially of” or “consisting of”
While this invention has been particularly shown and described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
