Patent Application
20250001156
The present disclosure generally relates to devices for disinfecting and flushing patient connectors used for intravenous (IV) administration of medication and other fluids to or from patients. More specifically, the present disclosure relates to a disinfection and flushing device that requires only one coupling to the patient connector.
Vascular access devices (VAD's) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD's, peripheral catheters and central venous catheters. Several types of access hubs, ports or valves are coupled to a VAD when delivering a fluid or pharmaceutical. A Luer connector is a common way to couple or join syringes, catheters, hubbed needles, IV tubes, etc. to each other. When VADs are used for medical patient care, there are potential risks of occlusions and contamination of components.
If not properly maintained, VADs can become occluded. To ensure VADs are used properly and do not become occluded, standards of practice have been developed. These standards include a cleaning procedure, which is commonly referred to as a flush procedure or flushing a catheter. VAD standards of practice usually recommend flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and parenteral nutrition. The goal of these flush procedures is to confirm catheter patency, avoid drug incompatibilities, ensure the complete drug dose administration, prevent thrombus formation, and minimize the risk of blood stream infections. Flush procedures require diverse types and amounts of flush solutions. Commonly used flush solutions are saline and/or heparin lock solution. The type of flush solution and amount vary depending on the specific type of catheter. After flushing, the practitioner is then able to administer a dosage of medical fluid, followed by a post-administration flushing. Medication delivery and companion flushing through VAD delivery systems also inherently expose the delivery system to potential contamination.
Bacteria and other microorganisms may gain entry into a patient's vascular system from diverse types of patient connectors, including by way of non-limiting example, access hubs, ports or valves, upon their connection to the VAD when delivering a fluid or pharmaceutical. Each patient connector, whether an access hub, port, valve or other type of connection, is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially lethal. In order to decrease CRBSI cases and to ensure VAD's are used and maintained correctly, standards of practice have been developed, which include disinfecting and cleaning procedures. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and caps are also incorporated into the Infusion Nurses Standards (INS) guidelines.
In developed markets, when utilizing an IV catheter, a needleless patient connector will typically be used to close off the system and then subsequently be accessed to administer medication or other necessary fluids via the catheter to the patient. INS Standards of Practice recommend the use of a needleless connector and state that it should be “consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate/alcohol combination prior to each access.” The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be living on the surface and possibly lead to a variety of catheter related complications including CRBSI. Nurses will typically utilize a 70% isopropyl alcohol (IPA) pad to complete this disinfection task by doing what is known as “scrubbing the hub.” Currently many nursing units mandate the practice of scrubbing the patient's IV connector hub, even if the connector is presently coupled to an existing disinfection cap.
Typically, four disinfection caps and four scrubbing procedures are required to administer a single drug through a VAD system in a Saline-Administration of drug-Saline (SAS) workflow process. The first disinfection scrub prepares the patient's VAD connector for drug delivery and receipt of a first flushing syringe to dissolve potential occlusions within the VAD delivery system and its IV catheter. The first flushing syringe is removed after completion of the pre-flush. Thereafter a second disinfection scrub prepares the catheter hub for connection to a medication delivery syringe. A third disinfection scrub prepares the catheter hub for connection of a second flushing syringe to complete a post-medication delivery flush. Lastly, after removal of the second flushing syringe, a fourth disinfection scrub is performed, followed by sealing of the catheter hub with a cap or a locking syringe. In the case of a or Saline-Administration of drug-Saline-Heparin (SASH) workflow process, a third, heparin flushing procedure is required after the second saline flush, which requires a third flush syringe and a fifth disinfection scrub. When more than one drug is administered to a patient, during the workflow process, each additional drug dose is followed by hub disinfection before initiating the next dispensing task.
Throughout the sequence of procedures necessary to prevent occlusions within VAD systems and to administer medication to a patient there are contamination and microorganism transmission risks that can cause a CRBSI every time a syringe is connected or disconnected from the patient's VAD connector. It would be desirable to minimize the number of VAD connections and disconnections needed to administer one or more drugs to a patient, as well as the number of VAD scrubbing procedures necessary to administer medication to a patient through a VAD hub or other device, in order to reduce contamination risk. Reducing the number of VAD connections and disconnections beneficially would reduce clinician time and reduce the number of syringes and disinfection caps needed to administer one or more medications to a patient.
The disinfection and flushing device of the present disclosure requires only a single coupling of a disinfection cap of the device to the IV patient connector, both to scrub the patient connector and to administer flushing solution through the connector via a flush syringe that is already coupled to a housing portion of the device. The disinfection cap and housing portions of the device are coupled together during the initial patient connector scrub and flush operation. Thereafter, in some embodiments, the housing and its attached, spent flush syringe, are selectively separable from the disinfection cap portion of the device, so that the disinfection cap remains in place on the patient connector, thereby sealing the connector.
Single coupling connection of the disclosed device to the patient connector ensures passive connector scrubbing action, in compliance with Society for Healthcare Epidemiology of America (SHEA) and Infusion Nurses Standards (INS) guidelines, followed by IV-line flushing. The disclosed device enhances compliance with nursing disinfection guidelines, reduces touch contamination by promoting an aseptic, no touch, passive scrubbing technique, reduces microbial growth against those microbes commonly associated with CRBSI and simplifies workflow. By incorporating passive scrubbing, disinfection capability within the disinfection cap of the device, intermediate the flushing fluid flow path from the syringe to the patient connector, clinicians will not need to remember whether the patient connector/hub has been scrubbed prior to coupling the flush syringe to the IV connector. Thereafter, if the disclosed device, is used solely for intermitting flushing prior to administration of drugs or other fluids through the patient connector, the disinfection cap is selectively removed to allow drug infusion through the patient connector. Alternatively, if the disclosed device was used for final patient connector flushing after drug administration, the housing and flush syringe are separated from the disinfection cap, leaving the cap in place on the patient connector. In practice, when performing a SAS workflow process, it is possible to administer one or more drugs through a patient connector with only two devices of the present disclosure. The first device scrubs and flushes the patient connector; then one or more drugs is/are administered through the now scrubbed/flushed patient connector. Thereafter, the second device performs the final scrub and flush and leaves its disinfection cap in situ on the patient connector. SASH workflow requires a third one of the disinfection/flushing devices of the present disclosure to perform the final heparin flush of the patient connector.
One aspect of the present disclosure pertains to a device for both disinfecting and flushing of an intravenous patient connector in only one device connection. The device includes a guide housing having an internal, first, circumferential wall surface. The guide housing has a proximal end wall defining a first through aperture therein, and a distal end wall defining second through aperture. The housing has a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls. The device further includes an end cap captured within and translatable within the first internal cavity. A proximal end of the end cap defines an inlet and a first Luer connector adapted for engagement, through the first through aperture of the housing, with a corresponding Luer tip of a flush syringe. The distal end of the end cap defines a shaft with a spiked tip. The shaft defines an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap. The device further includes a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end. The second circumferential wall surface defines a second Luer connector adapted for engagement with a corresponding Luer connector of an IV patient connector. The respective first and second cavities are aligned with each other so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity of the disinfection cap. An elastomeric sleeve is captured within the second internal cavity. The sleeve has a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap. A disinfection pad is captured within the second internal cavity, intermediate the elastomeric sleeve and the distal open end of the disinfection cap. The disinfection pad defines a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap. The disinfection pad also defines a distal end surface adapted for disinfection of a corresponding patient IV connector when the disinfection cap is coupled to a connector. In some embodiments, a pre-filled flush syringe is coupled to the first Luer connector of the end cap. In device operation, the coupled flush syringe is advanced into the housing, causing translation of the spiked tip of the end cap into the disinfection cap, which in turn pierces the elastomeric sleeve and enables direct fluid communication of flushing solution contained within the coupled syringe between the inlet of the end cap and the distal open end of the disinfection cap, and in turn into the coupled patient connector.
Another aspect of the present disclosure pertains to a system for disinfecting and flushing an intravenous patient connector in only one device connection. The system includes a guide housing having an internal, first, circumferential wall surface, a proximal end wall defining a first through aperture therein, a distal end wall defining second through aperture therein, and a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls. An end cap is captured within and translatable within the first internal cavity of the housing. A proximal end of the end cap defines an inlet and a first Luer connector. The corresponding distal end of the end cap defines a shaft with a spiked tip. The shaft defines an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap. The system includes a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end. The second circumferential wall surface defines a second Luer connector. The respective first and second cavities are aligned with each other so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity. An elastomeric sleeve is captured within the second internal cavity. The sleeve has a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap. A disinfection pad is captured within the second internal cavity of the disinfection cap, intermediate the elastomeric sleeve and the distal open end of the disinfection cap. The pad defines a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap. The disinfection pad defines a distal end surface. The system includes a pre-filled flush syringe having a syringe barrel containing a flushing solution, a translatable plunger within the syringe barrel, and a third Luer connector that is inserted through the first through aperture of the guide housing and coupled to the first Luer connector of the end cap. The inlet of the end cap is in fluid communication with the flushing solution contained within the syringe barrel. The system further includes a patient connector having a connector body defining a fourth Luer connector that is coupled to the second Luer connector within the disinfection cap, with the distal end surface of the disinfection pad in contact with the fourth Luer connector. Advancement of the flush syringe into the first cavity translates the spiked tip of the end cap, piercing the elastomeric sleeve and enabling fluid communication and flow of the flushing solution from the flushing syringe through the patient connector, via the inlet, internal lumen and outlet of the end cap. Advancement of the syringe plunger dispenses the flushing solution into the patient connector.
In some embodiments, after the patient connector is flushed with the flush syringe that is coupled to the housing, both the syringe and the housing portion of the device are selectively decoupled from the disinfection cap portion of the device by releasing a selectively engageable locking mechanism. Upon release of the housing from the disinfection cap, the latter remains in place to seal the patient connector and avoid exposure of the connector end surface and its lumen to the environment. In other embodiments, the entire device cap and housing, along with the flush syringe that is coupled to the housing, are selectively decoupled from the patient connector, for further patient drug administration and the like. In some device embodiments, the locking mechanism facilitates selective removal of the entire device and attached flush syringe from the patent port or only removal of the housing and syringe, leaving the disinfection cap affixed to the patient connector. In other device embodiments, the locking mechanism only allows removal of the housing and syringe. In yet other device embodiments, the disinfection cap and the housing are permanently coupled to each other; the entire device, as well as the flush syringe, are removed by decoupling the disinfection cap from the IV patient connector.
Exemplary embodiments of the disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:
To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale.
The patient connector disinfection and flushing device of the present disclosure requires only a single coupling of a disinfection cap of the device to the IV patient connector, both to scrub the patient connector and to administer flushing solution through the connector via a flush syringe that is already coupled to a housing portion of the device. The disinfection cap and housing portions of the device are coupled together during the initial patient connector scrub and flush operation. Thereafter, in some embodiments, the housing and its attached, spent flush syringe, are selectively separable from the disinfection cap portion of the device, so that the disinfection cap remains in place on the patient connector. In other embodiments, the entire device, including the disinfection cap, the housing, and the separately coupled flush syringe are disconnected from the patient connector, so that drugs can be administered through the connector. Optionally, after drug administration, a second device of the present disclosure is utilized to provide a final scrubbing and flushing of the patient connector; whereupon after separation of its guide housing and spent flush syringe, its disinfection cap remains in place on the patient connector.
In this disclosure, a convention is followed wherein the distal end of a device is the end closest to a patient, e.g., for delivery of one or more drugs to the patient, and the proximal end of the device is the end away from the patient and closest to a clinician or other medical practitioner. With respect to terms used in this disclosure, the following definitions are provided.
As used herein, the use of “a,” “an,” and “the” includes the singular and plural.
As used herein, the term “catheter related bloodstream infection” or “CRBSI” refers to any infection resulting from the presence of a patient connector, catheter or IV line.
As used herein, the term “Luer connector” refers to a connection collar of a medical device (e.g., a VAD) that is the standard way of attaching needleless patient connectors, syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector comprises male and female interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Threaded Luer connectors include an additional outer rim of threads, allowing them to be more secure. The Luer connector male end is generally associated with a flush syringe and can interlock and connect to the female end located on the patient connector (including by way of non-limiting example a needleless patient connector) or other type of vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the patient connector or other type of hub of a vascular access device. (VAD). A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.
As used herein, ISO 80369-7:2016 defines a specification for standard Luer connectors including a 6% taper between the distal end and the proximal end. A male standard Luer connector increases from the open distal end to the proximal end. A female standard Luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, a male standard Luer connector has an outer cross-sectional diameter measured 0.75 mm from the distal end of the tip of between 3.970 mm and 4.072 mm. The length of the male standard Luer taper is between 7.500 mm to 10.500 mm. The outer cross-sectional diameter measured 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. As used herein, the phrases “male standard Luer connector” and “female standard Luer connector” shall refer to connectors having the dimensions described in ISO 80369-7, which is hereby incorporated by reference in its entirety.
As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “tip”, “hub”, “thread”, “protrusion/insert”, “tab”, “slope”, “wall”, “top”, “side”, “bottom” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually or to require specific spatial orientations, to implement various aspects of the embodiments of the present disclosure.
According to still further exemplary implementations of the embodiments of the present disclosure, a needleless connector-type patient connector or other medical device to be cleaned may comprise female threads that are sized and have a thread pattern that will engage with a standard ISO 594-2 type of male fitting and/or male threads that are sized and have a thread pattern that will engage with a standard ISO 594-2 type of female fitting. An example of an ISO 594-2 type of fitting is a Q-style fitting.
In one or more embodiments, a female connector-type, patient connector or other medical device to be cleaned may be selected from the group consisting essentially of: needle-type connectors (for direct injection into a patient or insertion into a drug vial for aspiration of a drug dose therefrom), needle-free connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, In Vision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, In Vision, Vadsite, Bionector, etc.
Before describing exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The patient connector disinfection and flushing concepts of this disclosure are capable of being implemented in other embodiments and of being practiced or being conducted in many ways.
The following non-limiting examples demonstrate principles according to one or more embodiments of the disclosure. In the
Referring now to
In summary, the guide housing 44 functions as an enclosure to restrain the end cap 62 therein, to guide translation of the end cap within the first internal cavity 60, and to prevent inadvertent piercing of the elastomeric sleeve 94 by the spiked tip 76 before intended flushing of the patient connector 30. The guide housing 44 structure enables it to be coupled to the disinfection cap 46.
The disinfection cap 46 has an internal, second, circumferential wall surface 82. An inserted, annular-shaped, proximal end wall 84 of the disinfection cap 46 defines a third through aperture 86 for receipt of the shaft 74 of the end cap 62. The disinfection cap 46 has distal open end 88 for receipt of the patient connector 30; its second circumferential wall surface 82 defines a second Luer connector 90 for coupling to the corresponding threaded Luer connector 32 of the patient connector. A second internal cavity 92 is defined within the second circumferential wall surface 82, the proximal end wall 84 and the distal open end 88 of the disinfection cap 46.
The disinfection cap 46 and the guide housing 44 are slidably coupled to each other in nested fashion; when nested, the respective first 60 and second 92 cavities are aligned with each other, so that the spiked tip 76 of the end cap 62 is translatable within the third through aperture 86 into the second cavity. While the embodiment of
An elastomeric sleeve 94 is captured within the second internal cavity 92 of the disinfection cap 46, which functions as a pierceable, rescalable septum for the cap. The elastomeric sleeve 94 has a peripheral flange 96 that is captured between the proximal end wall 84 and an annular internal bushing 98 of the disinfection cap 46. The elastomeric sleeve 94 has a tubular stem portion 100 that projects into the distal portion of the second internal cavity 92, for receiving the shaft 74 and the spiked tip 76 of the end cap 62. A corresponding distal tip 102 of the tubular stem portion 100 is pierceable by the spiked tip 76. The tubular stem portion 100 of the elastomeric sleeve 94 includes an axially expandable bellows 104, which extends axially upon insertion therein of the shaft 74 of the end cap 62. Comparing
During assembly of the disinfection cap 46, elastomeric sleeve 94 is inserted into the second internal cavity 92 from the proximal end 64 of the cap, with the tubular stem portion 100 passing through a center aperture of the internal bushing 98. Next, the annular, proximal end wall 84 is inserted into the second internal cavity, capturing the sleeve's peripheral flange 96.
Components of the disinfection and flushing device 42, and the other embodiments described herein, are constructed by injection molding or vacuum thermal forming. Exemplary materials used to construct the guide housing 44, the disinfection cap 46 and the end cap 62 include thermoplastic polymers. The elastomeric sleeve 94 is constructed by compression molding of cross-linked rubber or thermoplastic elastomer materials. An exemplary hardness range for the elastomeric sleeve is 25-100 Shore A, and more particularly 45-80 Shore A. Generally, the components of the disinfection and flushing device 42 are constructed with types of medical grade, plastic materials such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.
As illustrated in
The disinfection pad 110 retains disinfectant or antimicrobial agent in its porous structure due to surface tension and releases disinfectant or antimicrobial agent when squeezed or compressed by contact with the patient connector 30 or other medical device that is to be cleaned by the disinfection cap 46. The disinfection cap 46 is compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent includes variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol. ethanol, 2-propanol, butanol, methylparaben, ethyl paraben, propylparaben, propyl gallate, butylated hydroxy anisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel. In one or more specific embodiments, the disinfectant or antimicrobial agent is 70% isopropyl alcohol (IPA). As shown in
As the disinfection cap 46 is coupled to the patient connector 30, cap rotation needed to mate thread engagement between the corresponding threaded Luer connectors 32 and 90 ensures sufficient scrubbing of the connector, in compliance with Infusion Nurses Standards (INS) guidelines. The threaded engagement process also establishes a leak proof connection between the disinfection cap 46 and the patient connector 30.
Web peel lid 116 covers the distal open end 88 of the disinfection cap 46. In other embodiments, the device does not include a web peel lid covering the distal open end of the inspection cap. In one or more embodiments, the web peel lid 116 is a peelable seal, which comprises an aluminum or multi-layer polymer film peel back top. The web peel lid 116 minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the distal open end 88 of the disinfection cap 46, provides leak prevention and protection of the second internal cavity 92 that is formed within the disinfection cap, protects the absorbed, infiltrated contents of the disinfection pad 110 or other disinfectant media contained within the second internal cavity, and/or maintains a sealed, sterilized environment within the disinfection cap. Seal composition of the web peel lid 116 provides a sufficient environmental seal between its aluminum or polymer film and the disinfection cap's distal open end 88 at a range of temperatures, pressures, and humidity levels expected within a medical treatment facility. In some embodiments, the web peel lid 116 is heat-sealed or induction-sealed to the distal open end 88 of the disinfection cap 46. In other embodiments, the web peel lid 116 is scaled to the distal open end 88 of the disinfection cap 46 with pressure or thermally sensitive adhesive.
The guide housing 44 has a pivoting guide housing lid 118 to block inadvertent advancement translation of the syringe 48 and the end cap 62 within the guide housing's first internal cavity 60. A distal end 120 of the guide housing lid 118 is pivotally coupled to the guide housing 44. As depicted in
As previously described, the disinfection cap 46 and the guide housing 44 are slidably coupled to each other in nested fashion. In some embodiments, the slidably coupled guide housing and disinfection cap are coupled together with a locking mechanism. In the device embodiment 42 of
The locking mechanism in
As shown in
In some embodiments, a single, mutually paired, engaging bayonet pin 124 and female receptor slot 126 is incorporated in the locking mechanism. In other device embodiments, the locking mechanism comprises more than two pairs of mutually engaging pins and receptor slots. In some embodiments, the bayonet pins are oriented on the guide housing while the receptor slots are oriented in the disinfection cap.
The disinfection and flushing device 342 of system 340, shown in
The device 342 permanently couples the guide housing 344 and the disinfection cap 346 to each other. After completion of a flushing procedure, the disinfection cap 346 is unscrewed from patient connector 30, as shown in
During assembly of device 342, the tubular shaft portion 300 of the elastomeric sleeve 394 is inserted through the internal bushing 98 formed within the guide housing 344/disinfection cap 346, followed by insertion of the end cap 62. Thereafter the annular-shaped, proximal end wall 52 is inserted within the first internal cavity 60, to retain and capture the end cap 62 within the internal cavity. The threaded Luer connector 72 of the syringe 48 is coupled to the corresponding first Luer connector 68 of the end cap 62 and the device 342 is ready for coupling to, disinfection and flushing of a patient connector 30, as shown in
An exemplary process for using either of the device embodiments 42 or 142 of the present disclosure in performing a Saline-Administration of drug-Saline (SAS) or Saline-Administration of drug-Saline-Heparin (SASH) workflow process is as follows:
Reference throughout this specification to “one embodiment,” “certain embodiments,” “various embodiments,” “one or more embodiments” or “an embodiment” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in various embodiments,” “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
Although the disclosure herein provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope thereof. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.
