Iv access port cap for providing antimicrobial protection.
Abstract
A cap (300) is configured to provide antimicrobial protection to a female luer port of an IV device. The cap distributes an antimicrobial solution within the intraluminal surface of the hole when the cap is attached to the hole. A cap is also designed to distribute an antimicrobial solution around the outer surfaces of the hole. Once attached to a port, the cap can form a seal that minimizes evaporation of the antimicrobial solution from within the lumen or lumen of a port. Therefore, the cap can provide antimicrobial protection against another device that is attached to the port once the cap is removed.

Term
9.9 yearsleft in the term
Expires 5 August 2036.
- Priority and filed
- Granted
- Today
- Expires
20 claims: 3 independent, 17 dependent
- 1REIVINDICACIONES Habiéndose descrito la invención como antecede, se reclama como propiedad lo contenido en las siguientes reivindicaciones:1. Una tapa para un orificio de un dispositivo intravenoso, caracterizada porque comprende: un cuerpo que tiene una cavidad;un accionador colocado en contacto con la cavidad;y un material absorbente que contiene una solución antimicrobiana, el material absorbente que está contenido dentro del cuerpo tal que es comprimible;en donde cuando la tapa se conecta a un orificio de un dispositivo intravenoso, el accionador se hace avanzar en la cavidad y comprime el material absorbente provocando que la solución antimicrobiana fluya sobre una superficie intraluminal del orificio.
- 2La tapa de conformidad con la reivindicación 1, caracterizada porque el accionador comprende un lumen, la solución antimicrobiana que fluye a través del lumen en un lumen del orificio.
- 3La tapa de conformidad con la reivindicación 2, caracterizada porque el accionador comprende un luer macho en el cual se forma el lumen.
- 4La tapa de conformidad con la reivindicación 1, caracterizada porque la solución antimicrobiana fluye a través de una separación entre el cuerpo y una superficie exterior del accionador y sobre una superficie exterior del orificio.
- 5La tapa de conformidad con la reivindicación 1, caracterizada porque el cuerpo incluye un sello que hace contacto con el accionador cuando la tapa se conecta al orificio, formando de este modo un sello entre el accionador y el cuerpo.
- 6La tapa de conformidad con la reivindicación 1, caracterizada porque la concentración de un agente antimicrobiano dentro de la solución antimicrobiana se selecciona tal que cuando la solución antimicrobiana se mezcla con el fluido contenido dentro del lumen del orificio, la concentración del agente antimicrobiano permanece mayor que la concentración inhibitoria mínima del agente antimicrobiano.
- 7La tapa de conformidad con la reivindicación 1, caracterizada porque el orificio es un luer hembra en el cual se inserta el accionador.
- 8La tapa de conformidad con la reivindicación 1, caracterizada porque el orificio es un conectador sin aguja en el cual se inserta el accionador.
- 9La tapa de conformidad con la reivindicación 1, caracterizada porque el accionador incluye una saliente que se coloca dentro de un lumen en el cuerpo, la saliente tiene un lumen a través del cual fluye la solución antimicrobiana.
- 10La tapa de conformidad con la reivindicación 9, caracterizada porque el accionador incluye una pluralidad de dientes que se extienden a través de las correspondientes aberturas en el cuerpo.
- 11La tapa de conformidad con la reivindicación 10, caracterizada porque la solución antimicrobiana fluye a través de las aberturas cuando se fuerza al accionador en la cavidad.
- 12La tapa de conformidad con la reivindicación 1, caracterizada porque el accionador incluye un lumen, el que tiene un revestimiento antimicrobiano.
- 13Una tapa para un orificio de un dispositivo intravenoso, caracterizada porque comprende:un cuerpo que tiene una cavidad;un accionador colocado dentro de la cavidad, el accionador que tiene un lumen;y , un material absorbente que contiene una solución antimicrobiana, el material absorbente que está contenido dentro de la cavidad entre el accionador y una superficie interior del cuerpo;en donde antes de que la tapa se conecte a un orificio de un dispositivo intravenoso, el material absorbente permanecen no comprimido y cuando la tapa se conecta a un orificio de un dispositivo intravenoso, el accionador comprime el material absorbente provocando que la solución antimicrobiana fluya a través del lumen del accionador y en un lumen del orificio.
- 14La tapa de conformidad con la reivindicación 13, caracterizada porque el accionador se hace de un tamaño tal que existe una separación entre un borde exterior del accionador y una pared de la cavidad, la solución antimicrobiana que también fluye a través de la separación en una superficie exterior del orificio.
- 15La tapa de conformidad con la reivindicación 14, caracterizada porque el accionador incluye una pluralidad de dientes que se extienden a través de las correspondientes aberturas en el cuerpo, la solución antimicrobiana que fluye a través de las aberturas sobre la superficie exterior del orificio.
- 16La tapa de conformidad con la reivindicación 13, caracterizada porque el cuerpo incluye un sello para sellar el lumen del accionador.
- 17La tapa de conformidad con la reivindicación 13, caracterizada porque el accionador comprende un luer macho.
- 18Una tapa para un conectador sin aguja de un dispositivo intravenoso, caracterizada porque comprende:un cuerpo que tiene una cavidad;un material absorbente colocado dentro de la cavidad, el material absorbente que contiene una solución antimicrobiana;y un accionador colocado dentro de la cavidad contra el material absorbente, el accionador que se puede mover dentro de la cavidad para comprimir el material absorbente tal que al ser conectada la tapa a un conectador sin aguja, el conectador sin aguja provoca que el accionador comprima el material absorbente liberando la solución antimicrobiana sobre una superficie intraluminal del conectador sin aguja.
- 19La tapa de conformidad con la reivindicación 18, caracterizada porque el accionador comprende un lumen, la solución antimicrobiana que fluye a través del lumen del accionador sobre la superficie intraluminal del conectador sin aguja.
- 20La tapa de conformidad con la reivindicación 19, caracterizada porque la solución antimicrobiana también fluye alrededor de una superficie exterior del accionador sobre una superficie exterior del conectador sin aguja.
Independent claims20
115 paragraphs in 1 section, as filed
(54) Title: INTRAVENOUS ACCESS HOLE COVER (IV) TO PROVIDE ANTIMICROBIAL PROTECTION.
(54) Title: IV ACCESS PORT CAP FOR PROVIDING ANTIMICROBIAL PROTECTION.
(57) Summary
A cap (300) is configured to provide antimicrobial protection to a female luer port of an IV device. The cap distributes an antimicrobial solution within the intraluminal surface of the hole when the cap is attached to the hole. A cap is also designed to distribute an antimicrobial solution around the outer surfaces of the hole. Once attached to a port, the cap can form a seal that minimizes evaporation of the antimicrobial solution from within the lumen or lumen of a port. Therefore, the cap can provide antimicrobial protection against another device that is attached to the port once the cap is removed.
(57) Abstract
A cap (300) is configured to provide antimicrobial protection to a female luer port of an intravenous device. The cap distributes an antimicrobial solution within the intraluminal surfaces of the port when the cap is connected to the port. A cap is also designed to distribute an antimicrobial solution around the exterior surfaces of the port. Once connected to a port, the cap can form a seal that minimizes the evaporation of the antimicrobial solution from within the lumen of a port. The cap can therefore provide antimicrobial protection against another device that is connected to the port once the cap is removed.
INTRAVENOUS (IV) ACCESS HOLE COVER TO PROVIDE ANTIMICROBIAL PROTECTION
Field of Invention
The present invention relates generally to caps for providing antimicrobial protection to an IV access port or other type of device having a female luer connection. In particular, the caps of the present invention can be used to distribute an antimicrobial solution within the intraluminal space of a female luer device.
Background of the Invention
Currently, there are several products available to cap a hole in an IV device (for example, a catheter or other infusion device). In this description, the hole will generally be used to describe any type of connector for interconnecting two devices. For example, Figure 1 generally illustrates a port 100 that is configured as a female luer lock connector, while Figure 2 illustrates a port 200 that is configured as a needleless female luer connector. Typically, a needleless connector employs a valve that seals the lumen or lumen of the device from the outside environment and is pierced or otherwise separated by a male connector to gain access to the lumen or lumen.
Ref.:268161
In this description, a female luer connector is to be interpreted as any connector that has an inner lumen or lumen that tapers to fit a corresponding male connector that has the same or similar degree of taper. These female luer connectors can include luer lock and luer slip (or non-lock luer) connectors.
Intravenous devices can employ openings to provide quick access to a patient's vasculature. These holes also allow the device to remain within the patient's vasculature even when access to the vasculature is not needed. When an IV device port is not in use, it is desirable to keep the port clean and free of bacteria and other microbes. If the hole becomes contaminated with microbes while it is not in use, the microbes may flood into the patient's vasculature once the hole is used again to gain access to the patient's vasculature. Therefore, maintaining a sterile orifice is essential to minimize the risk of infection.
To maintain the sterility of an orifice, various types of caps have been designed. Typically these caps contain an antimicrobial solution that is applied to the outer surfaces of the hole when a cap is attached to the hole. For example, some caps employ an alcohol soaked material that is placed inside the cap cavity so that the material cleans by scrubbing the outer surfaces of the hole when the cap is screwed on. Once screwed, these caps can retain a quantity of the antimicrobial solution around the outer surface of the hole to ensure that the outer surface remains sterile until the cap is removed.
These caps have proven effective in disinfecting the outer surfaces of the hole. However, current designs only disinfect the exterior surfaces. Any microbes that may exist within the intraluminal space will remain the same even after these current caps are used.
Alternatively, to address this risk of infection, some ports are configured to have antimicrobial coatings on the intraluminal surfaces. With these coatings, intraluminal surfaces can remain sterile even if microbes come into contact with the surfaces. These coatings can dissolve fluid within the lumen to effectively spread antimicrobial agents throughout the lumen or lumen. However, there are several disadvantages to the use of antimicrobial coatings on the intraluminal surfaces of the holes. For example, holes that use antimicrobial coatings are significantly more expensive to produce. As a result, many facilities choose not to use them. Also, for a coating to be effective, it must retain its antimicrobial properties for at least the amount of time that the hole is usable (eg, up to 7 days). To achieve this, relatively thick coatings or highly concentrated coatings are used. This causes the concentration of the antimicrobial agents to be very high during the initial time of use which presents a risk of toxicity.
Brief Description of the Invention
The present invention extends to caps for providing antimicrobial protection to a female luer port of an intravenous device. The caps of the present invention are designed to distribute an antimicrobial solution within the intraluminal surfaces of the orifice. Additionally, in some embodiments, the caps are also designed to distribute an antimicrobial solution around the outer surfaces of the hole. Accordingly, the caps of the present invention provide a complete solution for disinfecting a port of an intravenous device.
In one embodiment, the present invention is implemented as a cap for a port of an intravenous device. The lid may comprise a body having a cavity; an actuator positioned within the cavity; and an absorbent material containing an antimicrobial solution. The absorbent material is contained within the cavity between the actuator and an interior surface of the body. When the cap is attached to a port in an IV device, the actuator is forced into the cavity and compresses the absorbent material causing the antimicrobial solution to flow over an intraluminal surface of the port.
In some embodiments, the actuator comprises a lumen or lumen through which the antimicrobial solution flows to reach a lumen or lumen of the port.
In some embodiments, the actuator comprises a male luer in which the lumen or lumen is formed.
In some embodiments, the antimicrobial solution flows through a gap between the body and an outer surface of the actuator and onto an outer surface of the orifice.
In some embodiments, the body includes a seal with which the actuator contacts when the cap is connected to the port, thereby forming a seal between the actuator and the body.
In some embodiments, the concentration of an antimicrobial agent within the antimicrobial solution is β
selected such that when the antimicrobial solution is mixed with the fluid contained within the lumen or lumen of the orifice, the concentration of the antimicrobial agent remains greater than the minimum inhibitory concentration of the antimicrobial agent.
In some embodiments, the port is a female luer into which the actuator is inserted.
In some embodiments, the port is a needleless connector into which the actuator is inserted.
In some embodiments, the actuator includes a projection that is positioned within a lumen or lumen in the body, the projection having a lumen or lumen through which the antimicrobial solution flows.
In some embodiments, the actuator includes a plurality of teeth that extend through corresponding openings in the body.
In some embodiments, the antimicrobial solution flows through the openings when the actuator is forced into the cavity.
In some embodiments, the actuator includes a lumen that has an antimicrobial coating.
In another embodiment, the present invention is implemented as a cap for a port of an intravenous port. The lid may comprise a body having a cavity; an actuator positioned within the cavity, the actuator having a lumen; and an absorbent material containing an antimicrobial solution, the absorbent material that is contained within the cavity between the actuator and an interior surface of the body. Before the cap is attached to a hole in an IV device, the absorbent material remains uncompressed. Then, when the cap is connected to a port of an intravenous device, the actuator compresses the absorbent material causing the antimicrobial solution to flow through the lumen or lumen of the actuator and into a lumen or lumen of the port.
In some embodiments, the actuator is sized such that there is a gap between an outer edge of the actuator and a wall of the cavity, the antimicrobial solution also flowing through the gap on an exterior surface of the orifice.
In some embodiments, the actuator includes a plurality of teeth that extend through corresponding openings in the body. The antimicrobial solution flows through the openings on the outer surface of the hole.
In some embodiments, the body includes a seal to seal the actuator lumen or lumen.
In some embodiments, the actuator comprises a male luer.
In another embodiment, the present invention is implemented as a cap for a needleless connector of an intravenous device. The lid may comprise a body having a cavity; an absorbent material placed within the cavity, the absorbent material containing an antimicrobial solution; and an actuator positioned within the cavity against the absorbent material. The actuator is movable within the cavity to compress the absorbent material such that when the cap is connected to a needleless connector, the needleless connector causes the actuator to compress the absorbent material releasing the antimicrobial solution onto an intraluminal surface of the connector without needle.
In some embodiments, the actuator comprises a light or lumen. The antimicrobial solution flows through the lumen or lumen of the actuator onto the intraluminal surface of the needleless connector.
In some embodiments, the antimicrobial solution also flows around an outer surface of the actuator onto an outer surface of the needleless connector.
This brief description is provided to introduce a selection of compounds in a simplified manner which are further described later in the detailed description. This brief description is not intended to identify key characteristics or essential characteristics of the claimed subject matter.
Additional features and advantages of the invention will be set forth in the description that follows, and in part will be obvious from the description or may be learned by practice of the invention. The characteristics and advantages of the invention can be achieved and obtained by means of the instruments and combinations specifically pointed out in the appended claims. These and other features of the present disclosure will become more fully apparent from the following description and appended claims or may be learned by practice of the invention as set forth hereinafter.
Brief Description of Figures
In order to describe the manner in which the aforementioned and other advantages and characteristics of the invention can be obtained, a more particular description of the invention briefly described above will be given by reference to specific embodiments thereof which are illustrated in the figures. annexes. Understanding that these figures represent only typical embodiments of the invention and therefore are not to be considered as limiting its scope, the invention will be described and explained with additional specificity and additional detail through the use of the attached figures in which :
Figure 1 illustrates a perspective view of an example of a prior art port that is configured as a female luer lock connector.
Figure 2 illustrates a perspective view of an example of a prior art port that is configured as a needleless female luer connector.
Figure 3 illustrates a perspective view of a cap according to one or more embodiments of the invention that can be used to apply an antimicrobial solution to the intraluminal surfaces of a port.
Figure 4 illustrates a cross-sectional view of a cap according to one or more embodiments of the invention in which an actuator can be moved within the body of the cap to cause an antimicrobial solution to be squeezed from an absorbent material contained within. of the body and distributed through the actuator to the intraluminal space of a hole.
Figure 5 illustrates a cross-sectional view of a lid having a body that is comprised of two pieces in accordance with one or more embodiments of the invention.
Figure 6 illustrates a cross-sectional view of a cap that is configured to connect to a hole that is configured as a luer slip connector in accordance with one or more embodiments of the invention.
Figures 7A-7C illustrate a sequence of how the cap depicted in Figure 4 connects to a port in an intravenous device. Figure 7A illustrates the cap prior to contact with the hole. Figure 7B illustrates that as the cap is being forced into the hole, the actuator is forced into the absorbent material causing the antimicrobial solution to flow into the orifice through gaps formed by actuator movement and through the actuator lumen. . Figure 7C illustrates that, once the cap is fully connected to the port, the actuator is forced against a seal to seal the port lumen.
Figure 8 illustrates a cross-sectional view of the cap depicted in Figure 4 when an orifice is connected that does not include a shoulder against which the actuator presses.
Figures 9A and 9B illustrate a sequence of how the cap depicted in Figure 4 can be used in an orifice employing a septum.
Figure 10A illustrates a cross-sectional view of an alternative embodiment of a cap that employs teeth to facilitate the flow of antimicrobial solution to the exterior surfaces of the orifice.
Figure 10B illustrates a broken away view of the cap of Figure 10A.
Figures 11A-11C illustrate a sequence of how the cap depicted in Figure 10A connects to a port in an intravenous device. Figure 11A illustrates the cap in contact with the hole. Figure 11B illustrates that as the cap is being forced into the hole, the actuator is forced into the absorbent material causing the antimicrobial solution to flow into the orifice through gaps formed by actuator movement and through light or actuator lumen. Figure 11C illustrates that once the cap is fully connected to the port, the actuator is forced against a seal to cause additional flow of the antimicrobial solution to be only through the lumen or lumen of the actuator.
Detailed description of the invention
The present invention extends to caps for providing antimicrobial protection to a female luer port of an intravenous device. The caps of the present invention are designed to distribute an antimicrobial solution within the intraluminal surfaces of the orifice. Additionally, in some embodiments, the caps are also designed to distribute an antimicrobial solution around the outer surfaces of the hole. Accordingly, the caps of the present invention provide a complete solution for disinfecting a port of an intravenous device.
In one embodiment, the present invention is implemented as a cap for a port of an intravenous device. The lid may comprise a body having a cavity; an actuator positioned within the cavity; an absorbent material containing an antimicrobial solution. The absorbent material is contained within the cavity between the actuator and an interior surface of the body. When the cap is connected to a hole in an IV device, the actuator is forced into the cavity and compresses the absorbent material causing the antimicrobial solution to flow over an intraluminal surface of the hole.
In some embodiments, the actuator comprises a lumen or lumen through which the antimicrobial solution flows to reach a lumen or lumen of the port.
In some embodiments, the actuator comprises a male luer in which the lumen or lumen is formed.
In some embodiments, the antimicrobial solution flows through a gap between the body and an outer surface of the actuator and onto an outer surface of the orifice.
In some embodiments, the body includes a seal that the actuator contacts when the cap is connected to the port, thereby forming a seal between the actuator and the body.
In some embodiments, the concentration of an antimicrobial agent within the antimicrobial solution is selected such that when the antimicrobial solution mixes with the fluid contained within the lumen or lumen of the orifice, the concentration of the antimicrobial agent remains greater than the minimum inhibitory concentration. of the antimicrobial agent.
In some embodiments, the port is a female luer into which the actuator is inserted.
In some embodiments, the port is a needleless connector into which the actuator is inserted.
In some embodiments, the actuator includes a projection that is positioned within a lumen on the body, the projection having a lumen through which the antimicrobial solution flows.
In some embodiments, the actuator includes a plurality of teeth that extend through corresponding openings in the body.
In some embodiments, the antimicrobial solution flows through the openings when the actuator is forced into the cavity.
In some embodiments, the actuator includes a lumen that has an antimicrobial coating.
In another embodiment, the present invention is implemented as a cap for a port of an intravenous device. The lid may comprise a body having a cavity; an actuator positioned within the cavity, the actuator having a lumen; and an absorbent material containing an antimicrobial solution, the absorbent material that is contained within the cavity between the actuator and an interior surface of the body. Before the cap is attached to a hole in an IV device, the absorbent material remains uncompressed. Then, when the cap is connected to a port of an intravenous device, the actuator compresses the absorbent material causing the antimicrobial solution to flow through the lumen of the actuator and into a lumen or lumen of the port.
In some embodiments, the actuator is made of a size such that there is a gap between an outer edge of the actuator and a wall of the cavity, the antimicrobial solution also flows through the gap onto an exterior surface of the orifice.
In some embodiments, the actuator includes a plurality of teeth that extend through corresponding openings in the body. The antimicrobial solution flows through the openings on the outer surface of the hole.
In some embodiments, the body includes a seal to seal the actuator lumen or lumen.
In some embodiments, the actuator comprises a male luer.
In another embodiment, the present invention is implemented as a cap for a needleless connector of an intravenous device, the cap may comprise a body having a cavity; an absorbent material placed within the cavity, the absorbent material containing an antimicrobial solution; and an actuator positioned within the cavity against the absorbent material. The actuator is movable within the cavity to compress the absorbent material such that when the cap is connected to a needleless connector, the needleless connector causes the actuator to compress the absorbent material releasing the antimicrobial solution onto an intraluminal surface of the connector without needle.
In some embodiments, the actuator comprises a lumen. The antimicrobial solution flows through the lumen of the actuator onto the intraluminal surface of the needleless connector.
In some embodiments, the antimicrobial solution also flows around an outer surface of the actuator onto an outer surface of the needleless connector.
Figure 3 illustrates a perspective view of a cap 300 in accordance with one or more embodiments of the invention. As shown, cap 300 comprises a body 301 and an actuator 302. Body 301 is generally formed to allow cap 300 to connect to a female luer connector such as port 100. If the cap is designed to connect to In a female luer lock connector, the inner surface of the body may include threads (eg, as shown in Figure 4). In contrast, if the cap is designed to connect to a female luer slip connector, the interior surface of the body may or may not include threads. In either case, actuator 302 can be configured as a male luer connector to allow actuator 302 to be inserted into female luer port 100.
<td></td><td>Figure 4</td><td>illustrates a view in</td><td>section</td>
<td colspan="2">transverse cap</td><td>3 00. As shown, the</td><td>cap 300</td>
<td>It includes</td><td>body 301,</td><td>actuator 302 and</td><td>material</td>
<td colspan="2">absorbent 303 placed</td><td colspan="2">between body 301 and actuator</td>
<td>302.</td><td colspan="3">cap 300 includes 310 threads and is therefore a</td>
<td>example</td><td colspan="2">of a cap designed for a connector</td><td>closing</td>
<td colspan="3">female luer. The actuator 302 has a tip that</td><td>is designed</td>
<td>as a</td><td>luer connector</td><td>male to allow the</td><td>tip is</td>
<td>insert</td><td colspan="2">into the lumen of a female luer connector.</td><td></td>
<td></td><td colspan="2">Figure 4 represents the cap 300 before</td><td>what I know</td>
connect to a hole. Before connection, the actuator
302 it is positioned against the interior surface of body 301 and does not comprise absorbent material 303. In some embodiments, actuator 3 02 can be held in this position by an adhesive, welding, or other physical force between body 301 and actuator 302. In others In embodiments, the actuator 302 can be held in this position by the absorbent material 303. In other words, the absorbent material 303 may be rigid enough to retain the position of the actuator 302 until a substantial force is applied against the actuator 302. In either case, the actuator 302 is designed not to compress the absorbent material 303 until cap 300 connects to a hole. A seal (not shown) may be applied above the actuator and possibly the body opening 301 to seal the absorbent material 303 from the outside environment until the cap 300 is to be used.
Figure 5 illustrates a cross-sectional view of an alternative embodiment of cover 300. In this alternative embodiment, body 301 comprises two pieces, a surface piece 301a and a bottom piece 301b. This two-piece design can be used to facilitate fabrication (for example, to facilitate positioning of actuator 302 within body 301). If the design of Figure 4 or Figure 5 is used, layer 300 will function the same as will be described later.
Figure 6 illustrates a cross-sectional view of another alternate embodiment of cap 300. In this embodiment, body 301 does not include threads but is configured to form a friction fit with the outer surface of a hole. Accordingly, a cap according to this alternative embodiment can be used on a non-locking female luer connector. Despite the type of hole to which the cap 300 will be connected, it will be desirable to secure the body 301 to the hole (for example by threads or a friction fit) to allow a seal to be formed between the actuator 302 and the body 301 once. the cap is attached. The role of this stamp will be further described below with reference to Figure 7C.
With continued reference to Figures 4-6, absorbent material 303 is saturated with an antimicrobial solution that remains within absorbent material 303 until absorbent material 303 is compressed. Actuator 302 is designed to provide a fluid path to distribute the antimicrobial solution to a hole when cap 300 is attached to the hole. The primary fluid path is through lumen or lumen 320. However, a secondary fluid path is also provided around the exterior of actuator 302. The distribution of the antimicrobial solution is illustrated in Figures 7A-7C.
Figures 7A-7C illustrate a sequence that occurs when cap 300 is attached to a port. Although Figures 7A-7C illustrate the design of cap 300 as shown in Figure 4, the same sequence will be presented when presenting a cap designed as shown in Figures 5 or 6. Also, for simplicity of illustration, the cap 300 is shown as being connected to hole 100. However, the same sequence will occur when cap 300 is connected to any hole that is configured as a female luer connector. Examples of holes in which the Cap 300 can be used include the BD Q-Syte<sup>MR </sup>(manufactured by Becton, Dickinson and Company), the CareFusion MaxPlus<sup>MR</sup> Clear (manufactured by CareFusion Corp), and the LifeShield MicroClave<sup>MR</sup> (manufactured by Hospira, Inc.) among many others.
Figure 7A shows the state of the cap 300 prior to contact with the hole 100. In this state, the cap 300 is as shown in Figure 4. The hole 100 is shown to include an internal flange 111 against which the Actuator tip 3 02 presses when cap 3 00 connects to hole. Port 100 is also shown to include threads 110 and is therefore an example of a luer lock connector. Accordingly, the cap 300 is connected to the hole 100 by threading the cap into the hole.
As shown in Figure 7B, as cap 300 is initially inserted into and advanced over hole 100, the tip of actuator 302 makes contact with shoulder 111 of orifice 100. This contact forces the actuator upward away from the body. 301 and absorbent material 303. Compression of absorbent material 303 causes the antimicrobial solution to flow out of the absorbent material. The arrows in Figure 7B indicate the routes along which the absorbent material will flow.
The primary pathway along which the antimicrobial solution flows is through the lumen 320 of the actuator 302. Because the lumen 320 aligns with the lumen 120 of the port 100, the antimicrobial solution that flows through the Lumen 320 will eventually be distributed along the surfaces of lumen 120 and into any fluid contained within lumen 120. In this manner, the intraluminal surfaces of orifice 100 can be disinfected.
The secondary path is around actuator 302 as represented by the outer arrows in Figure 7B. The antimicrobial solution will flow along the secondary path until the upper surface of the actuator 302 contacts the seal 304 formed along the inner surface of the body 301 as shown in Figure 7C. Contact between actuator 302 and seal 304 prevents antimicrobial solution from flowing around actuator 302 and therefore forces additional flow through lumen 320. In this manner, an adequate amount of antimicrobial solution will flow into the intraluminal space hole 100.
As shown in Figure 7C, after cap 300 has been attached, the antimicrobial solution will be contained within lumen 320 and lumen 120 as well as in the spaces between the outer surface of actuator 302 and the inner surface of body 301. This antimicrobial solution outside of actuator 302 can disinfect the top and outer surfaces of orifice 100. Because the connection between hole 100 and cap 300 may not be fluid tight, the antimicrobial solution is allowed to drain between threads 110 and 310 and onto the outer surfaces of hole 100. Also, in some embodiments, where an airtight seal is not formed (or at least not initially formed when the antimicrobial solution flows around the actuator 302) this antimicrobial solution can flow into the orifice opening 100 between the outer surface of the actuator 302 and the inner surface of the hole 100. In this way, intraluminal surfaces that otherwise cannot be reached by the antimicrobial solution that has flowed through fluid 320 can still be disinfected.
Accordingly, the design of cap 300 allows the intraluminal surfaces of an orifice to be disinfected. Because the lumen of orifice 100 can typically contain a fluid (for example, a saline solution or other solution that was infused into the patient), the antimicrobial solution can be mixed with the fluid to improve the distribution of antimicrobial agents throughout along the light or lumen 120.
When cap 300 is fully connected to hole 100, a seal can be formed between actuator 302 and seal 304 as shown in Figure 7C. The tight fit between the male luer driver 302 and the female luer hole 100 can also form a seal between these two connectors. Consequently, lumens 120 and 320 can be substantially sealed off from the outside environment, thereby limiting the amount of antimicrobial solution within lumen 120 that evaporates after cap 300 has been attached. The antimicrobial solution can therefore remain active until the cap is removed for attachment of another device. In this way, when another device is connected to the port, the antimicrobial solution that remains within lumen or lumen 120 can disinfect the tip of the device. Accordingly, cap 300 not only disinfects port 100 when not in use, but can also disinfect other devices that connect to port after cap 300 has been removed.
Figure 8 illustrates a cross-sectional view of an alternative embodiment in which a hole 100a does not include a shoulder against which the tip of actuator 302 presses. In these cases, the frictional force created when actuator 302 is inserted into lumen 120 may be sufficient to force actuator 302 upward into absorbent material 303. This frictional force may also be sufficient to form a seal between actuator 302 and port 100.
Figures 9A and 9B illustrate a cross-sectional view of another alternate embodiment in which the cap 300 is connected to a hole 200 that is configured as a needleless connector that includes a divided septum 230. As shown in Figure 9A, As the tip of actuator 302 makes initial contact with septum 230 and is forced through septum 230, actuator 302 is forced upward to initiate flow of the antimicrobial solution. Actuator 302 will pass through septum 230 and eventually contacts a shoulder within lumen 220 of hole 200 (or if hole 200 does not contain a shoulder, it may contact the tapered sides of the hole). As shown in Figure 9B, when fully connected, cap 300 is placed in a similar manner in hole 200 as cap 300 is placed in hole 100. Accordingly, the cap 300 can be used to disinfect the intraluminal surfaces of orifices of various designs and configurations.
Figure 10A illustrates a cross-sectional view of another embodiment of a cap 1000. Cap 1000, like cap 300, includes a body 1001, an actuator 1002, and an absorbent material 1003. However, actuator 1002 and the Bottom surface of the body 1001 has a different configuration to improve the flow of absorbent material to the outer surfaces of a hole.
Figure 10B illustrates a cut away cross-sectional view of cap 1000 in which actuator 1002 is shown removed from body 1001. As shown, actuator 1002 includes a central boss 1053 which forms lumen 1020. The actuator 1002 also includes teeth 1052 that extend from the bottom surface of the actuator 1002. The bottom of the body 1001 is configured to accommodate the actuator 1002. For example, body 1001 includes a lumen 1050 within which protrusion 1053 is contained and openings 1051 through which they extend in teeth 1052. Figures 11A11C illustrate how this configuration of cap 1000 improves antimicrobial solution flow. to the exterior surfaces of a hole while still delivering sufficient antimicrobial solution to the lumen or lumen of the hole.
Figure 11A illustrates cap 1000 on actuator 1002 connected to the upper surface of hole 1100. As shown, the design of actuator 1002 causes teeth 1052 to first contact hole 1100. Then, in Figure 11D, the upward force on teeth 1052 causes actuator 1002 to compress absorbent material 1003 resulting in antimicrobial solution flowing through lumen 1020 and around the exterior of actuator 1002 in the same manner as described with reference to Figure 7B.
However, due to the placement of the apertures 1051 near the edges of the hole 1100, the antimicrobial solution flowing through the apertures 1051 will flow more easily onto the outer surfaces of the hole 1100. Additionally, as with the cap 300, the Primary path of the antimicrobial solution flow is through lumen 1020 and into lumen 1120 of port 1100.
Figure 11C illustrates cap 1000 once fully connected to port 1100. As shown, in this position, port 1100 has forced actuator 1002 upward until it contacts seal 1004. At this point, the antimicrobial solution is will force it to flow through the 1020 light or lumen. However, the antimicrobial solution that flowed around the actuator 1002 and is contained within the internal spaces of the body 1001 will be allowed to flow out through the openings 1051 on the exterior surfaces of the orifice 1100.
Although Figure 11C shows that there is a gap between the boss 1053 and the internal surfaces of the lumen 1050 when the cap 1000 is fully connected, in some embodiments the dimensions of the boss 1053 and the lumen 1050 can be configured so that the boss 1053 forms a tight seal within lumen 1050 when actuator 1002 is in the upward position. The formation of a seal between the boss 1053 and the lumen 1050 may be desirable when a tight seal is not formed between the orifice 1100 and the body 1001.
The caps of the present invention also provide the advantage of minimizing the concentrations of antimicrobial solution that must be used to ensure that the orifice is properly disinfected. For example, as noted in the background, a problem that arises when antimicrobial coatings are used is that the coatings are too concentrated and therefore can present toxicity problems. In contrast, because the caps of the present invention are intended for one-time use and unfold when the orifice is not in use, concentrations of the antimicrobial solution can be minimized. In other words, you found the coatings that must remain active from the moment they are applied to the hole (for example when they are manufactured) until the hole will no longer be used, the caps of the present invention will only remain in the hole between the uses. Because the volume of fluid in the orifice is static and fixed, the concentration of the antimicrobial solution will not change when the cap is in place. Therefore, a reduced concentration of antimicrobial solution can be employed in the caps of the present invention as long as they still provide adequate antimicrobial protection. In some embodiments, the concentration of the antimicrobial solution (or the concentration once mixed with the fluid already present within the lumen or lumen of the orifice) can be only greater than the minimum inhibitory concentration of the antimicrobial agent in the solution.
Many different types of antimicrobial solutions can be used in the caps of the present invention. For example, any antimicrobial agent that is soluble in alcohol, saline or saline / heparin solution can be employed. The concentration of the antimicrobial agent within the antimicrobial solution can be selected so that the resulting concentration of the agent once the antimicrobial solution is mixed with the fluid in the orifice lumen is above the minimum inhibitory concentration of the antimicrobial agent. Suitable antimicrobial agents include CHA and CHG, among others.
In alternative embodiments, the actuator lumen can be coated with an antimicrobial coating. In these embodiments, the cap may or may not also include the absorbent material that contains the antimicrobial solution. For example, when the cap does not include the absorbent material, antimicrobial protection can be provided when fluid within the lumen of the orifice contacts the antimicrobial liner within the lumen of the actuator. The dry antimicrobial coating can be dissolved in the fluid to thereby disinfect the lumen or lumen of the orifice. The provision of an antimicrobial coating on the lumen or lumen of the actuator as opposed to on the lumen or lumen of the orifice may allow a lower concentration of antimicrobial agent to be used for the reasons described above.
When the cap includes the absorbent material and an antimicrobial coating, the flow of the antimicrobial solution from the absorbent material can be directed partially or completely around the exterior of the actuator to ensure distribution on the exterior surfaces of the orifice. Some of the antimicrobial solution can be designed to flow through the lumen in the actuator to help distribute the antimicrobial coating throughout the lumen or lumen of the orifice. In this way, an antimicrobial solution can still be directed to both the intraluminal and outer surfaces of the hole.
The present invention may be incorporated in other specific forms without departing from its essential spirit or characteristics. The modalities described are to be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the invention is indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalence of the claims are to be encompassed within their scope.
It is noted that in relation to this date, the best method known to the applicant to carry out the present invention is the one that is clear from the present description of the invention.
17 sheets
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35 members in 11 offices
Members35
| Document | Office | Kind | |
|---|---|---|---|
| US2015231384A1 | United States of America | A1 | |
| CA2938604A1 | Canada | A1 | |
| WO2015126701A1 | World Intellectual Property Organization (WIPO) | A1 | |
| CN204601380U | China | U | |
| US9283369B2 | United States of America | B2 | |
| US2016158520A1 | United States of America | A1 | |
| SG11201606244WA | Singapore | A | |
| AU2015219311A1 | Australia | A1 | |
| CN106029151A | China | A | |
| EP3107611A1 | European Patent Office (EPO) | A1 | |
| MX2016010233AThis record | Mexico | A | |
| JP2017506124A | Japan | A | |
| BR112016018935A2 | Brazil | A2 | |
| US9750929B2 | United States of America | B2 | |
| US2017368327A1 | United States of America | A1 | |
| US10124157B2 | United States of America | B2 | |
| US2019001115A1 | United States of America | A1 | |
| AU2015219311B2 | Australia | B2 | |
| CN106029151B | China | B | |
| AU2019210572A1 | Australia | A1 | |
| JP6574430B2 | Japan | B2 | |
| JP2019198689A | Japan | A | |
| EP3107611B1 | European Patent Office (EPO) | B1 | |
| EP3659662A1 | European Patent Office (EPO) | A1 | |
| AU2019210572B2 | Australia | B2 | |
| ES2780899T3 | Spain | T3 | |
| CA2938604C | Canada | C | |
| US11090477B2 | United States of America | B2 | |
| JP6924231B2 | Japan | B2 | |
| BR112016018935B1 | Brazil | B1 | |
| US2021338995A1 | United States of America | A1 | |
| US11752319B2 | United States of America | B2 | |
| US2023364407A1 | United States of America | A1 | |
| MX374890B | Mexico | B | |
| US12280232B2 | United States of America | B2 |
1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Grant or registrationFG | FG |
Numbers
- Publication
- 2016010233
- Application
- 10233
Titles2
- Spanish
- TAPA DE ORIFICIO DE ACCESO INTRAVENOSO (IV) PARA PROPORCIONAR PROTECCION ANTIMICROBIANA.
- English
- INTRAVENOUS ACCESS HOLE COVER (IV) TO PROVIDE ANTIMICROBIAL PROTECTION.
Classification
- CPC, 6
- A61M39/162
- A61M25/0017
- A61M2025/0056
- A61M39/20
- A61M39/0208
- A61M39/165
- IPC, 3
- A61M25 00
- A61M39 16
- A61M39 20