Patent Description:
In this specification, a ported catheter should be understood as a catheter that includes a port through which fluids may be infused into the lumen of the catheter and ultimately into the vasculature of a patient. An example of a ported catheter <NUM> is shown in <FIG>. Ported catheter <NUM> includes a port <NUM> which is typically configured as a female luer connector. Another device (e.g. a male luer connector) may be connected to port <NUM> to inject or withdraw a fluid within the lumen of the ported catheter <NUM>. <FIG> also illustrates an example of a ported catheter <NUM> that includes a port <NUM> configured as a needleless female luer connector.

In this specification, a female luer fitting should be understood as any component that can be attached to an infusion therapy device to form a port or ports of the device. <FIG> illustrates various examples of female luer fittings on an infusion therapy device <NUM>. These female luer fittings include fittings <NUM> and <NUM> formed in a Y-adapter and fitting <NUM> formed on a flow control device. <FIG> illustrates another example of an infusion therapy device <NUM> that includes a fitting <NUM> in the form of a port attached to a catheter via an extension tube. Other examples of fittings include stopcocks, adapters, connectors, valves, etc..

In the remainder of the specification, ported catheter and female luer fitting will be referred to generally as a port. Accordingly, the present invention extends to ports having an integrated elastomeric septum for providing an antimicrobial barrier.

In prior art devices such as those shown in <FIG>, the ports are typically configured as female luer connectors. To gain access to these ports, a male luer connector is inserted into the female luer connector. If the male luer connector contains any microbes on its surface, these microbes are likely to pass into the lumen of the female luer connector where they can be infused into the patient's vasculature. Once inside the patient's vasculature, these microbes can cause serious infections. Therefore, it is critical that the interface between ports and connected devices be maintained free of microbes.

Many techniques have been employed for disinfecting the surfaces of ports and connected devices to minimize the occurrence of microbial infections. These techniques include manually wiping the surfaces as well as using caps containing antimicrobial solution to disinfect the ports between uses. Such caps have also been designed to clean the surface of a device prior to connecting the device to the port. Although such techniques reduce the risk of microbes entering the lumen of the port, they are not satisfactory in many cases. For example, even after cleaning a surface of a device, the surface may become contaminated prior to connecting the device. Also, in some cases, the surface may not be cleaned at all or may not be cleaned adequately. In any case, once the device is connected, any microbes present on the device may easily migrate onto surfaces within the port or into fluid contained within the port. Once the microbes are within the port, it can be difficult to kill the microbes as they quickly may spread throughout the lumen of the infusion therapy device. <CIT> describes an intravascular device comprising a port having a lumen, the lumen including an annular recess; and an antimicrobial septum positioned within the annular recess, the antimicrobial septum containing an antimicrobial lubricant for providing antimicrobial protection to another device when the other device is inserted into the lumen and through the antimicrobial septum. <CIT> discloses an analogous intravascular device, wherein the external surfaces and/or the slit of septum are coated with an antimicrobial coating.

The present invention extends to ports that include an antimicrobial septum for disinfecting devices that are attached to the ports. The antimicrobial septum can be positioned within the lumen of the port. The lumen can include an annular recess for securing the antimicrobial septum in place during use. The antimicrobial septum can include an antimicrobial lubricant which transfers onto a device, such as a male luer, as the device passes through the septum thereby killing any microbes that may be present on the surfaces of the device.

The antimicrobial septum is configured in a ring shape. The inner surfaces of the antimicrobial septum contain grooves. The grooves can facilitate the compression of the septum as a device passes through it, while also increasing the surface area of the septum on which antimicrobial lubricant can be contained.

The present invention is implemented as an intravascular device that includes a port having a lumen and an antimicrobial septum that is positioned within an annular recess formed within the lumen. The antimicrobial septum contains an antimicrobial lubricant for providing antimicrobial protection to another device when the other device is inserted into the lumen and through the antimicrobial septum.

The antimicrobial septum comprises a ring and in some embodiments, the ring is an elongated ring.

In some embodiments, the elongated ring is positioned such that when the other device is connected to the port, the other device does not extend completely through the elongated ring.

The antimicrobial septum comprises a ring having a plurality of grooves that extend into an inner surface of the ring.

The antimicrobial lubricant is contained within the grooves.

In some embodiments, the intravascular device also includes a second septum positioned at an opening of the port. The second septum seals fluids within the lumen of the port.

In some embodiments, the port comprises a female luer.

In some embodiments, the other device comprises a male luer and the annular recess is positioned such that when the other device is connected to the port the male luer extends partially into the antimicrobial septum.

In some embodiments, the intravascular device is a ported catheter.

In some embodiments, the intravascular device is a female luer fitting.

In some embodiments, the antimicrobial septum comprises a ring having an internal channel. The internal channel has an opening that extends at least partially around the internal surface of the ring. The internal channel contains an antimicrobial agent that is released from the internal channel when the other device is inserted through the ring.

In another embodiment, the present invention is implemented as a ported catheter that includes: a catheter adapter; a port extending from the catheter adapter, the port having a lumen that includes an annular recess; and an antimicrobial septum positioned within the annular recess. The antimicrobial septum contains an antimicrobial lubricant that is transferred to a device when the device is connected to the port.

The antimicrobial septum comprises a ring.

In some embodiments, the ported catheter also includes a second septum for maintaining a fluid within the lumen of the port.

In another embodiment, the present invention is implemented as a female luer fitting that includes: a female luer connector having a lumen, the lumen having an annular recess; and an antimicrobial septum positioned within the annular recess. The antimicrobial septum contains an antimicrobial lubricant for disinfecting a male luer connector that extends through the antimicrobial septum.

The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

As used in this specification, an antimicrobial septum is any septum that can provide antimicrobial protection to a device inserted through the septum. In most of the described embodiments, this antimicrobial protection is provided in the form of an antimicrobial tube that is applied on the surface of a septum. In such cases, the material of which the septum is made need not provide any antimicrobial protection. In other embodiments, however, the septum may be made of a material that incorporates antimicrobial agents. For example, the material can be configured to elute an antimicrobial agent into a fluid contacting the septum. Accordingly, an antimicrobial septum can be construed as any septum that can be used to distribute an antimicrobial agent.

<FIG> (not according to the invention) illustrate a first example of a port <NUM> comprising a body <NUM> forming a lumen <NUM>. The inner surface of the lumen is configured with an annular recess 501a within which an antimicrobial septum <NUM> may be contained. In some embodiments, annular recess 501a can conform sufficiently to the width and thickness of antimicrobial septum <NUM> so that no adhesive is required to hold antimicrobial septum <NUM> within the recess. However, antimicrobial septum <NUM> may be secured within annular recess 501a using an appropriate adhesive. As shown in <FIG>, annular recess 501a can be shaped to contain a septum <NUM> having flared edges 510a. The use of flared edges 510a (which may be formed on the top and/or bottom of septum <NUM>) can assist in maintaining septum <NUM> within annular recess 501a. In any case, antimicrobial septum <NUM> is configured to remain within annular recess 501a even when a device (e.g. a male luer connector) is inserted and withdrawn through the septum.

In this first embodiment (not according to the invention), antimicrobial septum <NUM> is configured as a continuous disk that includes slits 510a to allow a device to be inserted through the septum. <FIG> provides a top view of port <NUM> to illustrate the continuous disk shape of antimicrobial septum <NUM>. As shown, antimicrobial septum <NUM> extends fully across lumen <NUM>. Although slits 510a are shown as forming an X shape, other arrangements of slits 510a can also be used. Antimicrobial septum <NUM> can be made of an elastomeric material to allow the septum to deform and compress when a device is inserted through the septum.

<FIG> illustrates how antimicrobial septum <NUM> can contain an antimicrobial lubricant <NUM>. As shown, antimicrobial lubricant <NUM> can be applied to antimicrobial septum <NUM> including on a top surface, a bottom surface, and within slits 510a. However, in some embodiments, antimicrobial lubricant <NUM> may be applied to fewer surfaces of antimicrobial septum <NUM> than is shown. In some embodiments, antimicrobial lubricant <NUM> may contain an antimicrobial agent that remains active for extended periods of time so that antimicrobial lubricant <NUM> can be applied to antimicrobial septum <NUM> at the time of manufacture. In other embodiments, antimicrobial lubricant <NUM> can be applied to antimicrobial septum <NUM> at a later time such as prior to port <NUM> being used or between uses of port <NUM>.

<FIG> illustrates port <NUM> when a device <NUM> has been connected to the port. Typically, device <NUM> will be configured as a male luer connector that extends into lumen <NUM> and through antimicrobial septum <NUM>. As device <NUM> passes through antimicrobial septum <NUM>, antimicrobial lubricant <NUM> will be transferred onto the surfaces of the device thereby killing any microbes that may be present on the surfaces. These surfaces can include the exterior surfaces of the device as well as surfaces within a lumen of the device. For example, because antimicrobial lubricant <NUM> can be present on the top surface and within slits 510a of antimicrobial septum <NUM>, the antimicrobial lubricant can pass into the lumen of device <NUM> as it is pressed through the septum. In this way, antimicrobial lubricant <NUM> can be distributed over a substantial amount of the device's surface to minimize the potential that microbes present on the device will pass through antimicrobial septum <NUM> without being killed.

Accordingly, antimicrobial septum <NUM> provides a barrier to microbes that may be present on the surface of a device that is connected to port <NUM>. Current infusion therapy devices often employ a port that includes a septum. However, such septa are designed to provide a fluid-tight seal to prevent fluid within the port from exiting the port when the port is not being used. For this reason, such septa (hereinafter referred to as split septa) are typically placed at or overtop the opening of the port as opposed to within the lumen of the port.

In some embodiments of the invention, an antimicrobial septum can be configured to provide a fluid-tight seal to prevent fluid within the lumen from passing through the septum. Antimicrobial septa configured in this manner may be desirable when no other means for sealing the flow of fluid is provided.

The present disclosure can also extend to ports that employ a split septum to form a fluid-tight seal. For example, <FIG> (not according to the invention) illustrates a cross-sectional view of a port <NUM> that includes a split septum <NUM> in addition to an antimicrobial septum <NUM>. As described above, antimicrobial lubricant <NUM> can be applied to antimicrobial septum <NUM>. Accordingly, when a device is connected to port <NUM>, any microbes on the device, including microbes that may have passed from split septum <NUM> to the device, can be killed as the device passes through antimicrobial septum <NUM>.

Another advantage provided by employing antimicrobial septum <NUM> in a port that also includes a split septum <NUM> is that fluid retained within port <NUM> by split septum <NUM> will be exposed to antimicrobial lubricant <NUM>. This fluid can distribute antimicrobial lubricant <NUM> throughout lumen <NUM> including above and below antimicrobial septum <NUM>. Accordingly, in some embodiments, antimicrobial septum <NUM> does not form a fluid-tight seal thereby allowing fluid within lumen <NUM> to pass from one side of the antimicrobial septum to another. One benefit of providing a non-fluid-tight antimicrobial septum is that slits 510a can be relatively large thereby forming a gap in which antimicrobial lubricant <NUM> may be contained. With more antimicrobial lubricant <NUM> within slits 510a, a greater amount of antimicrobial protection can be provided.

<FIG> (not according to the invention) illustrate a second embodiment of a port <NUM> that includes an antimicrobial septum <NUM> in accordance with one or more implementations of the disclosure. As shown, port <NUM> comprises a body <NUM> forming a lumen <NUM>. The inner surface of the lumen is configured with an annular recess 701a within which an antimicrobial septum <NUM> may be contained, as described above.

Antimicrobial septum <NUM> is configured as a ring that includes slits 710a that extend into and along the inner surface of the ring. <FIG> provides a top view of port <NUM> to illustrate the ring shape of antimicrobial septum <NUM>. As shown, antimicrobial septum <NUM> extends partially into lumen <NUM> leaving a channel through which a device can be inserted. In some aspects, the inner diameter of antimicrobial septum <NUM> can be less than the outer diameter of a device that will be inserted through the septum. In such aspects, slits 710a facilitate the compression of antimicrobial septum <NUM> as the septum conforms to the advancing device. Slits 710a can also enable antimicrobial septum <NUM> to contain more antimicrobial lubricant <NUM>. In other words, slits 710a increase the surface area of antimicrobial septum <NUM> on which antimicrobial lubricant <NUM> can be present.

<FIG> illustrates how antimicrobial septum <NUM> can contain an antimicrobial lubricant <NUM> in accordance with one or more aspects of the disclosure. As shown, antimicrobial lubricant <NUM> can be applied to antimicrobial septum <NUM> including on a top surface, a bottom surface, an inner surface of the ring shape, and within slits 710a. However, in some aspects, antimicrobial lubricant <NUM> may be applied to fewer surfaces of antimicrobial septum <NUM> than is shown.

<FIG> illustrates port <NUM> when a device <NUM> has been connected to the port. As device <NUM> passes through antimicrobial septum <NUM>, antimicrobial lubricant <NUM> will be transferred onto the surfaces of the device thereby killing any microbes that may be present on the surfaces as was described above. As device <NUM> compresses antimicrobial septum <NUM>, the inner surfaces of slits 710a can become exposed allowing the antimicrobial lubricant that is present on these inner surfaces to pass onto the device.

<FIG> illustrates a port <NUM> in accordance with the claimed invention. Port <NUM> can be similar to port <NUM> except that port <NUM> includes an antimicrobial septum <NUM> that is configured with grooves 810a as opposed to slits. Grooves 810a may be preferred over slits 710a because the grooves provide additional surface area on which antimicrobial lubricant <NUM> may be contained. Also, grooves 810a can be appropriately sized to cause antimicrobial lubricant <NUM> to fill the grooves. In other words, the distance between opposing walls of a groove can be configured so that the attractive force between the antimicrobial lubricant and the surfaces of the walls is less than the force of gravity on the lubricant. In this way, antimicrobial lubricant <NUM> will not flow out of grooves 810a before a device is inserted through antimicrobial septum <NUM>.

<FIG> illustrates a port <NUM> that is similar to port <NUM> in that port <NUM> includes a split septum <NUM> as well as antimicrobial septum <NUM>. Alternatively, port <NUM> could include antimicrobial septum <NUM> in place of antimicrobial septum <NUM>. As described above, split septum <NUM> can form a fluid-tight seal to retain fluid within the lumen of port <NUM>. Antimicrobial lubricant <NUM> can be configured to be relatively insolvent in the fluid so that it remains on antimicrobial septum <NUM> even when fluid is present within the lumen. However, antimicrobial lubricant <NUM> can also be configured to transfer some antimicrobial agents to the fluid to provide antimicrobial protection throughout the lumen of port <NUM>.

Suitable lubricants that can be used as antimicrobial lubricant <NUM> include medical grade silicone lubricants that include chlorhexidine diacetate or chlorhexidine gluconate. However, any other suitable lubricant could also be used, and therefore the present invention should not be limited to any specific lubricant.

<FIG> illustrate a port <NUM> that includes an antimicrobial septum <NUM> in accordance with one or more implementations of the invention. Port <NUM> is similar to port <NUM> except that antimicrobial septum <NUM> is elongated to form an elongated ring or tube shape. Antimicrobial septum <NUM> therefore forms a disinfecting channel within lumen <NUM>. Antimicrobial septum <NUM> is shown as included slits 1010a; however, antimicrobial septum <NUM> could also be configured with grooves similar to grooves 810a in place of slits 1010a.

Antimicrobial septum <NUM> functions in a similar manner as antimicrobial septum <NUM>. For example, as shown in <FIG>, when a device <NUM> is connected to port <NUM>, the device extends through antimicrobial septum <NUM> contacting antimicrobial lubricant <NUM> contained thereon. Because antimicrobial septum <NUM> is elongated, it may provide a greater amount of antimicrobial protection against a device. In other words, the elongated shape of antimicrobial septum <NUM> provides a greater amount of surface area on which antimicrobial lubricant <NUM> may be contained. This surface area can be increased by employing slits 1010a or grooves, as described above. A port with an elongated antimicrobial septum may also incorporate a split septum similar to ports <NUM> and <NUM> described above.

In some embodiments, the length and position of antimicrobial septum <NUM> can be configured so that a device extends fully through antimicrobial septum <NUM> when connected to port <NUM> as is shown in <FIG>. However, in other embodiments, the length and position of antimicrobial septum <NUM> can be configured so that the device does not fully extend through the septum as is shown in <FIG>. One benefit of configuring antimicrobial septum <NUM> in this manner is that fluid injected from the device will have to pass through a portion of the channel formed by antimicrobial septum <NUM>. As the fluid passes through this channel, the fluid may contact the antimicrobial lubricant on the exposed portion of antimicrobial septum <NUM> thereby providing antimicrobial protection to the fluid as it passes into lumen <NUM>.

<FIG> illustrate a port <NUM> that includes an antimicrobial septum <NUM> in accordance with one or more implementations of the invention. As shown in <FIG> and <FIG>, septum <NUM> includes an internal channel 1110a within which an antimicrobial agent 1110b is contained. The opening of internal channel 1110a extends around the inside diameter of the ring shape of septum <NUM>. The inside diameter of septum <NUM> can be configured so that the septum is compressed when a connector is inserted into port <NUM>. In this way, as septum <NUM> is compressed, antimicrobial agent 1110b will be released out from internal channel 1110a and onto the surface of the connector as is shown in <FIG>.

In some embodiments, septum <NUM> can include inward and/or outward protrusions 1110c at the opening of internal channel 1110a. <FIG> illustrates an example where septum <NUM> includes inward and outward protrusions 1110c. Protrusions 1110c can assist in the compression of septum <NUM> to enhance the amount of antimicrobial agent that is released when septum <NUM> is compressed. For example, outward protrusions can increase the amount of compression the septum experiences when a connector is inserted through the septum.

Claim 1:
An intravascular device comprising:
a port (<NUM>) having a lumen (<NUM>), the lumen including an annular recess (801a);
an antimicrobial septum (<NUM>) positioned within the annular recess (801a),
characterised in that the antimicrobial septum comprises a ring having a plurality of grooves (810a) that extend into an inner surface of the ring; and
wherein an antimicrobial lubricant (<NUM>) is contained within said grooves and is configured to provide antimicrobial protection to another device when the other device is inserted into the lumen (<NUM>) and through the antimicrobial septum (<NUM>).