Patent Description:
Modern medical treatment often requires medical professionals to introduce fluids into a patient or withdraw fluids from a patient. For example, a patient may need treatment that requires a medical professional to withdraw urine or blood from the urethra or a vein, respectively. Conversely, the medical professional may need to introduce drugs or nutrients into the patient's vein (i.e., intravenously). To create a path for the flow of fluid into or from the patient, some methods involve use of a catheter where one end of the catheter is inserted into the patient. The other end of the catheter connects to a fluid reservoir, such as an intravenous (IV) bag or drainage bag connected through an IV line or other tubing. A needleless access connector may be coupled between the catheter and fluid reservoir to allow a medical practitioner to remove or add devices (e.g., IV bags) to the catheter without the use of a needle. However, fluid transfer devices can present a risk of infection a patient as the prolonged exposure leads to growth of bacteria or other microorganisms that can be transferred to the patient. <CIT> relates to sterile medical injection catheter ports utilizing a new antimicrobial polymer mixture filled injection port barrier cover. This barrier cover, when screwed onto the injection port, protects the injection port from the colonization of microbes from the inadvertent contamination of the port with contaminated surfaces, including skin and other potential contaminants. <CIT> relates generally to medical connectors of the type used in the handling and administration of parenteral fluids, and more particularly, to a needle-free connector employing a valve mechanism that compensates for negative fluid displacement, i.e., drawing fluid into the connector, as the connector returns to its unaccessed state from an accessed state. <CIT> relates to photocatalytic and superhydrophilic implantable device surfaces that are responsive to electromagnetic stimulation and uses thereof. <CIT> relates to an antiseptic cap and packaging for use with a connector are provided. The antiseptic cap includes a material containing an antiseptic solution. Upon application of the cap to the connector, the material compresses thereby releasing the antiseptic solution. Packaging of the antiseptic cap typically includes a cap holder and a lid. A user could remove the cap from the cap holder before applying it to a connector. Alternatively, the cap holder may be used to apply the cap to the connector.

The disclosed subject matter relates to antimicrobial medical devices. In certain embodiments, an antimicrobial medical device is disclosed that comprises a fluid transfer device configured to couple between a patient and a fluid reservoir; a fluid pathway extending through the fluid transfer device; at least one first electrode coupled to the fluid transfer device, the at least one first electrode comprising a first conductive material; and at least one second electrode coupled to the fluid transfer device and spaced apart from the at least one first electrode, the at least one second electrode comprising a second conductive material different from the first conductive material and being configured to form at least one galvanic cell with the at least one first electrode.

In certain embodiments, an antimicrobial needleless connector is disclosed that comprises a housing having an internal cavity and configured to couple between a patient and a fluid reservoir; a fluid pathway extending through the housing; a valve disposed within the internal cavity and configured to open and close the fluid pathway; at least one first electrode coupled the housing, the valve, or a combination thereof, the at least one first electrode comprising a first conductive material; and at least one second electrode coupled to the housing, the valve, or a combination thereof, the at least one second electrode being spaced apart from the at least one first electrode, the at least one second electrode comprising a second conductive material different from the first conductive material and being configured to form at least one galvanic cell with the at least one first electrode.

In certain embodiments, an antimicrobial catheter is disclosed that comprises a tubular member configured to couple between a patient and a fluid reservoir; a lumen extending through the tubular member and providing a fluid pathway to transfer fluid; at least one first electrode disposed around the fluid pathway, the at least one first electrode comprising a first conductive material; and at least one second electrode disposed around the fluid pathway and spaced apart from the at least one first electrode, the at least one second electrode comprising a second conductive material different from the first conductive material and being configured to form at least one galvanic cell with the at least one first electrode.

In one or more implementations, not all of the depicted components in each figure may be required, and one or more implementations may include additional components not shown in a figure. Variations in the arrangement and type of the components may be made without departing from the scope of the subject disclosure. Additional components, different components, or fewer components may be utilized within the scope of the subject disclosure.

The detailed description set forth below is intended as a description of various implementations and is not intended to represent the only implementations in which the subject technology may be practiced. As those skilled in the art would realize, the described implementations may be modified in various different ways, all without departing from the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

Antimicrobial medical devices and treatment methods, and more particularly, an electroceutical needless connector, catheter, or other electroceutical fluid transfer device may employ electrodes capable of forming a galvanic cell to combat the growth of bacteria. A galvanic cell (also referred to as a "voltaic" cell) is a type of electrochemical cell that can generate current from spontaneous reduction-oxidation reactions (also referred to as "redox") occurring within the cell. A galvanic cell includes two different electrodes spaced apart from one another and connected or connectable by an electrolytic or electrically conducting solution. For example, a galvanic cell may have two complementary electrodes made of zinc (Zn) and silver (Ag), respectively, that cause redox reactions when contacted and connected with an electrolytic solution. In this example, the Zn electrode provides the anode where oxidation occurs and the Ag electrode provides the cathode where the reduction reaction occurs. A variety of other conductive materials or metals may be suitable for the electrodes, provided that they are dissimilar and capable of forming a galvanic electric field. These electrodes may be implemented as dots, bands, or larger areas in close proximity on fluid transfer devices to create a galvanic electric field in the presence of body tissue or fluid.

An example of an antimicrobial fluid transfer device implemented as a needleless access connector employing a valve is shown in <FIG>. <FIG> is a three-dimensional view showing components of a needless access connector <NUM> in unassembled form. <FIG> are cut-away views of the assembled needless access connector <NUM> showing closed and open states, respectively.

Needleless access connector <NUM> includes housing <NUM>, which has a female luer fitting <NUM> at its proximal end (on a top portion <NUM> of the housing) and a male luer fitting <NUM> at its distal end (on a base portion <NUM> of the housing). Although male and female luer fittings are shown, it will be appreciated that other types of connection interfaces may be employed without departing from principles described herein. Needless access connector <NUM> also includes a valve <NUM>, which sits inside housing <NUM> and on top of base portion <NUM>. Housing <NUM>, including top portion <NUM> and base portion <NUM>, can be made of rigid material, such as polycarbonate or another rigid plastic, and the valve <NUM> can be made from an elastic material, such as liquid silicone, so that it is collapsible within the housing <NUM>. Additionally or alternatively, housing <NUM> and/or valve <NUM> may be made from, include, or otherwise be physically coupled to conductive materials that form electrodes capable of generating a galvanic electric field.

When in use, male luer fitting <NUM> is connected to, e.g., a catheter or to a female luer, and female luer fitting <NUM> is connected to a fluid reservoir, e.g., an IV bag or male luer. Female luer fitting <NUM> is connected to the fluid reservoir via a second male luer fitting <NUM>, which has a hollow member (as shown in <FIG>) and is inserted through the top of female luer fitting <NUM>. The insertion of male luer <NUM> collapses valve <NUM> down into internal cavity <NUM> to break the seal and open a fluid flow path <NUM>. <FIG> shows collapsible valve <NUM> in the collapsed position after insertion of male luer <NUM> into female luer <NUM>. Male luer <NUM> delivers fluid, e.g., from an IV bag, which flows through the internal cavity <NUM>, around valve element <NUM>, into channels in male luer fitting <NUM>, and into the catheter or female luer.

Another example of a needleless access connector employing a valve is shown in <FIG> are cut-away views of the assembled needleless access connector <NUM> showing closed and open states, respectively.

The needleless access connector <NUM> is implemented as a split septum type of connector in which valve <NUM> is opened by piercing the proximal end of the connector with a blunt cannula <NUM>. Needleless access connector <NUM> includes housing <NUM>, which has a male luer fitting <NUM> at its distal end (on a base portion <NUM> of the housing). Needleless access connector <NUM> also includes a valve <NUM>, which sits inside housing <NUM> and on top of base portion <NUM>. Housing <NUM>, including top portion <NUM> and base portion <NUM>, can be made of rigid material, such as polycarbonate or another rigid plastic, and the valve <NUM> can be made from an elastic material, such as liquid silicone, so that it can separate within the housing <NUM> when opened and return to its original position to form a seal when closed. Additionally or alternatively, housing <NUM> and/or valve <NUM> may be made from, include, or otherwise be physically coupled to conductive materials that form electrodes capable of generating a galvanic electric field.

When in use, male luer fitting <NUM> is connected to, e.g., a catheter or to a female luer, and the proximal end is connected to a fluid reservoir, e.g., an IV bag or male luer. The insertion of blunt cannula <NUM> separates the valve <NUM> down into internal cavity <NUM> to break the seal and open a fluid flow path <NUM>, which extends substantially straight through the housing <NUM> from the proximal end to the distal end. <FIG> shows split septum valve <NUM> in the separated and opened position after insertion of blunt cannula <NUM>. Cannula <NUM> delivers fluid, e.g., from an IV bag, which flows through valve <NUM> and into the catheter or female luer.

The fluid passing through the fluid flow path <NUM> or fluid flow path <NUM> may be an electrolytic solution, such as saline, that forms a galvanic cell with electrodes coupled to the fluid flow path to activate an electric field. For example, with reference to <FIG>, dissimilar electrodes made from dissimilar conductive materials may be coupled to the valve <NUM> (e.g., disposed on an exterior surface thereof), coupled to the housing <NUM> (e.g., disposed on an interior surface thereof), or coupled to both the valve <NUM> and the housing <NUM> in a manner that permits contact with the fluid flow path <NUM>. In some implementations, the housing <NUM> may be at least partially made from, include, or be otherwise coupled to one or more electrodes of a first type (e.g., Ag), and the valve <NUM> may be at least partially made from, include, or be otherwise coupled to one or more electrodes of a second type (e.g., Zn). An electrolytic solution (e.g., saline) flowing through the housing <NUM> or otherwise contacting the electrodes may activate an electric field to combat biofilm buildup. As another example, with reference to <FIG>, dissimilar electrodes made from dissimilar conductive materials may be coupled to the valve <NUM> (e.g., disposed on a surface between the split portion), coupled to the housing <NUM> (e.g., disposed on an interior surface thereof), or coupled to both the valve <NUM> and the housing <NUM> in a manner that permits contact with the fluid flow path <NUM>.

Examples of valves employing spaced apart electrodes are shown in <FIG>. An example of a catheter employing spaced apart electrodes is shown in <FIG>. These examples illustrate some exemplary structural arrangements for galvanic electrodes in a fluid transfer device, but it will be appreciated that various other structural arrangements for electrodes in a needless connector, catheter, or other fluid transfer device are possible without departing from principles described herein.

<FIG> is a three-dimensional view of a valve <NUM>, which may be included in a needless connector within an interior cavity of a connector housing. The valve <NUM> includes a plurality of annular electrodes <NUM>, <NUM>, which are disposed around the valve on an exterior surface thereof. The electrodes include a plurality of electrodes <NUM> of a first type of conductive material (e.g., Ag) and an electrode <NUM> of a second type of material (e.g., Zn) interposed between the electrodes <NUM>. The electrode <NUM> is also shown with a thinner structure than the electrodes <NUM>. Although only three electrodes are shown, more electrodes may be included. For example, four, five, six, eight, ten, twenty, fifty, or more electrodes may be configured with a repeating or alternating pattern (e.g., cathode, anode, cathode, anode, and so forth). Although the electrodes <NUM>, <NUM> are shown positioned on a surface of the valve <NUM>, it is possible for either one or both types of annular electrodes <NUM>, <NUM> to be disposed around the valve <NUM> by positioning them on an interior surface of the housing, for example. Each electrode may be disposed on a non-conductive surface and generally spaced apart from the other electrodes to avoid ohmic contact with each other when in an inactive state.

<FIG> is a three-dimensional view of a valve <NUM> that may be included in a needless connector within an interior cavity of a connector housing. The valve <NUM> includes a plurality of electrodes islands <NUM>, <NUM> (or "dots") disposed on a proximal tip of the valve <NUM> corresponding to a fluid entry end of the needless connector. Multiple electrode islands <NUM> of a first type of conductive material (e.g., Ag) are arranged in a two dimensional matrix interposed with multiple electrode islands <NUM> of a second type of conductive material (e.g., Zn). The multiple electrode islands <NUM> of the second type are also each shown as being generally smaller than the first type of electrode islands <NUM>. Employing multiple electrodes of one or both types of electrode in a matrix or repeating pattern, such as the examples shown in <FIG>, allows for the creation of multiple galvanic cells in accordance with multiple pairings of dissimilar electrodes.

An example of a catheter employing galvanic electrodes is depicted in <FIG> is a three-dimensional view of a catheter <NUM> designed to be inserted into a cavity of a patient's body and left in the patient for an extended period of time. The catheter <NUM> includes a tubular member having a lumen <NUM> extending therethrough to provide a fluidic pathway for transferring fluid between a patient and a fluid reservoir to or from the patient. The catheter <NUM> further includes annular electrodes <NUM> having a first conductive material and annular electrodes <NUM> having a second conductive material different from the first conductive material and interposed between the first electrodes <NUM> in an alternating pattern. The second type of electrodes <NUM> are also shown as thinner and smaller than the first type of electrodes <NUM>. The components of the catheter <NUM> shown in <FIG> may be configured to remain in a patient for a prolonged period of time, and the electrodes <NUM>, <NUM> may activate a galvanic electric field or current in response to contact with body fluid or tissue of the patient.

According to some embodiments, an indicator may be provided on a fluid transfer device to provide a mechanism for indicating a charge remaining in a galvanic cell. This may be useful to, for example, indicate a lifetime remaining for antimicrobial functions of the device and inform a decision of a medical practitioner (e.g., a nurse or a doctor) to change or replace the device.

An example of an indicator coupled to a needless connector is shown in <FIG> is a cut-away view of needless access connector <NUM> including a housing <NUM> and a valve <NUM> disposed within an interior cavity of the housing <NUM>. The needless access connector <NUM> may, for example, share features in common with any of the above described needless access connectors. Additionally or alternatively, the needless access connector <NUM> can include an indicator <NUM> operatively coupled to electrodes <NUM> disposed on the housing <NUM> and/or valve <NUM>. The indicator <NUM> includes a first contact <NUM> operatively coupled to at least one electrode of a first type, and a second contact <NUM> operatively coupled to at least one electrode of a second type. A thermochromic material (e.g., ink or dye) is coupled between the first contact <NUM> and second contact <NUM> and visible from an exterior of the housing <NUM>.

A compressible insulating material and/or space may separate the first contact <NUM> from the first electrode(s) and the second contact <NUM> from the second electrode(s) when in a neutral or uncompressed state. When a user (e.g., a medical practitioner) presses against the first contact <NUM> and the second contact <NUM>, this causes the first contact <NUM> and the second contact <NUM> to contact the first and second electrodes, respectively, and complete a circuit that causes current to through the thermochromic material. The thermochromic material is temperature sensitive and provides a varying visual appearance (e.g., changed color) in relation to its temperature. A resistance in or coupled to the thermochromic material may also cause increased heat generation or temperature in relation to increased current. As a result, the appearance of the thermochromic material provides a visual indication of the amount of current flowing through it, and thus, the amount of charge remaining in the galvanic cell(s). Additionally or alternatively, other components that produce a perceptible visual change in response to changes in current, voltage, and/or heat can be used in the indicator circuit, such as thermoluminescent and/or electroluminescent materials.

A phrase "at least one of" preceding a series of items, with the terms "and" or "or" to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase "at least one of does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.

It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary approaches. Unless explicitly stated otherwise, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in different order. Some of the steps, operations, or processes may be performed simultaneously.

The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented. These may be performed in serial, linearly, in parallel or in different order.

Terms such as top, bottom, front, rear, side, horizontal, vertical, and the like refer to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, such a term may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

The disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.

All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later come to be known to those of ordinary skill in the art are intended to be encompassed by the claims. §<NUM>(f) or §<NUM>, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for".

The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and the various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation.

Claim 1:
An antimicrobial medical device (<NUM>, <NUM>) comprising:
a fluid transfer device configured to couple between a patient and a fluid reservoir, the fluid transfer device comprising: a housing (<NUM>, <NUM>) having an internal cavity (<NUM>, <NUM>); and a valve (<NUM>) disposed within the internal cavity (<NUM>, <NUM>);
a fluid pathway extending through the fluid transfer device, wherein the fluid pathway extends through the housing (<NUM>, <NUM>); and characterized by:
a plurality of first annular electrodes (<NUM>) coupled to the fluid pathway and disposed around the valve (<NUM>) , the plurality of first annular electrodes (<NUM>) comprising a first conductive material; and
a second annular electrode (<NUM>) coupled to the fluid pathway and interposed between the plurality of first annular electrodes (<NUM>), the second annular electrode (<NUM>) comprising a second conductive material different from the first conductive material and being configured to form at least one galvanic cell with the plurality of first annular electrodes (<NUM>).