Patent Description:
A formidable challenge of modern medical treatment is control of infection in the spread of pathogenic organisms. One area where this challenge is constantly presented is in infusion therapy of various types. Infusion therapy is one of the most common healthcare procedures. Hospitalized, home care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the vascular system of the patient. Infusion therapy may be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, treat cancerous growths, maintain blood pressure and heart rhythm, or many other clinically significant uses.

Infusion therapy is facilitated by a vascular access device. The vascular access device may access the patient's peripheral or central vasculature. The vascular access device may be indwelling for short-term (days), moderate term (weeks), or long-term (months to years). The vascular access device may be used for continuous infusion therapy or for intermittent therapy.

A common vascular access device comprises a plastic catheter inserted into a patient's vein. The catheter length may vary from a few centimeters for peripheral access, to many centimeters for central access and may include devices such as peripherally inserted central catheters (PICC). The catheter may be inserted transcutaneously or may be surgically implanted beneath the patient's skin. The catheter, or any other vascular access device attached thereto, may have a single lumen or multiple lumens for infusion of many fluids simultaneously.

A vascular access device may serve as a nidus, resulting in a disseminated BSI (blood stream infection). This may be caused by failure to regularly flush the device, a non-sterile insertion technique, or by pathogens that enter the fluid flow path through either end of the path subsequent to catheter insertion. When a vascular access device is contaminated, pathogens adhere to the vascular access device, colonize, and form a biofilm. The biofilm is resistant to most biocidal agents and provides a replenishing source of pathogens to enter a patient's bloodstream and cause a BSI.

One approach to preventing biofilm formation and patient infection is to provide an anti-pathogenic coating on various medical devices and components. However, some medical devices and components comprise materials or features which are incompatible with anti-pathogenic coatings. Thus, although methods exist for providing an anti-pathogenic coating on various medical devices and components, challenges still exist. Accordingly, it would be an improvement in the art to augment or even replace current techniques with other techniques. Such techniques are disclosed herein. <CIT> discloses a bloodless catheter assembly which prevents the backflow of fluid therethrough by utilization of a self-closing valve. <CIT> discloses a two-stage, sterilizable connector for use in processing blood, assuring sterility when entering a blood bag to add agents required in processing blood. <CIT> discloses an intravenous catheter assembly including a valve located in the catheter hub and made of needle-penetrable self-sealing material. <CIT> discloses a flushable catheter assembly having a septum and including a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter.

The subject matter of the invention is defined by independent claim <NUM>.

In order to overcome the limitations discussed above, the present invention relates to a catheter assembly in accordance with claim <NUM> for selectively coating surfaces of medical devices that contact blood or other fluids as part of an infusion therapy.

The present invention includes a medical device having a fluid pathway. A septum is slidably housed within the fluid pathway. A septum actuator is disposed in a fixed position within the fluid pathway. In operation, the septum can be advanced toward the septum actuator, which can pierce the septum, opening the septum and permitting fluid flow therethrough. In some examples, both the septum actuator and the septum have at least one surface exposed to the fluid pathway. An anti-pathogenic material can be applied to these surfaces.

In some instances, the septum has a tubular shape. The septum has a barrier member. The septum thus forms a proximal cavity. The barrier member can have a slit extending between a distal and proximal side of the barrier member. The barrier member divides the septum into the proximal cavity and a distal cavity, and a portion of the septum actuator is disposed within the distal cavity.

According to the invention, an anti-pathogenic material including a lubricant agent is applied to the probe portion of the septum actuator to reduce friction between the septum actuator and the septum during activation of the device.

Certain aspects of the present invention further include a color code system, whereby the identity of the anti-pathogenic material is identified based upon the color of the medical device.

In other aspects of the present invention, a ventilation channel can be interposed between the septum and an inner surface of the infusion therapy device. The anti-pathogenic material can be applied to a surface of the ventilation channel. The anti-pathogenic material applied to the surface of the ventilation channel can have a thickness less than that which would occlude the ventilation channel to permit venting through the ventilation channel.

Some aspects of the present invention include a medical device having a compatible surface that includes at least one mechanical bond to facilitate binding between the surface and an anti-pathogenic material. Other aspects of the invention include providing a chemical bond between a compatible surface of a medical device and an anti-pathogenic material by surface cross-linking.

In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. These drawings depict only typical embodiments of the invention and are not therefore to be considered to limit the scope of the invention.

The presently preferred embodiment of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

The term "proximal" is used to denote a portion of a device which, during normal use, is nearest the user and furthest from the patient. The term "distal" is used to denote a portion of a device which, during normal use, is farthest away from the user wielding the device and closest to the patient. The term "activation" of valve mechanism or septum is used to denote the action of opening or closing of such valve. For example, in some embodiments a catheter assembly is provided having a septum and a septum actuator, wherein the catheter assembly undergoes activation when the septum actuator is advanced through the septum, thereby providing a fluid pathway through the septum.

The term "critical dimension" is used to denote at least one of a height, a length, a width, a depth, a diameter, a thickness, an angle, a texture, or other structural feature of a surface of a medical device which is critical to the operation of the device. For example, in some embodiments a medical device may include a surface that is configured to interface with another device or component. As such, the surface may include a critical dimension that is configured to accommodate optimal interaction between the surface of the medical device and the interfacing device or component. Thus, in some embodiments a surface having a critical dimension must remain unmodified to preserve the intended and/or desired interaction of the surface in operating or using the medical device. Conversely, the term "noncritical dimension" is used to denote at least one of a height, a length, a width, a depth, a diameter, a thickness, an angle, a texture, or other structural feature of a medical device with is not critical to the operation of the device.

The terms "chemical bond" or "chemical bonding" are used to denote an attraction between atoms that allows an anti-pathogenic material to be applied to a desired surface of a medical device. For example, in some instances an anti-pathogenic material of the present invention is applied to the surface of an infusion therapy medical device via chemical bonding, wherein atoms of the anti-pathogenic material and atoms of the medical device are chemically attracted to one another. Chemical bonding may include any type of atomic bond, such as a covalent bond, an ionic bond, dipole-dipole interactions, London dispersion force, Van der Waals force, and hydrogen bonding. A chemical bond may further be denoted by the terms "cross-linking" or "surface cross-linking" for some embodiments.

The terms "mechanical bond" or "mechanical bonding" are used to denote a physical, non-chemical interaction between two or more materials. For example, in some instances a surface of a medical device is altered to include a texture, a groove, and/or a ridge having a void which holds an anti-pathogenic material via capillary force. In other embodiments, a mechanical bond comprises a structural feature which provides increased surface area to a surface of a medical device. Further, in some embodiments, a mechanical bond comprises a hydrophilic or hydrophobic material or coating that is applied to a surface of a medical device to attract an anti-pathogenic material. A mechanical bond may further be denoted by the term "mechanical interlock" for some embodiments.

The term "compatible surface" is used to denote a surface of a medical device which includes a noncritical dimension, or a surface which includes a critical dimension that will not be adversely affected by the addition of an anti-pathogenic material or coating.

The terms "rigid" or "semirigid" are used to denote a physical property of an anti-pathogenic material, wherein the material is deficient in, or devoid, or mostly devoid of flexibility. Alternatively, these terms are used to denote an inflexible or mostly inflexible physical property of an anti-pathogenic material when applied or coated onto a surface of a device. In some instances, the term semirigid is understood to describe a physical property of an anti-pathogenic material that is rigid to some degree or in some parts.

The term "modified rheology" is used to denote a physical property of an anti-pathogenic material, wherein the viscosity of an anti-pathogenic material is modified to prevent excessive migration of the anti-pathogenic material once applied to a surface of a device. As such, the modified rheology of the anti-pathogenic material prevents or substantially prevents contact between the anti-pathogenic material and adjacent surfaces or components.

The term "anti-pathogenic" is used to denote a material, such as a coating material, that acts against pathogens. Pathogens may include any organism or substance capable of causing a disease, such as bacteria, viruses, protozoa and fungi. Accordingly, an "anti-pathogenic material" as contemplated herein includes any material having properties for acting against a pathogen.

The present invention relates generally to systems for applying anti-pathogenic materials to various surfaces of medical devices. In particular, the present invention relates to systems for applying anti-pathogenic materials to surfaces of medical devices for infusion therapies, wherein the surface comprises a portion of a fluid pathway of the medical device. In some instances, an anti-pathogenic material is applied to a surface comprising a noncritical dimension. In some embodiments, an anti-pathogenic material is applied to one or more surfaces of a medical device prior to assembling the medical device. In other embodiments, an anti-pathogenic material is applied to the first portion or component of a medical device and subsequently transferred to a second portion or component of the medical device through controlled migration of the anti-pathogenic material. In other instances, an anti-pathogenic material is intermixed with, or incorporated into the material of the medical device during a molding process of the device. Further, in some instances an anti-pathogenic material is applied to or incorporated into the material of a medical device such that the anti-pathogenic material elutes out from the material of the medical device into the immediate surroundings of the coated medical device.

In general, an anti-pathogenic material in accordance with the present invention may include any material having anti-pathogenic properties which may be applied to the surface of a medical device, such as an infusion therapy device. For example, in some embodiments an anti-pathogenic material may include an antimicrobial composition, as taught in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. In some embodiments, an anti-pathogenic material may further include an anti-infective or antimicrobial lubricant, as taught in <CIT> and <CIT>. Further, in some embodiments an anti-pathogenic material is incorporated into the material of a medical device, or a component thereof, such as a septum actuator.

Some embodiments of the present invention comprise a medical device or component having at least one surface that defines a portion of a fluid pathway through the medical device, such as an infusion therapy device (e.g., a catheter assembly or Luer adapter). The surface of the medical device is coated with an anti-pathogenic material to prevent colonization of pathogens on the coated surface.

The application of an anti-pathogenic material to the surface of a medical device results in the addition of a layer or "coat" of anti-pathogenic material to the surface. This layer of anti-pathogenic material has a dimension (i.e. thickness) which may affect a relationship between the coated surface and an interfacing or adjacent component of the medical device. For example, in some embodiments a medical device may include an aperture having a diameter to compatibly receive a second medical device, such as by a friction, press, mechanical or interference fit. As such, the diameter of the aperture includes critical dimensions to ensure proper fitting between the aperture and the second medical device. In this example, the addition of an anti-pathogenic material to the surface of the aperture will adjust the diameter of the aperture thereby adversely affecting the ability of the aperture to receive the second medical device.

Accordingly, in some embodiments of the present invention it is undesirable to modify or coat a surface of a medical device or component wherein the surface includes a critical dimension that will be adversely affected by the addition of the anti-pathogenic material. Thus, a method for coating a medical device with an anti-pathogenic material, includes a first step of identifying surfaces of the medical device which include noncritical dimensions. The method may further include a step whereby the surfaces having noncritical dimensions are then coated with an anti-pathogenic material. Some methods may further include steps for identify and isolating surfaces of the medical device having critical dimensions, prior to coating the remaining surfaces with an anti-pathogenic material.

In further examples of the teachings of the present invention, a catheter assembly device <NUM> is shown in <FIG>. Catheter assembly device <NUM> provides a non-limiting example of a medical device having various surfaces which may be coated with an anti-pathogenic material. Accordingly, catheter assembly device <NUM> provides a representative embodiment on which to demonstrate and discuss the methodologies of the present invention relating to the selection and coating of surfaces with an anti-pathogenic material.

Referring now to <FIG>, a cross-section view of a catheter assembly <NUM> is shown. Catheter assembly <NUM> generally includes a catheter <NUM> coupled to a distal end <NUM> of a catheter adapter <NUM>. Catheter <NUM> and catheter adapter <NUM> are integrally coupled such that an internal lumen <NUM> of catheter adapter <NUM> is in fluid communication with a lumen <NUM> of catheter <NUM>. Catheter <NUM> generally comprises a biocompatible material having sufficient rigidity twisting pressures associated with insertion of the catheter into a patient. In some embodiments, catheter <NUM> comprises a metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof. In other embodiments, catheter <NUM> comprises a rigid, polymer material, such as vinyl or silicon.

Catheter assembly <NUM> may further include features for use with an over-the-needle catheter assembly. For example, a flexible or semi flexible polymer catheter may be used in combination with a rigid introducer needle to enable insertion of the catheter into the vasculature of a patient. Surgically implanted catheters may also be used.

Once inserted into a patient, catheter <NUM> and catheter adapter <NUM> provide a fluid conduit to facilitate delivery of a fluid to and/or retrieval of a fluid from a patient, as required by a desired infusion procedure. Thus, in some embodiments the material of the catheter <NUM> and the catheter adapter <NUM> are selected to be compatible with bio-fluids and medicaments commonly used in infusion procedures. Additionally, in some embodiments a portion of the catheter <NUM> and/or catheter adapter <NUM> is configured for use in conjunction with a section of intravenous tubing (not shown) to further facilitate delivery of a fluid to or removal of a fluid from a patient.

The various embodiments of the present invention may be adapted for use with any medical device or accessory having a lumen in which is placed a septum. For example, in some embodiments a female Luer adapter coupled to a section of intravenous tubing may comprise a septum and a septum actuator in accordance with the present teachings. In other embodiments, one or more ends of a y-port adapter may comprise a septum and a septum actuator in accordance with the teachings of the present invention.

In some embodiments, a proximal end <NUM> of the catheter adapter <NUM> includes a flange <NUM>. Flange <NUM> provides a positive surface which may be configured to enable coupling of intravenous tubing or a Luer adapter to the catheter assembly <NUM>. In some embodiments, flange <NUM> further includes a set of threads to accept a Luer adapter via a threaded connection.

In some embodiments, a septum <NUM> is slidaby housed with internal lumen <NUM> of catheter adapter <NUM>. Septum <NUM> generally comprises a flexible or semi-flexible polymer plug having an outer diameter that is configured to fit within internal lumen <NUM>. In some embodiments, septum <NUM> is tube shaped having one or more internal cavities. The barrier surface <NUM> is disposed between a distal end and a proximal end of the septum <NUM> divides the interior of septum <NUM> into a proximal cavity <NUM> and a distal cavity <NUM>. In other embodiments, barrier surface <NUM> can be disposed at or near the distal or proximal end of septum <NUM>. A slit <NUM> can be formed in barrier surface <NUM> for selectively opening fluid communication between proximal cavity <NUM> and distal cavity <NUM>. As shown, some septum embodiments have a substantially H-shaped cross section. When positioned within catheter adapter <NUM>, barrier surface <NUM> divides inner lumen <NUM> of catheter adapter <NUM> into a proximal fluid chamber <NUM> and a distal fluid chamber <NUM>. Thus, the presence of septum <NUM> can control or limit passage of fluid between the proximal and distal fluid chambers <NUM> and <NUM>. As shown, septum <NUM> can be held in place within internal lumen <NUM> via contact with one or more inner surfaces of the internal lumen, contact with anti-pathogenic material, and/or contact with probe <NUM> of septum actuator <NUM>.

Catheter assembly <NUM> further comprises a septum actuator <NUM>. Septum actuator <NUM> is generally fixedly positioned within distal fluid chamber <NUM> and has a portion that is positioned adjacent septum <NUM>. In some instances, septum actuator <NUM> comprises a base <NUM> that is coupled to catheter adapter <NUM>. For example, as shown, base <NUM> can be at least partially inserted into the proximal end of catheter <NUM>. In that configuration, base <NUM> acts as a wedge forming a press fit between catheter <NUM> and catheter adapter <NUM> to, at least partially, retain catheter <NUM> and base <NUM> in place. In another example, base <NUM> can be coupled directly to catheter adapter <NUM> via a fastener, adhesive, bonding technique, or molding. As shown, septum actuator <NUM> can have a tubular configuration with a hollow interior that forms a lumen <NUM> in fluid communication with lumen <NUM> of catheter <NUM>. As further shown, septum actuator <NUM> further comprises a probe <NUM> which is positioned adjacent barrier surface <NUM> of septum <NUM> prior to activation of catheter assembly <NUM>. Probe <NUM> can include barbs or other features for preventing proximal movement of septum <NUM> after septum activation.

In some embodiments, septum actuator <NUM> may comprise various features to facilitate use of septum actuator <NUM> within catheter assembly <NUM>. For example, septum actuator <NUM> may include various vents <NUM> and other structural features to control fluid flow through and around septum actuator <NUM>, as taught in <CIT> and <CIT>.

Septum <NUM> is slidably housed within catheter adapter <NUM>, such that septum <NUM> comprises an independent component of catheter assembly <NUM>. As such, septum <NUM> is capable of being advanced in a distal direction, in which septum actuator <NUM> pierces through slit <NUM>, opening a fluid path through septum <NUM>. This process is illustrated in <FIG> and described in greater detail with reference to that figure.

According to the invention, septum <NUM> and septum actuator <NUM> may be coated with an anti-pathogenic material prior to being inserted into catheter adapter <NUM>. In some instances, septum <NUM> and/or septum actuator <NUM> is coated with a rigid or semirigid anti-pathogenic material such that fluid which bypasses these structures comes in contact with the anti-pathogenic material. In other instances, septum <NUM> and/or septum actuator <NUM> is coated with a viscous or fluid anti-pathogenic material such that the anti-pathogenic material is transferred to surfaces of catheter assembly <NUM> which come in contact with the anti-pathogenic material. Further still, in some instances the material of septum <NUM> and/or septum actuator <NUM> comprises an anti-pathogenic material or agent. For example, the material of septum actuator <NUM> may include an anti-pathogenic material which is incorporated into or and mixed with the material of septum actuator <NUM> during a manufacturing process. In some instances, the anti-pathogenic material is capable of eluding out of septum <NUM> or septum actuator <NUM> into the surrounding areas within the catheter adapter <NUM>. For example, a fluid passing through catheter adapter <NUM> may be treated with the anti-pathogenic material of septum actuator <NUM> by either directly contacting the anti-pathogenic material or by contacting anti-pathogenic material which has eluded from the material of septum actuator <NUM>.

In some embodiments, a septum <NUM> and septum actuator <NUM> are provided within a fluid pathway of catheter assembly <NUM>, such that all fluid passing through catheter assembly <NUM> come in contact with septum <NUM> and septum actuator <NUM>, or pass in proximity to these structures through their immediate surroundings. Thus, some embodiments of the present invention provide anti-pathogenic treatment of a fluid within catheter assembly <NUM> by providing a septum <NUM> and/or septum actuator <NUM> having an external or exposed surface which is coated with anti-pathogenic material. Further, embodiments of the present invention prevent bacterial colonization within a fluid pathway of catheter assembly <NUM> by providing a septum <NUM> and septum actuator <NUM> having an anti-pathogenic coating material coated thereon. In some instances, an anti-pathogenic material is applied to various surfaces of septum <NUM> and septum actuator <NUM> which comprise noncritical dimensions. In other instances, an anti-pathogenic material is applied to various surfaces of septum <NUM> and septum actuator <NUM> which comprise critical and noncritical dimensions. Further still, in some instances an anti-pathogenic material is applied to all surfaces of septum <NUM> and septum actuator <NUM> which may come in contact with a fluid flowing through a fluid pathway of catheter assembly <NUM>.

As discussed previously, various surfaces of catheter assembly <NUM> comprise critical dimensions which may be adversely affected by the addition of an anti-pathogenic coating or material. For example, portions of base <NUM> of septum actuator <NUM> can comprise critical dimensions configured to fixedly couple septum actuator <NUM> to catheter adapter <NUM>. Accordingly, in some embodiments it is undesirable to apply an anti-pathogenic material to those portions of base <NUM>. Similarly, in some embodiments it is undesirable to apply an anti-pathogenic material to the outer surface of septum <NUM>, wherein the diameter of the outer surface of septum <NUM> comprises a critical dimension configured to form an interface with groove <NUM>. Moreover, it may be undesirable to apply an anti-pathogenic material to other such structures, interfaces, and features of the catheter assembly, which comprise critical dimensions.

Catheter adapter <NUM> further comprises various surfaces which may be coated with an anti-pathogenic material, wherein the surfaces include noncritical dimensions. For example, in some embodiments the inner surface of the distal fluid chamber <NUM> comprises a noncritical dimension and is therefore coated with an anti-pathogenic material. Similarly, the inner and outer surfaces of probe <NUM> of septum actuator <NUM> comprise noncritical dimensions and are therefore coated with anti-pathogenic material. Certain surfaces of proximal fluid chamber <NUM> further include noncritical dimensions and may therefore be coated with anti-pathogenic material, as shown. In particular, surfaces disposed proximal to septum <NUM> comprise noncritical dimensions.

In general, anti-pathogenic material may be applied to any internal or external surface of a medical device, or a component of a medical device, wherein the surface comprises or is exposed to a fluid pathway through the medical device. The surface may further include a critical or non-critical dimension. Pathogens within a fluid passing through the medical device are thus prevented from colonizing within the medical device. In some embodiments, the thickness of the anti-pathogenic material is proportionate to a duration of effectiveness of the anti-pathogenic material on the coated surface. Thus, the duration of effectiveness of the coating may be increased by increasing the thickness of the anti-pathogenic material applied to the surface. The duration of effectiveness may further be modified through modifying the physical properties of the anti-pathogenic material to increase or decrease the rate at which the anti-pathogenic agents are capable of eluting out of the coating material.

As shown, in some examples, a rigid or semirigid anti-pathogenic material <NUM> is selected which is configured to permit long-term elution of the anti-pathogenic agents contained within the material <NUM>. As such, it is desirable to provide the anti-pathogenic material to much of the fluid path surface area of catheter assembly <NUM>. According to the present invention, a viscous, fluid anti-pathogenic material <NUM> is selected which further comprises a lubricant agent. For example, in some embodiments an anti-pathogenic material <NUM> is provided which further includes a silicon lubricant agent, such as MED-<NUM> (manufactured by NuSil Technology, LLC). The inclusion of a lubricious agent reduces friction between interfacing components of catheter assembly <NUM>. According to the present invention, as further shown, anti-pathogenic material <NUM> is applied to the probe portion <NUM> of septum actuator <NUM>, thereby reducing friction between septum actuator <NUM> and septum <NUM>. Further, anti-pathogenic material <NUM> is applied to the outer diameter of septum <NUM> thereby reducing friction between septum <NUM> and catheter adapter <NUM> and permitting septum <NUM> to slide within internal lumen <NUM>. In some embodiments, anti-pathogenic material <NUM> further provides a fluid-tight seal between septum <NUM> and the outer surface of probe <NUM>. Further, in some embodiments, anti-pathogenic material <NUM> provides a fluid-tight seal to slit <NUM> of septum <NUM> prior to activation or provides a fluid-tight seal to slit <NUM> following removal of probe <NUM> from septum <NUM>. Still further, in some embodiments, anti-pathogenic material <NUM> provides between septum <NUM> and catheter adapter <NUM>.

Anti-pathogenic material <NUM> may be applied to portions of probe <NUM> and/or septum <NUM> prior to assembling catheter assembly <NUM>. In some embodiments, anti-pathogenic material <NUM> is capable of flowing or migrating when brought into contact with other surfaces. Accordingly, in some embodiments excess anti-pathogenic material <NUM> from probe <NUM> is applied to septum <NUM> following assembly of catheter assembly <NUM>, as shown. In other embodiments, anti-pathogenic material <NUM> comprises a modified rheology to prevent or control excessive migration of anti-pathogenic material <NUM> within catheter adapter <NUM>. For example, anti-pathogenic material <NUM> may further include rheological modifiers to increase the viscosity of the material, such as silica, talc or clay.

The process for coating or applying the anti-pathogenic material to compatible surfaces of catheter assembly <NUM> may be accomplished by dipping the desired portions or components of the device in their respective coating material <NUM> and/or <NUM>. Alternatively, anti-pathogenic materials may be sprayed onto the desired surfaces. In some embodiments, surfaces having critical dimensions are masked or otherwise protected prior to applying the anti-pathogenic material to the remaining surfaces. Compatible surfaces may further include a mechanical feature to encourage mechanical binding between the coating material and the compatible surface.

For example, a compatible surface may be designed to include a physical feature that increases mechanical binding of the coating material, such as a texture, a groove, a ridge or some other feature which increases the surface area of the compatible surface. In some embodiments, a mechanical bond is facilitated by a mechanical interlock comprising a void which holds the anti-pathogenic material by capillary force or surface tension forces. In other embodiments, a mechanical interlock comprises a hydrophilic or hydrophobic material or coating that is applied to the compatible surface to attract the anti-pathogenic material.

Further, in some embodiments the anti-pathogenic material is chemically bound to the compatible surface of the catheter assembly or medical device by a chemical bond, such as surface cross-linking. For example, in some embodiments a compatible surface of a device comprises a polymer material that is capable of forming chemical bonds with at least one component of an anti-pathogenic material. Non-limiting examples of polymer materials which may be used to achieve surface cross-linking include polycarbonate, polyester, and polyurethane. In some instances, an anti-pathogenic material is applied to a compatible surface of a device and then cured to achieve surface cross-linking between the anti-pathogenic material and the surface of the device.

Referring still to <FIG>, for some infusion therapy techniques, air flow between the distal and proximal chambers <NUM> and <NUM> may be desirable. For example, for those embodiments comprising a septum <NUM> having a fluid-tight slit <NUM>, passage of air from the distal chamber <NUM> to the proximal chamber <NUM> can be restricted prior to opening or activating the septum <NUM> with the septum activator <NUM>, as previously discussed. Thus, when the catheter <NUM> of the catheter assembly <NUM> is inserted into the vascular system of a patient, a positive pressure develops within the distal chamber <NUM> thereby preventing a desired flashback of the patient's blood into the catheter adapter <NUM>. An observable flashback is generally desirable to confirm accurate placement of the catheter tip within the vein of the patient. Thus, some embodiments include features or elements to enable airflow between the distal chamber <NUM> and the proximal chamber <NUM>, without requiring activation of the septum <NUM> with the septum activator <NUM>. As such, some embodiments of the present invention provide an observable flashback, as generally desired for infusion procedures.

For example, in some embodiments a plurality of air ventilation channel <NUM> is interposed between septum <NUM> and the inner surface of catheter adapter <NUM>. Such air vent channels <NUM> can extend from beyond the distal end of septum <NUM> to beyond the proximal end of septum <NUM> when septum <NUM> is in a pre-actuated position, as shown. The air vent channels <NUM> can relieve the positive pressure within the distal chamber <NUM> by providing an access for air to bypass septum <NUM> into proximal chamber <NUM>. In some embodiments, the air vent channels <NUM> are constructed by removing portions of the inner surface of the catheter adapter, resulting in a plurality of generally parallel grooves. In some embodiments, air vent channels <NUM> are sized and shaped to permit airflow, but to restrict fluid flow through air vent channels <NUM>. In other embodiments, air vent channels <NUM> are sized and shaped to permit airflow and fluid flow, but to restrict fluid flow to less than or equal to a predetermined flow rate. <FIG> shows the catheter assembly <NUM> of <FIG>, having septum <NUM> and anti-pathogenic material removed to permit a more clear view of air vent channels <NUM>.

In some embodiments, an anti-pathogenic material is applied to one or more surfaces of the ventilation channel <NUM>, the anti-pathogenic material applied to the surface of the ventilation channel <NUM> having a thickness less than that which would occlude the ventilation channel <NUM>.

Referring now to <FIG>, catheter assembly <NUM> is shown following activation with a Luer adapter <NUM>. Catheter assembly <NUM> is activated as septum <NUM> is advanced distally thereby causing probe <NUM> to pierce through slit <NUM> of septum <NUM>. In some embodiments, septum <NUM> is advanced distally as Luer adapter <NUM> is inserted into opening <NUM> of catheter adapter <NUM>. In some embodiment, opening <NUM> (shown in <FIG>) comprises a diameter and inner wall surface angle that is configured to receive probe <NUM> of Luer adapter <NUM> in a friction or interference fit. Accordingly, in some embodiments, it is undesirable to apply an anti-pathogenic material to opening <NUM>, wherein an anti-pathogenic coating would adversely affect the fit of probe <NUM> within opening <NUM>.

Alternatively, in some embodiments, opening <NUM> may be coated with an anti-pathogenic material <NUM> that is viscous, yet fluid enough to be displaced by probe <NUM> upon coupling of Luer adapter <NUM> to proximal end <NUM>. In these embodiments, the anti-pathogenic material may act as sealant between probe <NUM> and opening <NUM>, wherein probe <NUM> removes the necessary excess amount of anti-pathogenic material to leave a small amount of anti-pathogenic material between the interfacing surface of opening <NUM> and probe <NUM>.

In some embodiments, an anti-pathogenic material <NUM> is configured to transfer to interfacing surface within the catheter assembly <NUM> following activation. For example, in some embodiments, anti-pathogenic material on probe <NUM> of septum actuator <NUM> is transferred to septum <NUM> and the septum slit <NUM> as probe <NUM> pierces through slit <NUM>. Further, anti-pathogenic material <NUM> on septum <NUM> is transferred to the inner surfaces of internal lumen <NUM> as septum <NUM> is advanced distally within catheter adapter <NUM>. Thus, anti-pathogenic material <NUM> may be applied to various surfaces of catheter assembly <NUM> in anticipation of further distribution of the anti-pathogenic material following activation of the catheter assembly <NUM>. In other examples, anti-pathogenic material <NUM> comprises a rigid or semirigid material that is not transferred during activation of catheter assembly <NUM>.

In some embodiments, various other structural features and/or surfaces of catheter assembly <NUM> may include critical dimensions on which it is undesirable to apply an anti-pathogenic material. For example, in some infusion therapy techniques it is desirable to permit a controlled flow of fluid through the septum <NUM> prior to activating the septum <NUM>. Thus, in some embodiments, slit <NUM> may further comprise a leak orifice having an opening diameter calculated to permit controlled flow of liquid or air between the proximal and distal fluid chambers <NUM> and <NUM>. As this leak orifice may include critical dimensions, it may be undesirable to block or reduce the calculated opening diameter by the addition of an anti-pathogenic material.

Referring now to <FIG>, a septum <NUM> is shown within a catheter adapter <NUM> having structural features to maintain the position of septum <NUM> within lumen <NUM> of catheter adapter <NUM> and thus prevent it from moving out opening <NUM> in proximal end <NUM> of catheter adapter <NUM>. For example, in some embodiments, septum <NUM> comprises one or more fins <NUM> which can abut a proximal stop <NUM> of catheter adapter <NUM> to prevent further proximal movement of septum <NUM>. Fins <NUM> can comprise any protrusion, hook, latch, or other suitable structure configured to form a barrier surface, such as the illustrated flat proximal surface of fins <NUM>. Proximal stop <NUM> can include a protrusion extending from the inner surface of catheter adapter <NUM>. Proximal stop <NUM> can extend radially partially or completely about a portion of internal lumen <NUM>. In some embodiments, to accommodate the one or more fins <NUM>, septum <NUM> and internal lumen <NUM> are shaped and sized to provide a gap between septum <NUM> and internal lumen <NUM> in which fins <NUM> and proximal stop <NUM> reside. As discussed previously, various surfaces of catheter adapter <NUM> can be coated with an anti-pathogenic material <NUM> and/or <NUM>. This can include coating portions of the fins <NUM>, proximal stop <NUM>, and portions of the catheter adapter <NUM> in proximity to the proximal stop <NUM> and fins <NUM>.

As further shown in <FIG>, in some embodiments, the septum actuator <NUM> does not include barbs (e.g., barbs <NUM> of <FIG>). Rather, septum <NUM> can be retained in an activated position (shown in <FIG>) via forces between septum <NUM> and septum actuator <NUM>. In other embodiments, septum <NUM> can return to a pre-activated location (shown in <FIG>) after removal of the inserted device (e.g., Luer adapter <NUM> of <FIG>).

Referring now to <FIG>, an alternative configuration is shown for maintaining the position of septum <NUM> within lumen <NUM> of catheter adapter <NUM> and preventing it from moving out opening <NUM> in proximal end <NUM> of catheter adapter <NUM>. As shown, septum <NUM> includes fins <NUM>, similar to those of septum <NUM> of <FIG>. However, the proximal stop <NUM> of <FIG> is replaced with channels <NUM> or grooves, which are configured to retain a fin <NUM> therein, while permitting septum <NUM> to slide proximally during septum activation. Thus, channels <NUM> can be long enough to accommodate movement of septum <NUM> from a pre-activation location (e.g., shown in <FIG>) to an activation location (e.g., shown in <FIG>). In some embodiments, various surfaces of fins <NUM> and/or channels <NUM> can be coated with an anti-pathogenic material <NUM> and/or <NUM>.

Referring now to <FIG>, an alternative septum configuration is shown for providing increased structural support to septum <NUM> during septum activation. As shown, septum <NUM> can included a reinforced portion <NUM> on its proximal end <NUM>. Reinforced portion <NUM> can assist to prevent septum collapse during septum activation. In general, reinforced portion <NUM> can include a sidewall <NUM> having an increased thickness over the remaining sidewalls <NUM> of septum <NUM>. Reinforced portion <NUM> can include a thickness of between about <NUM>% to <NUM>% thicker than the remaining sidewalls <NUM> of septum <NUM>. As shown in <FIG>, reinforced portion <NUM> can bulge outwardly from septum <NUM>. <FIG> shows an embodiment of a septum <NUM> having a reinforced portion <NUM> that bulges inwardly.

<FIG> further shows an example of a septum <NUM> having a barrier member <NUM> disposed on a proximal end <NUM> of septum <NUM>. In this configuration, septum <NUM> does not include a distal cavity (e.g., distal cavity <NUM> of <FIG> and <FIG>). Rather, in such embodiments, septum <NUM> is retained against probe <NUM> of septum activator <NUM> instead of residing within the septum's distal cavity.

Claim 1:
A catheter assembly (<NUM>), comprising:
a catheter adapter (<NUM>) having a lumen (<NUM>);
a catheter (<NUM>) coupled to a distal end (<NUM>) of the catheter adapter (<NUM>), the catheter (<NUM>) including a lumen (<NUM>) in fluid communication with the lumen (<NUM>) of the catheter adapter (<NUM>);
wherein the catheter assembly (<NUM>) further comprises:
a septum (<NUM>) slidably housed within the lumen (<NUM>), the septum (<NUM>) including a barrier surface (<NUM>) that divides the lumen (<NUM>) into a proximal cavity (<NUM>) and a distal cavity (<NUM>);
a septum actuator (<NUM>) disposed in a fixed position within the distal cavity (<NUM>), the septum actuator (<NUM>) extending proximally into the distal cavity (<NUM>), the septum actuator (<NUM>) having a probe (<NUM>) having an outer surface and an inner surface, the inner surface forming a lumen (<NUM>) in fluid communication with the lumen (<NUM>) of the catheter adapter (<NUM>) and the lumen (<NUM>) of the catheter (<NUM>);
characterized in that the catheter assembly (<NUM>) further comprises:
an anti-pathogenic material applied to the inner surface of the septum actuator (<NUM>), the outer surface of the septum actuator (<NUM>), and an outer diameter of the septum (<NUM>), wherein the anti-pathogenic material comprises a lubricant agent and the outer diameter of the septum (<NUM>) is configured to fit within the lumen (<NUM>) thereby reducing friction between the septum (<NUM>) and the catheter adapter (<NUM>) and permitting the septum (<NUM>) to slide distally within the lumen (<NUM>) during septum activation.