Patent Description:
Hospitalized, home care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the vascular system. 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 a 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 is a catheter that is inserted into a patient's vein. The catheter length may vary from a few centimeters for peripheral access to many centimeters for central access. 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 group of vascular access and other devices used to access the vasculature of a patient may be collectively referred to as an extravascular system.

One example of an extravascular system including a catheter is the BD NEXrVA(TM) Closed IV (intravenous) Catheter System, by Becton, Dickinson and Company. This system includes an over-the-needle, peripheral intravascular catheter made from polyurethane, another catheter used as an integrated extension tubing with a Y adapter and slide clamp, a vent plug, a Luer access device or port, and a passive needle-shielding mechanism.

The design of the BD NEXIVA(TM) IV catheter can be described as a closed system since it protects clinicians or operators from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals, after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NEXIVA(TM) device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with another vascular access device such as an infusion set connection or a Luer access device or port.

A current procedure of initiating the use of an extravascular system such as the BD NEXIVA(TM) Closed IV Catheter System is as follows. A device operator inserts the needle into the vasculature of a patient and waits for flashback of blood to travel into the device to confirm that the needle is properly located within the vasculature of the patient. The blood travels into and along the catheter of the device because a vent plug permits air to escape the device as blood enters the device. After an operator confirms proper placement, the operator clamps the catheter to halt the progression of blood through the catheter, removes the vent plug, replaces the vent plug with another vascular access device such as an infusion set connection or a Luer access port, unclamps the catheter, flushes the blood from the catheter back into the vasculature of the patient, and re-clamps the catheter.

Many current procedures like the procedure described above present challenges that need to be overcome. For example, the procedure may include an unnecessary number of steps and amount of time to simply insert and prepare an extravascular system for use within the vasculature of a patient. Further, by removing the vent plug, the fluid path of the system is temporarily exposed to potential contamination from the external environment of the extravascular system.

Rather than using a vent plug, some operators attempt to solve the problem above by simply loosening a Luer access device and permitting air to escape from the system during flashback and then tightening the Luer access device to stop blood from advancing along the catheter. Unfortunately, this procedure is also prone to user error, a lack of consistent and accurate control of blood flow through the system potentially leading to blood exposure and loss of body fluids, and unnecessary risk of contamination.

Thus, what are needed are improvements to many of the systems and methods described above. Such systems and methods can be improved by providing more efficient vascular access device septum venting systems and methods.

<CIT> describes a catheter and introducer needle assembly which includes a catheter adapter at its proximal end having a hollow septum disposed therein. The septum preferably is hollow to minimize drag as the introducer needle is removed therefrom. If desired a gel or lubricious material may be disposed in the cavity.

<CIT> relates to the sampling, drainage or infusion of liquids from or to the human or animal body and in particular but not exclusively to a device for use in intravenous infusion via a cannula.

<CIT> discloses an introducer catheter apparatus having a body with a first bore along a longitudinal axis and a second bore in fluid communication with the first bore and extending from the first bore to the exterior surface at the side of the body, a fluid delivering means disposed on the second bore as the exterior surface of the body and the fluid communication with the second bore, and a flexible hollow tube means disposed in the first bore, a deformable sealing means disposed in the first bore between the second end of the body and the position within the first bore where the second bore connects to the first bore and a retractable needle means extends through the body including the deformable sealing means and a flexible hollow tube means and the tip of said needle when therein disposed extends past a distal end of the flexible hollow tube means. <CIT> discloses a vascular access device comprising a medical connector device that has a body with a first connector end and a second connector end suitable for connection of or to other vascular access devices. Further, there is a gas permeable vent including an adapter capable of connecting to the body, wherein the gas permeable vent is capable of venting a gas from the interior chamber of the body to the exterior of the body, the vent including venting material capable for acting as a barrier to liquid while permitting gas to permeate through the material.

The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available vascular access systems, devices, and methods. The current invention is directed to a medical connector device including the features of claim <NUM>. Preferred embodiments of the current invention are described in claims <NUM> and <NUM>. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS.

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 embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. The currently claimed invention is directed to the embodiments shown with respect to <FIG>. The remaining embodiments do not fall under the scope of the claims.

Referring now to <FIG>, an extravascular system <NUM>, such as the BD NEXIVA(TM) Closed IV (intravenous) Catheter System, by Becton, Dickinson and.

Company, is used to communicate fluid with the vascular system of a patient. An example of the system <NUM>, as shown in <FIG> , includes multiple vascular access devices such as an intravascular needle <NUM>; an over-the-needle, peripheral intravascular catheter <NUM> made from polyurethane; an integrated extension tubing <NUM> (also referred to herein as a catheter) with a Y adapter <NUM> and slide clamp <NUM>; a vent plug <NUM>; a Luer access device or port <NUM>; and a passive needle-shielding mechanism <NUM>. Any adapter used to connect two or more vascular access devices may be used in place of the Y adapter <NUM>.

The system <NUM> is a closed system since it protects clinicians or operators from blood exposure during the catheter <NUM> insertion procedure. Since the needle <NUM> is withdrawn through a septum that seals after the needle <NUM> has been removed and both ports of the Y adapter <NUM> are closed, blood is contained within the system <NUM> during catheter <NUM> insertion. The pressure exerted on the needle <NUM> as it passes through the septum wipes blood from the needle <NUM>, further reducing potential blood exposure. The slide clamp <NUM> on the integrated extension tubing <NUM> is provided to eliminate blood exposure when the vent plug <NUM> is replaced with another vascular access device such as an infusion set connection or another Luer access device or port <NUM>.

As mentioned above, a current procedure of initiating the use of the extravascular system <NUM> is as follows. A device operator will insert the needle <NUM> into the vasculature of a patient and wait for flashback of blood to travel into the system <NUM> to confirm that the needle <NUM> is properly located within the vasculature of the patient. The blood travels into and along the catheters <NUM> and <NUM> because a vent plug <NUM> permits air to escape the system <NUM> as blood enters the system <NUM>. After an operator confirms proper placement, and after adequate venting of the system <NUM> has occurred, the operator clamps the catheter <NUM> to halt the progression of blood through the catheters <NUM> and <NUM>, removes the vent plug <NUM>, replaces the vent plug <NUM> with another vascular access device such as an infusion set connection or a Luer access device similar or identical to Luer access device or port <NUM>, unclamps the catheter <NUM>, flushes the blood from the catheters <NUM> and <NUM> back into the vasculature of the patient, and re-clamps the catheter <NUM>. Alternate vents and venting procedures are desired and will be discussed with reference to the figures following <FIG>.

Referring now to <FIG>, a vascular access device <NUM> includes a septum <NUM> in communication with a vent <NUM>. The vent <NUM> includes an adapter that includes a Luer taper <NUM>. The Luer taper <NUM> is capable of penetrating into the slit <NUM> of the septum <NUM>, providing communication between the external and internal environments of the vascular access device <NUM>.

Referring now to <FIG>, the adapter <NUM> of <FIG> is shown in perspective view connected to a vent plug <NUM>. The adapter <NUM> includes a Luer taper <NUM> capable of insertion into the slit <NUM> of a septum <NUM>. The vent plug <NUM> acts as both a gas permeable vent and a barrier to fluid between the interior of the device <NUM> and the external environment. The vent plug may include any venting material capable of acting as a barrier to liquid while permitting gas to permeate through the material from an internal chamber of the device <NUM> to the external environment in which the device <NUM> is placed.

Referring now to <FIG>, an alternate adapter <NUM> may be combined with the vent plug <NUM> of <FIG>. The alternate adapter <NUM> similarly includes a Luer taper <NUM> capable of insertion into the slit <NUM> of a septum <NUM> of a vascular access device <NUM> such as a Luer access device. The adapter <NUM> also includes wings <NUM> extending from the upper body of the adapter <NUM>, so as to permit an operator to easily remove the adapter <NUM> after the extravascular system <NUM> has been fully vented of all gas through the vent plug <NUM>. After either adapter <NUM> or <NUM> has been removed from a vascular access device <NUM>, the septum <NUM> of the device <NUM> will close, preventing any additional liquid, such as blood, from escaping the device <NUM>, and consequently the extravascular system <NUM>.

Referring now to <FIG>, a vascular access device <NUM> includes a septum <NUM> in communication with a vent. The vent includes a vented cannula <NUM>, high-density polyethylene fibers such as those in the TYVEK(R) material by DuPont, or other similar material. The vented cannula <NUM> is located within the slit <NUM> of the septum <NUM>. The vented cannula <NUM> includes a vent notch <NUM> through which gas may escape from an interior chamber <NUM> of the device <NUM> to the external environment in which the device <NUM> is placed. The vent notch <NUM>, when the vented cannula <NUM> is fully inserted into the device <NUM>, is located at a position below the septum <NUM>.

Below the vent notch <NUM>, the vented cannula <NUM> also includes one or more features <NUM> capable of exercising the septum <NUM> upon removal of the cannula <NUM> from the device <NUM>. The purpose of the feature <NUM> is to ensure that the septum <NUM> fully recovers after the vented cannula <NUM> is removed therefrom. Recovery of the septum <NUM> requires that the two opposing surfaces of the slit <NUM> of the septum <NUM> come fully into contact with each other after removal of any device therefrom. Full recovery of the septum <NUM> will prevent any liquid from escaping from the interior chamber <NUM> to the external environment. If needed, a second and any number of additional features <NUM> can be added to the end of the vented cannula <NUM> to create a second or additional exercising of the septum <NUM> upon cannula <NUM> removal.

In addition to the one or more features <NUM>, a biocompatible gel may be added to the surface of the features <NUM> to assist in sealing any hole which may exist between the two surfaces of the slit <NUM> in the septum <NUM> until the septum <NUM> is able to fully recover and be completely sealed. In order to ensure that the vented cannula <NUM> only vents gas from the interior chamber <NUM> to the external environment, a hydrophobic membrane <NUM> or other similar filter may be placed at the external end of the vented cannula which resides outside the septum <NUM> while the vent notch <NUM> resides within the interior chamber <NUM>. The hydrophobic membrane <NUM> may also include a dust cover <NUM> capable of encapsulating or otherwise protecting the top disc <NUM> of the septum <NUM> during device <NUM> use. Such a protective cover <NUM> will help to ensure minimal infection of the sterile device <NUM> during use.

Referring now to <FIG>, a vascular access device <NUM> includes a septum <NUM>, which when accessed, is placed in communication with at least one vent plug <NUM>. The at least one vent plug <NUM> may be placed anywhere on or near the septum <NUM> such that the vent plug <NUM> is capable of being closed when the septum <NUM> is actuated. <FIG> shows a first vent plug <NUM> on the left portion of the device <NUM> that has been closed as a result of septum <NUM> actuation. <FIG> also shows an open vent plug <NUM> on the right portion of the device <NUM>. The open vent plug <NUM> permits gas to escape through a gas permeable hydrophobic portion <NUM> of the vent plug <NUM> when the vent plug <NUM> is not fully engaged or closed. When the vent plug <NUM> is fully engaged or closed, the hydrophobic portion <NUM> will be lodged within the body of the device <NUM> such that only a solid portion of the vent plug <NUM> is in communication with the interior chamber <NUM> of the device <NUM>. The hydrophobic portion <NUM> may include any venting material discussed throughout this disclosure.

Referring now to <FIG>, a vascular access device <NUM> includes a vent located within the slit <NUM> of a septum <NUM> of the device <NUM>. The vent is formed of an elongated venting material <NUM> such as a porous plastic material or porous fibrous material such as a Porex material, or TYVEK(R) material from DuPont. The venting material <NUM> is folded at the end that is inserted into the septum <NUM> in order to facilitate insertion of the material <NUM> at the fold <NUM> into the slit <NUM> of the septum <NUM>.

At its opposite end, the venting material <NUM> may include additional folds capable of providing a pull tab <NUM> and a protective covering <NUM>. The pull tab <NUM> provides a structure which an operator may pull in order to fully remove the venting material <NUM> from the device <NUM>. The protective covering <NUM> is intended to act as a shield or barrier of an operator's fingers or other instruments from touching the top surface of the top disc <NUM> of the septum <NUM> during device <NUM> use. By acting as a protective covering, the covering <NUM> prevents septum <NUM> contamination on the face or top surface of the septum <NUM> that would otherwise occur or exist if the venting material <NUM> were pulled straight out of the slit <NUM> as illustrated in <FIG>.

Referring now to <FIG>, a top view of the device <NUM> of <FIG> is shown. The top view reveals the pull tab <NUM> extending from the outer circumference of the device <NUM> so as to ensure that an operators fingers or other instruments do not come into contact with the septum <NUM>. The remaining protective covering <NUM> also ensures that the top surface of the top disc <NUM> of the septum <NUM> is neither touched prior to or during removal of the venting material <NUM>.

Referring now to <FIG>, any other structure may be placed within the slit <NUM> of a septum <NUM> of a vascular access device <NUM>, such as a micro tube array <NUM>. The micro tube array <NUM> includes an outer structure <NUM> encapsulating a venting material <NUM>, which is permeable to gas, but not liquid. Thus, the venting material <NUM> will permit the escape of gas from a vascular access device <NUM> without permitting liquid to escape from the device <NUM>. The micro tube array <NUM> includes multiple microtubules <NUM> aligned and secured to each other in parallel.

Referring now to <FIG> , a structure similar to the micro tube array <NUM> of <FIG> is shown as an integrated micro tube array <NUM>. The micro tube array <NUM> includes multiple microtubules of venting material <NUM>. However, the microtubules <NUM> are placed into contact with each other and are collectively supported and encased by an integrated casing <NUM>.

Referring now to <FIG>, a structure similar to the micro tube array
<NUM> of <FIG> and the integrated micro tube array <NUM> of <FIG> is shown as a laminated film vent <NUM>. The laminated film vent also includes multiple microtubules of venting material <NUM> encased within a top layer <NUM> that is laminated and sealed along the edges of the bottom layer <NUM>. The top and bottom layers <NUM> and <NUM> provide support to and encompass the microtubules <NUM>.

The supporting materials <NUM>, <NUM>, <NUM>, and <NUM> of <FIG> are not permeable to fluid. However, the microtubules <NUM> are permeable to gas, but not liquid. In this manner, the structures described with reference to <FIG> provide a structure capable of venting a vascular access device <NUM> through the slit <NUM> of the septum <NUM> of the device <NUM>.

Referring now to <FIG>, a vascular access device <NUM> may be combined with a venting plug <NUM>. The venting plug <NUM> may include a porous strip <NUM> capable of insertion into the slit <NUM> of a septum <NUM> of the device <NUM>. The porous strip <NUM> will be thin enough to provide adequate venting through the slit <NUM> without unnecessarily stressing the septum <NUM> in a manner that prevents a septum <NUM> from fully closing or otherwise sealing upon removal of the venting plug <NUM>. To facilitate a low stress porous strip <NUM>, a cross section of the porous strip <NUM> may include tapered ends or may include a thin cross section without tapered ends. The porous strip <NUM> is permeable to gas but not liquid, permitting air to flow from an internal chamber <NUM> of the device <NUM> to the external environment in which the device <NUM> is placed.

The porous strip is secured at its external end to a handle <NUM>. The handle <NUM> may be a simple handle such as that shown in <FIG>, or may be a much larger handle such as that shown in <FIG>, capable of encapsulating the top disc <NUM> of the septum <NUM>. By encapsulating the top disc <NUM> of the septum <NUM>, the handle <NUM> provides an additional antimicrobial barrier capable of ensuring maximal device <NUM> sterility during the venting procedure of the extravascular system <NUM> to which the device <NUM> is attached.

Referring now to <FIG>, <FIG>, a vascular access device <NUM> may include a vent with either a cannula <NUM> with interference housing or a small bore cannula inserted within the slit <NUM> of a septum <NUM> of the device <NUM>. The cannulas are secured to an external end cap <NUM> with snap thread arms <NUM> capable of securing to the external threads <NUM> of the device <NUM>. The end cap <NUM> also includes a venting plug or venting membrane <NUM> on its external surface capable of filtering air or other gas through the cannulas <NUM> and <NUM> while preventing the escape of liquid such as blood from the device <NUM>. As with all venting materials in this disclosure, the vent plug or membrane <NUM> may include any of the venting materials discussed throughout this disclosure.

The cannula <NUM> with interference housing includes additional housing body along its cross section in order to add additional support and an additional sealing mechanism at a certain cross section of the device <NUM>. Thus the interference housing of the cannula <NUM> will provide a continuous, sealed, connection of the body <NUM> of the device <NUM>, the septum <NUM>, and the interference housing of the cannula <NUM>, such that only the lumen <NUM> of the cannula <NUM> provides an open space through which fluid, such as a gas, may escape.

The arms <NUM> may be used as a snap thread connection capable of being rapidly secured to and detached from the threads <NUM> of the device <NUM>. The vent may also include a gel seal <NUM> between the lower surface of the body of the end cap <NUM> and the upper surface of the top disc <NUM> of the septum <NUM>. The gel seal <NUM> provides an additional seal, insulator, and elastic buffer between the vent and the device <NUM>. The gel seal <NUM><NUM> may be formed as a sealing ring <NUM> around the circumference of the bottom surface of the end cap <NUM>.

Referring now to <FIG>, a vascular access device <NUM> includes a vent that includes a preinstalled venting plug <NUM> inserted into the slit <NUM> of a septum <NUM> of the device <NUM>. The plug <NUM> may be preinstalled into the device <NUM> prior to operator use, and may be removed by an operator after flashback of blood is achieved within the extravascular system <NUM> to which the device <NUM> is attached during the venting procedure.

Referring now to <FIG>, the venting plug <NUM> of <FIG> is shown in close-up view. The venting plug <NUM> includes a semi-permeable venting material <NUM> that allows gas flow but not liquid flow through the venting material <NUM>. The venting material <NUM> may be any venting material discussed throughout this disclosure. The venting plug <NUM> may be formed in two halves by an ultrasonic weld <NUM> or other means of securement. The venting plug <NUM> may be formed of a polycarbonate or other rigid plastic or other material.

Referring now to <FIG>, a vascular access device <NUM> includes a septum <NUM> having a top disc <NUM> and at least one bi-stable spring <NUM> embedded within the top disc <NUM>. The bi-stable spring <NUM> holds the septum <NUM> in convex position, opening an air channel <NUM> as a vent through which air may flow during venting of the device <NUM>. The air channel <NUM> will preferably be adequately narrow such that when a liquid such as blood comes into contact with the air channel, the cohesive properties of the liquid will be bound to the surfaces of the slit <NUM> of the septum <NUM>, causing the flow of liquid to slow or halt prior to its final escape into the external environment outside of the slit <NUM>.

Upon full venting of the device <NUM>, an operator may insert the tip of another vascular access device, such as a syringe, into the septum <NUM>, causing the at least one bi-stable spring <NUM> to snap into concave position, closing the slit <NUM> and the air channel <NUM> of the septum <NUM>. After the at least one bi-stable spring <NUM> has snapped or flipped into concave shape, forcing the septum <NUM> and top disc <NUM> in a downward direction <NUM>, no further gas or liquid will be permitted to escape the device <NUM>, and the septum <NUM> may be used for future access and use consistent with its purpose without reversing the at least one bi-stable spring <NUM> into convex shape, causing the air channel <NUM> to reopen.

Referring now to <FIG>, a vascular access device of any of the embodiments of this disclosure may include a chamber <NUM> in communication with a septum <NUM>. The chamber <NUM> may be filled with biocompatible gel <NUM>. The device <NUM> may be prefilled with the biocompatible gel <NUM> in the chamber <NUM> in order to stop blood or other liquid from entering into the chamber <NUM> and/or other areas that are hard to flush. Areas that are hard to flush include those areas which persistently harbor trapped air bubbles or other trapped medications or fluids and later inconveniently release those air bubbles or trapped fluids at an uncontrolled rate during future use of the device <NUM>.

The prefilled gel <NUM>, upon initial access of the septum <NUM> of the device <NUM>, is initially pushed into the fluid path <NUM> of the device <NUM> and the extravascular system <NUM>. As the gel <NUM> enters into the fluid path <NUM>, it dissolves into the surrounding intravenous fluid infused into the device <NUM>. Any venting member, such as a cannula or other vent material or member mentioned throughout this disclosure, will extend through the slit <NUM> of the septum <NUM>, through the body of gel <NUM>, and into the end of the fluid path <NUM>, such that the opening of the venting member is exposed to the fluid path <NUM>.

Referring now to <FIG>, the vascular access device <NUM> of <FIG> is shown after initial actuation of the septum <NUM>. A layer of the gel <NUM> remains in order to prevent blood adhesion, unwanted trapped air bubbles, or other unwanted stagnant fluid flow after a blood draw or other use of the device <NUM>. The layer of remaining gel <NUM> is coated on the inner surface of the bottom of the septum <NUM> and of the body of the device <NUM> within the chamber <NUM>. An alternate gel material that is less solvent than the gel previously discussed may be used to more permanently reside on the surface of the chamber <NUM>.

Referring now to <FIG>, a vascular access device <NUM> may include a vent including at least one needle <NUM> capable of penetrating the septum <NUM> of the device <NUM> in order to vent the extravascular system <NUM> to which the device <NUM> may be attached. The at least one needle <NUM> may penetrate through a molded or drilled hole within the body of the device <NUM> in order to penetrate through the bottom disc <NUM> of the septum <NUM>, as shown in <FIG>. The tip <NUM> of the at least one needle <NUM>, having penetrated through the bottom disc <NUM> of the septum <NUM>, will thus be exposed to gas residing within the device <NUM>.

The body of the device <NUM> will preferably provide adequate support and lateral pressure against the bottom disc <NUM>. Thus, after the at least one needle <NUM> is removed from the bottom disc <NUM>, the hole where the at least one needle <NUM> penetrated through the septum <NUM> will fully seal and close. The sealed septum <NUM> will prevent any further gas or liquid from escaping through the septum <NUM> into the external environment in which the device <NUM> is placed.

Referring now to <FIG>, a perspective view of the vascular access device <NUM> of <FIG> is shown combined with a protective cover <NUM> including at least one vent hole <NUM> through the cover <NUM>. The protective cover <NUM> is secured to the device <NUM> such that the top disc of the septum <NUM> is protected from microbial exposure. The protective cover <NUM> includes a finger grip <NUM> or other structure intended to enable an operator to be able to remove the protective cover <NUM> from the device <NUM> as desired. The protective cover <NUM> also includes at least one snap <NUM> capable of securing the protective cover <NUM> to a lower ledge <NUM> on the outer surface of the body of the device <NUM>.

The protective cover <NUM> of the <FIG> may include the at least one needle <NUM> described with reference to <FIG>. For example, the protective cover may include two needles <NUM> at opposing ends of the finger grip <NUM>, inserted within the vent holes <NUM> and secured to the protective cover <NUM>. Thus, with the protective cover <NUM> engaged, or attached to, the device <NUM>, the needle <NUM> will penetrate through the bottom disc <NUM> of the septum <NUM>, providing a vent from the interior chamber of the device <NUM> to the external atmosphere in which the device <NUM> is placed. Alternatively, the protective cover <NUM> may not include any needle <NUM>. Rather, an operator may insert any standard needle or any other device including a needle into the at least one vent hole <NUM> in order to vent the device <NUM>. After any needle is removed from the device <NUM>, the bottom disc <NUM> of the septum <NUM> will seal, preventing any further venting of fluid.

Referring now to <FIG> and <FIG>, a vascular access device <NUM> may include a vent in communication with a septum <NUM>. The vent may include a hydrophobic thread <NUM> placed within the slit <NUM> of the septum <NUM>. Small airflow gaps <NUM> capable of venting gas from the device <NUM> into the external environment exist within the slit <NUM> and adjacent the thread <NUM>. To inhibit the travel of fluid through the air flow gaps <NUM>, the thread <NUM> may be a hydrophobic thread, such as a thread made of TEFLON(R) material by DuPont.

The thread <NUM> may be connected to a pull tab <NUM> which enables an operator to remove the thread <NUM> from the slit <NUM> of the septum <NUM> after the device <NUM> is fully vented from gas residing therein. The thread <NUM> may be connected as a single thread by both ends to the pull tab <NUM> such that the thread forms a continuous loop <NUM>. Alternatively, the pull tab <NUM> may be connected to one or more individual threads <NUM> that do not form a loop <NUM>. Any number of loops <NUM> or individual threads <NUM> may be combined to form a single vent for the device <NUM>.

Referring now to <FIG>, a vascular access device <NUM> may include a vent formed of a flexible plastic catheter tubing <NUM> in communication with a septum <NUM>. The catheter tubing <NUM> may be formed of a soft plastic material that flattens or is otherwise compliant under the restorative force of the septum <NUM> along its slit <NUM>. The inner lumen <NUM> of the at least one catheter <NUM> may include a hydrophobic surface and/or any venting material discussed throughout this disclosure.

A flattened cannula vent <NUM> may be inserted within the slit <NUM> of a septum <NUM> of a vascular access device <NUM>. The flattened cannula vent may be formed of a flattened metal or other rigid cannula material and may include a similar hydrophobic or venting material within the lumen <NUM> of the cannula <NUM>. The flattened cross section and rounded narrow corners <NUM> of the vent <NUM> will provide minimal stress <NUM> to the body of the septum <NUM>. Under minimal or reduced stress <NUM>, the septum <NUM> will be more likely to fully recover and seal after the cannula vent <NUM> is removed from the slit <NUM> of the septum <NUM>.

A round cannula vent <NUM> may also be inserted within the slit <NUM> of a septum <NUM> of a vascular access device <NUM>. The round cannula vent <NUM> will provide high stress <NUM> to the body of the septum <NUM> in contrast to the reduced or minimal stress <NUM> of the flattened cannula vent <NUM> shown in <FIG>. A preferred cannula vent will provide minimal prolonged stress to the slit <NUM> and body of a septum <NUM> such that the septum <NUM> will be able to fully recover and seal after the cannula vent is removed from the slit <NUM>.

A vascular access device <NUM> may also include a septum <NUM> with a vent inserted into the slit <NUM> of the septum <NUM>. A cross section of the vent includes a substantially symmetrical cross <NUM> formation with a length that is greater than the width of the cross <NUM>. The length of the cross <NUM> spans to near the full length of the slit <NUM>. The width of the cross <NUM> provides structure capable of opening the slit <NUM> to an adequate degree capable of providing four sections of vent volume between each of the four ends of the cross <NUM> and the slit <NUM>. Each of the ends of the cross <NUM> are rounded in order to prevent any damage or cutting into the material of the septum <NUM>. The total vent volume between the cross <NUM> and the surfaces of the slit <NUM> will be adequate to vent air or other gas from an extravascular system <NUM> to which the device <NUM> is attached, and may include any venting material and/or hydrophobic material or surfaces thereon.

Because the cross <NUM> provides minimal opening of the slit <NUM> of the septum <NUM>, it will minimize the amount of stress and consequently the memory of the body of the septum <NUM>, permitting the septum to fully recover and become sealed after the cross <NUM> is removed from the device <NUM>.

The cross <NUM> will thus provide less stress on the material of the septum <NUM> than the round cannula <NUM>. The round cannula <NUM> will provide a higher level of stress <NUM> and consequently greater septum memory and more likelihood that leaks will occur within the slit <NUM> of the septum <NUM>. If molded, the cross <NUM> will preferably be molded, such that the flash locations <NUM> will be located on any outer surface of the cross <NUM> that does not come into contact with the surface of the slit <NUM> of the septum <NUM>. Thus, the remaining material at the flash locations <NUM> will be unable to damage the surface of the interior surface of the septum <NUM>, causing rips, tears, or other actuations likely to damage or otherwise loosen or dislodge material from the septum <NUM>.

Referring now to <FIG>, a vascular access device <NUM> includes a vent placed within the septum <NUM> of the device <NUM>. The vent includes a rigid tubing <NUM> placed within the slit <NUM> of the septum <NUM> and connected to a venting membrane or venting plug <NUM> located on the exterior of the device <NUM>. The internal end of the rigid tubing <NUM> or catheter may include a funnel <NUM> capable of receiving any structure <NUM> attached to the end of a stylet <NUM> that has been threaded through the lumen of the rigid tubing <NUM>. The stylet <NUM> may be connected at its internal end to the structure <NUM> and at its external end to a puller <NUM>.

During use, an operator may permit the device <NUM> to vent while the rigid tubing is inserted into the septum <NUM>. After venting, the operator may pull the puller <NUM>, causing the stylet <NUM> to pull the structure <NUM> through the funnel <NUM> of the rigid tubing <NUM>, causing the rigid tubing <NUM>, venting membrane <NUM>, stylet <NUM> and structure <NUM> to be removed from the device <NUM>. After these structures are removed from the device <NUM>, the slit <NUM> of the septum <NUM> will return to its original resting, and sealed, position, preventing any additional gas and/or liquid from leaking through the septum <NUM> into the external environment.

Referring now to <FIG>, a vascular access device <NUM> may include a vent in communication with a septum <NUM>. The vent includes an activatable venting channel <NUM> secured to the device <NUM> by means of a venting channel housing <NUM>. The venting channel housing <NUM> may include threads <NUM> that correspond with threads <NUM> of the device <NUM>. When the threads <NUM> are engaged with the threads <NUM>, the housing <NUM> is secured to the device <NUM>, placing a first end of the venting channel <NUM> in accessible communication with the slit <NUM> of the septum <NUM>.

At a second end of the venting channel <NUM>, a vent plug housing <NUM> that includes the venting channel <NUM> as its lumen, includes a vent plug or vent membrane <NUM>. The vent plug or vent membrane <NUM> may include any venting material capable of permeability to gas but not liquid as discussed throughout this disclosure. The housing <NUM> may further include a vent activation stop <NUM> on its interior surface capable of stopping the vent channel housing <NUM> from advancing too far into and through the slit <NUM> of the septum <NUM>. When the vent activation stop <NUM> comes into contact with a vent channel stop <NUM>, the housing <NUM> will no longer advance into the device <NUM>.

Claim 1:
A medical connector device, comprising:
a vascular access device (<NUM>) comprising a body having an interior chamber (<NUM>) and a first connector end and a second connector end for connection of or to other vascular access devices, and a septum (<NUM>) having a slit (<NUM>) disposed within the first connector end;
a gas permeable vent (<NUM>, <NUM>, <NUM>) including an adapter (<NUM>, <NUM>) capable of penetrating into the slit (<NUM>) of the septum (<NUM>), wherein the gas permeable vent (<NUM>, <NUM>, <NUM>) is capable of venting a gas from the interior chamber (<NUM>) of the body to the exterior of the body;
wherein the gas permeable vent (<NUM>, <NUM>, <NUM>) includes a vent plug (<NUM>) secured to the adapter, the vent plug (<NUM>) including venting material capable for acting as a barrier to liquid while permitting gas to permeate through the material.