Patent Publication Number: US-2022233817-A1

Title: Catheter adapter port valve

Description:
RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 15/644,467, filed on Jul. 7, 2017, entitled CATHETER ADAPTER PORT VALVE, which is a continuation of U.S. patent application Ser. No. 13/417,525, filed on Mar. 12, 2012, entitled CATHETER ADAPTER PORT VALVE, which are incorporated herein in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to port valves used in catheter assemblies. In medicine, catheter assemblies are used to place a catheter properly into the vascular system of a patient. Once in place, catheters such as intravenous (or “IV”) catheters may be used to infuse fluids including normal saline, medicinal compounds, and/or nutritional compositions into a patient in need of such treatment. Catheters additionally enable the removal of fluids from the circulatory system and monitoring of conditions within the vascular system of the patient. 
     One type of commonly used catheter is a peripheral intravenous catheter. These short, indwelling intravenous catheters are often used to provide an entry route for medications, fluid for hydration, and in some cases, for parenteral feeding, into a patient. Such catheters are generally short in length, ranging from about one-half to about three inches in length, and are generally made of flexible biocompatible materials. Peripheral intravenous catheters are often provided as “over-the-needle” catheters mounted over an introducer needle with a sharp distal tip. A portion of the catheter including at least the distal tip of the catheter securely grips the outside of the needle to prevent catheter peelback during insertion of the catheter into the circulatory system of the patient. Although several techniques for placing such catheters are practiced in the art, many generally include the step of inserting at least a portion of the needle into the target vessel and then sliding the catheter over the needle into place. 
     Once placement of the needle has been confirmed, the medical personnel may remove the needle, leaving the catheter in place. A septum within the catheter adapter can prevent the outflow of fluid during and following removal of the introducer needle. These septum structures are generally elastomeric and are designed to closely conform to the shape of a needle during storage and use to prevent leaking, then to seal upon removal of the needle. However, if the needle is left within the septum for long periods, the septum may not completely seal after the needle is removed, having conformed, in part, to the shape of the withdrawn needle. An incompletely sealed septum can increase the risk of blood exposure to medical personnel, since blood may flow through the small opening in the slit of the septum. It would thus be an improvement in the art to provide a catheter assembly with more reliable sealing functionality. Such a catheter assembly is disclosed herein. 
     SUMMARY OF THE INVENTION 
     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 catheter assemblies. Thus, these catheter assemblies are developed to include a valve that is located on a port of a catheter adapter. Placing the valve on the port can avoid the problems involved when a valve is in the path of an introducer needle. This valve can further provide the ability to infuse and withdraw fluids through the port. 
     Accordingly, in some aspects of the invention, a catheter assembly is provided that includes a catheter adapter having an inner lumen. A port in the catheter adapter can form an opening into the inner lumen. A valve can be coupled to the port and which selectively seal the opening of the port. The catheter assembly can also have a catheter tube and a septum within the inner lumen that seals the proximal end of the inner lumen. 
     Various types of valves can be incorporated into the port to provide medical personnel with the ability to infuse and withdraw fluids through the port. Non-limiting examples of valves include an elastomeric septum, a ball valve, and an iris valve. The valve can be a one-way valve or a two-way valve. The valve can be located on a removable luer access connector that can be connected and disconnected from the port. Alternatively, the valve can be located on a luer access connector that is fixedly connected to the port. The valve can be a luer access valve that accommodates the insertion of a luer device, such as those commonly used in the medical industry. Moreover, a body portion of the port can include luer threads that can secure a luer device to the catheter adapter. In some configurations, the port can be disposed at an angle relative to the longitudinal axis of the catheter in order to modify the direction at which fluids are infused into the inner lumen. This angle can be between about 15° to about 90°. 
     Additionally, the valve on a port can provide a number of benefits when used with blood control-type catheter assemblies. Blood control-type catheter assemblies can have an internal blood control valve that may remain permanently open after it is activated by the insertion of a luer. In these instances, the valve can provide medical personnel with an additional point of connection that has a limited risk of blood exposure. Accordingly, in some implementations of the invention, the valve on the port is utilized with a catheter assembly having an internal blood control valve. The blood control valve may include a blood control septum located within the inner lumen of the catheter adapter. A septum activator may also be located within the inner lumen at a location that is behind the blood control septum. When a separate luer device is inserted into the proximal end of the catheter adapter, the septum activator is advanced forward through the blood control septum, activating the blood control septum. 
     In some aspects of the invention, a button that extends outwardly from a sidewall of the catheter adapter can activate and deactivate the blood control septum. The button can be connected to the septum activator and configured to move the septum activator distally through the septum when the button is pressed. In some implementations, the button is configured to be pressed inwardly towards the inner lumen, and a translating mechanism translates the inward movement of the button to a distal movement of the septum activator. 
     These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. The present invention does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment of the invention. 
    
    
     
       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. 
         FIG. 1  illustrates a cross-sectioned, side view of a representative catheter assembly having a port and a valve. 
         FIG. 2  illustrates a perspective, top view of the catheter assembly of  FIG. 1 . 
         FIG. 3  illustrates a partial cross-sectioned view of a representative ball valve on a port. 
         FIG. 4  illustrates a partial cross-sectioned view of a representative iris valve on a port. 
         FIG. 5  illustrates a top view of the iris valve of  FIG. 4 . 
         FIG. 6  illustrates a cross-sectioned view of a representative removable valve on a port. 
         FIG. 7  illustrates a perspective view of another representative catheter assembly having a valve on a port and a needle extending through the catheter assembly. 
         FIG. 8  illustrates a cross-sectioned view of the catheter assembly of  FIG. 7  taken along line  8 - 8  of  FIG. 7  with the needle removed. 
         FIG. 9  illustrates a cross-section view of yet another representative catheter assembly having a removable valve on a port. 
         FIG. 10  illustrates a partial cross-sectioned view of a representative push-button mechanism for actuating a blood control septum within a catheter assembly. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The presently preferred embodiments of the present invention can be 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. 
     As used herein, the term “proximal”, “behind”, “top”, “up”, or “upwardly” refers to a location on the device that is closest to the clinician using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term “distal”, “forward”, “bottom”, “down”, or “downwardly” refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. 
     As used herein, the term “in” or “inwardly” refers to a location with respect to the device that, during normal use, is toward the inside of the device. Conversely, as used herein, the term “out” or “outwardly” refers to a location with respect to the device that, during normal use, is toward the outside of the device. 
       FIG. 1  illustrates a cross-sectioned view of one embodiment of a catheter assembly  10 . As shown, the catheter assembly  10  generally includes a catheter  12  coupled to the distal end  26  of a catheter adapter  14 . The catheter  12  and the catheter adapter  14  are integrally coupled such that an inner lumen  16  of the catheter adapter  14  extends into the catheter  12 . The catheter  12  generally includes a biocompatible material that is made of a flexible or a semi-flexible polymer. The catheter  12  may be used in combination with a rigid introducer needle  20 , as shown, to enable insertion of the catheter  12  into a patient. It is contemplated that other types of implantable catheter assemblies may also be used in combination with the present invention. 
     After the introducer needle  20  is removed from the catheter  12  and catheter adapter  14 , fluids may be infused into the patient. These fluids can include normal saline, medicinal compounds, and/or nutritional compositions (including total parenteral nutrition, or “TPN”). Fluids, such as blood samples, can also be removed from the circulatory system of the patient through the catheter  12  for monitoring of conditions within the vascular system of the patient. 
     In some embodiments, a needle septum  22  is disposed within the catheter adapter  14  to prevent the outflow of fluid during and following removal of the introducer needle  20 . The needle septum  22  can be elastomeric and be designed to closely conform to the shape of an introducer needle  20  to prevent leaking. The needle septum  22  can also seal upon removal of the needle due to axial compression forces on the needle septum  22  that induces it to close. 
     In some instances, fluids may be infused and withdrawn from the catheter  12  through a port  30  in a sidewall  32  of the catheter adapter  14 . The port  30  can form an opening  34  extending through a sidewall  32  of the catheter adapter  14 . The sidewall  32  can be any wall of the catheter adapter  14  that extends substantially longitudinally (in relation to the longitudinal axis  24 ) along the catheter adapter  14 . A port  30  can be a side port or a top port. The port  30  can form a fluid path from the external environment into the inner lumen  16  of the catheter adapter  14 . 
     To prevent contamination from entering the catheter adapter  14  through the port  30 , a valve  40  can be coupled to the port  30  that provides selective access through the port  30 . In some embodiments, the valve  40  can be a two-way valve. A two-way valve is a valve  40  that permits fluid flow in two directions through the valve  40  when the valve  40  is open. Non-limiting examples of a two-way valve include a split septum, a ball valve, and an iris valve. Thus, a two-way valve can permit fluid to be introduced into the catheter adapter  14  (a first way) and to be withdrawn from the catheter adapter  14  (a second way). In other embodiments, the valve  40  is a one-way valve, which is a valve  40  that only permits substantial fluid flow in a single direction when the valve  40  is open. A non-limiting example of a one-way valve is a check valve. In some embodiments, no other valves are used to regulate fluid flow through the port  30  other than the valve  40 . By thus positioning the valve  40  on a port  30  of a catheter adapter  14 , the valve  40  can avoid problems caused when an introducer needle  20  is left within an in-line valve for an extended time. 
     In some configurations, the port  30  can be disposed at an angle  42  relative to the longitudinal axis  24  of the catheter adapter  14 . The angle  42  can be measured between the portion of the longitudinal axis  24  extending to the proximal end of the catheter adapter  14  and the central axis  38  of the port  40 . For example, the angle  42  of the port  30  of  FIG. 1  is about 90° and the angle  42  of the port  30  of  FIG. 6  is about 45°. The angle  42  can at least partially control to the direction at which fluids are infused though the port  30 . Thus, the angle  42  of the port  30  can be modified to facilitate use, optimize performance, and/or optimize fluid flow within the inner lumen  16 . In some embodiments, the angle  42  is between about 15° to about 30°. In other embodiments, the angle  42  is between about 30° to about 45°. In still other embodiments, this angle  42  is between about 45° to about 60°. In yet other embodiments, the angle  42  is between about 60° to about 90°. Accordingly, in some embodiments, the angle  42  is between about 15° to about 90°. 
     The port  30  can include a port body  36  having one or more integrated body portions, which extend outwardly from the sidewall  32  of the catheter adapter  14 . Typical plastic materials such as, for example, polycarbonate, polyethylene, polypropylene and co-polyesters could be used to form the port body  36 . The port body  36  can define an inlet  44  and a bore  48  extending between the inlet  44  and the opening  34  of the inner lumen  18 . The inlet  44  and at least a portion of bore  48  can be shaped and sized in conformity with at least some of the International Standards Organization (ISO) standards for a female luer connection. This will allow a male luer slip or male luer lock to be connected to port  30 . 
     In various embodiments, the exterior of the port body  36  can include one or more luer threads  50  in any number of thread configurations available to provide and interlock between mating devices. The luer threads  50  can allow another medical device having a male luer lock to be connected to and interlocked with the port  30 . Alternatively, as shown in  FIG. 9 , the port body  36  can also have no luer threads to accommodate luer slip and luer lock connections. 
       FIGS. 1 through 9  illustrate various types of valves  40  that can be used in accordance with various embodiments of the port  30 . These valve types are not presented as an exhaustive set of valve types, and thus it will be understood that other suitable valves  40  can be utilized in port  30 . Reference will first be made to the valve  40  of  FIG. 1 . The valve  40  can include an elastomeric septum  56  that can form a fluid barrier until it deforms to allow fluid flow therethrough. The septum  56  can be located on the inlet  44 , within the inlet  44 , or within the bore  48  of the port body  36 . Materials such as silicone, silicone rubber, or polyisoprene can be used to form septum  56 . The septum  56  can be formed as a single piece of elastomeric material that is formed to having various shapes and features. Alternatively, the septum  56  can be a two-piece configuration having a flexible inner material, such as silicon or silicone rubber, and a more rigid outer portion, such as an outer ring. The outer ring can be formed of a plastic or metal or other suitable material. The septum  56  can also include a slit  58 . In some configurations, at least a portion of the septum  56  is glued to the port body  36  using one or more adhesives. Additionally or alternatively, in some configurations, at least a portion of the septum  56  is held in place between two or more portions of the port body  36 . 
       FIG. 2  illustrates a perspective top view of the catheter assembly  10  of  FIG. 1 . As shown, the port  30  can be accessed, with a male luer device (such as the luer access connector  80  of  FIG. 6 ) that is inserted through the slit  58  of the septum  56 . The male luer device can be interlocked with the luer threads  50  if the male luer device includes a luer lock. In this manner, a separate access device can be coupled to the catheter adapter  14  through the port  30  to establish fluid communication therethrough. Additionally, a syringe, needle, or other such device can be inserted through the slit  58  of the septum  58  to withdraw fluids therethrough. 
       FIGS. 3 to 5  will now be referenced. These figures illustrate the use of manually activated valves  40  that can control the flow of fluid through the port  30 . Reference will first be made to  FIG. 3 , which illustrates a ball valve  60  that includes a spherical member  66  disposed within the bore  48  of the port  30 . The spherical member  66  can have a hole  64  through the middle so that when the hole  64  is in line with a central axis  38  of the port  30 , the ball valve  60  is open. By turning the spherical member  66 , such as with an actuator  62 , the hole  64  becomes perpendicular to the central axis  38  of the port body  36  and the ball valve  60  is closed. An actuator  62  can be coupled to the spherical member  66  such that as the actuator  62  is turned, the spherical member  66  is moved between the open and the closed positions. In some configuration, as shown, the actuator  62  includes the gripping portion  68  that is shaped and sized to accommodate the fingers of a medical personnel and to provide leverage for turning the actuator  62 . 
     Some embodiments of the ball valve  60  are configure so that the hole  64  through the spherical member  66  is in conformity with at least some of the ISO standards for a female luer connection, as described above. This configuration can permit the insertion of a male luer into the hole  64  of the spherical member  66  as the male luer is inserted into the port  30 . Additionally, as shown, a cap  70  can be removably coupled to the inlet  44  of the port  30 . The cap  70  can cover the inlet  44  and prevent contamination from entering therein. 
       FIGS. 4 and 5  illustrate another manually activated valve  40 , an iris valve.  FIG. 4  illustrates a cross-sectioned view of the iris valve  72 . The iris valve  72  can generally includes a series of plates  74  that can fold in on each other and expand out to open and close the port  30 . When actuated, this series of plates  74  can open by degrees to provide a variable sized opening through the iris valve  72 .  FIG. 5  illustrates a top perspective view of the iris valve  72 . As shown, the iris valve  72  is in a closed position with the series of plates  72  forming a barrier across the port  30  that seals the opening  34  into the inner lumen  16  of the catheter adapter  14 . An actuator  62  can be coupled to the iris valve  72  such that as the actuator  62  is moved, the iris valve  72  is moved between the open and the closed positions. In some configuration, as shown, the actuator  62  includes the gripping portion  68  that is shaped and sized to accommodate the fingers of a medical personnel and to provide leverage for turning the actuator  62 . 
     Reference will now be made to  FIG. 6 , which illustrates a port  30  with a central axis  38  disposed at an angle  42  of approximately 45° relative to the longitudinal axis  24  of the catheter adapter  14 . As shown, in some embodiments, the port  30  can be coupled to a removable valve  40 . The removable valve  40  can be selectively coupled to the port body  36 , such as, via the luer threads  50 . For instance, the removable valve  40  can be coupled to a removable luer access connector  80 . A non-limiting example of such a luer access connector  80  is described in United States Published Patent Application No. 2003/0109853, filed on Dec. 7, 2001, entitled, “Needleless luer access connector,” which is herein incorporated by reference in its entirety. Other such luer access connectors  80  can also be used. As shown, some embodiments of a luer access connector  80  can include a housing  82  having a top housing portion  94  and bottom housing portion  96 . A septum  84  can be located in top housing portion  94  of the luer access connector  80  to control fluid flow therethrough. The septum  84  can have a top portion  86 , a medial portion  88 , and a bottom portion  90 . The bottom portion  21  of the septum  84  can be disposed and/or held in tension between the top housing portion  94  and bottom housing portion  96 . Additionally, a slit  92  can be formed in septum  84  which extends longitudinally through proximal portion  86 , medial portion  88 , and distal portion  90  of the septum  84 . 
     The bottom housing portion  96  of the luer access connector  80  can have an outlet  100  that is sized and configured as a male luer taper that complies with the ISO standards for a male luer taper and which thus can be inserted into the bore  48  of the port  30 . Moreover, the bottom housing portion  96  can include a luer lock collar  98  formed about the outlet  100  to selectively lock the luer access connector  80  to the luer threads  50  of the port body  36 . 
     Turning now to  FIG. 7 , in some embodiments, the top housing portion  94  of the luer access connector  80  is connected directly and/or fixedly to the port body  36 . This configuration can reduce the overall port size and number of require parts included in the port  30 . 
       FIG. 8  depicts a cross-sectioned view of the catheter assembly of  FIG. 7  taken along line  8 - 8  of  FIG. 7 . As shown, in embodiments where top housing portion  94  of a valve housing  82  is directly connected to the port body  36 , the bottom portion  90  of the septum  84  can be held in tension between the top housing portion  94  and the port body  36 . Moreover, to secure this connection, the top housing portion  94  and the port body  36  can be bonded together to prevent contamination of the port  30 . Any standard bonding technique, such as chemical adhesive or ultrasonic welding can be used to bond top housing portion  94  of the housing to port body  36 . In addition, as shown, the shape and size of the port body  36  can be configured to accommodate the movement of the septum  84 . 
     As further shown in  FIG. 8 , in some embodiments, a port  30  and the valve  40  are used with a blood control-type catheter assembly  10 . Blood control-type catheter assemblies  10  generally includes a blood control septum  110  disposed within the inner lumen  16  of the catheter assembly  10 . The blood control septum  110  can open by a septum activator  112  when a luer device (not shown) is inserted into the proximal end  28  of the catheter adapter  14 . The luer device can advance the septum activator  112  distally through the blood control septum  110  to form an open fluid path therethrough. A representative blood control-type catheter assembly is disclosed in United States Published Patent Application No. 2011/0046570, entitled “Systems and methods for providing a flushable catheter assembly,” filed Aug. 20, 2009, which is herein incorporated by reference in its entirety. 
     A valve in the port  30  can provide a number of benefits to the blood control-type catheter assemblies  10 . For instance, a blood control septum  110  may remain open after the septum activator  112  is inserted through the blood control septum  110 . This blood control septum  110  may remain open, even after the male luer that advanced the septum activator  122  is removed. In this open state, fluids can flow out the catheter adapter  14  and be exposed to medical personnel. However, using the valve on the port  30 , medical personnel can access the inner lumen  16  of the catheter adapter  14  without being exposed to the patient&#39;s blood. 
     Specific reference will now be made to the components of the blood control-type catheter assembly  10  depicted in  FIG. 8 . As shown, a catheter assembly  14  can have a blood control septum  110  located within the inner lumen  16  of the catheter adapter  14 . A septum activator  112  can be located within the inner lumen  16  at a location that is behind the blood control septum  110 . The blood control septum  110  can generally comprises a flexible or semi-flexible polymer plug. The blood control septum  110  can have an outer diameter that is configured to compatibly seat within a groove or channel  114  formed on an inner surface  116  of the catheter adapter  14 . Alternatively, a groove or channel can be formed in the outer surface of the blood control septum  110 , which interlocks with one or more features on the inner surface  116  of the catheter adapter  14 . In some embodiments, the blood control septum  110  is barrel shaped, while in other configurations, the blood control septum  110  is substantially cylindrical or disk shaped. The blood control septum  110  can be elastomeric and include one or more slits  118  through which the septum activator  112  can be inserted. 
     The septum activator  112  can be a probe-like structure that is primarily housed behind the septum  110  within the inner lumen  16  of the catheter adapter  14 . The septum activator  112  generally comprises a tubular body  122  that is rigid or semi-rigid. The tubular body  122  further comprises an inner lumen  124  for facilitating flow of a fluid and/or liquid through the septum activator  112 . The distal end of the tubular body  122  can be shaped and sized to compatibly enter within the one or more slits  118  of the septum  110 . 
     Referring now to  FIG. 9 , in some instances, as shown, the exterior of the port body  36  may have no luer threads. This can allow for a luer access connector  80  or another separate luer device having a male luer slip to be connected to the port body  36 . This type of port  30  can thus enable a wide variety of devices to be connected therein. Furthermore, in some instances, a septum  56 , such as that shown in  FIG. 1 , can be included within the port  30  to avoid blood exposure when the separate luer device is removed from the port  30 . 
     Turning now to  FIG. 10 , in some embodiments, the septum activator  112  of a blood control-type catheter assembly  10  can be activated and/or deactivated by pressing a button  130  on a port  30 . The button  130  can enable medical personnel to manually activate and deactivate the septum  110  as needed. In operation, the septum activator  112  can be advanced distally through the septum  110  when the button  130  is pressed a first time, and withdrawn from the septum  110  when the button  130  is pressed a second time. In some configurations, the button  130  is coupled to the sidewall  32  and extends outwardly from the catheter adapter  14 . Moreover, the button  130  can be coupled directly to the septum activator  112  or be indirectly coupled thereto via one or more connecting members. For example, the button  130  can be coupled to one or more translating mechanisms  134  that translate the inward movement of the button  130  to distal or proximal movements of the septum activator  112 . 
     From the foregoing it will be understood, that a catheter assembly of the present invention can include a valve that is located on a port of a catheter adapter rather than in-line with the needle path of an introducer needle. This valve on a port can avoid problems caused when a needle is left within septum for an extended period and further provide the ability to infuse and withdraw fluids through the port. This valve can be a two-way valve that facilitates the infusion and withdrawal of fluids to and from the catheter assembly. When used with blood control-type catheter assemblies, the valve can reduce the likelihood of blood contamination when connecting and disconnecting various components to the catheter assembly. Some configurations also include a push-button septum activator that can provide medical personnel with the ability to manually activate and deactivate the blood control valve as needed. 
     The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.