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    • 专利摘要:
    systems and methods for providing a ventable catheter assembly. it is a purgeable/washable catheter assembly having features to allow selective activation of fluid flow through the catheter assembly. a septum is placed within the catheter adapter of the catheter assembly of the catheter assembly and includes a path that is closed before being opened by guidance through a septum activator also positioned within the catheter adapter. a plurality of air vent channels are interposed between the septum and the inner surface of the catheter adapter to allow for a "backflow" of blood during insertion of the catheter into a patient. the septum activator is advanced through the path of the septum as a coupler is attached to a proximal opening of the catheter adapter.
    公开号:BR112013001047B1
    申请号:R112013001047-9
    申请日:2011-03-16
    公开日:2021-09-14
    发明作者:Marty L. Stout；Weston F. Harding；Ray S. Isaacson；Jonathan K. Burkholz；Austin Jason Mckinnon
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Background of the invention
    [001] The present invention relates to infusion devices, specifically, peripheral intravenous (IV) catheters. In particular, the invention relates to a purgeable/washable peripheral IV catheter assembly having features to allow selective activation of fluid flow through the catheter assembly.
    [002] Catheters are commonly used in a variety of infusion therapies. For example, catheters are used in infusing fluids such as normal saline, various medications, and total parenteral nutrition in a patient, collecting blood from a patient, as well as monitoring the various parameters of the patient's vascular system.
    [003] Typically, catheters or needles are attached to a catheter adapter to allow attachment of an IV tube to the catheter. Therefore, following placement of the catheter or needle in a patient's vasculature, the catheter adapter is coupled to a fluid source through a section of the IV tube in order to verify proper placement of the needle and/or catheter in the vessel The clinician usually checks for a “return” of blood in a return chamber of the catheter assembly.
    [004] Once proper placement of the catheter is confirmed, the clinician must then attach the catheter adapter to a section of the IV tube. This process requires the clinician to manually occlude the vein in order to avoid unwanted exposure to blood. Manual obstruction of the patient's vein requires the clinician to awkwardly maintain pressure on the patient's vein while simultaneously attaching the catheter adapter and IV tubing.
    [005] A common yet undesirable practice is to allow blood to temporarily and freely flow from the catheter adapter while the clinician locates and attaches the IV tube to the catheter adapter. Another common practice is to attach the catheter adapter to the IV tube before placing the needle or catheter into the patient's vein. While this method can prevent unwanted exposure to blood, a positive pressure within the IV line can also prevent a desirable return.
    [006] Complications associated with infusion therapy include significant morbidity and even mortality. These complications can be caused by regions of stagnant fluid flow within the vascular access device or in areas close to the extravascular system. These are regions where fluid flow is limited or non-existent due to the conformation of the septum or valve mechanism in the extravascular system or fluid dynamics in such an area of the extravascular system. Blood, air bubbles, or infused medications can become trapped within these stagnant flow regions as a result of limited or non-existent fluid flow. When blood becomes trapped within the extravascular system, bacteria can reproduce leading to infections. When a different medication is infused into the extravascular system, or when the extravascular system is exposed to physical trauma, the extravascular system fluid flow can become altered, releasing trapped air bubbles or residual medications back into the system's active fluid pathway extravascular. This release of air bubbles and residual medication into the active fluid pathway of the extravascular system can result in significant complications.
    [007] Released air bubbles can block fluid flow through the extravascular system and prevent its proper functioning. More seriously, the released air bubbles can enter the patient's vascular system and block blood flow, causing tissue damage and even stroke. Furthermore, residual medications can interact with currently infused medications causing precipitates within the extravascular system and preventing its proper functioning. Additionally, residual medications can enter the patient's vascular system and cause unintended and/or unwanted effects.
    [008] Correspondingly, there is a need in the art for a catheter assembly that allows for desirable controlled return without risks of unwanted exposure to blood occurring. Additionally, there is a need in the art to provide a valve mechanism in a catheter assembly that eliminates, avoids, or limits stagnant flow regions within vascular access devices and the extravascular system in order to provide better purging properties. . In the present document, such catheter assembly is described. Brief summary of the invention
    [009] Aiming to overcome the limitations discussed above, the present invention relates to a purgeable/washable peripheral IV catheter assembly having features to allow a selective activation of fluid flow through the catheter assembly. The catheter assembly of the present invention generally includes a catheter coupled to a catheter adapter. In general, the catheter includes a metallic material, such as titanium, surgical steel, or an alloy, as is commonly known in the art. In some embodiments, a polymeric catheter can be used in combination with a metallic introducer needle, as is commonly known and used in the art.
    [010] In some embodiments of the present invention, a septum is positioned within a lumen of the catheter assembly to prevent or limit the flow of a fluid through the catheter adapter. In general, the septum includes a flexible or semi-flexible material that is compatible with exposure to blood, medications, and other fluids commonly encountered during infusion procedures. In some embodiments, a groove is provided on an inner surface of the catheter adapter, and the septum is seated within the groove. As such, the position of the septum within the catheter adapter is maintained.
    [011] In some implementations of the present invention, a closed or partially closed path such as a slit or a small hole is additionally provided in a septum barrier surface. The trajectory allows fluid to bypass the septum and flow through the catheter adapter. In some embodiments, the trajectory is a slit that is closed before being opened or activated by a probe or septum activator positioned within the lumen of the catheter adapter. Before being opened or activated, the slit prevents fluid from passing through the catheter adapter. Therefore, in some embodiments, a plurality of air vent channels are interposed between the septum and the slit to allow air to flow through the catheter adapter before the slit is opened. Air vents prevent positive pressure build-up within the catheter adapter, thus allowing blood to flow back into the catheter and into a chamber ahead of the catheter adapter.
    [012] The septum activator generally includes a plastic or metallic tubular body having a probe end and a contact end. The probing end is positioned adjacent the septum path, and the contact end is positioned adjacent a proximal opening of the catheter adapter. The probing end of the septum activator is advanced through the septum path when a probe is inserted into the proximal opening of the catheter adapter. As the probe contacts the septum activator contact surface, the septum activator is advanced in a distal direction through the catheter adapter immediately after the probing end of the septum activator opens its path through the septum. Once opened, a free flow of fluid is allowed through the catheter assembly.
    [013] Finally, the presence of the septum activator within the lumen of the catheter adapter can result in aberrant fluid flow that leads to undesirable stagnation and clotting of fluids within the catheter assembly. Therefore, in some embodiments of the present invention, the septum activator further includes multiple flow deflectors and/or flow diversion channels to maintain proper fluid flow within the catheter adapter. Brief description of the various views of the drawings
    [014] In order that the manner in which these and other features and advantages of the invention are obtained is more readily understood, a more particular description of the invention briefly described above will be provided by reference to the specific embodiments thereof that are illustrated in the attached drawings. These drawings describe only typical embodiments of the invention and, therefore, are not to be considered as limiting the scope of the invention.
    [015] Figure 1 is a cross-sectional view of an indwelling catheter having a prior art flow control valve mechanism.
    [016] Figure 2 is a cross-sectional view of the prior art indwelling catheter of Figure 1 following removal of an introducer needle.
    [017] Figure 3 is a cross-sectional view of the prior art indwelling catheter of Figures 1 and 2 following insertion of a connector from a vascular access device.
    [018] Figure 4 is a perspective view of one embodiment of a catheter assembly in accordance with the present invention.
    [019] Figure 5A is an exploded cross-sectional view of a catheter assembly in accordance with the present invention.
    [020] Figure 5B is a perspective view of an embodiment of a septum according to the present invention.
    [021] Figure 6A is a cross-sectional view of an inner lumen of a catheter adapter that demonstrates fluid flow without the presence of a septum activator according to a representative embodiment of the present invention.
    [022] Figure 6B is a perspective view of an embodiment of a septum activator according to the present invention.
    [023] Figure 6C is a side view of an embodiment of a septum activator disposed in an inner lumen of a catheter adapter according to the present invention, following activation.
    [024] Figure 6D is a side view of an embodiment of a septum activator disposed in an inner lumen of a catheter adapter according to the present invention, demonstrating fluid flow through the catheter adapter.
    [025] Figure 7 is a cross-sectional view of an assembled catheter assembly in accordance with the present invention, prior to activation.
    [026] Figure 8 is a cross-sectional view of an assembled catheter assembly in accordance with the present invention, following activation.
    [027] Figure 9 is a cross-sectional view of a catheter-on-needle assembly assembled in accordance with the present invention, prior to activation.
    [028] Figure 10 is a cross-sectional view of a catheter assembly over the needle mounted in accordance with a representative embodiment of the present invention, following the removal of the introducer needle.
    [029] Figures 11A to 11D are cross-sectional views of the septum having various features and a configuration according to representative embodiments of the present invention.
    [030] Figure 12 is a cross-sectional view of a catheter-over-needle assembly mounted in accordance with a representative embodiment of the present invention, following activation.
    [031] Figure 13 is a cross-sectional view of a catheter body having a flow control valve mechanism and a septum activator according to a representative embodiment of the present invention, before activation.
    [032] Figure 14 is a cross-sectional view of a catheter body having a flow control valve mechanism and a septum activator according to a representative embodiment of the present invention, following the activation.
    [033] Figure 15 is a cross-sectional view of a catheter body having a flow control valve mechanism and a septum activator according to a representative embodiment of the present invention, before activation.
    [034] Figure 16 is a cross-sectional view of a catheter body having a flow control valve mechanism according to the representative modality shown in Figure 15, following activation.
    [035] Figure 17 is a cross-sectional view of a catheter body having a flow control valve mechanism and a septum activator according to a representative embodiment of the present invention, prior to activation.
    [036] Figure 18 is a cross-sectional view of a catheter body having a flow control valve mechanism according to the representative embodiment shown in Figure 17, following activation.
    [037] Figure 19 is a cross-sectional view of a catheter body having a flow control valve mechanism and a septum activator according to a representative embodiment of the present invention, before activation.
    [038] Figure 20 is a cross-sectional view of a catheter body having a flow control valve mechanism according to the representative embodiment shown in Figure 19, following activation.
    [039] Figure 21 is a cross-sectional view of a vented blood control valve and a Y-port adapter having a flow control valve mechanism according to a representative embodiment of the present invention, prior to activation .
    [040] Figure 22 is a cross-sectional view of a vented blood control valve and a Y-port adapter having a flow control valve mechanism according to a representative embodiment of the present invention, following activation .
    [041] Figure 23 is a cross-sectional view of a vented blood control valve and a single-port straight luer adapter having a flow control valve mechanism in accordance with a representative embodiment of the present invention, above of activation.
    [042] Figure 24 is a cross-sectional view of a vented blood control valve and a single-port straight luer adapter having a flow control valve mechanism in accordance with a representative embodiment of the present invention , following activation. Detailed description of the invention
    [043] The presently preferred embodiment of the present invention will be better understood by reference to the drawings, with similar numerical references indicating identical or functionally similar elements. It will be readily appreciated that the components of the present invention, as generally described and illustrated in the figures, can be arranged and designed in a wide variety of different configurations. Therefore, the more detailed description below, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of the presently preferred embodiments of the invention.
    [044] The term “proximal” is used to denote a portion of a device that, during normal use, is closer to the user and further away from the patient. The term “distal” is used to denote a portion of a device that, during normal use, is further away from the user handling the device and closer to the patient. The term “activation” of the valve or septum mechanism is used to denote the opening or closing action of such a valve.
    [045] An example of a prior art extravascular system is described in US Patent No. 7,008,404 and shown in Figures 1 to 3. An indwelling catheter has, as shown in Figure 1, a hollow catheter body 1, a catheter 2 fitted into a retainer 1b provided at a distal end of the catheter body 1, a septum 3 fitted into the catheter body 1, and a hollow impeller 4 slidably fitted into the catheter body 1. The catheter tube 2, septum 3, and impeller 4 are coaxially aligned in this order.
    [046] Catheter body 1 is tubular in shape. An inner surface 1a is tapered towards the distal end, with a gradually reduced diameter. The catheter body 1 is preferably a transparent or semi-transparent material so that it shows the interior, allowing the verification of internal movement. Suitable materials for catheter body 1 include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene and the like.
    [047] The catheter 2 is press-fitted into the tube retainer 1b that communicates at its proximal end with the inside of the catheter body 1. It is preferred that a lubricating coating is provided to all or part of the catheter. 2 for the purpose of reducing resistance caused by insertion through the skin or into a blood vessel. Suitable materials for catheter 2 include, but are not limited to, thermoplastic resins such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyurethane, and the like. Preferably, catheter 2 is formed from a thermoplastic hydrophilic polyurethane which softens upon exposure to physiological conditions present in the patient's body.
    [048] The septum 3 is generally tubular in shape having a proximal end 8 and a membrane section 9 having a smooth flat surface 10 located at the distal end 11. Typically, the septum 3 further includes a single needle slit 3a or a valve opening located around the center of the membrane section 9, extending through the membrane section 9, so as to facilitate penetration of the septum 3 by the introducer needle 5. The opposing slit surfaces of the needle slit 3a are designed to conform accurately to the shape of introducer needle 5 during storage and prevent fluid leakage during and after removal of introducer needle 5, then seal by removing introducer needle 5. With impeller 4 inserted, the slit 3a expands forward in the distal direction and opens, providing fluid communication between catheter 2 and the back of catheter body 1. An annular bulge 3b is provided over the inner surface of a rear opening of septum 3, for engaging a shoulder 4c at the distal end of impeller 4 for the purpose of limiting movement of impeller 4 in the proximal direction and preventing displacement of impeller 4 from septum 3. a plurality of spans 3c between an outer periphery of septum 3 and the inner surface 1a of catheter body 1. The distal and proximal spaces divided by septum 3 communicate with each other through spans 3c. Therefore, septum 3 slides smoothly with air passing through gaps 3c.
    [049] Impeller 4 is typically constructed from a rigid thermoplastic material or a similar material, and has a lumen extending through it. The impeller 4 has a tubular portion 4a, a tapered flange 4b connected to the proximal rear end of the tubular portion 4a, and a shoulder 4c that projects from an outer periphery of the tubular portion 4a. Therefore, an annularly shaped interstitial space is created between the tubular portion 4a and the inner surface 1a of the catheter body 1. The distal anterior end of the tubular portion 4a is chamfered to facilitate its penetration into the slit 3a of the septum 3, and is supported by sliding mode through the annular protrusion 3b of the septum 3. The tapered flange 4b has a tapered inner surface for the purpose of facilitating the insertion of the needle 5 therein. The peripheral surface of the flange 4b contacts the inner surface 1a of the catheter body 1 and serves to provide stability to the impeller 4 and maintain the coaxial position with respect to the catheter 2. However, the peripheral surface of the flange 4b does not form a fluid seal with inner surface 1a.
    [050] The indwelling catheter is prepared for use in such a state as shown in Figure 1 with the front end of needle 5 protruding from the front end of catheter 2. In this state, needle 5 penetrates through septum 3, providing a hermetic connection to water between these, and thus preventing blood leakage.
    [051] The indwelling catheter in this state is inserted into a patient's body. Then, as shown in Figure 2, needle 5 is removed with tube 2 retained in the patient's body. The septum 3 maintains a fluid seal upon removal of the needle 5 and is retained in the catheter body 1 by an annular protrusion 1e. Impeller 4 is retained in a proximal position and accepts the interaction of annular boss 3b and shoulder 4c.
    [052] A connector 6 (eg, a luer connector) of a vascular access device is then inserted from the proximal end of catheter body 1. When pressed into catheter body 1, connector 6 pushes into its distal end the impeller 4. Therefore, the impeller 4 slides forward in the distal direction to press at its distal end the slit 3a of the open septum 3, thus activating the flow control valve to the open position. The septum 3 is then pressed against the inner surface of a tapered cavity 1c of the catheter body 1 which interrupts the forward movement of the impeller 4 in a distal position as shown in Figure 3, thus providing a match between the catheter. 2 and the vascular access device. The tapered inner surface 1a of the catheter body 1 allows for smooth insertion of the connector 6 and close contact between an outer surface 6a of the connector 6 and the inner surface 1a through a snap fit for the purpose of preventing fluid leakage out of the proximal end of catheter body 1.
    [053] However, it should be noted that this valve mechanism has small interstitial spaces/areas within the catheter body 1 in which fluids can flow during use, which results in areas of little or no fluid flow. For example, in use, fluid can flow between the peripheral surface of the flange 4b and the inner surface 1a of the catheter body 1 and in the interstitial space 98 between the outer periphery of the tubular portion 4a and the inner surface 1a. Furthermore, fluid can flow in the interstitial space 99 which is the gap 3c between the outer periphery of the septum 3 and the inner surface 1a of the catheter body 1. The little or no fluid flow that exists in the spaces/areas 98 and 99 makes it very difficult to subsequently purge any blood, medication, or air bubbles that may flow into these areas during catheter use.
    [054] Referring now to Figure 4, a catheter assembly 101 is illustrated. The catheter assembly 101 generally includes a catheter 12 coupled to a distal end 32 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 is in fluid communication with a lumen 18 of the catheter 12. The catheter 12 generally comprises a biocompatible material having rigid enough to withstand the pressures associated with inserting the catheter into a patient. In some embodiments, catheter 12 comprises a metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof. In other embodiments, catheter 12 comprises a rigid polymeric material such as vinyl. A tip portion 20 of the catheter is generally configured to include an oblique cutting surface 48. The oblique cutting surface 48 is used to provide an opening in a patient to allow insertion of the catheter 12 into the patient's vascular system.
    [055] Catheter mount features can be incorporated for use with an over-the-needle catheter mount. For example, a flexible or semi-flexible polymeric catheter can be used in combination with a rigid introducer needle to allow insertion of the catheter into a patient. Surgically implanted catheters can also be used.
    [056] Once inserted into a patient, catheter 12 and catheter adapter 14 provide a fluid conduit to facilitate the delivery of a fluid and/or the recovery of a fluid from a patient, as required by a procedure. of desired infusion. Therefore, in some embodiments, the material of catheter 12 and catheter adapter 14 are selected so that they are compatible with biofluids and drugs commonly used in infusion procedures. Additionally, in some embodiments, a portion of catheter 12 and/or catheter adapter 14 is configured for use in conjunction with a section of intravenous tubing 40 to further facilitate delivery of a fluid or removal of a fluid from a patient.
    [057] In some embodiments, a proximal end 22 of the catheter adapter 14 includes a flange 28. The flange 28 provides a positive surface that can be configured to allow coupling of an intravenous tubing or patient conduit 40 to the fitting of a catheter 101. In some embodiments, flange 28 includes a set of threads 30. Threads 30 are generally provided and configured to matchably receive a complementary set of threads 44 that comprise a portion of a male luer or conduit coupler 42. Conduit coupler 42 is generally fluid-tightly coupled to an end portion of patient conduit 40 in a fluid-tight manner. In some embodiments, an inner portion of conduit coupler 42 is extended outwardly to provide a probe surface 46.
    [058] The probe surface 46 is generally configured to fit compatible within a proximal end 22 of the catheter adapter 14. After insertion of the probe 46 into the proximal end 22 of the catheter adapter 14, the conduit coupler 42 is rotated to interlock coupler 42 and flange 28 (through thread sets 30 and 44). During the interlocking process of coupler 42 and flange 28, probe 46 is advanced into lumen 16 of catheter adapter 14 to an inserted position (as shown in Figure 8). The inserted position of probe surface 46 activates catheter assembly 101 to allow fluid flow through catheter 12 and catheter adapter 14. Once conduit coupler 42 and catheter adapter 14 are secured, a fluid can be delivered to a patient through patient conduit 40 and inserted catheter 12.
    [059] Referring now to Figure 5A, an exploded cross-sectional view of a catheter assembly 101 is shown. In some embodiments, the catheter adapter 14 includes various design features and components to control and/or limit the fluid flow through the catheter assembly 101. For example, in some embodiments of the present invention, a septum 50 is positioned within the inner lumen 16 of the catheter adapter 14. The septum 50 generally comprises a flexible or semi-flexible polymeric plug having an outer diameter that is configured to fit compatible within a groove or channel 60 formed on an inner surface 24 of the catheter adapter 14. In some embodiments, the septum 50 is barrel-shaped having a barrier surface 52 comprising a distal end of septum 50 and further having an opening 54 comprising a proximal end of septum 50. When positioned within channel 60, the barrier surface 52 of septum 50 divides inner lumen 16 of catheter adapter 14 into a front fluid chamber 62 and a rear fluid chamber 64. Therefore, the presence of septum 50 controls or limits fluid passage between the front fluid chambers. and back 62 and 64. Specifically, a chosen configuration of the barrier surface 52 of the septum 50 largely determines the ability of a fluid to flow through the inner lumen 16 of the catheter adapter 14.
    [060] For example, in some embodiments, the barrier surface 52 of the septum 50 is configured to include a slit 56. The slit 56 is configured to provide selective access or flow of a fluid through the barrier surface 52. In some embodiments , the slit 56 is configured to remain in a closed fluid impermeable position until it is activated or opened by advancing a septum activator 80 through the slit 56 in a distal direction 390. In some embodiments, the barrier surface 52 comprises a slot 56. In other embodiments, the barrier surface 52 is modified to include multiple slots 56 and 66, as shown in Figure 8.
    [061] In some therapeutic infusion techniques, it may be desirable to allow a controlled flow of fluid through the septum 50 before activating the septum 50 with the septum activator 80. Therefore, in some embodiments, the cleft 56 further comprises , an exhaust port 58. The exhaust port 58 is positioned on the barrier surface 52 and comprises an aperture diameter calculated to allow a controlled flow of liquid or air between the front and rear layers 62 and 64. In some embodiments. , barrier surface 52 is modified to include a single exhaust port 58. In other embodiments, barrier surface 52 is configured to include multiple exhaust ports. In yet other embodiments, the barrier surface 52 does not include a slit 56, but instead includes at least one exhaust port 58. For these embodiments, the septum 50 generally comprises an elastic material such that when the septum activator 80 is advanced in a distal direction 390, a leading edge 92 of the septum activator 80 contacts the barrier surface 52 and stretches the exhaust port 58 to provide a larger orifice, thus allowing for increased flow of air and/or fluid through the catheter adapter 14.
    [062] The slot or channel 60 in which the septum is seated comprises a recessed portion of the inner surface 24 of the catheter adapter 14. The outer diameter of the septum 50 is generally configured to fit compliantly and securely within the channel 60. For example, in some embodiments, the outer diameter of septum 50 is selected so that it is slightly smaller than the diameter of channel 60 and slightly larger than the diameter of inner lumen 16. As such, septum 50 is retained within channel 60 while using the 101 catheter assembly.
    [063] In some therapeutic infusion techniques, airflow between the front and rear chambers 62 and 64 may be desirable. For example, for those embodiments that comprise a septum 50 having a fluid impermeable slit 56, the passage of air from the front chamber 62 to the rear chamber 64 is prohibited prior to opening or activating the septum 50 through the septum activator 80 , as previously discussed. Therefore, when catheter 12 of catheter assembly 101 is inserted into a patient's vascular system, positive pressure builds up within front chamber 62, thereby preventing a desired return of the patient's blood to the catheter. teter 14. An observable feedback is generally desirable to confirm accurate placement of the tip of catheter 20 into the patient's vein. Therefore, some embodiments of the present invention include features or elements to allow airflow between the front chamber 62 and the rear chamber 64 without requiring activation of the septum 50 with the septum activator 80. As such, some embodiments of the present invention provide observable feedback, as generally desired for infusion procedures.
    [064] For example, in some embodiments, the barrier surface 52 of the septum 50 is modified to include an exhaust port 58, as previously discussed. In other embodiments, a plurality of air vent channels 70 are interposed between the septum 50 and the inner surface 24 of the catheter adapter 14. The air vent channels 70 relieve positive pressure within the forward chamber 62 by providing an access for air to bypass septum 50 in rear chamber 64. In some embodiments, air vent channels 70 are constructed by removing surface portions of channel 60, resulting in a plurality of generally parallel grooves.
    [065] In addition to allowing airflow between the front and rear chambers 62 and 64, the vent channels 70 can be configured to allow fluid to flow through the catheter adapter 14 prior to activating or opening the slit 56 with the septum activator 80. In some embodiments, the rate at which air and/or fluid flow between the front and rear chambers 62 and 64 is adjusted by fabricating the catheter adapter 14 to include a greater or lesser number of channels. vent 70. In other embodiments, the rate at which air and/or fluid flow between the front and rear chambers 62 and 64 is adjusted by fabricating the catheter adapter 14 so that it includes vent channels 70 having an area at larger or smaller cross section. Therefore, in some embodiments, the rate at which air and/or fluid flow between the front and rear chambers 62 and 64 is increased by fabricating a catheter adapter 14 having an increased number of vent channels 70, or vent channels 70 having a larger cross-sectional area. Conversely, in other embodiments, the rate at which air and/or fluid flow between the front and rear chambers 62 and 64 is reduced by fabricating a catheter adapter 14 having a reduced number of vent channels 70, or vent channels. vent 70 having a smaller cross-sectional area.
    [066] Continuing with reference to Figure 5A, the septum activator 80 comprises a probe-like structure that is primarily housed in the rear chamber 64 of the catheter adapter 14. The septum activator 80 comprises, in general, a tubular body 82 having a distal end 84 and a proximal end 86. The tubular body 82 comprises a rigid or semi-rigid material, such as a plastic or metallic material. Tubular body 82 further comprises an internal lumen 88 to facilitate the flow of a fluid and/or liquid through septum activator 80.
    [067] The distal end 84 of the tubular body 82 is configured to be compatiblely inserted into the opening 54 of the septum 50. The distal end 84 further includes a probe surface 90 that extends through the opening 54 of the septum. 50 to a position proximal to barrier surface 52 of septum 50, as shown in Figure 8. Probing surface 90 is advanced through slit 56 and 66, or through exhaust port 58 as the septum activator is advanced through catheter adapter 14 in a distal direction 390. Advancement of septum activator 80 through catheter adapter 14 will be discussed in detail, in accordance with Figures 7 and 8.
    [068] In yet other embodiments, the septum 50 is coated with a hydrophobic coating, or with a polymeric swelling coating to repel or prevent fluid from flowing through the vent channels 70. A hydrophobic coating is generally selected to reduce surface energy of septum 50 and/or adapter 14 so as to inhibit blood absorption in air vents 70. In some embodiments, a surface of septum 50 or catheter adapter 14 is coated with a polymeric polyxylylene material, such as parylene. Parylene is a chemically resistant coating with good barrier properties for inorganic and organic fluids, strong acids, caustic solutions, gases and water vapors. In some embodiments, a parylene coating is applied to the outer surface of the septum 50 through vapor deposition. In other embodiments, a polyxylylene polymer coating is applied to a vent channel 70 through vapor deposition.
    [069] In some embodiments, a dehydrated polymeric material is applied to a surface of the septum 50 or catheter adapter 14 comprising the vent channels 70. A dehydrated polymer is generally selected to expand or swell upon contact with a fluid. As such, when the dehydrated polymer swells, a flow through the vent channels 70 is blocked or obstructed by the swollen polymer. Initially, the dehydrated polymer generally comprises a thin profile prior to exposure to moisture. However, when exposed to moisture the polymer absorbs moisture which increases the polymer profile to block flow through the vent 70. Therefore, coating the septum 50 and/or catheter adapter 14 with a desired coating allows if there is an air flow between the front and rear chambers 62 and 64, a flow of fluid through the vent channels 70 is still avoided.
    [070] Referring now to Figure 5B, an embodiment of a septum 150 is shown. In some embodiments, an outer surface 166 of the septum 150 is modified to include a plurality of recessed grooves 72. The recessed grooves 72 provide paths between the front and rear chambers 62 and 64 through which air and/or fluid can flow. Therefore, in some embodiments, channel 60 does not include air vent channels 70, but instead, outer surface 166 of septum 150 is modified to provide a desired flow between front and rear chambers 62 and 64.
    [071] The patient's blood pressure is largely responsible for the rate at which blood and air flow through septum 50 and 150 of the catheter assembly 101. As such, the rate of flow through the system is affected by the combined effective hydraulic diameter of all flow paths. Therefore, in some embodiments, the hydraulic diameter of the vent channels 70 and/or the recessed slots 72 are modified to increase or decrease the flow rate through the catheter assembly 101. In other embodiments, the hydraulic diameter of the vent channels 70 and/or the recessed slots 72 are reduced, thus resulting in substantially reduced or interrupted flow through the ventilation means. The governing equation for controlling the flow rate through the ventilation medium is given in Equation 1, where BP is the blood pressure, A is the surface area of the ventilation medium, o is the surface tension of blood, and P is the perimeter of the ventilation means. Equation 1:BP(A) = ó(P)
    [072] Therefore, according to Equation 1, when the perimeter of the ventilation means is small, the ventilation means will allow air ventilation, but will prevent blood flow due to the relatively high surface tension (ó) of blood . However, when the perimeter of the ventilation medium is increased, the surface tension between the blood and the ventilation is reduced, thus allowing blood to flow slowly through the ventilations and around the septum to provide a desirable return, but controlled. Therefore, by adjusting the various variables in Equation 1, a desired flow is achieved. Therefore, based on the size and/or number of ventilations around the septum, designing the catheter assembly will provide a customized, controlled, and predictable blood flow around the 50 or 150 septum. controlled slow blood flow as a means of providing a visual indicator that the catheter is in the blood vessel, without the risk of immediate exposure to blood. In other embodiments, it is only desirable to allow air to pass through the vents.
    [073] Referring now to Figure 6A, there is shown a cross-sectional view of an inner lumen of a catheter adapter 14. In some embodiments, the catheter adapter 14 includes a forward fluid chamber 62 and a fluid chamber. rear fluid 64 fluidly connected through a narrow channel or port 160. As configured, and in some embodiments, a fluid path 170 is defined through which a fluid 146 flows downstream from the rear fluid chamber 64, through from port 160 and into front fluid chamber 62. Fluid path 170 continues through front fluid chamber 62 and exits distal end 32 into a catheter (not shown) or other downstream conduit. While fluid 146 fills the entire lumen of catheter adapter 14, fluid path 170 is generally restricted to a narrow path through a central portion of the cross-section of catheter adapter 14. Consequently, fluid 146 that does not form part of narrow fluid path 170 stagnates or circulates within the dead zones 156. The fluid 146 trapped within these dead zones is prevented from mixing sufficiently with the fluid 146 in the fluid path 170. In some embodiments, stagnation results in increased and localized concentrations of chemicals, bodily fluids and/or medications that can lead to precipitation, clotting, or administration of dangerously high doses of medications. Therefore, in some embodiments of the present invention, a septum activator 80 having capabilities to eliminate dead zones 156 within the lumen of catheter adapter 14 is provided.
    [074] Referring now to Figure 6B, there is shown a perspective view of the septum activator 80. In some embodiments, the distal end 84 of the tubular body 82 comprises a first diameter 100 that is less than a second diameter 102 of the proximal end 86. The narrower distal end 84 is configured to be compliantly inserted into the opening 54 of the septum 50, while the wider proximal end 86 is configured to fit compliantly within the rear chamber 64 of the adapter. of catheter 14. In some embodiments, the septum activator further includes a tapered intermediate section 104 for engaging the distal 84 and proximal 86 ends.
    [075] In some embodiments, the proximal end 86 of the septum activator 80 further includes a retaining spring 110. The retaining spring 110 generally comprises an outwardly oriented portion of the tubular body 82 configured to engage with compatible mode a 68 septum activator retention slot, as shown in Figures 5A, and 7-8. The interaction between retainer spring 110 and slot 68 limits lateral movement of septum activator 80 within lumen 16 of catheter adapter 14. Therefore, the width of retainer slot 68 determines or limits the displacement distance of the septum activator 80 within catheter adapter 14. Additionally, the interaction between retaining spring 110 and slot 68 prevents removal of septum activator 80 from catheter adapter 14. In some embodiments, septum activator 80 comprises a plurality of detent springs 110, while in other embodiments, the septum activator 80 comprises a single detent spring 110.
    [076] In some embodiments, the septum 80 activator further comprises features to direct or divert the flow of fluid around and/or through the septum 80 activator. Flow bypass can be important to avoid stagnation or coagulation of fluids within the dead zones 156 of the septum activator 80 and/or the lumen 16 of the catheter adapter 14, resulting in blockages. Additionally, stagnant fluid flow through catheter assembly 101 can result in an accumulation of unwanted drug concentrations within catheter adapter 14 and/or septum activator 80, as previously discussed. Highly undesirable concentrations can result in ineffective treatment causing serious side effects, including death. Therefore, in some embodiments, septum activator 80 is modified to include flow deflectors 120 and flow bypass channels 130 to provide a purgeable/washable catheter mounting system 101.
    [077] Flow deflectors 120 generally comprise inwardly and outwardly angled portions of septum activator 80 on the outer surface. Flow deflectors 120 are positioned so that they protrude in a flow path through catheter adapter 14. Therefore, as fluid contacts flow deflectors 120 the fluid flow path is impeded. This disturbance results in redirecting fluid flow both through the inner lumen 88 of the septum activator 80, and between the outer surface of the septum activator 80 and the inner surface 24 of the catheter adapter 14. In some embodiments, the retaining spring 110 also serves as a flow deflector 120.
    [078] A flow bypass channel 130 is provided to allow an exchange of fluid between the lumen of the catheter adapter 16 and the inner lumen 88 of the septum activator 80. Therefore, the flow bypass channel 130 prevents stagnation and /or occluding fluid between the inner surface 24 of the catheter adapter 14 and the outer surface of the septum activator 80. In some embodiments, the flow bypass channel 130 comprises a window or an opening in the surface of the tubular body 82. In other embodiments, the flow diverter channel 130 further comprises a tab or an angled surface to further direct fluid to flow through the channel 130.
    [079] The proximal end 86 of the septum activator 80 further includes a contact surface 140. The contact surface 140 comprises the more proximal end portion of the septum activator 80 and is positioned within the rear chamber 64 of the adapter. catheter 14 adjacent to proximal opening 26 of catheter adapter 14, as shown in Figure 7, below.
    [080] Referring now to Figure 6C, an embodiment of a septum 180 activator is shown positioned in the lumen of a catheter adapter 14 (shown in spectrum). In some embodiments, the septum 180 activator is configured to include various recirculation features. For example, in some embodiments, septum activator 180 includes multiple vents 200 configured to divert fluid from fluid path 170 into dead zones 156. Therefore, as fluid flows into and through septum activator 180, the fluid within the septum activator 180 passes through the vents 200 and into the dead zones 156 between the outer surface of the activator 180 and the inner wall surface of the catheter adapter 14. The bypass fluid mixes with the fluid in the dead zones 156 to purge fluid from the dead zones 156 and therefore avoid stagnation and/or overconcentration, as previously discussed.
    [081] In some embodiments, septum activator 180 is further modified to include bleed fins 220. Bleed fins 220 generally comprise a perpendicular extension of the outer surface of activator 180 that extends into dead zones 156 between activator 180 and the inner wall surface of catheter adapter 14. Bleed tabs 220 are provided to deflect and redirect fluid within fluid path 170 in dead zones 156. As such, fluid within dead zones 156 mixes with fluid in fluid path 170 to prevent stagnation and/or overconcentration of fluid within catheter adapter 14.
    [082] Finally, in some embodiments, the flow bypass channel 130 is modified to include a flow deflector 230. The flow deflector 230 comprises a beveled distal surface of the flow bypass channel 130 positioned to bypass fluid within the fluid path 170 into the dead zones 156 of the forward fluid chamber 62. Therefore, as the fluid 146 flows through the septum activator 180, a portion of the fluid is bypassed through the flow bypass channel 130 and into the dead zone 156 through the flow deflector 230 as shown in Figure 6D.
    [083] Continuing the reference to Figure 6D, a septum 180 activator in cross section is positioned inside a catheter adapter 14 in cross section. As previously discussed, recirculation features can be added to the proximal 86 and distal 186 ends of the septum activator 180. In some embodiments, the proximal end 86 of the septum activator 180 is modified to include curved window features 240 that redirect flow of a fluid 246 in the dead zones 156 of the rear fluid chamber 64. Therefore, the curved surface 242 of the window feature 240 alone and/or in combination with other recirculation features promotes mixing of the fluid within the dead zones 156 to avoid stagnation and overconcentration of fluids within the catheter adapter 14.
    [084] In some embodiments, the recirculation features are placed in a symmetrical configuration to induce better purge. In other embodiments, the recirculation features are placed in an asymmetrical configuration to better induce purge. Finally, in some embodiments, the recirculation features are used in combination with the additional diffusion, circulation, and recirculation features of the Septum Activator 180 to aid the Septum Activator 180's fluid purging capability. Additional surfaces of the septum 180 activator can be modified to increase or decrease the flow, mixing and purging efficiency of fluids within the septum 180 activator, as desired.
    [085] Referring now to Figure 7, there is shown a cross-sectional view of the assembled catheter assembly 101 prior to activation of septum 50 through septum activator 80. Prior to activation, septum activator 80 is fully positioned within the rear fluid chamber 64 of the catheter adapter 14. Additionally, the retainer springs 110 are engaged within the retainer slot 68 and positioned proximate the proximal end of the retainer slot 68. The contact surface 140 of the septum activator 80 is positioned proximate to opening 26 of catheter adapter 14 such that a proximal opening 142 of septum activator 80 is in a plane generally parallel to the plane of catheter adapter opening 26. Finally, the outwardly oriented retaining springs 110 mate on the surface of slot 68, thus maintaining the inactive position of septum activator 80 within catheter adapter 14.
    [086] Referring now to Figure 8, there is shown a cross-sectional view of the catheter assembly 101 following the activation of the septum 50 through the septum activator 80. Upon insertion of the coupler 42 into the proximal opening 26 of the adapter catheter 14, probe portion 46 of coupler 42 contacts contact surface 140 of septum activator 80. Septum activator 80 is advanced in a distal direction 390 as coupler 42 is further inserted into the proximal opening 26 of catheter adapter 14. As coupler 42 is advanced further into proximal opening 26, probing surface 90 of septum activator 80 passes through barrier surface 52 of septum 50. As such, probing surface 90 of the septum activator 80 is positioned within the front chamber 62 providing a fluid path through the septum 50.
    [087] In some embodiments, the catheter assembly 101 is configured to allow the septum activator 80 to return to a position fully within the rear chamber 64 following removal of the coupler 42 from the catheter adapter 14. Therefore, when the coupler 46 is removed or detached from the catheter assembly 101, the fluid path through the septum 50 is closed again. In some embodiments, detent spring 110 is configured to flex inward upon contact between contact surface 140 of septum activator 80 and probe 46 of coupler 42. When detent spring 110 flexes inwardly, the probing surface 90 of septum activator 80 is temporarily advanced in a distal direction 390 to guidely open slots 66 and 56, or escape hole 58. When contact between probe 46 and contact surface 140 ceases , the detent spring 110 returns to its relaxed position. The relaxed position moves the probing surface 90 of the septum activator 80 away from the barrier surface 52, thus allowing closure of the slits 66 and 56.
    [088] Referring now to Figure 9, there is shown a cross-sectional view of a catheter assembly 300 incorporating an introducer needle 350. Proximal end 352 of needle 350 may be coupled to a needle connector (not shown) or an insert assembly (not shown) to facilitate a user to hold and manipulate the needle 350 during catheterization. For the sake of clarity in this illustration, the remainder of the needle assembly has been removed.
    [089] Prior to activation, the septum activator 380 is fully positioned within the rear chamber 364 of the catheter adapter 314. A path is provided through the inner lumen 316 of the activator 380 for the purpose of allowing the passage of the introducer needle 350 An intermediate portion of needle 350 passes through septum 356 and continues through forward chamber 362 and into flexible catheter 312. A tip portion (not shown) of needle 350 extends beyond a tip portion (not shown) of the catheter. - have 312 such that the needle tip is available to gain access to a patient's vasculature.
    [090] The slit 366 of the septum 356 is opened by guidance by the introducer needle 350. In some embodiments, a seal is formed between the outer surface of the needle 350 and the slit 366. Therefore, the flow of fluid and air bypass the septum through the interface between needle 350 and slit 366. In some embodiments, a channel or path is provided between slit 366 and needle 350 to allow for controlled flow or flow between these two components.
    [091] In other embodiments, a lubricant such as a non-wetting lubricant is applied to the interface between needle 350 and slit 366 to further eliminate possible fluid and/or air flow. A non-wetting lubricant may also be beneficial to prevent tears or other damage to the gap from occurring when the needle is removed from the catheter assembly following catheterization. A non-wetting lubricant can also facilitate a proper realignment of the slit halves 366 following the removal of needle 350. Non-limiting examples of a non-wetting lubricant include known Teflon-based non-wetting materials such as Endura, available from Endura Coating Co.; A20, E-20, 1000-S20, FEP Green, PTFE and X-40 available from Tiodize; Cammie 2000 available from AE Yale; 21845 available from Ladd Research; MS 122-22, MS 122DF, MS-143DF, MS-122V MS-122VM, MS143V, MS-136W, MS-145W, U0316A2, U0316B2, MS-123, MS-125, MS-322 and MS-324 available together Miller-Stetheson; and 633T2 available from Otto Bock can also be used. Several non-Teflon based non-wetting lubricant-type materials include Dylyn, available from ART; Nyebar, Diamonex, NiLAD, TIDLN, Kiss-Cote, titanium oxide; Fluocad Fluorochemical Coating FC-722, available from 3M; Permacot available from Dupont; Plasma Tech 1633 available from Plasma Tech, Inc.; and silicone sprays.
    [092] In some embodiments, the distal end 384 of the septum activator 380 is elongated such that the contact surface 340 is positioned closer to the proximal opening 326 of the catheter adapter 314. Correspondingly, a coupler having a portion The shortened probe tube (not shown) may sufficiently contact the contact surface 340 to advance the distal end 384 through the septum 356. In other embodiments, the distal end 384 of the septum activator 380 is configured to include an inner diameter with substantially the same size and outer diameter of introducer needle 350. As such, the inner diameter of distal end 384 is configured to allow passage of needle 350 while maintaining a minimum tolerance 382 between the outer surface of needle 350 and the inner surface of the distal end 384 of septum activator 380. This minimum tolerance 382 provides a seal, thus preventing flow or flow of blood between needle 350 and septum activator 380 while removing needle 350 from catheter assembly 300.
    [093] In some embodiments, a translation slot 368 is provided within the rear chamber 364. The translation slot 368 generally comprises an annular recess having a predetermined length 370. The translation slot 368 is further configured to receiving vent fins 320 such that vent fins 320 are retained within slot 368. Therefore, length 370 represents the maximum lateral distance that septum activator 380 is allowed to travel within rear chamber 364. , a proximal end of groove 368 is defined by an annular groove 372. In other embodiments, a distal end of groove 368 is defined by a second annular groove 374. In still other embodiments, the second annular groove 374 forms a proximal end. of the septum channel 60.
    [094] Referring now to Figure 10, there is shown a cross-sectional view of the catheter assembly 300 following the removal of the introducer needle 350. Upon removal of the introducer needle 350, the slit 366 of the septum 356 is no longer opened. by orientation and therefore recloses and seals to prevent fluid and/or air flow through the slit 366. As previously discussed, in some embodiments, the slit 366 includes an exhaust port (not shown) to allow for an exhaust port. controlled flow between front and rear chambers 362 and 364. In other embodiments, a plurality of vent channels 70 are provided between the outer surface of septum 356 and septum channel 60.
    [095] Referring now to Figures 11A through 11D, septum 356 may include various configurations and features to stabilize distal end 384 of septum activator 380. For example, in some embodiments, septum 356 is configured to include a diameter inner 358 substantially equal to the outer diameter of distal end 384 of septum activator 380, as shown in Figure 11A. In other embodiments, septum 356 is configured to have an inner annular groove or protrusion 360 having an inner diameter 358 substantially equal to the outer diameter of distal end 384, as shown in Figure 11B. Therefore, in both embodiments, distal end 384 is radially supported by septum 356.
    [096] Referring to Figure 11C, in some embodiments, an inner surface 376 of septum 356 is modified to include one or more protrusions 391. In some embodiments, exhaust 391 comprises a concave annular recess configured to receive a positive feature 392 that comprises a distal end portion 384 of septum activator 380. In other embodiments, exhaust 391 comprises a unique indentation sized and configured to receive feature 392 of septum activator 380. In still other embodiments, exhaust 391 comprises a positive feature and feature 392 comprises a negative feature or demoted feature (not shown). Therefore, in some embodiments, the interaction between the 391 exhaust and the 392 feature provides both radial support and axial retention of the 380 septum activator within the 314 catheter adapter. This configuration can eliminate the need for additional retention features , such as clips and retaining slots.
    [097] Referring now to Figure 11D, septum 356 includes a dome profile 394 to counter pressure applied to distal end 386 of septum 356 following removal of introducer needle 350. Dome profile 394 provides a additional resistance to the distal side 386 of septum 356, thereby increasing the fluid pressure required to overcome septum 356. In some embodiments, as blood reaches septum 356, dome profile 394 assists septum 356 in closing due to pressure from the blood flow within front chamber 362. In other embodiments, septum 356 comprises a generally flat profile as shown in Figures 5A, 5B and 7-11C or may include a combination of flat or curved surfaces (not shown ).
    [098] Referring now to Figure 12, there is shown a cross-sectional view of the catheter assembly 300 following the activation of the septum 356 through the septum activator 380. Upon insertion of a coupler 342 into the proximal opening 326 of the adapter of catheter 314, probe portion 346 of coupler 342 contacts contact surface 340 of septum activator 380. Septum activator 380 is correspondingly advanced in a distal direction 390 as coupler 342 is further inserted into proximal opening 326, thereby causing vent fins 320 to translate within translation slot 368. As coupler 342 is further advanced into proximal opening 326, probing surface 348 of septum activator 380 passes through slit 366 of septum 356. As such, probing surface 348 of septum activator 380 is positioned within forward chamber 362 providing a fluid path through septum 356.
    [099] Referring now to Figures 13 to 20, there is shown a series of valves according to some modalities that help to eliminate or further reduce areas of little or no fluid flow that occur within a vascular access device containing a valve mechanism comprising a septum and a septum activator or impeller.
    [0100] Figures 13 and 14 show an embodiment of the invention in which a jacket 45 is used to prevent fluid from flowing into any interstitial spaces that are areas of little or no fluid flow.
    [0101] Figure 13 shows a septum 43 that forms a fluid seal in the lumen 341 of the catheter body 41 after needle removal, with the septum activator or impeller 344 in the proximal position. Sleeve 45 is secured around impeller 344 to form a fluid seal between an outer periphery 53 of proximal portion 348 of impeller 344 and inner surface 354 of lumen 341. Therefore, no fluid can flow between the proximal end of impeller 344 and inner surface 354 of lumen 341 in interstitial space 498. Figure 14 shows impeller 344 in the distal position in which fluid can only flow through lumen 51 of impeller 344. Sleeve 45 still maintains a fluid seal between the outer periphery 53 of the impeller 344 and the inner surface 54 of the lumen 341. Therefore, no fluid can flow into the interstitial spaces 498. In addition, the tapered outer surface 351 of the distal portion of the sleeve 45 reduces the size of the interstitial space 498 when the impeller 344 is in the distal position. Liner 45 is made from a softer elastomeric material, such as liquid silicone rubber, for example, and is secured to impeller 344 through suitable molding procedures, such as insert molding, injection molding, and the like. molding techniques or a combination of molding techniques.
    [0102] Figures 15 and 16 show another embodiment of the invention having a valve mechanism that uses a seal at the proximal end 65 and the distal end 75 of a tubular septum activator 365, to prevent fluid from flowing into the interstitial spaces 698 and 699 between activator 365 and inner surface 74 of lumen 363 of catheter body 61. Distal seal 75 is incorporated into septum 63 to prevent any fluid flow between the distal end of activator 365 and the proximal surface of septum 63 when the impeller is in the proximal position as shown in Figure 15 or the distal position as shown in Figure 16. The proximal seal 65 is a continuous torus or toroidal-shaped band around the outer circumference of the proximal end of the activator 365 that forms a seal of fluids with the inner surface 74 of the lumen 363 of the catheter body 61 in both proximal and distal activating positions. Proximal seal 65 is made from a softer elastomeric material, such as liquid silicone rubber, for example, and is molded over activator 365 and held in position by edge 367 on the outer surface of the proximal end of activator 365 Activator 365 has a series of fins 369 extending and evenly distributed around the circumference of outer surface 371. These fins 369 are long enough to contact a portion 73 of inner surface 74 of lumen 363 and are used to limit movement of activator 365 along the catheter body by contacting septum 63 in the distal direction and contacting the indentation or step 378 of inner surface 74 in the proximal direction.
    [0103] Figures 17 to 20 show some embodiments having valve mechanisms that are configured to exclude small confined interstitial spaces, thus eliminating areas of little or no fluid flow.
    [0104] Figures 17 and 18 show an embodiment in which septum 83 surrounds most of the activator 383. Activator 383 includes a head section, a tubular section and a plunger. The plunger having a diameter at least equal to that of the lumen 385 of the catheter body 81 such that no fluid can pass between the inner surface 94 and the plunger 80 is located at the proximal end of the activator 383. The septum 83 has an outer diameter at least equal to that of lumen 82 along its entire length such that no interstitial space is present between septum 83 and inner surface 94 of lumen 385. In addition, septum 83 has a lumen 85, the inner diameter of this is equal to the outer diameter of tubular section 87 of activator 383, thus forming an additional fluid seal along the length of tubular section 87. Furthermore, the relative lengths of activator 383 and septum 83 are such so that the distal face 389 of the plunger 381 is in intimate contact with the proximal end 388 of the septum 83 when the activator 383 is in the distal position, as shown in Figure 18. Therefore, there is no interstitial space between the plunger 381 and the septum 83. The head section is located at the distal end of the activator 383 and includes longitudinal notches 387 in the sidewall of the lumen 91 for the purpose of allowing fluid flow to diverge out of the lumen 91 of the activator 383 and reduce the possibility of little or no flow area 393 around the distal face of septum 83 on inner surface 74.
    [0105] Figures 19 and 20 show a further embodiment of a valve mechanism in which a septum 103 includes a tubular section 107 having a distal end 108 and a membrane section 109 having a proximal flat surface located at the proximal end 105. A Tubular section 107 of septum 103 is substantially disposed within septum compartment 111 and its distal movement is prevented by the annular shoulder or recess 121 formed in the surface of lumen 385. A fluid seal is formed between the periphery of membrane section 109 and the inner surface 114 of the proximal section 110 of lumen 385 to prevent fluid flow from passing through the septum 103 when the valve is closed. In some embodiments, the septum 103 further includes a needle slit 113 or valve opening located around the center of the membrane section 109, extending through the membrane section 109, to facilitate penetration of the septum 103 by the needle. introducer 5. A septum activator 304 is located in the proximal section of lumen 385 and includes a tubular portion 115. In some embodiments, the tubular portion or sleeve portion 115 further includes a plurality of longitudinal notches or flow channels 116 in the side wall, evenly distributed around the circumference or tubular portion 115 and located at the distal end or actuating end 117 such that a gap is formed between the actuating end 117 and the membrane 109.
    [0106] Figure 19 shows the 304 septum activator in the proximal position following the removal of the introducer needle 5. In particular, the actuating end 117 of the 304 septum activator is positioned against the flat proximal surface of the membrane section 109 of the septum. 103 to form an interface. The diameter of lumen 385 in proximal section 310 is approximately equal to the outer diameter of connector 106 (eg, a luer connector) of a vascular access device, septum activator 304 and membrane section 109, such that there are no gaps interstitials between connector 106 (shown in Figure 20), a contact end of septum activator 304, and membrane section 109. Inner surface 114 and proximal section 310 of first lumen 385 are further sealed by membrane section 109.
    [0107] Referring now to Figure 20, the 304 septum activator is shown in the distal position whereby connector 106 has repositioned the 304 septum activator forward in a distal direction, thus causing the end of actuation 117 of septum activator 304 deforms membrane section 109. This deformation results in the formation of a fluid path whereby fluid bypasses membrane section 109 through notches 116, subsequently flowing between the periphery of the membrane section 109 and inner surface 114, and oriented through opening 118 in the sidewall of tubular portion 107. This divergent fluid path around the periphery of membrane section 109 causes turbulent fluid flow that reduces the possibility of stagnation or a area of low flow that occurs near shoulder 119 in lumen 385. Then, fluid continues to flow along the inside diameter of tubular portion 107 and into distal section 112 of lumen 385.
    [0108] Referring now to Figures 21 and 22, in some embodiments, the catheter assembly 101 further comprises an auxiliary port at y 700 configured to include a blood control valve 710 in accordance with any of the teachings of present invention. Although control valve 710 is shown incorporated into an auxiliary portion at y 700, the various blood control valves of the present invention may be incorporated into any single-use or multi-purpose blood control valve system that permits passage. of air (ie, ventilations), but stop the flow of blood.
    [0109] In some embodiments, a blood control valve 710 is positioned within the straight luer portion 720 of the closed IV catheter system 101, as shown. In other embodiments, a blood control valve 710 is positioned within the y-luer portion 730 of the closed IV catheter system 101. In still some embodiments, a blood control valve 710 is positioned within the straight portion 720 and the y 730 luer portion of the IV catheter system 101 (not shown). In some embodiments, blood control valve 710 comprises a septum 722 disposed within the port at y 700, the valve 710 further comprising a vent channel 740 interposed between the septum 722 and the port at y 700 to allow passage of at least air or blood at a desired flow rate.
    [0110] Initially, the valve system is in a non-activated position, as shown in Figure 21. The non-activated position allows venting of the closed system in channels 740 located between the luer adapter 720 and the valve septum 722 In some embodiments, channels 740 are sized to allow airflow but prevent blood flow. Therefore, the vented valve replaces the need to include a vent plug to prepare IV line 40. During the catheterization process, blood is allowed to flow in IV line 40 until it reaches septum 722, at this point, flow of blood ceases. The clinician can then simply attach any connecting device 750 to allow for infusion, blood collection, or fluid delivery, as shown in Figure 22.
    [0111] In some embodiments, the clinician may simply add a cap or cover (not shown) to the 720 luer port, thereby preventing contamination prior to the last use. Upon attachment of connecting device 750, valve septum activator 710 is advanced through septum 722 via opening valve 710 to allow for free fluid flow and normal infusion therapy practices. Unlike other valve systems, the long-term cannula compression fit and valve integration do not apply to the y 700 port as the 710 valve remains inactive and closed during storage and throughout the device's shelf life. .
    [0112] In some embodiments, the 700 y-port 710 blood control valve considerably simplifies the clinician's technique of placing an IV catheter, and makes subsequent connections thereto. For example, in some embodiments, the closed IV catheter system 101 eliminates the need for a separate vent plug device to the y 700 port to facilitate IV line preparation 40. In other embodiments, the closed IV catheter system 101 eliminates the need to tighten the vent plug over the luer adapter as well as the need to activate a fixed extension clamp. In addition, in some embodiments, the closed IV catheter system 101 eliminates the need to disconnect the vent plug, being careful not to come into contact with the blood contained within the vent plug, as well as the need to discard any vent plugs. contaminated ventilation vent. In addition, the closed IV catheter system 101 eliminates the need to open the fixed extension clamp after catheterization.
    [0113] Referring now to Figures 23 and 24, in some embodiments, the catheter assembly 101a further comprises a single port rectilinear luer adapter 700a configured to include a blood control valve 710 in accordance with either of the teachings of the present invention. In some embodiments, a blood control valve 710 is positioned with the straight luer adapter 700a of the closed IV catheter system 101a, as shown. In some embodiments, the blood control valve 710 comprises a septum 722 disposed within a lumen of the rectilinear luer adapter 700a, the valve 710 further comprising a vent channel 740 interposed between the septum 722 and an inner surface. of the 700a straight luer adapter to allow a controlled passage of at least air or blood at a desired flow rate.
    [0114] Initially, the valve system is in a non-activated position, as shown in Figure 23. The non-activated position allows venting of the closed system in channels 740 located between the 700a luer adapter and the 722 valve septum In some embodiments, channels 740 are sized to allow airflow but prevent blood flow. Therefore, the vented valve replaces the need to include a vent plug to prepare IV line 40. During the catheterization process, blood is allowed to flow in IV line 40 until it reaches septum 722, at this point, flow of blood ceases. The clinician can then simply attach any connecting device 750 to allow for infusion, blood collection, or fluid delivery, as shown in Figure 24.
    [0115] In some modalities, the clinician may simply add a cap or cover (not shown) to the 720 luer port, thereby preventing contamination prior to the last use. Upon attachment of connecting device 750, valve septum activator 710 is advanced through septum 722 via opening valve 710 to allow for free fluid flow and normal infusion therapy practices. Unlike other valve systems, the long-term cannula compression fit and valve integration do not apply to the 700a straight luer as the 710 valve remains inactive and closed during storage and throughout the device's shelf life.
    [0116] In some embodiments, the 700a rectilinear luer blood control valve 710 considerably simplifies the clinician's technique of placing an IV catheter, and making subsequent connections thereto, as discussed in accordance with Figures 21 and 22, above.
    [0117] Any septum described herein can be made from a variety of materials and through a variety of fabrication methods. For example, the septum can be formed from liquid silicone rubber by suitable molding procedures, such as insert molding, injection molding, other molding techniques, or a combination of molding techniques. The septum 103, or any septum described herein, may also include an antimicrobial substance coating on any of its surfaces, especially those surfaces that have contact with the fluid.
    [0118] The present invention may be incorporated into other specific forms without departing from its structures, methods, or other essential features as comprehensively described herein and claimed below. The modalities described are to be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the invention is indicated by the appended claims, rather than the above description. All changes contained in the meaning and equivalence range of the claims must fall within their scope.
    权利要求:
    Claims (11)
    [0001]
    1. A system for controlling fluid flow in a closed IV catheter assembly, comprising: a y-adapter having a straight portion (720) and a y portion (730), the straight portion (720) and the y portion (730) being connected to an IV line (40); the straight portion (720) includes a blood control valve (63) within an inner lumen of the straight portion (720), the blood control valve (710) comprising: a septum (722) disposed within the inner lumen of the straight portion (720); and a vent channel (740) interposed between the septum (722) and an inner surface of the inner lumen of the straight portion (720), the vent channel (740) having a surface area and perimeter selected to allow passage of hair. minus one of air and blood at a desired flow rate; CHARACTERIZED by the fact that the straight portion (720), which includes the blood control valve (63), also includes a septum activator (365) within the inner lumen of the straight portion (720), the septum activator ( 365) comprising a continuous torus or toroidal-shaped band around an outer circumference of the septum activator (365) that forms a fluid seal with an inner surface of the inner lumen of the straight portion (720) when the septum activator ( 365) is in both a proximal and a distal position.
    [0002]
    2. The system of claim 1, further comprising a septum activator (80) disposed within a portion of the inner lumen of the straight portion (720) adjacent to the septum (722), a distal end of the septum activator (80) in contact with a proximal surface of the septum (722), and a proximal end of the septum activator (80) being positioned adjacent an opening in the straight portion (720), wherein the proximal end of the septum activator (80) is accessed by inserting an external device (750) into the opening of the straight portion (720).
    [0003]
    3. System according to claim 2, characterized in that it further comprises a lumen that forms a fluid path through the septum activator (80), the lumen having an internal diameter configured to allow the passage of a fluid.
    [0004]
    4. System according to claim 3, CHARACTERIZED by the fact that the septum activator (80) comprises a plurality of flow deflectors (120) configured to improve fluid circulation within at least one of the septum activator (80) and an interstitial space between the septum activator (80) and the inner surface of the inner lumen of the straight portion (720).
    [0005]
    5. System according to claim 3, CHARACTERIZED by the fact that the septum activator (80) further comprises a flow diversion channel (130).
    [0006]
    6. System according to claim 2, CHARACTERIZED by the fact that the proximal surface of the septum (722) further includes a cavity to house the distal end of the septum activator (80), and a distal surface of the septum ( 722) is dome-shaped.
    [0007]
    7. System according to claim 6, CHARACTERIZED by further comprising an exhaust (391) located on an inner surface of the cavity, the exhaust (391) being configured to receive a retaining feature (392) located on the end distal from the septum activator (80), wherein an interaction between the detent feature (392) and the exhaust (391) prevents removal of the septum activator (80) from the septum (722).
    [0008]
    8. The system according to claim 2, characterized in that it further comprises an antimicrobial coating applied to at least one of the straight portion, the septum, the ventilation channel and the septum activator.
    [0009]
    9. System according to claim 1, CHARACTERIZED by the fact that the straight portion (720) comprises a luer connector.
    [0010]
    10. System according to claim 1, CHARACTERIZED by the fact that the y-shaped portion (730) comprises a luer connector.
    [0011]
    11. System according to claim 1, CHARACTERIZED by the fact that the IV line (40) extends from the y-adapter to the catheter adapter (14).
    类似技术:
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-05-05| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-03-16| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-08-03| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-09-14| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/03/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    US36451210P| true| 2010-07-15|2010-07-15|
    US61/364,512|2010-07-15|
    US13/042,103|US8574203B2|2009-02-11|2011-03-07|Systems and methods for providing a flushable catheter assembly|
    US13/042,103|2011-03-07|
    PCT/US2011/028716|WO2012009028A1|2010-07-15|2011-03-16|Systems and methods for providing a flushable catheter assembly|
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