• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    catheter assembly and perforated septum valve. it is a septum activator. the septum activator has an outer tubular body and an inner tubular body. the outer tubular body and the inner tubular body have a plurality of openings therein. the inner tubular body has a first position relative to the outer tubular body and a second position relative to the outer tubular body. in the first position, the plurality of openings in the inner tubular body does not overlap with the plurality of openings in the outer tubular body. in the second position, the plurality of openings in the inner tubular body overlaps the plurality of openings in the inner tubular body.
    公开号:BR112013001036B1
    申请号:R112013001036-3
    申请日:2011-03-16
    公开日:2021-06-22
    发明作者:Marty L. Stout；Jonathan K. Burkholz；Douglas Anjewierden
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Background
    [001] 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. Typically, catheters are attached to a catheter adapter that supports the catheter and provides an attachment to the IV tube. In general, following placement of the catheter into a patient's vasculature, the catheter adapter can be attached to a fluid source through a section of the IV tube to infuse fluids into the patient.
    [002] In order to verify proper placement of the catheter in the blood vessel, the clinician generally checks for a “return” of blood from the patient's vasculature into a catheter return chamber or catheter adapter. Once proper placement of the catheter is confirmed, the clinician must either secure the catheter adapter to a section of the IV tube, or continue to manually occlude the vein to avoid unwanted exposure to blood. The process of attaching the catheter adapter to the IV tubing section requires the clinician to awkwardly maintain pressure on the patient's vein while simultaneously attaching the catheter adapter and IV tubing. 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 catheter in the patient's vein. While this method can prevent unwanted exposure to blood, a positive pressure from the IV tube into the catheter may not allow for unwanted return and therefore reduces a clinician's ability to comply with proper placement of the catheter.
    [003] Consequently, there is a need in the art for a catheter assembly that allows for a desirable and controlled return without the risk of encountering an undesirable exposure to blood. In this document, this catheter assembly is described. summary
    [004] In order to overcome the limitations discussed above, the present invention relates to a perforated septum valve that provides selective activation of fluid flow through the catheter assembly while minimizing or eliminating blood exposure. In addition, confirmation of catheter placement can be enhanced by an additional return chamber that is created by including a seal around the outside of the septum activator. The combination of the perforated septum valve and the seal around the septum activator can provide a longer payback period in which clinicians can ensure that a catheter is properly placed in a patient's blood vessel. Additionally, the septum activator can provide selective openings that open during activation and close when the septum activator is in a deactivated position. When closed, the openings form a barrier surface for the additional return chamber. When open, the openings provide fluid pathways through the septum activator that can purge fluid contained in the additional return chamber around the septum activator.
    [005] In one aspect, a septum activator has an outer tubular body and an inner tubular body. The outer tubular body and the inner tubular body have a plurality of openings. The inner tubular body has a first position with respect to the outer tubular body and a second position with respect to the outer tubular body. In the first position, the plurality of openings in the inner tubular body does not overlap the plurality of openings in the outer tubular body. In the second position, the plurality of openings in the inner tubular body overlaps the plurality of openings in the inner tubular body.
    [006] Some implementations include one or more of the following aspects. The inner tubular body moves from the first position to the second position as the inner tubular body or outer tubular body is rotated about a longitudinal axis of the inner body. The inner tubular body can move from the first position to the second position as the inner tubular body or the outer tubular body is translated along a longitudinal axis of the inner body. The plurality of openings in the outer tubular body may include a plurality of openings in a proximal portion of the outer tubular body and a plurality of openings in a distal portion of the outer tubular body, and the plurality of openings in the inner tubular body may include a plurality of openings in a proximal portion of the inner tubular body and a plurality of openings in a distal portion of the inner tubular body. The inner tubular body and the outer tubular body may have a tapered portion. A seal can be placed on an outer surface of the septum activator. One or more vents can be arranged in the seal, with one or more vents having a cross-sectional area less than or equal to 0.01935 mm2(0.00003 inch2). One or more interlocking features may be between the inner tubular body and the outer tubular body which retains the inner tubular body within the outer tubular body.
    [007] In another aspect, a catheter assembly includes a catheter adapter, a septum, and a septum activator. The catheter adapter has a lumen extending through it. The septum is disposed within the lumen. A septum activator is disposed within the lumen proximal to the septum. The septum activator has an inner tubular body and an outer tubular body. The outer tubular body of the septum activator has a plurality of openings. The inner tubular body of the septum activator is disposed within the outer tubular body and having a plurality of openings. The inner tubular body has a first position with respect to the outer tubular body and a second position with respect to the outer tubular body. In the first position, the plurality of openings in the inner tubular body does not overlap the plurality of openings in the outer tubular body. In the second position, the plurality of openings in the inner tubular body overlaps the plurality of openings in the inner tubular body.
    [008] Some implementations include one or more of the following aspects. The inner tubular body can move from the first position to the second position as the inner tubular body or outer tubular body is rotated about a longitudinal axis of the inner body. The inner tubular body can move from the first position to the second position as the inner tubular body or outer tubular body is translated along a longitudinal axis of the inner body. The plurality of openings in the outer tubular body may include a plurality of openings in a proximal portion of the outer tubular body and a plurality of openings in a distal portion of the outer tubular body. The plurality of openings in the inner tubular body may include a plurality of openings in a proximal portion of the inner tubular body and a plurality of openings in a distal portion of the inner tubular body. The inner tubular body and the outer tubular body may have a tapered portion. A seal may be disposed between an outer surface of the septum activator and the catheter adapter, with the seal sealing the portion of the septum activator distal to the lumen from the portion of the septum activator proximal to the lumen. One or more vents may be disposed in the seal, with one or more vents having cross-sectional areas less than or equal to 0.01935 mm2(0.00003 inch2). One or more interlocking features may be between the inner tubular body and the outer tubular body which retains the inner tubular body within the outer tubular body. The volume outside the septum activator may be between the septum and the seal forming a return chamber. When the inner tubular body is in the second position, the inner tubular body and the outer tubular body form a fluid-tight barrier and can be between an inner lumen of the inner tubular body and the return chamber. One or more flow restrictors may be between the septum and an inner surface of the catheter adapter, with one or more flow restrictors having cross-sectional areas greater than 0.01935 mm2 (0.00003 inch2).
    [009] In another aspect, a catheter assembly includes a catheter adapter, a septum, and a septum activator. The catheter adapter has a lumen extending through it. The septum is disposed within the lumen. A septum activator is disposed within the lumen proximal to the septum. The septum activator has an inner tubular body and an outer tubular body. The outer tubular body of the septum activator has a plurality of openings. The inner tubular body of the septum activator is disposed within the outer tubular body and has a plurality of openings. The inner tubular body has a first position with respect to the outer tubular body and a second position with respect to the outer tubular body. In the first position, the plurality of openings in the inner tubular body does not overlap the plurality of openings in the outer tubular body. In the second position, the plurality of openings in the inner tubular body overlaps the plurality of openings in the inner tubular body. An annular seal is disposed between an outer surface of the septum activator and an inner surface of the lumen, with the seal arranged around a proximal portion of the septum activator. One or more vents are placed between the seal and the body lumen. Brief description of the various views of the drawings
    [010] In order that the manner in which the aforementioned 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 represented with reference to the specific embodiments 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.
    [011] Figure 1 is a perspective view of a catheter assembly, according to some embodiments.
    [012] Figure 2 is a perspective view of a catheter assembly that follows the removal of an introducer needle, according to some modalities.
    [013] Figure 3 is an exploded cross-sectional view of a catheter assembly, according to some embodiments.
    [014] Figure 4 is a cross-sectional perspective view of a catheter assembly with a septum activator in a disabled position, according to some embodiments.
    [015] Figure 5 is a cross-sectional perspective view of the catheter assembly of Figure 4 with the septum activator in an activated position, according to some embodiments.
    [016] Figure 6 is a perspective view of a septum, according to some modalities.
    [017] Figure 7 is a cross-sectional view in perspective of a septum activator in a first position, according to some modalities.
    [018] Figure 8 is a cross-sectional view in perspective of the septum activator of Figure 7 in a second position, according to some modalities.
    [019] Figure 9 is a cross-sectional perspective view of a catheter assembly with a septum activator in an off position in relation to the septum, according to some modalities.
    [020] Figure 10 is a cross-sectional perspective view of the catheter assembly of Figure 9 with the septum activator in an activated position relative to the septum, according to some modalities.
    [021] Figure 11A is a perspective view of another septum activator in a first position, according to some modalities.
    [022] Figure 11B is a cross-sectional perspective view of the septum activator of Figure 11A.
    [023] Figure 12A is a perspective view of the septum activator of Figures 11A-11B in a second position, according to some embodiments.
    [024] Figure 12B is a cross-sectional perspective view of the septum activator of Figure 12A.
    [025] Figure 13 is a cross-sectional perspective view of another catheter assembly with a septum activator in an off position relative to the septum, according to some embodiments.
    [026] Figure 14 is a cross-sectional perspective view of the catheter assembly of Figure 13 with the septum activator in an activated position relative to the septum, according to some modalities. Detailed description of the invention
    [027] The embodiment of the present invention will be better understood with 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.
    Referring now to Figure 1, a catheter assembly 10 is illustrated. Catheter assembly 10 generally includes a catheter 12 coupled to a distal end 16 of a catheter adapter 14. Catheter 12 and catheter adapter 14 are integrally coupled such that an inner lumen of catheter adapter 14 is in fluid communication with an inner lumen of catheter 12. Catheter 12 generally comprises a biocompatible material having sufficient stiffness to withstand pressures associated with the insertion of the catheter into a patient.
    [029] In some embodiments, as shown, the catheter 12 is an over-the-needle catheter that is made of a flexible or semi-flexible polymeric material and that can be used in combination with a rigid introducer needle 22. The rigid introducer needle 22 allows for insertion of the catheter over the non-rigid needle into a patient. Introducer needle 22 may be coupled to a needle connector 26 that is selectively coupled to proximal end 18 of catheter adapter 14. Introducer needle 22 is typically inserted through catheter 12 such that a tip of needle 22 extends beyond the tapered tip 20 of catheter 12. Insertion of introducer needle 22 into the patient's vein creates an opening in the vein through which tapered tip 20 of catheter 12 is inserted. The outer surface of the tapered tip 20 allows for a gradual insertion of the catheter 12 into the opening.
    [030] In other embodiments, the catheter 12 is not an over-the-needle catheter, but comprises a rigid polymeric material such as vinyl. Rigid catheters can include an oblique cutting surface that is used to provide an opening in a patient to allow insertion of catheter 12 into the patient's vascular system. Consequently, in some embodiments, catheter 12 comprises a metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof. In still other embodiments, surgically implanted catheters can also be used in combination with the present invention.
    [031] Catheter 12 can be a peripheral-type intravenous catheter that comprises, in general, a short or truncated catheter for insertion into a small peripheral vein. Such catheters generally comprise a diameter of about a 14 gauge or smaller catheter (on a Stubs scale), and are between about 13 mm and 52 mm in length. Peripheral intravenous catheters are typically designed for temporary placement. The short length of the catheter facilitates convenient placement of the catheter. In other embodiments, catheter 12 is a midline or central catheter, which can be longer and used for longer periods.
    [032] Referring now to Figure 2, once the catheter 12 is inserted into the patient's vein, the introducer needle 22 is proximally removed from the catheter 12 to provide a fluid conduit through the inner lumen 36 of the catheter 12, which can be connected to a fluid source. In some embodiments, a portion of catheter 12 and/or catheter adapter 14 is configured to be connected to a section of intravenous tube 40 to further facilitate delivery of a fluid or removal of a fluid from a patient. In some embodiments, a proximal end 18 of catheter adapter 14 includes a flange 32. Flange 32 provides a positive surface that can be configured to allow coupling of an IV tube 40 or patient conduit to the catheter assembly 10. In some embodiments, flange 32 includes a set of threads 30. Threads 30 are generally provided and configured to matchably receive a complementary set of threads 44 comprising a male luer portion or conduit coupler 42. The conduit coupler 42 is generally coupled to an end portion of patient conduit 40 in a fluid impermeable manner. In some embodiments, an inner portion of conduit coupler 42 is extended outwardly to provide a probe member 46.
    [033] Probe member 46 can be compliantly inserted into a proximal end 18 of catheter adapter 14 to activate the septum, thereby opening a fluid path within catheter adapter 14. In some configurations, if - guiding the insertion of probe member 46 into proximal end 22 of catheter adapter 14, conduit coupler 42 is interlocked to coupler 42 and flange 28 (via thread assemblies 30 and 44), such as by rotation. During the process of interlocking coupler 42 and flange 28, probe member 46 is advanced into lumen 36 of catheter adapter 14 to an inserted position (as shown in Figures 8 and 12). As shown in Figures 8 and 12, as IV tube 40 is connected to catheter adapter 14, probe member 46 advances into lumen 36 of catheter adapter 14, forcing a septum activator to pierce through the septum. 50. The perforation of the septum 50 opens the septum and provides a fluid path through which fluids from the intravenous tube 40 flow through the perforated septum 50 and catheter 12 in the patient. The process of perforating the septum 50 is described in detail below. As will be understood, prior to insertion of probe member 46, the inner lumen 36 of catheter adapter 14 is sealed to prevent exposure of blood from the return.
    [034] Reference is now made to Figures 3 and 4. Figure 3 depicts an exploded cross-sectional view of a catheter assembly 10. Figure 4 depicts a cross-sectional view of an assembled catheter assembly 10. septum activator 80 of Figure 4 has an alternative structure to that of Figure 3, as explained below. These figures, along with Figure 6, describe the embodiments of perforated septum valves, which include a septum having an open and closed slit by advancing and retracting a probe-type septum activator therethrough.
    [035] As shown, in some embodiments, a septum 50 is positioned within the inner lumen 36 of the catheter adapter 14 to control fluid flow therein. Septum 50 generally comprises a flexible or semi-flexible polymer plug having an outer diameter that is configured to fit compatibly within a groove or channel 60 formed on an inner surface 66 of the catheter adapter 14. in some embodiments, the septum 50 is barrel-shaped and has a barrier member 52 at its distal end and a cavity 54 at its proximal end. When positioned within channel 60, barrier member 52 of septum 50 divides inner lumen 36 of catheter adapter 14 into a front fluid chamber 62 and a rear fluid chamber 64. Therefore, the presence of septum 50 may limiting the passage of fluid between the front and rear fluid chambers 62 and 64.
    [036] In some embodiments, the barrier member 52 of the septum 50 includes a slit 56. The slit 56 can provide selective access or flow of a fluid through the barrier surface 52 as it opens (active) and closes ( deactivates) in response to septum activator 80. In some embodiments, slit 56 is configured to remain in a closed fluid impervious position until it is activated or opened by advancing a septum activator 80 through slit 56 in a distal direction. 72. In some cases, the barrier member 52 comprises a single slit 56. In other cases, the barrier member 52 is modified to include multiple slits 56, such as two slits 56 that form a cross or x shape. In other cases, the barrier member 52 is modified to include three slits 56 forming a Y-shape.
    [037] The septum activator 80 comprises a probe-like structure that serves to activate and deactivate the septum 50 in response to insertion and removal of the probe member 46. The septum activator 80 can be primarily housed in the rear chamber 64 of the adapter of catheter 14, proximal to septum 50. In some embodiments, septum activator 80 is a tubular body 82 having a distal end 84 and a proximal end 86. The tubular body 82 can be made of a rigid or semi-rigid material, such as a plastic or metallic material. Tubular body 82 may have an internal lumen 88 which facilitates the flow of a fluid and/or liquid through septum activator 80 when septum activator 80 pierces through slit 56 of septum 50.
    [038] The distal end 84 of the tubular body 82 can be configured to be compatiblely inserted into the cavity 54 on the proximal side of the septum 50 such that it is positioned where it can pierce through the slit 56 of the barrier member 52 to form a fluid path through it. Distal end 84 further includes a main surface 90 that can be inserted through opening 54 of septum 50 to a position proximal to barrier member 52 of septum 50, as shown in Figure 6. When forced distally, main surface 90 advances through slit 56 as septum activator 80 is moved from an off position as shown in Figure 4 to an on position as shown in Figure 5.
    [039] In order to properly align the septum activator 80 within the inner lumen 36 of the catheter adapter 14, one or more alignment structures may be included between the outer surface of the septum activator 80 and the inner surface 66 of the catheter adapter 14. For example, as shown in Figure 4, one or more alignment tabs 110 may protrude from the outer surface of the septum activator 80 and be inserted into one or more alignment grooves 112 formed within the surface. internal 66 of the catheter adapter 14. As the septum activator translates longitudinally within the catheter adapter, one or more alignment tabs 110 follow within one or more alignment slots 112 to keep the septum activator 80 properly aligned. inside the catheter adapter 14. In some configurations, there are three, four, five, or six alignment fins 110, each inserted into a similar number of slots. of alignment 112.
    [040] In addition to activating septum 50, septum activator 80 can form barrier surfaces of a return chamber 116 that contain fluid. Barrier surfaces define the outside of the return chamber 116 and can prevent fluid therefrom. In general, returns occur when introducer needle 22 and/or catheter 12 enter a patient's blood vessel, puncturing the blood vessel, and opening a fluid path through catheter 12. The patient's blood pressure forces the blood to stop. outside the blood vessel in the catheter assembly 10. When the catheter adapter 14 or a portion thereof is transparent or semi-transparent, as in some embodiments, blood flow through its inner lumen 36 is observable and may indicate to a clinician that the catheter 12 is currently located within the patient's blood vessel. If blood flow stops, the clinician may understand that catheter 12 is no longer located within the blood vessel or that some other factor is restricting blood flow within catheter 12. Therefore, a return that can last is desirable. enough for a clinician to properly place a catheter.
    [041] Referring to Figure 4, in some embodiments, blood generally enters catheter assembly 10 and follows a return path 114 through catheter assembly 10. Fluid path 114 enters front chamber 62, which can be a first return chamber as it includes the volume that can be observed to be filled with blood. The blood then flows through flow restrictors 70 arranged around the septum 50 and enters the return chamber 116, which may be a second return chamber. In cases where catheter adapter 14 or a portion thereof is transparent or semi-transparent, a clinician can observe this blood flow filling these chambers, which indicates proper placement of catheter 12.
    [042] As mentioned, during return, blood enters the return chamber 116 through one or more flow restrictors 70 interposed between the septum 50 and the inner surface 66 of the catheter adapter 14 to provide a flow path for return . In general, septum 50 sits within a slot or channel 60 that comprises a recessed portion of the inner surface 66 of catheter adapter 14. The outer diameter of septum 50 may fit compliantly and securely within channel 60. For example, in some embodiments, the outer diameter of septum 50 is selected to be either slightly smaller than the diameter of channel 60 or slightly larger than the diameter of inner lumen 16. As such, septum 50 is retained within channel 60 during the use of the catheter assembly 10. Flow restrictors 70 can permit the passage of air and fluid therethrough while generally regulating flow rates. The size of the cross-sectional area of each flow restrictor can at least partially control the rate of fluid flow therethrough. For example, as the cross-sectional area of flow restrictors 70 increases, the potential rate of fluid flow through flow restrictors 70 increases. Similarly, flow restrictors 70 having smaller cross-sectional areas will reduce fluid flow therethrough. The sizes and configurations of flow restrictors 70 and other components are described in detail below.
    [043] The volume between the septum activator 80, the catheter adapter 14, and the septum 50 can at least partially define a return chamber 116, shown in Figure 4. In some configurations, the outer surface 92 of the septum activator 80 is a barrier surface of the return chamber 116 that prevents fluid from flowing between the inner lumen 88 of the septum activator 80 and the volume of space around the outer surface 92 of the septum activator 80. Consequently, as shown in in some cases, the septum activator 80 is just a solid tube and a single distal opening.
    [044] As fluid enters the return chamber 116, a seal 98 disposed between the septum 50 and the inner surface 66 of the catheter adapter 14 can prevent fluid from flowing out of the proximal end of the catheter adapter 14. In some embodiments, seal 98 surrounds septum activator 80, as shown, forming a barrier surface of return chamber 116 that prevents proximal flow of fluid beyond seal 98. In some embodiments, seal 98 is attached to the surface. outer 92 of septum activator 80. In other embodiments, seal 98 is coupled to inner surface 66 of catheter adapter 14. By adjusting the location of seal 98, the volume of return chamber 116 increases or decreases. Therefore, the seal 98 can be positioned at various locations between the proximal and distal ends of the septum activator 80. For example, the seal 98 can be disposed on a proximal portion of the septum activator 80, such as the proximal half of the septum activator. septum 80 as shown. More specifically, in a non-limiting example, the seal 98 is disposed at the proximal end 86 of the septum activator 80, as shown in Figure 8, which will be described below. In addition, the seal 98 can circumscribe a portion of the outer surface 92 of the septum activator 80 in a ring-like fashion, as shown, to seal the area around a portion of the septum activator 80.
    [045] In some embodiments, the seal 98 can provide a fluid impermeable barrier around the septum activator 80 that prevents blood from leaking through the proximal end of the return chamber 116 and out of the catheter assembly 10. For example, seal 98 may have an outer diameter greater than or equal to the inner diameter of lumen 36 of catheter adapter 14 to block fluid flow through the entire area between septum activator 80 and catheter adapter 14. 98 can also be made from a flexible material such that it can properly conform to the inner surface 66 of the catheter adapter 13 to form a seal thereon. Accordingly, seal 98 may comprise a non-rigid material, such as an elastomeric material. In other cases, seal 98 is made from other flexible, semi-flexible, or semi-rigid materials that can provide a fluid impermeable seal between catheter adapter 14 and septum activator 80.
    [046] Initially, during return, blood flowing through catheter 12 forces air to flow through flow restrictors 70. This initial blood infusion can be very rapid as blood flows through catheter 12 into the front chamber 62. The front chamber 62 can serve as a first return chamber that provides a first indication to clinicians that blood is flowing in the catheter assembly 10. By observing this blood flow, a clinician can verify that the catheter 12 has entered. in a blood vessel. However, in some cases, the time for this initial return to occur is too fast and does not last long enough for a clinician to verify proper catheter placement. Consequently, in some configurations, a second return chamber 116 is provided on the proximal side of the septum 50 which provides extended feedback indications. Consequently, air and blood within the front chamber 62 can flow through the flow restrictors 70 disposed between the septum 50 and the catheter adapter 14 in the second return chamber 116. Due to the fact that the size of the flow restrictors 70 controls the flow of blood therethrough, the rate of return in the second return chamber 116 can be regulated to provide longer average return periods.
    [047] When blood begins to flow in the catheter assembly, a positive pressure develops within the front chamber 62, the first return chamber, and the second return chamber 116. This pressure can reduce or prevent blood flow in the catheter assembly 10, thereby preventing a desired return of blood from the patient to catheter adapter 14. Therefore, some modalities include features or elements to allow airflow through or around seal 98 to relieve this pressure. positive by allowing air, but not blood, to exit through it. As such, some embodiments of the present invention provide full observable feedback, as generally desired for infusion procedures.
    [048] In some embodiments, the seal 98 of the septum activator 98 is modified to include one or more flow restrictors 100. In other embodiments, one or more vents 120 (shown in Figure 6), in the form of channels, are interposed between seal 98 and inner surface 66 of catheter adapter 14. These vents 100 relieve positive pressure within return chamber 62, 116 providing an access for air to bypass seal 98 in the external environment. In some embodiments, vents 100 are constructed by removing portions of the surface of seal 98, resulting in a plurality of generally parallel grooves. In other embodiments, the vents 100 are formed as channels through the seal 98 rather than over the surface of the seal 98.
    [049] In some embodiments, the rate at which air and/or fluid flow through the vents 100 in the seal 98 is adjusted by fabricating the catheter adapter 14 to include a greater or lesser number of vents 100 or by changing the cross-sectional area of the vents 100. Therefore, in some embodiments, the rate at which air and/or fluid flows out of the second return channel 116 is increased by making catheter adapter 14 having an increased number of vents 100, or vents 100 with a larger cross-sectional area. Conversely, in other embodiments, the rate at which air and/or fluid flow from the second return chamber 116 is reduced by fabricating a catheter adapter 14 with a reduced number of vents 100, or vents 100 having a smaller cross-sectional area.
    [050] A person skilled in the art will appreciate that the patient's blood pressure is largely responsible for the rate at which blood and air flow through the septum 50 and the ventilations 100 around the seal 98. As such, the rate of flow through of system is affected by the combined effective hydraulic diameter of all flow paths. Therefore, in some embodiments, the hydraulic diameter of the vents 100 is modified to increase or decrease the flow rate through the catheter assembly 10. In other embodiments, the hydraulic diameter of the vents 100 is reduced, thus resulting in substantially flow. reduced or interrupted by means of ventilation. 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 the blood, and P is the perimeter of the ventilation means.

    [051] Therefore, according to Equation 1, when the perimeter of the ventilation medium is small, the ventilations 100 will allow an air ventilation, but will prevent blood flow due to the relatively high surface tension (ó) of blood. However, when the perimeter of ventilation is increased, the surface tension between the blood and ventilation 100 is reduced, thus allowing blood to flow slowly through the ventilations and around the septum in order to provide a desirable return, however 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, the design of the catheter assembly will provide personalized, controlled and predictable blood flow through the seal 100.
    [052] In some embodiments, one or more vents 100 are designed to allow airflow and stop blood flow. In some modes, the number of 100 breaths is between 1 and 40. In other modes, the number of 100 breaths is between 1 and 20. In some modes, six or more 100 breaths are included. While in other modes, five or fewer 100 ventilations are included. Consequently, in some embodiments, the vents 100 have a cross-sectional area between about 0.00452 and 0.02581 mm2 (0.000007 and 0.00004 inch2). In other embodiments, the vents 100 have a cross-sectional area between about 0.00645 and 0.01935 mm2 (0.00001 and 0.00003 inch2). In other embodiments, the vents 100 have a cross-sectional area of about 0.0129 mm2 (0.00002 inch2). For example, in some embodiments, vents 100 have a height of about 0.0254 to 0.0762 mm (0.001 to 0.003 inches) and a width of about 0.254 mm (0.010 inches). In other embodiments, the vents have a height of about 0.0508 to 0.0762 mm (0.002 to 0.003 inches) and a width of about 0.127 mm (0.005 inches).
    [053] Similarly, one or more flow restrictors 70 between the septum 50 and the inner surface 66 of the catheter adapter 14 can be specifically configured to allow blood and air to pass therethrough at an estimated range of flow rates . For example, one or more flow restrictors 70 can allow blood to flow therethrough at a rate of between about 10 and 200 ml/hr. In other cases, one or more flow restrictors 70 may allow blood to flow therethrough at a rate of between about 15 and 150 ml/hr. In still other cases, one or more flow restrictors 70 may allow blood to flow therethrough at a rate of between about 50 and 100 ml/hr. At these rates, the blood flow rate in the return chamber 116 can be measured to provide a clinician with adequate time to correctly locate the catheter within a patient's blood vessel. Consequently, in some embodiments, the flow restrictors 70 have a cross-sectional area greater than 0.01935 mm2 (0.00003 inch2). In other embodiments, the flow restrictors 70 have a cross-sectional area greater than 0.02581 mm2 (0.00004 inch2). In other embodiments, the vents 100 have a cross-sectional area of about 0.06452 mm2 (0.0001 inch2). In other embodiments, the vents 100 have a cross-sectional area of about 0.64516 mm2 (0.001 inch2).
    [054] Referring now to Figure 5, there is shown a cross-sectional view of the catheter assembly 10 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 member 46 of coupler 42 contacts contact surface 96 of septum activator 80. Septum activator 80 is advanced in a distal direction 72 as coupler 42 is further inserted into lumen 36 of catheter adapter 14. As coupler 42 is further advanced into lumen 36, probing surface 92 of septum activator 80 passes through barrier member 52 of septum 50. As such, probing surface 92 of septum 50. septum activator 80 is positioned within front chamber 62 providing a fluid path through the open slit 56 of septum 50.
    [055] During septum activation, the volume of the return chamber 116 decreases as the septum activator 80 advances in the distal direction 72. The reduction in volume can create a positive pressure within the return chamber 116 that can induce that fluids within return chamber 116 flow back through flow restrictors 70 in front chamber 62, along fluid flow path 115. This fluid can flow out of catheter assembly 10 with the infusion of fluids from of the IV tube 40.
    [056] In some embodiments, the catheter assembly 10 is configured to allow the septum activator 80 to return to a fully disabled position 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 10, the fluid path through the septum 50 is closed again.
    [057] Referring now to Figure 6, a septum 104 is described, according to some modalities. As shown, an outer surface 108 of the septum 104 is modified to include a plurality of recessed grooves 106. The recessed grooves 106 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 restrictor channels and flow 70, but instead, outer surface 108 of septum 104 is modified to provide a desired flow between front and rear chambers 62 and 64. The shape and the size of these slots can be selected, as mentioned, to provide the desired flow rate therethrough. For example, one or more ventilations 132 can allow blood to flow through them at a rate of between about 10 and 200 ml/hr. In another case, one or more ventilations 132 may allow blood to flow through them at a rate of between about 15 and 150 ml/h. In still other cases, one or more ventilations 132 may allow blood to flow through them at a rate between about 50 and 100 ml/h.
    [058] Reference is now made to Figures 7 to 14, which describe alternative embodiments of septum activators that provide a selective opening to flow out of the return chamber 116. The septum activators may include an inner tubular body 115 and an outer tubular body 113, which can be moved relative to one another between a first and a second position. In the present document, reference is made to the movement of the inner tubular body or the outer tubular body. These references are merely representational. It will be appreciated that, in other embodiments, one or both of the tubular bodies may be moved to alter the relative positions of the inner and outer tubular bodies with respect to each other.
    [059] In some configurations, in a first position, a plurality of openings in each of the inner 115 and outer 113 tubular bodies do not overlap, and no fluid can pass between the inner lumen 88 of the inner tubular body 115 and the chamber of return 116. The septum activator may be in this first position during return such that fluid entering the return chamber 116 remains there. In some configurations, in a second position, the plurality of openings in each of the inner 115 and outer 113 tubular bodies overlap, and fluid can pass between the inner lumen 88 of the inner tubular body 115 and the return chamber 116. septum activator may be in this second position following the return during fluid infusion through the catheter assembly 10 such that the fluid in the return chamber 116 can flow.
    [060] Referring to Figures 7 to 10, a septum activator 111 is described having an outer tubular body 113 provided with openings 122 in its proximal portion 136 and openings 120 in its distal portion 134. An inner tubular body 115 is located within the inner lumen 140 of the outer tubular body 113. The inner tubular body 115 also has openings 118 in its proximal portion and openings 117 in its distal portion. As described in Figure 7, the inner tubular body 115 is in a first position relative to the outer tubular body 113. In this position, the openings of the inner 115 and outer 113 tubular bodies do not overlap. In this first position, as shown in Figure 9, the portions of the septum activator 111 forming the barrier surfaces to the return chamber 116 are closed such that fluid cannot pass between the inner lumen 88 of the tubular body. inner 115 and return chamber 116. As shown, in this position, the most distal opening 120 of outer tubular body 113 is open, however, is separate from return chamber 116 as it is inserted into cavity 54 of septum 50, as shown in Figure 9. The most proximal opening 118 of the inner tubular body 115 is also open, however, it is disposed proximal to the seal 124, so it does not form a barrier surface of the return chamber 116. Therefore, in some embodiments, each opening between the septum 50 and seal 124 is closed when the inner 115 and outer 113 tubular members are in a first position.
    [061] As described in Figure 8, the inner tubular body 115 is in a second position relative to the outer tubular body 113. In this position, the openings of the inner 115 and outer 113 tubular bodies overlap forming the openings that extend through of both the inner 115 and outer 113 tubular bodies. In this second position, as shown in Figure 10, the overlapping openings of the septum activator 111 create openings in the barrier surfaces of the return chamber 116 that allow fluid to pass between. the inner lumen 88 of the inner tubular body 115 and the return chamber 116. In some cases, as the openings overlap, the return chamber 116 is filled with blood or other fluids. Therefore, fluid may be forced out of the flow restrictors 70 or may enter the inner lumen 88 of the inner tubular body 115 as the fluid is infused into the catheter adapter 14. Consequently, the overlapping openings drain and/or flow. the fluid from the return chamber 116.
    [062] In order to provide a hermetic fluid barrier that prevents the escape of fluid from the return chamber 116 into the inner lumen 88 of the inner tubular body 115, the outer surface of the inner tubular body 115 may have approximately the same dimensions and geometry that the inner surface of the outer tubular body 113. Additionally, in some embodiments, a lubricant, such as a non-wetting lubricant, may be disposed between the inner tubular body 115 and the outer tubular body 113 which helps to reduce or limit the flow of fluid through them.
    [063] In some embodiments, the septum activator 111 includes a seal 124 that forms a barrier surface of the return chamber 116. The seal 124 may function similarly to the seals 98 of Figures 3 to 5. As shown, the seal 124 may have a triangular shape, with an angled distal surface 144 and a proximal flat surface 142 that faces proximally. The seal 124 may have an outer diameter that is equal to or slightly greater than the inner diameter of an inner lumen 36 of a catheter adapter 14 such that the seal forms a fluid impermeable seal around the septum activator 111 Similarly, similar to the seals 124 illustrated in Figures 3 to 5, the seal 124 may include one or more vents (not shown) shaped and sized to allow air, but not blood, to pass therethrough. Vents can be disposed over the outer surface of the seal 124 or through the seal 124.
    [064] In order to allow the overlap of two or more openings, in some configurations, the inner tubular body 115 and the outer tubular body 113 have a corresponding arrangement of openings. For example, each of the openings 117, 118 of the inner tubular body 115 may align with an opening 120, 122 of the outer tubular body 113 when in the second position. In non-limiting examples, the inner tubular body 115 and the outer tubular body 113 have between one and fifteen openings that align with a similar number of openings in the outer tubular body. For example, the inner tubular body 115 may have six openings 117, 118 which overlap with six openings 120, 122 of the outer tubular body 113 when in the second position as shown. In another example, the inner tubular body 115 and the outer tubular body 113 have eight openings. In other configurations, the openings of the inner tubular body 115 do not line up with those of the outer tubular body 113, but each opening may align with the other at varying points along the movement between the first and second positions to provide an opening surface area. large in multiple locations between first and second positions.
    [065] In some configurations, such as those described in Figures 7 to 10, the inner tubular body 115 moves from a first position to a second position relative to the outer tubular body 113 as the inner tubular body is translated along the longitudinal axis 133 of the septum activator 111. For example, in some configurations, one or both of the inner 115 or outer 113 tubular bodies are translated distally along the longitudinal axis 133. In some configurations, one or both the inner 115 or outer 113 tubular bodies are proximally translated along the longitudinal geometric axis 133. As described in Figure 8, the inner tubular body 115 moves from a first position to a second position with respect to the outer tubular body 113 to As the inner tubular body 115 is translated distally along the longitudinal axis 133. In some embodiments, the force required for t sliding the inner tubular body 115 into the outer tubular body 113 is less than the force required to pierce the septum 50 such that the septum activator 80 begins piercing the septum 50 only after the inner tubular body 115 is in the second position with respect to the outer tubular body 113. In other embodiments, the forces are equal, or the force required to pierce the septum 50 is less than the translation force.
    [066] In order to prevent the removal of the inner tubular body 115 from the outer tubular body 113, the septum activator 111 may include one or more interlock features between these two bodies. As shown in Figures 7 and 8, in some embodiments, a recess 128 is formed on the inner surface of the outer tubular body 115 which receives an annular ring 126 formed on the outer surface of the inner tubular body 115. The recess 128 may extend longitudinally spaced far enough apart to allow the inner tubular body 115 to translate between the first and second positions. Additionally, recess 128 may limit the movement of the inner tubular body 115 such that it is not removed from the outer tubular body 113 or is inserted too far distally into the outer tubular body 113.
    [067] In some embodiments, tapered portions 130, 138 of outer tubular bodies 113 and inner 115, rather than one or more interlock features, limit distal movement of inner tubular body 115 within outer tubular body 113. For example As shown, as the inner tubular body 115 is distally translated, its tapered portion 138 contacts the tapered portion 130 of the outer tubular body 113 which restricts any further distal movement of the inner tubular body 115.
    [068] In some configurations, the inner tubular body 115 and the outer tubular body 113 are substantially the same lengths. Having similar lengths, the inner tubular body 115 and outer tubular body 113 form a constant wall thickness septum activator 111 when in the second position, as shown in Figure 8. However, as shown in Figure 7, in a first In position, the inner tubular body 115 can be stepped from the outer tubular body 113, forming a longer septum activator 111.
    [069] Figures 9 and 10 depict a septum activator 111 of Figure 8 and 9 in a catheter assembly 10. Similar to the septum activator 80 of Figures 3 to 5, the septum activator 111 can be configured so that it is compatiblely inserted into the cavity 54 on the proximal side of the septum 50 such that it is positioned where it can be pierced through the slit 56 of the barrier member 52 to form a fluid path therethrough. Distal end 134 includes a main surface that can be inserted through septum 50 to a position proximal to barrier member 52 of septum 50, as shown in Figure 10.
    [070] As shown in Figure 9, when the septum activator 111 is disposed in a disabled position in the catheter adapter 12, and the inner tubular body 115 is in a first position relative to the outer tubular body 113, the septum activator 111 forms a barrier surface of the return chamber 116. Therefore, during return, fluid flows along the fluid flow path 180 in the return chamber 116. When the tubular body 115 is in a first position relative to the body Outer tubular 113, septum activator 111 can form a fluid impermeable barrier that emits fluids from return chamber 116 into the inner lumen 88 of inner tubular body 115. As mentioned, as fluid enters the return chamber 116. return 116, the clinician can be provided with an observable indicator that catheter 12 is properly placed.
    [071] Referring to Figure 10, once the catheter 12 is properly placed, a conduit coupler 42 can connect an intravenous tube 40 to the catheter adapter 14 so that fluid is infused into the patient. As the conduit coupler is inserted into the catheter adapter 14, the probe member 46 enters the inner lumen 36 of the catheter adapter and contacts the contact surface 132 of the inner tubular body 115. As the member probe 46 advances further distally, it moves the inner tubular body 115 from a first position to a second position, with openings 117, 118 in inner tubular body 115 overlapping openings 120, 122 in outer tubular body 113 forming openings that pass through the septum activator 111. At this point, one or more fluid paths 190 are opened between the inner lumen 88 of the inner tubular body 115 and the return chamber 116. When the probe member 46 is fully advanced, septum activator 111 pierces septum 50, opening a fluid path therethrough. As fluid is infused into catheter assembly 10, fluid flows along one or more fluid flow paths 190, 192 into and out of overlapping openings of septum activator 111, through inner lumen 888 of the body. inner tubular 115, and/or through flow restrictors 70 between septum 50 and catheter adapter 14. In this way, fluids within return chamber 116 can be fluidized out of catheter assembly 10.
    [072] Figures 11A to 14 describe alternative embodiments of a septum activator 150 which, like the septum activator of Figures 7 to 10, provides a barrier surface for a return chamber 116 that can be selectively opened to flow fluids from the return chamber 116. Referring to Figures 11A-11B, there is described a septum activator 150 having an outer tubular body 152 having openings 166 in its proximal portion 164 and openings 156 in its distal portion 162. Inner tubular body 154 is located within inner lumen 140 of outer tubular body 152. Inner tubular body 154 also has openings 158 in its proximal portion and openings 160 in its distal portion. As described in Figures 11A-11B, the inner tubular body 154 is in a first position relative to the outer tubular body 152. In this position, the openings of the inner 154 and outer 152 tubular bodies do not overlap. In this first position, as shown in Figure 13, the portions of the septum activator 150 that form the barrier surfaces to the return chamber 116 are closed such that fluid cannot pass between the inner lumen 88 of the inner tubular body 154. and the return chamber 116.
    [073] As described in Figures 12A-12B, the inner tubular body 154 is in a second position relative to the outer tubular body 152. In this position, the openings of the inner 154 and outer 152 tubular bodies overlap forming extending openings through both the inner 154 and outer 152 tubular bodies. In this second position, as shown in Figure 14, the overlapping openings of the septum activator 150 create openings in the barrier surfaces to the return chamber 116 that allow fluid to pass. between the inner lumen 88 of the inner tubular body 154 and the return chamber 116. Fluid passing from the inner lumen 88 of the inner tubular body 154 through these overlapping openings enters the return chamber 116, thus fluid flowing from the return chamber 116.
    [074] In addition to having different configurations that allow movement between a first and a second position, the septum activator 150 of Figures 11A to 14 may have features, functions, and properties similar to those of the septum activator 111 of Figures 7 to 10 For example, in some configurations, the septum activator 150 provides a hermetic fluid barrier that prevents the escape of fluid from the return chamber 116 into the inner lumen 88 of the inner tubular body 154. In some configurations, the septum activator 150 includes a seal 124 that may have one or more vents. In some configurations, the inner tubular body 154 of the septum activator 150 has a plurality of openings 158, 160 that align with a similar number of openings 166, 156 in the outer tubular body 152. In some configurations, the inner tubular body 154 and the outer tubular body 152 has substantially the same lengths.
    [075] As described in Figures 11A to 12B, the inner tubular body 154 moves from a first position to a second position relative to the outer tubular body 152 as the inner tubular body is rotated about the longitudinal axis 133 of the septum activator 150. The rotational direction is illustrated by an arrow 168. In other cases, the direction of rotation is in the opposite rotational direction. As described in Figures 11A-11B, as the inner tubular body 154 moves from a first position to a second position relative to the outer tubular body 152, the openings 158, 160 in the inner tubular body 154 overlap the openings 166 156 in the outer tubular body 152.
    [076] In order to prevent the removal of the inner tubular body 154 from the outer tubular body 152, the septum activator 150 may include one or more interlock features between these two bodies. As shown in Figures 11A-11B, in some embodiments, a groove 170 is formed on the inner surface of the outer tubular body 152 which receives an annular ring 172 formed on the outer surface of the inner tubular body 154. The dimensions of the inner surface of the groove 170 may be approximately the same as those of the outer surface of annular ring 172. In some configurations, annular ring 172 may rotate within groove 170 to allow inner tubular body 154 to rotate from a first position to a second position. Additionally, the combination of groove 170 and annular ring 172 can interlock inner tubular body 154 within outer tubular body 152 to hold the two together.
    [077] Figures 13 and 14 depict a septum activator 150 within a catheter assembly 10. Similar to the septum activator 80, 111 of Figures 3 to 5 and 9-10, the septum activator 150 can be configured. so that it is compatiblely inserted into the cavity 54 on the proximal side of the septum 50 such that it is positioned where it can pierce through the slit 56 of the barrier member 52 to form a fluid path therethrough. The distal end includes a main surface that can be inserted through the septum 50 to a position proximal to the barrier member 52 of the septum 50, as shown in Figure 14.
    [078] As shown in Figure 13, when the septum activator 150 is disposed in a disabled position in the catheter adapter 12, and the inner tubular body 154 is in a first position relative to the outer tubular body 152, the septum activator 150 forms a barrier surface of the return chamber 116. Therefore, during return, fluid can flow along a fluid flow path 180 in the return chamber 116. When the tubular body 115 is in a first relative position to the outer tubular body 152, the septum activator can form a fluid impermeable barrier that prevents leakage of fluid from the return chamber 116 into the inner lumen 88 of the inner tubular body 154. As fluid enters the return chamber 116, the clinician is provided with an observable indicator that catheter 12 is properly placed.
    [079] Referring to Figure 14, once the catheter 12 is properly placed, a conduit coupler 42 can connect an intravenous tube 40 to the catheter adapter 14 for fluid to be infused into the patient. As conduit coupler 42 is inserted into catheter adapter 14, probe member 46 enters inner lumen 36 of catheter adapter and contacts contact surface 132 of inner tubular body 154. probe 46 is fully advanced, septum activator 150 pierces septum 50. Once fully inserted, conduit coupler 41 can be secured to catheter adapter 14. As mentioned, this connection can be between the threads on both the conduit coupler 42 as in catheter adapter 14.
    [080] The action of rotating conduit coupler 42 (in a direction represented by arrow 168) to connect it to catheter adapter 14 can rotate inner tubular body 154 from a first position to a second position, wherein openings 158, 160 in inner tubular body 154 overlap openings 160, 166 in outer tubular body. At this point, one or more fluid paths 184, 188 are open between the inner lumen 88 of the inner tubular body 154 and the return chamber 116.
    [081] In some configurations, friction between the probe member 46 and the septum activator allows movement of the inner tubular body 154 from a first position to a second position. In some embodiments, the coefficient of friction between the contact surface 132 of the septum activator 150 and the main surface 170 of the probe member 46 provides sufficient friction to transfer the rotational movement of the probe member 46 to the inner tubular body 154. in other embodiments, the probe member 46 does not contact the contact surface 132, but is inserted into the inner lumen 88 of the inner tubular body 154 and the outer surface of the probe member contacts the inner surface of the tubular body. inner 154. In some embodiments, the coefficient of friction between the outer surface of probe member 46 and the inner surface of inner tubular body 154 is sufficient to transfer rotational movement from probe member 46 to inner tubular body 154. In some embodiments, contact surface 132, main surface 170, probe member 46, or inner surface of inner tubular body 154 include a r. A gripping feature that provides sufficient friction to reduce or eliminate slippage between the septum activator 150 and the probe member 46. The gripping feature can include a sticky material, a rough surface, or the like.
    [082] After the septum activator 150 activates the septum 50 and the inner tubular member 154 is in a second position relative to the outer tubular body 152, fluid can be infused into the catheter assembly 10. catheter 10 may flow along one or more fluid flow paths 184, 186, 188 into and out of overlapping openings of septum activator 150, through inner lumen 88 of inner tubular body 154, and through restrictors flow 70 between septum 50 and catheter adapter 14. In this way, fluid within return chamber 116 can be fluidized out of catheter assembly 10.
    [083] From the above, it can be seen that a perforated septum valve can provide selective activation of fluid flow through the catheter assembly while minimizing or eliminating blood exposure. The perforated septum valve can enhance a clinician's ability to confirm placement of the catheter by providing an additional return chamber between a seal around the outside of the septum activator and the septum. Additionally, the septum activator can provide selective openings that open during activation and close when the septum activator is in a deactivated position. When closed, the openings form a barrier surface for the additional return chamber. When open, the openings provide fluid pathways through the septum activator that can flow fluid contained in the additional return chamber around the septum activator.
    [084] The present invention may be incorporated in 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 (13)
    [0001]
    1. A septum activator (111, 150) comprising: an outer tubular body (113, 152) having a plurality of openings (120, 122, 158, 160) therein; an inner tubular body (115, 154) disposed within the outer tubular body (113, 152) and having a plurality of openings (118, 158, 160) therein, the inner tubular body (115, 154) having a first relative position. to the outer tubular body and a second position relative to the outer tubular body; wherein in the second position, the plurality of openings (118, 158, 160) of the inner tubular body overlap the plurality of openings (120, 122, 158, 160) of the outer tubular body to form openings extending through both of the inner tubular body and outer tubular body; CHARACTERIZED by the fact that it comprises a seal (124) disposed on an outer surface of the septum activator (111, 150); and one or more holes disposed in the seal (124), each of the one or more holes permitting the passage of air and prohibiting the passage of blood.
    [0002]
    2. Septum activator (111, 150), according to claim 1, CHARACTERIZED by the fact that the inner tubular body (115, 154) moves from the first position to the second position as the inner tubular body (115, 154) or the outer tubular body (113, 152) is rotated about a longitudinal axis of the inner body.
    [0003]
    3. Septum activator (111, 150), according to claim 1, CHARACTERIZED by the fact that the inner tubular body (115, 154) moves from the first position to the second position as the inner tubular body (115, 154) or the outer tubular body (113, 152) is translated along a longitudinal axis of the inner body.
    [0004]
    4. Septum activator (111, 150), according to claim 1, CHARACTERIZED by the fact that the plurality of openings in the outer tubular body (113, 152) includes a plurality of openings in a proximal portion of the outer tubular body ( 113, 152) and a plurality of openings in a distal portion of the outer tubular body (113, 152); and wherein the plurality of openings in the inner tubular body (115, 154) includes a plurality of openings in a proximal portion of the inner tubular body (115, 154) and a plurality of openings in a distal portion of the inner tubular body (115, 154).
    [0005]
    5. Septum activator (111, 150), according to claim 4, CHARACTERIZED by the fact that the inner tubular body (115, 154) and the outer tubular body (113, 152) have a tapered portion.
    [0006]
    6. Septum activator (111, 150), according to claim 1, CHARACTERIZED by the fact that each of the one or more holes has a cross-sectional area less than or equal to 0.0001935 cm2 (0.00003 in2 ).
    [0007]
    7. Septum activator (111, 150), according to claim 1, CHARACTERIZED by the fact that it further comprises one or more interlocking features between the inner tubular body (115, 154) and the outer tubular body (113, 152) which retain the inner tubular body (115, 154) within the outer tubular body (113, 152).
    [0008]
    8. Septum activator according to any one of claims 1 to 7, CHARACTERIZED by the fact that the septum activator is disposed within a catheter assembly (10) comprising: a catheter adapter (14) having a lumen (36) extending therethrough; and a septum (50) disposed within the lumen.
    [0009]
    9. Septum activator (111, 150), according to claim 8, CHARACTERIZED by the fact that the seal (124) is disposed between the outer surface of the septum activator (111, 150) and the catheter adapter (14 ), the seal (124) seals the portion of the septum activator (111, 150) distal to the lumen (36) from the portion of the septum activator proximal to the lumen.
    [0010]
    10. Septum activator (111, 150), according to claim 8, CHARACTERIZED by the fact that it further comprises one or more interlocking features between the inner tubular body (115, 154) and the outer tubular body (113, 152) which retain the inner tubular body (115, 154) within the outer tubular body (113, 152).
    [0011]
    11. Septum activator (111, 150), according to claim 8, CHARACTERIZED by the fact that the volume outside the septum activator (111, 150) between the septum (50) and the seal (124) forms a chamber return (116).
    [0012]
    12. Septum activator (111, 150), according to claim 11, CHARACTERIZED by the fact that when the inner tubular body (115, 154) is in the second position, the inner tubular body (115, 154) and the body Outer tubular (113, 152) form a fluid tight barrier between an inner lumen (36) of the inner tubular body (115, 154) and the return chamber (116).
    [0013]
    13. Septum activator (111, 150), according to claim 8, CHARACTERIZED by the fact that each of the one or more holes has a cross-sectional area greater than 0.0001935 cm2 (0.00003 in2).
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    同族专利:
    公开号 | 公开日
    JP5805187B2|2015-11-04|
    BR112013001036A2|2017-10-24|
    AU2011279750B2|2014-09-25|
    EP2593168B1|2020-07-29|
    US8357119B2|2013-01-22|
    CN103068433B|2015-11-25|
    CN103068433A|2013-04-24|
    US20120016302A1|2012-01-19|
    JP2013534454A|2013-09-05|
    AU2011279750A1|2013-02-28|
    WO2012009029A1|2012-01-19|
    ES2824845T3|2021-05-13|
    EP2593168A1|2013-05-22|
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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]|
    2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-05-05| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
    2020-11-10| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-08| B09W| Decision of grant: rectification|Free format text: RETIFICACAO DA PUBLICACAO DE DEFERIMENTO POR TER SIDO EFETUADA COM INCORRECAO. TAL PUBLICACAO NAO IMPLICA NA ALTERACAO DA DATA DO DEFERIMENTO E NOS PRAZOS DECORRENTES DA MESMA. |
    2021-06-22| B16A| Patent or certificate of addition of invention granted|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
    US36457610P| true| 2010-07-15|2010-07-15|
    US61/364,576|2010-07-15|
    US36539110P| true| 2010-07-19|2010-07-19|
    US61/365,391|2010-07-19|
    US13/042,114|2011-03-07|
    US13/042,114|US8357119B2|2010-07-15|2011-03-07|Catheter assembly and pierced septum valve|
    PCT/US2011/028723|WO2012009029A1|2010-07-15|2011-03-16|A catheter assembly and pierced septum valve|
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