• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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    • 专利摘要:
    NON-PENETRANTING AND MULTIPLE-STRETCHING BLOOD CONTROL VALVES The present invention relates to infusion devices, specifically to peripheral intravenous (IV) catheters. In particular, the present invention relates to peripheral IV catheter assemblies having characteristics to allow selective and reversible activation of fluid flow through the catheter assembly. Some implementations of the present invention include various septa valve configurations having a barrier surface that is tensioned to orient the barrier surface and provide a path through the septum valve.
    公开号:BR112014008327B1
    申请号:R112014008327-4
    申请日:2012-10-04
    公开日:2020-11-24
    发明作者:S. Ray Isaacson；Kelly D. Christensen；Lawrence J. Trainer；Weston F. Harding
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    [0001] [001] The present invention relates to infusion devices, specifically a peripheral intravenous (IV) catheters. In particular, the present invention relates to peripheral IV catheter assemblies having characteristics to allow selective and reversible activation of fluid flow through the catheter assembly.
    [0002] [002] Catheters are commonly used for a variety of infusion therapies. For example, catheters are used for infusing fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient, drawing blood from a patient, or monitoring various parameters of the patient's vascular system.
    [0003] [003] Catheters and / or needles are typically attached to a catheter adapter to allow attachment of the IV tube to the catheter. Thus, following the placement of the catheter or needle in a patient's vasculature, the catheter adapter is coupled to a fluid source via an IV tube section. In order to check the proper position of the needle and / or catheter in the blood vessel, the doctor generally confirms that there is "return" of blood in a return chamber of the catheter set.
    [0004] [004] Once the proper placement of the catheter is confirmed, the doctor must then attach the catheter adapter to an IV tube section, or continue to manually occlude the vein to avoid undesirable exposure to blood. The process of coupling the catheter adapter to the IV tube section requires the physician to maintain pressure in a complicated way in the patient's vein while coupling the catheter adapter and the IV tube. A common and still undesirable practice is to allow blood to temporarily flow freely from the catheter adapter while the doctor locates and couples 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 in the patient's vein. Although this method can prevent undesirable exposure to blood, positive pressure within line IV can also prevent desirable return.
    [0005] [005] Some catheter sets additionally use a septum driver and a split septum, in which the septum driver is mechanically advanced through a septum slit to provide a fluid path through the septum. However, once advanced through the septum, the septum trigger becomes lodged within the septum cleft and is unable to return to its initial position. As such, the fluid path remains in an open position thereby allowing uncontrolled flow of fluids through the septum.
    [0006] [006] Therefore, there is a need in the art for a catheter assembly that allows controlled flow of fluid by the user. Various modalities of said catheter assembly are described here. Summary of the Invention
    [0007] [007] In order to overcome the limitations discussed above, the present invention relates to a rinsable peripheral IV catheter set having characteristics to allow selective activation of fluid flow through the catheter set. The catheter assembly of the present invention generally includes a catheter coupled to a catheter adapter. The catheter generally 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 insertion needle, as is commonly known and used in the art.
    [0008] [008] 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. The septum generally includes a flexible or semi-flexible material that is compatible with exposure to blood, medication, and other fluids commonly found during infusion procedures. In some embodiments, a groove is provided on an internal surface of the catheter adapter, where the septum is disposed within the groove. As such, the position of the septum within the catheter adapter is maintained.
    [0009] [009] In some implementations of the present invention, a closed or partially closed path, such as a slit or a plurality of slits, is additionally provided on a septum barrier surface. The path allows the fluid to pass the septum and flow through the catheter adapter. In some embodiments, the path is a slit that is closed before being opened or activated by a probe or septum driver positioned within the lumen of the catheter adapter. Before opening or activating, the slot prevents fluid from passing through the catheter adapter. Thus, in some embodiments, a plurality of air ventilation channels are arranged between the septum and the groove to allow air to flow through the catheter adapter before the slot is opened. Air vents prevent the increase of positive pressure inside the catheter adapter thereby allowing blood to return inside the catheter and a front chamber of the catheter adapter.
    [0010] [010] The septum actuator generally includes a tubular plastic or metallic body having a probe tip and a contact tip. The probe tip is positioned adjacent to the septum path, and the contact tip is positioned adjacent to the proximal opening of the catheter adapter. The probe end of the septum trigger is advanced against the septum when a probe is inserted into the proximal opening of the catheter adapter. As the probe contacts the contact surface of the septum trigger, the septum trigger is advanced in a distal direction thereby deforming or otherwise displacing the septum barrier surface and the distal direction. When in the tensioned position, the gap or cracks in the barrier surface assume an open position thereby allowing free flow of fluid through the catheter assembly. With the release of the septum trigger, the gap or cracks in the barrier surface summarizes its closed position. Brief Description of the Different Views of the Drawings
    [0011] [011] So that the manner in which the above characteristics and other characteristics and advantages of the present invention are obtained will be readily understood, a more particular description of the present invention briefly described above will be made with reference to the specific modalities thereof which are illustrated in the attached drawings. Said drawings illustrate only typical embodiments of the present invention and are therefore not considered to limit the scope of the present invention.
    [0012] [012] Figure 1 is a perspective view of an embodiment of a catheter assembly according to a representative embodiment of the present invention.
    [0013] [013] Figure 2 is an exploded cross-sectional view of a catheter assembly according to a representative embodiment of the present invention.
    [0014] [014] Figure 3, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated and a non-activated configuration according to a representative modality of present invention.
    [0015] [015] Figure 4, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated and non-activated configuration according to a representative modality of present invention.
    [0016] [016] Figure 5 is a cross-sectional side view of a catheter adapter and an integrated plunger and septum according to a representative embodiment of the present invention, before activation.
    [0017] [017] Figure 6 is the perspective view of an integrated plunger and septum according to a representative embodiment of the present invention, after activation.
    [0018] [018] Figure 7 is a cross-sectional side view of the device of figure 5 after activation by a septum trigger according to a representative embodiment of the present invention, after activation.
    [0019] [019] Figure 8 is a cross-sectional perspective view of the device shown in Figure 5, according to a representative embodiment of the present invention.
    [0020] [020] Figure 9, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a probe device, and a septum in an activated and a non-activated configuration according to a representative modality of present invention.
    [0021] [021] Figure 10, shown in the AC parts, shows a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated and non-activated configuration according to a representative embodiment of the present invention. .
    [0022] [022] Figure 11, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated and a non-activated configuration according to a representative modality of present invention.
    [0023] [023] Figure 12 is a cross-sectional side view of a catheter adapter, a septum actuator, and an integrated actuator and a restriction collar according to a representative embodiment of the present invention, before activation.
    [0024] [024] Figure 13 is the perspective view of an integrated driver and a restriction collar according to a representative embodiment of the present invention.
    [0025] [025] Figure 14 is a side perspective view of the device shown in figure 12, after activation.
    [0026] [026] Figure 15, shown in parts A and B, shows a side view in cross section of a catheter adapter, a septum driver, and a septum in an activated and an inactivated configuration, in which the septum includes a spring rigid clamp sheet according to a representative embodiment of the present invention.
    [0027] [027] Figure 16 is a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated configuration, in which the septum slit is minimized according to a representative embodiment of the present invention.
    [0028] [028] Figure 17, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a septum driver, and a septum in an activated and a non-activated configuration according to a representative modality of present invention.
    [0029] [029] Figure 18, shown in parts A and B, shows a cross-sectional side view of a catheter adapter, a septum trigger, and a septum in an activated and an inactivated configuration, where the septum comprises a septum post activation according to a representative embodiment of the present invention.
    [0030] [030] Figure 19, shown in parts A-C, shows a catheter adapter, a septum, a septum driver in an activated and an unactivated configuration according to a representative embodiment of the present invention. Detailed Description of the Invention
    [0031] [031] The currently preferred embodiment of the present invention will be better understood with reference to the drawings, where similar reference numbers indicate identical elements or similar functionality. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures here, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the present invention as claimed, but is merely representative of currently preferred embodiments of the present invention.
    [0032] [032] With reference now to figure 1, a catheter assembly 10 is illustrated. Catheter assembly 10 generally includes a catheter 12 attached to the distal end 32 of a catheter adapter 14. Catheter 12 and catheter adapter 14 are integrally coupled so that an inner lumen 16 of catheter adapter 14 is in communication of fluid with a lumen 18 of catheter 12. Catheter 12 generally comprises a biocompatible material having sufficient rigidity to withstand pressures associated with insertion of the catheter into a patient. In some embodiments, catheter 12 comprises a flexible or semi-flexible polymer material, such as silicone or polytetra-fluoroethylene. Catheter 12 may additionally comprise a rigid metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof.
    [0033] [033] Those skilled in the art will readily note that the features of the present invention can be incorporated for use with a catheter assembly over the needle. For example, those skilled in the art will note that a flexible or semi-flexible polymer catheter can be used in combination with a rigid introducer needle to allow insertion of the catheter into a patient. Those skilled in the art will additionally note that surgically implanted catheters can also be used in combination with the present invention.
    [0034] [034] Once inserted into a patient, catheter 12 and catheter adapter 14 provide a fluid conduit to facilitate the delivery of a fluid to and / or the recovery of a fluid from a patient, as required by a procedure infusion desired. Thus, in some modalities, catheter material 12 and catheter adapter 14 are selected to be compatible with bio-fluids 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 an intravenous section tube 40 to additionally facilitate the delivery of a fluid to or the removal of a fluid from a patient.
    [0035] [035] In some embodiments, the 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 the attachment of an intravenous tube or patient conduit 40 to the catheter assembly 10 In some embodiments, the flange 28 includes a set of threads 30. The threads 30 are generally provided and configured to receive in a compatible manner a set of complementary threads 44 comprising a portion of a coupling device or male luer 42. The device of coupling 42 is generally coupled to an end portion of patient conduit 40 in a fluid hermetically. In some embodiments, an inner portion of the coupling device 42 is extended outwardly to provide a probe surface 46.
    [0036] [036] The surface of probe 46 is generally configured to insert in a compatible manner within the proximal end 22 of catheter adapter 14. After insertion of probe 46 into proximal end 22 of catheter adapter 14, the device coupling 42 is rotated to interlock coupling device 42 and flange 28 (via thread sets 30 and 44). During the interlocking process the coupling device 42 and the flange 28, the surface of the probe 46 are advanced in the lumen16 of the catheter adapter 14 to an inserted position. The inserted position of the probe surface 46 activates catheter assembly 10 to allow fluid flow through catheter 12 and catheter adapter 14. Once the coupling device 42 and catheter adapter 14 are attached, a fluid can be sent to a patient via patient conduit 40 and the catheter inserted 12.
    [0037] [037] With reference now to figure 2, an exploded cross-sectional view of a catheter assembly 10 is shown. In some embodiments, the catheter adapter 14 includes various features and design components to control and / or limit the flow of fluid through the catheter assembly 10. For example, in some embodiments of the present invention a septum or septum valve 50 is positioned within the inner lumen 16 of the catheter adapter 14. The septum 50 generally comprises a flexible, or semi-flexible polymer plug having an outside diameter that is configured to fit in a compatible manner within a groove or channel 60 formed on a surface internal 24 of catheter adapter 14. In some embodiments, the septum 50 is cylindrical or can be formed having the barrier surface 52 comprising the distal end of the septum 50 and additionally having an opening 54 comprising the proximal end of the septum 50. When positioned within the channel 60, the barrier surface 52 of the septum 50 divides the inner lumen 16 of the catheter adapter 14 in a fluid chamber 62 and a rear fluid chamber 64. Thus, the presence of the septum 50 controls or limits the flow of fluid between the front and rear fluid chambers 62 and 64. Specifically, a chosen configuration of the barrier surface 52 of the septum 50 determines greatly enhances the ability of a fluid to flow through the inner lumen 16 of catheter adapter 14.
    [0038] [038] For example, in some embodiments the barrier surface 52 of the septum 50 is configured to include a slit 56. Slit 56 is configured to provide selective access or flow of a fluid through a barrier surface 52. In some embodiments , the slot 56 is configured to remain in a fluid-tight closed position until it is activated or tensioned in an open configuration by advancing a septum driver 80 against the barrier surface 52 in the distal direction 290. In some embodiments, the slot 56 it is configured to allow an introduction needle or other probe device to pass through to aid in the patient's subsequent catheterization or treatment. In some embodiments, the barrier surface 52 comprises a slit 56. In other embodiments, the barrier surface 52 comprises a plurality of slits.
    [0039] [039] In general, slit 56 forms a fluid tight seal before being triggered by the septum trigger 80. However, for some infusion therapy techniques, it may be desirable to allow a controlled flow of fluid through the septum 50 before to activate the septum 50 with the septum actuator 80. Thus, in some embodiments, the slot 56 does not form a fluid-tight seal. Instead, slit 56 forms a leak port to allow controlled flow of liquid or air between the front and rear chambers 62 and 64 (not shown).
    [0040] [040] The groove or channel 60 within which the septum is disposed comprises a slit portion of the inner surface 24 of the catheter adapter 14. The outer diameter of the septum 50 is generally configured to match and firmly fit within the channel 60 For example, in some embodiments the outer diameter of the septum 50 is selected to be not only relatively smaller than the diameter of the channel 60 but also relatively larger than the diameter of the inner lumen 16. As such, the septum 50 is retained within of channel 60 when using catheter set 10.
    [0041] [041] For some infusion therapy techniques, airflow between the front and rear chambers 62 and 64 may be desirable. For example, for embodiments comprising a septum 50 having a fluid tight slot 56 and 66, the passage of air from the front chamber 62 to the rear chamber 64 is prohibited before opening or activating the septum 50 via the septum 80, as previously discussed. Thus, when catheter 12 of catheter assembly 10 is inserted into a patient's vascular system, positive pressure develops within the front chamber 62 thereby preventing the desired return of the patient's blood into catheter adapter 14. A return observable is generally desirable to confirm the accurate placement of the catheter tip 20 into the patient's vein. Thus, some embodiments of the present invention include features or elements to allow air flow between the front chamber 62 and the rear chamber 64, without requiring activation of the septum 50 with the septum actuator 80. As such, some embodiments of the present invention provide an observable return, as generally desired for infusion procedures.
    [0042] [042] For example, in some embodiments, slot 56 is modified to allow a controlled leak of air or liquid, as previously discussed. In other embodiments, the plurality of air ventilation channels 70 is arranged between the septum 50 and the inner surface 24 of the catheter adapter 14. The air ventilation channels 70 relieve positive pressure inside the front chamber 62 by providing access for the air to pass the septum 50 inside the rear chamber 64. In some embodiments, the air ventilation channels 70 are constructed by removing portions of the surface of the channel 60, resulting in a plurality of generally parallel grooves. In other embodiments, an external septum surface 50 is modified to include a plurality of generally parallel grooves (not shown), as shown and taught in US patent application serial number 12 / 544,625, which is incorporated herein by reference. .
    [0043] [043] Continuing with reference to figure 2, the septum driver 80 comprises a probe-like structure which is mainly housed in the rear chamber 64 of the catheter adapter 14. The septum driver 80 generally comprises a tubular body 82 having the end distal 84 and the proximal end 86. The tubular body 82 comprises a rigid or semi-rigid material, such as plastic or metallic material. The tubular body 82 additionally comprises an internal lumen 88 to facilitate the flow of a fluid and / or liquid through the septum actuator 80. The septum actuator 80 can additionally include various features 110, 120 and 130 to retain the septum actuator 80 inside the catheter adapter 14, and to optimize the flow of fluid through and around the septum driver 80.
    [0044] [044] The distal end 84 of the tubular body 82 is configured to contact in a compatible manner and thereby deform the barrier surface 52 of the septum 50. The distal end 84 is generally configured to insert in a compatible manner within the opening 54 of the septum 50. The distal end 84 additionally includes a probe surface 90 that extends through the opening 54 of the septum 50 to a position proximal to the barrier surface 52 of the septum 50. The probe surface 90 is advanced against the barrier surface 52 as the septum driver 80 is advanced through the catheter adapter 14 in the distal direction 290.
    [0045] [045] Referring now to figures 3A and 3B, a septum with a bistable function 50 is shown to have a concave barrier surface 52. Prior to activation, septum 50 forms a fluid tight seal in slot 56. As the septum driver 80 is advanced distally 290, the barrier surface 52 is tensioned or oriented in an open position, as shown in figure 3B. When probe 46 is removed from the catheter adapter 14, the flexible nature of the septum 50 guides the septum driver 80 in a proximal direction 292 so that a fluid tight seal is again formed in the slot 56, as shown in figure 3A.
    [0046] [046] In some embodiments, the septum driver and the septum are integrated into a single flexible plunger unit, as shown in figures 4A and B. For the present embodiment, the septum 50 comprises a disk-shaped member having a portion center to which the shaft portion of the actuator 80 is attached. Prior to activation, the septum 50 forms a fluid tight seal around its perimeter surface against the inner surface of the catheter adapter 14. In some embodiments, the septum 50 additionally it comprises a plurality of microventilations to allow air leakage but not fluid leakage. Thus, the present modality provides multiple accesses with a means of cannula compatibility and air ventilation.
    [0047] [047] In some embodiments, the inner surface of the catheter adapter 14 additionally comprises a plurality of grooves so that as the septum 50 is oriented in the distal direction 290, the perimeter surface of the septum 50 overlaps the grooves 78 of that thereby breaking the fluid-tight seal around its perimeter surface, as shown in figure 4B. Thus, fluid is allowed to pass through a driver ventilation portion 80 and pass into the front fluid chamber 62 through slots 78. When probe 46 is removed from catheter adapter 14, the flexible nature of the septum 50 orients the septum driver in the proximal direction 292 so that the fluid tight seal is once again established around the septum perimeter 50, as shown in figure 4A.
    [0048] [048] Referring now to figures 5-8, another mode of a septum and the integrated septum trigger is shown. In some embodiments, a septum and the integrated septum actuator are provided in which the septum actuator 80 comprises a rigid plastic drive device having a ring-shaped base and extension arms that are coupled to a dome-shaped septum or disc 50. The septum and the integrated septum driver are positioned within the catheter adapter 14 so that septum 50 is immobilized and the septum driver 80 is able to move in the proximal and distal direction. The septum 50 additionally comprises a plurality of microventilations that open when the septum is oriented in a distal direction 290 by the septum driver 80. The septum driver 80 is oriented in the distal direction 290 as the probe 46 is threaded over catheter adapter 14, as shown in figure 7. When probe 46 is unscrewed from catheter adapter 14, the flexible or restorative nature of septum 50 guides septum driver 80 in the proximal direction 292 thereby closing the septum microventilation, as shown in figures 5 and 8.
    [0049] [049] Referring now to Figures 9A and 9B, in some embodiments the septum 50 comprises a convex barrier surface 52. Prior to activation, the septum 50 forms the fluid tight seal in the slot 56. As the probe 46 is advanced in the distal direction 290, the barrier surface 52 is oriented in an open position, as shown in figure 9B. When probe 46 is removed from catheter adapter 14, the flexible nature of the septum 50 summarizes its fluid tight seal in slot 56, as shown in figure 9A.
    [0050] [050] In some embodiments, the catheter assembly 10 additionally comprises a burst cone 66. Referring now to Figures 10A-10C, the burst cone 66 is provided as a rigid barrier over which the septum 50 is guided by the actuator septum 80. Prior to activation, the outer perimeter of septum 50 forms the fluid-tight seal with the inner surface of catheter adapter 14. As probe device 46 is advanced in the distal direction 290, the septum driver 80 comes into contact with the septum 50, thereby orienting the septum 50 over the breaking cone 66, as shown in figure 10B. When oriented, the hermetic seal of the septum fluid 50 is broken in this way allowing the passage of fluid between the septum 50 on the inner surface of catheter adapter 14. The channels formed in the septum driver 80 and the rupture cone 66 additionally allow the fluid passage through catheter adapter 14. When probe 46 is removed from catheter adapter 14, the flexible nature of septum 50 orients the septum driver 80 in a proximal direction 292 so that the fluid tight seal is again formed between the septum 50 and the catheter adapter 14, as shown in figure 10A.
    [0051] [051] Referring now to figures 11A and 11B, in some embodiments the septum 50 and the septum actuator 80 are configured so that the actuator 80 is not allowed to fully penetrate the septum 50. In some embodiments, this is due to the shortened space of the catheter adapter in which the septum driver 80 is allowed to transit within. In other embodiments, the length of the barrier surface 52 is such that when the septum driver 80 penetrates the septum 50, the barrier surface 52 contacts the edge 94 of the catheter adapter 14 thereby flexing and relatively deforming the barrier surface 52. When this occurs, the distal end of the septum driver 80 is mechanically prevented from exceeding the narrow diameter caused by the interaction between the edge 94 and the barrier surface 52. As such, the flexible and restoration nature and the geometric configuration of the septum 50 orients the septum actuator 80 in the proximal direction 292 following removal of the probe 46 from the catheter adapter 14, as shown in figure 11 A.
    [0052] [052] Referring now to figures 12-14, in some embodiments the septum driver 80 and septum 50 comprise an integrated elastomeric unit. In particular, in some embodiments the catheter adapter 14 is configured to accommodate a restriction collar 68 that includes an outer surface that forms a fluid tight seal with the inner surface of the catheter adapter 14, and additionally includes a central path through the which the septum / septum trigger 80, 50 is retained. The septum driver portion of the integrated device additionally comprises a spring characteristic 81 which creates a tension across the integrated device thereby pulling the septum portion 50 of the integrated device against the distal surface of the restriction collar 68 to form the airtight seal a fluid, as shown in figures 12 and 13. With the insertion of a probe device 46 into the catheter adapter 14, the probe device comes into contact with the septum actuator portion 80 of the integrated device thereby temporarily negating the characteristics of spring 81 when the seal breaks between the septum portion 50 of the integrated device and the restriction collar 68, as shown in figure 14. The fluid is then allowed to flow through the central path of the restriction collar 68 and exceeds the septum portion 50 of the integrated device. When probe 46 is removed from the catheter adapter 14, the flexible nature of the spring characteristics 81 guides the integrated device in the proximal direction 292, thereby re-establishing the fluid tight seal between the septum portion 50 and the restriction collar 68.
    [0053] [053] Referring now to figures 15A and 15B, in some embodiments the septum 50 additionally comprises a rigid clamp leaf spring 76 which is located internally within the septum 50. The catheter adapter 14 additionally comprises a rigid, perforated pin 74 which prevents the distal end of septum 50 from sticking during septum activation. Clamp leaf springs 76 are provided as a rigid element for compressing the distal end of the septum 50 when the septum 50 is compressed by the probe device 46, as shown in figure 15B. Collet leaf springs 76 additionally provide a rigid structure on which the barrier surface 52 is oriented in an open position. When probe 46 is removed from the catheter adapter 14, the flexible nature of the septum 50, and in particular the distal end of the septum 50, guides the proximal portion of the septum 50 and the clamp leaf spring 76 in the proximal direction 292 , so that the fluid tight seal is again formed in the slot 56, as shown in figure 15A.
    [0054] [054] Referring now to figure 16, in some embodiments the septum slit 56 is undersized so that the septum driver 80 is prevented from completely penetrating the slit 56. As such, when the probe device 46 is removed from of the catheter adapter 14, the flexible nature of the septum 50, due to the undersized septum slit 56, guides the septum driver 80 in the proximal direction 292 so that the fluid tight seal is once again formed in the slit 56. In In other words, the septum has a small slit so that the silicone or other septum material 50 will exert a return or restoring force by moving the driver 80 back to its initial state in the fluid flow seal through the fluid adapter. catheter 14.
    [0055] [055] With reference to figures 17A and 17B, a rear flange of the septum 50 is elongated so that before activation of the septum 50, the rear flange is positioned in proximity to the rigid opposite surface of the septum driver 80. As far as Since the septum driver is advanced in the distal direction 290, the rear flange is compressed between the septum driver 80 and an internal feature of the catheter adapter 14. Following the removal of a probe device 46 from the catheter adapter 14 , the flexible nature of the rear septum flange 50 guides the septum driver 80 in the proximal direction 292 so that the fluid tight seal is again formed in the slot 56, as shown in figure 17B.
    [0056] [056] In other embodiments, the septum 50 comprises an integrated septum trigger, shown as a post-activation septum 98. Post-activation 98 is positioned so that when probe device 46 is inserted into catheter adapter 14, the probe 46 contacts post-activation 98 thereby orienting the barrier surface portion 52 in a distal direction 290, thereby opening slot 56, as shown in figure 18B. With the removal of probe 46 from catheter adapter 14, the flexible nature of barrier surface 52 guides post-activation 98 and barrier surface 52 to its original closed and sealed orientation, as shown in figure 18A.
    [0057] [057] In some embodiments, septum 50 comprises a co-labable septum, as shown in figures 19A-19C. In particular, some embodiments comprise an elastomeric septum that is designed with a pre-perforated slit 56 for its length to allow insertion and retention of the cannula until the time the cannula is disposed in the vein and removed. Micro-vents close to the sealing surface allow air to be vented, but not to leak liquid. With the engagement of the probe device 46, several cutting areas allow the septum cylinder to stick to itself in this way allowing an opening of a path of liquid fluid through the catheter adapter 14. With the removal of the probe device 46, the natural elastomeric properties of the septum 50 force the septum back to its relaxed resting state and seal the fluid path. An advantage of said modality is that the actuation part, or the septum driver, and the septum comprise a single integrated component. The present embodiment can additionally allow a smooth cleaning surface at the proximal opening of the catheter adapter 14.
    [0058] [060] The present invention can be incorporated into other specific forms without deviating from its structures, methods, or other essential features as widely described here and claimed hereinafter. The described modalities must be considered in all aspects as illustrative, and not restrictive. The scope of the present invention, therefore, is indicated by the appended claims, rather than by the preceding description. All changes that are inserted in the meaning and in the equivalence range of the claims must be included within its scope.
    权利要求:
    Claims (20)
    [0001]
    Integrated septum (50) and septum trigger (80), FEATURED for comprising a base having a fluid path and an extension arm extending out of the base, the extension arm being coupled to a septum (50), the septum (50) being deformable from a relaxed position to a tensioned position, where the tensioned position guides the septum (50) to provide a path around an external surface of the septum.
    [0002]
    Integrated septum and septum trigger according to claim 1, CHARACTERIZED by the fact that the septum (50) still comprises a plurality of microventilations that open when the septum (50) is in a tensioned position.
    [0003]
    Integrated septum and septum trigger according to claim 1, CHARACTERIZED by the fact that it still comprises a plurality of extension arms.
    [0004]
    Integrated septum and septum actuator according to claim 1, CHARACTERIZED by the fact that the septum (50) is at least one or in the form of a dome or disk shape.
    [0005]
    Integrated septum and septum actuator according to claim 1, CHARACTERIZED by the fact that the septum (50) is mechanically deformed from the relaxed position to a tensioned position.
    [0006]
    Integrated septum and septum trigger according to claim 2, CHARACTERIZED by the fact that the relaxed position closes the path around the external surface of the septum (50) and closes the plurality of microventilations.
    [0007]
    Integrated septum and septum trigger, according to claim 1, CHARACTERIZED by the fact that the septum (50) comprises an elastic material.
    [0008]
    Integrated septum and septum trigger, according to claim 1, CHARACTERIZED by the fact that the septum (50) is flexible.
    [0009]
    System for controlling fluid flow in a catheter set, FEATURED for understanding: an intravenous catheter assembly (10) having a catheter adapter (14) comprising an internal lumen; an integrated septum (50) and septum actuator (80) arranged within a portion of the internal lumen, the integrated septum (50) and septum actuator (80) comprise a base having a fluid path and an extending arm extends out of the base, the extension arm being attached to a septum being deformable from a relaxed position to a tensioned position, in which a path around an external surface of the septum (50) is closed when the septum is in the relaxed position, and the path around the outer surface of the septum is opened when the septum is in a tensioned position.
    [0010]
    System according to claim 9, CHARACTERIZED by the fact that it comprises a plurality of microventilations that open when the septum (50) is in a tensioned position, and in which the proximal end of the base is accessed through the insertion of an external device in the proximal opening of the catheter adapter (14).
    [0011]
    System according to claim 10, CHARACTERIZED by additionally comprising a lumen forming a fluid path through the base and the extension arms.
    [0012]
    System according to claim 9, CHARACTERIZED by additionally comprising a ventilation channel disposed between the septum (50) and an internal surface of the internal lumen of the catheter adapter (14), the ventilation channel having a surface area and a perimeter selected to allow at least one air and blood to pass to a desired flow coefficient.
    [0013]
    System according to claim 10, CHARACTERIZED by the fact that the distal end of the extension arms is fixedly fixed to a proximal surface of the septum (50).
    [0014]
    System according to claim 10, CHARACTERIZED by the fact that the integrated septum (50) and septum actuator (80) are slidably housed within the portion of the internal lumen and are able to move between the proximal position and the distal position, where when the integrated septum (50) and the septum trigger (80) is in the proximal position the septum (50) is in the relaxed position, and where when the integrated septum and the septum trigger (50) is in the distal position, the distal end of the extension arms orients the septum (50) to the tensioned position.
    [0015]
    System according to claim 9, CHARACTERIZED by the fact that it additionally comprises a plurality of extension arms.
    [0016]
    Method of manufacturing a catheter set having characteristics to control the flow of fluid within the catheter set, the CHARACTERIZED method for understanding: provide an integrated septum and septum trigger device comprising a base having a fluid path and an extension arm extending out of the base, the extension arm being coupled to a septum being deformable from a relaxed position to a tensioned position, where the tensioned position guides the septum to provide a path around an external surface of the septum; providing an intravenous catheter assembly (10) having a catheter adapter (14) comprising an internal lumen; and arrange the integrated septum (50) and septum actuator (80) within a portion of the internal lumen of the catheter adapter (14).
    [0017]
    Method according to claim 16, CHARACTERIZED by the fact that it additionally comprises the arrangement of an integrated septum and a septum driver within the portion of the internal lumen adjacent to the proximal opening of the catheter adapter (14), wherein the end proximal base is accessed by inserting an external device into the proximal opening of the catheter adapter (14).
    [0018]
    Method according to claim 16, CHARACTERIZED in that it additionally comprises a plurality of extension arms.
    [0019]
    Method according to claim 16, CHARACTERIZED by additionally comprising fixedly attached to a distal end of the extension arms to a proximal surface of the septum.
    [0020]
    Method according to claim 16, CHARACTERIZED in that it further comprises a step for providing the septum with a plurality of microventilations that are closed when the septum is in the relaxed position, and are open when the septum is in the tensioned position.
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-11-24| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161544238P| true| 2011-10-06|2011-10-06|
    US61/544.238|2011-10-06|
    US13/644,244|US9155863B2|2011-10-06|2012-10-03|Multiple use stretching and non-penetrating blood control valves|
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