• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    MULTIPLE USE BLOOD CONTROL VALVE CONTAINING CIRCUMFERENTIAL CRACKS. Built-in catheter assembly featuring a deformable septum containing one or more slits, in which the septum is temporarily deformed by a septum actuator to open one or more slits enabling the lateral passage of fluid and air through the septum.
    公开号:BR112014008198B1
    申请号:R112014008198-0
    申请日:2012-10-05
    公开日:2021-05-11
    发明作者:Marty L. Stout；Austin Jason Mckinnon
    申请人:Becton Dickinson And Company；
    IPC主号:
    专利说明:

    FUNDAMENTALS OF THE INVENTION
    [001] The present invention relates to infusion devices, specifically to peripheral intravenous (IV) catheters. In particular, the invention relates to an embedded peripheral IV catheter assembly having features enabling activation of fluid flow through the catheter assembly.
    [002] Catheters are commonly used for a variety of infusion therapies. For example, catheters are used to infuse fluids, such as normal saline, various medications, and complete parenteral nutrition, with a patient, to draw blood from the patient, or to monitor various parameters of the patient's vascular system.
    [003] Typically, catheters and/or needles are coupled with a catheter adapter to enable the fixation of the IV tubing in the catheter. The catheter or needle is then placed in the patient's vascular system, with the catheter adapter being coupled to a fluid source via a section of IV tubing. In order to verify proper placement of the needle and/or catheter in the blood vessel, the clinician generally ensures that there is any "backflow" of blood into a reflux chamber of the catheter assembly.
    [004] Once proper placement of the catheter occurs, the clinician must then secure the catheter adapter to a section of IV tubing, or proceed to draw in the vein to prevent unwanted exposure of blood. The process of attaching the catheter adapter to the IV tubing section requires the clinician with difficulty maintaining pressure on the patient's vein while simultaneously attaching the catheter adapter and IV tubing. A common, however undesirable, practice is to allow blood to flow temporarily and freely from the catheter adapter while the clinician locates and couples the IV tubing close to the catheter adapter. Another common practice is to attach the catheter adapter to the IV tubing before placing the needle and catheter in the patient's vein. While this method can prevent unwanted exposure of blood, the possible pressure within the IV line can also prevent the necessary backflow.
    [005] Some of the sets of catheters still make use of a septum actuator and a septum divider, in which the septum actuator is mechanically advanced through a septum slit to provide a fluid path through the septum. However, once advanced through the septum, the septum actuator becomes lodged inside the septum slit and is unable to return to its initial position. Resulting in the fluid path remaining in an open position making it impossible to control the flow of fluid through the septum.
    [006] Consequently, there is a need in the field for a catheter assembly that allows the user to control the flow of fluid, and at the same time provide the desirable backflow without the risk of encountering an undesirable exposure of blood. Such a catheter assembly is described in this report. SUMMARY OF THE INVENTION
    [007] In order to overcome the limitations discussed above, the present invention relates to an embedded peripheral IV catheter set having features to enable selective activation of fluid flow through the catheter set. The catheter assembly of the present invention generally includes a catheter coupled to the catheter adapter. In general, the catheter includes a metallic material, such as titanium, steel or a surgical alloy, as is common knowledge in the field. In some modalities, a polymeric catheter can be used in combination with a needle with a metallic introducer, as used and already known in the area.
    [008] In some embodiments of the present invention, a septum is positioned within a lumen of the catheter assembly preventing or restricting fluid flow through the catheter adapter. In general, the septum includes a flexible or semi-flexible material compatible with exposure to blood, medications, and other fluids commonly encountered during infusion procedures. In some embodiments, a slot is provided adjacent an inner surface of the catheter adapter, where the septum is accommodated within the slot. Therefore, the septum positioning inside the catheter adapter is preserved.
    [009] In some implementations of the present invention, a closed or partially closed path, such as a slit or a plurality of slits is provided further on a septum barrier surface. The path allows the lateral passage of fluid through the septum flowing through the catheter adapter. In some embodiments, the pathway consists of a slit that is closed before being opened or activated by means of a probe or septum actuator positioned within the lumen of the catheter adapter. Before being opened or activated, the slit prevents fluid from passing through the catheter adapter. Thus, in some embodiments, a plurality of air vent channels are interposed between the septum and the groove allowing air to flow through the catheter adapter prior to opening the gap. Ventilating air prevents positive pressure from building up inside the catheter adapter by allowing blood to flow back into the catheter and to a front chamber of the catheter adapter.
    [010] The septum actuator generally includes a metallic or plastic tubular body having a probe end and a contact end. The probing end is positioned adjacent the septum pathway, and the contact end is positioned adjacent an opening proximate the catheter adapter. The probing end of the septum actuator is advanced against the septum when inserting a probe into the opening near the catheter adapter. Once the probe contacts the contact surface of the septum actuator, the septum actuator is advanced in a retraction direction deforming the septum barrier surface and the retraction direction. When in this skewed position, the slits in the barrier surface assume an open position allowing for a free flow of fluid through the catheter assembly.
    [011] Finally, the presence of the septum actuator within the lumen of the catheter adapter can result in abnormal fluid flow leading to undesirable stagnation and coagulation of the fluids within the catheter assembly. Thus, in some embodiments of the present invention, the septum actuator further includes various features such as flow deflectors and/or flow dispersion channels, preserving proper fluid flow within the catheter adapter. BRIEF DESCRIPTION OF THE DIFFERENT VIEWS OF THE DRAWINGS
    [012] In order that the characteristics and advantages mentioned above and others more to be obtained will be readily understood, a more particular description has been presented with reference to their specific modalities illustrated through the attached drawings. These drawings describe only typical embodiments of the invention and are not to be construed as restricting the scope of the invention.
    [013] Figure 1 comprises a perspective view of an embodiment of a catheter assembly according to a representative embodiment of the present invention.
    [014] Figure 2 consists of an enlarged cross-sectional view of a catheter assembly according to a representative embodiment of the present invention.
    [015] Figure 3A comprises a perspective view of a non-activated septum according to a representative embodiment of the present invention.
    [016] Figure 3B consists of a perspective view of a septum actuated according to a representative modality of the present invention.
    [017] Figure 3C consists of a perspective view of an actuated septum showing a central crevice according to a perspective mode of the present invention.
    [018] Figure 3D comprises a perspective view of a non-activated septum showing a plurality of straight slits in a circumferential pattern according to a representative embodiment of the present invention.
    [019] Figure 3E consists of a perspective view of a non-activated septum showing two sets of crevices in advanced circles according to a representative modality of the present invention.
    [020] Figure 4A comprises a cross-sectional view of a set of catheter installed in accordance with a representative embodiment of the present invention, then activation.
    [021] Figure 4B comprises a detailed cross-sectional view of a set of catheter installed according to a representative embodiment of the present invention, after activation.
    [022] Figure 5 is a cross-sectional view of a set of catheter installed according to a representative embodiment of the present invention, before activation. DETAILED DESCRIPTION OF THE INVENTION
    [023] The presently preferred embodiment of the present invention will be better understood with reference to the drawings, where similar reference numerals indicate functionally identical or similar elements. It should be readily understood that the components of the present invention, described and illustrated generally in the figures of the report, can be arranged and designed in a wide variety of different configurations. Thus, the more detailed description which follows is not intended to restrict the scope of the invention as claimed but is merely representative of the currently preferred embodiments of the invention.
    [024] Referring to Figure 1, there is an illustration of a catheter assembly 10. The catheter assembly 10 generally includes a catheter 12 coupled to a distal end 32 of a catheter adapter 14. The catheter 12 and catheter adapter 14 are integrally coupled so that an inner lumen 16 of catheter adapter 12 is in fluid communication with lumen 18 of catheter 12. In general, catheter 12 comprises of a semi-flexible polymeric material such as such as silicone, polyurethane, or polytetrafluoroethylene. Catheter 12 may further comprise of a rigid metallic material, such as titanium, stainless steel, nickel, or molybdenum, surgical steel, and alloys thereof. In some circumstances, catheter 12 comprises a flexible polymeric material used in combination with a rigid cannula, such as an introducer needle (not shown) to assist in the catheterization process.
    [025] One skilled in the art will appreciate that features of the present invention can be incorporated for use with a catheter assembly in addition to the needle. For example, one skilled in the art will appreciate that a semi-flexible or flexible polymer catheter can be used in combination with a rigid introducer needle to enable insertion of the catheter into the patient. One skilled in the art will further appreciate that surgically implanted catheters can also be employed in combination with the present invention.
    [026] Once introduced into the patient, the catheter 12 and the catheter adapter 14 provide a conduit to the fluid facilitating the supply of fluid and/or its withdrawal from the patient, according to the desired infusion procedures. Thus, in some embodiments, the material of the catheter 12 and the adapter of the catheter 14 are selected to be compatible with bio-fluids and drugs commonly used in infusion procedures. Furthermore, in some embodiments, a portion of the catheter 12 and/or the catheter adapter 14 is configured for use in conjunction with an intravenous tubing section 40 further facilitating fluid delivery to or removal from the patient.
    [027] In some embodiments, a proximal end 22 of the catheter adapter 14 includes a flange 28. The flange 28 provides with a positive surface that can be configured to enable the coupling of an intravenous tubing or conduit to the patient 40 along catheter assembly 10. In some embodiments, flange 28 includes a filament assembly 30. In general, filaments 30 are provided and configured to compliantly admit a complementary filament assembly 44 comprising a portion of a male Luer or a conduit coupler 42. In general, conduit coupler 42 is coupled together with an end portion of patient conduit 40 in a fluid-tight manner. In some embodiments, an inner portion of conduit coupler 42 extends outwardly providing a probe surface 46.
    [028] In general, the probing surface 46 is configured for compatible insertion into a proximal end 22 of the catheter adapter 14. Then the insertion of probe 46 into the proximal end 22 of the catheter adapter 14, the conduit coupler 42 is rotated to lock coupler 42 and flange 28 (via filament assemblies 30 and 44). During the locking process of coupler 42 and flange 28, probe surface 40 is advanced into lumen 16 of catheter adapter 14 to an insertion position. The insertion position of probe surface 46 activates catheter assembly 10 enabling fluid flow through catheter 12 and catheter adapter 14. Once conduit coupler 42 and catheter adapter 12 are secured, fluid can be delivered to a patient via patient conduit 40 and insertion catheter 12.
    [029] Referring to Figure 2, an enlarged cross-sectional view of a catheter assembly 10 is shown. In some embodiments, the catheter adapter 12 includes various features and model components for control and/ or limiting fluid fluid through the catheter assembly 10. For example, in some embodiments of the present invention, a septum 50 is positioned within the inner lumen 16 of the catheter adapter 14. In general, the septum 50 consists of an insert. semi-flexible elastomeric polymer, such as silicone or TPE. As a rule, the septum 50 comprises an outer diameter configured to fit compatibly within a groove or channel 60 formed adjacent an inner surface 24 of the catheter adapter 14. In some embodiments, the septum 50 is drum or can be configured by incorporating a barrier surface 52 comprising a distal end of septum 50 and further having an aperture consisting of an end proximal of septum 50. When positioned within channel 60, barrier surface 52 of septum 50 divides the lumen internal 16 of catheter adapter 14 in a front fluid chamber 62 and a rear fluid chamber 64. The presence of septum 50 controls or limits the passage of fluid between the front and rear fluid chambers 62 and 64. Specifically, a configuration chosen from the barrier surface 52 of the septum 50 largely determines the ability of a fluid to flow through the inner lumen 16 of the catheter adapter 14.
    [030] For example, in some embodiments, the barrier surface 52 of the septum 50 is configured to include a gap 56. The gap 56 is configured to provide selective access or flow of a fluid through the barrier surface 52. in some embodiments, slit 56 is configured to remain in a closed, fluid-tight position until activated or skewed into an open configuration by advancing a septum actuator 80 against a barrier surface 52 in a retracted direction. 290. In some embodiments, barrier surface 52 comprises a slit 56. In other embodiments, barrier surface 52 is modified to include multiple slits 56 and 66, as shown. In particular, in some embodiments, barrier surface 52 consists of a central slit 56 and a plurality of circumferential slits 66. The center slit 56 may include any configuration, and in some embodiments comprises a three slit configuration. The circumferential slots 66 may further include any configuration, and in some embodiments may comprise a plurality of arcuate slots.
    [031] In general, the center slit 56 and circumferential slits 66 form a fluid tight seal before being actuated by the septum actuator 80. However, for some infusion therapy techniques, it may be desirable to allow for a controlled flow of fluid through septum 50 prior to activating septum 50 with septum actuator 80. Thus, in some embodiments, center slit 56 does not form a fluid tight seal. Instead, the center slit 56 forms an exhaust port allowing for the controlled flow of liquid or air between the front and rear chambers 62 and 64.
    [032] The groove or channel 60 where the septum is accommodated consists of a recessed portion of the inner surface 24 of the catheter adapter 14. The outer diameter of the septum 50 is configured, as a rule, to be compatible and to accommodate fixedly within the channel 60. For example, in some embodiments, the outer diameter of septum 50 is selected to either have a diameter slightly smaller than the diameter of channel 60 or slightly larger than the diameter of inner lumen 16. To do this, septum 50 is retained within of channel 60 when using catheter assembly 10.
    [033] For some infusion therapy techniques, airflow between the front and rear chambers 62 and 64 may be desirable. For example, for those modalities consisting of a septum 50 incorporating a fluid-tight slit 56 and 66, the passage of air from the front chamber 62 to the rear chamber 64 is prevented from opening or actuating the septum 50 via the actuator of septum 80, as previously discussed. Thus, when catheter 12 of catheter assembly 10 is inserted into a patient's vascular system, a positive pressure develops within front chamber 62 preventing a desired backflow of blood from the patient to catheter adapter 14. In general, a observable reflux is desirable to confirm accurate placement of the catheter tip within the patient's vein. Thus, some modalities of the present invention include features or elements that enable the air flow between the front chamber 62 and the rear chamber 64, without requiring the activation of the septum 50 with the septum actuator 80. For that, some modalities of the present invention provide with observable reflux, as generally desired for infusion procedures.
    [034] For example, in some modalities, the central gap 56 is modified in order to allow the controlled escape of air or liquid, as previously discussed. In other embodiments, a plurality of air vent channels 70 are interposed between the septum 50 and the inner surface 24 of the catheter adapter 14. The air vent channels 70 relieve on positive pressure within the front chamber 62 providing with an access for lateral passage of air through septum 50 towards rear chamber 64. In some embodiments, air vent channels 70 are constructed by removing portions of channel surface 60, resulting in a plurality of generally parallel grooves. . In other embodiments, an outer surface of septum 50 is modified to include a plurality of generally parallel grooves (not shown), as shown and taught in U.S. patent application serial number 12/544825, incorporated herein by reference.
    [035] Continuing with reference to Figure 2, the septum actuator 80 comprises a probe-shaped structure primarily housed in the rear chamber 64 of the catheter adapter 14. The septum actuator 80 comprises, as a rule, a tubular body 82 having a distal end 84 and a proximal end 86. The tubular body 82 comprises a rigid or semi-rigid material, such as a plastic or metallic material. The tubular body 82 further comprises an internal lumen 88 to facilitate the flow of a fluid and/or a liquid through the septum actuator 80. The septum actuator 80 may further comprise of various features 110, 120 and 130 for retention of the septum actuator 80 within the catheter adapter 14, and to optimize fluid flow through and around the septum actuator 80.
    The distal end 84 of the tubular body 82 is configured for compatible confinement and forming the barrier surface 52 of the septum 50. The distal end 84 is generally configured for compatible insertion within the opening 54 of the septum 50. The distal end 84 further includes a probe surface 90 which extends through the opening 54 of the septum 50 to a position proximate to the barrier surface 52 of the septum 50. The probe surface 90 is advanced against the barrier surface 52 as the septum actuator 80 is advanced through the catheter adapter 14 in the offset direction 290. In some embodiments, the probe surface 90 comprising a selected minimum outside diameter may be larger than the maximum size of the opening 57 of the center slit 56 when septum 50 is engaged. For this purpose, the probe surface 90 is prevented from passing through the central slit 56. The impossibility of the probe surface 90 to pass through the central slit 56 causes the septum actuator 80 to return to its initial position following removal of the conduit coupler 42 from catheter adapter 14, wherein septum 50 returns to its initial relaxed configuration. In some circumstances, the diameter of the probe surface 90 is constant over the entire length of the septum actuator 80.
    [037] Referring now to Figures 3A and 3B, there is the presentation of the septum 50. The shapes and configuration of the central gap 56 and the circumferential gaps 66 are provided, in general, in order to present a closed configuration, relaxed before of activation, as shown in Figure 3A, and an open configuration, deformed after activation, as shown in Figure 3B. Consequently, the barrier surface 52 of the septum 50 generally incorporates elastic properties where the barrier surface 51 is caused to be elastically deformed, and later returns to its initial, relaxed configuration. When deformed, the slits 56 and 66 are skewed into an open position allowing fluid and air to laterally pass the barrier surface 52 flowing freely between the front and rear fluid chambers 62 and 64.
    [038] The septum 50 may include any configuration of crevices in accordance with the teachings of the present invention. For example, in some embodiments, the septum 50 consists of a simple central slit 56, shown in accordance with Figure 3C. The center slit 56 comprises of a maximum opening size 57 which is configured to be smaller than the minimum outside diameter of the probing surface 90 of the septum actuator 80. For this purpose, the septum actuator 80 is prevented from passing through the center slot 56 once the septum actuator 80 is advanced in the offset direction 290.
    [039] In other embodiments, the septum 50 comprises a plurality of slits in straight circles 67, as shown in Figure 3D. In general, the circumferential slits 67 are positioned radially and around the center slit 56 so that an extension of each slit 67 is approximately perpendicular along a radial line outward from the center of the septum 50. In other embodiments , the septum 50 comprises of two or more sets of slits in circumferences, as shown in Figure 3E. The septum 50 may comprise a first set of circumferential slits 66 provided at a first radial distance from the central slit 56, and further comprise a second set of circumferential slits 69 provided a second radial distance from the slit center 56, where the second distance is greater than the first distance. Furthermore, in some modalities, the first and second sets of crevices on circles 66 and 69 are advanced and/or partially overlapped.
    [040] Those of skill in the art will appreciate that the specific configurations and orientations of the circumferential and central crevices of the present invention can be practiced in any variety of formats to carry out the teachings of the current invention. Consequently, the various modalities presented are not intended to be restrictive. Rather, the figures are merely provided as a mechanism for demonstrating the relevant principles of the present invention.
    [041] Referring now to Figure 4A, the septum 50 and barrier surface 52 are presented in a deformed, activated configuration. In some embodiments, the septum actuator 80 is advanced into the catheter adapter 14 in an offset direction 290 so that the leading edge 92 of the septum actuator 80 contacts and biases the inner surface of the barrier surface 52 thereby deforming the barrier surface 52, center slit 56 and circumferential slits 66 in an offset direction 290. To do this, center slit 56 and circumferential slit 66 are open allowing free flow of fluid between front fluid chamber 62 and rear fluid chamber 64 as shown in Figure 5B. Upon release of the septum activator 80, the elastic or resilient properties of the barrier surface 52 reposition the septum activator 80 in an approach direction 390 enabling the barrier surface 52, the center gap 56 and the gaps in circles 66 return to their initial relaxed configurations, as shown in Figure 5. Consequently, the adjusted configuration of the septum fluid 50 is re-established.
    [042] In some embodiments, the catheter assembly 10 further comprises and introduces the needle (not shown) to assist a user in accessing their vein during the catheterization process. The central slit 56 allows the passage of the introducer needle through the septum 50, enabling a sharp tip of the introducer needle to extend away from the tip portion 20 of the catheter 12. Following the catheterization procedure, the introducer needle is removed from the catheter assembly 10 and safely discarded.
    [043] In some embodiments, the introducer needle is coated with a significant amount of silicone or similar fluid, such as fluorosilicone. The purpose of sheath fluid is threefold. First, the coating fluid acts as a lubricant between the outer surface of the introducer needle and the interface surfaces of the central slit 56. Thus, upon withdrawal of the septum introducer needle 50, the coating fluid prevents unwanted adhesion between the outer surface of the introducer needle and the interface surfaces of the center slit 56. Second, excess sheath fluid accumulates within the center slit 56 serving the septum seal 50 preventing blood from flowing back through. of the septum by removing the needle with an introducer. Excess sheath fluid accumulates within the central slit 56 once the introducer needle is removed from the catheter assembly 10. In particular, when the introducer needle is withdrawn through the septum 50, the interface surfaces of the center slit 56 act to clean the coating fluid from the outer surface of the introducer needle by displacing the coating fluid within the center slit 56. Third, the coating fluid acts as a lubricant preventing adhesion between opposing surfaces of the slit central 56.
    [044] The sheath fluid can include any biocompatible lubricant. In some embodiments, the sheath fluid comprises a lubricant, such as a non-wetting lubricant applied at an interface between the introducer needle and the center slit 56 to further eliminate possible leakage of fluid and/or air. A non-wetting lubricant can also be beneficial in preventing tears or other types of gap damage that can occur when removing the needle from the catheter assembly following catheterization, a non-humidifying lubricant can also facilitate proper realignment of the opposing surfaces of center slot 56 after needle removal with introducer. Non-limiting examples of a non-wetting lubricant include known Teflon based non-wetting materials such as Endura from Endura Coating Co.; A20, E-20, 1000-S20, FEP Green, PTFE and X-40 from Tiodize; Cammie 2000 of AE Yale; 21845 from Ladd Research; MS 122-22, MS 122DF, MS-143DF, MS-122V MS-122VM, MS143V, MS-136W, MS-145W, U0316A2, U0316B2, MS-123, MS-125, MS-322 and MS-324 from Miller -Stepheson; and the 633T2 from Otto Bock can also be used. Several types of materials other than Teflon based non-wet lubricants include Dylyn, from ART; Nyebar, Diamonex, NiLAD, TIDLN, Kiss-Cote, Titanium Oxides; 3M Fluocad Fluorochemical FC-722 Coating; Permacot by Dupont; Plasma Tech 1633 from Plasma Tech, Inc.; and silicone sprays and dimmers from Nusil and/or Dow Chemical.
    [045] The present invention can be embodied in other types of formats without deviating from their structures, methods, or other essential characteristics as already amply described and claimed below. The described modalities must be considered in all their aspects in terms of illustration only, and not restrictive. The scope of the invention, therefore, is indicated by the attached table of claims, instead of the previous descriptive part. All changes that fall within the meaning and equivalent scope of the claims must be included within this scope.
    权利要求:
    Claims (16)
    [0001]
    1. Septum (50), comprising a body (82) having a proximal end (22) and a distal end (32), the proximal end (22) having an opening (54) and the distal end (32) forming a barrier (52), with the barrier (52) being capable of being deformed from a relaxed position to a skewed position, with the barrier (52) further comprising a gap (56) having a closed configuration and an open configuration, wherein the gap comprises the closed configuration when the barrier (52) is in the relaxed position, and the gap comprises the open configuration when the barrier (52) is in the biased position; CHARACTERIZED by the fact that the barrier (52) is configured to be mechanically deformed from the relaxed to the skewed position by a septum actuator (80) advancing against a proximal surface of the barrier (52), the gap (56) having a maximum opening size that is smaller than an outer diameter of an end remote from the septum actuator (80), so that the end remote from the septum actuator (80) is prevented from passing through the barrier (52) when the barrier (52) is in the skewed position.
    [0002]
    2. Septum, according to claim 1, CHARACTERIZED by the fact that the closed configuration is fluid hermetic.
    [0003]
    3. Septum, according to claim 1, CHARACTERIZED by the fact that the septum (50) comprises an elastic material.
    [0004]
    4. Septum, according to claim 1, CHARACTERIZED by the fact that the septum (50) is resilient.
    [0005]
    5. Septum, according to claim 1, CHARACTERIZED by the fact that the gap comprises a plurality of gaps (56, 66, 67).
    [0006]
    6. Septum, according to claim 1, CHARACTERIZED by the fact that the plurality of crevices (56, 66, 67) comprise a central crevice (56) surrounded by a plurality of elongated crevices, each of the elongated crevices being arranged circumferentially involved in the central crevice (56).
    [0007]
    7. Septum according to claim 6, CHARACTERIZED by the fact that the plurality of elongated crevices comprise at least one of a plurality of arcuate crevices (66) and a plurality of straight crevices (67).
    [0008]
    8. Septum, according to claim 1, CHARACTERIZED by the fact that the gap is a central gap.
    [0009]
    9. A system for controlling fluid flow in a catheter assembly, comprising: an intravenous catheter assembly (10), a catheter adapter comprising an internal lumen (16); a septum (50) disposed within a portion of the inner lumen, with the septum a barrier surface capable of being deformed from a relaxed position to a skewed barrier, further comprising a gap, a closed configuration and an open configuration, wherein the gap comprises the closed configuration when a barrier is in the relaxed position, and the gap comprises an open configuration when a barrier is in the skewed position; CHARACTERIZED by the fact that the barrier (52) is configured to be deformed from a relaxed to a biased position by the septum actuator (80) advancing against a proximal surface of the barrier (52), the gap (56) having a maximum opening size that is smaller than an outer diameter of an end remote from the septum actuator (80), so that the end remote from the septum actuator (80) is prevented from passing through the barrier (52) when the barrier (52) is in the skewed position.
    [0010]
    10. System according to claim 9, CHARACTERIZED in that the septum actuator is disposed within a portion of the inner lumen adjacent to the septum, the distal end of the septum actuator contacting a proximal surface of the septum, and one end proximal to the septum actuator positioned adjacent to an opening of the catheter adapter, where the proximal end of the septum actuator is accessed by inserting an external device into the opening of the catheter adapter.
    [0011]
    11. System, according to claim 10, CHARACTERIZED by the fact that it further comprises a lumen forming a fluid path through the septum actuator.
    [0012]
    12. System according to claim 9, CHARACTERIZED in that it further comprises an interposed channel between the septum and an inner surface of the inner lumen of the catheter adapter, the ventilation channel having a surface area and a selected perimeter to allow passage of at least one of air and blood at a desired flow rate.
    [0013]
    13. System according to claim 10, CHARACTERIZED by the fact that the proximal surface of the septum also includes a cavity for housing the far end of the septum actuator.
    [0014]
    14. System according to claim 9, CHARACTERIZED by the fact that the gap comprises a central gap surrounded by a plurality of elongated arcuate gaps arranged circumferentially around the central gap.
    [0015]
    15. System according to claim 10, CHARACTERIZED by the fact that the septum actuator is slidably housed within the portion of the inner lumen and is able to move between a close position and a far position, in which when the actuator septum is in the proximate position the septum is in the relaxed position, and when the septum actuator is in the far position, the far end of the septum actuator skews the septum in the skewed position.
    [0016]
    16. A method for manufacturing a catheter assembly (10) having characteristics for controlling the flow of fluid within the catheter assembly (10), the method comprising: providing with a septum (50) having a barrier surface ( 52) capable of being deformed from a relaxed to a skewed position, the barrier (52) further comprising a gap (56) having a closed configuration and an open configuration, wherein the gap comprises the closed configuration when the barrier ( 52) is in the relaxed position, and the gap (56) comprises the open configuration when the barrier (52) is in the skewed position; provide a septum actuator (80); providing an intravenous catheter assembly (10) having a catheter adapter (14) comprising an internal lumen (16); and disposing the septum (50) within a portion of the inner lumen (16) of the catheter adapter (14), CHARACTERIZED by the fact that the barrier (52) is configured to be deformed from a relaxed position to a position biased by the septum actuator (80) advancing against a proximal surface of the barrier (52), the gap (56) having a maximum aperture size that is smaller than an outer diameter of a distal end of the septum actuator (80) so that the distal end of the septum actuator (80) is prevented from passing through the barrier (52) when the barrier (52) is in the biased position.
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    CN103945896B|2016-04-06|
    引用文献:
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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]|
    2020-09-29| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-11| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161544158P| true| 2011-10-06|2011-10-06|
    US61/544.158|2011-10-06|
    US13/644,841|US9155864B2|2011-10-06|2012-10-04|Multiple use blood control valve with center and circumferential slits|
    US13/644.841|2012-10-04|
    PCT/US2012/058874|WO2013052746A1|2011-10-06|2012-10-05|Multiple use blood control valve with center and circumferential slits|
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