• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    INTRAVENOUS CATHETER WITH DUCK BUCKET VALVE. A catheter assembly is revealed, which includes a catheter adapter (14). An orifice (50) is arranged in the catheter adapter to provide selective access to the inside of the catheter adapter and can be used for fluid flushing or infusion. A valve (70) is disposed within the catheter adapter which includes the unidirectional valve portion (76) which prevents the flow of fluid directed proximally. The valve further includes a portion of flexible tube (78) that covers an opening between the orifice and the catheter adapter.
    公开号:BR112014008253B1
    申请号:R112014008253-7
    申请日:2012-10-04
    公开日:2020-12-08
    发明作者:Austin Jason Mckinnon；Jeffrey Charles O'bryan
    申请人:Becton Dickinson And Company；
    IPC主号:
    专利说明:

    BACKGROUND
    [001] The current invention relates to intravenous (IV) infusion devices, including IV catheters. In particular, the invention relates to an IV catheter assembly having a blood control valve on it and an activating accessory that allows access to the interior of the IV catheter assembly.
    [002] IV catheters are generally used for a variety of infusion therapies, including infusing fluids into a patient, drawing blood from a patient, or monitoring various parameters of the patient's vascular system. Catheters are typically connected to a catheter adapter that accommodates the IV tubing fitting in the catheter. Blood control catheters include an internal blood control valve that is opened by inserting a male luer or other object at a proximal end of the catheter adapter. Non-limiting examples of blood control valves are revealed in Publication of United States Patent Application No. 2011/0046570, filed on August 20, 2009, entitled “Systems and Methods for Providing a Flushable Catheter Assembly”, which is incorporated herein by reference in its entirety. Thus, following the placement of the catheter into a patient's vasculature, an IV fluid source can be connected to the catheter adapter, opening the blood control valve. Once connected, fluid from the IV source can begin to flow into a patient through the catheter.
    [003] Some catheter adapters allow verification of the proper placement of the catheter in the blood vessel before the fluid infusion begins, providing a return chamber of the catheter assembly where a “return” of the blood can be observed. To confirm return on catheter sets that do not include a blood control valve, a clinician must manually close the vein to prevent unwanted exposure to blood. In contrast, blood control valves can eliminate the need for such manual closure, while also reducing the likelihood of exposure to blood during catheter placement.
    [004] Despite the many advantages of blood control catheters, some traditional procedures involving vascular access systems are not possible with blood control catheters. Devices and systems that overcome these deficiencies are revealed here. SUMMARY OF THE INVENTION
    [005] The present invention was developed in response to problems and needs in the art that have not yet been fully solved by the systems and methods currently available. Thus, these systems and methods are developed to feature a valve within a catheter adapter that provides the dual function of a one-way valve through the lumen of the catheter adapter and an orifice valve.
    [006] In one aspect of the invention, a catheter assembly includes a catheter adapter, an orifice disposed in the catheter adapter and a valve disposed within the catheter adapter. The catheter adapter has a proximal end, a distal end and a lumen extended between the proximal end and the distal end. The hole opens inside the lumen. The valve is arranged within the lumen and includes a portion of flexible tube and a portion of a one-way valve. A portion of the flexible tube portion covers an opening between the orifice and the lumen. The unidirectional valve portion limits the flow of fluid through the valve to flow in a proximal direction.
    [007] These and other features and advantages of the present invention can be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and appended claims, or can be learned by practicing the invention as presented below. The present invention does not require that all of the advantageous features and advantages described herein be incorporated into each embodiment of the invention. BRIEF DESCRIPTION OF THE DRAWINGS
    [008] In order that the manner in which the aforementioned and other characteristics and advantages of the invention are obtained is easily understood, a more particular description of the invention briefly described above will be transmitted by reference to its specific modalities which are illustrated in the attached drawings . These drawings represent only typical embodiments of the invention and should therefore not be considered to limit the scope of the invention.
    [009] Figure 1 is a perspective view of a catheter set having an orifice, according to some modalities.
    [010] Figure 2 is a sectional view of a catheter adapter having a valve, according to some modalities.
    [011] Figure 3 is a sectional view of the catheter adapter of figure 2 having a cap, according to some modalities.
    [012] Figure 4 is a sectional view of the catheter adapter of figure 2 connected to an infusion device, according to some modalities.
    [013] Figure 5 is a sectional view of the catheter adapter and cap of figure 2 while the fluid is infused through a lateral orifice, according to some modalities.
    [014] Figure 6 is a sectional view of another catheter adapter having a valve and a valve activator, according to some modalities.
    [015] Figure 7 is a sectional view of the catheter adapter of Figure 6 having a cap, according to some modalities.
    [016] Figure 8 is a sectional view of a catheter adapter and cover of figure 7 illustrating a flow path of the fluid that enters the lateral orifice, according to some modalities.
    [017] Figure 9 is a sectional view of a catheter adapter in figure 6 with the valve activator moved to an activated position, according to some modalities. DETAILED DESCRIPTION OF THE INVENTION
    [018] The currently preferred embodiments of the present invention can be understood by reference to the drawings, in which similar reference numerals indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures here, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of currently preferred embodiments of the invention.
    [019] Furthermore, the figures may show simplified or partial views and the dimensions of the elements in the figures may be exaggerated or otherwise not in proportion for clarity. In addition, the singular forms "one", "one" and "o", "a" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a terminal includes reference to one or more terminals. In addition, where reference is made to a list of elements (for example, elements a, b, c), such reference is designed to include any of the elements listed by itself, any combination of less than all the elements listed and / or a combination of all the elements listed.
    [020] The term “substantially” means that the characteristic, parameter or value recited does not need to be reached exactly, but that deviations or variations, including, for example, tolerances, measurement error, limitations of measurement accuracy and other known factors for those skilled in the art can occur in quantities that do not detract from the effect that the feature was designed to provide.
    [021] As used here, the term "proximal", "top", "above" or "up" refers to a location on the device that is closest to the clinician using the device and furthest from the patient in conjunction with whom the device is used when the device is used in its normal operation. Conversely, the term "distal", "bottom", "below" or "down" refers to a location on the device that is furthest from the clinician using the device and closer to the patient together with whom the device is used when the device is used in its normal operation.
    [022] As used here the term "inside" or "inside" refers to a location in relation to the device that, during normal use, is inside the device. Conversely, as used here, the term "out" or "out" refers to a location with respect to the device that, during normal use, is outside the device.
    [023] Referring now to Figure 1, a catheter assembly 10 is illustrated, which generally includes a catheter 12 coupled to a distal end 32 of a catheter adapter 14. The catheter assembly 10 can be a control catheter assembly 10 when it includes a blood control valve on it. The catheter 12 and the catheter adapter 14 are integrally coupled, such that the inner lumen 16 of the catheter adapter 14 is in fluid communication with the lumen 18 of the catheter 12. The catheter adapter 14 can include an orifice 50, which will be described in more detail with reference to figure 2. The catheter 12 generally comprises a biocompatible material having sufficient stiffness to withstand the pressures associated with inserting the catheter into a patient. A tip portion 20 of the catheter is generally configured to include a chamfered cutting surface 48. The chamfered cutting surface 48 is used to produce an opening in a patient to allow insertion of catheter 12 into the patient's vascular system.
    [024] One skilled in the art will find that the features of the present invention can be incorporated for use with a catheter assembly over the needle, which may include the tapered end rather than a beveled cut surface 48. For example, one versed in The technician will verify that a flexible or semi-flexible polymer catheter can be used in combination with a rigid needle to allow insertion of the catheter into a patient. One skilled in the art will also find that surgically implanted catheters or other types of catheters can also be used.
    [025] Once inserted into a patient, catheter 12 and catheter adapter 14 produce a fluid channel to facilitate the delivery of a fluid to and / or the recovery of a fluid from a patient, as required by a procedure desired infusion. Thus, in some modalities, the material of the catheter 12 and the catheter adapter 14 are selected to be compatible with biofluids and drugs commonly used in infusion procedures. Additionally, in some embodiments, a portion of catheter 12 and / or catheter adapter 14 is configured for use in conjunction with a section of intravenous tubing 40 to facilitate delivery of a fluid to or removal of a fluid from a patient.
    [026] 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 enable coupling of the intravenous tubing or a channel coupler 42 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 complementary set of threads 44 comprising a portion of a male luer or channel coupler 42. The coupler of channel 42 is generally coupled to an end portion of the patient's channel in a fluid-tight manner. In some embodiments, the inner portion of the channel coupler 42 is extended outwardly to produce a probe surface 46.
    [027] In some embodiments, the proximal end 22 to the catheter adapter 14 includes a female luer connector having a female luer connection and / or female luer lock threads. The female luer connection can be arranged at least in part within the proximal portion of the lumen 16 of the catheter adapter 14. Additionally, the previously mentioned flange 28 and / or threads 30 may comprise the female luer lock threads. The female luer connector can therefore be configured to connect to a male luer lock or a male luer slip. Each of these components can be sized and configured in accordance with at least some of the International Standards Organization (ISO) standards for female and male luer connections under current or future standards. In this way, the proximal end 22 to the catheter adapter 14 can be configured, thus, to connect to a male luer lock or a male slip luer of channel coupler 42, line IV, luer access connector, needle hub, plug ventilation or other IV device known or developed in the future.
    [028] The surface of the probe 46 is generally configured to insert in a compatible manner within a proximal opening 26 at the proximal end 22 of the catheter adapter 14. Following the insertion of probe 46 at the proximal end 22 of the catheter adapter 14, the channel coupler 42 is rotated to lock coupler 42 and flange 28 (via thread sets 30 and 44). During the locking process of coupler 42 and flange 28, probe 46 is advanced into lumen 16 of catheter adapter 14 to an inserted position (as shown in figure 4). The inserted position of the probe surface 46 activates the catheter assembly 10 to allow fluid flow through catheter 12 and catheter adapter 14. Once the channel 42 coupler and catheter adapter 14 are attached, a fluid can be delivered to a patient via patient channel 40 and the catheter inserted 12.
    [029] Reference will now be made to Figure 2, which represents a sectional view of the catheter adapter 14. As shown, the catheter adapter 14 may include an orifice 50, such as a side orifice. Orifice 50 can have various uses, including for infusing fluids into the inner lumen 60 of catheter adapter 14. Such infusions can wash medications and other fluids from inner lumen 60 and can be used to prepare catheter assembly 10. O orifice 50 may include an aperture 52 disposed between the orifice body 50 and the inner lumen 60 of the catheter adapter 14. The orifice body 50 may extend away from the catheter adapter 14. In various embodiments, an orifice cover ( not shown) selectively covers orifice 50 to prevent contamination and exposure of orifice 50. This way, in use, a clinician can open the orifice cover and infuse fluid into orifice 50 through opening 52 into the inner lumen 16 of the catheter adapter 14. When the fluid infusion is complete, the clinician can close the orifice cover.
    [030] In some embodiments, catheter adapter 14 includes a valve 70 that can serve the dual function of selectively sealing both orifice 50 and inner lumen 60 of catheter adapter 14. Valve 70 can divide lumen 16 in a distal lumen chamber 62 and a proximal lumen chamber 64. In some embodiments, valve 70 includes a one-way valve portion 76, such as the duckbill portion shown. In some embodiments, this one-way valve portion 76 allows flow in the distal direction, but resists flow, such as up to or more than a standard venous pressure (for example, approximately 500 Pa to approximately 1500 Pa), in the direction proximal. Due to resistance to flow in the proximal direction, valve 70 can prevent blood leakage out of proximal opening 26 of catheter adapter 14. Furthermore, the one-way valve portion 76 may have minimal burst pressure in the distal direction, to allow fluid flow when fluid begins to be introduced at the proximal end 22 of catheter adapter 14.
    [031] As shown in figure 2, valve 70 can include a tube portion 78 and a one-way valve portion 76. Tube portion 78 may be generally tubular in shape including, but not limited to, a cylindrically formed tube having a circular or semicircular cross section. Other tubular configurations may include tubular shapes having other cross sections, including a triangle, square, pentagon, heptagon, octagon, other polymers, ellipses, ovals or other suitable cross sections. The tube portion 78 can extend longitudinally around a longitudinal geometric axis of the catheter adapter 14. Furthermore, the tube portion 78 can have external dimensions that approximate the internal dimensions of the internal lumen 16 of the catheter adapter 14 .
    [032] The unidirectional valve portion 76 can provide unidirectional valve functionality by limiting fluid flow in a single direction, such as the distal direction. As mentioned, the one-way valve portion 76 may be a duckbill valve, which may include two inwardly oriented flaps 80, 82 which are predisposed together to a central position, forming a slit 84. Flaps 80, 82 can be extend from the tube portion 78 inwardly and distally. Thus configured, the two inwardly oriented flaps 80, 82 can push together to close the valve in response to a flow of fluid in a proximal direction (towards the distal end of the catheter adapter 14). In addition, the two inwardly oriented flaps 80, 82 can be separated to open a gap between these flaps 80, 82 in response to a flow of fluid in the distal direction. As shown, the one-way valve portion 76 can be a duckbill-style valve, while in other embodiments, the one-way valve portion 76 can be any other pressure-activated valve that allows easy flow in the distal direction, but support venous pressure in the proximal direction (to the proximal end of the catheter adapter 14).
    [033] In some embodiments, a one-way valve portion 76 of valve 70 is configured to open under the pressure of infusing a fluid through the proximal opening of lumen 26 of catheter adapter 14. As such, the one-way valve portion 76 it can open automatically during the fluid infusion and automatically close when the infusion stops. This capability can eliminate the need for a valve actuator that mechanically opens the valve.
    [034] In some embodiments, one or more slits 84 within valve 70 allow an introducer needle (not shown) to pass through valve 70, thereby enabling a sharp needle tip to extend distally beyond the tip portion 20 of catheter 12. Following the catheterization procedure, the needle is removed from the catheter set 10 and is safely discarded.
    [035] In some embodiments, the needle is coated with a significant amount of silicone or similar fluid, such as fluorosilicone. The purpose of the coating fluid is threefold. First, the coating fluid acts as a lubricant between the outer surface of the needle and the interface surfaces of the slit 84. Thus, with removal of the needle from the valve 70, the coating fluid prevents unwanted adhesion between the outer surface. of the needle and the interface surfaces of the slit 84. Second, excess coating fluid builds up inside the slit 84, thereby helping to seal the valve 70 to prevent blood from flowing back through the septum following removal of the needle . Excessive coating fluid accumulates within slot 84 when the needle is removed from catheter assembly 10. In particular, when the needle is being removed through valve 70, the interface surfaces of slot 84 act to sweep the coating fluid from the outer surface of the needle, thereby shifting the coating fluid into slot 84. Third, the coating fluid acts as a lubricant to prevent unwanted adhesion between opposite surfaces of slot 84.
    [036] The coating fluid can include any biocompatible lubricant. In some embodiments, the coating fluid comprises a lubricant, such as a non-wetting lubricant that is applied at an interface between the needle and the slit 84 to further eliminate the possible leakage of the fluid and / or air. A non-wetting lubricant can also be beneficial to prevent tearing or other damage to the crack that may occur when the needle is removed from the catheter assembly following the catheterization. A non-wetting lubricant can also facilitate proper realignment of the opposite surfaces of the slit 84 following removal of the needle. 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 from AE Yale; 21845 to 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 633T2 by Otto Bock can also be used. Various Teflon-based non-wetting lubricant materials include Dylyn, from ART; Nyebar, Diamonex, NiLAD, TIDLN, Kiss-Cote, titanium oxide; Fluocad Fluorochemical Coating FC-722, 3M; Dupont Permacote; Plasma Tech 1633 from Plasma Tech, Inc. and silicone sprayers.
    [037] With reference also to figure 2, in modalities where the catheter adapter 14 includes an orifice 50, the valve 70 can function as an orifice valve. It will be understood that, in other embodiments, the catheter adapter 14 does not include an orifice 50. As shown, the tube portion 78 of the valve 70 can be positioned within the inner lumen 60 of the catheter adapter 14, such that the surface outer 74 of the tube portion 78 covers the opening 52 of the orifice 50. Thus positioned, the valve 70 can prevent the fluid inside the lumen 76 from flowing out of the orifice 50. In addition, the valve 70 can be configured to at least least partially collapse when fluid is introduced into orifice 50, thereby allowing fluid to pass through opening 54 into the inner lumen 60 of catheter adapter 14.
    [038] Valve 70 can be designed to at least partially collapse inward when a predetermined pressure is applied to valve 70 through opening 52 of orifice 50. The predetermined pressure can generally be less than the amount of force pressing against the valve 70 through opening 54 during an infusion of fluid via orifice 50. In various embodiments, the tube portion of valve 70 is flexible or semi-flexible. Valve 70 can be made of various flexible or semi-flexible materials including, for example, silicone, silicone rubber, polypropylene or other suitable materials. The flexibility or stiffness of the material can affect the predetermined pressure required to open the valve 70 and allow the fluid inside the catheter adapter 14. A more flexible material may require a lower predetermined pressure, while a more rigid material may require a greater predetermined pressure .
    [039] As shown, the tubular shape of the tube portion 78 of the valve 70 produces a channel within the valve body 70 that can collapse under the predetermined pressure. The tubular shape can also produce structural resistance that holds the outer surface 62 of the valve 70 against the opening 52 of the orifice until the predetermined pressure is applied. The wall thickness of the tube-shaped valve 70 can be selected to adjust the predetermined pressure required to open the valve 70. Thus, by increasing the wall thickness of the tube portion 78, greater pressure is required to open the valve 70. By decrease in wall thickness, less pressure is required. In addition, wall thicknesses can be adjusted based on the flexibility for the stiffness of the material that forms valve 70. For example, a stiffer material can allow for thinner walls that allow the same threshold force to open the orifice valve as a thicker wall made of a more flexible material. Thus, the flexibility of valve 70 combined with the shape and size of valve 70 can allow valve 70 to collapse when a predetermined pressure is applied to valve 70 via opening 54.
    [040] In various embodiments, valve 70 is seated within a groove or channel 90, which comprises a recessed portion of the inner surface of catheter adapter 14. The outer diameter of valve 70 can generally be configured to fit in a compatible manner and safe within groove or channel 90. For example, in some embodiments, the outer diameter of valve 70 is selected to be both less than or approximately equal to the diameter of groove or channel 90 and slightly larger than the diameter of inner lumen 60 As such, valve 70 can be retained within groove or channel 90 when using catheter assembly 10. In other configurations, other features, such as protrusions at the proximal and distal ends of valve 70, help retain valve 70 in place.
    [041] As shown in figure 2, catheter adapter 14 and double function valve 70 have several beneficial characteristics. For example, valve 70 does not require a valve actuator / activator to open as required in blood control valves. This can reduce the number of components required. This same feature can allow the catheter adapter 14 to have a reduced length that it would need if it housed a valve actuator / activator. Additionally, since valve 70 opens under pressure from the infusion line and closes automatically to the pressure of the vein, it is reusable.
    [042] As shown in figure 3, in some configurations, the proximal opening of lumen 26 of catheter adapter 14 can be closed with a lid 100 during a catheter washing procedure or other procedure. Cap 100 can selectively close at the proximal opening of lumen 26 and close that opening. For example, according to some medical customs, such as European medical customs, a cap 100 is attached to the proximal opening of lumen 26 during an initial wash of catheter assembly 10 or for infusion to prevent fluid from flowing out of the proximal opening. 26 of the catheter adapter 14.
    [043] As shown in figure 4, as mentioned during an initial flushing or fluid infusion procedure, the one-way valve portion 76 of valve 70 can be forced open by fluid 110, which can allow fluid 110 to pass from the source fluid 112 through lumen 60 of catheter adapter 14 in the distal direction. At the same time, valve 70 can prevent fluid from escaping through orifice 50. When fluid source 112 is removed, valve 70 can close in the absence of fluid force. When closed, the one-way valve portion 76 can stop the leakage of fluid and / or blood in the proximal direction past valve 70. Additionally, as shown, during this type of fluid infusion, tube portion 78 of valve 70 can be held against opening 52 of orifice 50 to prevent infused fluid 110 from escaping through that opening 52.
    [044] As shown in figure 5, during an initial washing procedure or for infusion through orifice 50, fluid 110 can flow from orifice 50 into the proximal chamber of lumen 64. As the fluid enters the proximal chamber of the lumen 64, the pressure inside that chamber increases, opening valve 70. When valve 70 opens, fluid 110 can flow into the distal chamber of lumen 62 and continue to the patient.
    [045] As shown, valve 70 and / or catheter adapter 14 can be configured to force fluid 110 to the proximal side of valve 70 instead of to the distal side of valve 70 or to both sides simultaneously. In this way, the distal end of valve 70 can form a seal with the inner surface of catheter adapter 14. For example, the outer portions on the distal side of valve 70 can be adhered to the inner surface of catheter adapter 14 to form a seal around the distal end of valve 70. In another example, the outer portions on the distal side of valve 70 may have a larger outside diameter or other external dimensions than the portions of valve 70 proximal to that end. Similarly, the internal dimensions of the catheter adapter 14 around the distal side of the valve 70 may have a smaller internal diameter than the portions of the catheter adapter 14 proximal to that area. These examples can form a firmer seal between the distal end of the valve 70 and the catheter adapter 14 which encourages fluid flow into the proximal chamber of the lumen 64. In yet another example, the outer portions of the proximal side of the valve 70 they may have a smaller outside diameter or other outside dimensions than the valve portions 70 distal to that end. Similarly, the internal dimensions of the catheter adapter 14 around the proximal side of the valve 70 may have a larger internal diameter than the portions of the catheter adapter 14 distal to that area. These examples can form a weaker seal between the proximal end of the valve 70 and the catheter adapter 14 which encourages the flow of fluid into the proximal chamber of the lumen 64.
    [046] As shown in figure 6, in some embodiments, the catheter adapter 14 includes a valve activator 140. The valve activator 140 can provide a mechanism within the catheter adapter 14 that has a proximal contact surface 144 that is touched by a vascular access device inserted into opening 26 of catheter adapter 14. The scan access device can urge contact surface 144 to advance valve activator 140 distally through slit 84 of valve 70 (shown in figure 9). When it moves distally forward, the probing surface 142 of valve activator 140 incites flaps 80, 82 of the one-way valve portion 76 to open slit 84. Valve activator 140 may include a probe portion 146 that it can have a cross section that is formed and dimensioned, so that it can be inserted through slit 84 of valve 70. Furthermore, valve activator 140 can have various characteristics, structures and configurations and can be moved and retained within of catheter adapter 14 as described in United States Patent Application Publication 2011/0046570, filed on August 20, 2009, entitled “Systems and Methods for Providing a Flushable Catheter Assembly”, which is incorporated herein by reference in its entirety .
    [047] As shown in figures 7 and 8, in embodiments having a valve actuator 140, a cover 100 can be provided that has a truncated male luer 150. In some configurations, the cover 100 may include a truncated male luer 150 that is not long enough to advance valve activator 140 to open valve 70. For example, the male luer collar 152 on the cover may extend further than the truncated male luer 150 inside that collar 152. As shown in 8, when the cap 100 is attached to the proximal end 22 of the catheter adapter 14, the fluid 110 entering the orifice 50 can wash the proximal chamber of the lumen 64 around the valve activator 140 and subsequently pass through the valve 70.
    [048] As shown in figure 9, when a separate device 112 is inserted into the proximal opening of lumen 26 of catheter adapter 14, valve activator 140 can be advanced distally through slit 84 of valve 70, opening valve 70. In this way, the valve 70 can be opened when the catheter adapter 14 is connected to a separate device 112, such as an IV infusion device.
    [049] The present catheter set 10 can have several benefits. For example, the present catheter assembly can be washed through the side / top hole 50. Since the wash can originate from the side hole, and a cap 100 can be kept on the proximal end of the catheter adapter 14 until the first connection of the IV set is made, which fully opens the valve for infusion, thus, the catheter set can remain closed and sterile for a longer period. The present catheter set 10 can also reduce the number of components and assembly steps required.
    [050] The present invention can be embodied in other specific forms without departing from its structures, methods or other essential characteristics as widely described here and claimed below. The described modalities should be considered in all aspects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the preceding description. Any changes that arise within the meaning and equivalence range of the claims must be covered within its scope.
    权利要求:
    Claims (13)
    [0001]
    1. A catheter assembly (10), comprising: a catheter adapter (14) having a proximal end (22), a distal end (32) and a lumen (62) extending between the proximal end (22) and the end distal (32), an orifice (50) disposed in the catheter adapter (14), the orifice (50) opening inward the lumen (16); and a valve (70) disposed within the lumen (16), the valve (70) including a portion of the flexible tube (78) and a portion of the one-way valve (76), a portion of the portion of the flexible tube (78) covering a opening between the orifice (50) and the lumen (16), the one-way valve portion (76) limiting fluid flow through the valve (70) to flow in a distal direction, the tube portion (78) further comprising a shape cylindrical, the unidirectional valve portion (76) further comprising a duckbill valve, the unidirectional valve portion (76) being arranged at the proximal end (22) of the valve (70), wherein the unidirectional valve portion (76) is configured to withstand at least medium venous pressure in a proximal direction, FEATURED by the fact that the catheter adapter (14) is configured to force fluid received through the orifice (50) to a proximal side of the valve (70 ).
    [0002]
    2. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the tube portion (78) is a cylindrical shaped tube portion.
    [0003]
    3. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the unidirectional valve portion (76) includes a duckbill valve arranged at the proximal end (22) of the valve (70).
    [0004]
    4. Catheter assembly (10) according to claim 3, CHARACTERIZED by the fact that the unidirectional valve portion (76) includes two or more flaps (80, 82) coupled to the tube portion (78) of the valve ( 70), the two or more flaps (80, 82) extending inwardly and distally from the tube portion (78).
    [0005]
    5. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the flexible tube portion (78) is configured to at least partially collapse inward when a pressure of a fluid being infused into the orifice (50) is applied to the portion of the flexible tube portion (78) covering the opening between the orifice (50) and the lumen (16).
    [0006]
    6. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the valve (70) is arranged within a channel within an internal surface of the catheter adapter (14).
    [0007]
    7. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the distal end (32) of the valve (70) forms a seal with the inner surface of the catheter adapter (14).
    [0008]
    8. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that it still comprises a separate vascular access device having a probe portion (146) configured to be inserted into a proximal opening (26) of the adapter catheter (14), the probe portion (146) being long enough to pierce through the slit (84) of the one-way valve portion (76) of the valve (70).
    [0009]
    9. Catheter assembly (10), according to claim 8, CHARACTERIZED by the fact that the probe portion (146) includes a proximal portion (26) having external dimensions that approximate internal dimensions of the lumen (16, 18 ).
    [0010]
    10. Catheter assembly (10) according to claim 8, CHARACTERIZED by the fact that the probe portion (146) includes an activator portion formed and sized to be inserted through the unidirectional valve portion (76 ) of the valve (70).
    [0011]
    11. Catheter set (10) according to claim 1, CHARACTERIZED by the fact that it still comprises a valve activator (140) disposed within the lumen (16) on a proximal side of the valve (70), the activator of valve (140) having a probe portion (146) configured to be inserted through the unidirectional valve portion (76) of the valve (70).
    [0012]
    12. Catheter assembly (10) according to claim 11, CHARACTERIZED by the fact that it still comprises a cap (100) having a truncated male luer (150).
    [0013]
    13. Catheter set (10), according to claim 1, CHARACTERIZED by the fact that it also comprises a valve activator (140) disposed inside the lumen (16, 18) on a proximal side of the valve (70), the valve activator (140) having a probe portion (146) configured to be inserted through the one-way valve portion (76) of the valve (70).
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-15| B09A| Decision: intention to grant|
    2020-12-08| 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
    US201161544168P| true| 2011-10-06|2011-10-06|
    US61/544,168|2011-10-06|
    US13/644,163|2012-10-03|
    US13/644,163|US9126012B2|2011-10-06|2012-10-03|Intravenous catheter with duckbill valve|
    PCT/US2012/058743|WO2013052661A1|2011-10-06|2012-10-04|An intravenous catheter with duckbill valve|
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