• 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:
    TRANSFER VALVE OF A BLOOD CONTROL CATHETER. The present invention relates to a catheter assembly that includes a catheter adapter having a blood control valve. A passageway is disposed in the catheter adapter to provide selective access to the interior of the catheter adapter. A shut-off valve is disposed within the catheter adapter to control access between the interior of the catheter adapter and the passage. The passage valve includes a flexible tube, a portion of the flexible tube covering an opening between the passage and the catheter adapter.
    公开号:BR112014008357B1
    申请号:R112014008357-6
    申请日:2012-10-04
    公开日:2021-04-20
    发明作者:Ralph L. Sonderegger；S. Ray Isaacson
    申请人:Becton, Dicknson And Company；
    IPC主号:
    专利说明:

    Background
    [0001] Blood control valves can be used with catheter assemblies or other vascular access devices to prevent unwanted blood exposure from the catheter assembly or other similar vascular access device. In general, a blood control valve includes the septum and a septum activator. The septum can include a flexible barrier including one or more slits through which the septum activator can be introduced. In use, the septum activator is advanced through the septum cleft(s) to selectively open the septum and form a fluid pathway along its length. Non-limiting examples of blood control valves are disclosed in United States Patent Application Publication No. 2011/0046570, filed August 20, 2009, entitled "Systems and Methods for Providing a Flushable Cateter Assembly", which is incorporated into this document in its entirety by means of this citation. summary
    [0002] The present invention was developed in response to problems and needs in the art that have not yet been completely solved by current systems and methods available. Thus, these systems and methods are designed to provide a lateral passage in a blood control catheter assembly, which includes a catheter assembly having a blood control valve, and a passage valve. The bypass valve can prevent fluid from leaking into the catheter assembly through the side passage.
    [0003] In one aspect of the invention, a catheter assembly includes a catheter adapter, a passageway disposed in the catheter adapter, and a passage valve disposed within the catheter adapter. The catheter adapter has an internal lumen, into which the passageway opens. The shut-off valve including a flexible tube, a portion of it covering an opening between the passage and the inner lumen. The passage valve can thus provide selective one-way access to the internal lumen of the catheter adapter via the passage.
    [0004] In another aspect of the invention, the catheter assembly includes a catheter adapter, a passageway disposed in the catheter adapter, and a passage valve disposed within the catheter adapter. The catheter adapter has an internal lumen, into which the passageway opens. The shut-off valve including a flexible tube, a portion thereof covering an opening between the passage and the inner lumen. The catheter adapter houses a blood control valve that includes a septum activator and a septum. The septum seals off a portion of the inner lumen. One or more slits may extend through the septum to provide selective access through the septum. The passage valve can thus provide selective one-way access to the internal lumen of the catheter adapter via the passage. In addition, the catheter adapter may provide a passageway adjacent to the septum activator disposed within the catheter adapter.
    [0005] Some implementations of the invention include one or more of the features noted below. The catheter adapter may include a blood control valve disposed within the inner lumen of the catheter adapter. The blood control valve can include a septum and a septum activator. By-pass valve and septum can be integrated together. The septum may include a distal barrier surface with a slit extending therethrough. The crossover valve flexible tube may extend along the length following a longitudinal axis of the catheter adapter, and the septum may have a barrier surface that is perpendicular to the longitudinal axis. A portion of the septum activator may be positioned within an inner channel of the bypass valve flexible tube before and during septum activation. The inner channel of the flexible tube may have an inner diameter that is greater than the outer diameter of the portion of the septum activator disposed within an inner channel before and during septal activation. The passage may include a body that is generally oriented substantially perpendicular to a longitudinal axis of the inner lumen. The flexible tube of the shut-off valve may be a cylindrical tube. The bypass valve may be disposed within a recessed portion of the inner surface of the inner lumen of the catheter adapter. The shut-off valve hose can be made of silicone, silicone rubber, and/or polypropylene.
    [0006] These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will be better evidenced from the description below and the appended claims, or may be learned by practicing the invention, as described below. . The present invention does not require that all useful features and all advantages described herein be incorporated into all embodiments of the invention. Brief Description of the Various Views of the Invention
    [0007] In order that how to obtain these and other features and advantages of the invention is readily understood, a more particular description of the invention briefly described above will be provided with reference to its specific embodiments which are illustrated in the attached drawings. These drawings represent only typical embodiments of the invention and, therefore, should not be considered to limit the scope of the invention.
    [0008] Figure 1 is a perspective view of a catheter assembly provided with a passage, according to some embodiments.
    [0009] Figure 2 is a perspective view in cross section of a catheter assembly provided with a passage and a passage valve, according to some modalities.
    [0010] Figure 3 is a perspective view of a cylindrical tubular passage valve, according to some embodiments.
    [0011] Figure 4 is a perspective view in cross section of a catheter assembly provided with an integrated passage valve and septum, according to some embodiments. Detailed Description of the Invention
    [0012] Presently preferred embodiments of this invention can be understood in reference to the drawings, in which like reference numerals indicate identical or functionally similar elements. It will immediately be appreciated that the components of the present invention, in the general form described and illustrated in the figures, could be arranged and designed in a wide spectrum of different configurations. Thus, the more detailed description below, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of the embodiments of the invention presented herein.
    [0013] In addition, the Figures may show simplified or partial views, and the dimensions of elements in the Figures may be exaggerated or not proportionate for clarity. In addition, the singular forms “a”, “an”, “the” and “a” include the plural, unless the context clearly indicates otherwise. Thus, for example, reference to a terminal includes reference to one or more terminals. In addition, when referring to a list of elements (eg a, b, c elements), that reference is intended to include any of the listed elements, any combination that includes a minor number of all listed elements, and/or a combination of all listed elements.
    [0014] The term "substantially" means that the quoted characteristic, parameter, or value need not be obtained exactly, and deviations or variations may occur, including, for example, tolerances, measurement errors, measurement accuracy limitations and other familiar factors to individuals skilled in the art in amounts that do not exclude the effect that the feature is intended to provide.
    [0015] As used herein, the term "proximal", "top", "top" or "upward" refers to a location on the device that is closest to the physician using the device and farthest away from the patient where the device is used when the device is used in its normal operation. In contrast, the term "distal", "bottom", "down" or "downward" refers to a location on the device that is farthest away from the physician using the device and closer to the patient where the device is used when the device is used in its normal operation.
    [0016] As used herein, the term "in" or "inward" refers to a location in relation to the device which, during normal use, is directed to the interior of the device. By contrast, as used herein, the term "outside" or "outside" refers to a location in relation to the device that, during normal use, is directed away from the device.
    [0017] Referring to Figure 1, a catheter assembly 10 is illustrated. Catheter assembly 10 generally includes a catheter 12 coupled to a distal end 32 of a catheter adapter 14. Catheter assembly 10 may be a blood control catheter assembly 10 when it includes a blood control valve. Catheter 12 and catheter adapter 14 are integrally coupled so that an inner lumen 16 of catheter adapter 14 is in fluid communication with a lumen 18 of catheter 12. Catheter adapter 14 may include a passage 50, which will be described in more detail referring to Figure 2. In general, catheter 12 comprises a biocompatible material with sufficient stiffness to withstand the pressures associated with insertion of the catheter into the patient. A portion of the tip 20 of the catheter is generally configured to include a beveled cutting surface 48. The beveled cutting surface 48 is used to provide an opening in the patient and allow insertion of the catheter 12 into the patient's vascular system.
    [0018] The person skilled in the art will appreciate the fact that the features of the present invention can be incorporated for use with an outside-needle catheter assembly, as shown in Figures 2 and 4, which may include the tapered end instead. of a beveled cutting surface 48. For example, one skilled in the art will appreciate that a flexible or semi-flexible polymer made catheter can be used in combination with a rigid needle to allow insertion of the catheter into the patient. A person skilled in the art will appreciate the fact that surgically implanted catheters or other types of catheters can also be used.
    [0019] Once inserted into the patient, the catheter 12 and catheter adapter 14 can provide a fluid duct to facilitate delivery of a fluid to and/or recovery of a fluid from the patient, as needed for the desired infusion procedure. Thus, in some embodiments, the catheter 12 material 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 to facilitate delivery of a fluid or removal of a fluid from the patient.
    [0020] In some embodiments, a proximal end 22 of catheter adapter 14 includes a flange 28. Flange 28 provides a positive surface that can be configured to allow coupling of intravenous tubing or a duct coupler 42 to catheter assembly 10 In some embodiments, flange 28 includes a thread assembly 30. Threads 30 are generally provided and configured to compatibly receive a complementary thread assembly 44 comprising a portion of a male luer or duct coupler 42. The duct coupler 42 it is generally fluid-tightly coupled to an end portion of the patient's duct. In some embodiments, an inner portion of the duct coupler 42 is extended outwardly to provide a probe surface 46.
    [0021] In some embodiments, the proximal end 22 to the catheter adapter 14 includes a female luer connector having a female luer nip and/or female luer locking threads. The female luer neck may be disposed at least in part within the proximal portion of the lumen 16 of the catheter adapter 14. Additionally, the aforementioned flange 28 and/or threads 30 may comprise the female luer lock threads. The female luer connector can then be configured to connect to a male luer latch or a male luer ramp. Each of these components can be sized and configured in accordance with at least some of the International Standards Organization (ISO) standards for male and female luer connections regulated by current or future standards. Accordingly, the proximal end 22 to catheter adapter 14 can then be configured to connect to a male luer latch or male luer ramp of duct coupler 42, IV line, luer access connector, needle connector, ventilation outlet, or other known or future-developed IV device.
    [0022] The surface of probe 46 is generally configured to be inserted compliantly within a proximal end 22 of catheter adapter 14. After insertion of probe 46 into proximal end 22 of catheter adapter 14, duct coupler 42 may be rotated to lock coupler 42 and flange 28 (through thread sets 30 and 44). During the interlocking process of duct coupler 42 and flange 28, probe 46 may be advanced into lumen 16 of catheter adapter 14 to an inserted position. The inserted position of probe surface 46 activates catheter assembly 10 allowing fluid to flow through catheter 12 and catheter adapter 14. Once duct coupler 42 and catheter adapter 14 are secured, fluid can be delivered. to the patient through the patient duct and inserted catheter 12.
    [0023] Now, Figure 2 will be mentioned, which represents a cross-sectional view of a catheter assembly 10. As shown, the catheter assembly 10 may include a passage 50, e.g., a side passage. Passage 50 can have various uses, as known in the art, including for infusing fluids into the inner lumen 76 of the catheter adapter 14. Such infusions can flush medications and other fluids from the inner lumen 76 and can be used to prepare the set of catheter 10. The passage 50 may include an opening 54 disposed between the body 56 of the passage 50 and the inner lumen 76 of the catheter adapter 14. The body 56 of the passage 50 is spaced apart from the catheter adapter 14. The passage 50 can be covered by a passageway cover 52 which can prevent contamination and exposure of passageway 50. Accordingly, in use, the physician opens passageway cover 52 and infuses a fluid into passageway 50 through opening 54 to inner lumen 76 of the catheter adapter 14. When the fluid infusion is complete, the clinician can close the cover of passage 52.
    [0024] As shown in Figure 2, the catheter adapter 14 may include a blood control valve. As shown, the blood control valve can be disposed on a proximal side of the septum. As already mentioned, the blood control valve may include septum 70 and a septum activator 72 that opens septum 70. Septum 70 may include one or more slits 74 through a barrier member 75 of the septum. In some embodiments, the barrier member may be formed in a distal portion of septum 70. Septum activator 72 may be inserted into one or more slits 74 during septum activation to establish a fluid pathway through septum 70. As also shown, a needle connector 80 can be coupled to the proximal end of catheter adapter 14, and a needle 86 (e.g., an introducer needle) can extend from needle connector 80, through septum 70 and the catheter 12. After proper placement of the catheter, needle 86 can be removed from catheter adapter 14.
    [0025] In some embodiments, one or more slits 74 within the septum 70 allow the passage of the needle 86 through the barrier member 75 of the septum 70, thus providing a sharp tip of the needle 86 to extend distally beyond the portion. of tip 20 of catheter 12. As already mentioned, after the catheterization procedure, needle 86 can be removed from catheter assembly 10 and safely discarded.
    [0026] In some embodiments, needle 86 is coated with a significant amount of silicone or similar fluid, such as fluorinated silicone. This sheath fluid has three purposes. First, the sheath fluid acts as a lubricant between the outer surface of the needle 86 and the facing surfaces of the slit 74. Thus, upon withdrawal of the needle 86 from the septum 70, the sheath fluid prevents unwanted adhesion between the outer surface of the needle 86 and the facing surfaces of slit 74. Second, excess sheath fluid accumulates within slit 74 and assists in sealing septum 70 by preventing blood flow back through the septum after removal of needle 86. covering fluid accumulates within the slit 74 as the needle 86 is removed from the catheter assembly 10. In particular, when the needle 86 is being withdrawn through the septum 70, the facing surfaces of the slit 74 act to remove the fluid. of covering the outer surface of the needle 86, displacing the covering fluid into the slit 74. Third, the covering fluid acts as a lubricant to prevent undesirable adhesion between opposing surfaces of the slit. 74.
    [0027] The sheath fluid can include any biocompatible lubricant. In some embodiments, the sheath fluid comprises a lubricant such as a non-wetting lubricant that is applied to an interface between the needle 86 and the slit 74 to further eliminate possible fluid and/or air leaks. A non-wetting lubricant may also be beneficial in preventing tearing or any other damage to the gap that may occur when the needle is removed from the catheter assembly after catheterization. A non-wetting lubricant can further facilitate the correct realignment of opposing surfaces of slit 74 after removal of needle 86. Non-limiting examples of a non-wetting lubricant include non-wetting Teflon-based materials such as Endura, from Endura Coating Co. ; A20, E-20, 1000-S20, FEP Green, PTFE and X-40 from Tiodize company; Cammie 2000 from 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 of the company Miller-Stepheson; and 633T2 from Otto Bock can also be used. Several non-Teflon-containing non-wetting lubricant-type materials include Dylyn, from the ART Company; Nyebar, Diamonex, NiLAD, TIDLN, Kiss-Cote, titanium oxide; Fluocad Fluorochemical Coating FC-722, from 3M Company; Permacot by Dupont; Plasma Tech 1633 from Plasma Tech, Inc.; and silicone sprays.
    [0028] As further shown in Figure 2, the catheter adapter 14 may also include a crossover valve 60. In various embodiments, such as those shown, the crossover valve 60 comprises a generally cylindrical tube. The shut-off valve 60 may be positioned within the inner lumen 76 of the catheter adapter 14 so that an outer surface 62 of the shut-off valve 60 covers the opening 54 of the passage 50. Positioned in this way, the shut-off valve 60 can impede fluid flows out of passage 50 of internal lumen 76. In addition, passage valve 60 may be configured to allow fluid access to internal lumen 76 of passage 50 by retracting, at least partially, when fluid is introduced. in passage 50.
    [0029] Consequently, the shut-off valve 60 may be designed to contract internally when a predetermined pressure is applied to the shut-off valve 60 of the opening 54 of the passage 50. The predetermined pressure can generally be less than the amount of force applied against the valve. of passage 60 through opening 54 during infusion of fluid through passage 50. Accordingly, in various embodiments, valve 70 is flexible or semi-flexible. The shut-off valve 60 can be produced from a variety of flexible or semi-flexible materials, including, for example, silicone, silicone rubber, polypropylene, or other suitable materials. The flexibility or rigidity of these materials can influence the predetermined pressure required to open the shut-off valve 60. For example, a more flexible material may require a lower predetermined pressure.
    [0030] As shown, the crossover valve 60 may have a portion of tube having a generally tubular shape, including, among others, a cylindrical-shaped tube having a circular or semicircular cross section. Other tubular configurations can include tubular shapes with other cross-sectional shapes, including triangular, square, pentagonal, heptagonal, octagonal, other polygonal, elliptical, oval, or other suitable cross-section. In some embodiments, as shown in Figure 3, the shut-off valve 60 consists of only a portion of tube. Figure 3 illustrates a perspective view of a cylindrical shaped gate valve 60, in accordance with some embodiments.
    [0031] As shown, the crossover valve tube portion 60 may be disposed at a location proximal to the septum 70. In this way, a portion of the septum activator 72 can extend through the crossover valve tube portion 60 before and during septal activation. Thus, the inner channel 64 of the crossover valve 60 can have an inner diameter greater than the outer diameter of the portions of the septum activator 72 that are disposed within the inner channel 64. In this way, the septum activator 72 can move. within the shut-off valve without interfering with the shut-off valve 60, which could result in the involuntary opening of the shut-off valve 60. Thereby, the shut-off valve 60 can provide an internal channel 64 through which a portion of septum activator 72 may extend. The inner channel 64 can also provide a space in which a portion of the passage valve 60 can contract to open the passage 50.
    [0032] The tubular shape can also provide a structural strength that holds the outer surface 62 of the gate valve 60 against the opening 54 in the absence of the pressure of the passage 50. The thickness of the walls of the tube-shaped gate valve 60 can be selected to set the predetermined pressure required to open the shut-off valve 60. Increasing wall thickness requires more pressure to open the shut-off valve 60. By reducing the wall thickness, less pressure is required for the valve opening 60. Additionally, wall thicknesses can be adjusted for flexibility to provide rigidity to the material forming the gate valve 60. For example, a stiffer valve may have thinner walls than a more flexible valve . Accordingly, the flexibility of the shut-off valve 60 combined with the shape and size of the shut-off valve 60 can define, at least in part, the predetermined pressure required to open the shut-off valve 60.
    [0033] In various embodiments, the crossover valve 60 is seated within a groove or channel 94 (shown in Figure 4), which comprises a recessed portion of the inner surface 78 of the catheter adapter 14. Generally the outer diameter of the valve port 60 can be configured to fit compliantly and firmly within groove or channel 94. For example, in some embodiments, the outside diameter of gate valve 60 is selected to either be slightly smaller than the diameter of groove or channel 94 or to be slightly larger than the diameter of the inner lumen 76. In this way, the bypass valve 60 can be retained within the groove or channel 94 during use of the catheter assembly 10.
    [0034] Now specifically mentioned will be Figure 4, which depicts a crossover valve combined with the septum to form a combined septum and crossover valve 90. The combined septum and crossover valve 90 may be an integrated structure that is formed from of a single material as a single piece. As shown, the combined septum and shut-off valve 90 may include a portion of the flexible tubing that extends longitudinally around a longitudinal axis of the catheter adapter 14. The barrier member 75 of the septum may be substantially perpendicular to the portion of the septum. flexible tubing, or in other words, can be disposed in a plane substantially perpendicular to the longitudinal axis of the catheter adapter 14.
    [0035] This septum and gate valve combined in one piece 90 can minimize manufacturing costs and simplify the assembly procedure. Consequently, the material selected for the combined septum and shut-off valve 90 can accommodate the functional requirements of the septum and shut-off valve. In some embodiments, the combined septum and gate valve 90 are formed in a common molding process. As further shown, the combined septum and gate valve 90 can include various internal and external structures, such as an internal ridge 92.
    [0036] In use, the shape of the combined septum and passage valve 90 may contract when subjected to the insertion force of a fluid into passage 50. The contracted shape provides a channel between the inner surface 78 of the catheter adapter 14 and the outer surface 62 of the crossover valve 60. After fluid is infused into the catheter adapter 14, the crossover valve resumes the uncontracted shape that closes the passage 50. During the infusion of fluid through the catheter adapter 14, the pressure within inner lumen 76 presses shut-off valve 60 against opening 56, keeping shut-off valve 60 closed.
    [0037] For some infusion therapy techniques, airflow between the distal side and the proximal side of septum 70 may be desirable. For example, for some embodiments comprising a septum 70 having a fluid-tight slit 74, the passage of air from the septum 70 is prohibited prior to opening or activating the septum 70 via the septum activator 72, as already discussed. Thus, when catheter 12 of catheter assembly 10 is inserted into a patient's vascular system, positive pressure develops distal to septum 70 preventing the desired return of blood from the patient to catheter adapter 14. Generally noticeable return it is desirable to confirm the exact placement of the tip of the catheter 20 in the patient's vein. Accordingly, some embodiments of the present invention include features or elements that enable airflow between the distal and proximal sides of septum 70 without requiring activation of septum 70 with septum activator 72. Thus, some embodiments of the present invention invention provide noticeable feedback, as is generally desired in infusion procedures.
    [0038] For example, a plurality of air vent channels (not shown) may be interposed between the septum 70 and the inner surface 78 of the catheter adapter 14. The air vent channels can relieve positive pressure distal to the septum. 70 providing an access to divert air from the septum 70 to the rear chamber 64. In some embodiments, the air vent channels are constructed by removing the surface portions of the channel 94, resulting in a plurality of generally parallel grooves.
    [0039] In addition to allowing airflow between the distal side and the proximal side of the septum 70, the air vent channels can be configured to allow fluid flow through the catheter adapter 14 before activating or opening the slit 74 with septum activator 72. In some embodiments, the rate of air and/or fluid flow is adjusted by fabricating catheter adapter 14 to include a greater or lesser number of air vent channels. In other embodiments, the air and/or fluid flow rate is adjusted by fabricating the catheter adapter 14 to include air vent channels having a greater or lesser cross-sectional area. Thus, in some embodiments, the air and/or fluid flow rate is increased by fabricating a catheter adapter 14 that has both a greater number of vent channels and vent channels with a larger cross-sectional area. In contrast, in other embodiments, the air and/or fluid flow rate is decreased by fabricating a catheter adapter 14 that has both a smaller number of air vent channels and air vent channels with a smaller area of transversal section.
    [0040] The present invention may be incorporated into other specific forms without deviating from its structures, methods, or other essential features as broadly described in this document and claimed below. The modalities described must be considered in all their aspects as merely illustrative and not restrictive. The scope of the invention, therefore, is especially indicated by the appended claims, and not by the above description. All changes to the meaning and equivalence range of claims are included in their scope.
    权利要求:
    Claims (15)
    [0001]
    1. Catheter assembly (10) comprising: a catheter adapter (14) which forms an internal lumen (16) extending along a longitudinal axis of the catheter adapter (14), the catheter adapter (14) having a distal end (32) configured to couple to a catheter (12) and a proximal end (22); a side passage (50) disposed in the catheter adapter (14), the side passage (50) forming an opening (54) in the inner lumen (16) of the catheter adapter (14); a septum (70) disposed within the inner lumen (16) of the catheter adapter (14); a stopcock (60, 90) disposed within the inner lumen (16) of the catheter adapter (14), CHARACTERIZED in that it comprises: the septum (70) comprising a barrier member (75) extending through the inner lumen (16) perpendicular to the longitudinal axis, thus forming a seal between a distal portion and a proximal portion of the inner lumen (16), the barrier member (75) being positioned distally to the side passage (50); the crossover valve (60) comprising a flexible tube having an inner diameter and an outer diameter that is the same as a diameter of the inner lumen (16), the crossover valve (60) being positioned proximal to the barrier member (75) and being positioned to cover the opening (54) formed by the side passage (50); and a septum activator (72) positioned within the inner lumen (16) proximal to the barrier member (75), the septum activator (72) having a distal portion with an outer diameter that is less than the inner diameter of the tube. flexible valve of the crossover valve (60), the distal portion of the septum activator (72) extending through the crossover valve (60) and being configured to extend through the barrier member (75) to open a fluid pathway therethrough. of the septum (70).
    [0002]
    2. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the passage valve (60) and the septum (70) form an integrated member in a single piece (90).
    [0003]
    3. Catheter assembly (10), according to claim 2, CHARACTERIZED by the fact that the barrier member (75) includes a slit (74) therethrough.
    [0004]
    4. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the passage (50) includes a body (56) that is generally oriented perpendicular to a longitudinal axis of the internal lumen (16, 76).
    [0005]
    5. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the flexible tube of the passage valve (60) is a tube of cylindrical shape.
    [0006]
    6. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the passage valve (60) is disposed within a recessed portion of the inner surface (78) of the inner lumen (16) of the adapter of catheter (14), so that the outer diameter of the flexible tube is the same as the diameter of the recessed portion of the inner lumen (16).
    [0007]
    7. Catheter assembly (10) comprising: a catheter adapter (14) that forms an internal lumen (16) that extends along a longitudinal axis of the catheter adapter (14), the catheter adapter (14) having a distal end (32) configured to couple to a catheter (12) and a proximal end (22); a side passage (50) disposed in the catheter adapter (14), the side passage forming an opening (54) in the inner lumen (16) of the catheter adapter (14); a blood control valve (70, 72) disposed within the inner lumen (16), the blood control valve (70, 72) comprising a septum (70); CHARACTERIZED in that it comprises: a blood control valve comprising a septum activator positioned proximal to the septum (70), the septum (70) comprising a barrier member (75) that extends through the inner lumen (16) perpendicular to the axis longitudinal geometric, thus forming a seal between a distal portion and a proximal portion of the inner lumen (16), the barrier member (75) being positioned distally to the side passage; and a crossover valve (60, 90) disposed within the inner lumen (16) proximal to the barrier member (75), the crossover valve (60) comprising a flexible tube with an outer surface (62) covering the opening ( 54) formed by the side passage, the flexible tube having an inside diameter configured to allow a distal portion of the septum activator (72) to extend through the flexible tube and deflect the barrier member (75).
    [0008]
    8. Catheter assembly (10), according to claim 7, CHARACTERIZED by the fact that the passage valve (60) and the septum (70) of the blood control valve form an integrated member in a single piece (90) .
    [0009]
    9. Catheter assembly (10), according to claim 8, CHARACTERIZED by the fact that the barrier member (75) includes one or more slits (74).
    [0010]
    10. Catheter assembly (10), according to claim 7, CHARACTERIZED by the fact that the passage (50) includes a body (56) that is generally oriented perpendicular to the longitudinal axis of the inner lumen (16, 76 ).
    [0011]
    11. Catheter assembly (10), according to claim 7, CHARACTERIZED by the fact that the flexible tube is a cylindrical tube.
    [0012]
    12. Catheter assembly (10), according to claim 7, CHARACTERIZED by the fact that the passage valve (60) is a separate component of the septum (70).
    [0013]
    13. Catheter assembly (10), according to claim 7, CHARACTERIZED by the fact that the passage valve (60) is disposed within a recessed portion of the inner surface (78) of the inner lumen (16) of the adapter. catheter (14).
    [0014]
    A catheter assembly (10) according to claim 7, characterized in that it further comprises a passageway cover (50) covering the side passageway.
    [0015]
    15. Catheter assembly (10) comprising: a catheter adapter (14) having a distal end (32) coupled to a catheter (12) and a proximal end (22), the catheter adapter (14) forming a lumen ( 18) extending from the distal end (32) to the proximal end (22) along a longitudinal axis, the catheter adapter (14) further including a side passage (50) that forms an opening (54) to the lumen (18); a septum (70) positioned within the lumen (18), CHARACTERIZED in that it comprises: the septum (70) comprising a barrier member (75) that extends through the inner lumen (16) perpendicular to the longitudinal geometric axis, forming thus a seal between a distal portion and a proximal portion of the inner lumen (16), the barrier member (75) being positioned distally to the opening (54) formed by the side passage (50); a flexible tube (60, 90) positioned within the lumen (18) proximal to the barrier member (75) so that an outer surface (62) of the flexible tube covers the opening (54) formed by the side passage (50) ; and a septum activator (72) positioned proximal to the barrier member (75), the septum activator (72) having a distal portion that extends through the flexible tube and is configured to bypass the barrier member (75) when the septum activator (72) is moved distally.
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    AU2012318631A1|2014-04-24|
    EP2763742A2|2014-08-13|
    CN103957989A|2014-07-30|
    MX344741B|2017-01-05|
    CA2851235C|2020-01-14|
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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]|
    2020-10-06| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-03-30| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-04-20| 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
    US201161544174P| true| 2011-10-06|2011-10-06|
    US61/544.174|2011-10-06|
    US13/644,200|US9155876B2|2011-10-06|2012-10-03|Port valve of a blood control catheter|
    US13/644.200|2012-10-03|
    PCT/US2012/058748|WO2013052665A2|2011-10-06|2012-10-04|Port valve of a blood control catheter|
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