Catheter system

Abstract

A catheter system may include a needleless connector that may include a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector. The catheter system may include an exhaust assembly, which may include a proximal component and a distal component. The proximal component may include a male luer adapter, which may include a male luer. The distal member may include a distal end coupled to the proximal end of the needleless connector, and a proximal end coupled to the male luer adapter. In response to the proximal member moving from the proximal position to the distal position relative to the distal member, the male luer of the male luer adapter may open the valve to expel air inside the catheter system.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2021 / 034294, Chinese application number 202180041503.1, application date May 26, 2021, and name “Duct Exhaust Components and Related Systems and Methods”. Technical Field

[0002] The present disclosure relates to a duct exhaust assembly and related systems and methods. Background Art

[0003] Catheters are commonly used for various infusion therapies. For example, catheters can be used to deliver fluids (e.g., saline solution, various medications, and total parenteral nutrition) to patients. Catheters can also be used to draw blood from patients.

[0004] One common type of catheter is an over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC is mounted on an introducer needle with a sharp distal tip. The PIVC and introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the needle pointing upward, away from the patient's skin. The PIVC and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0005] To verify proper placement of the introducer needle and / or PIVC in the blood vessel, the clinician typically confirms a "flashback" of blood in the flashback lumen of the PIVC assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the introducer needle, leaving the PIVC in place for future blood draws and / or infusions. The PIVC assembly can be coupled to an extension kit, which can allow for connection of an infusion or blood draw device at a location removed from the PIVC insertion site.

[0006] In some cases, catheters used for infusion may be pre-primed to remove air before insertion into the patient's vasculature. If air bubbles are allowed to enter the patient's vasculature, they may form an embolism, which can cause serious harm to the patient.

[0007] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided merely to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0008] In certain embodiments, the catheter system may include a catheter assembly and a needle assembly coupled to the catheter assembly. In certain embodiments, the needle assembly may include a needle hub and an introducer needle. In certain embodiments, the proximal end of the introducer needle may be fixed in the needle hub.

[0009] In some embodiments, the catheter assembly can include a catheter adapter that can include a distal end and a proximal end. In some embodiments, the catheter adapter can include a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly can include an extension tube extending from and / or integrated within the side port. In some embodiments, an adapter (e.g., a Y-type adapter or a T-type adapter) can be coupled to the extension tube.

[0010] In some embodiments, the catheter assembly can include a catheter that can extend from a distal end of a catheter adapter and can be secured within the catheter adapter. In some embodiments, the catheter can include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.

[0011] In certain embodiments, the guide needle can extend through the catheter. In certain embodiments, in response to the guide needle and / or catheter being inserted into the patient's vascular system, the guide needle can be withdrawn from the catheter to the proximal side and removed from the catheter assembly. In certain embodiments, the catheter can stay in the patient's vascular system for drawing blood and / or infusion.

[0012] In some embodiments, the catheter system may include a needleless connector, which may include a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector. In some embodiments, the distal end of the needleless connector may be coupled to a catheter assembly. In some embodiments, the distal end of the needleless connector may be coupled to an adapter.

[0013] In some embodiments, the catheter system can include a vent assembly that can include a proximal component and a distal component. In some embodiments, the proximal component can include a male luer adapter that can include a male luer. In some embodiments, the distal component can include a distal end that can be coupled to a proximal end of a needleless connector. In some embodiments, the distal component can include a proximal end coupled to the male luer adapter. In some embodiments, the male luer of the male luer adapter can open a valve in response to movement of the proximal component relative to the distal component from a proximal position to a distal position.

[0014] In some embodiments, the male luer adapter can include a first set of threads. In some embodiments, the distal end of the distal component can include a second set of threads. In some embodiments, the first set of threads can be arranged with a different hand-threading direction than the second set of threads. For example, the first set of threads can be left-handed, and the second set of threads can be right-handed. Thus, in response to moving the proximal component from a proximal position to a distal position by further screwing the proximal component onto the distal component, the likelihood of the distal component becoming loose from the needleless connector can be reduced.

[0015] In some embodiments, the outer surface of the distal component can include a third set of threads. In some embodiments, the third set of threads can have the same direction of rotation as the first set of threads, so that the proximal component and the distal component can be threaded together. For example, the third set of threads can be left-handed.

[0016] In some embodiments, the outer surface of the needleless connector can include a fourth set of threads. In some embodiments, the fourth set of threads can have the same direction of rotation as the second set of threads, so that the needleless connector and the distal component can be threaded together. For example, the fourth set of threads can be right-handed.

[0017] In some embodiments, the inner surface of the proximal component may include a first protrusion. In some embodiments, the outer surface of the distal component may include a second protrusion and a third protrusion located proximal to the second protrusion. In some embodiments, in response to movement of the proximal component from the proximal position to the distal position, the first protrusion may move proximal to the third protrusion. In some embodiments, in response to the proximal component being in the distal position, the first protrusion may be proximal to the second protrusion.

[0018] In some embodiments, the outer surface of the distal component can include a channel. In some embodiments, the second and third projections can be disposed within the channel. In some embodiments, the first projection can move proximally within the channel in response to movement of the proximal component from a proximal position to a distal position. Thus, in some embodiments, the channel can provide alignment of the proximal component relative to the distal component.

[0019] In some embodiments, the proximal component may include a male luer, a proximal projection extending from the male luer, and a distal projection extending from the male luer. In some embodiments, the male luer may extend through the proximal end of the distal component. In some embodiments, the inner surface of the distal component may include another projection. In some embodiments, in response to the proximal component moving from a proximal position to a distal position, the proximal projection may move distally of the other projection. In some embodiments, in response to the proximal component being in the proximal position, the distal projection may be located distally of the other projection and the proximal projection may be located proximal of the other projection.

[0020] In some embodiments, a method may include actuating an exhaust assembly that is coupled to the needleless connector. In some embodiments, the actuating exhaust assembly may include moving the proximal component from a proximal position to a distal position, which may open a valve. In some embodiments, the method may include pre-priming the catheter assembly after actuating the exhaust assembly, which may allow air to be removed by extending through the path of the needleless connector, the distal component, and the proximal component. In some embodiments, the method may include inserting the catheter assembly into the patient's vascular system after the pre-priming catheter assembly. In some embodiments, the method may include inserting the catheter assembly into the patient's vascular system and pre-priming the catheter assembly with blood. In some embodiments, the catheter assembly may be pre-primed with blood in response to the catheter assembly inserting into the vascular system. In some embodiments, after the catheter assembly is inserted into the vascular system and pre-primed with blood, blood may be flushed back into the vascular system.

[0021] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and not limiting, of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and measures shown in the accompanying drawings. It should also be understood that, unless so protected, the embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description should not be construed as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0023] Figure 1 is an upper perspective view of an example catheter system according to some embodiments;

[0024] Figure 2A is an exploded view of an example vent assembly and an example needleless connector, according to some embodiments.

[0025] Figure 2B According to some embodiments Figure 2A Exploded and cutaway views of the exhaust assembly and needleless connector.

[0026] Figure 2C is coupled to Figure 2A A cross-sectional view of the vent assembly of the needleless connector.

[0027] Figure 3A is another example exhaust assembly according to some embodiments and Figure 2A Exploded view of the needleless connector.

[0028] Figure 3B According to some embodiments Figure 3A Exhaust components and Figure 2A Exploded and cross-sectional views of the needleless connector.

[0029] Figure 3C is coupled to Figure 2A Needleless connector Figure 3A A cross-sectional view of the exhaust assembly.

[0030] Figure 4A is another example exhaust assembly according to some embodiments and Figure 2A Exploded view of the needleless connector.

[0031] Figure 4B According to some embodiments Figure 4A Exhaust components and Figure 2A Exploded and cross-sectional views of the needleless connector.

[0032] Figure 4C is coupled to Figure 2A Needleless connector Figure 4A A cross-sectional view of the exhaust assembly.

[0033] Figure 4D According to some embodiments Figure 4A A cross-sectional view of a portion of an exhaust assembly illustrating example proximal components at a proximal position.

[0034] Figure 4E According to some embodiments Figure 4A A cross-sectional view of a portion of an exhaust assembly showing proximal components at a distal position.

[0035] Figure 5A is another example exhaust assembly according to some embodiments and Figure 2A Exploded view of the needleless connector.

[0036] Figure 5B is coupled to Figure 2A Needleless connector Figure 5A sectional view of an exhaust assembly showing another example proximal component at a proximal position.

[0037] Figure 5C is coupled to Figure 2A Needleless connector Figure 5A A cross-sectional view of an exhaust assembly showing proximal components in a distal position.

[0038] Figure 5D According to some embodiments Figure 5B A cross-sectional view of a portion of an exhaust assembly.

[0039] Figure 5E According to some embodiments Figure 5C A cross-sectional view of a portion of an exhaust assembly. DETAILED DESCRIPTION

[0040] Now refer to Figure 1 In some embodiments, catheter system 10 can include catheter assembly 12 and needle assembly 14 coupled to catheter assembly 12. In some embodiments, needle assembly 14 can include needle hub 16 and introducer needle 18. In some embodiments, the proximal end of introducer needle 18 can be secured within needle hub 16.

[0041] In some embodiments, the catheter assembly 12 can include a catheter adapter 20, which can include a distal end 22 and a proximal end 24. In some embodiments, the catheter adapter 20 can include a side port 26 disposed between the distal end 22 of the catheter adapter 20 and the proximal end 24 of the catheter adapter 20. In some embodiments, the catheter assembly 12 can include an extension tube 28 extending from and / or integrated within the side port 26. In some embodiments, an adapter 30 (e.g., a Y-adapter or a T-adapter) can be coupled to the extension tube 28 at its proximal end.

[0042] In some embodiments, catheter assembly 12 may include a catheter 32 that may extend from distal end 22 of catheter adapter 20 and may be secured within catheter adapter 20. In some embodiments, catheter 32 may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.

[0043] In some embodiments, introducer needle 18 can extend through catheter 32. In some embodiments, in response to inserting introducer needle 18 and / or catheter 32 into the patient's vasculature, introducer needle 18 can be withdrawn proximally from catheter 32 and removed from catheter assembly 12. In some embodiments, catheter 32 can remain within the patient's vasculature for use in withdrawing blood and / or administering fluids.

[0044] In some embodiments, the catheter system 10 can include one or more needleless connectors 34 that can be coupled to specific ports of the adapter 30. In some embodiments, the needleless connector 34 can include a MAXZERO® available from Beckton Dickinson, Inc. of Franklin Lakes, New Jersey. TM In some embodiments, the cap 36 can be coupled to the proximal end of the particular needleless connector 34. In some embodiments, the distal end 38 of the needleless connector 34 can be coupled to the adapter 30.

[0045] Now refer to Figures 2A-2CIn some embodiments, the needleless connector 34 may include a distal end 38, a proximal end 40, and a valve 42 disposed between the distal end 38 of the needleless connector 34 and the proximal end 40 of the needleless connector 34. In some embodiments, the distal end 38 of the needleless connector 34 may be coupled to the catheter assembly 12 (e.g., see Figure 1 ).

[0046] In some embodiments, the catheter system 10 can include a vent assembly 44, which can include a proximal component 46 and a distal component 48. In some embodiments, the proximal component 46 can include a male luer adapter 50, which can include a male luer 52. In some embodiments, the proximal component 46 can include a vent membrane 54 that is permeable to air but impermeable to liquids. In some embodiments, the vent membrane 54 can be disposed at a proximal end 56 of the proximal component 46. In some embodiments, the fluid path can extend through the male luer 52 and can terminate at the vent membrane 54, which can be aligned with the male luer 52.

[0047] In some embodiments, the distal member 48 can include a distal end 58 that can be coupled to the proximal end 40 of the needleless connector 34. In some embodiments, the distal member 48 can include a proximal end 60 that is coupled to the male luer adapter 50. In some embodiments, in response to movement of the proximal member 46 relative to the distal member 48 from a proximal position to a distal position, the male luer 52 of the male luer adapter 50 can open the valve 42, e.g., as Figure 2C shown.

[0048] In some embodiments, the male luer adapter 50 can include a first set of threads 62. In some embodiments, the distal end 58 of the distal component 48 can include a second set of threads 64. In some embodiments, the first set of threads 62 can be arranged with a different hand-threading than the second set of threads 64. For example, the first set of threads 62 can be left-handed, and the second set of threads 64 can be right-handed. Thus, in response to moving the proximal component 46 from a proximal position to a distal position by further threading the proximal component 46 onto the distal component 48, the likelihood of the distal component 48 becoming stuck on the needleless connector 34 when attempting to unscrew the vent assembly 44 from the needleless connector 34 can be reduced. Thus, the different hand-threading of the first and second sets of threads 62, 64 can allow the vent assembly 44 to be easily removed from the needleless connector 34.

[0049] In some embodiments, the outer surface of the distal component 48 can include a third set of threads 66. In some embodiments, the third set of threads 66 can have the same direction of rotation as the first set of threads 62, so that the proximal component 46 and the distal component 48 can be threaded together. For example, the third set of threads 66 can be left-handed.

[0050] In some embodiments, the outer surface of the needleless connector 34 can include a fourth set of threads 68. In some embodiments, the fourth set of threads 68 can have the same direction of rotation as the second set of threads 64, so that the needleless connector 34 and the distal component 48 can be threaded together. For example, the fourth set of threads 68 can be right-handed.

[0051] In some embodiments, a method may include actuating an exhaust assembly 44, which may be coupled to the needleless connector 34. In some embodiments, actuating the exhaust assembly 44 may include moving the proximal component 46 from a proximal position to a distal position, which may open the valve 42. In some embodiments, the valve 42 may include an accordion valve or any other suitable type of valve. In some embodiments, a blunt cannula 69 may extend through the valve 42 and may include one or more flow holes so that air can be removed through a path extending through the needleless connector 34, the distal component 48, and the proximal component 46.

[0052] In some embodiments, the method can include pre-priming catheter assembly 12 after actuating vent assembly 44, which can remove air from catheter assembly 12 that could be harmful to the patient. In some embodiments, catheter assembly 12 can be pre-primed with a pre-priming solution (e.g., saline). In some embodiments, the method can include inserting catheter assembly 12 into the patient's vasculature after pre-priming catheter assembly 12.

[0053] In some embodiments, the method may include pre-priming catheter assembly 12 with blood after actuating vent assembly 44, which may remove potentially harmful air from catheter assembly 12. In some embodiments, catheter assembly 12 may be inserted into the patient's vasculature and blood may be allowed to fill catheter assembly 12 to expel the air through vent assembly 44. In some embodiments, the blood filling catheter assembly 12 may be flushed back into the patient's vasculature with a flushing solution (e.g., saline).

[0054] In these embodiments, during pre-priming of the catheter assembly 12, the catheter assembly 12 and one or more of the following may be filled with blood: the extension tube 28 (see FIG. Figure 1 ), adapter 30 (see Figure 1 ), needleless connector 34, distal component 48, and proximal component 46. In some embodiments, the catheter assembly 12 is inserted into the vascular system and the extension tube 28 is primed with blood (see Figure 1 ), adapter 30 (see Figure 1 ), needleless connector 34, distal component 48, and one or more of proximal component 46 and the catheter assembly, blood can be flushed back into the vascular system with a flushing solution. In some embodiments, a flushing device can be coupled to proximal component 46 to flush blood back into the vascular system.

[0055] Now refer to Figures 3A-3B In some embodiments, the first set of threads 62 can be arranged with the same threading direction as the second set of threads 64. In some embodiments, when the proximal component 46 is in the distal position, the first set of threads 62 and the third set of threads 66 can be permanently locked and / or locked with a force greater than the unscrewing force between the distal component 48 and the needleless connector 34. Thus, in response to moving the proximal component 46 from the distal position (in which the valve 42 can be opened) to the proximal position by unscrewing the proximal component 46 until it is disengaged from the needleless connector 34, the likelihood of the distal component 48 becoming stuck on the needleless connector 34 when attempting to unscrew the vent assembly 44 from the needleless connector 34 can be reduced.

[0056] Now refer to Figures 4A-4E In some embodiments, the inner surface of the proximal component 46 may include a first protrusion 70. In some embodiments, the outer surface of the distal component 48 may include a second protrusion 72 and a third protrusion 74 located distal to the second protrusion 72. In some embodiments, in response to the proximal component 46 moving from the proximal position to the distal position, the first protrusion 70 may move distal to the third protrusion 74. In some embodiments, in response to the proximal component 46 being in the distal position, the first protrusion 70 may be located distal to the second protrusion 72 and between the second protrusion 72 and the third protrusion 74. In some embodiments, in response to the first protrusion 70 moving distal to the second protrusion 72, the proximal component 46 may be snapped onto the distal component 48.

[0057] In some embodiments, the outer surface of the distal component 48 can include a channel 76. In some embodiments, the second protrusion 72 and the third protrusion 74 can be disposed within the channel 76. In some embodiments, in response to movement of the proximal component from the proximal position to the distal position, the first protrusion 70 can move distally within the channel 76. Thus, in some embodiments, the channel 76 can provide alignment of the proximal component 46 relative to the distal component 48.

[0058] In some embodiments, one or more of the first protrusion 70, the second protrusion 72, and the third protrusion 74 can be annular. In some embodiments, the proximal component 46 can include at least two first protrusions 70. In some embodiments, the distal component 48 can include at least two second protrusions 72 and / or at least two third protrusions 74. In some embodiments, the distal component 48 can include at least two channels 76. In some embodiments, one or more of the following can be opposite to each other: two first protrusions 70, two second protrusions 72, two third protrusions 74, and two channels 76. In some embodiments, the distal component 48 can be integrally formed as a single unit. In some embodiments, the proximal component 46 can be integrally formed as a single unit.

[0059] Now refer to Figures 5A-5E In some embodiments, the proximal component 46 can include a male luer 78, a proximal projection 80 extending from the male luer 78, and a distal projection 82 extending from the male luer 78. In some embodiments, the male luer 78 can extend through the proximal end 60 of the distal component 48. In some embodiments, the inner surface of the distal component 48 can include another projection 84. In some embodiments, in response to movement of the proximal component from the proximal position to the distal position, the proximal projection 80 can move distally of the other projection 84. In some embodiments, in response to the proximal component 46 being in the proximal position, the distal projection 82 can be located distally of the other projection 84 and the proximal projection 80 can be located proximal to the other projection 84.

[0060] In some embodiments, one or more of the proximal protrusion 80, the distal protrusion 82, and the further protrusion 84 can be annular. In some embodiments, the proximal component 46 can include at least two proximal protrusions 80 and / or at least two distal protrusions 82. In some embodiments, the distal component 48 can include at least two further protrusions 84. In some embodiments, one or more of the following can be opposite to each other: two proximal protrusions 80, two distal protrusions 82, and two further protrusions 84.

[0061] In some embodiments, the outer diameter of the proximal component 46 at the distal protrusion 82 and the proximal protrusion 80 can be larger than the inner diameter of the distal component 48 at the other protrusion 84, so that the distal protrusion 82 and the proximal protrusion 80 can be configured to compress slightly to pass through the other protrusion 84. In some embodiments, the distal protrusion 82 and the proximal protrusion 80 can be configured to buckle over the other protrusion 84, which can increase the difficulty of removing the proximal component 46 from the distal component 48 and / or the difficulty of moving the proximal component 46 from the distal position (in which the valve 42 can be opened) to the proximal position. In some embodiments, in response to the proximal component 46 being in the distal position, the proximal protrusion 80 can contact the other protrusion 84.

[0062] In some embodiments, actuating the vent assembly coupled to the needleless connector 34 (which includes the distal component 48 and the proximal component 46) can include moving the proximal component 46 from a proximal position to a distal position. In some embodiments, in response to the movement of the proximal component 46 from the proximal position to the distal position, the proximal projection can move distally of the other projection 84.

[0063] All examples and conditional language listed herein are intended for teaching purposes to help readers understand the present invention and the concepts of the inventors to promote the art, and are to be interpreted as not being limited to these specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A catheter system comprising: a needleless connector comprising a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector; An exhaust assembly, the exhaust assembly comprising: a proximal component comprising a male luer adapter having a male luer; and A distal component, the distal component comprising: a distal end coupled to the proximal end of the needleless connector; and coupled to the proximal end of the male Luer adapter, wherein the proximal component is movable relative to the distal component between a proximal position and a distal position, wherein in response to movement of the proximal component from the proximal position to the distal position, the male luer of the male luer adapter opens the valve, wherein the inner surface of the proximal component comprises a first protrusion, wherein the outer surface of the distal component comprises a second protrusion and a third protrusion located distally of the second protrusion, wherein in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distally of the third protrusion, wherein in response to the proximal component being in the distal position, the first protrusion is located distally of the second protrusion, wherein the outer surface of the distal component further comprises a channel, wherein the second protrusion and the third protrusion are disposed within the channel, wherein in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distally within the channel.

2. The catheter system according to claim 1, wherein The distal end of the distal member includes a set of threads, wherein an outer surface of the needleless connector includes another set of threads.

3. A catheter system comprising: a needleless connector comprising a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector; An exhaust assembly, the exhaust assembly comprising: a proximal component comprising a male luer, a proximal projection extending from the male luer, and a distal projection extending from the male luer; and A distal component, the distal component comprising: a distal end coupled to the proximal end of the needleless connector; a proximal end, wherein the male luer extends through the proximal end of the distal member; and an inner surface, the inner surface comprising another protrusion; The proximal component is movable relative to the distal component between a proximal position and a distal position, wherein the proximal projection moves distally of the other projection in response to movement of the proximal component from the proximal position to the distal position.

4. The catheter system of claim 3, wherein: In response to the proximal component being in the proximal position, the distal projection is located distally of the other projection and the proximal projection is located proximal of the other projection.

5. The catheter system of claim 3, further comprising a catheter assembly coupled to the distal end of the needleless connector, wherein The catheter assembly comprises: a catheter adapter comprising a distal end, a proximal end, and a side port; an extension tube extending from the side port; an adapter coupled to the extension tube, wherein the distal end of the needleless connector is coupled to the adapter; and A catheter extends from the distal end of the catheter adapter.

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