Vascular access instruments and related devices and methods
By designing a Y-shaped adapter and diaphragm structure in the catheter system, the problem of catheter blockage was solved, enabling efficient blood collection and fluid infusion, and reducing needle prick pain and costs.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2021-07-20
- Publication Date
- 2026-08-04
AI Technical Summary
Existing catheters are prone to blockage after prolonged insertion into the patient's body, making blood collection difficult. Additional needle punctures increase patient suffering and material costs.
A catheter system was designed, including a catheter hub, a Y-shaped adapter, a diaphragm, and a needle assembly. The flow path state is changed by the movement of the diaphragm, which enables the switching between blood collection and fluid infusion, reducing dead space and the risk of blockage.
It improves the efficiency of blood collection via catheter, reduces the need for additional needle pricks, and lowers patient discomfort and material costs.
Smart Images
Figure CN113952591B_ABST
Abstract
Description
Technical Field
[0001] This disclosure generally relates to vascular access devices, systems, and methods. More specifically, this disclosure relates to catheter systems and related devices and methods. Background Technology
[0002] Catheters are commonly used to deliver fluids into a patient's vascular system. For example, catheters can be used to infuse saline solutions, various medications, or total parenteral nutrition. Catheters can also be used to draw blood from a patient.
[0003] The catheter may include a peripheral venous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal tip. The catheter and guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, and the bevel of the needle faces upward away from the patient’s skin. The catheter and guide needle are typically inserted into the patient’s vascular system through the skin at a small angle.
[0004] To verify proper placement of the guide needle and / or catheter in a blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.
[0005] For several reasons, drawing blood using a catheter can be difficult, especially when the catheter remains in the vascular system for more than a day. When a catheter is inserted into a patient for an extended period, the catheter or vein can become more prone to narrowing, constriction, kinking, blockage by debris (e.g., fibrin or platelet clots), and the catheter tip can adhere to the vascular system. Therefore, catheters are frequently used to collect blood samples during catheter placement, but not often during the catheter's residence time. Consequently, when a blood sample is needed, an additional needle prick is typically used to provide venous access for blood collection, which can be painful for the patient and result in higher material costs.
[0006] In some cases, to avoid additional needle pricks, vascular access devices can be used to access the patient's vascular system via a catheter. Vascular access devices can be inserted into the vascular system through a catheter to prolong the catheter's lifespan and allow blood to be drawn through the catheter without the need for additional needle pricks.
[0007] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the implementations described herein can be practiced. Summary of the Invention
[0008] This disclosure generally relates to vascular access devices, systems, and methods. More specifically, this disclosure relates to catheter systems and related devices and methods. In some embodiments, the catheter system may include a catheter hub that may include a distal end, a proximal end, a side port disposed between the distal and proximal ends of the catheter hub, and a lumen extending through the distal and proximal ends of the catheter hub. In some embodiments, the catheter system may include a catheter extending distally from the distal end of the catheter hub.
[0009] In some embodiments, the catheter system may include a Y-adapter, which may include a distal end, a first port, and a second port. In some embodiments, the catheter system may include an extension tube, which may include a distal end integrated with a side port and a proximal end integrated with the distal end of the Y-adapter. In some embodiments, the catheter system may include a diaphragm disposed within the Y-adapter. In some embodiments, the diaphragm may include a distal end, a proximal end, a lumen extending through the distal end of the diaphragm, a side opening in fluid communication with the diaphragm lumen, and a vent extending from the proximal end of the diaphragm. In some embodiments, the diaphragm may be movable between a pre-charge position and an infusion position. In some embodiments, in response to the diaphragm being in the pre-charge position, the vent may be aligned with the side port. In some embodiments, in response to the diaphragm being in the infusion position, the side opening may be aligned with the side port.
[0010] In some embodiments, the diaphragm may be coupled to the housing, the housing extending proximally from the Y-shaped adapter. In some embodiments, the Y-shaped adapter may include a slot disposed around a portion of the circumference of the Y-shaped adapter. In some embodiments, the slot may include a notch. In some embodiments, the housing may include a protrusion. In some embodiments, the protrusion may be disposed within the notch in response to the diaphragm being in a pre-charged position. In some embodiments, the housing may be moved distally in response to the diaphragm moving from the pre-charged position to the infusion position, and the protrusion may slide along the slot.
[0011] In some embodiments, the lumen of the diaphragm may be aligned with the longitudinal axis of the Y-shaped adapter. In some embodiments, the outer surface of the proximal end of the diaphragm may be non-circular and may correspond to the shape of the inner surface of the housing. In some embodiments, the length of the extension tube may be less than that of the BD NEXIVA trademark closed venous catheter system or other catheter systems known in the art. In some embodiments, the length of the extension tube may be 1-4 inches, 1-3 inches, 1-2 inches, or other suitable lengths.
[0012] In some embodiments, the housing may be coupled to the needle assembly. In some embodiments, the needle assembly may include a body, a needle extending proximally from the body, and an elastomeric sheath coupled to the body and covering the needle. In some embodiments, the catheter system may include a blood collection tube retainer coupled to the body of the needle assembly. In some embodiments, the body may be integrally formed with the housing as a single unit.
[0013] In some embodiments, the catheter system may include a needle hub coupled to the proximal end of the catheter hub. In some embodiments, the needle hub may include a flashback chamber. In some embodiments, the catheter system may include a guide needle extending distally from the needle hub and through the catheter.
[0014] In some embodiments, the catheter system may include another extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end may be coupled to a second port of a Y-adapter. In some embodiments, the catheter system may include another Y-adapter coupled to the proximal end of another extension tube. In some embodiments, the catheter system may include a needleless connector coupled to a second port.
[0015] In some embodiments, another diaphragm may be disposed within the second port and may be configured to allow air passage but not blood passage. In some embodiments, a needleless connector may be coupled to the second port of a Y-adapter. In some embodiments, the needleless connector may include a distal end and a proximal end, and the catheter system may include another extension coupled to the proximal end of the needleless access connector. In some embodiments, the catheter system may include another diaphragm disposed within the first port of the Y-adapter. In some embodiments, the diaphragm may be positioned in an open position in response to needle assembly coupling to the first port.
[0016] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and not intended to limit the scope of this disclosure. It should be understood that the various embodiments are not limited to the arrangements and vascular access tools shown in the accompanying drawings. Furthermore, the drawings are not necessarily drawn to scale. It should also be understood that the various embodiments can be combined with each other. For example, one or more features of a particular vascular access device may be combined with one or more features of another particular vascular access device. It should also be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of this disclosure, unless claimed. Therefore, the following detailed description should not be construed as limiting. Attached Figure Description
[0017] Exemplary embodiments will be described and explained in additional specific detail using the accompanying drawings, in which:
[0018] Figure 1This is a top perspective view of a prior art catheter system according to some embodiments;
[0019] Figure 2 This is a top perspective view of a catheter system according to some embodiments, showing an exemplary Y-shaped adapter coupled to an exemplary needle assembly;
[0020] Figure 3 According to some embodiments Figure 2 The upper perspective view of the catheter system shows a Y-shaped adapter connected to an exemplary needleless connector;
[0021] Figure 4A According to some embodiments Figure 2 A cross-sectional view of the catheter system, showing the Y-shaped adapter connected to the needle assembly;
[0022] Figure 4B According to some embodiments Figure 2 A cross-sectional view of the catheter system shows a Y-shaped adapter and an example sliding fit connected to the needle assembly.
[0023] Figure 4C According to some embodiments Figure 2 A cross-sectional view of a portion of the conduit system, showing a Y-shaped adapter integrally formed as a single unit with the needle assembly;
[0024] Figure 5 According to some embodiments Figure 2 A partial sectional view of the Y-shaped adapter of the conduit system;
[0025] Figure 6 According to some embodiments Figure 2 Side view of the Y-shaped adapter of the conduit system;
[0026] Figure 7 It is a connection to an exemplary cap according to some embodiments. Figure 2 A three-dimensional view of the upper part of the Y-shaped adapter of the conduit system;
[0027] Figure 8 It is connected to an exemplary blood collection tube according to some embodiments. Figure 2 A three-dimensional view of the upper part of the Y-shaped adapter of the conduit system;
[0028] Figure 9 This is a top perspective view of another catheter system according to some embodiments;
[0029] Figure 10A According to some embodiments Figure 9 Upper perspective view of an exemplary diaphragm and an exemplary housing of a conduit system;
[0030] Figure 10BAccording to some embodiments Figure 9 Another upper perspective view of the diaphragm and housing of the conduit system;
[0031] Figure 10C According to some embodiments Figure 9 Cross-sectional view of the diaphragm and shell of the conduit system;
[0032] Figure 10D According to some embodiments Figure 9 A three-dimensional view of the upper part of the diaphragm of the catheter system;
[0033] Figure 10E It is along Figure 10B The line 10E-10E cut Figure 9 Cross-sectional view of the diaphragm and shell of the conduit system;
[0034] Figure 11A According to some embodiments Figure 11A The upper perspective view of an exemplary Y-shaped adapter for a conduit system shows the diaphragm in the pre-charged position;
[0035] Figure 11B According to some embodiments Figure 11A The upper perspective view of the Y-shaped adapter of the conduit system shows the diaphragm in the pre-charge position;
[0036] Figure 11C According to some embodiments Figure 11A The upper perspective view of an exemplary Y-shaped adapter for a conduit system shows the diaphragm in the pre-charged position;
[0037] Figure 11D According to some embodiments Figure 11A A top perspective view of the Y-shaped adapter of the catheter system, showing the diaphragm in an exemplary infusion position; while
[0038] Figure 11E According to some embodiments Figure 11A Another upper perspective view of the Y-shaped adapter of the catheter system, showing the diaphragm in the infusion position. Detailed Implementation
[0039] Now for reference Figure 1The prior art catheter system 10 is illustrated. The prior art catheter system 10 includes a catheter hub 12 having a side port 14 and a long extension tube 16 extending from the side port 14. A Y-shaped adapter 18 is typically positioned proximal to the long extension tube 16. A catheter 20 can extend from the catheter hub 12 and can be inserted into the patient's vascular system via a guide needle 22. After the catheter 20 is positioned within the vascular system, the guide needle 22 is removed from the prior art catheter system 10. The prior art catheter system 10, with the catheter 20 located within the vascular system, can be used for blood aspiration or fluid infusion. The long extension tube 16 can create a tortuous blood flow path and reduce blood pressure, thereby slowing blood collection time. Furthermore, the Y-shaped adapter 18 may retain blood or fluid and may not flush effectively.
[0040] Now for reference Figure 2-6 In some embodiments, the catheter system 24 may include a catheter hub 26, which may include a distal end 28, a proximal end 30, a side port 32 disposed between the distal end 28 and the proximal end 30 of the catheter hub 26, and a lumen 34 extending through the distal end 28 and the proximal end 30 of the catheter hub 26. In some embodiments, the catheter system 24 may include a catheter 36 extending distally from the distal end 28 of the catheter hub 26. In some embodiments, the catheter 36 may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, a needle hub 38 may be removably coupled to the proximal end 30 of the catheter hub 26. In some embodiments, a guide needle 40 may extend from the needle hub 38 and through the catheter 36 at an insertion position to insert the catheter system 24 into the patient's vascular system.
[0041] In some embodiments, the catheter system 24 may include a Y-adaptor 42, which may include a distal end 44, a first port 46, and a second port 48. In some embodiments, the first port 46 and / or the second port 48 may include a Luer adapter, such as a concave Luer adapter. In some embodiments, the catheter system 24 may include an extension tube 50, which may include a distal end 52 integrated with a side port 32 and a proximal end 54 integrated with the distal end 44 of the Y-adaptor 42. In some embodiments, a clamp may be disposed on the extension tube 50. In other embodiments, the extension tube 50 may not include a clamp.
[0042] In some embodiments, the Y-adapter 42 can reduce or eliminate dead space, in which blood is trapped during blood collection or fluid is trapped during infusion. Additionally, the Y-adapter can provide ventilation, which can facilitate blood collection. In some embodiments, a large angle between the first port 46 and the second port 48, such as, for example, 90° or between 60° and 90°, can reduce dead space. In some embodiments, the length of the first port 46 and / or the second port 48 can also be shortened to reduce dead space. In some embodiments, the length of the first port 46 and / or the second port 48 can be 1-2 inches or other suitable lengths, which can reduce dead space and improve flushing.
[0043] In some embodiments, the diaphragm 56 may be disposed within the second port 48 and may be configured to allow air to pass through but not fluids such as blood. For example, the outer surface of the diaphragm 56 may include one or more grooves 58 and / or the inner surface of the second port 48 may include one or more grooves. In some embodiments, the dimensions of the grooves 58 and / or the grooves on the inner surface may allow air to pass through but not fluids.
[0044] In some embodiments, the needleless connector 60 may be coupled to the second port 48 of the Y-adapter 42. In some embodiments, the needleless connector 60 may be coupled to the second port 48 after blood collection is completed. In some embodiments, the needleless connector 60 may include a first end 62 and a second end 64, and the catheter system 24 may include another extension tube coupled to the second end 64 of the needleless connector 60.
[0045] In some embodiments, the catheter system 24 may include another diaphragm 66 disposed within the first port 46 of the Y-adapter 42. In some embodiments, the other diaphragm 66 may be positioned in an open position in response to the needle assembly 68 being coupled to the first port 46, for example as... Figures 4A-4B As shown. In some embodiments, the needle assembly 68 may include a body 70, a needle 72 extending proximally from the body 70, and an elastomeric sheath 74 coupled to the body 70 and covering the needle 72. In some embodiments, the needle assembly 68 may include a Luer adapter, such as a convex Luer adapter, which may be coupled to the first port 46. In some embodiments, the Luer adapter may be threaded (e.g., see...). Figure 4A ) or sliding fit (e.g., see Figure 4B In some embodiments, the needle assembly 68 may be pre-attached to the catheter system 24 in the kit. In some embodiments, the body 70 may be integrally formed as a single unit with the housing, for example, as shown in the figure. Figure 4C As shown. In some embodiments, after blood collection is complete, the needle assembly 68 can be removed and replaced with a Luer adapter.
[0046] In some embodiments, the catheter system 24 may include a blood collection tube retainer 76 coupled to the body 70 of the needle assembly 68, for example, Figure 8 As shown. In some embodiments, the blood collection tube retainer 76 may be coupled to the body 70 of the needle assembly 68 via one or more threads or other suitable means. In some embodiments, the blood collection tube retainer 76 may be configured to receive a blood collection tube. In response to pressure on the blood collection tube within the blood collection tube retainer 76, the needle 72 may pierce the elastomeric sheath 74 and the cap of the blood collection tube to provide fluid communication between the catheter system 24 and the blood collection tube.
[0047] In some embodiments, during blood collection, blood may flow proximally through catheter 36, catheter hub 26, extension tube 50, Y-adapter 42, and needle assembly 68. In some embodiments, blood collection may be performed while catheter 36 is inserted into the vascular system and / or after catheter 36 has remained within the vascular system due to diaphragm 66 being engaged by needle assembly 68. In some embodiments, after catheter 36 has been inserted into the vascular system, needleless connector 60 may prevent contamination prior to a later blood collection event. In some embodiments, needle assembly 68 further includes a cap 78 disposed on an elastomeric sheath 74, such as... Figure 7 As shown, this can prevent contamination.
[0048] Now for reference Figure 9-1 1. The catheter system 80 may include a catheter hub 26, which may include a distal end 28, a proximal end 30, a side port 32 disposed between the distal end 28 and the proximal end 30 of the catheter hub 26, and a lumen 34 extending through the distal end 28 and the proximal end 30 of the catheter hub 26. In some embodiments, the catheter system 24 may include a catheter 36 extending distally from the distal end 28 of the catheter hub 26. In some embodiments, the catheter 36 may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter system 80 may be similar to or identical to the catheter system 24 in terms of one or more of the included features and / or operations.
[0049] In some embodiments, the needle hub 38 may be removably coupled to the proximal end 30 of the catheter hub 26. In some embodiments, the guide needle 40 may extend from the needle hub 38 and through the catheter 36 at an insertion position to insert the catheter system 24 into the patient's vascular system.
[0050] In some embodiments, the catheter system 80 may include a Y-adapter 82, which may include a distal end 84, a first port 86, and a second port 88. In some embodiments, the first port 86 and / or the second port 88 may include a Luer adapter, such as a concave Luer adapter. In some embodiments, the catheter system 80 may include an extension tube 50, which may include a distal end 52 integrated with a side port 32 and a proximal end 54 integrated with the distal end 84 of the Y-adapter 82. In some embodiments, a clamp may be disposed on the extension tube 50. In other embodiments, the extension tube 50 may not include a clamp.
[0051] In some embodiments, the Y-shaped adapter 82 may include a diaphragm 90 disposed within the Y-shaped adapter 82. In some embodiments, the diaphragm 90 may include one or more of the following: a distal end 92, a proximal end 94, a lumen 96 extending through the distal end 92 of the diaphragm 90, a side opening 98 in fluid communication with the lumen 96 of the diaphragm 90, and a vent 100 extending from the proximal end 94 of the diaphragm 90. In some embodiments, the diaphragm 90 may, for example... Figure 11A-11B The precharge position shown and, for example Figure 11D-11E The infusion position can be moved between the indicated positions. In some embodiments, in response to the diaphragm 90 being in the pre-charged position, the vent 100 can be aligned with the side port 32.
[0052] In some embodiments, the conduit system 80 may include another extension tube 102, which may include a distal end 104 and a proximal end 106. In some embodiments, the distal end 104 may be coupled to a second port 88 of a Y-adapter 82. In some embodiments, the conduit system 80 may include another Y-adapter 108 coupled to the proximal end 106 of the other extension tube 102. In some embodiments, the conduit system 80 may include a needleless connector 60 coupled to the second port 88. In some embodiments, when the diaphragm 90 is in the pre-charge position, one or more of the following may be pre-charged: the other extension tube 102, the other Y-adapter 108, and the needleless connector 60 may be pre-charged with a pre-charge solution, such as saline. In some embodiments, the vent 100 may facilitate the movement of air from the other extension tube 102 to the external environment. In some embodiments, in response to the diaphragm 90 being in the pre-charge position, air may flow through the vent 100 and enter the external environment. In some embodiments, the vent 100 may extend to the proximal side of the proximal end 106 of the Y-shaped adapter 82, or there may be a small space between the inner surface of the Y-shaped adapter 82 and the outer surface of the diaphragm 90 proximal to the vent 100, and this small space may allow air to pass through to the external environment.
[0053] In some embodiments, in response to the diaphragm 90 being in the infusion position, the side opening 98 may be aligned with the side port 32. Thus, fluid can flow from another extension tube 102 through the side opening 98 out of the distal end 92 of the diaphragm 90, through the extension tube 50, and through the catheter hub 26 and catheter 36 into the patient's vascular system.
[0054] In some embodiments, the diaphragm 90 may be coupled to a housing 110, which extends from the proximal end 106 of the Y-adapter 108. In some embodiments, the Y-adapter 108 may include a slot 112 disposed around a portion of the circumference of the Y-adapter 108. In some embodiments, the slot 112 may include a notch 114. In some embodiments, the housing 110 may include a protrusion 116. In some embodiments, the protrusion 116 may be disposed within the notch 114 in response to the diaphragm 90 being in a pre-charged position. In some embodiments, the distal end of the housing 110 contacts a stepped surface of the diaphragm 90 to facilitate movement of the diaphragm 90 in response to movement of the housing 110.
[0055] In some embodiments, slot 112 may include another recess 118. In some embodiments, recess 114 and the other recess 118 may be located at opposite ends of slot 112. In some embodiments, in response to diaphragm 90 moving from pre-charge position to infusion position, housing 110 may move distally, and protrusion 116 may slide along slot 112. In some embodiments, in response to diaphragm 90 being in infusion position, protrusion 116 may be located within another recess 118.
[0056] In some embodiments, the lumen 96 of the diaphragm 90 may be aligned with the longitudinal axis 120 of the Y-shaped adapter. In some embodiments, the outer surface of the proximal end 94 of the diaphragm 90 may be non-circular and may correspond to the shape of the inner surface of the housing 110.
[0057] In some embodiments, the housing 110 may be coupled to the needle assembly 68. In some embodiments, the needle assembly 68 may include a body 70, a needle 72 extending proximally from the body 70, and an elastomeric sheath 74 coupled to the body 70 and covering the needle 72. In some embodiments, the catheter system 80 may include a blood collection tube retainer coupled to the body of the needle assembly 68, for example, such as... Figure 8 As shown. In some embodiments, the body 70 may be integrally formed with the housing 110 as a single unit.
[0058] In some embodiments, catheter system 80 may include a needle hub 38 coupled to the proximal end 30 of catheter hub 26. In some embodiments, needle hub 38 may include a flashback chamber. In some embodiments, catheter system 24 may include a guide needle 40 extending distally from needle hub 38 and through catheter 20.
[0059] All examples and conditional language described herein are for educational purposes, intended to help the reader understand the invention and the concepts contributed by the inventors to advance the art, and are to be interpreted as not being limited to these specifically enumerated examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.
Claims
1. A catheter system comprising: A catheter hub includes a distal end, a proximal end, a side port disposed between the distal end and the proximal end of the catheter hub, and a lumen extending through the distal end and the proximal end of the catheter hub. A catheter extending distally from the distal end of the catheter hub; A Y-shaped adapter, comprising a remote end, a first port, and a second port; An extension tube comprising a distal end integrated with the side port and a proximal end integrated with the distal end of the Y-shaped adapter; and A diaphragm disposed within the Y-shaped adapter, wherein the diaphragm includes a distal end, a proximal end, a lumen extending through the distal end of the diaphragm, a side opening in fluid communication with the lumen of the diaphragm, and a vent extending from the proximal end of the diaphragm, wherein the diaphragm is movable between a pre-charge position and an infusion position, wherein in response to the diaphragm being in the pre-charge position, the vent is aligned with a second port, and wherein in response to the diaphragm being in the infusion position, the side opening is aligned with the second port.
2. The catheter system according to claim 1, wherein, The diaphragm is coupled to a housing that extends from the proximal end of the Y-shaped adapter, wherein the Y-shaped adapter further includes a slot disposed around a portion of the circumference of the Y-shaped adapter, wherein the slot includes a notch, wherein the housing includes a protrusion, wherein the protrusion is disposed within the notch in response to the diaphragm being in a pre-charged position, wherein the housing moves distally in response to the diaphragm moving from the pre-charged position to the infusion position, and the protrusion slides along the slot.
3. The catheter system according to claim 2, wherein, The outer surface of the proximal end of the diaphragm is non-circular and corresponds to the shape of the inner surface of the housing.
4. The catheter system of claim 2, wherein the housing is coupled to the needle assembly, wherein the needle assembly includes a body, a needle extending proximally from the body, and an elastomeric sheath coupled to the body and covering the needle.
5. The catheter system of claim 4, further comprising a blood collection tube retainer coupled to the body of the needle assembly.
6. The catheter system according to claim 4, wherein, The main body and the shell are integrally formed into a single unit.
7. The catheter system of claim 1, further comprising: A needle hub connected to the proximal end of the catheter hub, wherein the needle hub includes a flashback chamber; and A guide needle that extends distally from the needle hub and passes through the catheter.
8. The catheter system of claim 1, further comprising: Another extension tube includes a distal end and a proximal end, wherein the distal end is coupled to the second port of the Y-shaped adapter; and Another Y-shaped adapter is attached to the proximal end of the other extension tube.
9. The catheter system of claim 1, further comprising a needleless connector coupled to the second port.
10. The catheter system according to claim 1, wherein, The lumen of the diaphragm is aligned with the longitudinal axis of the Y-shaped adapter.
11. The catheter system of claim 1, wherein the diameter of the distal end of the septum is greater than the diameter of the proximal end of the septum, and the septum includes a stepped surface.
12. The catheter system according to claim 11, wherein, The diaphragm is coupled to the housing, which extends from the proximal end of the Y-shaped adapter, wherein the vent is linear and extends proximally to a stepped surface, wherein the distal end of the housing contacts the stepped surface.