Vascular Access Instruments and Related Devices and Methods

Abstract

The catheter system 80 can include a catheter hub having a distal end, a proximal end, and a side port disposed between the distal end of the catheter hub and the proximal end of the catheter hub; a catheter 36 extending distally from the distal end of the catheter hub; a Y-adapter 82 having a distal end 84, a first port 86, and a second port 88; an extension tube 50 having a distal end integrated with the side port and a proximal end integrated with the distal end of the Y-adapter; and a septum disposed within the Y-adapter, the septum including a vent.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to vascular access instruments and related devices and methods. [Background technology]

[0002] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse normal saline, various medications, or total parenteral nutrition. Catheters may also be used to withdraw blood from a patient.

[0003] The catheter may include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter may be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle pointing upward, away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0004] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the clinician typically confirms that blood "flashback" is present within the flashback chamber of the catheter assembly. After needle placement is confirmed, the clinician can temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid injection.

[0005] Blood collection using a catheter can be difficult for several reasons, especially when the catheter's indwelling time in the vasculature exceeds one day. When a catheter remains inserted within a patient's body for an extended period of time, the catheter or vein may become more susceptible to narrowing, collapse, kinking, blockage by detachments (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. As a result, while catheters are often used to obtain blood samples at the time of catheter placement, catheters are less frequently used to obtain blood samples during the catheterization period. Thus, when a blood sample is required, an additional needle stick is often used to provide venous access for blood collection, which can be painful for the patient and can result in higher material costs.

[0006] In some cases, to avoid additional needle sticks, a vascular access device can be used to access a patient's vascular system through a catheter. The vascular access device can be inserted through the catheter into the vascular system to extend the life of the catheter and allow blood withdrawal through the catheter without additional needle sticks.

[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 only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0008] FIELD OF THE DISCLOSURE The present disclosure relates generally to vascular access devices, systems, and methods. More particularly, the present disclosure relates to catheter systems and related devices and methods. In some embodiments, the catheter system can include a catheter hub, which can include a distal end, a proximal end, a side port disposed between the distal end of the catheter hub and the proximal end of the catheter hub, and a lumen extending through the distal end of the catheter hub and the proximal end of the catheter hub. In some embodiments, the catheter system can include a catheter extending distally from the distal end of the catheter hub.

[0009] In some embodiments, the catheter system can include a Y-adapter, the Y-adapter including a distal end, a first port, and a second port. In some embodiments, the catheter system can include an extension tube, the extension tube including a distal end integrated with the side port and a proximal end integrated with the distal end of the Y-adapter. In some embodiments, the catheter system can include a septum disposed within the Y-adapter. In some embodiments, the septum can include a distal end, a proximal end, a lumen extending through the distal end of the septum, a side opening in fluid communication with the lumen of the septum, and a vent extending from the proximal end of the septum. In some embodiments, the septum can be movable between a priming position and an infusion position. In some embodiments, the vent is configured to: Second In some embodiments, in response to the septum being in the injection position, the side opening may be aligned with Second It may be aligned with the port.

[0010] In some embodiments, the septum can be coupled to a housing extending out from the proximal end of the Y-adapter. In some embodiments, the Y-adapter can include a slot disposed around a portion of the circumference of the Y-adapter. In some embodiments, the slot can include a notch. In some embodiments, the housing can include a protrusion. In some embodiments, the protrusion can be disposed within the notch in response to the septum being in the priming position. In some embodiments, in response to the septum being moved from the priming position to the injection position, the housing can be moved distally and the protrusion can slide along the slot.

[0011] In some embodiments, the lumen of the septum can be aligned with the longitudinal axis of the Y-adapter. In some embodiments, the outer surface of the proximal end of the septum can be non-circular and correspond to the shape of the inner surface of the housing. In some embodiments, the length of the extension tube can be shorter than that of the BD NEXIVA™ Closed IV Catheter System or other catheter systems known in the art. In some embodiments, the length of the extension tube can be 1 inch (2.54 cm) to 4 inches (10.16 cm), 1 inch (2.54 cm) to 3 inches (7.62 cm), 1 inch (2.54 cm) to 2 inches (5.08 cm), or another suitable length.

[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 holder coupled to the body of the needle assembly. In some embodiments, the body may be monolithically formed as an integral unit with the housing.

[0013] In some embodiments, the catheter system can include a needle hub coupled to the proximal end of the catheter hub. In some embodiments, the needle hub can include a flashback chamber. In some embodiments, the catheter system can include an introducer needle extending through the catheter distally from the needle hub.

[0014] In some embodiments, the catheter system can include another extension tube. The another extension tube can include a distal end and a proximal end. In some embodiments, the distal end can be coupled to a second port of the Y-adapter. In some embodiments, the catheter system can include another Y-adapter coupled to a proximal end of the another extension tube. In some embodiments, the catheter system can include Another Y adapter The needleless connector may include a needleless connector coupled to the

[0015] In some embodiments, another septum may be disposed within the second port and may be configured to allow air to pass through but not blood. In some embodiments, a needleless connector may be coupled to the second port of the Y-adapter. In some embodiments, the needleless connector may include a distal end and a proximal end, and the catheter system may include a needleless connector. Needle In some embodiments, the catheter system may include a separate extension tube coupled to the proximal end of the connector. In some embodiments, the catheter system may include a separate septum disposed within the first port of the Y-adapter. In some embodiments, the septum may be disposed in an open position in response to the needle assembly being coupled to the first port.

[0016] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure as claimed. It is to be understood that the various embodiments are not limited to the arrangements and vascular access devices illustrated in the figures. Also, the figures are not necessarily to scale. It is also to be understood that embodiments may be combined. 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 is also to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the various embodiments of the present disclosure, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0017] The exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying figures.

[0018] [Figure 1] FIG. 1 is a top perspective view of a prior art catheter system, according to some embodiments. [Figure 2] FIG. 1 is a top perspective view of a catheter system showing an exemplary Y-adapter coupled to an exemplary needle assembly, according to some embodiments. [Figure 3] FIG. 3 is a top perspective view of the catheter system of FIG. 2 showing an exemplary Y-adapter coupled to an exemplary needleless connector, according to some embodiments. [Figure 4A] 3 is a cross-sectional view of the catheter system of FIG. 2 showing a Y-adapter coupled to a needle assembly, according to some embodiments. [Figure 4B] 3 is a cross-sectional view of the catheter system of FIG. 2 showing a Y-adapter coupled to a needle assembly and an exemplary slip fit, according to some embodiments. [Figure 4C]3 is a cross-sectional view of a portion of the catheter system of FIG. 2 showing a Y-adapter monolithically formed as an integral unit with a needle assembly, according to some embodiments. [Figure 5] FIG. 3 is a partial cutaway view of a Y-adapter of the catheter system of FIG. 2, according to some embodiments. [Figure 6] FIG. 3 is a side view of a Y-adapter of the catheter system of FIG. 2, according to some embodiments. [Figure 7] FIG. 3 is a top perspective view of a Y-adapter of the catheter system of FIG. 2 coupled to an exemplary cap, according to some embodiments. [Figure 8] FIG. 3 is a top perspective view of a Y-adapter of the catheter system of FIG. 2 coupled to an exemplary blood collection tube, according to some embodiments. [Figure 9] FIG. 1 is a top perspective view of another catheter system, according to some embodiments. [Figure 10A] FIG. 10 is a top perspective view of an exemplary septum and an exemplary housing of the catheter system of FIG. 9, according to some embodiments. [Figure 10B] FIG. 10 is another top perspective view of the septum and housing of the catheter system of FIG. 9, according to some embodiments. [Figure 10C] FIG. 10 is a cross-sectional view of a septum and housing of the catheter system of FIG. 9, according to some embodiments. [Figure 10D] FIG. 10 is a top perspective view of a septum of the catheter system of FIG. 9, according to some embodiments. [Figure 10E] 10E is a cross-sectional view of the septum and housing of the catheter system of FIG. 9 taken along line 10E-10E of FIG. 10B. [Figure 11A] FIG. 11B is a top perspective view of an exemplary Y-adapter of the catheter system of FIG. 11A showing the septum in a priming position, according to some embodiments. [Figure 11B] FIG. 11B is a top perspective view of the Y-adapter of the catheter system of FIG. 11A showing the septum in a priming position, according to some embodiments. [Figure 11C] FIG. 11B is a top perspective view of an exemplary Y-adapter of the catheter system of FIG. 11A showing the septum in a priming position, according to some embodiments. [Figure 11D] FIG. 11B is a top perspective view of the Y-adapter of the catheter system of FIG. 11A showing the septum in an exemplary injection position, according to some embodiments. [Figure 11E] FIG. 11B is another top perspective view of the Y-adapter of the catheter system of FIG. 11A showing the septum in an injection position, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0019] Referring now to FIG. 1 , a prior art catheter system 10 is shown. The prior art catheter system 10 includes a catheter hub 12 with a side port 14 and a long extension tube 16 extending from the side port 14. A Y-adapter 18 is often disposed at the proximal end of the long extension tube 16. A catheter 20 can extend from the catheter hub 12 and be inserted into a patient's vascular system via an introducer needle 22, which is detached from the prior art catheter system 10 after the catheter 20 is positioned within the vascular system. The prior art catheter system 10 with the catheter 20 positioned within the vascular system can be used for blood withdrawal or fluid injection. The long extension tube 16 can create a tortuous blood flow path, lowering blood pressure and slowing blood withdrawal times. Additionally, the Y-adapter 18 can retain blood or fluid and not flush well.

[0020] 2-6 , in some embodiments, the catheter system 24 can include a catheter hub 26 having a distal end 28, a proximal end 30, a side port 32 disposed between the distal end 28 of the catheter hub 26 and the proximal end 30 of the catheter hub 26, and a lumen 34 extending through the distal end 28 of the catheter hub 26 and the proximal end 30 of the catheter hub 26. In some embodiments, the catheter system 24 can include a catheter 36 extending distally from the distal end 28 of the catheter hub 26. In some embodiments, the catheter 36 can include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, a needle hub 38 can be removably coupled to the proximal end 30 of the catheter hub 26. In some embodiments, an introducer needle 40 can extend from the needle hub 38 through the catheter 36 at an insertion position to insert the catheter system 24 into the patient's vascular system.

[0021] In some embodiments, the catheter system 24 can include a Y-adapter 42, which can 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 can include a luer adapter, such as a female luer adapter. In some embodiments, the catheter system 24 can include an extension tube 50, which can include a distal end 52 integrated with the side port 32 and a proximal end 54 integrated with the distal end 44 of the Y-adapter 42. In some embodiments, a clamp can be disposed on the extension tube 50. In other embodiments, the extension tube 50 need not include a clamp.

[0022] In some embodiments, the Y-adapter 42 can reduce or eliminate dead space where blood can become trapped during blood draw or fluid can become trapped during injection. Additionally, the Y-adapter can provide venting, thereby facilitating blood draw. In some embodiments, a large angle between the first port 46 and the second port 48, such as 90° or an angle 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 inch (2.54 cm) to 2 inches (5.08 cm), or another suitable length, thereby reducing dead space and improving flushing.

[0023] In some embodiments, a septum 56 may be disposed within the second port 48 and may be configured to impermeable to air but not to fluids, such as blood. For example, the outer surface of the septum 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 for impermeability to air but not to fluids.

[0024] In some embodiments, a needleless connector 60 can be coupled to the second port 48 of the Y-adapter 42. In some embodiments, the needleless connector 60 can be coupled to the second port 48 after blood collection is completed. In some embodiments, the needleless connector 60 can include a first end 62 and a second end 64, and the catheter system 24 can include another extension tube coupled to the second end 64 of the needleless connector 60.

[0025] In some embodiments, the catheter system 24 may include another septum 66 disposed within the first port 46 of the Y adapter 42. In some embodiments, the other septum 66 may be disposed in an open position in response to a needle assembly 68 being coupled to the first port 46, as shown, for example, in FIGS. 4A-4B . 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 male luer adapter, that may be coupled to the first port 46. In some embodiments, the luer adapter may be threaded (see, for example, FIG. 4A ) or snug-fit (see, for example, FIG. 4B ). In some embodiments, the needle assembly 68 may be pre-attached to the catheter system 24 in a kit. In some embodiments, the body 70 may be monolithically formed as an integral unit with the housing, as shown, for example, in FIG. 4C . In some embodiments, needle assembly 68 may be removed and replaced with a luer connector after blood collection is completed.

[0026] In some embodiments, the catheter system 24 may include a blood collection tube holder 76 coupled to the body 70 of the needle assembly 68, as shown, for example, in FIG. 8 . In some embodiments, the blood collection tube holder 76 may be coupled to the body 70 of the needle assembly 68 via one or more threads or another suitable means. In some embodiments, the blood collection tube holder 76 may be configured to receive a blood collection tube. In response to depression of the blood collection tube within the blood collection tube holder 76, the needle 72 may penetrate 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.

[0027] In some embodiments, during blood collection, blood can flow proximally through the catheter 36, catheter hub 26, extension tubing 50, Y-adapter 42, and needle assembly 68. In some embodiments, blood collection can occur by the needle assembly 68 accessing the septum 66 when the catheter 36 is inserted into the vasculature and / or later while the catheter 36 is indwelling within the vasculature. In some embodiments, the needleless connector 60 can prevent contamination after the catheter 36 is inserted into the vasculature and before a subsequent blood collection. In some embodiments, the needle assembly 68 further includes a cap 78 disposed on the elastomeric sheath 74, which can prevent contamination, as shown, for example, in FIG. 7 .

[0028] 9-11 , a catheter system 80 can include a catheter hub 26 that can include a distal end 28, a proximal end 30, a side port 32 disposed between the distal end 28 of the catheter hub 26 and the proximal end 30 of the catheter hub 26, and a lumen 34 extending through the distal end 28 of the catheter hub 26 and the proximal end 30 of the catheter hub 26. In some embodiments, the catheter system 80 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 intravenous 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 with respect to one or more included features and / or operation.

[0029] In some embodiments, the needle hub 38 may be removably coupled to the proximal end 30 of the catheter hub 26. In some embodiments, an introducer needle 40 extends from the needle hub 38 through the catheter 36 in the insertion position to provide a catheter system 80 can be inserted into the patient's vascular system.

[0030] In some embodiments, the catheter system 80 can include a Y-adapter 82. The Y-adapter 82 has a distal end 84, a first port 88 , and the second port 86 In some embodiments, the first port 88 and / or a second port 86 may include a luer adapter, such as a female luer adapter. In some embodiments, the catheter system 80 may include an extension tube 50 having a distal end 52 integrated with the 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.

[0031] In some embodiments, the Y-adapter 82 may include a septum 90 disposed within the Y-adapter 82. In some embodiments, the septum 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 septum 90, a side opening 98 in fluid communication with the lumen 96 of the septum 90, and a vent 100 extending from the proximal end 94 of the septum 90. In some embodiments, the septum 90 may be movable between a priming position, as shown, for example, in FIGS. 11A-11B, and an injection position, as shown, for example, in FIGS. 11D-11E. In some embodiments, in response to the septum 90 being in the priming position, the vent 100 Second port 86 may be aligned with

[0032] In some embodiments, the catheter system 80 can include another extension tube 102. The another extension tube 102 can include a distal end 104 and a proximal end 106. In some embodiments, the distal end 104 can be connected to a second port of the Y-adapter 82. 86In some embodiments, the catheter system 80 may include another Y-adapter 108 coupled to the proximal end 106 of another extension tube 102. In some embodiments, the catheter system 80 may include Another Y-adapter 108 The septum 90 may include a needleless connector 60 coupled to the proximal end of the Y-adapter 82. In some embodiments, one or more of the following: the further extension tube 102, the other Y-adapter 108, and the needleless connector 60 may be primed with a priming solution, such as saline, when the septum 90 is in the priming position. In some embodiments, the vent 100 may facilitate the movement of air from the further extension tube 102 to the external environment. In some embodiments, in response to the septum 90 being in the priming position, air may flow through the vent 100 into the external environment. In some embodiments, the vent 100 may be (not shown) or there may be a small space between the inner surface of the Y-adapter 82 and the outer surface of the septum 90 proximal to the vent 100, which may allow air to pass to the external environment.

[0033] In some embodiments, in response to the septum 90 being in the injection position, the side opening 98 Second port 86 Thus, fluid can flow from another extension tube 102, through the side opening 98, out the distal end 92 of the septum 90, through the extension tube 50, through the catheter hub 26 and catheter 36, and into the patient's vasculature.

[0034] In some embodiments, the septum 90 is a Y-adapter. 82 The proximal end of (not shown) In some embodiments, the Y-adapter may be coupled to a housing 110 extending outwardly from the Y-adapter. 82 Y-shaped adapter 82The housing 110 may include a slot 112 disposed around a portion of the circumference of the septum 90. 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 septum 90 being in the priming position. In some embodiments, the distal end of the housing 110 contacts a stepped surface on the septum 90 to facilitate movement of the septum 90 in response to movement of the housing 110.

[0035] In some embodiments, slot 112 may include another notch 118. In some embodiments, notch 114 and another notch 118 may be disposed at opposite ends of slot 112. In some embodiments, housing 110 may be moved distally in response to septum 90 being moved from the priming position to the injection position, and protrusion 116 may slide along slot 112. In some embodiments, protrusion 116 may be disposed within another notch 118 in response to septum 90 being in the injection position.

[0036] In some embodiments, the lumen 96 of the septum 90 is aligned with the longitudinal axis of the Y-adapter. (not shown) In some embodiments, the outer surface of the proximal end 94 of the septum 90 may be non-circular and may correspond to the shape of the inner surface of the housing 110.

[0037] 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 holder coupled to the body of the needle assembly 68, as shown, for example, in FIG. 8. In some embodiments, the body 70 may be monolithically formed as an integral unit with the housing 110.

[0038] In some embodiments, the catheter system 80 can include a needle hub 38 coupled to the proximal end 30 of the catheter hub 26. In some embodiments, the needle hub 38 can include a flashback chamber. In some embodiments, the catheter system 80 catheter distal to the needle hub 38 36 The catheter may include an introducer needle 40 extending therethrough.

[0039] All examples and conditional language recited herein are intended for educational purposes to aid the reader in understanding the invention and concepts provided by the inventors to further the art, and are not to be construed as being limited to such examples and conditions specifically recited. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations could be made thereto without departing from the spirit and scope of the invention.

Claims

1. 1. A catheter system comprising: a catheter hub having a distal end, a proximal end, a side port disposed between the distal end and the proximal end, and a lumen extending through the distal end and the proximal end; a catheter extending distally from the distal end of the catheter hub; a Y-adapter having a distal end, a first port, and a second port; an extension tube having a distal end integrated with the side port and a proximal end integrated with the distal end of the Y-adapter; a septum disposed within the Y-adapter, the septum comprising a distal end, a proximal end, a lumen extending through the distal end of the septum, a side opening in fluid communication with the lumen of the septum, and a vent extending from the proximal end of the septum, the septum being movable between a priming position and an injection position, wherein the vent is aligned with the second port in response to the septum being in the priming position, and the side opening is aligned with the second port in response to the septum being in the injection position; A catheter system comprising:

2. 2. The catheter system of claim 1, wherein the septum is coupled to a housing extending outward from a proximal end of the Y-shaped adapter, the Y-shaped adapter further comprising a slot disposed around a portion of a circumference of the Y-shaped adapter, the slot comprising a notch, and the housing comprising a protrusion, the protrusion being disposed within the notch in response to the septum being in the priming position, and the housing being moved distally and the protrusion sliding along the slot in response to the septum being moved from the priming position to the injection position.

3. The catheter system of claim 2 , wherein the outer surface of the proximal end of the septum is non-circular and corresponds to the shape of the inner surface of the housing.

4. 3. The catheter system of claim 2, wherein the housing is coupled to a needle assembly, the needle assembly comprising 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 holder coupled to the body of the needle assembly.

6. The catheter system of claim 4 , wherein the body is monolithically formed as an integral unit with the housing.

7. a needle hub coupled to the proximal end of the catheter hub, the needle hub comprising a flashback chamber; an introducer needle extending through the catheter distally from the needle hub; The catheter system of claim 1 further comprising:

8. another extension tube having a distal end and a proximal end, the distal end coupled to the second port of the Y-adapter; and another Y-adapter coupled to the proximal end of the another extension tube; The catheter system of claim 1 further comprising:

9. The catheter system of claim 1 , further comprising a needleless connector coupled to the second port.

10. The catheter system of claim 1 , wherein the lumen of the septum is aligned with the longitudinal axis of the Y-adapter.

11. The catheter system of claim 1 , wherein the distal end of the septum comprises a larger diameter than the proximal end of the septum, and the septum comprises a stepped surface.

12. 12. The catheter system of claim 11, wherein the septum is coupled to a housing extending outward from a proximal end of the Y-adapter, the vent is linear and extends distally to the stepped surface, and the distal end of the housing contacts the stepped surface.

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