Catheter vent assembly and related systems and methods

Abstract

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. The catheter system may include a vent 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 component 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 movement of the proximal component from a proximal position to a distal position relative to the distal component, the male luer of the male luer adapter may open a valve to vent air within the catheter system.

Description

Background Art

[0001] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to inject fluids such as saline, various drugs, and total parenteral nutrition into a patient. Also, a catheter can be used to draw blood from a patient.

[0002] A common type of catheter is the over-the-needle peripheral intravenous catheter ("PIVC"). As its name implies, the over-the-needle PIVC may be mounted on an introducer needle having a sharp distal tip. The PIVC and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing away from the patient's skin. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0003] To verify proper placement of the introducer needle and / or PIVC in a blood vessel, a clinician generally confirms that there is a "flashback" of blood in the flashback chamber of the PIVC assembly. Once the needle placement is confirmed, the clinician may temporarily occlude the flow within the vasculature, withdraw the introducer needle, and leave the PICV in place for subsequent blood sampling or transfusion. The PIVC assembly may be coupled to an extension set, which may allow for the coupling of an injection or blood sampling device at a location removed from the insertion site of the PIVC.

[0004] In some instances, a catheter used for fluid infusion may be prepared prior to insertion into a patient's vasculature to remove air. If air bubbles are allowed to enter the patient's vasculature, an embolism may form, which could cause significant harm to the patient.

[0005] The subject matter claimed in this specification is not limited to embodiments that solve any disadvantages or that operate only in the environments described above. Rather, this background is provided only to illustrate an example of a technical area where some of the embodiments described in this specification may be practiced.

Summary of the Invention

Means for Solving the Problems

[0006] In some embodiments, the catheter system may include a catheter assembly and a needle assembly coupled to the catheter assembly. In some embodiments, the needle assembly may include a needle hub and an introducer needle. In some embodiments, the proximal end of the introducer needle may be fixed within the needle hub.

[0007] In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end and a proximal end. In some embodiments, the catheter adapter may 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 may include an extension tube extending from and / or integrated within the side port. In some embodiments, an adapter, such as a Y adapter or a T adapter, may be coupled to the extension tube.

[0008] In some embodiments, the catheter assembly may include a catheter that may extend from the distal end of the catheter adapter and may be fixed within the catheter adapter. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.

[0009] In some embodiments, the introducer needle may extend through the catheter. In some embodiments, in response to the introducer needle and / or catheter being inserted into the patient's vasculature, the introducer needle may be withdrawn proximally from the catheter and removed from the catheter assembly. In some embodiments, the catheter may be retained within the patient's vasculature for blood sampling and / or fluid infusion.

[0010] 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 the catheter assembly. In some embodiments, the distal end of the needleless connector may be coupled to an adapter.

[0011] In some embodiments, the catheter system may include a vent assembly that may include a proximal component and a distal component. In some embodiments, the proximal component may include a male luer adapter, which may include a male luer. In some embodiments, the distal component may include a distal end that may be coupled to the proximal end of the needleless connector. In some embodiments, the distal component may include a proximal end that may be coupled to the male luer adapter. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position relative to the distal component, the male luer of the male luer adapter may open the valve.

[0012] In some embodiments, the male luer adapter may include a first thread set. In some embodiments, the distal end of the distal component may include a second thread set. In some embodiments, the first thread set may be arranged in a direction different from that of the second thread set. For example, the first thread set may be a left-handed thread, and the second thread set may be a right-handed thread. Thus, by further screwing the proximal component into the distal component, the possibility of unscrewing the distal component from the needleless connector can be reduced in response to the movement of the proximal component from the proximal position to the distal position.

[0013] In some embodiments, the outer surface of the distal component may include a third thread set. In some embodiments, the third thread set may be in the same direction as the first thread set so that the proximal component and the distal component can be screwed together. For example, the third thread set may be left-handed.

[0014] In some embodiments, the outer surface of the needleless connector may include a fourth thread set. In some embodiments, the fourth thread set may be in the same direction as the second thread set so that the needleless connector and the distal component can be screwed together. For example, the fourth thread set may be right-handed.

[0015] 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 proximal to the second protrusion. In some embodiments, in response to the 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.

[0016] In some embodiments, the outer surface of the distal component may include a channel. In some embodiments, the second and third protrusions may be disposed within the channel. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the first protrusion may move proximally within the channel. Thus, in some embodiments, the channel may provide alignment of the proximal component relative to the distal component.

[0017] In some embodiments, the proximal component may include a male luer, a proximal protrusion extending from the male luer, and a distal protrusion 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 protrusion. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the proximal protrusion may move distally relative to the other protrusion. In some embodiments, in response to the proximal component being in the proximal position, the distal protrusion may be distal relative to the other protrusion and the proximal protrusion may be proximal relative to the other protrusion.

[0018] In some embodiments, the method may include actuating a vent assembly that can be coupled to a needleless connector. In some embodiments, actuating the vent assembly may include moving a proximal component from a proximal position to a distal position, which may open a valve. In some embodiments, the method may include priming the catheter assembly after actuating the vent assembly, which may allow for removal of air through a path extending through the needleless connector, the distal component, and the proximal component. In some embodiments, the method may include inserting the catheter assembly into a patient's vasculature after priming the catheter assembly. In some embodiments, the method may include inserting the catheter assembly into a patient's vasculature and priming the catheter assembly with blood. In some embodiments, the catheter assembly may be primed with blood in response to inserting the catheter assembly into the vasculature. In some embodiments, after inserting the catheter assembly into the vasculature and priming the catheter assembly with blood, blood may be flashbacked into the vasculature.

[0019] It should be understood that both the foregoing summary description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It should also be understood that the embodiments may be combined, or other embodiments may be used, and that structural changes may be made without departing from the scope of the various embodiments of the invention unless so claimed. Accordingly, the following detailed description should not be construed in a limiting sense.

[0020] Exemplary embodiments are described and explained in more specific and detailed manner by using the accompanying drawings.

Brief Description of the Drawings

[0021]

Figure 1

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Figure 5D

Figure 5E

[0022] Referring now to FIG. 1, in some embodiments, the catheter system 10 may include a catheter assembly 12 and a needle assembly 14 coupled to the catheter assembly 12. In some embodiments, the needle assembly 14 may include a needle hub 16 and an introducer needle 18. In some embodiments, the proximal end of the introducer needle 18 may be fixed within the needle hub 16.

[0023] In some embodiments, the catheter assembly 12 may include a catheter adapter 20, which may include a distal end 22 and a proximal end 24. In some embodiments, the catheter adapter 20 may include a side port 26 disposed between the distal end 22 and the proximal end 24 of the catheter adapter 20. In some embodiments, the catheter assembly 12 may include an extension tube 28 extending from and / or integrated within the side port 26. In some embodiments, an adapter 30, such as a Y adapter or a T adapter, may be coupled to the extension tube 28 at the proximal end of the extension tube 28.

[0024] In some embodiments, the catheter assembly 12 may extend from the distal end 22 of the catheter adapter 20 and may include a catheter 32 that may be fixed within the catheter adapter 20. In some embodiments, the catheter 32 may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.

[0025] In some embodiments, the introducer needle 18 may extend through the catheter 32. In some embodiments, in response to the introducer needle 18 and / or the catheter 32 being inserted into the patient's vasculature, the introducer needle 18 may be withdrawn proximally from the catheter 32 and removed from the catheter assembly 12. In some embodiments, the catheter 32 may remain within the patient's vasculature for blood sampling and / or fluid infusion.

[0026] In some embodiments, the catheter system 10 may include one or more needleless connectors 34 that may be coupled to a particular port of the adapter 30. In some embodiments, the needleless connector 34 may include a MAXZERO™ needleless connector available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable needleless connector. In some embodiments, the cap 36 may be coupled to the proximal end of a particular needleless connector 34. In some embodiments, the distal end 38 of the needleless connector 34 may be coupled to the adapter 30.

[0027] Referring now to FIGS. 2A-2C, in 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 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 (see, e.g., FIG. 1).

[0028] In some embodiments, the catheter system 10 may include a vent assembly 44 that may include a proximal component 46 and a distal component 48. In some embodiments, the proximal component 46 may include a male luer adapter 50 that may include a male luer 52. In some embodiments, the proximal component 46 may include a vent membrane 54 that may be permeable to air but not to liquid. In some embodiments, the vent membrane 54 may be disposed at the proximal end 56 of the proximal component 46. In some embodiments, the fluid path may extend through the male luer 52 and may terminate at the vent membrane 54 that may be aligned with the male luer 52.

[0029] In some embodiments, the distal component 48 may include a distal end 58 that may be coupled to the proximal end 40 of the needleless connector 34. In some embodiments, the distal component 48 may include a proximal end 60 that may be coupled to the male luer adapter 50. In some embodiments, in response to movement of the proximal component 46 from a proximal position to a distal position relative to the distal component 48, the male luer 52 of the male luer adapter 50 may open the valve 42, as shown, for example, in FIG. 2C.

[0030] In some embodiments, the male luer adapter 50 may include a first thread set 62. In some embodiments, the distal end 58 of the distal component 48 may include a second thread set 64. In some embodiments, the first thread set 62 may be arranged in a direction different from that of the second thread set 64. For example, the first thread set 62 may be left-handed, and the second thread set 64 may be right-handed. Thus, by further screwing the proximal component 46 into the distal component 48, as the proximal component 46 moves from the proximal position to the distal position, the possibility that the distal component 48 adheres to the needleless connector 34 while attempting to unscrew from the vent assembly 44 can be reduced. Thus, the first thread set 62 and the second thread set 64 in different directions may allow the vent assembly 44 to be easily removed from the needleless connector 34.

[0031] In some embodiments, the outer surface of the distal component 48 may include a third thread set 66. In some embodiments, the third thread set 66 may be in the same direction as the first thread set 62 so that the proximal component 46 and the distal component 48 can be screwed together. For example, the third thread set 66 may be left-handed.

[0032] In some embodiments, the outer surface of the needleless connector 34 may include a fourth thread set 68. In some embodiments, the fourth thread set 68 may be in the same direction as the second thread set 64 so that the needleless connector 34 and the distal component 48 can be screwed together. For example, the fourth thread set 68 may be right-handed.

[0033] In some embodiments, the method may include actuating a vent assembly 44 that may be coupled to the needleless connector 34. In some embodiments, actuating the vent assembly 44 may include moving a 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, the blunt cannula 69 may extend through the valve 42 and may include one or more flow holes such that air can be removed through a path that extends through the needleless connector 34, the distal component 48, and the proximal component 46.

[0034] In some embodiments, the method may include priming the catheter assembly 12 after actuating the vent assembly 44, which may remove air from the catheter assembly 12 that may be harmful to the patient. In some embodiments, the catheter assembly 12 may be primed with a priming solution, such as saline. In some embodiments, the method may include inserting the catheter assembly 12 into the patient's vasculature after priming the catheter assembly 12.

[0035] In some embodiments, the method may include priming the catheter assembly 12 with blood after actuating the vent assembly 44, which may remove air from the catheter assembly 12 that may be harmful to the patient. In some embodiments, the catheter assembly 12 may be inserted into the patient's vasculature and blood may be allowed to fill the catheter assembly 12 to expel air passing through the vent assembly 44. In some embodiments, the blood filling the catheter assembly 12 may be flushed back into the patient's vasculature with a flush solution, such as saline.

[0036] In these embodiments, one or more of the catheter assembly 12 and extension tube 28 (see FIG. 1), adapter 30 (see FIG. 1), needleless connector 34, distal component 48, and proximal component 46 may be filled with blood during priming of the catheter assembly 12. In some embodiments, after inserting the catheter assembly 12 into the vasculature and priming one or more of the catheter assembly and extension tube 28 (see FIG. 1), adapter 30 (see FIG. 1), needleless connector 34, distal component 48, and proximal component 46 with blood, the blood may be flushed back into the vasculature with a flush solution. In some embodiments, the flushing device may be coupled to the proximal component 46 to flush the blood back into the vasculature.

[0037] Referring now to FIGS. 3A - 3B, in some embodiments, the first thread set 62 may be arranged in the same direction as the second thread set 64. In some embodiments, the first thread 62 and the third thread set 66 may be permanently / locked with a force greater than the unscrewing force between the distal component 48 and the needleless connector 34 when the proximal component 46 is in the distal position. Thus, in response to movement of the proximal component 46 from the distal position (where the valve 42 can be opened) to the proximal position by unscrewing the proximal component 46 from the needleless connector 34 until detachment from the needleless connector 34, the likelihood that the distal component 48 becomes fixed to the needleless connector 34 while attempting to unscrew the vent assembly 44 from the needleless connector 34 may be reduced.

[0038] Referring now to FIGS. 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 distal to the second protrusion. In some embodiments, in response to movement of the proximal component 46 from a proximal position to a distal position, the first protrusion 70 may move distally 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 distal to the second protrusion 72 or may be between the second protrusion 72 and the third protrusion 74. In some embodiments, the proximal component 46 may snap to the distal component 48 in response to the first protrusion 70 being moved distally relative to the second protrusion 72.

[0039] In some embodiments, the outer surface of the distal component 48 may include a channel 76. In some embodiments, the second protrusion 72 and the third protrusion 74 may be disposed within the channel 76. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the first protrusion 70 may move proximally within the channel 76. Thus, in some embodiments, the channel 76 may provide alignment of the proximal component 46 relative to the distal component 48.

[0040] In some embodiments, one or more of the first protrusion 70, the second protrusion 72, and the third protrusion 74 may be annular. In some embodiments, the proximal component 46 may include at least two of the first protrusions 70. In some embodiments, the distal component 48 may include at least two of the second protrusions 72 and / or at least two of the third protrusions 74. In some embodiments, the distal component 48 may include at least two of the channels 76. In some embodiments, one or more of two of the first protrusions 70, two of the second protrusions 72, two of the third protrusions 74, and two of the channels 76 may face each other. In some embodiments, the distal component 48 may be formed monolithically as a single unit. In some embodiments, the proximal component 46 may be formed monolithically as a single unit.

[0041] Referring now to FIGS. 5A - 5E, in some embodiments, the proximal component 46 may include a male luer 78, a proximal protrusion 80 extending from the male luer 78, and a distal protrusion 82 extending from the male luer 78. In some embodiments, the male luer 78 may extend through the proximal end 60 of the distal component 48. In some embodiments, the inner surface of the distal component 48 may include another protrusion 84. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the proximal protrusion 80 may move distally relative to the other protrusion 84. In some embodiments, in response to the proximal component 46 being in the proximal position, the distal protrusion 82 may be distal relative to the other protrusion 84, and the proximal protrusion 80 may be proximal relative to the other protrusion 84.

[0042] In some embodiments, one or more of the proximal projection 80, the distal projection 82, and the other projections 84 may be annular. In some embodiments, the proximal component 46 may include at least two of the proximal projections 80 and / or at least two of the distal projections 82. In some embodiments, the distal component 48 may include at least two of the other projections 84. In some embodiments, one or more of two of the proximal projections 80, two of the distal projections 82, and two of the other projections 84 may face each other.

[0043] In some embodiments, the outer diameter of the proximal component 46 at the distal projection 82 and the proximal projection 80 may be greater than the inner diameter of the distal component 48 at the other projections 84, such that the distal projection 82 and the proximal projection 80 may be configured to slightly compress to pass through the other projections 84. In some embodiments, the distal projection 82 and the proximal projection 80 may be configured to snap past the other projections 84 that may increase the difficulty of removing the proximal component 46 from the distal component 48 and / or moving the proximal component 46 from a distal position (where the valve 42 may be open) to a proximal position. In some embodiments, the proximal projection 80 may contact the other projections 84 in response to the proximal component 46 being in the distal position.

[0044] In some embodiments, operating the vent assembly, including the distal component 48 and the proximal component 46, and being coupled to the needleless connector 34 may include moving the proximal component 46 from a proximal position to a distal position. In some embodiments, in response to moving the proximal component 46 from the proximal position to the distal position, the proximal projection may move distally relative to the other projections 84.

[0045] All examples and conditional language recited herein are intended for educational purposes to aid in understanding the invention and the concepts provided by the inventors to promote the art, and are to be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the invention have been described in detail, it is to be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the 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 and the proximal end of the needleless connector; A vent assembly comprising: A proximal component including a male Luer adapter having a male Luer; A distal component comprising: A distal end coupled to the proximal end of the needleless connector; and A proximal end coupled to the male Luer adapter; Wherein the vent assembly comprises a distal component; Wherein the proximal component is movable between a proximal position and a distal position relative to the distal component, and 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 male Luer adapter includes a first thread set, the distal end of the distal component includes a second thread set, and the first thread set is in a direction different from the second thread set.

2. The catheter system of claim 1, wherein the first thread set is a left-handed thread and the second thread set is a right-handed thread.

3. The catheter system of claim 2, wherein an outer surface of the distal component includes a third thread set that is left-handed.

4. The catheter system of claim 3, wherein an outer surface of the needleless connector includes a fourth thread set that is right-handed.

5. The catheter system of claim 1, wherein an inner surface of the proximal component includes a first protrusion, and an outer surface of the distal component includes a second protrusion and a third protrusion distal to the second protrusion, and in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distal to the third protrusion.

6. The catheter system of claim 5, wherein in response to the proximal component being in the distal position, the first protrusion is distal to the second protrusion.

7. ​ The outer surface of the distal component further comprises a channel, the second protrusion and the third protrusion are disposed within the channel, and in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distally within the channel, the catheter system of claim 6.

8. The male Luer adapter includes a first thread set, the distal end of the distal component includes a second thread set, and the first thread set is in the same direction as the second thread set, the catheter system of claim 1.

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