Winged needle set fixed
The connector system with a male Luer lock and hinged arm mechanism addresses the instability and contamination risks of winged needle sets in catheter systems, enhancing safety and efficiency by securing the needle set without adhesive tape.
Patent Information
- Application Number
- JP2021557636
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-03-26
- Filing Date
- 2020-03-27
- Publication Date
- 2025-01-24
- Estimated Expiration
- 2040-03-27
AI Technical Summary
Existing catheter systems face issues with securing winged needle sets, which can lead to accidental removal and needle stick hazards due to the use of adhesive tape, increasing the risk of contamination and inefficiency in the placement process.
A connector system featuring a male Luer lock with a tapered male discharge nozzle, locking ring, and a hinged arm mechanism secures the winged needle set, reducing the risk of bacterial contamination and needle stick hazards by ensuring stable attachment without adhesive tape.
The connector system provides a secure and efficient method for attaching winged needle sets to catheter assemblies, minimizing contamination risks and improving procedural safety and efficiency.
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Abstract
Description
[Technical field]
[0001] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline solution, various medicines, and parenteral nutrients into a patient. Catheters may also be used to withdraw blood from a patient. [Background technology]
[0002] A common type of catheter is the over-the-needle peripheral intravenous catheter ("PIVC"). As the name implies, an over-the-needle PIVC may be mounted over an introducer needle that has a sharp distal tip. The PIVC and introducer needle may 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 introducer needle are typically 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 within the vasculature, the user will typically confirm the presence of blood flashback in the flashback chamber of the PIVC assembly. Once placement of the introducer needle within the vasculature is confirmed, the user may temporarily shut off flow within the vasculature and withdraw the introducer needle, leaving the PIVC in place within the blood vessel. The PIVC may then be used for fluid injection and / or blood withdrawal.
[0004] The PIVC assembly may include an extension tube and a temporary (PRN) connector. For example, a winged needle set may be connected to the PRN connector to allow for flushing of the PIVC assembly. The winged needle set may be taped to the patient's skin to help prevent accidental removal of the winged needle set from the PRN connector, which could result in needle stick.
[0005] 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 implementations described herein may be practiced. Summary of the Invention [Means for solving the problem]
[0006] The present disclosure relates generally to a connector for securing a winged needle set to a catheter assembly, and associated systems and methods. In some embodiments, the connector for securing a winged needle set to a catheter assembly may comprise a male luer lock. In some embodiments, the male luer lock may comprise a tapered male discharge nozzle and a locking ring surrounding the tapered male discharge nozzle. In some embodiments, the locking ring may be internally threaded.
[0007] In some embodiments, the connector may comprise a septum arranged to prevent flow through the tapered male discharge nozzle. In some embodiments, the connector may comprise an arm, which may comprise a first end, a second end, and a hinge portion arranged between the first end and the second end. In some embodiments, the hinge portion may comprise a living hinge. In some embodiments, the first end may be coupled to the male luer lock. In some embodiments, the arm may be arranged to secure a winged needle set to the connector in response to movement of the hinge portion from an open position to a closed position.
[0008] In some embodiments, the second end of the arm may comprise a first protrusion, a second protrusion, and an opening disposed between the first protrusion and the second protrusion. In some embodiments, in response to the hinge portion being disposed in the closed position, the opening may align with the tapered male discharge nozzle. In some embodiments, the first protrusion may comprise a first protrusion and / or the second protrusion may comprise a second protrusion. In some embodiments, a portion of the opening between the first protrusion and the second protrusion may comprise a reduced diameter.
[0009] In some embodiments, the locking ring may extend beyond the end of the tapered male discharge nozzle, which may reduce the risk of bacterial contamination of the tapered male discharge nozzle. In some embodiments, the locking ring may comprise a flange. In some embodiments, the septum may comprise a cap and / or a stem extending from the cap. In some embodiments, the stem may extend into the tapered male discharge nozzle and / or the cap may rest on the flange, which may facilitate securing the septum within the connector.
[0010] In some embodiments, the stem may include one or more protrusions. In some embodiments, the tapered male discharge nozzle may be spaced from the locking ring by a cavity. In some embodiments, the connector may include one or more apertures, which connect the interior of the tapered male discharge nozzle with the cavity. In some embodiments, one or more protrusions of the septum may be disposed within the apertures, which may facilitate securing the septum within the connector.
[0011] In some embodiments, the tapered male discharge nozzle may be coupled to the locking ring at the attachment portion. In some embodiments, the one or more apertures may be proximate to the attachment portion. In some embodiments, the flange may be disposed between the cap and the one or more protrusions and / or may contact the one or more protrusions.
[0012] In some embodiments, the method of securing the winged needle set to the catheter assembly may comprise coupling a connector to the catheter assembly. In some embodiments, the method may comprise inserting the winged needle set through a septum and into a tapered male discharge nozzle. In some embodiments, the winged needle set may comprise a hub, a needle secured within the hub, and wings extending outwardly from the hub.
[0013] In some embodiments, the method may include moving the hinge portion from an open position to a closed position. In some embodiments, in response to the hinge portion being in the closed position, a wing of the winged needle set may be secured between the second end and the septum. In some embodiments, in response to the hinge portion being in the closed position, the winged needle set may extend through the opening. In some embodiments, moving the hinge portion from the open position to the closed position may include moving the portion of the winged needle set through a narrowed diameter. In some embodiments, the diameter of the portion of the winged needle set may be greater than the narrowed diameter.
[0014] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]
[0015] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A]FIG. 1 is a top perspective view of an example conventional catheter system. [Figure 1B] FIG. 1B is a top perspective view of a conventional connector of the conventional catheter system of FIG. 1A. [Figure 1C] FIG. 1C is a top perspective view of a conventional winged needle set inserted into the conventional connector of FIG. 1B. [Figure 1D] FIG. 1B is a top perspective view of the conventional catheter system of FIG. 1A applied to the skin of a patient. [Figure 2A] FIG. 1 is a top perspective view of an example catheter system, according to some embodiments. [Figure 2B] FIG. 2A is a top perspective view of an example connector of the catheter system of 2A, showing an example hinge of the connector in an open position, according to some embodiments. [Figure 2C] 2B coupled to another connector of the catheter system of FIG. 2A, according to some embodiments. [Figure 2D] 2C is a cross-sectional view of the connector of FIG. 2B showing an example septum removed, according to some embodiments. [Figure 2E] FIG. 2C is a top perspective view of an example winged needle set inserted into the connector of FIG. 2B, according to some embodiments. [Figure 2F] FIG. 2C is a top perspective view of the winged needle set inserted into the connector of FIG. 2B, showing the hinge in a closed position, according to some embodiments. [Figure 2G] FIG. 2C is a bottom perspective view of the winged needle set inserted into the connector of FIG. 2B, showing the hinge in a closed position, according to some embodiments. [Figure 2H] FIG. 13 is a top perspective view of a winged needle set, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] 1A-1C, a conventional catheter system is shown. The conventional catheter system 10 includes a catheter adapter 12, a catheter 14 extending distally from the catheter adapter 12, and an extension tube 16 extending proximally from the catheter adapter 12. The proximal end of the extension tube 16 may include an adapter 18. A PRN adapter 20 may be coupled to the adapter 18, and a winged needle set 22 may be inserted through a septum 24 of the PRN adapter 20 and bleed into the conventional catheter system 10.
[0017] 1D, the winged needle set 22 of the conventional catheter system 10 may be secured to the patient's skin with an adhesive tape. The adhesive tape may irritate the skin. Furthermore, application of the adhesive tape to the skin can be time consuming for the physician. Furthermore, if the adhesive tape peels off or becomes defective, the winged needle set 22 may be accidentally removed from the PRN adapter 20. The winged needle set 22 removed from the PRN adapter 20 poses a needle stick hazard to the physician or patient.
[0018] 2A, the catheter system 25 may include a catheter assembly 26. In some embodiments, the catheter assembly 26 may include a catheter adapter 28 and a catheter 30 extending distally from the catheter adapter 28. In some embodiments, the catheter adapter 28 may include a side port 32 in fluid communication with a lumen of the catheter adapter 28. In some embodiments, the catheter adapter 28 may include a proximal end 33, a distal end 34, and a lumen extending between the proximal end 33 and the distal end 34. In some embodiments, the catheter 30 may include a peripheral intravenous catheter ("PIVC"), a midline catheter, or a peripherally inserted central catheter ("PICC").
[0019] In some embodiments, the catheter assembly 26 may be removably coupled to a needle assembly, which may include a needle hub 36 and an introducer needle 38. The introducer needle 38 may include a sharpened distal tip 40. In some embodiments, the proximal end of the introducer needle 38 may be fixed within the needle hub 36. In some embodiments, the introducer needle 38 may extend through the catheter when the catheter assembly 26 is in an insertion position in preparation for insertion into a patient's blood vessel, as shown, for example, in FIG. 2A. In some embodiments, in response to the introducer needle 38 being inserted into a patient's blood vessel, a flashback of blood may flow through the sharpened distal tip of the introducer needle 38 and may be visible to a physician between the introducer needle 38 and another location within the catheter 30 and / or catheter assembly 26.
[0020] In some embodiments, in response to confirmation via blood flashback that the catheter 30 is within the patient's vein, the needle assembly is removed from the catheter assembly 26. In some embodiments, for example, as shown in FIG. 2A, when the needle assembly is coupled to the catheter assembly 26, the introducer needle 38 of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter 28.
[0021] In some embodiments, the catheter system 25 may include an extension set 42, which may include an extension tube 44 and a clamp 46. In some embodiments, the distal end of the extension tube 44 may be integral with the catheter adapter 28, for example, as shown in FIG. 2A. For example, the extension tube 44 may be integral with the side port 32 of the catheter adapter 28. In some embodiments, the extension tube 44 may be removably coupled to the catheter adapter 28. In some embodiments, the clamp 46 may occlude the extension tube 44 to prevent blood or other fluids from flowing through the extension tube 44.
[0022] In some embodiments, the extension set 42 may include an adapter 48 coupled to the proximal end of the extension tube 44. In some embodiments, the adapter 48 may include a Y adapter or another suitable connector. In some embodiments, a connector 50 may be coupled to the adapter 48. In some embodiments, the connector 50 may include a needleless connector or a PRN adapter. In some embodiments, the adapter 48 and / or connector 50 may be used to couple the catheter system 25 to a winged needle set 52 or another medical device for administering fluids or drawing blood.
[0023] 2B-2D, in some embodiments, the connector 50 may comprise a male luer lock 54. In some embodiments, the male luer lock 54 may comprise a tapered male discharge nozzle 56 and a locking ring 58 that surrounds the tapered male discharge nozzle 56. In some embodiments, the locking ring 58 may be internally threaded.
[0024] In some embodiments, the connector 50 may include a septum 60 positioned to prevent flow through the tapered male discharge nozzle 56. In some embodiments, the connector 50 may include an arm 62, which may include a first end 64, a second end 66, and a hinge portion 68 positioned between the first end 64 and the second end 66. In some embodiments, the hinge portion 68 may include an integral hinge, which may reduce the number of components and the cost of the connector 50. In some embodiments, the hinge portion 68 may include another suitable type of hinge. In some embodiments, the first end 64 may be coupled to the male luer lock 54.
[0025] In some embodiments, the second end 66 of the arm 62 may include a first protrusion 70, a second protrusion 72, and an opening 74 disposed between the first protrusion 70 and the second protrusion 72. In some embodiments, the first protrusion 70 may include a first protrusion 76 and / or the second protrusion 72 may include a second protrusion 78. In some embodiments, the portion of the opening 74 between the first protrusion 76 and the second protrusion 78 may include a reduced diameter 80, which may be smaller than a diameter 81 of the opening 74 near the hinge portion 68 (e.g., as shown in FIG. 2F ).
[0026] In some embodiments, the locking ring 58 may extend beyond the free end 82 of the tapered male discharge nozzle 56, which may reduce the risk of bacterial contamination of the tapered male discharge nozzle 56. In some embodiments, the locking ring 58 may comprise a flange 84. In some embodiments, the septum 60 may comprise a cap 86 and / or a stem 88 extending from the cap 86. In some embodiments, the stem 88 may extend into the tapered male discharge nozzle 56 and / or the cap 86 may rest on the flange 84, which may facilitate securing the stem 60 within the connector 50.
[0027] In some embodiments, the stem 88 may include one or more protrusions 90. In some embodiments, the tapered male discharge nozzle 56 may be spaced from the locking ring 58 by a cavity 92, which may be annular. In some embodiments, the connector 50 may include one or more apertures 94, which may connect the interior of the tapered male discharge nozzle 56 with the cavity 92. In some embodiments, the protrusions 90 of the septum 60 may be disposed within the apertures 94, which may facilitate securing the septum 60 within the connector 50. In some embodiments, the protrusions 90 may be disposed between the flange 84 and the tapered male discharge nozzle 56.
[0028] In some embodiments, the tapered male discharge nozzle 56 may be coupled to the locking ring 58 at an attachment portion 96. In some embodiments, the aperture 94 may be proximate to the attachment portion 96. In some embodiments, the flange 84 may be disposed between the cap 86 and the protrusion 90 and / or may contact the protrusion 90. In some embodiments, the protrusion 90 may extend into the cavity 92 and / or may contact the inner surface of the locking ring 58.
[0029] In some embodiments, the second end 66 of the arm 62 may include one or more shoulders 98, which may be angled. In some embodiments, the shoulders 98 may be angled at 90 degrees to facilitate securement of the winged needle set, or may be at another suitable angle.
[0030] 2F-2H, in some embodiments, the opening 74 may be positioned to receive a winged needle set 52. In some embodiments, the arms 62 may be positioned to secure the winged needle set 52 to the connector 50 in response to movement of the hinge portion 68 from an open position, e.g., as shown in Figures 2B-2E, to a closed position, e.g., as shown in Figures 2F-2G. In some embodiments, the winged needle set 52 may include a hub 102, a needle 104 secured within the hub 102, and wings 106 extending outwardly from one or more of the hubs 102.
[0031] In some embodiments, the opening 74 may be aligned with the tapered male discharge nozzle 56 in response to the hinge portion being placed in a closed position such that the winged needle set 52 may extend linearly through the connector 50.
[0032] In some embodiments, after the connector 50 is coupled to the catheter assembly, the winged needle set 52 may be inserted through the septum 60 and into the tapered male discharge nozzle 56. In some embodiments, the hinged portion 68 may be moved by a physician from an open position to a closed position by moving the second end 66 from an outer position to an inner position. In some embodiments, in response to the hinged portion 68 being in the closed position, one or more wings 106 of the winged needle set 52 may be secured between the second end 66 and the septum 60.
[0033] In some embodiments, in response to the hinge portion 68 being in the closed position, the winged needle set 52 may extend or be pushed through the opening 74. In some embodiments, the movement of the hinge portion 68 from the open position to the closed position may include movement of a portion of the winged needle set 52 through a narrowed diameter. In some embodiments, the first protrusion 70 and / or the second protrusion 72 may be formed from a resilient material. In some embodiments, as the winged needle set 52 moves through the narrowed diameter 80, the first protrusion 70 and the second protrusion 72 may be biased outwardly, and after the winged needle set 52 has been moved through the narrowed diameter, the first protrusion 70 and the second protrusion 72 may grip the winged needle set 52 and return inward. In some embodiments, one or more of the following may be integrally molded as a single unit: the tapered male discharge nozzle 56, the locking ring 58, the attachment portion 96, the first end 64 of the arm 62, and the second end 66 of the arm 62.
[0034] 2H, according to some embodiments, winged needle set 52 is shown. In some embodiments, a first end of extension tube 108 may be coupled to hub 102. In some embodiments, a second end of extension tube 108 may include an adapter 110, which may be configured to couple to an infusion or blood collection device. In some embodiments, needle 104 may be constructed of metal or another suitable material.
[0035] All examples and conditional language described herein are intended for educational purposes to aid the reader in understanding the concepts contributed by the inventor to further the invention and the art, and should be construed as having no limitations on such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention.
Claims
1. A connector for securing a winged needle set to a catheter assembly, comprising: The connector comprises: A male luer lock comprising a tapered male discharge nozzle and a locking ring surrounding the tapered male discharge nozzle, the locking ring having an internal thread; a septum positioned to prevent flow through the tapered male discharge nozzle; and an arm having a first end, a second end, and a hinge portion disposed between the first end and the second end, the first end coupled to the male luer lock, the arm being arranged such that in response to movement of the hinge portion from an open position to a closed position, the arm secures the winged needle set to the connector; the second end comprises a first protrusion, a second protrusion, and an opening disposed between the first protrusion and the second protrusion, the first protrusion comprising a first projection and the second protrusion comprising a second projection, a portion of the opening between the first protrusion and the second protrusion comprising a diameter, the first protrusion and the second protrusion being constructed from a resilient material and being arranged to bias outwardly when the winged needle set moves through the diameter; a septum having a cap and a stem extending from the cap, the stem extending into a tapered male discharge nozzle, the cap resting on the flange, the stem having a plurality of protrusions, the tapered male discharge nozzle spaced from the locking ring by a cavity adjacent the internal threads, and further comprising a plurality of apertures connecting an interior of the tapered male discharge nozzle to the cavity, the plurality of protrusions of the septum being disposed within the plurality of apertures.
2. 2. The connector of claim 1, wherein the opening is aligned with the tapered male discharge nozzle in response to the hinge portion being disposed in the closed position.
3. The connector of claim 1 , wherein the hinge portion comprises a living hinge.
4. 2. The connector of claim 1, wherein the locking ring extends beyond the distal end of the tapered male discharge nozzle.
5. 2. The connector of claim 1, wherein the tapered male discharge nozzle is coupled to the locking ring at an appendage, the plurality of apertures being adjacent to the appendage.
6. The connector of claim 1 , wherein the flange is disposed between the cap and the plurality of projections and contacts the plurality of projections.
7. 1. A method for securing a winged needle set to a catheter assembly, comprising: A connector, A male luer lock comprising a tapered male discharge nozzle and a locking ring surrounding the tapered male discharge nozzle, the locking ring being internally threaded; a septum positioned to prevent flow through the tapered male discharge nozzle; and an arm having a first end, a second end, and a hinge portion disposed between the first end and the second end; coupling a connector to the catheter assembly, the second end comprising a first protrusion, a second protrusion, and an opening disposed between the first protrusion and the second protrusion, the first protrusion comprising a first projection and the second protrusion comprising a second protrusion, a portion of the opening between the first protrusion and the second protrusion comprising a diameter, the first protrusion and the second protrusion being comprised of a resilient material; inserting a winged needle set, comprising a hub, a needle secured within the hub, and wings extending outwardly from the hub, through the septum and into a tapered male discharge nozzle; and moving the hinge portion from an open position to a closed position, wherein in response to the movement of the hinge portion from the open position to the closed position the first and second protrusions are biased outwardly and a portion of the winged needle set moves through the diameter, and in response to the hinge portion being in the closed position the winged needle set is secured between the second end and the septum; said locking ring comprising a flange, said septum comprising a cap and a stem extending from the cap, the stem extending into a tapered male discharge nozzle, said cap resting on the flange, said stem comprising a plurality of protrusions, said tapered male discharge nozzle spaced from the locking ring by a cavity, and further comprising a plurality of apertures connecting an interior of the tapered male discharge nozzle with the cavity, and wherein the plurality of protrusions of the septum are disposed within the plurality of apertures.
8. 8. The method of claim 7, wherein in response to the hinge portion being in the closed position, the winged needle set extends through the opening.
9. 8. The method of claim 7, wherein a diameter of the portion of the winged needle set is greater than a diameter of a portion of the opening between the first protrusion and the second protrusion.
10. The method of claim 7 , wherein the hinge portion comprises a living hinge.
11. 8. The method of claim 7, wherein the locking ring extends beyond the distal end of the tapered male discharge nozzle.
12. 8. The method of claim 7, wherein the tapered male discharge nozzle is coupled to the locking ring at an appendage, and the plurality of apertures are adjacent to the appendage.
13. The method of claim 7 , wherein the flange is disposed between the cap and the plurality of projections and contacts the plurality of projections.
Citation Information
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