Extension set to reduce kinking of extension tubes

The vascular access system with a brace and extension set addresses kinking and dislodging issues in extension tubes, ensuring stable fluid flow and patient safety through a curved tube configuration and connectors.

JP7778207B2Active Publication Date: 2025-12-01BECTON DICKINSON & CO
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Patent Information

Application Number
JP2024192823
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-04-06
Filing Date
2024-11-01
Publication Date
2025-12-01
Estimated Expiration
2040-04-07

AI Technical Summary

Technical Problem

Vascular access devices, particularly extension tubes in infusion therapy, are prone to kinking and dislodging, which can restrict fluid flow and pose a risk to patients.

Method used

The introduction of a vascular access system with a catheter adapter and an extension set that includes a brace to hold the extension tube in a curved position, reducing the likelihood of kinking and dislodging, featuring connectors, hubs, and a housing to maintain fluid flow.

Benefits of technology

The system effectively reduces kinking and dislodging of extension tubes, ensuring stable fluid flow and patient safety by maintaining catheter placement.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

To provide a vascular access system where kinking of an extension tube is reduced.SOLUTION: A vascular access system may comprise: a catheter adapter; and an extension set. The extension set may comprise: a first end having a first connector which is connected to a catheter adapter; a second end having a second connector; an extension tube arranged between the first and second ends; and a housing arranged between the first connector and the extension tube. The first connector comprises a lure lock connector. The housing comprises: a first end; a second end; and a fluid pathway extending through the first and second ends. The first end is connected to the first connector, the housing has a V-shaped part or U-shaped part between the first end and second end. The lure lock connector is formed integrally as a single unit with the V-shaped part or U-shaped part.SELECTED DRAWING: Figure 5A
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Description

[Technical Field]

[0001] The present invention relates to an extension set that reduces kinking of the extension tube. [Background technology]

[0002] Infusion therapy, a common medical procedure, can be facilitated by vascular access devices. Hospitalized patients, home care patients, and other patients receive fluids, medications, and blood products through vascular access devices inserted into their vascular system. Blood withdrawal is another common medical procedure that can be facilitated by vascular access devices.

[0003] A common type of catheter is the over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC may be fitted over an introducer needle with a sharp distal tip. The PIVC and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the needle pointing up, away from the patient's skin. The PIVC and introducer needle are generally inserted through the skin at a shallow angle into the patient's vasculature.

[0004] To confirm proper placement of the introducer needle and / or PIVC within the blood vessel, the user typically checks for a "flashback" of blood within the flashback chamber of the PIVC assembly. Once needle placement is confirmed, the user can temporarily block flow within the vessel and remove the introducer needle, leaving the PIVC in place within the vessel. The PIVC can then be used to withdraw or collect fluids and / or blood.

[0005] Often, PIVC assemblies include extension tubing that can be used to infuse fluids and / or withdraw blood at a site remote from the catheter insertion site, which can reduce the risk of obstructing the insertion site or dislodging the catheter from the patient's vasculature.

[0006] In some cases, a three-way stop valve may be connected to the extension tubing. The three-way stop valve can facilitate infusion through multiple medical devices connected to different ports of the three-way stop valve. Three-way stop valves are often prone to microbial growth and fluid retention within the three-way stop valve due to their internal structure. The three-way stop valve or extension tubing may be secured to the patient, which increases the likelihood of bending and kinking the extension tubing. Kinking can restrict or obstruct fluid flow through the catheter, impeding fluid and blood withdrawal and endangering the patient. Summary of the Invention [Problem to be solved by the invention]

[0007] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is provided only to illustrate one example technology area where certain embodiments described herein may be practiced. [Means for solving the problem]

[0008] The present disclosure generally relates to an intravenous catheter extension set. In some embodiments, a vascular access system may include a catheter adapter and an extension set. In some embodiments, a catheter may extend distally from the catheter adapter. In some embodiments, the catheter may include a PIVC, a midline catheter, or a peripherally inserted central catheter ("PICC").

[0009] In some embodiments, the extension set may include one or more of a first end, a second end, an extension tube between the first end and the second end, and a brace. In some embodiments, the first end may include a first connector and / or the second end may include a second connector. In some embodiments, the first connector may be configured to couple to a catheter adapter. In some embodiments, the brace may be configured to hold the extension tube in a curved position, thereby reducing the likelihood of the extension tube kinking and causing the catheter to become dislodged from the insertion site.

[0010] In some embodiments, the brace can include a hub that can include arms. In some embodiments, the arms can include connectors configured to connect to extension tubes. In some embodiments, the extension tubes can be curved between the hub and the connectors.

[0011] In some embodiments, the arms of the brace may be rigid. In some embodiments, the connectors of the arms may include openings through which the extension tubes may pass. In some embodiments, the connectors of the arms may include snap features configured to hold the extension tubes.

[0012] In some embodiments, the extension set may include one or more other extension tubes that may extend distally from the hub. In some embodiments, each of the other extension tubes may include a distal end and a proximal end. In some embodiments, a second connector may be coupled to the distal end of a particular one of the other extension tubes. In some embodiments, the second connector of the extension set may include one or more ports.

[0013] In some embodiments, the vascular access system may further include one or more needleless connectors that can be coupled to the second connector. In some embodiments, the first connector and / or the second connector may include a luer lock. In some embodiments, the first connector and / or the second connector may include a check valve.

[0014] In some embodiments, the vascular access system may include a housing that may be disposed between the first connector and the extension tube. In some embodiments, the housing may reduce the likelihood of the extension tube kinking and dislodging the catheter from the insertion site. In some embodiments, the housing may be U-shaped or V-shaped, and the fluid pathway may extend through the housing. In some embodiments, the housing may include a first end, a second end, and a fluid pathway extending through the first end and the second end. In some embodiments, the first end of the housing may be coupled to the first connector.

[0015] In some embodiments, the distal end of the extension tube may be coupled to the second end of the housing, and in some embodiments, the fluid path of the housing may be in fluid communication with the fluid path of the extension tube.

[0016] In some embodiments, the extension set may include one or more additional extension tubes that can extend distally from the second end of the housing. In some embodiments, each of the additional extension tubes may include a distal end and a proximal end. In some embodiments, the second connector may be coupled to the distal end of the one or more additional extension tubes.

[0017] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only 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 structural changes may be made, unless otherwise stated in the claims, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0018] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0019] [Figure 1] FIG. 1 is a top perspective view of a prior art vascular access system showing a kinked extension tube, according to an embodiment. [Figure 2A] FIG. 1 is a top perspective view of an exemplary vascular access system, according to an embodiment. [Figure 2B] 2B is a top perspective view of an exemplary extension set of the vascular access system of FIG. 2A, according to an embodiment. [Figure 2C] 2C is a bottom perspective view of the extension set of FIG. 2B according to an embodiment. [Figure 2D] 2C is a cross-sectional view of the extension set of FIG. 2B according to an embodiment. [Figure 3A] FIG. 3A is a proximal end view of an exemplary brace taken along line 3A-3A of FIG. 2B, according to an embodiment. [Figure 3B] FIG. 10 is a proximal end view of another exemplary brace, according to an embodiment. [Figure 4A] FIG. 10 is a top perspective view of another exemplary extension set, according to an embodiment. [Figure 4B] FIG. 10 is a top perspective view of another exemplary extension set, according to an embodiment. [Figure 5A]2B is a top perspective view of the vascular access system of FIG. 2A, according to an embodiment. [Figure 5B] FIG. 10 is a top perspective view of another exemplary extension set, according to an embodiment. [Figure 5C] FIG. 5C is a cross-sectional view of the extension set of FIG. 5B according to an embodiment. [Figure 6A] FIG. 10 is a top perspective view of another exemplary extension set, according to an embodiment. [Figure 6B] FIG. 10 is a top perspective view of another exemplary extension set, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0020] The present disclosure relates generally to an intravenous catheter extension set. Referring to FIG. 1 , a prior art vascular access system 10 is shown. The prior art vascular access system 10 includes a catheter adapter 12 and a catheter 14 extending distally from the catheter adapter 12. The catheter adapter 12 includes a proximal end 16, a distal end 18, and a lumen extending therebetween. The catheter adapter 12 includes an injection port 20 in fluid communication with the lumen of the catheter adapter 12. To ensure that the catheter 14 remains in the proper position, an adhesive tape 15 is applied to the catheter adapter 12 to secure the catheter 14 within an insertion site where the catheter 14 is inserted through the skin into the patient's vasculature.

[0021] The prior art vascular access system 10 includes an extension set 22 coupled to the proximal end 16 of the catheter adapter 12. The extension set 22 includes an extension tube 24 coupled to a three-way valve 26. The three-way valve 26 allows two or more infusion devices to be in fluid communication with the prior art vascular access system 10. The three-way valve 26 may be secured to the patient by adhesive tape 15. If the catheter adapter 12 and / or the three-way valve 26 are not sufficiently or properly secured by the adhesive tape 15, a kink 30 may form in the extension tube 24. The kink 30 may restrict or impede fluid flow through the catheter 14.

[0022] 2A-2D , in some embodiments, the vascular access system 32 may include an extension set 34 and a catheter assembly. In some embodiments, the extension set 34 may include one or more of a first end 36, a second end 38, an extension tube 40 between the first end 36 and the second end 38, and a brace 42. In some embodiments, the first end 36 may include a first connector 44 that may be coupled to a catheter adapter 46 of the catheter assembly. In some embodiments, the brace 42 may be configured to hold the extension tube 40 in a curved state. Thus, in some embodiments, the brace 42 may reduce the likelihood of kinking of the extension tube 40. In some embodiments, the brace 42 may also reduce the risk of the catheter 48 becoming dislodged from the insertion site.

[0023] In certain embodiments, the extension set 34 may be used with any suitable catheter assembly. In certain embodiments, the catheter assembly may include a BDVENFLON™ Pro Safety Shielded IV catheter. In these and other embodiments, the catheter adapter 46 may include an infusion port 47 in fluid communication with the lumen of the catheter adapter 46.

[0024] In certain embodiments, the catheter assembly may include a catheter adapter 46 and a catheter 48 extending distally from the catheter adapter 46. In certain embodiments, the catheter 48 may include a peripheral IV catheter (“PIVC”), a midline catheter, or a peripherally inserted central catheter (“PICC”). In certain embodiments, the catheter adapter 46 may include a proximal end 50, a distal end 52, and a lumen extending therebetween.

[0025] In some embodiments, the second end 38 of the extension set 34 can include a second connector 54, which may be configured to couple to a medical device, such as, for example, an infusion device or a blood removal device. In some embodiments, the first connector 44 and / or the second connector 54 may include a male or female Luer connector or another suitable connector. In some embodiments, the first connector 44 and / or the second connector 54 may include a Luer-slip or Luer-lock feature. In some embodiments, the first connector 44 may couple the extension set 34 to a proximal end 50 of a catheter adapter 46. In some embodiments, the extension set 34 may be removably coupled to the catheter adapter 46 via the first connector 44.

[0026] In some embodiments, first connector 44 and / or second connector 54 may include a valve to prevent fluid from leaking from the corresponding connector. In some embodiments, valve 56 may include a one-way valve, a check valve, or another suitable valve.

[0027] In some embodiments, the extension set 34 may include one or more other extension tubes 60. In some embodiments, the other extension tubes 60 may each include a distal end 62 and a proximal end 64. In some embodiments, the second connector 54 may be coupled to the distal end 62 of a particular one of the other extension tubes 60.

[0028] In some embodiments, the second connector 54 may include one or more ports. In some embodiments, the second connector 54 may be configured to couple to a needleless connector 65. In some embodiments, one or more of the other extension tubes 60 may be coupled to the same or a different connector as the second connector 54, thereby facilitating coupling of the extension set 34 to various medical devices.

[0029] In some embodiments, the brace 42 may include a hub 66, which may include arms 68 extending outwardly from the body of the hub 66. In some embodiments, the outer surface of the hub 66 may include one or more surface features to improve grip on the hub 66 and the extension set 34. For example, the outer surface of the hub 66 may include one or more protrusions. Additionally or alternatively, the outer surface of the hub 66 may include one or more grooves. In some embodiments, the arms 68 may be monolithically formed as a single unit with the remaining portion of the hub 66.

[0030] In certain embodiments, the other extension tube 60 can extend from the hub 66. In certain embodiments, the proximal end 64 of the other extension tube 60 may be coupled to the hub 66. For example, the proximal end 64 of the other extension tube 60 may be integral with the hub 66. In certain embodiments, the proximal end 64 of the other extension tube 60 may be removably coupled to the hub 66 via one or more connectors (not shown).

[0031] In certain embodiments, the extension tube 40 may be coupled to the hub 66. In certain embodiments, the extension tube 40 may include a first end 70 and a second end 72. In certain embodiments, the second end 72 of the extension tube 40 may be coupled to the hub 66. For example, the second end 72 of the extension tube 40 may be integral with the hub 66. In certain embodiments, the second end 72 of the extension tube 40 may be removably coupled to the hub 66 via one or more connectors (not shown).

[0032] In some embodiments, the extension tube 40 may be elongated and extend through the hub 66 and directly connect to the second connector 54. In some embodiments, the hub 66 may include the second connector 54, and the extension tube 40 may terminate within the hub 66. In these and other embodiments, the vascular access system 32 may not include another extension tube 60.

[0033] In certain embodiments, the hub 66 may include a lumen extending therethrough such that the second end 72 of the extension tube 40 may be in fluid communication with the other extension tubes 60. In certain embodiments, the fluid path extending through the extension set 34 may include one or more of the first connector 44, the extension tube 40, the hub 66, the other extension tubes 60, and the second connector 54.

[0034] In some embodiments, the arm 68 may include a coupling 74 configured to couple to the extension tube 40. In some embodiments, the extension tube 40 may be curved between the hub 66 and the coupling 74. In some embodiments, the extension tube 40 may be integral with the coupling 74 or may be removably coupled to the coupling 74.

[0035] In some embodiments, the brace 42 may be constructed of a rigid material. In some embodiments, the brace 42 may be constructed of a plastic, such as, for example, polyethylene. In some embodiments, the brace 42 may be constructed of any suitable material, including, for example, nylon, vinyl, polyurethane, etc. In some embodiments, the hub 66 may be constructed of a more rigid material than the arms 68. In some embodiments, the second end 72 of the extension tube 40 may be aligned with the longitudinal axis of the hub 66.

[0036] Referring to FIG. 3A, in one embodiment, the connector 74 may include an enclosed opening 80 extending through the arm 68, and the extension tube 40 may extend through the enclosed opening 80.

[0037] 3B, the coupling portion 74 may include a snap mechanism 76 or a fastener that may couple the extension tube 40 to the arm 68. In certain embodiments, the snap mechanism 76 and / or fastener may facilitate removable coupling of the extension tube 40 to the arm 68. In certain embodiments, the snap mechanism 76 may include an opening 77 that may include a diameter 78 that is smaller than the outer diameter of the extension tube 40 such that the extension tube 40 snaps within the opening 77. In certain embodiments, the fastener (not shown) may include a clip, clasp, hook, strap, or other suitable fastener.

[0038] 4A, an extension set 81 is shown, according to one embodiment. In one embodiment, the extension set 81 may include or correspond to the extension set 34 described with respect to FIGS. 2 and 3. In one embodiment, the extension set 81 may include only one of the other extension tubes 60.

[0039] In some embodiments, the other extension tubes 60 may include clamps 82. In some embodiments, the clamps 82 may selectively block the other extension tubes 60 to prevent fluid from flowing through the other extension tubes 60. It is understood that in some embodiments, one or more of the other extension tubes 60 described with respect to FIG. 2 may include clamps 82.

[0040] 4B , in some embodiments, second connector 54 of extension set 83 may include a Y adapter 84 or another suitable connector. In some embodiments, needleless connector 65 may be coupled to Y adapter 84. In some embodiments, second connector 54 of extension set 34 and / or extension set 81 may include a Y adapter 84.

[0041] 5A-5C, in some embodiments, vascular access system 32 may include extension set 85. In some embodiments, extension set 85 may include or correspond to one or more of extension set 34 described with respect to FIGS. 2-3, extension set 81 described with respect to FIG. 4A, and extension set 81 described with respect to FIG. 4B.

[0042] In some embodiments, the first end 36 of the extension set 85 may include a first connector 44 that may be coupled to the catheter adapter 46. In some embodiments, the second end 38 may include a second connector 54. In some embodiments, the extension tube 40 may be disposed between the first end 36 and the second end 38. In some embodiments, the extension set 85 may include a housing 86 that may be disposed between the first connector 44 and the extension tube 40. In some embodiments, the housing 86 may reduce the risk of kinking the extension tube 40 compared to if the extension tube 40 were directly coupled to the first connector 44.

[0043] In some embodiments, the housing 86 may include a first end 88 and a second end 90. In some embodiments, the first end 88 may be coupled to the first connector 44. In some embodiments, the housing 86 may be monolithically formed as a single unit with the first connector 44. In some embodiments, the first connector 44 may include a male or female Luer connector or other suitable connector. In some embodiments, the first connector 44 may include a Luer-slip or Luer-lock feature. As described above, in some embodiments, the first connector 44 may include a valve 56 to prevent fluid from leaking from the first connector 44. In some embodiments, the valve 56 may include a one-way valve, a check valve, or another suitable valve.

[0044] In some embodiments, the second end 90 may be coupled to the extension tube 40. In some embodiments, the housing 86 may be generally U-shaped or generally V-shaped. In some embodiments, the fluid pathway 92 may extend through the housing 86.

[0045] In some embodiments, the housing 86 may be constructed of a plastic, such as, for example, polyethylene or other suitable plastic. In some embodiments, the housing 86 may be constructed of a rigid material. In some embodiments, the housing 86 may be constructed of any suitable material, including, for example, nylon, vinyl, polyurethane, etc. In some embodiments, portions of the housing 86 may be constructed of a flexible material or plastic, while other portions may be constructed of a more rigid material.

[0046] In some embodiments, the housing 86 may be transparent or translucent. In some embodiments, the housing 86 may further include a support 87 extending between two arms that form the U- or V-shape of the housing 86. In some embodiments, the support 87 may help to maintain the U- or V-shape of the housing 86. In some embodiments, the housing 86 may not include the support 87.

[0047] In some embodiments, the distal end 62 of the extension tube 40 may be coupled to the second end 90 of the housing 86. In some embodiments, the proximal end 64 of the extension tube 40 may be coupled to the second connector 54. In some embodiments, the second connector 54 may be coupled to the needleless connector 65.

[0048] 6A, in certain embodiments, extension set 94 may include another extension tube 96 that may extend distally from second end 90 of housing 86. In certain embodiments, extension set 94 may include or correspond to one or more of extension set 34 described with respect to FIGS. 2 and 3, extension set 81 described with respect to FIG. 4A, extension set 83 described with respect to FIG. 4B, and extension set 85 described with respect to FIG. 5.

[0049] In certain embodiments, the other extension tube 96 may include a distal end 98 that may be coupled to the second end 90 of the housing 86. For example, the distal end 98 may be integral with the second end 90 of the housing 86, as shown in FIG. 6A. In certain embodiments, the distal end 98 may be removably coupled to the second end 90 of the housing 86 via one or more connectors (not shown).

[0050] In some embodiments, the other extension tube 96 may include a proximal end 100 that may be coupled to another connector 99. In some embodiments, the other connector 99 may be the same as or different from the second connector 54.

[0051] 6B, another extension set 102 may include a Y adapter 84 or another suitable connector. In some embodiments, the needleless connector 65 may be coupled to the Y adapter 84. In some embodiments, the second connector 54 of the extension set 83 and / or the extension set 94 may include the Y adapter 84. In some embodiments, the extension tube 40 and / or the other extension tube 96 may include a clamp 82.

[0052] All examples and conditional language set forth herein are for educational purposes to aid the reader in understanding the concepts the inventors have contributed to the development of the present invention and technology, and should be construed as not being limited to such specifically set forth examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. An extension set, a first connector; Housing and An extension tube, a second connector; Equipped with the first connector comprises a luer lock connector; the housing has a first end, a second end, and a fluid pathway extending through the first end and the second end, the first end is coupled to the first connector, the housing has a V-shape or a U-shape between the first end and the second end, and the luer lock connector is integrally formed as a single unit with the V-shape or the U-shape; the extension tube has a distal end and a proximal end, the distal end is coupled to the second end of the housing, the fluid path of the housing is in fluid communication with the fluid path of the extension tube; the second connector is coupled to the proximal end of the extension tube; the V-shape or the U-shape is closed between the first end and the second end; The housing further comprises a support extending between two arms forming the U-shape or the V-shape of the housing.

2. 2. The extension set of claim 1, wherein the extension set further comprises another extension tube extending distally from the second end of the housing, the another extension tube having a distal end and a proximal end, and a third connector coupled to the distal end of the another extension tube.

3. The extension set of claim 1 , further comprising a needleless connector coupled to the second connector.

4. The extension set of claim 1 , wherein the luer lock connector comprises a check valve.

5. 1. A vascular access system comprising: A catheter adapter; A catheter, Extension set and Equipped with the catheter adapter having a proximal end, a distal end, and a lumen extending therebetween; the catheter extends distally from the distal end of the catheter adapter; The extension set includes: a first connector; Housing and An extension tube, a second connector; Equipped with the first connector comprises a luer lock connector; the housing has a first end, a second end, and a fluid pathway extending through the first end and the second end, the first end is coupled to the first connector, the housing has a V-shape or a U-shape between the first end and the second end, and the luer lock connector is integrally formed as a single unit with the V-shape or the U-shape; the extension tube has a distal end and a proximal end, the distal end is coupled to the second end of the housing, the fluid path of the housing is in fluid communication with the fluid path of the extension tube; the second connector is coupled to the proximal end of the extension tube; the V-shape or the U-shape is closed between the first end and the second end; The vascular access system, wherein the housing further comprises a support extending between two arms forming the U-shape or the V-shape of the housing.

6. 6. The vascular access system of claim 5, wherein the extension set further comprises another extension tube extending distally from the second end of the housing, the other extension tube having a distal end and a proximal end, and a third connector coupled to the distal end of the other extension tube.

7. The vascular access system of claim 5 , further comprising a needleless connector coupled to the second connector.

8. The vascular access system of claim 5 , wherein the luer lock connector comprises a check valve.

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