EXTENSION SET

Abstract

Extension assembly to reduce extension tubing kinking. A vascular access system may include a catheter adapter and an extension assembly. The extension assembly may include a first end that has a first connector attached to the catheter adapter, a second end that has a second connector, an extension tube disposed between the first end and the second end, and a clamp configured to retain the extension tube in a curved position. Alternatively, the extension assembly may include a housing disposed between the first connector and the extension tube, wherein the housing is U-shaped or V-shaped, and a fluid pathway extends through the housing.

Description

1 / 14 “EXTENSION SET” BACKGROUND

[001] Infusion therapy, a common healthcare procedure, can be facilitated by a vascular access device. Hospitalized patients, those receiving home care, and other patients receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into the vascular system. Blood withdrawal is another common medical procedure that can be facilitated by a vascular access device.

[002] A common type of catheter is a peripheral intravenous catheter (“PIVC”) over a needle. As the name suggests, the PIVC over a needle can be fitted onto an introducer needle with a sharp distal tip. The PIVC and introducer needle can be fitted so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the needle bevel facing upward, away from the patient's skin. The PIVC and introducer needle are usually inserted at a shallow angle through the skin into the patient's vasculature.

[003] In order to verify proper placement of the introducer needle and / or PIVC in the vein, a user typically confirms that there is flashback of blood in a flashback chamber of a PIVC assembly. Once needle placement has been confirmed, the user can temporarily occlude flow in the vein and remove the introducer needle, leaving the PIVC in place within the vein. The PIVC can then be used for fluid infusion and / or blood withdrawal or collection.

[004] Often, PIVC assembly may include an extension tube, which can be used to infuse fluid and / or withdraw blood at a site removed from a catheter insertion site. This can reduce the risk of disturbing the insertion site or dislodging the catheter from the patient's vasculature.

[005] In some cases, a three-way shut-off valve may be attached to the extension tubing. The three-way shut-off valve may facilitate infusion by means of Petition 870250095442, dated 10 / 20 / 2025, page 8 / 45 2 / 14 of various medical devices are attached to different ports of the three-way shut-off valve. The three-way shut-off valve is often prone to microorganism growth due to the internal structure of the three-way shut-off valve and fluid stagnation within the three-way shut-off valve. The three-way shut-off valve or the extension tubing may become trapped in the patient, which can result in a kink in the extension tubing and an increased likelihood of kinking in the extension tubing. Kinking can limit or prevent fluid flow through the catheter, inhibiting fluid infusion and blood withdrawal and endangering the patient.

[006] The subject matter claimed in this document is not limited to modalities that resolve any disadvantages or that operate only in environments such as those described above. Instead, this background is provided only to illustrate an exemplary technology area in which some deployments described herein may be practiced. SUMMARY OF THE INVENTION

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

[008] In some embodiments, the extension set may include one or more of the following: a first end, a second end, an extension tube between the first end and the second end, and a clamp. 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 attach to the catheter adapter. In Petition 870250095442, dated 10 / 20 / 2025, page 9 / 45 3 / 14 In some modalities, the clamp can be configured to retain the extension tube in a curved position, which may reduce the likelihood of kinking of the extension tube and dislodging of the catheter from an insertion site.

[009] In some embodiments, the clamp may include a hub, which may include an arm. In some embodiments, the arm may include a coupling portion configured to couple to the extension tube. In some embodiments, the extension tube may be curved between the hub and the coupling portion.

[010] In some embodiments, the arm of the clamp may be rigid. In some embodiments, the coupling portion of the arm may include an opening and the extension tube may pass through the opening. In some embodiments, the coupling portion of the arm may include a fitting feature configured to retain the extension tube.

[011] In some embodiments, the extension assembly may include one or more other extension tubes, which may extend distally from the hub. In some embodiments, the other extension tubes may each include a distal end and a proximal end. In some embodiments, the second connector may be attached to the distal end of a specific extension tube among the other extension tubes. In some embodiments, the second connector of the extension assembly may include one or more ports.

[012] In some embodiments, the vascular access system may additionally include one or more needleless connectors, which may 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.

[013] In some modalities, the vascular access system may include a housing, which may be disposed between the first connector and the extension tube. In Petition 870250095442, dated 10 / 20 / 2025, p. 10 / 45 4 / 14 In some designs, the housing can reduce the likelihood of kinking of the extension tubing and dislodging of the catheter from an insertion site. In some designs, the housing may be U-shaped or V-shaped, and a fluid pathway may extend through the housing. In some designs, the housing may include a first end, a second end, and a fluid pathway extending through both the first and second ends. In some designs, the first end of the housing may be coupled to the first connector.

[014] In some embodiments, the distal end of the extension tube may be coupled to the second end of the housing. In some embodiments, the fluid pathway of the housing may be in fluid communication with a fluid pathway of the extension tube.

[015] In some embodiments, the extension assembly may include one or more additional extension tubes, which may 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 attached to the distal end of one or more of the additional extension tubes.

[016] It should be understood that both the preceding general description and the following detailed description are illustrative and explanatory and are not restrictive of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentation shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be used, and that structural changes, unless claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description, therefore, should not be taken in a limiting sense. BRIEF DESCRIPTION OF THE DRAWINGS

[017] The illustrative modalities will be described and explained with Petition 870250095442, dated 10 / 20 / 2025, p. 11 / 45 5 / 14 Specificity and additional details through the use of the attached drawings, in which: Figure 1 is a top perspective view of a prior art vascular access system, illustrating a kinked extension tube, according to some modalities; Figure 2A is a top perspective view of an exemplary vascular access system, according to some modalities; Figure 2B is a top perspective view of an exemplary extension set of the vascular access system of Figure 2A, according to some modalities; Figure 2C is a bottom perspective view of the extension assembly of Figure 2B, according to some embodiments; Figure 2D is a cross-sectional view of the extension assembly of Figure 2B, according to some embodiments; Figure 3A is a proximal end view of an exemplary clamp along line 3A-3A of Figure 2B, according to some embodiments; Figure 3B is a proximal end view of another exemplary cuff, according to some embodiments; Figure 4A is a top perspective view of another exemplary extension set, according to some embodiments; Figure 4B is a top perspective view of another exemplary extension set, according to some embodiments; Figure 5A is a top perspective view of the vascular access system in Figure 2A, according to some modalities; Figure 5B is a top perspective view of another exemplary extension set, according to some embodiments; Figure 5C is a cross-sectional view of the extension assembly of Figure Petition 870250095442, dated 10 / 20 / 2025, p. 12 / 45 6 / 14 5B, according to some modalities; Figure 6A is a top perspective view of another exemplary extension set, according to some embodiments; and Figure 6B is a top perspective view of another exemplary extension set, according to some embodiments. DESCRIPTION OF THE MODALITIES

[018] The present disclosure relates generally to intravenous catheter extension assemblies. Referring now to Figure 1, a prior art vascular access system 10 is illustrated. 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 between them. 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, 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 and into the vasculature of a patient.

[019] The vascular access system of the prior art 10 includes an extension assembly 22 attached to the proximal end 16 of the catheter adapter 12. The extension assembly 22 includes an extension tube 24 that is attached to a three-way valve 26. The three-way valve 26 allows more than one infusion device to be in fluid communication with the vascular access system 10 of the prior art. The three-way valve 26 can be secured to the patient with adhesive tape 15. If the catheter adapter 12 and / or the three-way valve 26 are not adequately or appropriately secured with adhesive tape 15, a kink 30 may form in the extension tube 24. The kink 30 may limit or impede fluid flow through the catheter 14.

[020] Referring now to Figure 2A-2D, in some forms, a system Petition 870250095442, dated 10 / 20 / 2025, p. 13 / 45 7 / 14 vascular access 32 may include an extension set 34 and a catheter assembly. In some embodiments, the extension set 34 may include one or more of the following: a first end 36, a second end 38, an extension tube 40 between the first end 36 and the second end 38, and a clamp 42. In some embodiments, the first end 36 may include a first connector 44, which may be coupled to a catheter adapter 46 of the catheter assembly. In some embodiments, the clamp 42 may be configured to retain the extension tube 40 in a curved position. Thus, in some embodiments, the clamp 42 may reduce the likelihood of kinking the extension tube 40. In some embodiments, the clamp 42 may also reduce the risk of dislodging a catheter 48 from the insertion site.

[021] In some embodiments, the extension set 34 can be used with any suitable catheter assembly. In some embodiments, the catheter assembly may include the BD VENFLON™ Pro Shielded IV Catheter. In these and other embodiments, the catheter adapter 46 may include an injection port 47 in fluid communication with a lumen of the catheter adapter 46.

[022] In some embodiments, the catheter assembly may include catheter adapter 46 and catheter 48 extending distally from catheter adapter 46. In some embodiments, catheter 48 may include a peripheral IV catheter (PIVC), an intermediate line catheter, or a peripherally inserted central catheter (PICC). In some embodiments, catheter adapter 46 may include a proximal end 50, a distal end 52, and the lumen extending between them.

[023] In some embodiments, the second end 38 of the extension assembly 34 may include a second connector 54, which may be configured to attach to a medical device, such as, for example, an infusion or blood withdrawal device. In some embodiments, the first connector 44 and / or the second connector 54 may include a male or female luer connector or other connector. Petition 870250095442, dated 10 / 20 / 2025, page 14 / 45 8 / 14 suitable. 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 assembly 34 to the proximal end 50 of the catheter adapter 46. In some embodiments, the extension assembly 34 may be removablely coupled to the catheter adapter 46 via the first connector 44.

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

[025] In some embodiments, the extension assembly 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 given among the other extension tubes 60.

[026] 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 a connector that is the same as or different from the second connector 54, which may facilitate the coupling of the extension assembly 34 to various medical devices.

[027] In some embodiments, the clamp 42 may include a cube 66, which may include an arm 68 extending outward from a cube 66 body. In some embodiments, an exterior of the cube 66 may include one or more surface features to improve handling of the cube 66 and the extension assembly 34. For example, the exterior of the cube 66 may include one or more protrusions. Additionally or alternatively, the exterior of the cube 66 may include one or more grooves. In some Petition 870250095442, dated 10 / 20 / 2025, page 15 / 45 In 9 / 14 modes, arm 68 can be formed monolithically as a single unit with a remaining portion of cube 66.

[028] In some embodiments, the other extension tubes 60 may extend from the hub 66. In some embodiments, the proximal ends 64 of the other extension tubes 60 may be coupled to the hub 66. For example, the proximal ends 64 of the other extension tubes 60 may be integrated with the hub 66. In some embodiments, the proximal ends 64 of the other extension tubes 60 may be removablely coupled to the hub 66 by means of one or more connectors (not shown).

[029] In some embodiments, the extension tube 40 can be coupled to the hub 66. In some embodiments, the extension tube 40 can include a first end 70 and a second end 72. In some embodiments, the second end 72 of the extension tube 40 can be coupled to the hub 66. For example, the second end 72 of the extension tube 40 can be integrated with the hub 66. In some embodiments, the second end 72 of the extension tube 40 can be removablely coupled to the hub 66 by means of one or more connectors (not shown).

[030] In some embodiments, the extension tube 40 may be lengthened and extend through the hub 66 and couple directly 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 the other extension tubes 60.

[031] In some embodiments, the hub 66 may include a lumen extending through it, so that the second end 72 of the extension tube 40 may be in fluid communication with the other extension tubes 60. In some embodiments, a fluid path extending through the extension assembly 34 may include one or more of the following: the first connector 44, the extension tube 40, the Petition 870250095442, dated 10 / 20 / 2025, p. 16 / 45 10 / 14 cube 66, the other extension tubes 60 and the second connector 54.

[032] In some embodiments, the arm 68 may include a coupling portion 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 portion 74. In some embodiments, the extension tube 40 may be integrated with the coupling portion 74 or removablely coupled with the coupling portion 74.

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

[034] Referring now to Figure 3A, in some embodiments, the coupling portion 74 may include an enclosed opening 80 that extends through the arm 68 and the extension tube 40 may extend through the enclosed opening 80.

[035] Referring now to Figure 3B, the coupling portion 74 may include a fitting mechanism 76 or a fastener, which may couple the extension tube 40 to the arm 68. In some embodiments, the fitting mechanism 76 and / or the fastener may facilitate the removable coupling of the extension tube 40 to the arm 68. In some embodiments, the fitting mechanism 76 may include an opening 77, which may include a diameter 78 smaller than an outside diameter of the extension tube 40 so that the extension tube 40 fits within the opening 77. In some embodiments, the fastener (not shown) may include a clip, clasp, hook, strap or other suitable fastener. Petition 870250095442, dated 10 / 20 / 2025, page 17 / 45 11 / 14

[036] Referring now to Figures 4A, an extension assembly 81 is illustrated, according to some embodiments. In some embodiments, the extension assembly 81 may include or correspond to the extension assembly 34 described in relation to Figures 2-3. In some embodiments, the extension assembly 81 may include only one of the other extension tubes 60.

[037] In some embodiments, the other extension tube 60 may include a clamp 82. In some embodiments, the clamp 82 may selectively close the other extension tube 60 to prevent fluid from flowing through the other extension tube 60. It is understood that in some embodiments, one or more of the other extension tubes 60 described in relation to Figure 2 may include the clamp 82.

[038] Referring now to Figure 4B, an extension set 83 is in some embodiments, the second connector 54 may include a Y adapter 84 or other suitable connector. In some embodiments, a needleless connector 65 may be coupled to the Y adapter 84. In some embodiments, the second connector 54 of the extension set 34 and / or the extension set 81 may include the Y adapter 84.

[039] Referring now to Figures 5A-5C, in some embodiments, the vascular access system 32 may include an extension set 85. In some embodiments, the extension set 85 may include or correspond to one or more of the extension set 34 described in relation to Figures 2-3, the extension set 81 described in relation to Figure 4A and the extension set 81 described in relation to Figure 4B.

[040] In some embodiments, the first end 36 of the extension assembly 85 may include the first connector 44, which may be coupled to the catheter adapter 46. In some embodiments, the second end 38 may include the 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 assembly 85 may include a housing 86, which may be disposed between the Petition 870250095442, dated 10 / 20 / 2025, p. 18 / 45 12 / 14 first connector 44 and extension tube 40. In some embodiments, housing 86 may reduce the risk of kinking of extension tube 40 compared to if extension tube 40 were coupled directly to first connector 44.

[041] 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 formed monolithically 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 mentioned, in some embodiments, the first connector 44 may include the valve 56 to prevent fluid from leaking out of the first connector 44. In some embodiments, the valve 56 may include a one-way valve, a check valve, or other suitable valve.

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

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

[044] In some embodiments, housing 86 may be transparent or translucent. In some embodiments, housing 86 may additionally include a Petition 870250095442, dated 10 / 20 / 2025, p. 19 / 45 13 / 14 support 87 extending between two arms forming a U-shape or a V-shape of housing 86. In some embodiments, support 87 may help to retain the U-shape or V-shape of housing 86. In some embodiments, housing 86 may not include support 87.

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

[046] Referring now to Figure 6A, in some embodiments, an extension assembly 94 may include another extension tube 96, which may extend distally from the second end 90 of the housing 86. In some embodiments, the extension assembly 94 may include or correspond to one or more of the extension assembly 34 described in relation to Figures 2-3, the extension assembly 81 described in relation to Figure 4A, the extension assembly 83 described in relation to Figure 4B and the extension assembly 85 described in relation to Figure 5.

[047] In some embodiments, the other extension tube 96 may include a distal end 98, which may be coupled to the second end 90 of the housing 86. For example, the distal end 98 may be integrated with the second end 90 of the housing 86, as illustrated, for example, in Figure 6A. In some embodiments, the distal end 98 may be removablely coupled to the second end 90 of the housing 86 by means of one or more connectors (not shown).

[048] In some embodiments, the other extension tube 96 may include a proximal end 100, which 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.

[049] Referring now to Figure 6B, another extension set 102 may include the Y 84 adapter or other suitable connector. In some embodiments, the Petition 870250095442, dated 10 / 20 / 2025, page 20 / 45 The 14 / 14 needleless connector 65 can be coupled to the Y adapter 84. In some embodiments, the second connector 54 of the extension assembly 83 and / or the extension assembly 94 may include the Y adapter 84. In some embodiments, the extension tube 40 and / or the other extension tube 96 may include the clamp 82.

[050] All examples and conditional language cited in this document are intended for pedagogical purposes to help the reader understand the invention and the concepts contributed by the inventor to advance the technique, and should be interpreted as being without limitation to those examples and conditions specifically cited. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and alterations could be made to them without departing from the spirit and scope of the invention. Petition 870250095442, dated 10 / 20 / 2025, p. 21 / 45

Claims

1 / 3 CLAIMS 1. Extension assembly (85), CHARACTERIZED in that it comprises: a first connector (44) comprising a luer lock connector; a housing (86) comprising a first end (36), a second end (90) and a fluid path (92) extending through the first end (36) and the second end (90), wherein the first end (36) is coupled to the first connector (44), wherein the housing (86) comprises a V-shape or a U-shape between the first end (36) and the second end (90), wherein the V-shape or the U-shape is enclosed between the first end (36) and the second end (90), wherein the luer lock connector is monolithically formed as a single unit with the V-shape or the U-shape;an extension tube (40) comprising a distal end (70) and a proximal end (72), wherein the distal end (70) is coupled to the second end (90) of the housing (86), wherein the fluid path (92) of the housing (96) is in fluid communication with a fluid path of the extension tube (40); and a second connector (54) coupled to the proximal end (72) of the extension tube (40).

2. Extension assembly (85), according to claim 1, CHARACTERIZED in that the extension assembly (85) further comprises another extension tube (96) extending distally from the second end (90) of the housing (86), wherein the other extension tube (96) comprises a distal end (98) and a proximal end (100), wherein a third connector (99) is coupled to the distal end (98) of the other extension tube (96).

3. Extension assembly (85), according to claim 1, CHARACTERIZED in that it further comprises a needleless connector (65) coupled to the second connector (54).

4. Extension assembly (85), according to claim 1, CHARACTERIZED in that the first connector (44) comprises the luer lock connector, wherein the luer lock connector comprises a check valve (56).

5. Extension assembly (85), according to claim 1, CHARACTERIZED in that the housing (86) is formed monolithically as a single unit with the first connector (44).

6. Extension assembly (34), CHARACTERIZED in that it comprises: a first end (36) comprising a first connector (44) configured to be coupled to a catheter adapter (46); a second end (38) comprising a second connector (54); a first extension tube (40) disposed between the first end (36) and the second end (38); and a clamp (42) configured to retain the first extension tube (40) in a curved position, wherein the clamp (42) comprises a rigid arm (68) and a hub (66) extending directly from the rigid arm (68), wherein the hub (66) is perpendicular to a longitudinal geometric axis of the rigid arm (68), wherein the rigid arm (68) comprises a coupling portion (74) configured to couple to the first extension tube (40), wherein the first extension tube (40) is curved between the hub (66) and the coupling portion (74), wherein the hub (66) is distal to the coupling portion (74);a second extension tube (60) extending directly from the hub (66) and in fluid communication with the first extension tube (40); and a third extension tube extending directly from the hub (66) and in fluid communication with the first extension tube (40).

7. Extension assembly (34), according to claim 6, CHARACTERIZED Petition 870260077139, dated 03 / 08 / 2026, page 9 / 13 3 / 3 by the fact that the coupling portion (74) of the rigid arm (68) comprises an enclosed opening (80), in which the first extension tube (40) extends through the enclosed opening (80).

8. Extension assembly (34), according to claim 6, CHARACTERIZED in that the coupling portion (74) of the rigid arm (68) comprises a fitting feature (76) configured to retain the first extension tube (40).

9. Extension assembly (34), according to claim 6, CHARACTERIZED in that the second extension tube (60) comprises a distal end (62) and a proximal end (64), wherein the second connector (54) is coupled to the distal end (62) of the second extension tube (60).

10. Extension assembly (34), according to claim 6, CHARACTERIZED in that it further comprises a needleless connector (65) coupled to the second connector (54).

11. Extension assembly (34), according to claim 6, CHARACTERIZED in that the first connector (44) comprises a luer lock connector, wherein the luer lock connector comprises a check valve (56).

12. Extension set (34), according to claim 6, CHARACTERIZED in that the second connector (54) comprises a multi-port connector. Petition 870260077139, dated 03 / 08 / 2026, page 10 / 13

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