Medical device hub and system for securing first medical device relative to second medical device

Abstract

A medical device hub includes a unitary housing defining a first fitting, a second fitting, and a mounting feature. The first accessory may be configured to be removably coupled with a first medical device, and may optionally include a threaded portion for coupling with the first medical device. In other configurations, the first fitting may be a male luer fitting. The second accessory may also be configured to be removably coupled with a second medical device, and may optionally include a threaded portion for coupling with the second medical device. In other configurations, the second fitting may be a male luer fitting.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. utility patent application No. 17 / 968,244, filed on October 18, 2022, and entitled “Medical Device Hub and System for Securing a First Medical Device Relative to a Second Medical Device,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to medical device hubs. Background Art

[0004] Currently, about 20% of all patients with long-term indwelling intravenous (IV) catheters suffer injuries due to catheter displacement. Some injuries result from the IV catheter accidentally piercing the wrong part of the patient's body. Other injuries are caused by the suturing of the base of the IV catheter to the patient's skin near the insertion site (called primary retention). A root cause of these problems is the inadvertent yanking or pulling of the IV catheter infusion extension line, which causes tension on the indwelling IV catheter line, thereby causing the IV catheter to displace from the patient's IV insertion site. This inadvertent yanking or pulling of the IV catheter extension line usually occurs when the patient mistakenly moves away from the IV infusion source, such as walking away from an IV bag hanging on an IV pole or an IV pole equipped with a pump. Alternatively, if the IV catheter extension line is hooked on other objects on or near the patient's bed, it may also occur that the IV catheter extension line is pulled.

[0005] These dislocation injuries are problematic because of the increased risk of infection and the surgical procedures required to treat the infection and / or replace the IV catheter.

[0006] Current solutions to the IV catheter migration problem described above have met with limited success. One approach involves the use of large amounts of tape around the IV catheter line and / or IV extension line in an attempt to hold the line to the patient's body (temporary auxiliary retention) so that inadvertent yanking or pulling forces / loads are not directly transmitted down to the IV insertion site or primary retention suture area. This approach has proven to be less effective, as is evident in the high percentage of current IV catheter migration-related injuries. Additionally, the use of large amounts of tape by clinicians is not ideal due to the erratic timing and manner of tape application.

[0007] Other solutions have been tried, such as auxiliary retention wearable strap devices. However, the effectiveness and adoption of these devices also tend to be low due to the IV catheter not having adequate one or more attachment or interface features between the catheter and the auxiliary retention device.

[0008] Accordingly, those skilled in the art continue to conduct research and development efforts in the field of medical device hubs and systems for securing a first medical device relative to a second medical device. Summary of the invention

[0009] A medical device hub is disclosed.

[0010] In one example, a medical device hub includes a unitary housing that defines a first fitting, a second fitting, and a mounting feature.

[0011] The first fitting may be configured to be detachably coupled to the first medical device. The first fitting may include a threaded portion configured to threadably engage with the first medical device. The first fitting may be an ISO-80369-7 Male Fluid Fitting.

[0012] The second fitting may be configured to be detachably coupled to a second medical device. The second fitting may include a threaded portion configured to threadably engage with the second medical device. The second fitting may be an ISO-80369-7 Female Fluid Fitting.

[0013] The mounting feature may be a flanged structure. The mounting feature may define at least one engagement feature. The housing may have a polymer material.

[0014] The medical device hub may include a second mounting feature defined by the housing. The second mounting feature may define at least one engagement feature. The medical device hub may include a fluid channel defined by the housing. The fluid channel may be in fluid communication with a first medical device and a second medical device.

[0015] Also disclosed is a system for securing a first medical device relative to a second medical device.

[0016] In one example, the system includes a first medical device, a second medical device in fluid communication with the first medical device, and a medical device hub positioned between the first medical device and the second medical device. The medical device hub includes a unitary housing that defines a first fitting, a second fitting in fluid communication with the first fitting, and a mounting feature.

[0017] The medical device hub of the system may also include a fluid channel defined by the housing. The first medical device may be in fluid communication with the second medical device through the fluid channel. The first medical device may be an indwelling IV catheter hub, and the second medical device may be a needleless connector. The system may also include an IV catheter lumen coupled to the first medical device and an IV extension line coupled to the second medical device.

[0018] The medical device hub of the system may include a mounting bracket removably coupled to a mounting feature of the medical device hub. The mounting bracket may include a bracket engagement structure configured to nest with the mounting feature of the medical device hub. The mounting feature may define at least one engagement feature. The mounting bracket engagement structure may include at least one mounting bracket engagement feature. The engagement feature may be configured to nest with the mounting bracket engagement feature.

[0019] The system may also include a retaining device that is removably coupled to the mounting bracket. The retaining device may be removably secured to a user. The retaining device may be one or more of an arm band and a strap. The mounting bracket may include at least one retaining device engagement feature, wherein the retaining device may be removably engaged with the retaining device engagement feature. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above and other features and advantages of the present disclosure and the manner in which they are achieved will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings, in which:

[0021] Figure 1 is a three-dimensional diagram of a hub of a medical device,

[0022] Figure 2 yes Figure 1 A three-dimensional cross-sectional view of a hub of a medical device;

[0023] Figure 3is a perspective schematic diagram of a system for securing a first medical device relative to a second medical device;

[0024] Figure 4 yes Figure 3 A three-dimensional schematic diagram of a portion of a system;

[0025] Figure 5 yes Figure 3 a perspective cutaway schematic diagram of a portion of a system; and

[0026] Figure 6 yes Figure 5 A three-dimensional schematic diagram of a portion of a system. DETAILED DESCRIPTION

[0027] Spatial or directional terms such as "left", "right", "inner", "outer", "above", "below", etc. should not be considered limiting as the invention may assume various alternative orientations.

[0028] All numbers used in the specification and claims should be understood to be modified by the term "about" in all cases. The so-called "about" refers to a range of plus or minus 10% of the stated value. As used in the specification and claims, the singular forms "a / an" and "the" include plural references unless the context clearly indicates otherwise. The terms "first", "second", etc. are not intended to refer to any particular order or sequence, but to different conditions, characteristics or elements. The so-called "at least" means "greater than or equal to".

[0029] The "one or more examples" mentioned herein means that one or more features, structures or characteristics described in conjunction with the example are included in at least one embodiment. The phrases "one or more examples" in different places in the specification may or may not refer to the same example.

[0030] As used herein, a system, device, structure, article, element, component, or hardware that is "configured to" perform a specific function is actually able to perform the specific function without any change, rather than just having the potential to perform the specific function after further modification. In other words, a system, device, structure, article, element, component, or hardware that is "configured to" perform a specific function is specifically selected, created, implemented, utilized, programmed, and / or designed for the purpose of performing a specific function. As used herein, "configured to" represents an existing characteristic of a system, device, structure, article, element, component, or hardware that enables the system, device, structure, article, element, component, or hardware to perform a specific function without further modification. For the purposes of this disclosure, a system, device, structure, article, element, component, or hardware that is described as "configured to" perform a specific function may be additionally or alternatively described as "suitable for" and / or "operably" perform the function.

[0031] Although the present invention has been described in detail based on what are currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such detail is for that purpose only and that the present invention is not limited to the disclosed embodiments, but, on the contrary, the present invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

[0032] Reference Figure 1 , Figure 1 A medical device hub 100 is disclosed. The medical device hub 100 is a single, unitary piece configured to couple with two or more medical devices. In one example, the medical device hub 100 is configured to removably couple a first medical device 220 with a second medical device 230 such that the first medical device 220 is in fluid communication with the second medical device 230. The medical device hub 100 is designed for an IV luer catheter hub. The disclosed design combines IV luer male luer, female luer, and one or more mounting bracket features in a single molded component. This combination of features allows the medical device hub 100 to be connected to IV catheter accessories, such as primary and / or secondary catheter tension load retaining devices.

[0033] In one aspect, the medical device hub 100 is designed to absorb at least a portion of any tension or other force / load applied to the first medical device 220 and / or the second medical device 230 in the event that a portion of the medical device 220, 230, or another medical device coupled to one or more of the first medical device 220 and / or the second medical device 230, becomes inadvertently pulled or entangled with an external structure. By absorbing at least a portion of any tension or other force / load, the first medical device 220, the second medical device 230, and / or any other medical device coupled to one or more of the first medical device 220 and / or the second medical device 230 are less likely to become dislodged and / or damaged.

[0034] Still refer to Figure 1 and Figure 2 In one or more examples, the medical device hub 100 includes a unitary housing 110. The unitary housing 110 can be a single molded piece having various engagement and coupling features. The unitary housing 110 can be composed of any material having the necessary material properties to absorb tensile shear or other pulling forces / loads while maintaining engagement with two or more medical devices. In one example, the housing 110 is composed of a polymer material.

[0035] In one example, the unitary housing 110 defines a first fitting 112. The first fitting 112 is configured to be removably coupled to a first medical device 220. The size and shape of the first fitting 112 can be designed to fit and nest closely with the first medical device 220. In one example, the first fitting 112 includes a threaded portion 116 that is configured to threadably engage with the first medical device 220. The threaded portion 116 can define a threaded channel surrounding a fluid channel 130 (described below) for accommodating the first medical device 220. For example, the threaded portion 112 of the first fitting 112 is located on an inner surface of the first fitting 112 so that when the first fitting is threadably engaged with the first medical device 220, the first medical device 220 is simultaneously partially accommodated within a portion of the medical device hub 100 while surrounding another portion of the medical device hub 100. In one specific, non-limiting example, the first fitting 112 is an ISO-80369-7 male fluid fitting.

[0036] Still refer to Figure 1 and Figure 2, the unitary housing 110 defines a second fitting 114. The second fitting 114 is in fluid communication with the first fitting 112. The second fitting 114 is configured to be removably coupled with a second medical device 230. The size and shape of the second fitting 114 can be designed to fit tightly and nest with the second medical device 230. In one example, the second fitting 114 includes a threaded portion 118 that is configured to threadably engage with the second medical device 230. For example, the threaded portion 118 of the second fitting 114 is located on an outer surface of the second fitting 114 so that when the second fitting is threadably engaged with the second medical device 230, the threaded portion 118 is contained within the second medical device 230. In addition, when in threaded engagement, the second medical device 230 is simultaneously partially contained within a portion of the medical device hub 100 while surrounding another portion of the medical device hub 100. In one specific, non-limiting example, the second fitting 114 is an ISO-80369-7 female fluid fitting.

[0037] Still refer to Figure 1 and Figure 2 The unitary housing 110 defines a mounting feature 120. In one example, the mounting feature 120 is a flange structure. The mounting feature 120 may define at least one engagement feature 122. Figure 1 and Figure 2 As shown, the mounting feature 120 may define more than one engagement feature 112. The mounting feature 120 is configured to removably couple with an auxiliary structure such as a retaining device 250 or a mounting bracket 240 to further secure the medical device hub 100 and associated medical devices 220, 230 to a patient or user 210.

[0038] The medical device hub 100 may also include a second mounting feature 124 defined by the housing 110. The second mounting feature 124 may be laterally opposite the mounting feature 120 relative to the central axis A. The second mounting feature 124 may be a mirror image of the mounting feature 120 such that they are designed to be substantially the same size and shape, and may define at least one engagement feature 122. For example, Figure 1 As shown, each of the mounting feature 120 and the second mounting feature 124 is a generally elongated structure parallel to the central axis A and includes engagement features 122 on both ends of the elongated structure. However, it is contemplated that the mounting feature 120 and the second mounting feature 124 may have different shapes and different numbers of engagement features 122 without affecting the function of the medical device hub 100.

[0039] Reference Figure 2In one or more examples, the medical device hub 100 further includes a fluid channel 130 defined by the housing 110. The fluid channel 130 is in fluid communication with the first medical device 220 and the second medical device 230. The fluid channel 130 can be configured to be nested within the first medical device 220, see Figure 5 , so that it is in fluid communication with the first medical device without affecting the fluid flow between the first medical device 220 and the second medical device 230. Similarly, Figure 5 As shown, the fluid channel 130 is configured to nest with the second medical device 230 so that they are in fluid communication without affecting the flow of fluid between the first medical device 220 and the second medical device 230. In one example, the fluid channel 130 is substantially defined by the first fitting 112 and has a diameter that is aligned with an inner diameter of a portion of the second medical device 230 that nests within the second fitting 114.

[0040] Reference Figure 3 , Figure 4 and Figure 5 , Figure 3 , Figure 4 and Figure 5 A system 200 is disclosed for securing a first medical device 220 relative to a second medical device 230. The system 200 is designed to securely place the first medical device 220 in fluid communication with the second medical device 230 in a manner that maintains structural integrity when tension or loads due to pulling or tugging are applied to one or more of the first medical device 220 and the second medical device 230. As a result, the two medical devices 220, 230 are less likely to become uncoupled and / or out of fluid communication than if the two medical devices 220, 230 were directly coupled together.

[0041] like Figure 3 , Figure 4 and Figure 5 As shown, the system 200 includes a first medical device 220 and a second medical device 230 in fluid communication with the first medical device 220. The first medical device 220 and the second medical device 230 can be components of a catheter, such as an intravenous (IV) catheter. In one example, the first medical device 220 is an indwelling IV catheter hub. In another example, the second medical device 230 is a needleless connector. The system 200 can also include other catheter components, including but not limited to an IV catheter lumen, an IV extension line coupled to the needleless connector.

[0042] Still refer to Figure 3 , Figure 4 and Figure 5, the system 200 includes a medical device hub 100 positioned between and in fluid communication with a first medical device 220 and a second medical device 230. As shown and described herein, the medical device 100 includes a unitary housing 110 defining a first fitting 112, a second fitting 114 in fluid communication with the first fitting 112, and a mounting feature 120. The mounting feature 120 may define at least one engagement feature 122, or may define two or more engagement features 122.

[0043] In one or more examples, the medical device hub 100 also includes a fluid channel 130 defined by the housing 110. In one example, the first medical device 220 is in fluid communication with the second medical device 230 through the fluid channel 130.

[0044] Reference Figure 5 and Figure 6 In one or more examples, the system 200 can also include a mounting bracket 240 that is removably coupled to the mounting feature 120 of the medical device hub 100. The mounting bracket 240 can include a bracket engagement structure 244 that is configured to nest with the mounting feature 120 of the medical device hub 100. The mounting bracket engagement structure 244 can include at least one mounting bracket engagement feature 246 or a plurality of engagement features 246. The engagement feature 122 of the mounting feature 120 can be configured to nest with the mounting bracket engagement feature 246. In one example, the mounting bracket 240 is a single, unitary piece having the features described above.

[0045] The system 200 may also include a retaining device 250. In one example, the retaining device 250 is removably coupled to the mounting bracket 240, see Figure 5 . The retaining device 250 can be removably secured to the user 210. The retaining device 250 can be any structure configured to comfortably and securely secure one or more medical devices and the medical device hub 100 to the user 210. For example, the retaining device 250 can be an armband 252 or a shoulder strap 254. The retaining device 250 can be secured to itself using a hook and loop structure, a buckle, a magnet, a clip, or other device for adjustably and removably securing to the user 210. In one specific, non-limiting example, the medical device hub 100 can be attached between an indwelling IV catheter hub that exits the IV catheter lumen and an IV needleless connector IV extension line. In this configuration, the medical device hub 100 can be attached to the retaining device 250 and / or strapped directly to the user 210 so that it can more effectively transfer the entire yank or pull load force from the IV extension line to the patient's body further away from the IV catheter insertion site.

[0046] The mounting bracket 240 may include at least one retainer engagement feature 242 for removably coupling with the retainer 250. The mounting bracket 240 may also include two or more retainer engagement features 242. In one example, the retainer 250 is removably engaged with the retainer engagement features 242.

[0047] Although non-limiting embodiments have been described in detail for purposes of illustration and description, it should be understood that such detail is for that purpose only, and that the embodiments are not limited to the disclosed embodiments, but rather, these embodiments or aspects are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, many of these features may be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed below may be directly dependent on only one claim, the disclosed possible implementations include each dependent claim in combination with each other claim in the claim group.

Claims

1. A medical device hub, comprising: A unitary housing, the unitary housing defining: First accessory; a second fitting, the second fitting being in fluid communication with the first fitting; as well as Installation features.

2. The medical device hub according to claim 1, wherein: The first accessory is configured to be removably coupled to a first medical device.

3. The medical device hub according to claim 1, wherein: The first fitting includes a threaded portion configured to threadably engage a first medical device.

4. The medical device hub according to claim 1, wherein: The first fitting is a male Luer fitting.

5. The medical device hub of claim 1, wherein: The second accessory is configured to be removably coupled to a second medical device.

6. The medical device hub of claim 1, wherein: The second fitting includes a threaded portion configured to threadably engage a second medical device.

7. The medical device hub of claim 1, wherein: The second fitting is a female Luer fitting.

8. The medical device hub of claim 1, wherein: The mounting feature is a flange structure.

9. The medical device hub of claim 1, wherein: The mounting feature defines at least one engagement feature.

10. The medical device hub of claim 1, wherein: The housing is composed of a polymer material.

11. The medical device hub of claim 1 , further comprising a second mounting feature defined by the housing.

12. The medical device hub of claim 11, wherein: The second mounting feature defines at least one engagement feature.

13. The medical device hub of claim 1, further comprising a fluid channel defined by the housing.

14. The medical device hub of claim 13, wherein: When the medical device hub is coupled to first and second medical devices, the fluid pathway is in fluid communication with the first and second medical devices.

15. A system for securing a first medical device relative to a second medical device, the system comprising: First medical device; a second medical device in fluid communication with the first medical device; as well as A medical device hub, the medical device hub being positioned between the first medical device and the second medical device, the medical device hub comprising: A unitary housing, the unitary housing defining: First accessory; a second fitting in fluid communication with the first fitting; and Installation features.

16. The system of claim 15, wherein: The medical device hub also includes a fluid passageway defined by the housing.

17. The system of claim 16, wherein: The first medical device is in fluid communication with the second medical device through the fluid pathway.

18. The system of claim 15, wherein: The first medical device is an indwelling IV catheter hub.

19. The system of claim 15, further comprising an IV catheter lumen coupled to the first medical device.

20. The system of claim 15, wherein: The second medical device is a needle-free connector.

21. The system of claim 15, further comprising an IV extension line coupled to the second medical device.

22. The system of claim 15, further comprising a mounting bracket removably coupled to the mounting feature of the medical device hub.

23. The system of claim 22, wherein: The mounting bracket includes a bracket engagement structure configured to nest with the mounting feature of the medical device hub.

24. The system of claim 23, wherein: The mounting feature defines at least one engagement feature; The mounting bracket engagement structure includes at least one mounting bracket engagement feature; and Wherein, the engagement feature is configured to nest with the mounting bracket engagement feature.

25. The system of claim 22, further comprising a retaining device removably coupled to the mounting bracket.

26. The system of claim 25, wherein: The retaining device is removably secured to a user.

27. The system of claim 25, wherein: The retaining device is one or more of an armband and a shoulder strap.

28. The system of claim 25, wherein: The mounting bracket includes at least one retaining device engagement feature, wherein the retaining device is removably engageable with the retaining device engagement feature.

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