Tactile features to guide user interaction with fluid connectors

Abstract

To provide a fluid connector that is easily connected to and disconnected from a base.SOLUTION: A fluid connector 100 for use with an infusion set includes a housing 106 having a cannula integral with and extending distally from a proximal interior surface of the housing. A proximal exterior surface of the housing has a portion with a tactile feature 110 having a center at a longitudinal axis 112 of the cannula to aid a user in connecting the fluid connector with an infusion set base.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority based on U.S. Provisional Application No. 62 / 773,662, filed on November 30, 2018. The disclosure thereof is incorporated herein by reference in its entirety.

[0002] The present invention relates to general infusion devices, and more particularly to infusion devices used with an infusion pump in subcutaneous infusion of insulin and other drugs.

Background Art

[0003] One mode of insulin infusion treatment includes infusion pump therapy via a catheter, a needle, or other types of cannulas. Infusion pumps provide the advantages of continuous insulin infusion, accurate dosing, and a programmable delivery schedule. At the same time, these advantages result in more accurate blood glucose control. In this mode of insulin infusion treatment, the infusion pump remains attached to the user, and the required dose of insulin is delivered to the user via the pump.

[0004] One type of cannula is a catheter, which is generally a tube that can be inserted into the body to enable fluid administration. In infusion pump therapy, the type and size of the catheter may vary, but generally, the catheter is a thin, flexible tube. However, depending on the application, it may be large and / or rigid. Instead of a soft plastic catheter, a rigid hollow metal needle can also be used.

[0005] One type of conventional infusion set is marketed by Medtronic as the Quick-Set® infusion set. In such a device, the infusion pump includes a catheter assembly connected to the pump via a tubing set, and a separate insertion device inserts and / or attaches the catheter assembly to the user via an introduction needle provided as part of the infusion set. It is also possible to combine the infusion set and insertion device, as in the Mio® infusion set marketed by Medtronic. The Mio® infusion set is an "all-in-one" design that combines the infusion set and insertion device into a single unit.

[0006] Another type of insulin infusion device, known as a "patch pump," has recently become available. Unlike conventional infusion pumps, a patch pump is an integrated device that combines almost all or all of the fluid components into a single housing that is adhesively attached to the infusion site, eliminating the need for separate infusion (tubing) sets. The patch pump adheres to the skin, contains insulin (or other medication), and delivers the drug over a period of time, either percutaneously or via an integrated subcutaneous minicatheter. Some patch pumps communicate wirelessly with a separate controller device (such as those marketed under the brand name OmniPod®), while others are completely self-contained.

[0007] Conventional infusion devices may include a fluid connector that can be releasably mounted to a base that can be fixed to the user's skin. The infusion pump supplies fluid to the catheter via the fluid connector and / or the base engagement.

[0008] However, there are concerns that such devices would be difficult to balance with the force required to detach the tube without pulling the catheter from the user's skin and the retention force necessary to secure the infusion component for daily infusions. Another concern is that if the user accidentally snags the extension tube on an external structure (such as a doorknob), the separation force needs to be designed so that the extension tube detaches from the fluid connector without removing the catheter from the user's skin. This would eliminate the need for the patient to obtain, connect, and reinsert a new infusion set. Yet another concern is the ability of many patients with reduced tactile sensation to properly and reliably connect and disconnect the fluid connector at the base. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] International Publication No. 2013 / 086463 [Overview of the project] [Problems that the invention aims to solve]

[0010] Therefore, one aspect of the present invention is to provide a fluid connector that is easy to connect to and disconnect from a base.

[0011] The aforementioned and / or other aspects of the present invention are achieved by providing a fluid connector for use in an injection set. The fluid connector includes a housing having a cannula that is integral with the proximal inner surface of the housing and extends distally therefrom. The proximal outer surface of the housing has a portion with tactile features centered on the longitudinal axis of the cannula, which assists the user in connecting the fluid connector to the injection set base.

[0012] The aforementioned and / or other aspects of the present invention are also achieved by providing a two-part fluid connector for use in an injection set. The fluid connector includes a fluid portion which is integral with the proximal inner surface of the fluid portion and includes a cannula extending therefrom. The fluid connector also includes a latch portion which is fixed to the fluid portion and has a pair of displaceable arms. Each displaceable arm includes a connector latch located at one cantilever end of the arm and an actuating lever located at the other cantilever end of the arm. The proximal portion of the actuating lever includes a lateral tactile feature to prevent distal slippage of the fluid connector from the user's grip.

[0013] The aforementioned and / or other aspects of the present invention are also achieved by providing a two-part fluid connector for use in an injection set. The fluid connector includes a fluid portion which is integral with the proximal inner surface of the fluid portion and includes a cannula extending therefrom. The fluid connector also includes a latch portion which is fixed to the fluid portion and has a pair of displaceable arms. Each displaceable arm includes a connector latch located at one cantilever end of the arm and an operating lever located at the other cantilever end of the arm. The rearmost part of the operating lever includes a lateral tactile feature to prevent the fluid connector from slipping forward from the user's grip.

[0014] Additional and / or other aspects and advantages of the present invention are described in the following description, become apparent therefrom, or can be acquired through the practice of the present invention. [Brief explanation of the drawing]

[0015] The aforementioned and / or other embodiments and advantages of the present invention will be more readily apparent from the following detailed description in conjunction with the accompanying drawings.

[0016] [Figure 1] Figure 1 shows a conventional fluid connector and its associated base. [Figure 2] Figure 2 shows a conventional fluid connector and its associated base. [Figure 3]Figure 3 is a diagram of a fluid connector and an associated base in the prior art. [Figure 4] Figure 4 is a diagram of a fluid connector and an associated base in the prior art. [Figure 5] Figure 5 is a side view of a fluid connector connected to a base in an embodiment of the present invention. [Figure 6] Figure 6 is a top view of the fluid connector of Figure 5. [Figure 7] Figure 7 is a perspective view of the flow path portion of the fluid connector of Figure 5. [Figure 8] Figure 8 is a perspective view of a fluid connector according to another embodiment of the present invention. [Figure 9] Figure 9 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 10] Figure 10 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 11] Figure 11 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 12] Figure 12 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 13] Figure 13 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 14] Figure 14 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 15] Figure 15 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 16] Figure 16 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 17] Figure 17 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 18] Figure 18 is a perspective view of a fluid connector according to another embodiment of the present invention. [Figure 19] Figure 19 is a perspective view of a fluid connector according to another embodiment of the present invention. [Figure 20]Figure 20 is a perspective view of a fluid connector according to another embodiment of the present invention. [Figure 21] Figure 21 is a top view of a fluid connector according to another embodiment of the present invention. [Figure 22] Figure 22 is a perspective view of a fluid connector according to another embodiment of the present invention. [Figure 23] Figure 23 is a perspective view of a fluid connector according to another embodiment of the present invention. [Modes for carrying out the invention]

[0017] Hereafter, embodiments of the present invention shown in the accompanying drawings will be referenced in detail, with similar reference numerals throughout referring to similar elements. The embodiments described herein illustrate, but are not limited to, the present invention by reference to the drawings.

[0018] The embodiments are not intended to be mutually exclusive. Features of one embodiment can be combined with those of other embodiments, as long as they do not contradict each other.

[0019] Those skilled in the art will understand that this disclosure is not limited in its application to the details of the configuration and arrangement of components described in the following description or shown in the drawings. The embodiments described herein are not limited to other embodiments, and can be implemented or performed in various ways. The words and terms used herein are for illustrative purposes only and should not be considered limiting. The use of “includes,” “contains,” or “has” and variations thereof herein means to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise limited, the terms “connected,” “joined,” and “mounted” herein and variations thereof are used broadly and include direct and indirect connections, combinations, and mountings. Furthermore, the terms “connected” and “mounted” and variations thereof are not limited to physical or mechanical connections or combinations. Furthermore, terms such as “top,” “bottom,” “bottom,” “top,” “front,” “rear,” “upper side,” “lower side,” “upper,” “downward,” and other directional descriptors are intended to facilitate the description of exemplary embodiments of the invention and are not intended to limit the structure. Terms of degree such as “substantially” or “approximately” are understood by those skilled in the art to indicate, for example, general tolerances relating to the manufacture, assembly, and use of an embodiment, encompassing a reasonable range including a given value and outside of that given value. When referring to structure or characteristics, the term “substantially” includes almost or completely characteristics.

[0020] Figure 1 is a perspective view of a two-component fluid connector 10 and associated base 80 in the prior art, as described in Patent Document 1, the entire disclosure of which is incorporated herein by reference. Figure 2 is an exploded perspective view of the fluid connector 10, Figure 3 is a bottom view of the fluid connector 10, and Figure 4 is a cross-sectional view of the fluid connector 10 connected to the base 80. The connector 10 includes two components: a flow channel portion 12 and a latch portion 14. The flow channel portion 12 and the latch portion 14 together form a housing 15. The latch portion 14 includes an operating lever 16, a fluid connector latch 18, and a rigid stop portion 20.

[0021] The operating lever 16, the fluid connector latch 18, and the rigid stop section 20 are integrally formed as a single structure. Furthermore, the operating lever 16, together with the respective fluid connector latches 18, forms an arm. These arms are displaceable relative to the flow path section 12. The fluid connector latch 18 is displaceable to a latch position in which at least a portion is located within the flow path section 12. Furthermore, the arms are elastically biased toward the latch position.

[0022] As best shown in Figures 1 and 4, the top surface of the fluid connector 10 is rounded to reduce the profile and minimize potential snagging when worn by a user.

[0023] The flow path portion 12 includes a tubing connector portion 22 for connecting the fluid connector 10 to the piping. The flow path portion 12 can be secured to the latch portion 14 by a snap-fit ​​engagement.

[0024] As shown in Figures 1, 3, and 4, the fluid channel section 12 has a blunt-headed cannula 22 extending distally from the proximal inner surface of the housing 15. When the fluid connector 10 is connected to the base 80 to which the patient cannula 84 inserted into the user's skin is attached, the blunt-headed cannula 22 passes through the partition wall 86 of the mushroom-shaped head 82 of the base 80, fluidly connecting the pump to the distal patient cannula 86 of the base 80.

[0025] Preferably, the user pushes the fluid connector 10 distally (i.e., straight down) to attach it to the corresponding base 80, and the contact with the mushroom-shaped head 82 of the base 80 pushes the fluid connector latch 18 outward, and once the fluid connector 10 avoids the mushroom-shaped head 82 and latches distally due to the inward elastic bias of the fluid connector latch 18, the fluid connector 10 is snapped into place.

[0026] To release the fluid connector 10 from the base 80, the user presses, for example, the operating lever 16 until it contacts the rigid stop 20. This action causes the fluid connector latch 18 to rotate and displace sufficiently radially outward, passing through the mushroom-shaped head 82, thereby disengaging the fluid connector latch 18 from the mushroom-shaped head 82 on the base 80. The user then lifts the fluid connector 10 proximally away from the base 80.

[0027] The operating lever 16 has finger bumps 24 positioned in the center above it, which can help the user find and use the operating lever 16.

[0028] However, many users may have reduced tactile sensation in their fingers, and a small size for the fluid connector 10 could make it difficult to connect to the base 80. Furthermore, the rounded surface of the fluid connector 10 could cause the user's fingers to slip when gripping the fluid connector. In addition, many fluid connectors on the market connect to the base by sliding horizontally (i.e., substantially parallel to the skin surface) or at a non-vertical angle. Therefore, a vertical connection between the fluid connector 10 and the base 80 may be unfamiliar to the user. The fluid connector 10 itself does not indicate how to connect it to the base 80. Furthermore, the central position of the finger bump 24 on the rounded operating lever 16 could potentially cause the user's fingers to slip.

[0029] Figure 5 is a side view of a fluid connector 100 connected to a base such as a base 80 in an embodiment of the present invention. Figure 6 is a top view of the fluid connector 100. The flow path portion 102 and the latch portion 104 together form a housing 106. The latch portion 104 is omitted from Figure 7, which is a perspective view of the flow path portion 102. Although not explicitly shown, the housing 106 has a blunt-headed cannula 105 extending distally from the proximal inner surface of the housing 106, similar to the housing 15 described above. The cannula 105 has a longitudinal axis 112 as shown in Figure 5.

[0030] As shown in Figures 5 to 7, the proximal outer surface of the fluid flow portion 102 has a portion 108 having a tactile feature 110, rather than a rounded top surface like that of the fluid connector 10. According to one embodiment, the portion 108 is preferably a flat top surface. According to another embodiment, the portion 108 is convex or concave. According to one embodiment, the tactile feature 110 protrudes and rises proximally from the surface 108. Preferably, the tactile feature 110 is centered on the longitudinal axis 112 of the cannula 105. Such a tactile feature 110 tactilely informs the user of the position of the longitudinal axis of the cannula, thus assisting the user when connecting the fluid connector 100 to the base 80. Thus, it informs the user of the position to place the fluid connector 10 in the center of the base 80 and to push down the fluid connector 10 to connect it to the base 80.

[0031] The tactile feature portion 110 is preferably raised, but according to some embodiments, the tactile feature portion 110 may be recessed. Furthermore, even if the tactile feature portion 110 is raised so as to protrude proximally from portion 108, preferably the height profile of the fluid connector 100 is not greater than at least the height profile of the fluid connector 10. Such a configuration can reduce snagging compared to the fluid connector 10.

[0032] In one embodiment, as shown in Figures 5 to 7, the tactile feature portion 110 consists of three bumps arranged in a triangle centered on the longitudinal axis 112 of the cannula. In Figure 8, the tactile feature portion 110 also consists of three bumps arranged in a triangle centered on the longitudinal axis 112 of the cannula, but the orientation of the triangle is reversed compared to the orientation of the triangle in Figure 7.

[0033] Figures 9 to 17 are top views of fluid connectors according to other embodiments of the present invention. In each of these embodiments, the tactile feature is positioned around the longitudinal axis 112 of the cannula. In Figure 9, the tactile feature 110 is a ring; in Figure 10, the tactile feature is a plurality of concentric rings; in Figure 11, the tactile feature 110 is cross-shaped, or intersecting, or crossed; in Figure 12, the tactile feature 110 is X-shaped; and in Figure 13, the tactile feature 110 is a crosshair.

[0034] As shown in Figures 14 and 15, the tactile feature portion 110 consists of a plurality of linear ribs. In Figure 14, the linear ribs are oriented to extend from front to rear of the housing 106, and in Figure 15, the linear ribs are oriented to extend laterally. Those skilled in the art will understand that other orientations of the linear ribs are possible without departing from the scope of the present invention.

[0035] As shown in Figures 16 and 17, the tactile feature portion 110 consists of multiple arched ribs. In Figure 16, the arched ribs are oriented in the same direction, while in Figure 17, the arched ribs are oriented in different directions. In some embodiments, the tactile feature portion 110 in Figures 9 to 17 is raised, and in some embodiments, the tactile feature portion in Figures 9 to 17 is recessed.

[0036] As shown in Figure 18, the operating lever 114 of the latch portion 104 includes a lateral tactile feature portion 116 located on the proximal portion of the operating lever 114. The lateral tactile feature portion 116 helps prevent distal slippage of the fluid connector 100 from the user's grip. In some embodiments, the lateral tactile feature portion 116 is recessed from the outer surface of the operating lever 114, but it is preferable that the lateral tactile feature portion 116 is raised (extending radially outward). Also, the lateral tactile feature portion 116 can help the user lift the fluid connector from the base 80, especially when the lateral tactile feature portion is raised. According to one embodiment, the lateral tactile feature portion 116 is a plurality of lateral cantilevered supports 116. According to one embodiment, the plurality of lateral cantilevered supports 116 include a plurality of lateral cantilevered polygons as shown in Figure 18. According to another embodiment (not shown), the plurality of lateral cantilevered columns 116 include a plurality of lateral cantilevered rectangular columns.

[0037] As shown in Figure 19, the lateral tactile feature portion 116 may include a plurality of rounded protrusions 116, and as shown in Figure 20, the lateral tactile feature portion 116 may include a plurality of cantilevered cylindrical supports 116.

[0038] Figures 21 and 22 show embodiments in which each operating lever 114 includes a lateral tactile feature 118 located at the rearmost part of the operating lever 114. According to one embodiment, the lateral tactile feature 118 includes a vertical ridge 118 that protrudes outward or is raised to prevent the fluid connector 100 from slipping forward from the user's grip. Those skilled in the art will understand that shapes other than a vertical ridge can be adopted without departing from the scope of the invention. For example, some embodiments include a recessed tactile feature 118.

[0039] In Figure 21, the unbiased or stationary position of the operating lever 16 of the conventional fluid connector 10 is shown by a dotted line. As seen in Figure 21, the unbiased position of the operating lever 114 is outwardly extended compared to the unbiased position of the operating lever 16 in the conventional technology. Furthermore, the rigid stop portion 120 is wider laterally than the rigid stop portion 20 of the conventional fluid connector 10, and the operating lever 114 has a laterally inwardly extending projection 122. The wide rigid stop portion 120 and the laterally inwardly extending projection 122, in combination, provide the operating lever with an inwardly compressed position where it is approximately parallel, or a released position where it is slightly beyond parallel. This new configuration also helps prevent the fluid connector 100 from slipping forward from the user's grip compared to the V-shaped released position of the operating lever 16 in the conventional technology.

[0040] As shown in Figure 23, the fluid connector 100 may include a combination of features to assist in positioning the fluid connector and prevent slippage from the user's grip. For example, the fluid connector may include a flat portion 108 with a tactile feature portion 110 positioned thereon, and the actuating lever 114 may include a laterally cantilevered polygon 116 and a vertical ridge 118. In some embodiments, some or all of the tactile feature portions 110, 114, and 116 are recessed. Furthermore, when stationary, the actuating lever 114 may spread laterally outward compared to the actuating lever 16 of the prior art. Furthermore, in some embodiments, the portion 108 may be concave or convex. Those skilled in the art will understand that other combinations of features can be used without departing from the scope of the present invention.

[0041] Although only a few embodiments of the present invention have been described, the present invention is not limited to the embodiments described. Those skilled in the art will understand that other modifications can be made to the disclosed embodiments without departing from the scope of the invention. Furthermore, any of the embodiments, features, and / or elements disclosed herein can be combined with each other to form a variety of additional combinations not specifically disclosed, provided that the embodiments, features, and / or elements are not inconsistent with each other. All such modifications and combinations are deemed to be within the scope of the present invention as defined by the appended claims and their equivalents.

Claims

1. A fluid connector that can be attached to and detached from the injection set base, A housing having a cannula that is integrated with the proximal inner surface of the housing and extends distally therefrom, The proximal outer surface of the housing has a flat upper portion and a tactile feature portion formed on the flat upper portion and having a shape centered on the longitudinal axis of the cannula, wherein when the user vertically connects the fluid connector to a head provided at the center of the injection set base, the tactile feature portion tactilely informs the user of the position of the longitudinal axis of the cannula, and informs the user of the position to place the fluid connector at the center of the injection set base and push down the fluid connector to connect the injection set base to the head.

2. The fluid connector according to claim 1, characterized in that the tactile feature portion includes three ridges arranged in a triangle centered on the longitudinal axis of the cannula.

3. The fluid connector according to claim 1, characterized in that the tactile feature portion comprises a ring centered on the longitudinal axis of the cannula.

4. The fluid connector according to claim 1, characterized in that the tactile feature portion includes a plurality of concentric rings centered on the longitudinal axis of the cannula.

5. The fluid connector according to claim 1, characterized in that the tactile feature portion includes an intersection centered on the longitudinal axis of the cannula.

6. The fluid connector according to claim 1, characterized in that the tactile feature portion includes an X-shape centered on the longitudinal axis of the cannula.

7. The fluid connector according to claim 1, characterized in that the tactile feature portion includes a crosshair centered on the longitudinal axis of the cannula.

8. The fluid connector according to claim 1, characterized in that the tactile feature portion comprises a plurality of linear ribs centered on the longitudinal axis of the cannula.

9. The fluid connector according to claim 1, characterized in that the tactile feature portion comprises a plurality of arc-shaped ribs centered on the longitudinal axis of the cannula.

10. A fluid connector according to claim 1, The aforementioned housing, The flow channel portion including the cannula, A latch portion fixed to the aforementioned flow path portion and having a pair of displaceable arms, Equipped with, Each of the aforementioned arms includes a connector latch located at one cantilever end of the arm and an operating lever located at the other cantilever end of the arm, The fluid connector is characterized in that the proximal portion of the operating lever includes a lateral tactile feature portion for preventing distal slippage of the fluid connector from the user's grip.

11. The fluid connector according to claim 10, characterized in that the rearmost part of the operating lever includes a second lateral tactile feature for preventing the fluid connector from slipping forward from the user's grip.

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