Haptic features to guide user interaction with fluid connectors

Abstract

A fluid connector for an infusion kit. The fluid connector includes a housing having a sleeve integral with and extending distally therefrom a proximal inner surface of the housing. The proximal outer surface of the housing includes a portion having a tactile feature centered on the longitudinal axis of the sleeve to assist a user in connecting the fluid connector to an infusion kit base.

Description

[0001] Case Analysis

[0002] This patent application is a divisional patent application. The original application of this divisional patent application (i.e., the parent application, office file number IIM193789) is a patent application filed on November 29, 2019, with application number 201911197014.6 and subject matter entitled "Tactile Feature Part for Guiding User Interaction with Fluid Connector".

[0003] Cross-references to related applications

[0004] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 773,662, filed November 30, 2018, pursuant to 35 USC 119(e), the contents of which are incorporated herein by reference in their entirety. Technical Field

[0005] This invention relates generally to infusion devices, and more specifically, to infusion devices used in conjunction with infusion pumps for the subcutaneous infusion of insulin and other drugs. Background Technology

[0006] One insulin infusion therapy modality includes infusion pump therapy via catheters, needles, or other types of cannulas. Infusion pumps offer the advantages of continuous insulin infusion, precise dosing, and programmable delivery schedules. Taken together, these advantages result in more accurate glycemic control. In this insulin infusion therapy modality, the infusion pump remains attached to the user, and the required dose of insulin is delivered to the user via the pump.

[0007] One type of cannula is a catheter, which is typically a tube that can be inserted into the body to allow fluid administration. In infusion pump therapy, the type and size of the catheter can vary, but generally, the catheter is a thin, flexible tube. However, in some applications, it may need to be larger and / or rigid. Rigid hollow metal needles can also be used instead of soft plastic catheters.

[0008] Medtronic sells a standard infusion kit as the Quick-Set® Infusion Kit. In such a device, the infusion pump includes a catheter assembly connected to the pump via a tubing kit, and a separate insertion device inserts and / or attaches the catheter assembly to the user via a guide needle provided as part of the infusion kit. The infusion kit and insertion device can also be combined, such as the Mio® Infusion Kit sold by Medtronic, which is an “all-in-one” design that combines the infusion kit and insertion device into a single unit.

[0009] Another type of insulin infusion device, known as a "patch pump," has recently become available. Unlike conventional infusion pumps, patch pumps are integrated devices that combine most or all of the fluid components in a single housing that adhesively attaches to the infusion site, eliminating the need for a separate infusion (tubing) kit. The patch pump adheres to the skin, contains insulin (or other medications), and delivers the drug transdermally or via an integrated subcutaneous microcatheter over a period of time. Some patch pumps communicate wirelessly with a separate controller device (such as those sold under the brand name OmniPod®), while others are completely standalone.

[0010] Conventional infusion devices may include a fluid connector that can be releasably attached to a base that can be secured to the user's skin. The infusion pump supplies fluid to the catheter via the fluid connector / base engagement.

[0011] However, concerns arise regarding this device that it is difficult to balance the force required to disconnect the tubing without removing the catheter from the user's skin with the retention force sufficient to hold the infusion components for routine infusions. Another concern is that the disconnecting force needs to be designed so that if the user accidentally trips over the extension tubing on an external structure (such as a doorknob), the extension tubing will disconnect from the fluid connector without removing the catheter from the user's skin, thus avoiding the need for the patient to obtain a new infusion kit and reconnect and reinsert it. Yet another concern is the patient's ability (many patients have reduced tactile sensation) to correctly and reliably connect and disconnect the fluid connector from the base. Summary of the Invention

[0012] One aspect of the present invention is therefore to provide a fluid connector that is easy to connect and disconnect from a base.

[0013] The foregoing and / or other aspects of the present invention are achieved by providing a fluid connector for an infusion kit. The fluid connector includes a housing having a sleeve integral with and extending distally from a proximal inner surface of the housing. A proximal outer surface of the housing includes a portion having a tactile feature centered on the longitudinal axis of the sleeve to assist a user in connecting the fluid connector to an infusion kit base.

[0014] The foregoing and / or other aspects of the present invention are also achieved by providing a two-piece fluid connector for an infusion kit. The fluid connector includes a fluid path portion comprising a sleeve integral with and extending from a proximal inner surface of the fluid path portion. The fluid connector also includes a latch portion secured to the fluid path portion and having a pair of movable arms. Each movable arm includes a connector latch disposed at a first cantilever end of the arm and an actuation lever disposed at an opposite cantilever end of the arm. The proximal portion of the actuation lever includes a lateral tactile feature to prevent the fluid connector from sliding distally from the user's grip.

[0015] The foregoing and / or other aspects of the present invention are also achieved by providing a two-piece fluid connector for an infusion kit. The fluid connector includes a fluid path portion comprising a sleeve integral with and extending from a proximal inner surface of the fluid path portion. The fluid connector also includes a latch portion secured to the fluid path portion and having a pair of movable arms. Each movable arm includes a connector latch disposed at a first cantilever end of the arm and an actuation lever disposed at an opposite cantilever end of the arm. The final portion of the actuation lever includes a lateral tactile feature to prevent the fluid connector from sliding forward from the user's grip.

[0016] Additional and / or other aspects and advantages of the invention will be set forth in the description which follows, or will become apparent from the description, or may be learned by practice of the invention. Attached Figure Description

[0017] The above and / or other aspects and advantages of one embodiment of the invention will be more readily understood from the following detailed description, taken in conjunction with the accompanying drawings, in which:

[0018] Figure 1-4 These are various views of the fluid connectors and associated bases of related technologies;

[0019] Figure 5 This is a side view of a fluid connector according to an embodiment of the present invention connected to a base;

[0020] Figure 6 yes Figure 5 Top view of the fluid connector;

[0021] Figure 7 yes Figure 5 A three-dimensional view of the fluid path portion of the fluid connector;

[0022] Figure 8 This is a perspective view of a fluid connector according to another embodiment of the present invention;

[0023] Figure 9-17This is a corresponding top view of a fluid connector according to other embodiments of the present invention;

[0024] Figure 18-20 These are corresponding perspective views of fluid connectors according to other embodiments of the present invention;

[0025] Figure 21 and 22 These are top and perspective views of a fluid connector according to another embodiment of the present invention;

[0026] Figure 23 This is a perspective view of a fluid connector according to another embodiment of the present invention. Detailed Implementation

[0027] The embodiments of the invention will be described in detail with reference to the accompanying drawings, wherein the same reference numerals refer to the same elements throughout. The described embodiments are illustrative with reference to the drawings but are not intended to limit the invention.

[0028] These embodiments are not intended to be mutually exclusive; features of one embodiment may be combined with other embodiments, as long as they do not contradict each other.

[0029] Those skilled in the art will understand that this disclosure is not limited to the application of the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. The embodiments herein can be other embodiments and can be practiced or performed in various ways. The wording and terminology used herein are for descriptive purposes and should not be considered limiting. The terms “comprising,” “including,” or “having,” and variations thereof, as used herein, are intended to cover the items listed thereafter and their equivalents, as well as additional items. Unless otherwise limited, the terms “connected,” “coupled,” and “mounted,” and variations thereof are used extensively herein and cover both direct and indirect connections, couplings, and installations. Furthermore, the terms “connected” and “coupled,” and variations thereof, are not limited to physical or mechanical connections or couplings. Additionally, terms such as “upper,” “lower,” “bottom,” “top,” “front,” “rear,” “upper,” “lower,” “upward,” “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 of exemplary embodiments of the invention to any particular location or orientation. Terms of degree, such as “substantially” or “approximately”, are understood by those skilled in the art to refer to a reasonable range around and including a given value, as well as ranges beyond the given value, such as general tolerances related to the manufacture, assembly, and use of an embodiment. When referring to a structure or characteristic, the term “substantially” includes most or all of the characteristics.

[0030] Figure 1 These are perspective views of a two-piece fluid connector 10 and an associated base 80, such as those found in publication WO 2013 / 086463, the contents of which are incorporated herein by reference in their entirety. Figure 2 This is an exploded perspective view of the fluid connector 10. Figure 3 This is a bottom view of the fluid connector 10. Figure 4 This is a cross-sectional view of the fluid connector 10 connected to the base 80. The fluid connector 10 includes two parts: a fluid path portion 12 and a latch portion 14. The fluid path portion 12 and the latch portion 14 together form the housing 15. The latch portion 14 includes an actuating lever 16, a fluid connector latch 18, and a rigid stop 20.

[0031] The actuating lever 16, the fluid connector latch 18, and the rigid stop 20 are integrally formed as a single structure. Furthermore, the actuating lever 16 and its corresponding fluid connector latch 18 form arms. These arms are displaceable relative to the fluid path portion 12. The fluid connector latch 18 can be displaced to a latched position, in which at least a portion of the fluid connector latch 18 is disposed within the fluid path portion 12. Additionally, the arms are resiliently biased toward the latched position.

[0032] like Figure 1 and Figure 4 As best shown, the top surface of the fluid connector 10 is rounded to reduce its profile and minimize the possibility of the user tripping over it when wearing it.

[0033] The fluid path portion 12 includes a pipe connector portion 22 for connecting the fluid connector 10 to a pipe. The fluid path portion 12 can be secured to the latch portion 14 via a snap-fit ​​engagement.

[0034] like Figure 1 , Figure 3 and Figure 4 As shown, the fluid path portion 12 has a blunt sleeve 22 extending distally from the proximal inner surface of the housing 15. When the blunt sleeve 22 is connected to the corresponding base 80 via a patient cannula 84 already inserted into the user's skin, the blunt sleeve 22 pierces the septum 86 in the mushroom-shaped head 82 of the base 80 to fluidly connect the pump to the patient cannula 86 on the distal side of the base 80.

[0035] Preferably, the user forces the fluid connector latch 18 outward (due to contact with the mushroom head 82 of the base 80) by pressing distally (i.e., straight down), and once the fluid connector latch has moved distally around the mushroom head 82 due to the inward elastic bias of the fluid connector latch 18, the fluid connector 10 is engaged in place, thereby attaching the fluid connector 10 to the corresponding base 80.

[0036] To release the fluid connector 10 from the base 80, the user squeezes, for example, the actuating lever 16 until it contacts the rigid stop 20. This action, by radially outward pivoting and displacing the fluid connector latch 18 fully away from the mushroom head 82, disengages the fluid connector latch 18 from the mushroom head 82 of the base 80. The user then lifts the fluid connector 10 proximally from the base 80.

[0037] The start lever 16 may have a finger protrusion 24 located in its center to help the user locate and use the start lever 16.

[0038] However, many users may have reduced tactile function in their fingers, and the small size of the fluid connector 10 can make connection to the base 80 difficult. Furthermore, due to the rounded surface of the fluid connector 10, the user's fingers may slip when gripping it. Additionally, many fluid connectors on the market connect to the base via horizontal sliding (i.e., substantially parallel to the skin surface) or at a non-vertical angle. Therefore, users may be unfamiliar with the vertical connection between the fluid connector 10 and the base 80. The fluid connector 10 itself does not indicate how to connect it to the base 80. Furthermore, the central position of the finger protrusion 24 on the rounded actuation lever 16 could potentially cause the user's fingers to slip.

[0039] Figure 5 This is a side view of a fluid connector 100 according to an embodiment of the present invention, connected to a base such as base 80. Figure 6 This is a top view of the fluid connector 100. The fluid path portion 102 and the latch portion 104 together form the housing 106. Figure 7 The latch part 104 is omitted. Figure 7 This is a perspective view of the fluid path portion 102. Although not explicitly shown, like the housing 15 described above, the housing 106 has a blunt sleeve 105 extending distally from the proximal inner surface of the housing 106. The sleeve 105 has... Figure 5 The longitudinal axis 112 is shown.

[0040] like Figure 5-7As shown, the proximal outer surface of the fluid path portion 102 includes a portion 108 with a tactile feature 110, rather than a rounded top surface like that of the fluid connector 10. According to one embodiment, portion 108 is preferably a flat-topped portion 108. According to other embodiments, portion 108 is convex or recessed. According to one embodiment, the tactile feature 110 protrudes proximally from the surface 108 and is raised. Preferably, the tactile feature 110 is centered on the longitudinal axis 112 of the sleeve 105. This tactile feature 110 helps the user connect the fluid connector 100 to the base 80 because it tactilely informs the user where the longitudinal axis of the sleeve is located, and thus informs the user where to center the fluid connector 10 on the base 80 and press the fluid connector 10 down to connect it to the base 80.

[0041] Although the tactile feature 110 is preferably raised, according to some embodiments, the tactile feature 110 may be recessed. Furthermore, even if the tactile feature 110 is raised to project proximally from portion 108, preferably, the height profile of the fluid connector 100 is at least no greater than the height profile of the fluid connector 10. This configuration provides a profile that reduces the likelihood of tripping compared to the fluid connector 10.

[0042] According to one embodiment, such as Figure 5-7 As shown, the tactile feature 110 consists of three protrusions arranged in a triangle centered on the longitudinal axis 112 of the sleeve. Figure 8 In the middle, the tactile feature section 110 is also three protrusions arranged in a triangle centered on the longitudinal axis 112 of the sleeve, but the orientation of the triangle is relative to... Figure 7 The orientation of the middle triangle is opposite.

[0043] Figure 9-17 These are corresponding top views of fluid connectors according to other embodiments of the present invention. In each of these embodiments, the tactile feature is centered on the longitudinal axis 112 of the sleeve. Figure 9 In the middle, the tactile feature part 110 is a ring, in Figure 10 In the middle, the tactile feature area consists of multiple concentric rings. Figure 11 In the middle, the tactile feature 110 is cross-shaped, cross-shaped, or cruciform, and... Figure 12 In the middle, the tactile feature part 110 is "X". Figure 13 The tactile feature 110 is cross-shaped.

[0044] exist Figure 14 and 15 In the middle, the tactile feature 110 consists of multiple linear ribs. Figure 14 In the middle, the linear ribs are oriented to extend in the front-rear direction of the shell 106, while Figure 15In this design, 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 invention.

[0045] exist Figure 16 and 17 In the middle, the tactile feature portion 110 consists of multiple arched ribs. Figure 16 In the middle, the arched ribs are oriented in the same direction, while in... Figure 17 In the middle, the arched ribs are oriented in different directions. According to some embodiments, Figure 9-17 The tactile feature 110 is raised, and in some embodiments, Figure 9-17 The tactile features are concave.

[0046] like Figure 18 As shown, the actuation lever 114 of the latch portion 104 includes a second lateral tactile feature 116 disposed on the proximal portion of the actuation lever 114. The second lateral tactile feature 116 helps prevent the fluid connector 100 from sliding distally from the user's grip. Preferably, the second lateral tactile feature 116 is a raised, radially outwardly extending feature, although according to some embodiments, the second lateral tactile feature 116 is recessed from the outer surface of the actuation lever 114. The second lateral tactile feature 116 also assists the user in lifting the fluid connector from the base 80, particularly if the lateral tactile feature is raised. According to one embodiment, the second lateral tactile feature 116 is a plurality of lateral cantilevered posts. According to one embodiment, the plurality of lateral cantilevered posts comprise a plurality of lateral cantilevered polygons, for example in… Figure 18 As shown in the figure. According to another embodiment (not shown), the plurality of lateral cantilever columns include a plurality of lateral cantilever rectangular columns.

[0047] like Figure 19 As shown, the second lateral tactile feature 116 may include a plurality of circular protrusions, and as Figure 20 As shown, the second lateral tactile feature 116 may include a plurality of cantilevered cylindrical columns.

[0048] Figure 21 and 22 One embodiment is shown in which each actuation lever 114 includes a lateral tactile feature 118 disposed on a corresponding rear portion of the actuation lever 114. According to one embodiment, the lateral tactile feature 118 includes an outwardly projecting or raised vertical ridge 118 to prevent the fluid connector 100 from sliding forward from the user's grip. Those skilled in the art will understand that shapes other than vertical ridges may be employed without departing from the scope of the invention. For example, some embodiments include a recessed tactile feature 118.

[0049] exist Figure 21In the diagram, the unbiased or idle position of the actuation lever 16 of the related technology fluid connector 10 is shown by a dashed line. From Figure 21 As can be seen, the unbiased position of the actuation lever 114 is flared outwards relative to the unbiased position of the actuation lever 16 in the related art. Furthermore, the rigid stop 120 is laterally wider than the rigid stop 20 of the fluid connector 10 in the related art, and the actuation lever 114 has a laterally inward protrusion 122. The wider rigid stop 120 and the laterally inward protrusion 122 combine to provide an inwardly compressed or released position where the individual actuation levers are approximately parallel, or slightly beyond parallel. This new configuration also helps prevent the fluid connector 100 from sliding forward from the user's grip, compared to the V-shaped release position of the actuation lever 16 in the related art.

[0050] like Figure 23 As shown, the fluid connector 100 may include a combination of features for assisting in the positioning of the fluid connector and features for preventing slippage from the user's grip. For example, the fluid connector may include a flat portion 108 on which tactile features 110 are provided, and an actuation lever 114 may include a laterally cantilevered polygon 116 and a vertical ridge 118. In some embodiments, some or all of the tactile features 110, 114, and 116 are recessed. Furthermore, when idle, the actuation lever 114 may be laterally outwardly flared compared to the actuation lever 16 of the related art. Additionally, in some embodiments, the portion 108 may be recessed or protruding. Those skilled in the art will understand that other combinations of features may be employed without departing from the scope of the invention.

[0051] Although only a few embodiments of the invention have been shown and described, the invention is not limited to the described embodiments. Those skilled in the art will understand that other changes can be made to the disclosed embodiments without departing from the scope of the invention. Furthermore, any embodiments, features, and / or elements disclosed herein can be combined with each other to form various additional combinations not specifically disclosed, provided that the combined embodiments, features, and / or elements do not contradict each other. All such variations and combinations are considered to be within the scope of the invention as defined by the appended claims and their equivalents.

Claims

1. A two-piece fluid connector for an infusion kit, the fluid connector comprising: The fluid path portion includes a sleeve (22) integral with the proximal inner surface of the fluid path portion and extending distally from the proximal inner surface in a vertical direction. as well as A latching portion, which is fixed to the fluid path portion and has a pair of movable arms, each arm comprising: A connector latch is provided at the first cantilever end of the arm; and An actuation lever (114) is disposed at the opposite cantilever end of the arm and extends in a direction not parallel to the vertical direction, wherein the proximal portion of the last part of the actuation lever includes a first lateral tactile feature, the first lateral tactile feature including a vertical ridge (118) that bulges radially outward from the outside of the actuation lever, and the proximal portion of the actuation lever prior to the last part includes a second lateral tactile feature (116) that bulges radially outward from the outside of the actuation lever to prevent the fluid connector from sliding distally from the user's grip.

2. The two-piece fluid connector according to claim 1, wherein, The second lateral tactile feature (116) includes a plurality of lateral cantilever columns.

3. The two-piece fluid connector according to claim 2, wherein, The lateral cantilever column is a roughly rectangular solid body.

4. The two-piece fluid connector according to claim 2, wherein, The lateral cantilever column is approximately cylindrical.

5. The two-piece fluid connector according to claim 2, wherein, The lateral cantilever column includes a lateral cantilever polygon.

6. A connector, the connector comprising: The fluid path portion includes a sleeve (22) integral with the proximal inner surface of the fluid path portion and extending distally in a vertical direction from the proximal inner surface of the fluid path portion. as well as A latching portion, which is fixed to the fluid path portion and has a pair of movable arms, each arm comprising: A connector latch is provided at the first cantilever end of the arm; and An actuation lever (114) is disposed at the opposite cantilever end of the arm and extends in a direction not parallel to the vertical direction, wherein the proximal portion of the last part of the actuation lever includes a first lateral tactile feature, the first lateral tactile feature including a vertical ridge (118) that bulges radially outward from the outside of the actuation lever, and the proximal portion of the actuation lever prior to the last part includes a second lateral tactile feature (116) that bulges radially outward from the outside of the actuation lever to prevent the connector from sliding from the user's grip in multiple directions, and wherein the proximal outer surface of the fluid path portion has a flat portion having a third tactile feature.

7. The connector according to claim 6, wherein, The third tactile feature is centered on the longitudinal axis of the sleeve to help the user connect the connector to the infusion kit base.

8. The connector according to claim 6, wherein: The fluid path portion includes a stop fixedly disposed thereon; The starting levers all include protrusions extending laterally and inward; and The laterally inward protrusion and the stop are configured to reach a release position, in which the actuating lever contacts the stop and is substantially parallel to it.

9. The connector according to claim 7, wherein, The third tactile feature includes three protrusions arranged in a triangle centered on the longitudinal axis of the sleeve.

10. The connector according to claim 7, wherein, The third tactile feature includes a ring centered on the longitudinal axis of the sleeve.

11. The connector according to claim 7, wherein, The third tactile feature includes multiple concentric rings centered on the longitudinal axis of the sleeve.

12. The connector according to claim 7, wherein, The third tactile feature includes a cross-shaped portion centered on the longitudinal axis of the sleeve.

13. The connector according to claim 7, wherein, The third tactile feature includes an "X"-shaped portion centered on the longitudinal axis of the sleeve.

14. The connector according to claim 7, wherein, The third tactile feature includes a crosshair section centered on the longitudinal axis of the sleeve.

15. The connector according to claim 7, wherein, The third tactile feature includes a plurality of linear ribs centered on the longitudinal axis of the sleeve.

16. The connector according to claim 7, wherein, The third tactile feature includes a plurality of arcuate ribs centered on the longitudinal axis of the sleeve.

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