Waterproof casing for insulin pumps

Abstract

A casing for an insulin delivery system includes a housing, a lid, and a gasket. The housing includes a first overmolded rubber member defining a first channel part. The lid includes a second overmolded rubber member defining a second channel part. The lid is couplable to the housing to define an enclosure and a cavity. The enclosure is configured to receive an insulin pump. The cavity receives the rubber members such that the channel parts define a channel when the lid is removably coupled to the housing. The channel encloses a tubing to fluidly couple the insulin pump to an outside of the casing. The gasket is received between the housing and the lid to seal the housing with the lid, preventing fluid ingress into the cavity and the enclosure and providing a waterproof seal between the cavity and the enclosure when the lid is removably coupled to the housing.

Description

WATERPROOF CASING FOR INSULIN PUMPSINVENTORS: JARROD KINGSPENCER JONES KIT MORRIS HOWARD KAY MILES BAILEYCROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of US Provisional Patent Application No. 63 / 552,961 filed on February 13, 2024, the entire contents of which are incorporated herein by reference.BACKGROUND1. Technical Field

[0002] The present disclosure relates, generally, to insulin delivery systems, and more particularly, relates to an insulin delivery system having a waterproof protective casing for an insulin pump.2. Description of the Prior Art

[0003] Insulin delivery systems are commonly applied to administer insulin to patients (e.g., diabetic patients) regularly and / or as needed for food or correction doses, e.g., as part of a basal- bolus insulin regimen. For activities such as bathing, swimming, etc., such systems are generally needed to be disconnected from the patient’ s body. This is because devices such as pump, electrical circuits, etc., of these systems, may be damaged as they can come in contact with water and / or elements of the outside environment. Such disconnections lead to interruptions in insulin administration and potentially prolonged periods of insufficient insulin in the patient’s body in case of a delay in reconnection of insulin delivery systems.1 Of 26FIRM:66962622vlSUMMARY

[0004] In one aspect of the disclosure, a casing for an insulin delivery system is disclosed. The casing includes a housing, a lid, and a gasket. The housing includes a first overmolded rubber member defining a first channel part. The lid includes a second overmolded rubber member defining a second channel part. The lid is removably couplable to the housing to cover the housing and define an enclosure and a cavity with the housing. The enclosure is configured to receive, at least in pail, an insulin pump. The cavity is configured to receive, at least in pail, the first overmolded rubber member and the second overmolded rubber member such that the first channel part and the second channel part define a channel when the lid is removably coupled to the housing, wherein the channel is configured to enclose a tubing to fluidly couple the insulin pump to an outside of the casing. The gasket is received between the housing and the lid to seal the housing with the lid, preventing an ingress of fluid into the cavity and the enclosure and providing a waterproof seal between the cavity and the enclosure when the lid is removably coupled to the housing.

[0005] In some additional, alternative, or selectively cumulative embodiments, one of the housing and the lid defines a groove and the other of the housing and the lid defines a seating for the gasket such that the gasket extends outwardly therefrom as a raised edge to be received, at least partly, into the groove when the lid is removably coupled to the housing.

[0006] In some additional, alternative, or selectively cumulative embodiments, the groove is a primary groove, the seating includes a secondary groove complementary to the primary groove to define the seating. The secondary groove at least partly receives the gasket therewithin.

[0007] In some additional, alternative, or selectively cumulative embodiments, the groove defines a first groove portion and a second groove portion. The first groove portion extends around the enclosure and the second groove portion extends around the cavity. Further, the gasket includes a2 Of 26FIRM:66962622vlfirst gasket portion and a second gasket portion. The first gasket portion is received within the first groove portion to provide a waterproof seal between the enclosure and the outside when the lid is removably coupled to the housing. The second gasket portion is received within the second groove portion to provide a waterproof seal between the cavity and the outside when the lid is removably coupled to the housing.[00081 In some additional, alternative, or selectively cumulative embodiments, each of the first groove portion and the second groove portion define a common groove portion. The first gasket portion and the second gasket portion complementarity defining a common gasket portion configured to be received within the common groove portion to provide the waterproof seal between the enclosure and the cavity when the lid is removably coupled to the housing.

[0009] In some additional, alternative, or selectively cumulative embodiments, the tubing passes through the common gasket portion to fluidly couple the insulin pump to the outside of the casing.

[0010] In some additional, alternative, or selectively cumulative embodiments, the first gasket portion and the second gasket portion are integrally formed.

[0011] In some additional, alternative, or selectively cumulative embodiments, the first overmolded rubber member and the second overmolded rubber member is made from silicone.

[0012] In some additional, alternative, or selectively cumulative embodiments, the channel defined by the first overmolded rubber member and the second overmolded rubber member is rated Shore 45A or lower.

[0013] In some additional, alternative, or selectively cumulative embodiments, wherein the housing defines one or more mating surfaces and the lid defines one or more engagement surfaces, the one or more engagement surfaces being correspondingly matable with the one or more mating surfaces, enabling the lid to be removably couplable to the housing.3 Of 26FIRM:66962622vl

[0014] In another aspect of the disclosure, an insulin delivery system is described. The insulin delivery system includes a power source, an insulin pump powered by the power source to supply pressurized insulin, a tubing fluidly coupled to the insulin pump to receive the pressurized insulin from the insulin pump, and a casing for enclosing the insulin pump and the tubing therewithin. The casing includes a housing and a lid. The housing includes a first overmolded rubber member defining a first channel part. The lid includes a second overmolded rubber member defining a second channel part. The lid is removably couplable to the housing to define an enclosure and a cavity with the housing. The enclosure is configured to receive, at least in part, the insulin pump. The cavity is configured to receive, at least in part, the first overmolded rubber member and the second overmolded rubber member such that the first channel part and the second channel part define a channel when the lid is removably coupled to the housing, wherein the channel is configured to enclose the tubing to fluidly couple the insulin pump to an outside of the casing. Further, the casing includes a gasket received between the housing and the lid to seal the housing with the lid, preventing an ingress of fluid into the cavity and the enclosure and providing a waterproof seal between the cavity and the enclosure when the lid is removably coupled to the housing.

[0015] In some additional, alternative, or selectively cumulative embodiments, one of the housing and the lid defines a groove and the other of the housing and the lid defines a seating for the gasket such that the gasket extends outwardly therefrom as a raised edge to be received, at least partly, into the groove when the lid is removably coupled to the housing.

[0016] In some additional, alternative, or selectively cumulative embodiments, the groove is a primary groove, the seating includes a secondary groove complementary to the primary groove to define the seating. The secondary groove at least partly receives the gasket therewithin.4 Of 26FIRM:66962622vl

[0017] In some additional, alternative, or selectively cumulative embodiments, the groove defines a first groove portion and a second groove portion. The first groove portion extends around the enclosure and the second groove portion extends around the cavity. Further, the gasket includes a first gasket portion and a second gasket portion. The first gasket portion is received within the first groove portion to provide a waterproof seal between the enclosure and the outside when the lid is removably coupled to the housing. The second gasket portion is received within the second groove portion to provide a waterproof seal between the cavity and the outside when the lid is removably coupled to the housing. In some additional, alternative, or selectively cumulative embodiments, the first gasket portion and second gasket portion define independent zones for the channel and enclosure.

[0018] In some additional, alternative, or selectively cumulative embodiments, each of the first groove portion and the second groove portion define a common groove portion. The first gasket portion and the second gasket portion complementarily defining a common gasket portion configured to be received within the common groove portion to provide the waterproof seal between the enclosure and the cavity when the lid is removably coupled to the housing.

[0019] In some additional, alternative, or selectively cumulative embodiments, the tubing passes through the common gasket portion to fluidly couple the insulin pump to the outside of the casing.

[0020] In some additional, alternative, or selectively cumulative embodiments, the first gasket portion and the second gasket portion are integrally formed.

[0021] In some additional, alternative, or selectively cumulative embodiments, the first overmolded rubber member and the second overmolded rubber member is made from silicone.5 of 26FIRM:66962622vl

[0022] In some additional, alternative, or selectively cumulative embodiments, the channel defined by the first overmolded rubber member and the second overmolded rubber member is rated Shore 45 A or lower.

[0023] In some additional, alternative, or selectively cumulative embodiments, wherein the housing defines one or more mating surfaces and the lid defines one or more engagement surfaces, the one or more engagement surfaces being correspondingly matable with the one or more mating surfaces, enabling the lid to be removably couplable to the housing.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is a perspective view of the casing of FIG. 1, in accordance with an embodiment of the disclosure;

[0025] FIG. 2 is an inside view of a housing of the casing illustrating an insulin pump, a tubing, and a gasket of the casing, in accordance with an embodiment of the disclosure;

[0026] FIG. 3 is an inner perspective view of the housing and at least a pail of the gasket removed, in accordance with an embodiment of the disclosure;

[0027] FIG. 4 is an outer perspective view of a lid of the casing, in accordance with an embodiment of the disclosure;

[0028] FIG. 5 is an outer perspective view of the housing illustrating a U-shaped clip of the casing along with a push button which may be manually actuated to activate the insulin pump, in accordance with an embodiment of the disclosure;

[0029] FIG. 6 is an inner perspective view of the lid of the casing, in accordance with an embodiment of the disclosure;

[0030] FIG. 7 is a perspective view of the housing illustrating mating surfaces of the housing that are matable with engagement surfaces of the lid, in accordance with an embodiment of the disclosure; and6 of 26FIRM:66962622vl

[0031] FIG. 8 is a top view of the casing illustrating the push button of FIG. 5, in accordance with an embodiment of the disclosure.DETAILED DESCRIPTION

[0032] Example embodiments are described below with reference to the accompanying drawings. Unless otherwise expressly stated in the drawings, the sizes, positions, etc., of components, features, elements, etc., as well as any distances therebetween, are not necessarily to scale, and may be disproportionate and / or exaggerated for clarity.

[0033] The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be recognized that the terms “comprise,” “comprises,” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. Unless otherwise specified, a range of values, when recited, includes both the upper and lower limits of the range, as well as any sub-ranges therebetween. Unless indicated otherwise, terms such as “first,” “second,” etc., are only used to distinguish one element from another. For example, one element could be termed a “first element” and similarly, another element could be termed a “second element,” or vice versa. The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0034] Unless indicated otherwise, the terms “about,” “thereabout,” “substantially,” etc. mean that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances,7 Of 26FIRM:66962622vlconversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0035] Spatially relative terms, such as “right,” left,” “below,” “beneath,” “lower,” “above,” and “upper,” and the like, may be used herein for ease of description to describe one element's or feature's relationship to another element or feature, as illustrated in the drawings. It should be recognized that the spatially relative terms are intended to encompass different orientations in addition to the orientation depicted in the figures. For example, if an object in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” can, for example, encompass both an orientation of above and below. An object may be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may be interpreted accordingly.

[0036] Unless clearly indicated otherwise, all connections and all operative connections may be direct or indirect. Similarly, unless clearly indicated otherwise, all connections and all operative connections may be rigid or non-rigid.

[0037] Like numbers refer to like elements throughout. Thus, the same or similar numbers may be described with reference to other drawings even if they are neither mentioned nor described in the corresponding drawing. Also, even elements that are not denoted by reference numbers may be described with reference to other drawings.

[0038] Many different forms and embodiments are possible without deviating from the spirit and teachings of this disclosure and so this disclosure should not be construed as limited to the example embodiments set forth herein. Rather, these example embodiments are provided so that this8 Of 26FIRM:66962622vldisclosure will be thorough and complete, and will convey the scope of the disclosure to those skilled in the art.

[0039] Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. The appearance of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments.

[0040] Referring to FIGS. 1 and 2, an insulin delivery system 100 is described. The insulin delivery system 100 may be a compact and portable unit which may be applied to patients suffering from diabetes, insulin deficiency, and / or similar disorders. The insulin delivery system 100 includes a power source 104, such as a battery, e.g., a lithium-ion battery, to generate power (see FIG.2). Various other conventionally available power sources that may be suited for powering any portable medical device may also be applied to generate power in the insulin delivery system 100, as well. Although aspects of the present disclosure are described in relation to delivery systems that deliver or administer insulin into a patient’s body, said aspects may be suitably applied to many other similar fluid delivery systems applicable for administering medicaments (e.g., liquid medicaments) to a variety of patients. All such systems fall within the ambit of the claimed subject matter. Among other devices of the insulin delivery system 100, the insulin delivery system 100 also includes an insulin pump 108, a tubing 112, and a casing 116, as shown.

[0041] The insulin pump 108 may be applied for supplying or injecting fluid and / or a volume of insulin into the patient. To this end, the insulin pump 108 may be powered by the power source104 to pressurize the volume of insulin stored within a reservoir, which may form part of the9 Of 26FIRM:66962622vlinsulin pump 108 itself - the reservoir is not shown as the same is contemplatable by someone in the art. The insulin pump 108 may include any known or conventionally available mechanism, now known or in the future developed, to generate a pumping action for the supply / administration of the volume of insulin into a patient’s body.

[0042] Referring to FIG. 2, the tubing 112 may define a conduit 120 for the pressurized insulin or the volume of insulin to flow therethrough. The tubing 112 may define a first end 124 and a second end 128. The first end 124 may be fixedly and fluidly coupled to an outport 132 of the insulin pump (e.g., by a luer connection or a press-fit connection) (not shown) so as to receive a volume of insulin (or a pressurized volume of insulin) from the insulin pump 108, while the second end 128 may be fixedly and fluidly coupled to an outlet 136 of the casing 116 (e.g., by a luer connection or a press-fit connection) (not shown). Effectively, the tubing may fluidly couple the insulin pump 108 to an outside of the casing 116. Although not limited, the tubing 112 may be flexible and may be made from silicone, or rubber, or a polymer, or a combination of these.

[0043] During a working of the insulin delivery system 100, as power from the power source 104 is sourced (e.g., by an activation or a manual depression of a switch or a push button) (see push button 140, also see FIG. 8), the insulin pump 108 is activated. As a result, the insulin pump 108 pressurizes the insulin, drawing the volume of insulin out of the reservoir. Further, the insulin pump 108 may force the insulin into the conduit 120 defined by the tubing 112 through the first end 124 of the conduit 120. In that manner, the tubing 112, fluidly coupled to the insulin pump 108, may receive the volume of insulin from the insulin pump 108. A continued push offered by a working of the insulin pump 108 may push the volume of insulin further into the conduit 120 and thereafter urge the volume of insulin to exit out of the tubing 112 through the second end 128 of the conduit 120 before flowing out of the casing through the outlet 136.10 01 26FIRM:66962622vl

[0044] Referring to FIGS. 3 through 6, the casing 116 may be used to accommodate and / or enclose the aforementioned devices, such as the power source 104, the insulin pump 108, and the tubing 112, therewithin. In so doing, the casing 116 may keep said devices protected from interference with external agents, e.g., elements that may be present in an environment 144 (see FIG. 1) surrounding the casing 116. According to an aspect of the present disclosure, the casing 116 may provide a waterproof sealing to keep water away from the aforementioned devices, such as the power source 104, the insulin pump 108, and / or the tubing 112, of the insulin delivery system 100. The waterproof sealing may also provide protection against influx of other external agents, such as fluids other than water, along with dust and debris, into the casing 116. Although not shown, the casing 116 may house other devices, e.g., integrated circuits, electrical connections, microcontrollers, etc., associated with the insulin pump 108, as well, and those that are described in the present disclosure arc exemplary . To provide the aforesaid protection and sealing, the casing 116 may include a housing 148, a lid 152, and a gasket 156.

[0045] The housing 148 may accommodate at least a portion of the insulin pump 108 and at least a portion of the tubing 112. To accommodate the insulin pump 108, the housing may include structural features such as guardrails (not shown) arranged therewithin to secure the insulin pump 108 to the housing 148. Although not limited, the housing 148 may include a plastic hard- shell and / or a high-grade, waterproof material (e.g., including ABS plastic, thermoplastic elastomers (TPE), and / or silicone). Further, the housing 148 may define one or more compartments, e.g., a first compartment 160 and a second compartment 164. The first compartment 160 may accommodate at least a portion of the insulin pump 108, and the second compartment 164 may accommodate at least a portion of the tubing 112. In some embodiments, the first compartment160 and the second compartment 164 may be used to accommodate additional devices, e.g., the11 of 26FIRM:66962622vlpower source 104, electrical connections, circuits, etc., as noted above, of the insulin delivery system 100. The housing 148 includes (e.g., within the second compartment 164) a first overmolded rubber member 170 defining a first channel part 174.

[0046] In some embodiments, the housing 148 defines first coupling features 172 (e.g., see FIG.7) that may enable the housing 148 to be coupled, e.g., removably coupled, with the lid 152. In this regard, the first coupling features 172 of the housing 148 may define one or more mating surfaces 176, as shown. The mating surfaces 176 may be formed on arms 180 (which may be in the form of flexible clasps) that extend away from a body of the housing 148, as shown. In some embodiments, the mating surfaces 176 may include projections to engage with corresponding coupling features (see second coupling features 173, FIG. 4) of the lid 152. In some embodiments, the arms 180 may be detachable from the body of the housing 148, and, optionally or additionally, may be altogether separable from the housing 148. The arms 180 are not shown in all figures for clarity.

[0047] The lid 152 may be removably couplable to the housing 148 to define an enclosure 184 and a cavity 188 with the housing 148 - the enclosure 184 and the cavity 188 are best visualizable through FIGS. 3 and 7 in relation to the housing 148 (but with the lid 152 removed from those views). In other words, the lid 152 may define a fully covered and / or closed enclosure (i.e., enclosure 184) along with a fully covered and / or closed cavity (i.e., cavity 188) with the housing 148 when the lid 152 is coupled with the housing 148. In some embodiments, portions (e.g., structural portions) at least partly defining the cavity 188 and the enclosure 184 may be partially present in each of the housing 148 and the lid 152. Such structural portions may include parts of the first compartment 160 and the second compartment 164 (see FIG. 3) of the housing 148 discussed above. As with the housing 148, the lid 152 may also complementarily define one or12 01 26FIRM:66962622vlmore compartments, e.g., a third compartment 162 and a fourth compartment 166 to at least partly define the cavity 188 and the enclosure 184 (see FIG. 6). In some embodiments, the third compartment 162 and the fourth compartment 166 also, at least partly, define the cavity 188 and the enclosure 184. As with the compartments of the housing 148, the third compartment 162 may accommodate at least a portion of the insulin pump 108, and the fourth compartment 166 may accommodate at least a portion of the tubing 112. In some optional embodiments, one of the housing 148 or the lid 152 can fully define the cavity 188 and / or the enclosure 184, as well. It may be noted that the first compartment 160 and the third compartment 162 define the enclosure 184 while the second compartment 164 and the fourth compartment 166 define the cavity 188.

[0048] The lid 152 includes (e.g., within the third compartment 162) a second overmolded rubber member 178 defining a second channel part 182. It will be appreciated that the first channel part 174 and the second channel part 182 together define a channel 186 when the lid 152 is removably coupled to the housing 148. The tubing 112 is enclosable within the channel 186 - annotations of the channel 186 in the figures are to be visualized when the first channel part 174 and the second channel part 182 are brought together during a coupling of the lid 152 to the housing 148. In effect, the cavity 188 is configured to receive, at least in part, the first overmolded rubber member 170 and the second overmolded rubber member 178 such that the first channel part 174 and the second channel part 182 define the channel 186 when the lid 152 is removably coupled to the housing 148. In some embodiments, each of the first overmolded rubber member 170 and the second overmolded rubber member 178 may be overmolded soft rubber members.

[0049] The channel 186 is configured to enclose (e.g., sealably enclose) the tubing 112. To this end, when the lid 152 is being coupled or being assembled to the housing 148, the tubing 112 may be positioned within any one of the first channel part 174 or the second channel part 182. As the13 of 26FIRM:66962622vllid 152 may be brought to be coupled and / or assembled with the housing 148, the first overmolded rubber member 170 and the second overmolded rubber member 178 may contact and press against each other. Also, the tubing 112 may fall into the channel 186 formed combinedly by the first channel part 174 and the second channel part 182 and be enclosed therewithin to be ready for use. In some embodiments, the channel 186 is a flexible elastomeric tubing passage integrated into the enclosure 184, comprising a variable-diameter compression channel that conforms to tubing diameter changes. This composition prevents fluid ingress while maintaining insulin flow.

[0050] In some embodiments, the channel 186 may define a diameter of 1.5 millimeters (mm) + / - 0.4 mm and a length of 35 mm + / - 2 mm. Although the values noted, it will be appreciated that these values are provided for illustrative purposes alone and can include other values. Further, the channel 186 forms a protective outlet portion of the tubing 112 that accommodates a 31.5mm + / - 2mm ISO luer connector. Although not limited, the channel 186 defined by the first overmolded rubber member 170 and the second overmolded rubber member 178 may define a varying cross- sectional area, e.g., along or between the first end 124 and the second end 128. In some embodiments, the channel 186 includes an overmolded soft rubber rated Shore 45 A or lower to define an adequate seal around the tubing 112 ensuring there is no leakage of fluid (e.g., insulin) with respect to the channel 186. Although not limited, both the first overmolded rubber member 170 and the second overmolded rubber member 178 may be housed, at least in pail, within the cavity 188 when the lid 152 is removably coupled to the housing 148.

[0051] As with the housing 148, the lid 152 may define the second coupling features 173 (e.g., see FIG. 4) that may enable the lid 152 to be coupled, e.g., removably coupled, with the housing 148. In this regard, the lid 152 may define one or more engagement surfaces 192, as shown in FIG. 4.The engagement surfaces 192 may be correspondingly matable with the mating surfaces 176 of14 01 26FIRM:66962622vlthe housing 148, enabling the lid 152 to be removably couplable to the housing 148. In some embodiments, the engagement surfaces 192 may include receptacles to receive (e.g., retentively receive) the projections of the mating surfaces 176. Once the lid 152 is coupled with the housing 148, the enclosure 184 and the cavity 188 may be defined by the casing 116. In some embodiments, the enclosure 184 may be configured to receive, at least in part, the insulin pump 108, and the cavity 188 may be configured to receive, at least in part, the tubing 112 such that the tubing 112 can fluidly couple the insulin pump 108 to the outside of the casing 116.

[0052] When mating with the engagement surfaces 192 of the lid 152, the arms 180 may engage and slide against a portion of the lid 152, deform and bias away or outwardly, and then snap into engagement with the engagement surfaces 192 of the lid 152, e.g., as soon as the projections may be received into the receptacles. To help achieve such engagement, the lid 152 and the housing 148 (and / or the engagements features provided thereon) may be complementarily shaped with respect to each other. In some embodiments, each of the lid 152 and the housing 148 may embody a rectangular shape, as exemplarily shown. One or more arms 180 defining corresponding mating surfaces (e.g., mating surfaces 176) may extend from each of the sides of such a rectangularly- shaped housing in order to be engaged with a corresponding number of engagement surfaces (e.g., engagement surfaces 192) defined on the a rectangularly-shaped lid.

[0053] Referring to FIGS. 3 and 6, the gasket 156 may be received between the housing 148 and the lid 152 to seal the housing 148 with the lid 152. The gasket 156 (or the sealing provided by the gasket 156) is applied to prevent an ingress of elements (e.g., fluid, water, dust) into the enclosure 184 and the cavity 188. In other words, the gasket 156 provides a waterproof seal between the enclosure 184 and the cavity 188 when the lid 152 is removably coupled to the housing 148, e.g.,15 01 26FIRM:66962622vlby way of the engagement between the engagement surfaces 192 and the mating surfaces 176. The gasket 156 may include a first gasket portion 196 and a second gasket portion 200, as shown.

[0054] In some embodiments, one of the housing 148 and the lid 152 defines a groove (see a groove 204 on the housing 148, FIG. 3) and the other of the housing 148 and the lid 152 defines a seating 208 for the gasket 156 such that the gasket 156 extends outwardly therefrom as a raised edge 158 to be received, at least partly, into the groove 204 when the lid 152 is removably coupled to the housing 148 - the seating 208 can be best understood by visualizing a placement of the gasket 156 in FIG. 6. In some embodiments, the seating 208 of the lid 152 may include a groove, as well. In such a case, the groove 204, noted above, may be a primary groove 206, and the seating 208 may include a secondary groove 210. Moreover, in such a case, the secondary groove 210 may be complementary to the primary groove 206. Also, the gasket 156 may be at least partly receivable into each of the primary groove 206 and the secondary groove 210.

[0055] The groove 204 may define a first groove portion 212 and a second groove portion 216. The first groove portion 212 may extend around the enclosure 184 (or around the first compartment 160) and the second groove portion 216 may extend around the cavity 188 (or around the second compartment 164). Each of the first groove portion 212 and the second groove portion 216 may meet at an interface to define a common groove portion 220. In some embodiments, the common groove portion 220 may be arranged as an interface between the enclosure 184 and the cavity 188, e.g., on a wall separating the enclosure 184 from the cavity 188. The first gasket portion 196 of the gasket 156 may be received within the first groove portion 212 to provide a continuous waterproof seal between the enclosure 184 and the outside when the lid 152 is (removably) coupled to the housing 148. The second gasket portion 200 of the gasket 156 may be received within the second groove portion 216 to provide a continuous waterproof seal between the cavity 188 and the16 01 26FIRM:66962622vloutside when the lid 152 is (removably) coupled to the housing 148. In some embodiments, the coupling mechanism of the waterproof seal between the enclosure 184 and the outside lid 152 is compression engagement. In some embodiments, the coupling mechanism of the waterproof seal between the cavity 188 and the outside when the lid 152 is (removably) coupled to the housing 148 is compression engagement. The first gasket portion 196 and the second gasket portion 200 may include different shapes and sizes, and, therefore, the overall gasket 156 may define an asymmetrical shape, e.g., asymmetrical about a central axis - this may be visualizable from FIG. 2.

[0056] With regard to the common groove portion 220, complementarity, the first gasket portion 196 and the second gasket portion 200 may define a common gasket portion 224 (see FIG. 6), as well, that may be received within the common groove portion 220. In so doing, the common gasket portion 224 may provide waterproof seal between the enclosure 184 and the cavity 188, as well, when the lid 152 is removably coupled to the housing 148, thus fluidly separating the enclosure 184 from the cavity 188. Discussions corresponding to the groove 204 may be contemplated for both the primary groove 206 and the secondary groove 210.

[0057] In some embodiments, a portion of the tubing 112 passes through the common gasket portion 224 (e.g., defining a tight fit or an interference fit with the common gasket portion 224) to fluidly couple and route the insulin pump 108 to the outlet 136 of the casing 116. In some embodiments, the first gasket portion 196 and the second gasket portion 200 may be integrally formed, e.g., by casting a suitable material in the same mold. In some embodiments, one of the overmolded rubber member, e.g., the first overmolded rubber member 170, can be integrally formed with the gasket 156.17 01 26FIRM:66962622vl

[0058] As part of some optional features of the casing 1 16, the lid 152 may include a screen 228 (e.g., a capacitive and touch responsive screen, see FIG. 1) allowing users or patients of the insulin delivery system 100 or the casing 116 to view status of dosages of insulin administration and also interact with and / or control the insulin pump 108. The screen 228 may be bonded (e.g., by using waterproof industrial grade adhesives) to an edge of a window formed in the lid 152. Further, in some embodiments, an outer surface of the housing 148 may include a pocket that can fixedly receive a U-shaped clip 232 (e.g., a metallic U-shaped clip, see FIG. 5). The U-shaped clip 232 may be used to secure the casing 116 to the patient (e.g., to a clothing or to any wearable item worn by the patient).

[0059] The sealed nature of the casing 116 isolates and protects the insulin pump 108 and other devices housed within the casing 116 from the environment outside of the casing 116. The configuration of the casing 116 as described herein has experimentally provided waterproofing up to 3 feet for up to 30 minutes. This allows patients to perform activities such as bathing and swimming, without the need to disconnect the casing 116 from his / her body, thus allowing an uninterrupted administration and optimized inflow of insulin into the patient’s body. Such uninterrupted administration enhances patient comfort, device usability, and ensures the longevity and functionality of the insulin pump 108 and other devices accommodated by the casing 116 in various environments and during a myriad of activities, e.g., which may include exposure to water, dust, and the elements of the general environmental outside the casing 116.

[0060] Moreover, the seal between the cavity 188 and the enclosure 184, e.g., by way of the common gasket portion 224, prevents any transfer or flow of fluid (if disposed outside the overmolded rubber members 170, 178 and / or the insulin pump 108) between the enclosure 184 and the cavity 188. In brevity, the casing 116 or the insulin delivery system 100, as a whole,18 01 26FIRM:66962622vlprovides a reliable, waterproof solution for safeguarding insulin pumps and the various devices housed therein from water and mechanical damage, in turn providing for an uninterrupted administration of insulin to patients.19 01 26FIRM:66962622vl

Claims

CLAIMSWhat is claimed is:

1. A casing for an insulin delivery system, the casing comprising: a housing including a first overmolded rubber member defining a first channel pail; a lid including a second overmolded rubber member defining a second channel part, the lid removably couplable to the housing to cover the housing and define an enclosure and a cavity with the housing, the enclosure configured to receive, at least in part, an insulin pump, the cavity configured to receive, at least in part, the first overmolded rubber member and the second overmolded rubber member such that the first channel part and the second channel pail define a channel when the lid is removably coupled to the housing, wherein the channel is configured to enclose a tubing to fluidly couple the insulin pump to an outside of the casing; and a gasket received between the housing and the lid to seal the housing with the lid, preventing an ingress of fluid into the cavity and the enclosure and providing a waterproof seal between the cavity and the enclosure when the lid is removably coupled to the housing.

2. The casing of claim 1, wherein one of the housing and the lid defines a groove and the other of the housing and the lid defines a seating for the gasket such that the gasket extends outwardly therefrom as a raised edge to be received, at least partly, into the groove when the lid is removably coupled to the housing.

3. The casing of claim 2, wherein the groove is a primary groove, the seating includes a secondary groove complementary to the primary groove to define the seating, the secondary groove at least partly receiving the gasket therewithin.20 of 26FIRM:66962622vl4. The casing of claim 1, wherein the groove defines a first groove portion and a second groove portion, the first groove portion extending around the enclosure and the second groove portion extending around the cavity, and the gasket including: a first gasket portion received within the first groove portion to provide a waterproof seal between the enclosure and the outside when the lid is removably coupled to the housing, and a second gasket portion received within the second groove portion to provide a waterproof seal between the cavity and the outside when the lid is removably coupled to the housing.

5. The casing of claim 4, wherein each of the first groove portion and the second groove portion define a common groove portion, the first gasket portion and the second gasket portion complementarity defining a common gasket portion configured to be received within the common groove portion to provide the waterproof seal between the enclosure and the cavity when the lid is removably coupled to the housing.

6. The casing of claim 5, wherein the tubing passes through the common gasket portion to fluidly couple the insulin pump to the outside of the casing.21 Of 26FIRM:66962622vl7. The casing of claim 4, wherein the first gasket portion and the second gasket portion are integrally formed.

8. The casing of claim 1, wherein the first overmolded rubber member and the second overmolded rubber member is made from silicone.

9. The casing of claim 1, wherein the channel defined by the first overmolded rubber member and the second overmolded rubber member is rated Shore 45 A or lower.

10. The casing of claim 1, wherein the housing defines one or more mating surfaces and the lid defines one or more engagement surfaces, the one or more engagement surfaces being correspondingly matable with the one or more mating surfaces, enabling the lid to be removably couplable to the housing.

11. An insulin delivery system comprising: a power source; an insulin pump powered by the power source to pressurize a volume of insulin; a tubing fluidly coupled to the insulin pump to receive the volume of insulin from the insulin pump; and a casing for enclosing the insulin pump and the tubing therewithin, the casing including: a housing including a first overmolded rubber member defining a first channel part;22 Of 26FIRM:66962622vla lid including a second overmolded rubber member defining a second channel part, the lid removably couplable to the housing to define an enclosure and a cavity with the housing, the enclosure configured to receive, at least in part, the insulin pump, the cavity configured to receive, at least in part, the first overmolded rubber member and the second overmolded rubber member such that the first channel part and the second channel part define a channel when the lid is removably coupled to the housing, wherein the channel is configured to enclose the tubing to fluidly couple the insulin pump to an outside of the casing; and a gasket received between the housing and the lid to seal the housing with the lid, preventing an ingress of fluid into the cavity and the enclosure and providing a waterproof seal between the cavity and the enclosure when the lid is removably coupled to the housing.

12. The insulin delivery system of claim 11, wherein one of the housing and the lid defines a groove and the other of the housing and the lid defines a seating for the gasket such that the gasket extends outwardly therefrom as a raised edge to be received, at least partly, into the groove when the lid is removably coupled to the housing.

13. The insulin delivery system of claim 12, wherein the groove is a primary groove, the seating includes a secondary groove complementary to the primary groove to define the seating, the secondary groove at least partly receiving the gasket therewithin.23 of 26FIRM:66962622vl14. The insulin delivery system of claim 11 , wherein the groove defines a first groove portion and a second groove portion, the first groove portion extending around the enclosure and the second groove portion extending around the cavity, and the gasket including: a first gasket portion received within the first groove portion to provide a waterproof seal between the enclosure and the outside when the lid is removably coupled to the housing, and a second gasket portion received within the second groove portion to provide a waterproof seal between the cavity and the outside when the lid is removably coupled to the housing.

15. The insulin delivery system of claim 14, wherein each of the first groove portion and the second groove portion define a common groove portion, the first gasket portion and the second gasket portion complementarity defining a common gasket portion configured to be received within the common groove portion to provide the waterproof seal between the enclosure and the cavity when the lid is removably coupled to the housing.

16. The insulin delivery system of claim 15, wherein the tubing passes through the common gasket portion to fluidly couple the insulin pump to the outside of the casing.

17. The insulin delivery system of claim 14, wherein the first gasket portion and the second gasket portion are integrally formed.24 Of 26FIRM:66962622vl18. The insulin delivery system of claim 11, wherein the first overmolded rubber member and the second overmolded rubber member is made from silicone.

19. The insulin delivery system of claim 11, wherein the channel defined by the first overmolded rubber member and the second overmolded rubber member is rated Shore 45 A or lower.

20. The insulin delivery system of claim 11, wherein the housing defines one or more mating surfaces and the lid defines one or more engagement surfaces, the one or more engagement surfaces being correspondingly matable with the one or more mating surfaces, enabling the lid to be removably couplable to the housing.25 Of 26FIRM:66962622vl

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