Check valve with flash seal

Abstract

A check valve assembly for fluid flow kits and devices is provided. The check valve assembly includes a housing having an inlet body and an outlet body. The inlet body includes a fluid inlet, a first sealing flange having a first height, a second sealing flange having a second height, and a central passage. The outlet body includes a fluid outlet and a stem having a centering post received by the central passage of the inlet body. A seal has an inner ring having a first thickness and an outer ring having a second thickness less than the first thickness. In a fully sealed position of the check valve assembly, the inner ring engages the first sealing flange and the outer ring engages the second sealing flange. Fluid flow kits and methods for manufacturing the check valve assembly are also provided.

Description

[0001] Cross-references to related applications

[0002] none Background Technology

[0003] In the medical field, check valves are used in devices that control the flow of fluid to a patient, such as for fluid flow due to gravity in intravenous (IV) venous systems or pump kits. Typical check valves are prone to low-flow leakage if particles are trapped between the elastomeric seal and the sealing flange. Having double sealing flanges presents a challenge because the sealing flanges need to be exactly the same height to eliminate any gaps that could allow leakage. The desired outcome is a medical fluid flow check valve that prevents low-flow leakage, thereby improving safety and reducing risk. Summary of the Invention

[0004] This disclosure provides a medical fluid flow check valve with double sealing rings.

[0005] In one or more embodiments, a check valve assembly is provided. The check valve assembly includes a housing having an inlet body. The inlet body includes a fluid inlet, a first sealing flange having a first height, a second sealing flange having a second height, and a central channel. The housing also includes an outlet body. The outlet body includes a fluid outlet and a rod having a centering post configured to be received by the central channel of the inlet body. The check valve assembly also includes a seal having an inner ring having a first thickness and an outer ring having a second thickness less than the first thickness. In a fully sealed position, the inner ring engages with the first sealing flange and the outer ring engages with the second sealing flange.

[0006] In one or more aspects, the first height of the first sealing flange is less than the second height of the second sealing flange. In one or more aspects, the first height of the first sealing flange and the first thickness of the inner ring are equal to the second height of the second sealing flange and the second thickness of the outer ring. In one or more aspects, the first sealing flange is a circular rib extending orthogonally from the inner surface of the inlet body and arranged around the central channel. In one or more aspects, the second sealing flange is a circular rib extending orthogonally from the inner surface of the inlet body and arranged concentrically around the first sealing flange. In one or more aspects, the diameter of the inner ring is greater than the diameter of the first sealing flange, and the diameter of the outer ring is greater than the diameter of the second sealing flange.

[0007] In one or more aspects, the end surface of one of the first and second sealing flanges is angled. In one or more aspects, only a tip portion of the end surface is engaged with the seal in a fully sealed position of the check valve assembly. In one or more aspects, the seal is coupled to the centering post via a central bore of the seal. In one or more aspects, the stem includes a shoulder and an inner ring of the seal is engaged by the shoulder. In one or more aspects, the seal is sandwiched between the shoulder of the stem and the end surface of the center passage. In one or more aspects, the inlet body and the outlet body are sealed together.

[0008] In one or more aspects, one of the inlet body and the outlet body is configured to couple with an intravenous tubing. In one or more aspects, a flexibility of the inner ring determines a cracking pressure of the check valve assembly. In one or more aspects, in an open fluid flow position of the check valve assembly, the inner ring is bent away from the first sealing flange and the outer ring is bent away from the second sealing flange. In one or more aspects, in a partially sealed position of the check valve assembly, the outer ring is engaged with the second sealing flange and the inner ring is bent away from the first sealing flange.

[0009] In one or more embodiments, a method of manufacturing the check valve assembly described above is provided. The method includes coupling a seal to a stem, where a centering post is inserted into a central bore of the seal and the seal rests on a shoulder of the stem. The method further includes connecting an inlet body to an outlet body, where an outer ring of the seal is loaded by a second sealing flange. The method further includes ultrasonically welding the inlet body to the outlet body, where an inner ring of the seal is fixed between the shoulder of the stem and an end surface of a center passage of the inlet body, and where the inner ring of the seal is loaded by a first sealing flange.

[0010] In one or more embodiments, a fluid flow kit is provided. The fluid flow kit includes a fluid inlet tube, a fluid outlet tube, and a check valve assembly. The check valve assembly includes a housing having an inlet body coupled to an outlet body, the inlet body having a fluid inlet, a center passage, and a first sealing flange having a different height than a second sealing flange, and the outlet body having a fluid outlet and a centering post received by the center passage. The check valve assembly further includes a seal coupled to the centering post, the seal having an inner ring and an outer ring, where the outer ring is thinner than the inner ring. In a fully sealed position of the check valve assembly, the inner ring is engaged with the first sealing flange and the outer ring is engaged with the second sealing flange. In an open fluid flow position of the check valve assembly, the inner ring is bent away from the first sealing flange and the outer ring is bent away from the second sealing flange. In a partially sealed position of the check valve assembly, the outer ring is engaged with the second sealing flange and the inner ring is bent away from the first sealing flange.

[0011] In one or more aspects, the first sealing flange is a circular rib extending orthogonally from the inner surface of the inlet body and arranged around the central channel, and wherein the second sealing flange is a circular rib extending orthogonally from the inner surface of the inlet body and concentrically arranged around the first sealing flange. In one or more aspects, the end surfaces of each of the first and second sealing flanges are angled, and wherein, in the fully sealed position of the check valve assembly, only a portion of each end surface engages with the seal.

[0012] Additional features and advantages of this disclosure will be set forth in the description which follows, and in part will be obvious from the description or may be learned by practice of the disclosure. The purposes and other advantages of this disclosure will be realized and obtained through the written description and claims, and the structures particularly pointed out in the drawings.

[0013] It should be understood that the foregoing overview and the following detailed description are exemplary and explanatory, and are intended to provide further explanation of the claimed disclosure. Attached Figure Description

[0014] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0015] Figure 1 A schematic diagram of a typical assembled infusion kit is depicted.

[0016] Figure 2 This is an exploded perspective view of an example check valve based on some aspects of this disclosure.

[0017] Figure 3 Based on some aspects of this disclosure Figure 2 A perspective view of the cross-section of a check valve.

[0018] Figure 4 It is in a pre-assembled state according to some aspects of this disclosure. Figure 2 A partial cross-sectional perspective view of a check valve.

[0019] Figure 5 Based on some aspects of this disclosure Figure 4 Front view of the check valve.

[0020] Figure 6 It is in an assembled state according to some aspects of this disclosure. Figure 2 A partial cross-sectional perspective view of a check valve.

[0021] Figure 7 Based on some aspects of this disclosure Figure 6 Front view of the check valve.

[0022] Figure 8 This is a perspective view of a check valve seal according to some aspects of this disclosure.

[0023] Figure 9 Based on some aspects of this disclosure Figure 8 Front view of the check valve seal.

[0024] Figure 10 It is in an open, flowing state according to some aspects of this disclosure. Figure 7 A schematic diagram of a check valve. Detailed Implementation

[0025] The detailed description below describes various constructions of the subject matter and is not intended to represent the only construction that can be practiced. The detailed description includes specific details to provide a thorough understanding of the subject matter. Therefore, dimensions are provided for certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concept of the subject matter.

[0026] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations, and may conform to desired applications or implementations.

[0027] like Figure 1 As shown, a typical infusion kit 30 may include a drip chamber 40, a check valve 50, a roller clamp 60, and a Y-connector 70, all connected together via conduit 20. A typical infusion kit 30 may include additional infusion components (e.g., clamping clips, filters) and may be formed by any combination of components and conduit 20.

[0028] Check valve 50 is typically formed of a flexible (e.g., elastomer) seal mounted within a fluid flow housing. Typically, the flexible seal is mounted such that it engages a sealing flange in the housing in the sealed position and bends away from the sealing flange in the open flow position. However, if particles in the fluid are trapped between the seal and the sealing flange, a gap will remain between the seal and the sealing flange when check valve 50 returns to the sealed position. This gap allows for fluid leakage (e.g., low-flow leakage) when check valve 50 is intended to be completely sealed to prevent any fluid flow.

[0029] According to aspects of the present disclosure, the check valve assembly is provided with a seal having dual sealing rings and a housing having dual sealing flanges. The outer seal prevents particulates (e.g., grit) from reaching the inner seal, thereby allowing the inner seal to fully close and seal fluid flow.

[0030] Figures 2-10 A check valve assembly according to some aspects of the present disclosure is shown as check valve 100. Check valve 100 includes a housing 110 having an inlet body 120, an outlet body 130, and a seal 140.

[0031] Inlet body 120 has a fluid inlet 122 configured to connect with a fluid source (e.g., an IV bag, an infusion pump, a needleless syringe) via an IV tube (e.g., tubing 20). Inlet body 120 includes a first sealing flange 124 and a second sealing flange 126, each disposed on an inner surface 121 of inlet body 120. For example, first and second sealing flanges 124, 126 can be configured as cylindrical ribs or teeth. As shown, first sealing flange 124 is a circular rib disposed about a central passage 128 in inlet body 120. Central passage 128 has an end surface 129. Figure 3

[0032] As shown, first sealing flange 124 has an inner diameter D1 and a height H1. Second sealing flange 126 is a circular rib disposed concentrically about first sealing flange 124, second sealing flange 126 having an inner diameter D2 and a height H2. Here, height H2 is greater than height H1 such that second sealing flange 126 extends further from inner surface 121 than first sealing flange 124. In some aspects of the present disclosure, end surface 123 of first sealing flange 124 and / or end surface 125 of second sealing flange 126 are angled such that only a tip portion of end surfaces 123, 125 engage seal 140 when check valve 100 is in a fully sealed (e.g., closed) position. Figure 5

[0033] Outlet body 130 has a fluid outlet 132 configured to connect with a downstream fluid component (e.g., roller clamp 60). Outlet body 130 includes a stem 134 having a centering post 136 configured to be received by central passage 128 of inlet body 120 and a shoulder 138.

[0034] Seal 140 includes an inner ring 142 and an outer ring 144. Inner ring 142 has a thickness T1 and outer ring 144 has a thickness T2, where thickness T1 is greater than thickness T2 (see Figure 9 ​​). The inner ring 142 has a diameter DS1 and the outer ring 144 has a diameter DS2, where the diameter DS2 is greater than the diameter DS1. The diameter DS1 of the inner ring 142 of the seal 140 is greater than the inner diameter D1 of the first seal flange 124, and the diameter DS2 of the outer ring 144 of the seal 140 is greater than the outer diameter D2 of the second seal flange 126. The seal 140 also includes a central bore 146 that mounts on the centering post 136 of the outlet body 130 and a portion of the inner ring 142 that rests on the shoulder 138 of the outlet body 130. The seal 140 can be formed of any flexible material (e.g., silicone), where the inner ring 142 is somewhat flexible, and the outer ring 144 is thinner and more flexible. For example, the outer ring can be as thin as a mold flash.

[0035] To assemble the check valve 100, the seal 140 is coupled / mounted on the centering post 136 of the outlet body 130 via the central bore 146 of the seal 140, with the inner ring 142 resting on the shoulder 138 of the outlet body 130. As shown in Figure 4 and 5 The inlet body 120 is coupled / mounted on the outlet body 130, which causes the outer ring 144 to be engaged and loaded by the second seal flange 126. As shown in Figure 6 and 7 The inlet body 120 and the outlet body 130 can then be sealed together (e.g., ultrasonic welded), which causes the inner ring 142 to be sandwiched and / or secured between the shoulder 138 of the outlet body 130 and the end surface 129 of the central passage 128, and further causes the inner ring 142 to be engaged and loaded by the first seal flange 124. Thus, during assembly of the check valve 100, the outer ring 144 is loaded first, and then the inner ring 142. In some aspects of the present disclosure, the inner ring 142 and the outer ring 144 have different pre-load forces.

[0036] As shown in Figure 10 When fluid is forced through sufficient force to pass into the check valve 100 through the fluid inlet 122, away from the first seal flange 124 and the second seal flange 126, respectively, by the inner ring 142 and the outer ring 144, the check valve 100 is in an open or fluid flow mode. Thus, in this open fluid flow position of the check valve assembly 100, the inner ring 142 is flexed away from the first seal flange 124, and the outer ring 144 is flexed away from the second seal flange 126. Fluid flows through the interior volume 112 of the housing 110 and out of the fluid outlet 132 of the outlet body 130. When the fluid pressure decreases or ends (e.g., the fluid flow slows or stops), the check valve 100 moves to a closed position.

[0037] When the check valve 100 is closed, the outer ring 144 first closes by flexing back to its starting position to engage the second sealing flange 126. This is because the outer ring 144 is thinner and more flexible than the inner ring 142, causing the outer ring 144 to flex faster and / or through a greater range of motion than the inner ring 142. By closing first, the outer ring 144 creates an initial seal that prevents particulate or grit from reaching the inner ring 142. Thus, in this partially sealed position of the check valve assembly 100, the outer ring 144 is engaged with the second sealing flange 126, and the inner ring 142 is still flexed away from the first sealing flange 124.

[0038] After the outer ring 144 is closed, the inner ring 142 then closes by flexing back to its starting position to engage the first sealing flange 124. Thus, the inner ring 142 is able to fully close because of the lack of particulate or grit caused by the early sealing of the outer ring 144. Thus, in this fully sealed position of the check valve assembly 100, the inner ring 142 is engaged with the first sealing flange 124, and the outer ring 144 is engaged with the second sealing flange 126.

[0039] For the seal 140, the inner ring 142 is the primary seal, and the outer ring 144 is the secondary seal. The characteristics of the inner ring 142 primary seal determine the opening pressure of the check valve 100 (e.g., the amount of fluid pressure required to open or unseal the seal 140), such as, for example, the flexibility of the inner ring 142. In some aspects of the disclosure, the opening pressure is determined by the inner ring 142 because the outer ring 144 secondary seal is very thin and offers little resistance to fluid pressure. In some aspects of the disclosure, the burst pressure is determined by the inner ring 142 because the inner ring 142 primary seal seals against the first sealing flange 124, which prevents any fluid from reaching the outer ring 144 secondary seal. Once the opening pressure is reached in the check valve 100, both the inner ring 142 primary seal and the outer ring 144 secondary seal are away from (e.g., unsealed) the first sealing flange 124 and the second sealing flange 126 to allow fluid to flow through the seal 140.

[0040] The operation of the check valve 100 can be altered by changing different elements. For example, increasing / decreasing one or both of the thicknesses T1 of the inner ring 142 and T2 of the outer ring 144, increasing / decreasing one or both of the diameters D1 of the inner ring 142 and D2 of the outer ring 144, increasing / decreasing one or both of the heights H1 of the first sealing flange 124 and H2 of the second sealing flange 126, and using various materials to change the stiffness or flexibility of one or both of the inner ring 142 and the outer ring 144 can change the opening pressure and / or flow characteristics of the check valve 100.

[0041] It should be understood that any particular order or hierarchy of blocks within the methods of the disclosed processes is an example of illustrative approaches. Based upon design or implementation preferences, alternative orderings or hierarchies of blocks can be implemented within the processes. In some embodiments, any block can be performed concurrently with other blocks. As such, the particular order or hierarchy of blocks disclosed should not be construed as limiting.

[0042] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other aspects.

[0043] The singular form of a element does not exclude the plural form of the element unless specifically stated so. The term "some" refers to one or more unless specifically stated otherwise. Positive adjectives, such as "one and only one," include both the singular and plural forms of the adjective. Headings and subheadings, if any, are used for convenience only and do not limit the application.

[0044] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations can be considered equivalents in at least some respects.

[0045] As used herein, the phrase "at least one of" preceding a series of items is an abbreviation for one or more of the items in the list. The phrase "at least one of" does not require selection of at least one item; rather, the phrase allows inclusion of any one item, and / or inclusion of at least one of any combination of the items, and / or inclusion of at least one of each item in the list. By way of example, the phrase "at least one of A, B, or C" can mean: only A, only B, or only C; or A, B, C; or any combination of A, B, and C.

[0046] Phrases such as "aspect" do not imply that such an aspect is necessary for the subject art, or that such an aspect applies to all constructions of the subject art. Disclosure relating to an aspect may apply to all constructions, or one or more constructions. An aspect may provide one or more examples. Phrases such as "aspect" may refer to one or more aspects, or vice versa. Phrases such as "embodiment" do not imply that such an embodiment is necessary for the subject art, or that such an embodiment applies to all constructions of the subject art. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "construction" do not imply that such a construction is necessary for the subject art, or that such a construction applies to all constructions of the subject art. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples. The phrase "such a construction" may refer to one or more constructions, or vice versa.

[0047] In one respect, unless otherwise stated, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those in the following claims, are approximate, not precise. In another respect, they are intended to have a reasonable range consistent with the functions they pertain to and with the custom of the art to which they belong.

[0048] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustration of an exemplary method. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes may be performed simultaneously. Some or all steps, operations, or processes may be performed automatically without user intervention. The appended method claims (if any) present the elements of various steps, operations, or processes in an exemplary order and are not intended to limit one to the specific order or hierarchy presented.

[0049] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for." Furthermore, to the extent that the term "comprising" is used in the detailed description and claims, it is intended to be

[0050] The title, background, summary, brief description of drawings, and abstract of the disclosure are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not intended to be limiting in any way. Submission of this application is in accordance with 35 U.S.C. § 1 12, first paragraph, as it is believed that the terms will not be used against the application. Furthermore, in the detailed description, it can be seen that the description provides illustrative examples and, in an effort to simplify the disclosure, various features are combined in various embodiments. The disclosed methods should not be interpreted as reflecting an intention that the claimed subject matter require a greater scope of features than is reflected in the examination of the patent application. To the contrary, the inventors have searched the prior art and have found no evidence of the necessity of the features beyond those explicitly recited in each claim. The following claims are hereby incorporated into the detailed description, each claim standing on its own as a separately claimed subject matter.

[0051] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims, wherein reference to an element in the meaning of the terms in the claims to the element includes any and all equivalents to the element. None of the claims are intended to invoke 35 U.S.C. § 1 12, paragraph six, unless the exact words "means for" are followed by a participle.

Claims

1. A check valve assembly comprising: a housing comprising: an inlet body comprising: a fluid inlet; a first sealing flange having a first height; a second sealing flange having a second height; and a central passage; and an outlet body comprising: a fluid outlet; and a stem having a centering post configured to be received by the central passage of the inlet body; and a seal comprising: an inner ring having a first thickness; and an outer ring having a second thickness that is less than the first thickness, wherein in a fully sealed position of the check valve assembly, the inner ring is engaged with the first sealing flange and the outer ring is engaged with the second sealing flange.

2. The check valve assembly of claim 1, wherein the first height of the first sealing flange is less than the second height of the second sealing flange.

3. The check valve assembly of claim 1, wherein the first height of the first sealing flange and the first thickness of the inner ring are equal to the second height of the second sealing flange and the second thickness of the outer ring.

4. The check valve assembly of claim 1, wherein the first sealing flange is a circular rib extending orthogonally from an inner surface of the inlet body and disposed about the central passage.

5. The check valve assembly of claim 4, wherein the second sealing flange is a circular rib extending orthogonally from an inner surface of the inlet body and disposed concentrically about the first sealing flange.

6. The check valve assembly of claim 1, wherein a diameter of the inner ring is greater than a diameter of the first sealing flange and a diameter of the outer ring is greater than a diameter of the second sealing flange.

7. The check valve assembly of claim 1, wherein an end surface of one of the first sealing flange and the second sealing flange is angled.

8. The check valve assembly of claim 7, wherein only a tip portion of the end surface is engaged with the seal in a fully sealed position of the check valve assembly.

9. The check valve assembly of claim 1, wherein the seal is coupled to the centering post via a central aperture of the seal.

10. The check valve assembly of claim 1, wherein the stem includes a shoulder and the inner ring of the seal is engaged by the shoulder.

11. The check valve assembly of claim 10, wherein the seal is sandwiched between the shoulder of the stem and an end surface of the central passage.

12. The check valve assembly of claim 1, wherein the inlet body and the outlet body are sealed together.

13. The check valve assembly of claim 1, wherein one of the inlet body and the outlet body is configured to be coupled with an intravenous tubing.

14. The check valve assembly of claim 1, wherein a flexibility of the inner ring determines an opening pressure of the check valve assembly.

15. The check valve assembly of claim 1, wherein in an open fluid flow position of the check valve assembly, the inner ring is bent away from the first sealing flange and the outer ring is bent away from the second sealing flange.

16. The check valve assembly of claim 1, wherein in a partially sealed position of the check valve assembly, the outer ring is engaged with the second sealing flange and the inner ring is flexed away from the first sealing flange.

17. A method of manufacturing the check valve assembly of claim 1, the method comprising: coupling a seal to a stem, wherein a centering post is inserted into a center hole of the seal and the seal rests on a shoulder of the stem; connecting an inlet body to an outlet body, wherein an outer ring of the seal is forced by the second sealing flange; and ultrasonically welding the inlet body to the outlet body, wherein an inner ring of the seal is fixed between the shoulder of the stem and an end surface of a center passage of the inlet body, and wherein the inner ring of the seal is forced by the first sealing flange.

18. A fluid flow kit comprising: a fluid inlet tube; a fluid outlet tube; and a check valve assembly comprising: a housing having an inlet body coupled to an outlet body, the inlet body having a fluid inlet, a center passage, and a first sealing flange, the first sealing flange having a different height than a second sealing flange, and the outlet body having a fluid outlet and a centering post received by the center passage; a seal coupled to the centering post, the seal having an inner ring and an outer ring, wherein the outer ring is thinner than the inner ring, wherein in a fully sealed position of the check valve assembly, the inner ring is engaged with the first sealing flange and the outer ring is engaged with the second sealing flange, wherein in an open fluid flow position of the check valve assembly, the inner ring is flexed away from the first sealing flange and the outer ring is flexed away from the second sealing flange, and wherein in a partially sealed position of the check valve assembly, the outer ring is engaged with the second sealing flange and the inner ring is flexed away from the first sealing flange.

19. The fluid flow kit of claim 18, wherein the first sealing flange is a circular rib extending orthogonally from an inner surface of the inlet body and disposed about the center passage, and wherein the second sealing flange is a circular rib extending orthogonally from the inner surface of the inlet body and disposed concentrically about the first sealing flange. In the fully sealed position of the check valve assembly, only a portion of each end surface is engaged with the seal.

20. The fluid flow kit of claim 18, wherein the end surface of each of the first and second seal flanges is angled, and wherein, ​

Images