Check valve assembly, intravenous injection kit, and method of manufacturing check valve assembly

Abstract

The present application relates to a check valve assembly comprising: an inlet body comprising a fluid inlet, a first sealing flange, and a second sealing flange; an outlet body including a fluid outlet; and a seal comprising an inner ring and an outer ring wherein, in a fully sealed position of the check valve assembly, the inner ring is configured to engage with the first sealing flange and the outer ring is configured to engage with the second sealing flange wherein 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. And the diameter of the outer ring is larger than that of the second sealing flange. The application also relates to an intravenous kit and a method of manufacturing a check valve assembly.

Description

[0001] This application is a divisional application of the invention application filed on May 7, 2021, with application number 202110525245.6 and entitled "Check Valve with Flanged Seal". Technical Field

[0002] This application relates to a check valve assembly, an intravenous injection kit including the check valve assembly, and a method of manufacturing the check valve assembly. 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 surfaces of one of the first and second sealing flanges are angled. In one or more aspects, in the fully sealed position of the check valve assembly, only the pointed tip of the end surface engages with the seal. In one or more aspects, the seal is coupled to a centering post via a central bore in the seal. In one or more aspects, the rod includes a shoulder, and the inner ring of the seal is engaged by the shoulder. In one or more aspects, the seal is sandwiched between the shoulder of the rod and the end surface of the central 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 connect to an intravenous infusion tubing. In one or more aspects, the flexibility of the inner ring determines the cracking pressure of the check valve assembly. In one or more aspects, in the open fluid flow position of the check valve assembly, the inner ring bends away from the first sealing flange, while the outer ring bends away from the second sealing flange. In one or more aspects, in the partially sealed position of the check valve assembly, the outer ring engages with the second sealing flange, while the inner ring bends away from the first sealing flange.

[0009] In one or more embodiments, a method of manufacturing the above-described check valve assembly is provided. The method includes coupling a seal to a rod, wherein a centering pin is inserted into a central bore of the seal, and the seal rests on a shoulder of the rod. The method further includes connecting an inlet body to an outlet body, wherein 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, wherein an inner ring of the seal is fixed between the shoulder of the rod and an end surface of a central channel of the inlet body, and wherein 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 pipe, a fluid outlet pipe, and a check valve assembly. The check valve assembly includes a housing having an inlet body coupled to an outlet body having a fluid inlet, a central channel, and a first sealing flange having a different height than a second sealing flange, and an outlet body having a fluid outlet and a centering post received by the central channel. The check valve assembly also includes a seal coupled to the centering post having an inner ring and an outer ring, wherein the outer ring is thinner than the inner ring. In a fully sealed position of the check valve assembly, the inner ring engages with the first sealing flange and the outer ring engages with the second sealing flange. In an open fluid flow position of the check valve assembly, the inner ring bends away from the first sealing flange, and the outer ring bends away from the second sealing flange. In a partially sealed position of the check valve assembly, the outer ring engages with the second sealing flange, and the inner ring bends 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 this disclosure, the check valve assembly is provided with a seal having double sealing rings and a housing having double sealing flanges. The outer seal prevents particles (e.g., gravel) from reaching the inner seal, thereby allowing the inner seal to close completely and seal fluid flow.

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

[0031] The inlet body 120 has a fluid inlet 122 configured to connect to a fluid source (e.g., an IV bag, infusion pump, needle-free injector) via an IV tube (e.g., conduit 20). The inlet body 120 includes a first sealing flange 124 and a second sealing flange 126, each disposed on an inner surface 121 of the inlet body 120. For example, the first and second sealing flanges 124, 126 may be configured as columnar ribs or teeth. Figure 3 As shown, the first sealing flange 124 is a circular rib arranged around the central channel 128 in the inlet body 120. The central channel 128 has an end surface 129.

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

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

[0034] Seal 140 includes an inner ring 142 and an outer ring 144. The inner ring 142 has a thickness T1 and the outer ring 144 has a thickness T2, wherein the thickness T1 is greater than the thickness T2 (see [link to seal]). Figure 9The inner ring 142 has a diameter DS1, and the outer ring 144 has a diameter DS2, wherein the diameter DS2 is larger than the diameter DS1. The diameter DS1 of the inner ring 142 of the seal 140 is larger than the inner diameter D1 of the first sealing flange 124, and the diameter DS2 of the outer ring 144 of the seal 140 is larger than the outer diameter D2 of the second sealing flange 126. The seal 140 also includes a center hole 146 mounted on a centering post 136 of the outlet body 130 and a portion of the inner ring 142 resting on a shoulder 138 of the outlet body 130. The seal 140 can be formed of any flexible material (e.g., silicone), wherein the inner ring 142 is slightly flexible, while the outer ring 144 is thinner and more flexible. For example, the outer ring can be as thin as a mold flash.

[0035] For assembling the check valve 100, the seal 140 is connected / mounted via a center hole 146 on the centering post 136 of the outlet body 130, wherein the inner ring 142 rests on the shoulder 138 of the outlet body 130. For example... Figure 4 and 5 As shown, the inlet body 120 is coupled / mounted onto the outlet body 130, which causes the outer ring 144 to be engaged and loaded by the second sealing flange 126. Figure 6 and 7 As shown, the inlet body 120 and outlet body 130 can then be sealed together (e.g., ultrasonically welded), which causes the inner ring 142 to be clamped and / or secured between the shoulder 138 of the outlet body 130 and the end surface 129 of the central channel 128, and further causes the inner ring 142 to be engaged and loaded by the first sealing flange 124. Therefore, during the assembly of the check valve 100, the outer ring 144 is loaded first, and then the inner ring 142 is loaded. In some aspects of this disclosure, the inner ring 142 and the outer ring 144 have different preload forces.

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

[0037] When the check valve 100 closes, the outer ring 144 first closes by bending back to its initial 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, resulting in the outer ring 144 bending faster and / or undergoing a greater range of motion than the inner ring 142. By closing first, the outer ring 144 creates an initial seal that prevents particles or grit from reaching the inner ring 142. Therefore, in this partially sealed position of the check valve assembly 100, the outer ring 144 engages with the second sealing flange 126, and the inner ring 142 remains bent away from the first sealing flange 124.

[0038] After the outer ring 144 closes, the inner ring 142 then closes by bending back to its initial position to engage the first sealing flange 124. Therefore, the inner ring 142 is able to close completely because of the absence of particles or grit caused by the earlier sealing of the outer ring 144. Thus, in this fully sealed position of the check valve assembly 100, the inner ring 142 engages with the first sealing flange 124, and the outer ring 144 engages with the second sealing flange 126.

[0039] For seal 140, inner ring 142 is the primary seal, and outer ring 144 is the secondary seal. The characteristics of the inner ring 142 primary seal determine the opening pressure of check valve 100 (e.g., the amount of fluid pressure required to open or close seal 140), for example, the flexibility of the inner ring 142. In some aspects of this 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 this disclosure, the rupture 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 check valve 100, both the inner ring 142 primary seal and the outer ring 144 secondary seal move away from the first sealing flange 124 and the second sealing flange 126 (e.g., open) to allow fluid flow through seal 140.

[0040] The operation of the check valve 100 can be altered by changing various parameters. For example, increasing / decreasing one or both of the thickness T1 of the inner ring 142 and the thickness T2 of the outer ring 144, increasing / decreasing one or both of the diameter D1 of the inner ring 142 and the diameter D2 of the outer ring 144, increasing / decreasing one or both of the height H1 of the first sealing flange 124 and the height 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 alter the opening pressure and / or flow characteristics of the check valve 100.

[0041] It should be understood that any particular order or hierarchy of the boxes in the disclosed process is illustrative of the example method. Based on design or implementation preferences, it should be understood that a particular order or hierarchy of the boxes in the process may be rearranged, or all of the boxes shown may be executed. In some implementations, any boxes may be executed simultaneously.

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

[0043] Unless otherwise specified, singular elements do not mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0044] The word “exemplary” is used here to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” should not be construed as preferred or advantageous over other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0045] As used herein, the phrase "at least one" preceding a series of items, separated by the term "or," modifies the list as a whole rather than each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, it allows for the meaning of including at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" could refer to: only A, only B, or only 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 of elements throughout the various aspects described in this disclosure, known or to be known by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be exclusive to the public, whether or not such disclosure is expressly stated in the claims. No claim element may be construed in accordance with 35 USC §112(f) unless the element is expressly stated using the phrase “for…” or, in the case of a method claim, using the phrase “for the step of…”. Furthermore, with regard to the use of the terms “comprising,” “having,” etc., the term is intended to be included in a manner similar to how the term “comprising” is interpreted when used as a transitional word in a claim.

[0050] The title, background, overview, description of drawings, and abstract of this disclosure are incorporated herein and are provided as illustrative examples rather than limiting descriptions. This application is filed on the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, it will be apparent from the detailed description that it provides illustrative examples, and various features are combined in various embodiments to simplify this disclosure. This approach to disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the following claims, the inventive subject matter lies in all features of fewer than those in a single disclosed construction or operation. The following claims are thus incorporated into the detailed description, each claim being an independent, separately claimed subject matter.

[0051] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language claims and to include all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to satisfy the requirements of 35 U.S.SC § 101, 102 or 103, nor should they be interpreted in this manner.

Claims

1. A check valve assembly comprising: an inlet body comprising a fluid inlet, a first sealing flange, and a second sealing flange; an outlet body comprising a fluid outlet; and a seal comprising an inner ring and an outer ring, wherein, in a fully sealed position of the check valve assembly, the inner ring is configured to engage with the first sealing flange and the outer ring is configured to engage with the second sealing flange, 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. a height of the first sealing flange and a thickness of the inner ring are equal to a height of the second sealing flange and a thickness of the outer ring.

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

3. The check valve assembly of claim 2, wherein, a thickness of the outer ring is less than a thickness of the inner ring.

4. The check valve assembly of claim 2, wherein, the first sealing flange is a circular rib extending orthogonally from an inner surface of the inlet body and disposed about a central passage of the inlet body.

5. The check valve assembly of claim 1, 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 5, wherein, an end surface of one of the first sealing flange and the second sealing flange is angled.

7. The check valve assembly of claim 1, wherein, only a tip portion of the end surface engages the seal in the fully sealed position of the check valve assembly.

8. The check valve assembly of claim 7, wherein, the outlet body comprises a centering post and wherein the seal is coupled to the centering post via a central aperture of the seal.

9. The check valve assembly of claim 1, wherein, the outlet body comprises a stem comprising a shoulder and wherein the inner ring of the seal is engaged by the shoulder.

10. The check valve assembly of claim 1, wherein, the seal is sandwiched between the shoulder of the stem and an end surface of a central passage of the inlet body.

11. The check valve assembly of claim 10, wherein, the inlet body and the outlet body are sealed together.

12. The check valve assembly of claim 1, wherein, the fluid inlet is configured to receive a first intravenous tubing and the fluid outlet is configured to receive a second intravenous tubing.

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

14. The check valve assembly of claim 1, wherein, a hardness of a material forming one of the inner ring and the outer 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 flexed away from the first sealing flange and the outer ring is flexed 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. The check valve assembly of claim 1, wherein, 18. An intravenous set comprising: a fluid inlet tube; a fluid outlet tube; and the check valve assembly of any one of claims 1-17.

19. A method of manufacturing the check valve assembly of claim 1, the method comprising: coupling a seal to an outlet body; connecting an inlet body to the outlet body, wherein an outer ring of the seal is forced by a second sealing flange; and ultrasonically welding the inlet body to the outlet body, wherein an inner ring of the seal is fixed between the inlet body and the outlet body, and wherein the inner ring of the seal is forced by the first sealing flange. ​ ​ ​

Images