Check valve with a flash seal

Abstract

To provide a check valve assembly for a fluid flow set and device.SOLUTION: A check valve assembly comprises a housing having an inlet body and an outlet body. The inlet body comprises a fluid inlet, a first seal bead having a first height, a second seal bead having a second height, and a central channel. The outlet body comprises a fluid outlet and a stem having a centering post received by the central channel of the inlet body. The seal has an inside ring with a first thickness, and an outside ring with a second thickness less than the first thickness. In a fully sealed position of the check valve assembly, the inside ring is in engagement with the first seal bead, and the outside ring is in engagement with the second seal bead. A fluid flow set, and a method for manufacturing a check valve assembly are also provided.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] Check valves are used in the medical field within devices that control the flow of fluid to a patient, such as intravenous (IV) gravity or diversion of fluid flow from a pump set.

Background Art

[0002] Typical check valves are prone to low-flow leakage when particulates are trapped between the elastomeric seal and the seal bead. Having double seal beads poses a problem because those seal beads need to be exactly the same height in order to eliminate the gaps that would allow leakage.

Summary of the Invention

Problems to be Solved by the Invention

[0003] It is desirable to provide a medical fluid flow check valve that prevents low-flow leakage, thus enhancing safety and reducing risk.

Means for Solving the Problems

[0004] The present disclosure provides a medical fluid flow check valve having a double sealing ring.

[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 seal bead having a first height, a second seal bead having a second height, and a central channel. The housing also includes an outlet body. The outlet body includes a fluid outlet and a stem 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 that is thinner than the first thickness. In the fully sealed position of the check valve assembly, the inner ring is in engagement with the first seal bead and the outer ring is in engagement with the second seal bead.

[0006] In one or more embodiments, the first height of the first seal bead is lower than the second height of the second seal bead. In one or more embodiments, the first height of the first seal bead and the first thickness of the inner ring are equal to the second height of the second seal bead and the second thickness of the outer ring. In one or more embodiments, the first seal bead is a circular rib that extends orthogonally from the inner surface of the inlet body and is disposed around the central channel. In one or more embodiments, the second seal bead is a circular rib that extends orthogonally from the inner surface of the inlet body and is disposed concentrically around the first seal bead. In one or more embodiments, the diameter of the inner ring is larger than the diameter of the first seal bead, and the diameter of the outer ring is larger than the diameter of the second seal bead.

[0007] In one or more embodiments, one end face of either the first seal bead or the second seal bead is inclined. In one or more embodiments, in the fully sealed position of the check valve assembly, only the tip of the end face is in engagement with the seal. In one or more embodiments, the seal is connected to the centering post through the central hole of the seal. In one or more embodiments, the stem includes a shoulder, and the inner ring of the seal is engaged with this shoulder. In one or more embodiments, the seal is sandwiched between the shoulder of the stem and the end face of the central channel. In one or more embodiments, both the inlet body and the outlet body are sealed.

[0008] In one or more embodiments, one of the inlet body and the outlet body is configured to be connected to the venous tubing. In one or more embodiments, the flexibility of the inner ring determines the cracking pressure of the check valve assembly. In one or more embodiments, in the open fluid flow position of the check valve assembly, the inner ring is deflected away from the first seal bead and the outer ring is deflected away from the second seal bead. In one or more embodiments, in the partially sealed position of the check valve assembly, the outer ring is in engagement with the second seal bead and the inner ring is deflected away from the first seal bead.

[0009] In one or more embodiments, a method of manufacturing the check valve assembly described above is provided. The method includes connecting a seal to the stem, including inserting a centering post into a central hole of the seal and the seal abutting against a shoulder of the stem. The method also includes connecting an inlet body to an outlet body, including the outer ring of the seal being biased by a second seal bead. The method further includes ultrasonically welding the inlet body to the outlet body, including the inner ring of the seal being fixed between a shoulder of the stem and an end face of a central channel of the inlet body and the inner ring of the seal being biased by a first seal bead.

[0010] In one or more embodiments, a fluid flow set is provided. The fluid flow set 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 connected to an outlet body, the inlet body having a first seal bead having a different height than a fluid inlet, a central channel, and a second seal bead, and the outlet body having a centering post received by a fluid outlet and the central channel. The check valve assembly also includes a seal connected to the centering post having an inner ring and an outer ring thinner than the inner ring. In a fully sealed position of the check valve assembly, the inner ring is in engagement with the first seal bead and the outer ring is in engagement with the second seal bead. In an open fluid flow position of the check valve assembly, the inner ring is deflected away from the first seal bead and the outer ring is deflected away from the second seal bead. In a partially sealed position of the check valve assembly, the outer ring is in engagement with the second seal bead and the inner ring is deflected away from the first seal bead.

[0011] In one or more embodiments, the first seal bead is a circular rib extending orthogonally from the inner surface of the inlet body and disposed around the central channel, and the second seal bead is a circular rib extending orthogonally from the inner surface of the inlet body and disposed concentrically around the first seal bead. In one or more embodiments, the respective end faces of the first seal bead and the second seal bead are inclined, and in the fully sealed position of the check valve assembly, only a part of each end face is in engagement with the seal.

[0012] Additional features and advantages of the present disclosure are set forth in the following description, will be apparent in part from the description, or may be taught by practice of the present disclosure. The objectives and other advantages of the present disclosure are realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure as claimed.

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

Brief Description of the Drawings

[0015]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0016] The following detailed description describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology may be practiced. The detailed description includes specific details for providing a complete understanding of the subject technology. Accordingly, dimensions are provided as non-limiting examples with respect to specific aspects. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0017] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Here, various aspects of the subject technology are disclosed according to specific but non-limiting examples. The various examples described in the present disclosure may be implemented according to the desired use or implementation in different ways and variations.

[0018] As shown in FIG. 1, a typical infusion set 30 can include a drip chamber 40, a check valve 50, a roller clamp 60, and a Y-connector 70, all of which are connected together by tubing 20. A typical infusion set 30 can include additional infusion components (e.g., pinch clamps, filters) and can be formed from any combination of components and tubing 20.

[0019] Typically, the check valve 50 is formed from a flexible (e.g., elastomeric) seal mounted within a fluid flow housing. Typically, the flexible seal is mounted to engage a seal bead within the housing in a closed position and to flex away from the seal bead in an open flow position. However, when particulates in the fluid are trapped between the seal and the seal bead, if the check valve 50 returns to the closed position, a gap remains between the seal and the seal bead. This gap allows fluid leakage (e.g., low flow rate leakage) when the check valve 50 is assumed to be fully sealed to prevent fluid flow.

[0020] According to aspects of the present disclosure, a check valve assembly is provided with a seal having a double sealing ring and a housing having a double seal bead. The outer seal prevents particulates (e.g., dust) from reaching the inner seal and thus allows the inner seal to fully close and seal the fluid flow.

[0021] FIGS. 2-10 show a check valve assembly shown as a check valve 100 according to some aspects of the present disclosure. The check valve 100 includes a housing 110 having an inlet body 120, an outlet body 130, and a seal 140.

[0022] The inlet body 120 has a fluid inlet 122 configured to connect to a fluid source (e.g., an IV bag, an infusion pump, a needleless syringe) via an IV tube (e.g., tubing 20). The inlet body 120 includes a first seal bead 124 and a second seal bead 126, which are disposed on the inner surface 121 of the inlet body 120, respectively. The first and second seal beads 124, 126 may be configured as, for example, cylindrical ribs or teeth. As shown in FIG. 3, the first seal bead 124 is a circular rib disposed around a central channel 128 within the inlet body 120. The central channel 128 has an end face 129.

[0023] As shown in FIG. 5, the first seal bead 124 has an inner diameter D1 and a height H1. The second seal bead 126 is a circular rib concentrically disposed around the first seal bead 124, and the second seal bead 126 has an inner diameter D2 and a height H2. Here, the height H2 is higher than the height H1, so that the second seal bead 126 extends further away from the inner surface 121 than the first seal bead 124 extends. In some aspects of the present disclosure, the end face 123 of the first seal bead 124 and / or the end face 125 of the second seal bead 126 is inclined such that only the tip portions of the end faces 123, 125 engage the seal 140 when the check valve 100 is in a fully sealed (e.g., airtight) position.

[0024] The outlet body 130 has a fluid outlet 132 configured to connect to a downstream fluid component (e.g., a roller clamp 60). The outlet body 130 includes a stem 134 having a centering post 136 and a shoulder 138, and the centering post 136 is configured to be received by the central channel 128 of the inlet body 120.

[0025] The seal 140 includes an inner ring 142 and an outer ring 144. The inner ring 142 has a thickness T1, the outer ring 144 has a thickness T2, and the thickness T1 is greater than the thickness T2 (see FIG. 9). The inner ring 142 has a diameter D s1has an outer ring 144 with a diameter D s2 has a diameter D s2 is the diameter D s1 which is larger than. The diameter D s1 of the inner ring 142 of the seal 140 is larger than the inner diameter D1 of the first seal bead 124, and the diameter D s2 of the outer ring 144 of the seal 140 is larger than the outer diameter D2 of the second seal bead 126. The seal 140 also includes a central hole 146 for attachment to the centering post 136 of the outlet body 130 and a portion of the inner ring 142 that abuts against the shoulder 138 of the outlet body 130. The seal 140 can be formed from any flexible material (e.g., silicone), 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 burr.

[0026] To assemble the check valve 100, the seal 140 is connected / attached to the centering post 136 of the outlet body 130 through the central hole 146 of the seal 140, and the inner ring 142 abuts against the shoulder 138 of the outlet body 130. As shown in FIGS. 4 and 5, the inlet body 120 is connected / attached to the outlet body 130, whereby the outer ring 144 engages the second seal bead 126 and is biased by this seal bead. As shown in FIGS. 6 and 7, the inlet body 120 and the outlet body 130 can then be sealed together (e.g., by ultrasonic welding), whereby the inner ring 142 is sandwiched and / or fixed between the shoulder 138 of the outlet body 130 and the end face 129 of the central channel 128, and further, the inner ring 142 engages the first seal bead 124 and is biased by this seal bead. Thus, during the assembly of the check valve 100, the outer ring 144 is biased first, and then the inner ring 142 is biased. In some aspects of the present disclosure, the inner ring 142 and the outer ring 144 have different preloading forces.

[0027] As shown in FIG. 10, when fluid enters through fluid inlet 122 with sufficient force to forcibly separate inner ring 142 and outer ring 144 from first seal bead 124 and second seal bead 126 respectively, check valve 100 enters the open mode, i.e., the fluid flow mode. Thus, in this open fluid flow position of check valve assembly 100, inner ring 142 is deflected away from first seal bead 124 and outer ring 144 is deflected away from second seal bead 126. The fluid flows out through fluid outlet 132 of outlet body 130 through the internal volume 112 of housing 110. When the fluid pressure decreases or stops (e.g., the fluid flow decelerates or stops), check valve 100 moves to the closed position.

[0028] When check valve 100 closes, outer ring 144 closes first by deflecting back to its starting position and engaging second seal bead 126. This occurs because outer ring 144 is thinner and more flexible than inner ring 142, and thus outer ring 144 is deflected earlier and / or over a greater range of motion than inner ring 142. By closing first, outer ring 144 provides the first seal to prevent particulates or dust from reaching inner ring 142. Thus, in this partially sealed position of check valve assembly 100, outer ring 144 is in engagement with second seal bead 126 while inner ring 142 remains deflected away from first seal bead 124.

[0029] After outer ring 144 has closed, inner ring 142 then closes by deflecting back to its starting position and engaging first seal bead 124. Thus, inner ring 142 can close completely because there are no particulates or dust provided by the earlier sealing of outer ring 144. Thus, in this fully sealed position of check valve assembly 100, inner ring 142 is in engagement with first seal bead 124 and outer ring 144 is in engagement with second seal bead 126.

[0030] Regarding seal 140, inner ring 142 is the primary seal and outer ring 144 is the secondary seal. The characteristics of inner ring 142, which is the primary seal, determine the cracking pressure of check valve 100 (e.g., the amount of fluid pressure required to open or breach seal 140), such as the flexibility of inner ring 142. In some aspects of the present disclosure, outer ring 144, which is the secondary seal, is very thin and has little resistance to fluid pressure, so the cracking pressure is determined by inner ring 142. In some aspects of the present disclosure, inner ring 142, which is the primary seal, is sealed against first seal bead 124, thereby preventing fluid from reaching outer ring 144, which is the secondary seal, so the cracking pressure is determined by inner ring 142. When the cracking pressure reaches within check valve 100, both inner ring 142, which is the primary seal, and outer ring 144, which is the secondary seal, move away from (e.g., open) first seal bead 124 and second seal bead 126, allowing fluid to flow through seal 140.

[0031] The operation of check valve 100 can vary by modifying various elements. For example, increasing / reducing either or both of the thickness T1 of inner ring 142 and the thickness T2 of outer ring 144, increasing / reducing either or both of the diameter D1 of inner ring 142 and the diameter D2 of outer ring 144, increasing / reducing either or both of the height H1 of first seal bead 124 and the height H2 of second seal bead 126, and using various materials to change the rigidity or flexibility of either or both of inner ring 142 and outer ring 144 can change the cracking pressure and / or flow characteristics of check valve 100.

[0032] Any particular order or hierarchy of blocks in the disclosed process method is understood to be an illustration of an exemplary approach. Based on design or implementation priorities, it is understood that a particular order or hierarchy of blocks in the process may be rearranged, or that all of the blocks shown may be performed. In some embodiments, any of the blocks may be performed simultaneously.

[0033] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This 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 general principles defined herein may be applied to other aspects.

[0034] References to elements in the singular are intended to mean "one or more" rather than "one and only one" unless specifically stated otherwise. Unless specifically stated to the contrary, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0035] The term "exemplary" is used herein to mean "serving as an example or illustration." An 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, the various alternative configurations and operations described herein may be considered at least equivalent.

[0036] As used herein, the phrase "at least one of" following a series of items modifies the items listed as a whole, rather than each of the items listed, when the term "or" is used to separate any of those items. The phrase "at least one of" does not require the selection of at least one of the items; rather, this phrase allows a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0037] The terms such as "aspect" do not imply that such an aspect is essential to the subject technology, nor that such an aspect applies to all configurations of the subject technology. The disclosure regarding an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. The terms such as "aspect" may refer to one or more aspects, and vice versa. The terms such as "example" do not imply that such an example is essential to the subject technology, nor that such an example applies to all configurations of the subject technology. The disclosure regarding an example may apply to all examples or one or more examples. An example may provide one or more examples. The terms such as "example" may refer to one or more examples, and vice versa. The terms such as "configuration" do not imply that such a configuration is essential to the subject technology, nor that such a configuration applies to all configurations of the subject technology. The disclosure regarding a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. The terms such as "configuration" may refer to one or more configurations, and vice versa.

[0038] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions, and other specifications described in this specification, including those in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range that does not conflict with the associated functions and the conventions of the technical field to which they belong.

[0039] It is understood that the specific order or hierarchy of the disclosed steps, operations, or processes are examples of exemplary approaches. Based on design priorities, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be automatically performed without user intervention. When there are appended method claims, the elements of the various steps, operations, or processes are presented in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0040] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, whether known now or later to become known to those skilled in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Further, nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112, paragraph (f), unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "step for". Moreover, to the extent that the terms "include", "have", etc. are used, such terms are intended to be inclusive in the same manner as the term "comprise" as interpreted when "comprise" is used as a transitional phrase in a claim.

[0041] The title, background, summary, brief description of the drawings, and abstract of the invention of this disclosure are hereby incorporated by reference into this disclosure, provided as exemplary illustrations of this disclosure, not as limiting descriptions thereof. This disclosure is submitted with the understanding that they are not to be used to limit the scope or meaning of the claims. Further, in the detailed description, the description provides exemplary illustrations and it can be seen that various features are grouped together in various embodiments for the purpose of brevity of this disclosure. The methods of this disclosure are not to be construed as indicating an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims show, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. The following claims are hereby incorporated by reference into the detailed description, and each claim stands on its own as a separately claimed subject matter.

[0042] The claims are not intended to be limited to the embodiments described in this specification, but rather should be given a full scope consistent with the language of the claims and should include all legal equivalents. However, none of the claims is intended to cover, nor should be construed to cover, subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103.

Claims

1. A check valve assembly comprising: a fluid inlet, a first seal bead, and a second seal bead, an inlet body including the same; a fluid outlet, an outlet body including the same; and including a check valve assembly including a seal, the seal including inner and outer rings, wherein in a fully sealed position of the check valve assembly, the inner ring is configured to engage the first seal bead and the outer ring is configured to engage the second seal bead, the diameter of the inner ring is larger than the diameter of the first seal bead, and the diameter of the outer ring is larger than the diameter of the second seal bead the check valve assembly.

2. The check valve assembly according to claim 1, wherein the height of the first seal bead and the thickness of the inner ring are equal to the height of the second seal bead and the thickness of the outer ring.

3. The check valve assembly according to claim 2, wherein the height of the first seal bead is lower than the height of the second seal bead.

4. The check valve assembly according to claim 2, wherein the thickness of the outer ring is thinner than the thickness of the inner ring.

5. The check valve assembly according to claim 1, wherein the first seal bead is a circular rib extending orthogonally from the inner surface of the inlet body and disposed around the central channel of the inlet body.

6. The check valve assembly according to claim 5, wherein the second seal bead is a circular rib extending orthogonally from the inner surface of the inlet body and disposed concentrically around the first seal bead.

7. The check valve assembly according to claim 1, wherein one end face of the first seal bead and the second seal bead is inclined.

8. The check valve assembly according to claim 7, wherein at the completely sealed position of the check valve assembly, only the tip of the end face is in an engaged state with the seal.

9. The check valve assembly according to claim 1, wherein the outlet body includes a centering post, and the seal is connected to the centering post through a central hole of the seal.

10. The check valve assembly according to claim 1, wherein the outlet body includes a stem having a shoulder, and the inner ring of the seal is engaged with the shoulder.

11. The check valve assembly according to claim 10, wherein the seal is sandwiched between the shoulder of the stem and the end face of the central channel of the inlet body.

12. The check valve assembly according to claim 1, wherein both the inlet body and the outlet body are sealed.

13. The check valve assembly according to claim 1, wherein the fluid inlet is configured to receive a first intravenous tube, and the fluid outlet is configured to receive a second intravenous tube.

14. The check valve assembly according to claim 1, wherein the flexibility of the inner ring determines the cracking pressure of the check valve assembly.

15. The check valve assembly according to claim 1, wherein the rigidity of the material forming one of the inner ring and the outer ring determines the cracking pressure of the check valve assembly.

16. The check valve assembly according to claim 1, wherein at the open fluid flow position of the check valve assembly, the inner ring is deflected away from the first seal bead and the outer ring is deflected away from the second seal bead.

17. The check valve assembly according to claim 1, wherein in a partially sealed position of the check valve assembly, the outer ring is in engagement with the second seal bead and the inner ring is deflected away from the first seal bead.

18. An intravenous (IV) set comprising a fluid inlet tube, a fluid outlet tube, the check valve assembly according to any one of claims 1 to 17, and an intravenous set.

19. A method of manufacturing the check valve assembly according to claim 1, comprising connecting the seal to the outlet body, connecting the inlet body to the outlet body such that the outer ring of the seal is biased by the second seal bead, ultrasonically welding the inlet body to the outlet body such that the inner ring of the seal is fixed between the inlet body and the outlet body and the inner ring of the seal is biased by the first seal bead, and a method.

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