Patent Application
20240149023
The present disclosure is directed to valve assemblies having improved ability to selectively allow flow of fluids through the medical device and prevent leakage of fluids from the proximal end of the device. Such improved valve assemblies also prevent leakage of fluids after repeated insertion and removal of medical instruments through the valve, such as catheters, introducers, tubes, lines, and ports that can be used for vascular or other devices. The valve assemblies can also be used as a connection for needles (e.g., fistula needles), hemodialysis circuits, feeding tubes, urinary drain catheters, or any other suitable means.
Catheters allow medical practitioners to administer infusion or removal of fluids from a patient. For example, catheters can function as a conduit that allows infusion of fluids, such as normal saline solution, therapeutic substances, and/or nutritional fluids into a patient. Alternatively, catheters can withdraw fluids such as blood or other bodily fluids as required by the particular medical procedure. In those cases where the medical practitioner intends to position the catheter into a vessel, the medical practitioner will look for a flow of blood back into the catheter (“flashback”) to verify placement of the catheter opening into a vessel. The number of different catheter insertion procedures and techniques is great and may include the use of a needle, dilator, stylet, or other medical devices within the catheter when placed.
Once properly positioned, the catheter's hub (or medical device positioned within the catheter) can be coupled to an adapter (typically a luer fitting) to enable fluid coupling of the catheter to the source of fluids or reservoir. However, in the case of an accidental disconnection between the catheter and the reservoir, there is a possibility for the patient to bleed out or to entrain air that will lead to an embolism, both of which are potentially life-threatening for the patient. Accidental disconnection can occur if the mating parts are not securely tightened. The mating parts can also become loose from patient movement, unwanted fidgeting, or other patient interference. Further, if the patients have any blood-borne pathogen (e.g., HIV, hepatitis, etc.), blood exposure for the caregiver is potentially lethal. As such, insertion of the catheter requires that the point of access remains sanitary. The period between insertion of the catheter and coupling of an adaptor can cause bodily fluids to escape through the catheter, causing an unsanitary condition for the medical practitioner who must handle the catheter for coupling of the adapter and/or remove the medical device inserted through the catheter. The caregiver often covers an open connection port with their finger to reduce the blood flow until making a mating connection. Since blood can be a medium for bacterial growth, infection chances can rise due to exposure at the time of catheter insertion.
As such, there remains a need for a valve assembly that permits controlled fluid flow that also reduces risk of infection by providing a tight seal with respect to the catheter. There also remains a need for a valve that slows blood loss to give the caretaker time to adequately clean the connection and wipe away any residual blood on the connection. There also remains a need for a valve that minimizes the blood exposure for the caregiver at the time of insertion, removal, or a change in catheters.
The illustrations and variations described herein are meant to provide examples of the methods and devices of the invention. It is contemplated that combinations of aspects of specific embodiments or combinations of the specific embodiments themselves are within the scope of this disclosure. The valve assemblies described herein can be used in any tubing assembly, especially medical tubing not only limited to catheter assemblies.
A catheter assembly configured for use with a male luer is provided. The catheter assembly can comprise a catheter hub having an interior chamber and a valve located in the interior chamber. The valve can comprise a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior. The valve can include a barrier layer having an arcuate shape that extends in the valve interior from the sidewall at the distal portion. The barrier layer can have at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer.
The catheter assembly can further comprise a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer. The sealing ring can have an exterior sealing surface that forms a seal between the valve and the interior chamber at the distal end. An exterior diameter of the valve can be smallest at a recessed portion located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface. The recessed portion can be configured to provide deformation of the valve. A thickness of the sidewall at the recessed portion can be less than a thickness of the barrier layer.
The catheter assembly can further comprise a protrusion on an exterior surface of the sidewall. The protrusion can be located proximally to the recessed portion. The protrusion can nest within an opening in the interior chamber such that upon insertion of the luer into the proximal portion of the valve, the protrusion reinforces an adjacent sidewall to reduce elastic deformation of the valve at the protrusion and causing increased outward elastic deformation of the sidewall at the recessed portion. Further distal advancement of the luer can cause elastic deformation of the barrier layer opening the at least one slit such that the fluid can pass through the barrier layer. A plurality of protrusions can be provided on the exterior surface of the sidewall. The plurality of protrusions can each couple with a plurality of openings within the interior chamber. A lubricant within the interior chamber can be further provided. As noted herein, the protrusions allow for any variation of the assemblies discussed herein to incorporate a valve within a hub without the need for any adhesives. Alternate variations can include the use of adhesives.
The sealing ring can comprise a rounded edge along a sealing ring circumference. This allows an option of assembling the devices herein without the use of additional fixtures to assemble the valve within a hub. The sealing ring can remain engaged with an inner surface of the chamber when the male luer engages the recessed portion. The valve can comprise a flange at a proximal end. The flange can engage with a proximal end of the catheter hub. A thickness of the sidewall can be less than the thickness of the barrier layer.
Another variation of the valves described herein includes a valve comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer that extends in the valve interior from the sidewall at the distal portion, the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween, a slit extending through the barrier layer at the interior recess, wherein the slit is in a normally closed configuration that prevents a fluid from passing through the barrier layer, wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit.
The present disclosure also includes a guard assembly for use with a tubing hub. In one variation the guard assembly includes a valve configured for positioning in the hub and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer at the distal portion having at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer; a needle that extends through the hub and the slit of the barrier layer; a clip having a pair of arms extending from opposite ends of a rear wall of the clip, the rear arms being resilient, where each arm of the pair arms extends obliquely in a distal direction towards the needle such that a mid portion of each arm crosses the needle causing a distal segment of each arm to be biased against the needle on opposite sides of the needle, where a portion of each of the distal segment of each arm comprises an anchor section that engages the sidewall to anchor the clip to the valve interior during axial movement of the needle through an opening in the wall and between the distal segment of each arm; wherein withdrawal of a distal end of the needle proximally to the distal segment of each arm causes movement of the distal segment of each arm over the distal end of the needle to shield the distal end of the needle and also resulting in the anchor section of each arm to disengage from the sidewall; wherein continued proximal movement of the needle relative to the wall causes a stop surface on the needle to engage the opening in the wall such that the clip moves with the needle and remains with the needle when removed from the valve and the tubing hub.
The guard assembly can have an anchor assembly where the anchor section of each arm elastically deforms the sidewall, such that upon disengagement the sidewall returns to a pre-deformed condition.
Variations of the guard assembly can include an anchor section of each arm that comprises an edge of the distal segment opposite to an edge of the distal segment that is biased against the needle. In an additional variation, the anchor section of each arm comprises a protrusion on each distal segment that extends from a top edge opposite to an edge of the distal segment that is biased against the needle. In yet another variation, the anchor section of each arm comprises a protrusion on each distal segment that extends from each side of the distal segment.
Variations of the guard assembly can have a distal segment of each arm that is a curved lip.
In another variation, a guard assembly for use with a tubing hub includes a valve configured for positioning in the hub and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer at the distal portion having at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer; a needle that extends through the hub and the slit of the barrier layer; and a clip having a first arms extending from an ends of a rear wall of the clip, the first arms being resilient, where the first arm extends obliquely in a distal direction towards the needle such that a mid portion of the first arm crosses the needle causing a distal segment the first arm to be biased against the needle, where a portion of the distal segment comprises an anchor section that engages the sidewall to anchor the clip to the valve interior during axial movement of the needle through an opening in the wall; wherein withdrawal of a distal end of the needle proximally to the distal segment causes movement of the distal segment over the distal end of the needle to shield the distal end of the needle and also resulting in the anchor section disengaging from the sidewall; wherein continued proximal movement of the needle relative to the wall causes a stop surface on the needle to engage the opening in the wall such that the clip moves with the needle and remains with the needle when removed from the valve and the tubing hub.
The present disclosure also includes a medical assembly for shielding a needle tip upon removal of a needle from a hub. For example, such a medical assembly includes a valve configured for positioning in an interior chamber of the hub and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer at the distal portion having at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer; a clip having a rear wall with an opening that permits passage of the needle therethrough, the rear wall having a first end and a second end on radially opposing sides of the needle; a first arm extending obliquely and distally from the first end towards the needle, the first arm comprising a first arm section comprising a first dimension and a second arm section comprising a second dimension, wherein the first dimension is larger than the second dimension; a second arm extending obliquely and distally from the second end towards the needle, the second arm comprising a first arm section comprising a first dimension and a second arm section comprising a second dimension, wherein the first dimension is larger than the second dimension, where the first arm and the second arm are resilient; and where the first arm section of the first arm and the first arm section of the second arm each cross an axis of the needle such that the second arm section of the first arm and the second arm section of the second arm are on opposing sides of the needle and are biased against the needle; where an anchor portion of the second arm section of the first arm and an anchor portion of the second arm section of the second arm anchor into the sidewall of the valve by deforming the sidewall of the valve to prevent movement of the clip relative to the needle during axial movement of the needle through the rear opening of the clip.
In another variation, the present disclosure includes a needle catheter assembly. For example, the catheter assembly can include a catheter hub having an interior chamber; a valve located in the interior chamber and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer having at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer; a needle positioned within the valve, the needle having a needle shaft terminating at a sharp tip at a distal needle end, the shaft further including a stop surface having an increased diameter relative to a regular diameter of the needle shaft; a clip having a rear wall at a proximal end, a first arm extends from a first end of the rear wall and a second arm extends from a second end of the rear wall, the first end and the second end being on opposite sides of the needle shaft; and the first arm having a first mid portion and the second arm having a second mid portion that both extend distally and laterally from the wall such that the first mid portion and second mid portion intersect a longitudinal needle axis of the needle shaft and extend away from the needle shaft; where a portion of a proximal end of the first arm extends laterally from the first mid portion towards the needle shaft to form a first needle guard and where a portion of a proximal end of the second arm extends laterally from the second mid portion towards the needle shaft to form a second needle guard, where the first arm and the second arm are resilient such that the first needle guard and second needle guard are biased against opposite sides of the needle shaft; wherein the first needle guard has a first anchor portion and the second needle guard has a second engagement surface, each of which engage the inner sidewall of the valve to prevent movement of the needle guard when the needle shaft moves through an opening in the rear wall and relative to the clip, wherein withdrawal of the distal end of the needle shaft proximally to the first needle guard and the second needle guard causes disengagement of the first engagement surface and the second engagement surface from the inner sidewall such that the first needle guard and second needle guard cover the sharp tip, wherein continued withdrawal of the needle shaft causes the stop surface to engage the rear wall such that the needle guard remains attached to the needle shaft upon removal of the needle shaft from the valve.
The present disclosure is related to the following commonly assigned patents and applications, the entirety of each of which is incorporated by reference: U.S. Pat. Nos.: U.S. Ser. No. 11/324,939 issued on May 10, 2022; U.S. Pat. Nos.: U.S. Pat. No. 8,105,288 issued on Jan. 31, 2012; U.S. Pat. No. 8,591,469 issued on Nov. 26, 2013; U.S. Pat. No. 9,775,973 issued on Oct. 3, 2017; U.S. Pat. No. 9,604,035 issued on Mar. 28, 2017; U.S. Ser. No. 10/828,465 issued on Nov. 10, 2020; U.S. publication nos.: US20200016375A1 published on Jan. 16, 2020, and US20210031009A1 published on Feb. 4, 2021; Provisional application nos.: 62/993,493 filed on Mar. 23, 2020; 63/037,496 filed on Jun. 10, 2020; and 63/037,841 filed on Jun. 11, 2020; U.S. Patent Application 63/367,403 filed Jun. 30, 2022; U.S. application Ser. No. 18/170,835 filed Feb. 17, 2023; U.S. application Ser. No. 17/812,397 filed Jul. 13, 2022, now U.S. Patent No. U.S. Ser. No. 11/607,525; U.S. application Ser. No. 17/822,975 filed Aug. 29, 2022; PCT international application no. PCT/US2023/069399 filed Jun. 29, 2023.
Each of the following figures diagrammatically illustrates aspects and variations to better understand the invention. Variation of the invention from the aspects shown in the figures is contemplated.
For a better understanding of the present invention, reference will be made to the following description of the embodiments, which is to be read in association with the accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations.
The terms “a” or “an”, as used herein, are defined as one or as more than one. The term “plurality”, as used herein, is defined as two or as more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising. (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.
Reference throughout this document to “some embodiments”, “one embodiment”, “certain embodiments”, and “an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.
The valve 104 includes a barrier layer 210 that extends from the sidewalls in an interior of the valve to prevent fluid flow. Variations of the valve 104 comprise barrier layers 210 that are opened through elastic deformation rather than pressure within the catheter assembly. For example, variations of the valves 104 require the male luer 106 to elastically deform the valve 104 and/or barrier layer 210 to permit fluid flow through the valve 104. In one additional variation, the barrier layer includes an arcuate or concave shape in an interior of the valve. The barrier layer 210 includes at least one slit 212 extending therethrough and has a normally closed configuration to prevent a fluid from passing therethrough the barrier layer 210. Alternatively, the barrier layer 210 can have a plurality of slits 212 that form a plurality of leaflet structures or flaps that open upon deformation of the valve 104.
The barrier layer 210 generally includes a flexible or semi-flexible material that is compatible with exposure to blood, medicaments, and other fluids commonly encountered during catheterization/infusion procedures. The valve 104 can be fabricated from a compliable and resilient material such that insertion of the male luer 106 causes the barrier layer 210 to stretch and deform to an open configuration.
In an additional variation, a distal end 202 of a valve 104 can have a sealing ring 214 located circumferentially around the valve and distally to the barrier layer 210. As shown, variations of the valve can have a sealing ring 214 that includes a radius. This radius can allow for assembly of the valve 104 into a hub without additional fixtures. The sealing ring 214 can have an exterior sealing surface that forms a seal between the valve 104 and the hub 102 at the distal end 202 of the valve. The sealing ring 214 will be circumferentially engaged with the inner surface of the hub 102 such that the sealing ring 214 maintains a seal during insertion of the male luer 106, ensuring that fluid does not pass from the catheter hub 102 to an outer surface of valve 104. Variations of the valve can include a sealing ring 214 that is made of the same material as the remainder of the valve 104. Alternatively, the sealing ring 214 can comprise a different material than the remainder of the valve. Additionally, the angle at which the sealing ring 214 is offset with respect to the longitudinal axis can be changed to compress the valve 104 with respect to the hub 102 at varying diameters.
As seen in
Variations of the catheter hub 102 can comprise pockets or openings 306 positioned near the proximal end 108 of the hub 102, which seat the protrusions 206 of the valve 104 when the valve 104 is located in the chamber 300. Positioning of the valve 104 in the chamber 300 can occur via insertion or via molding of the valve into the chamber 300. As noted above, the protrusions 206 reinforce the sidewall 204 at the protrusions 206 to increase outward elastic deformation of the sidewall 204 at the recessed portion 208. The protrusions 206 nest in the openings 306 to hold the valve 104 in place such that the valve 104 to limit longitudinal stretching of the valve wall adjacent to the protrusion. The protrusions 206 in the present designs disclosed herein can also eliminate the need for any adhesive to hold the valve in place. This effect creates a preferential zone for stretching and/or deformation of the valve to open the barrier layer. The protrusions 206 in the present designs disclosed herein can also eliminate the need for any adhesive to hold the valve in place.
Protrusions 206 can additionally have a protrusion sealing ring that can provide additional interference along the openings 306. An outer portion of the protrusion where the protrusion 206 meets the edge of opening 306 accommodates the protrusion sealing ring. The protrusion sealing ring has a greater diameter than the remainder of the protrusion in order to provide a seal against the openings 306 of the hub 102. This seal, similar to sealing ring 214, prevents leaking of any fluid through the assembly.
Both the hub 102 and the valve 104 can comprise flanges, 216, 308 respectively, at their respective proximal ends that engage each other when the protrusions 206 nest within the openings 306. The valve flange portion 216 comprises a diameter greater than a diameter of the sidewall 204 for sealing against a proximal surface of the catheter hub flange 308. Alternatively, in some variations the valve flange portion 216 can include openings or segments such that it is not circumferentially continuous about the sidewall 204.
As seen in
In additional variations of a valve, the thickness of the barrier layer 210 is greater than a thickness of the sidewall 204 at the recessed portion 208 as well as a thickness of the sidewall (excluding the regions where the protrusion 206 joins the sidewall). For example, the increased thickness of the barrier layer 210 permits the slit 212 to elastically return to a closed position once luer 106 is removed. The relatively thinner sidewall 204 reduces an offset distance between the internal diameter of the valve interior 218 and the inner surface 304 of chamber 300. Reducing this offset distance allows for insertion of the male luer 106 to a sufficient depth along a longitudinal axis to open the slit 212 at the barrier layer 210 of the valve 104 without being impeded by the sidewall 204 of the valve 104. For example, if the sidewall 204 is too thin, then the valve 104 can suffer from an increased risk of failure (e.g., cracking or splitting). The thickness of the barrier layer 210 increases relative rigidity in comparison with the remainder of the valve 104, allowing the slit 212 to close fully, increasing the likelihood that the slit returns to its original state to close the valve 104, preventing leakage. In some variations, the thickness differential also allows deformation of the valve to occur at the barrier layer rather than the sidewall or recessed portion 208.
Similar to the features in the variation shown in
As seen in
As noted herein, the valves 104 include barrier layers 210 that are opened through elastic deformation rather than pressure within the valve 104 or catheter assembly (not shown). The variation of the valve shown in 5B, which is a cross-sectional view of the valve 104 of
In an additional variation, the slit 212 is aligned to extend in longitudinal alignment between the two protrusions 206. Since the internal recess 222 also runs parallel to the slit, the contact surfaces 224 and 226 deform portions of the valve 104 and sidewall 204 that are not supported by the protrusions 206. This results in selective deformation of the barrier layer 210 to open the slit 212. It is noted that variations of the valve 104 do not require the protrusions 206, the sealing ring 214, and/or the recessed portion 208. Such variations can include the internal recess 222 alone or in combination with any of the previously mentioned features.
In additional variations of a valve, the thickness of the barrier layer 210 is greater than a thickness of the sidewall 204 at the recessed portion 208 as well as a thickness of the sidewall. For example, the increased thickness of the barrier layer 210 permits the slit 212 to elastically return to a closed position once luer 106 is removed. The relatively thinner sidewall 204 reduces an offset distance between the internal diameter of the valve interior 218 and the inner surface 304 of chamber 300. Reducing this offset distance allows for insertion of the male luer 106 to a sufficient depth along a longitudinal axis to open the slit 212 at the barrier layer 210 of the valve 104 without being impeded by the sidewall 204 of the valve 104. For example, if the sidewall 204 is too thin, then the valve 104 can suffer from an increased risk of failure (e.g., cracking or splitting). The thickness of the barrier layer 210 can increase relative rigidity in comparison with the remainder of the valve 104, allowing the slit 212 to close fully, increasing the likelihood that the slit returns to its original state to close the valve 104, preventing leakage. In some variations, the thickness differential also allows deformation of the valve to occur at the barrier layer rather than the sidewall or recessed portion 208.
As shown, the arms 152, 154 extend distally along the needle axis 126 and the mid portions 166168 also extend in an oblique or lateral angle from the ends 162, 164 of the wall 156 towards the needle axis 126 such that the mid portions 166168 intersect the longitudinal needle axis 126 and continue to extend away longitudinal needle axis 126 until a distal segment/end portion 170 of the first arm 152 and a distal segment/end portion 172 of the second arm 154 engage the needle on opposite sides from their location of the rear wall 156.
The distal segments/end portions 170172 of the arms 152, 154 continue to extend obliquely or laterally their respective mid portions 166, 168 back towards the longitudinal needle axis 126 such that the respective needle guards that have ends 174176 that bias against the needle due to the resiliency of the arms 152152 and/or clip 150. In the clip 150 variation shown in
The clip 150 described herein also include one or more anchor portions that engage a valve wall to prevent movement of the clip 150 during movement of the needle. In the variation of
In the variation shown in
Use of a valve 104 to anchor the clip 150 effectively secures the clip 150 within the valve 104 due to the ability of the valve wall 204 to deform. This prevents inadvertent release of the clip as compared to a groove or other seat in a relatively stiff material such as a catheter hub.
It is intended that any of the anchor portions described herein can be combined onto a single spring. Moreover, the shapes of the anchor portions illustrated above are for exemplary purposes only, the anchor portions can take a variety of shapes as required.
It is contemplated that any variation or aspect of a variation can be combined with any other variation (e.g., the disclosure includes combinations of the various features of the valves, clips, hubs, etc. shown above even if such features are shown separately in the illustrations).
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments without departing from the spirit or scope of the invention. For example, a wide variety of materials may be chosen for the various components of the embodiments. It is therefore desired that the present embodiments be considered in all respects as illustrative and not restrictive, reference being made to the appended claims as well as the foregoing descriptions to indicate the scope of the invention.
This application is a continuation of U.S. patent application Ser. No. 18/344,568 filed Jun. 29, 2023 and is a continuation-in-part of U.S. patent application Ser. No. 17/822,975 filed Aug. 29, 2022, which claims priority to U.S. Patent Application No. 63/367,403 filed Jun. 30, 2022, the contents each of which are incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 63367403 | Jun 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18344568 | Jun 2023 | US |
| Child | 17822975 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17822975 | Aug 2022 | US |
| Child | 18508709 | US |
