Filtering needle assembly with seal plug
Inventors
McCall, Jr., Charles Edward • Mosler, Theodore Jay • Fentress, James Kevin • Conley, Megan Anderson • Carr, Sue Ellen
Assignees
Publication Number
US-11857768-B1
Publication Date
2024-01-02
Expiration Date
2042-10-01
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Abstract
A filtering needle assembly for use in administering a liquid payload, including: a needle and connector portion; a filtering needle body cap; a seal plug, and a filter: The seal plug initially lacking a needle channel so that a distal end of a hollow needle must be forced through the distal end of the seal plug while the seal plug is retained by a holding tool with a hollow midline of adequate depth to receive the protruding end of the hollow needle. An attempt to reuse the filtering needle assembly with a second insertion of a hollow needle into the filtering needle assembly will not work as the distal end of the hollow needle will push the seal plug distally rather than traverse the seal plug.
Core Innovation
The invention is a filtering needle assembly designed for administering a liquid payload that includes a needle and connector portion, a filter needle cap body, a seal plug, and a filter. The hollow needle has a distal tip that must be forced through the seal plug’s initially sealed distal end, forming a seal around a distal portion of the needle. This prevents liquid payload from traveling down the needle's outside diameter and ensures that all liquid drawn into the syringe passes through the filter and needle lumen.
The seal plug is held by a holding tool with a hollow midline during assembly to enable the distal tip of the hollow needle to pierce the seal plug and form a seal. Once the hollow needle is removed, reinsertion of a needle through the same seal plug is prevented, as the seal plug is pushed distally rather than pierced again, thereby precluding reuse of the filtering needle assembly.
The problem being solved addresses risks associated with reuse of single-use filtering needle assemblies. Existing assemblies, including those from prior patents, lack features to prevent reinsertion of needles through the filter needle cap after initial use, which can risk patient safety by allowing contaminated or unfiltered liquids to be administered. The invention provides a mechanical means to prevent a second use, improving safety by ensuring single use of filtering needle assemblies.
Claims Coverage
The patent includes several independent claims that cover the structure of the filtering needle assembly and methods of its use and assembly. The claims focus on the assembly components and the prevention of repeated use through the seal plug mechanism.
Structure of filtering needle assembly with seal plug
A filtering needle assembly comprising a needle and connector portion with a hollow needle and hub, a filter needle cap body, a filter for removing debris, and a seal plug that forms a seal around a distal portion of the hollow needle after the needle tip is pushed through the seal plug. Removal of the hollow needle precludes reliable reinsertion because subsequent needle insertion pushes the seal plug distally rather than piercing it, thereby preventing reuse.
Seal plug dome shape and hollow interior
The seal plug has a dome shape with a convex distal end and a hollow interior open at the proximal face, allowing the hollow needle tip to travel through the interior before pushing through the plug material.
Seal plug rib rings for friction fit
The seal plug includes at least one rib ring creating a friction fit with the interior of the filter needle cap body, holding the seal plug in place during initial needle insertion and blocking liquid from traveling outside the needle lumen.
Use of outer cap
An outer cap with a closed distal end may be placed over the filtering needle assembly until use, protecting it until uncovered for filtering liquid.
Hub adapted to reversibly engage fluid fitting
The hub's open proximal end is adapted to reversibly engage a fluid fitting on a syringe such that the syringe can draw filtered liquid through the assembly and then be removed to expose the needle for administration.
Kit including filtering needle assembly and liquid payload
Provision of a kit containing the filtering needle assembly and a reservoir of liquid payload for administration after filtration.
Method for loading liquid and precluding reuse
A method of loading filtered liquid into a syringe using the filtering needle assembly and precluding loading a second quantity with a second syringe by preventing the second needle from traversing the seal plug.
Assembly method with holding tool
A method of assembling the filtering needle assembly by inserting the seal plug into the filtering needle cap body, holding it with a holding tool with an open midline while advancing the needle tip through the plug, removing the tool after insertion, and securing a filter in the cap body.
Method for making filtered needle assembly unusable with second needle
A method for preventing reuse by loading liquid through the assembly, removing the first needle, then attempting insertion of a second needle which pushes the seal plug distally without traversing it, thus failing to allow liquid to be drawn through.
The claims collectively cover the structural features of the filtering needle assembly centered on the seal plug that prevents reuse, the specific dome-shaped seal plug with friction fit rib rings, methods for assembling the device using a holding tool to enable initial needle piercing, and methods or kits for use and single-use enforcement to improve safety.
Stated Advantages
Prevents reuse of single-use filtering needle assemblies by mechanically blocking reinsertion of a needle after initial use, ensuring patient safety.
Prevents inadvertent or intentional second use, reducing the risk of administering contaminated or unfiltered liquid payloads.
Maintains a seal that allows effective suction to draw liquid payload through the hollow needle and filter during first use.
Enables a simple mechanical method without complex locking mechanisms to enforce single use.
Documented Applications
Administering pharmaceuticals or other liquid payloads requiring filtration before administration to human or veterinary patients.
Drawing filtered liquids from sealed reservoirs such as glass ampoules that may produce debris like glass shards.
Injecting nutraceuticals and blood products such as Prothrombin Complex C where filtered injection is beneficial.
Use in needle exchanges for reducing disease spread among intravenous drug users.
Loading liquid payloads through filters into syringes for subsequent injection or IV therapy through septum ports.
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