Filtering needle cap with a seal around a needle

Inventors

Carr, Sue E.Delgado, JessieBrowka, EdwardMcCall, JR., Charles E.Foshee, David L.

Assignees

Carrtech CorpGILERO LLC

Publication Number

US-10512728-B2

Publication Date

2019-12-24

Expiration Date

2034-05-19

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Abstract

A filtered needle for use in administering a liquid payload, including a needle and connector portion and a filtering needle cap. The filtering needle cap including a distal open end in fluid communication via an internal channel with a proximal open end of the filtering needle cap. The filtering needle cap proximal end sized to receive the distal end of the hub within the proximal end of the filtering needle cap to reversibly engage the hub when needle distal end is inserted into the internal channel. The filtering needle cap including a filter element and a seal to seal around an outside diameter of the hollow needle so that liquid payload is drawn into the lumen in the hollow needle as liquid payload is filtered and drawn into the fluid fitting. The filtering needle cap is designed to limit a dead volume of liquid payload drawn into the filtering needle cap but not entering into the distal end of the hollow needle.

Core Innovation

The invention relates to a filtered needle system configured for use in administering a liquid payload, such as pharmaceuticals, with a focus on a needle and connector portion combined with a filtering needle cap. The needle includes a hollow needle with a distal end opening to a lumen and a hub with a proximal end adapted to reversibly engage a fluid fitting, typically a syringe. The filtering needle cap features a distal open end in fluid communication through an internal channel with a proximal open end sized to receive the distal end of the hub and reversibly engage it when the hollow needle's distal end is inserted into the internal channel. The filtering needle cap incorporates a filter element that removes debris from the liquid payload as it is drawn through the cap into the needle lumen, and a seal formed by the intermediate portion of the filtering needle cap that seals around the needle's outer diameter closer to its distal end to ensure liquid is drawn into the lumen and not along the needle outside.

The invention addresses the problem of safely removing debris such as glass shards generated when opening glass ampoules containing liquid pharmaceuticals, which must be filtered before administration to a patient. Existing methods involve either a two-stage process with a filtered needle or straw that must be removed prior to administration, risking contamination and requiring costly disposable components; or a one-stage process employing a specially fabricated frangible needle which presents manufacturing challenges and risk of creating debris. The invention seeks to provide an inexpensive, reliable, and safer system for filtering liquid payloads by integrating a filtering needle cap with a sealing mechanism around the needle to limit dead volume and to allow a one-step filtering and administration procedure.

The filtering needle cap is designed to form a chamber sealed by direct contact around the needle's outside diameter without requiring an internal sleeve, ensuring that the syringe or fluid fitting draws liquid through the filtered pathway inside the needle. The positioning of the seal closer to the distal end of the needle minimizes dead volume—the volume of liquid drawn into the filtering needle cap but not entering the needle lumen, reducing waste. The system enables a method where the liquid payload is drawn through the filter element into the needle lumen while attached to the syringe, and then the filtering needle cap is removed to expose the needle for administration, all while maintaining sterility and reducing contamination risks.

Claims Coverage

The patent includes one independent apparatus claim and one independent method claim, each defining inventive features related to a filtered needle with a sealing filtering needle cap and a method for loading filtered liquid payload into a syringe using the filtered needle.

Filtered needle with a filtering needle cap forming a seal by direct contact without an internal sleeve

A filtered needle comprising a hollow needle, a hub adapted to reversibly engage a fluid fitting, and a filtering needle cap with a distal open end and a proximal open end sized to receive and engage the hub. The filtering needle cap includes a filter element for removing debris as liquid passes through and an intermediate portion sized to seal around the outside diameter of the hollow needle closer to the needle's distal end than proximal end without using a sleeve within the filtering needle cap, such that liquid is drawn into the needle lumen and impeded from traveling along the needle's outside diameter inside the filtering needle cap.

Method for loading filtered liquid payload into a syringe using filtered needle

A method involving obtaining a reservoir of liquid payload, using a filtered needle attached to a syringe where the filtered needle comprises a connector portion and filtering needle cap with a filter element and seal around the hollow needle. The method includes drawing the liquid payload through the filter element and needle lumen while the filtered needle is connected to the syringe, followed by removing the filtering needle cap to expose the needle distal end for administration.

The claims cover the structural inventive feature of a filtered needle cap that seals directly around the needle without an internal sleeve to ensure effective filtration and minimized dead volume, as well as a method encompassing continuous connection of the filtered needle to a syringe for drawing and administering filtered fluids to reduce contamination and procedural steps.

Stated Advantages

Provides an inexpensive and reliable system for filtering liquid payloads before delivery.

Minimizes dead volume of liquid payload drawn into the filtering needle cap but not entering the needle lumen, reducing waste.

Enables a one-step filtering and administration process that reduces risk of bacterial contamination by maintaining connection to the syringe during filtering and administration.

Allows the filtering needle cap to seal directly around the outside diameter of the needle without the need for a separate sleeve, simplifying design and manufacture.

Reduces handling steps compared to prior two-stage processes, limiting potential exposure to contamination.

Documented Applications

Filtering liquid pharmaceuticals stored in glass ampoules by removing glass shards before administration.

Administering other liquid payloads such as nutraceuticals requiring filtration before injection.

Use in public health needle exchange programs to limit disease spread by providing filtered needles.

Filtering blood products such as Prothrombin Complex C (PCC) before administration.

Drawing filtered liquid payloads into syringes for subsequent injection into patients, IV therapy ports, or other delivery sites.

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