Intravenous catheter apparatus with safety function and pressure controlled valve element

Inventors

BAID, RISHI

Assignees

Poly Medicure Ltd

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Publication Number

US-11116944-B2

Patent

Publication Date

2021-09-14

Expiration Date


Abstract

The invention relates to an intravenous catheter apparatus comprising: a catheter hub (12) arranged at a proximal end of a catheter tube (10), the catheter hub (12) having an inner surface (14) defining a chamber (16); a needle (20) defining an axial direction and having a needle tip (24), the needle (20) extending through the chamber (16) and the catheter tube (10) when in a ready position; a needle guard (32) slidably arranged on the needle (20) and at least partially received in the chamber (16) when the needle (20) is in the ready position, the needle guard (32) including a base portion (34) and first and second arms (36, 38) extending from the base portion (34), wherein the first arm (36) is deflected radially outwards by the needle (20) against a restoring force when the needle (20) is in the ready position whereby the needle guard (32) is brought into retaining contact with the catheter hub (12); and wherein the catheter apparatus includes a valve which separates a distal space arranged in distal direction from the valve from a proximal space arranged on proximal direction from the valve. The invention further provides that the valve opens based on a pressure differential between the pressure prevailing in the distal space and the pressure prevailing in the proximal space.

Core Innovation

The described invention provides an intravenous catheter apparatus including a catheter hub defining a chamber, and a needle arranged to extend through the chamber and the catheter tube in a ready position. A needle guard is slidably arranged on the needle and is at least partially received in the chamber when the needle is in the ready position, with a base portion and first and second arms extending from the base portion. The first arm is deflected radially outwards by the needle against a restoring force so that the needle guard is brought into retaining contact with the catheter hub.

The apparatus further includes a valve that separates a distal space from a proximal space and that opens based on a pressure differential between pressure prevailing in the distal space and pressure prevailing in the proximal space. The valve comprises a housing with a first opening and a second opening and an elastomeric member positioned in the housing. The elastomeric member has a continuous peripheral wall projecting from a surface and a slit extending through the surface, where a continuous portion of the peripheral wall creates a continuous sealable contact with the housing and partitions the housing into an upper section and a lower section.

In response to creating a pressure differential between the upper section and lower section, the elastomeric member is configured such that either the peripheral wall deflects from the housing permitting fluid flow around the elastomeric member while maintaining closure of the slit, or the slit opens permitting fluid flow through the elastomeric member while the peripheral wall is maintained in sealable contact with the housing. The described embodiments include different valve/housing configurations, with fluid-tight seals and fluid communication through housing openings and fluid channels.

Claims Coverage

The independent claim set is centered on one independent claim covering a needle/needle-guard safety arrangement and a pressure-differential elastomeric valve that separates distal and proximal spaces. The independent claim includes a principal inventive structure of the valve housing and elastomeric member, with alternative pressure-differential opening behaviors, and an additional independent structural safety feature for bringing the needle guard into retaining contact.

Pressure-differential elastomeric valve separating distal and proximal spaces

A valve which separates a distal space arranged in distal direction from the valve from a proximal space arranged on proximal direction from the valve, wherein the valve opens based on a pressure differential between the pressure prevailing in the distal space and the pressure prevailing in the proximal space, the valve comprising a housing having a first opening and a second opening; and an elastomeric member positioned in the housing, the elastomeric member comprising a continuous peripheral wall projecting from a surface; and a slit extending through the surface.

Continuous sealable peripheral wall partitioning the housing into upper and lower sections

A continuous portion of the peripheral wall creating a continuous sealable contact with the housing and partitioning the housing into an upper section and a lower section, the elastomeric member configured such that upon creating a pressure differential between the upper section and the lower section of the housing causes either: (i) the peripheral wall to deflect from the housing permitting fluid flow around the elastomeric member, while maintaining closure of the slit; or (ii) the slit to open permitting fluid flow through the elastomeric member, while the peripheral wall is maintained in sealable contact with the housing.

Needle guard arms bringing retaining contact with the catheter hub

A needle guard slidably arranged on the needle and at least partially received in the chamber when the needle is in the ready position, the needle guard including a base portion and a first arm and a second arm extending from the base portion, wherein the first arm is deflected radially outwards by the needle against a restoring force when the needle is in the ready position whereby the needle guard is brought into retaining contact with the catheter hub.

Across the independent claim coverage shown, the key inventive aspects are the safety needle guard brought into retaining contact via radial deflection under a restoring force, and a valve that separates distal and proximal spaces and opens based on a pressure differential using an elastomeric member with a continuous sealable peripheral wall and a slit that either remains closed while the peripheral wall deflects or opens while maintaining peripheral wall sealable contact.

Stated Advantages

Protection from accidental needle pricking.

Reduced blood reflux and reflux after aspiration.

Directional flow control via the valve opening behavior.

Low infusion cracking pressure.

Prevention of air ingress.

Improved flushing/mixing and reduced dead volume to limit thrombus and bacterial growth.

Compatibility with passage of an elongated medical device.

Documented Applications

Use in systems involving intravenous catheter apparatuses including central line applications such as PIC C and CVC.

Fluid handling contexts related to infusion and aspiration, including flushing/mixing to limit thrombus and bacterial growth.

Compatibility with passage of an elongated medical device such as a guidewire/cannula/elongated medical device.

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