Patent ID: 12194249

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiment of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

The term “proximal” is used to denote a portion of a device which, during normal use, is nearest the user and furthest from the patient. The term “distal” is used to denote a portion of a device which, during normal use, is farthest away from the user wielding the device and closest to the patient. The term “activation” of valve mechanism or septum is used to denote the action of opening or closing of such valve. For example, in some embodiments a catheter assembly is provided having a septum and a septum actuator, wherein the catheter assembly undergoes activation when the septum actuator is advanced through the septum, thereby providing a fluid pathway through the septum.

The present invention relates to blood control intravenous (IV) catheter assemblies having a septum actuator that is fixedly positioned within a catheter adapter of the IV catheter assembly. Further, the present invention relates to a multiple-use blood control IV catheter assembly comprising a septum that forced into a compressed or flexed state by inserting an external Luer device into the catheter adapter. The external Luer device advances the septum in a distal direction thereby compressing or flexing the septum and forcing a probe portion of the septum actuator through a slit of the septum. The fully inserted probe portion biases the slit into an open position thereby providing a pathway through the septum. In the compressed state, the septum comprises compressive potential energy that is stored until the external Luer device is removed from the catheter adapter.

As the external Luer device is removed from the catheter adapter, the compressive potential energy of the septum is released thereby restoring the septum to its original, uncompressed state or shape. In some instances, the release of the compressive potential energy results in the septum sliding in a proximal direction within the catheter adapter. As the septum slides in the proximal direction, the probe portion of the septum actuator is drawn into the slit, thereby allowing at least a portion of the slit to reseal and prevent passage of fluids through the septum and/or the septum actuator. Upon reinsertion of the external Luer device, the septum is again compressed and the probe portion of the septum actuator is again inserted fully through the slit to permit passage of fluid through the septum.

Referring now toFIG.1, an IV catheter assembly10is shown. Generally, IV catheter assembly10comprises a catheter adapter20having a proximal end22, a distal end24and a fluid pathway26extending therebetween. In some instances, proximal end22comprises a feature for coupling an external device to catheter adapter20. For example, in some embodiments proximal end22comprises a set of threads to compatibly receive a Luer adapter.

The catheter adapter20generally has a tubular shape. An inner surface28comprises various features and shapes configured to receive or accommodate various components of IV catheter assembly10. For example, in some embodiments inner surface28comprises a surface configured to support the base of an intravenous catheter12. Inner surface28may further include an annular recess32configured to fixedly receive and support a base42of septum actuator40. Further, in some embodiments inner surface28comprises an annular ridge or shelf38forming a distal stop to prevent or limit movement of septum50in distal direction14.

In some embodiments, inner surface28comprises a diameter60that is approximately equal to, or slightly smaller than an outer diameter of septum50. As such, a fluid tight seal is provided between the outer surface52of septum50and inner surface28. Further, diameter60is selected to provide a fluid tight seal against outer surface52, while still allowing septum50to slide within fluid pathway in distal and proximal directions14and16. In some embodiments, inner surface28further comprises a second annular ridge or shelf (not shown) forming a proximal stop to prevent or limit movement of septum50in proximal direction16.

In some instances, one or more vent channels is provided between outer surface52and inner surface28to permit air to bypass septum50when blood fills the distal portion of the fluid pathway. For example, in some instances outer surface52comprises one or more channels having a cross-sectional area configured to permit passage of air between the channel and inner surface28, and between distal and proximal fluid chambers27and29. In other embodiments, inner surface28comprises one or more grooves or recesses which provide a gap between inner surface28and outer surface52of septum50. The one or more grooves comprise a length that is greater than a length of septum50, such that the grooves or recesses overlap the length of septum50, thereby providing fluid communication between distal and proximal fluid chambers27and29via the grooves or recesses.

In some embodiments, a lubricant is applied between outer surface52and inner surface28to assist movement of septum50within fluid pathway26. A lubricant may include any material or combination of materials that are safe for use in infusion therapy procedures and devices. In some embodiments, a lubricant is provided which comprises silicon oil. In other embodiments, a lubricant is provided which further comprises an antimicrobial agent, such as chlorhexidine acetate.

IV catheter adapter20is preferably of a transparent or semi-transparent material so as to show the interior, enabling checking of movement inside. Suitable materials for IV catheter adapter20include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene and the like.

IV catheter assembly10may further include features for use with an over-the-needle catheter assembly. For example, a flexible or semi flexible polymer catheter may be used in combination with a rigid introducer needle to enable insertion of the catheter into the vasculature of a patient. Surgically implanted catheters may also be used.

Once inserted into a patient, catheter12and catheter adapter20provide a fluid conduit to facilitate delivery of a fluid to and/or retrieval of a fluid from a patient, as required by a desired infusion procedure. Thus, in some embodiments the materials of the catheter12and catheter adapter20are selected to be compatible with bio-fluids and medicaments commonly used in infusion procedures. Additionally, in some embodiments a portion of the catheter12and/or catheter adapter20is configured for use in conjunction with a section of intravenous tubing (not shown) to further facilitate delivery of a fluid to or removal of a fluid from a patient.

IV catheter assembly10further comprises a septum actuator40. In some embodiments, septum actuator40comprises a hollow structure having a base42that is configured to be coupled to, or interact with inner surface28. Septum actuator40further comprises a probe44that extends outwardly from base40towards proximal end22. In some instances, probe44comprises a hollow spike that is configured to insert into a slit54of septum50. Probe44is generally axially center within fluid pathway26and in alignment with slit54of septum50. Prior to compressing septum50, probe44abuts or is partially inserted through slit54, such that a portion of slit54remains closed or sealed, as shown inFIG.1A.

Septum50generally comprises a flexible, resilient polymer material comprising a self-sealing slit54. For example, in some embodiments septum50comprises an elastomeric polymer or rubber. In other embodiments, septum50comprises a silicon rubber.

In some instances, septum50comprises an outer surface52that is configured to form a fluid tight seal within inner surface28. In other instances, septum50comprises an outer surface52that includes one or more vent features to permit air to bypass septum50and provide fluid communication between distal and proximal fluid chambers27and29of catheter adapter20. Further, in some instances, inner surface28comprises one or more channels which form an air vent between catheter adapter20and septum50, as discussed previously.

In some instances, septum50is positioned in catheter adapter20thereby dividing fluid pathway26into a distal fluid chamber27and a proximal fluid chamber29. Thus, when slit54is sealed, septum50prevents fluids from bypassing septum50between distal and proximal fluid chambers27and29.

Outer surface52is further configured to slide in distal direction14as septum50is compressed by an external Luer device70, as shown inFIG.1B. External Luer device70may include any instrument or device capable of being inserted into proximal end22of catheter adapter20. For example, in some instances external Luer device70comprises a nozzle of a syringe or another needleless connector. In other instances, external Luer device70comprises a male Luer adapter.

In some embodiments, fluid is permitted to bypass septum50by inserting an external Luer device70into proximal opening22of catheter adapter20, such that external Luer device70contacts septum50and slides septum50in distal direction14. As septum50is slid in distal direction14, a distal surface56of septum50contacts distal stop38thereby limiting additional movement of distal surface56in distal direction14. As external Luer device70is further inserted into proximal end22, a proximal surface58continues to be advanced in distal direction14, thereby compressing septum50between external Luer device70and distal stop38. As this compression occurs, probe44of septum actuator40is advanced through slit54until probe44is fully inserted through slit54. Thus, in the compressed state the lumen46of septum actuator40provides fluid communication between distal and proximal fluid chambers27and29.

In the compressed state, septum50comprises compressive potential energy. Upon removal of external Luer device70, the stored compressive potential energy is released and septum50relaxes to its original shape. In the process of relaxing or returning to an uncompressed state, proximal surface58moves in proximal direction16and probe44is again enclosed within slit54, as shown inFIG.1A.

In some embodiments, distal surface56further comprises a compression cutout62. Cutout62provides a void which is filled by the remainder of septum50when compressed. Cutout62thus permits compression of septum50without damaging septum50and/or septum actuator40. In some embodiments, cutout62provides a raised edge or lip51on distal surface56. Raised lip51acts as a spring which stores the compressive potential energy when in the compressed state. The features of IV catheter assembly10provide a multiple-use blood control device, wherein the process of compressing and releasing septum50to control passage of fluid between distal and proximal fluid chambers27and29may be repeated as desired.

Referring now toFIG.2A, in some embodiments IV catheter assembly10further comprises a septum actuator140having a base142and a probe144, wherein probe144comprises a conical nozzle. Septum actuator140comprises a hollow structure having a tip146forming a proximal end of probe144. IV catheter assembly10further comprises a septum150having a slit154that is self-sealing. In some embodiments, septum150comprises an outer diameter is that is approximately equal to, or slight greater than inner diameter60of inner surface28. As such, a fluid tight seal is provided between inner surface28and outer surface152. However, in other instances one or more air vents is provided between septum50and inner surface28to permit communication of air between distal and proximal fluid chamber27and29.

In some embodiments, septum150is slidably positioned in proximal fluid chamber29. Septum150is configured to slide within proximal fluid chamber29in distal and proximal directions14and16. In some instances, inner surface28further comprises an annular ridge136which forms a proximal stop to prevent or limit movement of septum150in proximal direction16. Thus, in some embodiments septum150is positioned in proximal fluid chamber29such that tip146of probe144is partially inserted through slit154of septum150when septum150is in a resting or uncompressed state, as shown inFIG.2A. In other embodiments, tip146of probe144is positioned adjacent to slit154of septum150when septum150is in a resting or uncompressed state.

In some embodiments, fluid is permitted to bypass septum150by inserting external Luer device70into proximal opening22of catheter adapter20, wherein external Luer device70contacts septum150and slides septum150in distal direction14. As septum150is slid in distal direction14, the septum150is compressed between the conical nozzle of probe144and inner surface28, as shown inFIG.2B. As the compression of septum150occurs and septum150is slid further in distal direction14, tip146of probe144is fully inserted through slit154, thereby providing fluid communication between distal and proximal fluid chambers27and29. In some instances, a lubricant material is applied to either slit154or the outer surface of probe144to facilitate insertion of probe144through slit154without damaging septum150.

In the compressed state, septum150comprises compressive potential energy. Upon removal of external Luer device70, the stored compressive potential energy is released and septum150relaxes to its original shape. In the process of relaxing or returning to an uncompressed state, septum150travels in proximal direction16and tip146of probe144is again enclosed within slit154, as shown inFIG.2A.

In some instances, the conical nozzle shape of probe144assists in sliding septum150in proximal direction16following removal of external Luer device70. In particular, the angled outer surface of probe144reduces the angular frictional force between slit154and probe144. In some instances, a lubricous agent or material is applied between slit154and probe144to further reduce frictional forces therebetween.

The features of IV catheter assembly10thus provide a multiple-use blood control device, wherein the process of compressing and releasing septum150to control passage of fluid between distal and proximal chambers27and29may be repeated as desired.

In some embodiments, probe144comprises a hollow spike having an interior and an exterior. In some instances, probe144further comprises one or more windows which are configured to permit fluid communication between the interior and exterior of the hollow spike. As such, fluid that is trapped in the interstitial space156between the exterior of the hollow spike and inner surface28of catheter adapter20may pass through the one or more windows and into fluid pathway26.

The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

The various embodiments of the present invention may be adapted for use with any medical device or accessory having a lumen in which is seated a septum. For example, in some embodiments a female Luer adapter coupled to a section of intravenous tubing may comprise a septum and a septum actuator in accordance with the present teachings. In other embodiments, one or more ends of a y-port adapter may comprise a septum and a septum actuator in accordance with the teachings of the present invention.