US20160220805A1 - Intravenous catheter assembly design - Google Patents

Abstract

An intravenous catheter assembly. The intravenous catheter assembly including a catheter and a catheter hub having a catheter hub body, a septum, and a septum retainer, the catheter hub body having an internal wall defining a transition step, wherein the septum positioned such that a first end of the septum abuts up against the transition step, the septum retainer at least partially insertable within the catheter hub body and configured to secure the septum in position.

Description

RELATED APPLICATIONS
• The present application claims the benefit of U.S. Provisional Application Nos. 62/109,673; 62/109,710; 62/109,715; 62/109,722; 62/109,735; 62/109,742; 62/109,745; 62/109,750; 62/109,755; 62/109,759; 62/109,766, all of which were filed Jan. 30, 2015 and are hereby incorporated herein by reference in their entirety.
TECHNICAL FIELD
• The present disclosure relates generally to intravenous catheters, and more particularly to an intravenous catheter assembly that minimizes the risk of blood exposure to a clinician.
BACKGROUND
• Intravenous (IV) therapy is a versatile technique used for the administration of medical fluids to and withdrawal of bodily fluids from patients. IV therapy has been used for various purposes such as the maintenance of fluid and electrolyte balance, the transfusion of blood, the administration of nutritional supplements, chemotherapy, and the administration of drugs and medications. Fluids may be administered intravenously by injection through a hypodermic needle, or intermittently or continuously by infusion using a needle or catheter. The most common intravenous access method utilized by clinicians is the peripheral IV catheter.
• A peripheral IV catheter is made of soft, flexible plastic or silicone, generally between fourteen to twenty-four gauge in size. In the conventional venipuncture procedure, a catheter is inserted into a vein in the patient's hand, foot, or the inner aspect of the arm or any vein in the body that will accept an IV catheter. In order to properly place the IV catheter into a patient's vein, a sharp introducer needle is used to puncture the skin, tissue, and vein wall to provide a path for placement of the catheter into the vein.
• Referring toFIGS. 1 and 2, a conventional IVcatheter assembly20 configured for insertion of an “over-the needle”catheter22 is depicted.Catheter22 generally has afirst end26 for insertion into a biological site, asecond end28 and a flexible wall defining a lumen extending therebetween. Frequently, thesecond end28 of thecatheter22 is operably coupled to acatheter hub34. Thecatheter22 is operably coupleable to theneedle assembly20, in part by positioning thecatheter22 coaxially over aneedle24 of thesafety needle assembly20. Thecatheter22 thus rides with theneedle24 through the skin, tissue, and vein wall and into the patient's vein. Once thecatheter22 has entered the patient's vein, thecatheter22 can be advanced further into the vein as desired and theneedle24 can be withdrawn from thecatheter22. Thecatheter22 can then be secured into place on the patient and connected to an IV fluid supply line.
• Various catheter insertion devices have been developed to provide aneedle24 for catheterization. In some cases, a conventional hollowhypodermic needle24, such as that depicted inFIGS. 1 and 2, is used to facilitate catheterization. One such example of this type catheter insertion device is marketed by Smiths Medical ASD, Inc. of St. Paul, Minn., under the JELCO trademark, as described in U.S. Pat. Nos. 7,291,130 and 8,257,322 (depicting an IV catheter insertion device marketed by Smiths Medical ASD, Inc. under the INTUITIV Safety IV Catheters trademark), both of which are incorporated by reference herein. In other cases, the catheter insertion device provides a safety needle assembly that functions to house the sharpened tip of the needle to reduce the likelihood of an inadvertent needle stick, Examples of this type of catheter insertion device are described in U.S. Pat. No. 5,000,740 (depicting an IV catheter insertion device marketed by Smiths Medical ASD, Inc. under the PROTECTIV trademark), U.S. Pat. No. 7,736,342 (depicting an IV catheter insertion device marketed by Smiths Medical ASD, Inc. under the VIAVALVE trademark), both of which are incorporated by reference herein,
SUMMARY OF THE DISCLOSURE
• One embodiment of the present disclosure provides an intravenous catheter assembly including a catheter and a catheter hub. The catheter has a first end for insertion into a biological site, a second end and a flexible wall defining a lumen extending therebetween. The catheter hub has a first catheter hub portion, a second catheter hub portion, and a septum. The first catheter hub portion has a first end operably coupled to the second end of the catheter, a second end, and an internal wall defining a first internal fluid passageway therebetween. The internal wall of the first catheter hub portion further defines a side port in fluid communication with the internal fluid passageway. The second catheter hub portion has a first end operably coupled to the second end the first catheter hub portion, a second end, and an internal wall defining a second internal fluid passageway therebetween. The second catheter hub portion further has a baffle positioned within the internal fluid passageway between the first end and the second end of the second catheter hub portion. The septum is housed within the first internal fluid passageway of the first catheter hub portion and is retained in position by the baffle of the second catheter hub portion.
• In some versions, the first catheter hub portion and the second catheter hub portion are operably coupled together via a circumferential tongue and groove assembly. In some versions, the side port is configured to be connected to one or more lengths of hollow tubing so that the inside of the hollow tubing is in fluid communication with the internal fluid passageway. In some versions, the intravenous catheter assembly further includes hollow tubing connected to the side port, where the tubing includes a tube connector configured to be connected to an IV fluid supply line. In some versions, the septum is self-sealing, such that an insertion needle can pass therethrough and when withdrawn any void left by the withdrawn needle will seal to maintain fluid impermeability of the septum. In some versions, the septum has a first end positioned proximate to the side port that includes a peripheral chamfered lip configured to aid in enabling a fluid tight seal with the internal wall of the first catheter hub portion, in some versions, the catheter hub includes one or more wings extending radially outward from the catheter hub. In some versions, the wings are integrally molded onto the catheter hub. In some versions, the wings are coupled to the catheter hub via a collar that at least partially surrounds the catheter hub.
• Another embodiment of the present disclosure provides an intravenous catheter assembly including a catheter and a catheter hub. The catheter has a first end for insertion into a biological site, a second end and a flexible wall defining a lumen extending therebetween. The catheter hub has a catheter hub body and a septum. The catheter huh body has a first end operably coupled to the second end of the catheter, a second end, and an internal wall defining an internal fluid passageway therebetween. The internal wall of the catheter hub body further defines a side port in fluid communication with the internal fluid passageway. The septum is fixedly coupled within the internal fluid passageway of the catheter hub body between the second end and the side port. The septum has a first end positioned proximate to the side port that includes a peripheral chamfered lip configured to aid in enabling a fluid tight seal with the internal wall of the first catheter hub portion.
• In some versions, the side port is configured to be connected to one or more lengths of hollow tubing so that the inside of the hollow tubing is in fluid communication with the internal fluid passageway. In some versions, the intravenous catheter assembly further includes hollow tubing connected to the side port, wherein the tubing includes a tube connector configured to be connected to an IV fluid supply line. In some versions, the septum is self-sealing, such that an insertion needle can pass therethrough and when withdrawn any void left by the withdrawn needle will seal to maintain fluid impermeability of the septum. In some versions, the catheter hub includes one or more wings extending radially outward from the catheter hub. In some versions, the wings are integrally molded onto the catheter hub. In some versions, the wings are coupled to the catheter hub via a collar that at least partially surrounds the catheter hub. Another embodiment of the present disclosure provides an intravenous catheter assembly including a catheter and a catheter hub. The catheter has a first end for insertion into a biological site, a second end and a flexible wall defining a lumen extending therebetween. The catheter hub has a catheter hub body, a septum, and a septum retainer. The catheter hub body has a first end operably coupled to the second end of the catheter hub body, a second end, and an internal van defining an internal fluid passageway therebetween. The internal wall of the catheter hub body further defines a side port in fluid communication with the internal fluid passageway. The septum is positioned within the internal fluid passageway bet n the second end of the catheter hub body and the side port, wherein the septum has a first end positioned proximate to the side port. The septum retainer is configured to secure the septum in position within the internal fluid passageway. The septum retainer has a first end, a second end, and a wall defining an internal conduit therebetween. The septum retainer wall further defines one or more apertures in fluid communication with the internal fluid passageway of the catheter hub body, wherein the first end of the septum retainer is fixedly coupled to the first end of the catheter hub body, such that the lumen of the catheter is in fluid communication with the internal conduit of the septum retainer. The second end of the septum retainer includes a flared portion embedded within the septum.
• In some versions, the side port is configured to be connected to one or more lengths of hollow tubing so that the inside of the hollow tubing is in fluid communication with the internal fluid passageway. In some versions, the intravenous catheter assembly further includes hollow tubing connected to the side port, wherein the tubing includes a tube connector configured to be connected to an IV fluid supply line. In some versions, the septum is self-sealing, such that an insertion needle can pass therethrough and when withdrawn any void left by the withdrawn needle will seal to maintain fluid impermeability of the septum. In some versions, the septum has a first end positioned proximate to the side port that includes a peripheral chamfered lip configured to aid in enabling a fluid tight seal with the internal wall of the first catheter hub portion. In some versions, the catheter hub includes one or more wings extending radially outward from the catheter hub. In some versions, the wings are integrally molded onto the catheter hub. In some versions, the wings are coupled to the catheter hub via a collar that at least partially surrounds the catheter hub.
• Another embodiment of the present disclosure provides an intravenous catheter assembly having a two-way septum valve for controlling the flow of fluid in a closed system environment to and from a patient's blood vessel. The intravenous catheter assembly includes a catheter and a catheter hub. The catheter has a first end for insertion into a biological site, a second end and a flexible wall defining a lumen extending therebetween. The catheter hub has a catheter hub body, a septum, and a septum retainer. The catheter hub includes a catheter hub body, a two-way septum valve and a septum retainer. The catheter hub body has a first end operably coupled to the second end of the catheter, a second end, and an internal wall defining a first internal fluid passageway therebetween. The internal wall of the catheter hub body further defines a transition step within the first internal fluid passageway between a smaller diameter portion of the first internal fluid passageway proximal to the first end and a larger diameter portion of the first internal fluid passageway proximal to the second end. The two-way septum valve has a first end and a second end, wherein the two-way septum valve is positioned within the first internal fluid passageway such that the first end of the septum abuts up against the transition step. The septum retainer is at least partially insertable within the first internal fluid passageway of the catheter hub body and is configured to secure the two-way septum valve in position within the first internal fluid passageway. The septum retainer has an outer wall shaped and sized to interlock with the internal wall of the catheter hub body, and an internal wall defining a second internal fluid passageway.
• In some versions, when the catheter is inserted into a patient's blood vessel the first internal fluid passageway is in uninterrupted fluid communication with the patient's blood vessel having a venous blood pressure. In some versions, the two-way septum valve is shiftable between a first open position, a closed position and a second open position. In the first open position a first differential pressure between the venous blood pressure and pressure of fluid contained in the second internal fluid passageway enables a fluid flow towards the patient's blood vessel. The first differential pressure is met when the pressure of fluid contained in the second internal fluid passageway exceeds the venous blood pressure. In the closed position fluid flow through the fluid passageway of the two-way septum valve is inhibited. In the second open position a second differential pressure between the venous blood pressure and pressure of fluid contained in the second internal fluid passageway enables a fluid flow away from the patient's blood vessel. The second differential pressure is met when the venous blood pressure exceeds the pressure of fluid contained in the second internal fluid passageway by at least 8.5 inches of water. In some versions, the two-way septum valve is biased to the closed position.
• In some versions, the second differential pressure is met when the venous blood pressure exceeds the pressure of fluid contained in the second internal fluid passageway by at least 22 inches of water. In some versions, the second differential pressure is met when the venous blood pressure exceeds the pressure of fluid contained in the second internal fluid passageway by at least 40 inches of water. In some versions, a valve opening of the two-way septum valve is in the form of at least one slit. In some versions, the valve opening of the two-way septum valve is in the form of two crossed slits. In some versions, the two-way septum valve is substantially dome shaped. In some versions, the peak of the dome extends towards the first portion of the internal fluid passageway of the catheter hub. In some versions, the two-way septum valve includes a circumferential flange operably coupled to the catheter hub. In some versions, the circumferential flange is coupled to a central portion of the two-way septum valve by one or more circumferential living hinges. In some versions, the one or more circumferential living hinges pivot when the two-way septum valve shifts to the second open position. In some versions, the two-way septum valve includes two circumferential living hinges.
• The summary above is not intended to describe each illustrated embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
• The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:
• FIG. 1 is a perspective view depicting a conventional IV needle assembly with a catheter positioned over a needle.
• FIG. 2 is a perspective view depicting the conventional IV needle assembly ofFIG. 1 with the catheter removed from the needle.
• FIG. 3 is a fragmentary exploded sectional view depicting a first embodiment of an intravenous catheter assembly in accordance with an embodiment of the disclosure.
• FIG. 4 is a fragmentary sectional view depicting the intravenous catheter assembly ofFIG. 3 in an assembled state.
• FIG. 5 is an exploded perspective view depicting a catheter hub in accordance with an embodiment of the disclosure.
• FIG. 6 is a fragmentary cross sectional view depicting an intravenous catheter assembly operably coupled to a catheter insertion device in accordance with a second embodiment of the disclosure.
• FIG. 7 is a fragmentary cross sectional view depicting the intravenous catheter assembly ofFIG. 6.
• FIG. 8 is a perspective view depicting the intravenous catheter assembly ofFIG. 7, including views of internal parts.
• FIG. 9A is a fragmentary cross sectional view depicting an intravenous catheter assembly with a two-way septum valve operably coupled to a catheter insertion device in accordance with an embodiment of the disclosure.
• FIG. 9B is a fragmentary cross sectional view depicting the intravenous catheter assembly ofFIG. 9A, with the two-way septum valve in a first open position.
• FIG. 9C is a fragmentary cross sectional view depicting the intravenous catheter assembly ofFIG. 9A, with the two-way septum valve in a closed position.
• FIG. 9D is a fragmentary cross sectional view depicting the intravenous catheter assembly ofFIG. 9A, with the two-way septum valve in a second open position.
• FIG. 10 is a cross sectional view depicting a two-way septum valve in place in an overmolded ring in accordance with an embodiment of the disclosure.
• FIG. 11 is a perspective view depicting a two-way septum valve in accordance with an embodiment of the disclosure.
• FIG. 12 is a perspective view depicting an intravenous catheter assembly including tubing, a clamp and a tube connector in accordance with an embodiment of the disclosure.
• FIG. 13A is a fragmentary side view depicting a tube connector coupled with tubing in accordance with an embodiment of the disclosure.
• FIG. 13B is a cross sectional view depicting the tube connector ofFIG. 143 in a closed configuration.
• FIG. 13C is a fragmentary cross sectional view depicting the tube connector ofFIG. 13A in an open configuration, in conjunction with an IV fluid supply line.
• FIG. 14A is an exploded side view depicting a first catheter insertion device for use with an intravenous catheter assembly (not shown) in accordance with an embodiment of the disclosure.
• FIG. 14B is an exploded top view depicting the first catheter insertion device ofFIG. 14A.
• FIG. 15 is a perspective view depicting a first catheter insertion device operably coupled to an intravenous catheter assembly in accordance with an embodiment of the disclosure.
• FIG. 16A is a perspective view depicting a first catheter insertion device and an intravenous catheter assembly in accordance with an embodiment of the disclosure, wherein the first catheter insertion device and intravenous catheter assembly are separated from one another.
• FIG. 16B is a perspective view depicting the first catheter insertion device and the intravenous catheter ofFIG. 16A, wherein the first catheter insertion device and intravenous catheter assembly are operably coupled to one another.
• FIG. 17A is a top perspective view depicting a second catheter insertion device and an intravenous catheter assembly in accordance with an embodiment of the disclosure, wherein the second catheter insertion device is in a first position.
• FIG. 17B is a top perspective view depicting the second catheter insertion device and the intravenous catheter assembly ofFIG. 17A, wherein the second catheter insertion device is in a second position and separated from the intravenous catheter.
• FIG. 18A is a bottom perspective view depicting a second catheter insertion device and an intravenous catheter assembly in accordance with an embodiment of the disclosure, wherein the second catheter insertion device is in a first position.
• FIG. 18B is a bottom perspective view depicting the second catheter insertion device and the intravenous catheter ofFIG. 18A, wherein the second catheter insertion device is in a second position.
• FIG. 19 is a perspective view depicting a third catheter insertion device operably coupled to an intravenous catheter assembly in accordance with an embodiment of the disclosure.
• FIG. 20A is a perspective view depicting a catheter insertion device and an intravenous catheter assembly in accordance with an embodiment of the disclosure, wherein the catheter insertion device is in a first position.
• FIG. 20B is a perspective view depicting the catheter insertion device and the intravenous catheter assembly ofFIG. 20A, wherein a cap of the third catheter insertion device has been removed.
• FIG. 20C is a perspective view depicting the catheter insertion device and the intravenous catheter assembly ofFIG. 20A, wherein the third catheter insertion device is in a second position, with the needle housing separated from thecatheter hub304.
• While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims.
DETAILED DESCRIPTION
• Referring toFIGS. 1 and 2, a conventionalIV catheter assembly20 is depicted. Details of the conventionalIV catheter assembly20 are described in the Background section above.
First Embodiment
• Referring toFIGS. 3-5, anintravenous catheter assembly100 according to a first embodiment of the disclosure is depicted.Intravenous catheter assembly100 generally includes acatheter102 and acatheter hub104.Catheter hub104 can be comprised of a firstcatheter hub portion104A, a secondcatheter hub portion104B, and a valve and/orseptum114,
• Firstcatheter hub portion104A can have afirst end118, asecond end120, and aninternal wall117 defining a firstinternal fluid passageway116 therebetween. In one version, theinternal wall117 further defines aside port122. In other versions, theintravenous catheter assembly100 does not include a side port. In one version, thefirst end118 is operably coupled to thesecond end112 of thecatheter102. For example, aportion112 ofcatheter102 can extend into and overlap with firstcatheter hub portion104A so that thecatheter lumen108 is in fluid communication with the firstinternal fluid passageway116.
• In one version, theside port122 is in fluid communication with firstinternal fluid passageway116. In one version, theside port122 extends away from the firstinternal fluid passageway116 at an oblique angle to thecatheter lumen108.Side port122 can provide a connection point to one or more lengths of a tubing544 (as depicted for example inFIG. 12), so that the inside of thetubing544 is in fluid communication with theinternal fluid passageway116.
• The secondcatheter hub portion104B can have afirst end128 operably coupled to thesecond end120 the firstcatheter hub portion104A, asecond end130, and aninternal wall131 defining a secondinternal fluid passageway126 therebetween. In one version, thesecond end120 of firstcatheter hub portion104A and thefirst end128 of the secondcatheter hub portion104B can each define a respective first and second portion of acoupling124A/B, such thatsecond portion124B is configured to selectively couple withfirst portion124A. For example, in one version, each portion of thecoupling124 is configured with a circumferential tongue, a circumferential groove, or both a tongue and a groove to lock one portion of the coupling with the other portion. In other versions, respective portions of coupling can be friction fit, screwed, ultrasonically welded, adhered, or otherwise pieced together to completecoupling124. In this manner, firstcatheter hub portion104A can be locked together with secondcatheter hub portion104B during assembly.
• In one version, the secondcatheter hub portion104B further has abaffle132 positioned within the secondinternal fluid passageway126 between thefirst end128 and thesecond end130 of the secondcatheter hub portion104B. In one version, thebaffle132 can include anaperture134 sized to enable a needle to pass there through.
• Septum114 can have afirst end136, asecond end138 and anouter perimeter140. In one version, theseptum114 is constructed of a flexible, fluid impermeable material. For example, in one version,septum114 is constructed of silicon. In one version, theseptum114 is self-sealing, so that when a needle is withdrawn throughseptum114, any void left by the withdrawn needle will close and theseptum114 will maintain its fluid impermeability.
• In one version, theseptum114 is positioned partially within the firstinternal fluid passageway116 of firstcatheter hub portion104A, at least partially within thesecond end120.Septum114 can be constrained about its perimeter byinternal wall117 of firstcatheter hub portion104A. That is,septum114 is sized to be received within the firstinternal fluid passageway116 to create a fluid tight seal withinternal wall117 to guard against fluid within thelumen108 or firstinternal fluid passageway116 from escaping through thesecond end120 of firstcatheter hub portion104A. In one version,septum114 is adhered to theinternal wall117 of firstinternal fluid passageway116, so as to constrainseptum114 axially and facilitate a radial fluid tight seal withinternal wall117.Septum114 is constrained on itssecond end138 bybaffle132. Accordingly, in one version, theseptum114 is positioned within the firstinternal fluid passageway116 and constrained by the coupling of firstcatheter hub portion104A to secondcatheter hub portion104B. In another version, a feature such as a groove, step or baffle in the firstcatheter hub portion104A can constrainseptum114.
• In one version, thefirst end136 ofseptum114 includes a peripheralchamfered lip142. Peripheralchamfered lip142 is configured to aid in enabling a fluid tight seal withinternal wall117. In particular, the flexibility ofseptum114 and the structure of peripheralchamfered lip142 enable this portion of theseptum114 to deform under the internal fluid pressure of firstinternal fluid passageway116 to further aid in the creation of a fluid tight seal withinternal wall117. In one version, thesecond end138 of septum is also chamfered to aid in construction by reducing the possibility that excess septum material will get caught in thecoupling124 when firstcatheter hub portion104A is mated with secondcatheter hub portion104B. In other versions, peripheralchamfered lip142 can be filleted, or there can be no lip at all.
Second Embodiment
• Referring toFIGS. 6-8, anintravenous catheter assembly200 according to a second embodiment of the disclosure is depicted.Intravenous catheter assembly200 generally includes acatheter202 and acatheter hub204.Catheter hub204 can be comprised of acatheter hub body205, a valve and/orseptum214, and a valve and/orseptum retainer215.
• Catheter hub body205 can have afirst end218, asecond end220, and aninternal wall217 defining a firstinternal fluid passageway216 therebetween. In one version, theinternal wall217 further defines aside port222. In other versions, theintravenous catheter assembly200 does not include a side port. In one version, thefirst end218 is operably coupled to thesecond end212 of thecatheter202. For example, a portion ofcatheter202 can extend into and overlap withcatheter hub body205 so that thecatheter lumen208 is in fluid communication with theinternal fluid passageway216.
• In one version, theside port222 is in fluid communication with firstinternal fluid passageway216. In one version, theside port222 extends away from the firstinternal fluid passageway216 at an oblique angle to thecatheter lumen208.Side port222 can provide a connection point to one or more lengths of a tubing544 (as depicted for example inFIG. 12), so that the inside of thetubing544 is in fluid communication with theinternal fluid passageway216.
• Septum214 can have afirst end236, asecond end238 and anouter perimeter240. In one version, theseptum214 is constructed of a flexible, fluid impermeable material. For example, in one version,septum214 is constructed of silicone, polyisopren, or the like. In one version, theseptum214 is self-sealing, so that when aneedle160 is withdrawn throughseptum214, any void left by the withdrawn needle will close and theseptum214 will maintain its fluid impermeability.
• In one version, thefirst end236 ofseptum214 includes a peripheralchamfered lip242. Peripheralchamfered lip242 is configured to aid in enabling a fluid tight seal withinternal wall217. In particular, the flexibility ofseptum214 and the structure of peripheralchamfered lip242 enable this portion of theseptum214 to deform under the internal fluid pressure of firstinternal fluid passageway216 to further aid in the creation of a fluid tight seal withinternal wall217. In other versions, peripheralchamfered lip242 can be filleted, or there can be no lip at all.
• In one version, theseptum214 is positioned partially within theinternal fluid passageway216 proximal toside port222.Septum214 can be constrained about itsouter perimeter240 byinternal wall217 ofcatheter hub body205. In particular, in one version, theseptum214 is sized to be within the firstinternal fluid passageway216 to create a fluid tight seal withinternal wall217 to inhibit fluid within thelumen208 or firstinternal fluid passageway216 from escaping through thesecond end220 ofcatheter hub204.Septum214 can be axially constrained byseptum retainer215. As shown, an outer diameter of theouter perimeter240 of the septum may be out of contact with theinternal wall217 or in contact but at a lower pressure level than portions of theseptum214 proximal to thesecond end238. This may reduce the axial pressure on the needle in order to reduce needle withdrawal forces.
• Septum retainer215 can be configured to secure theseptum214 in position within theinternal fluid passageway216. In one version, theseptum retainer215 has afirst end219, asecond end221, and awall224 defining aninternal conduit227 therebetween.Internal conduit227 can be in fluid communication withcatheter lumen108. In one version, thewall224 can further define one ormore apertures223 in fluid communication with theinternal fluid passageway216 of thecatheter hub body205, thereby enabling fluid to flow pass throughlumen208, through one ormore apertures223, and intointernal fluid passageway216.
• In one version, thefirst end219 of theseptum retainer215 is operably coupled to thefirst end218 of the catheterhuh body205, such that thelumen208 of thecatheter202 is in fluid communication with theinternal conduit227 of theseptum retainer215. In one version, theinternal conduit227 can be tapered so that the diameter of the portion ofinternal conduit227 proximate to the connection tocatheter202 is approximately equal to the diameter of thelumen208. In one version, thefirst end219 ofseptum retainer215 is press fit into catheter huh204. In other versions,septum retainer215 is fixedly coupled tocatheter hub204 by adhesive, ultrasonic welding, or another method.
• In one version, thesecond end221 of theseptum retainer215 can include a flaredportion225 embedded within theseptum214, so thatseptum214 is fixedly coupled tocatheter hub body205 byseptum retainer215.
• Septums and Valves
• As depicted inFIGS. 3-8, theseptum114,214 can include a peripheral chamfered lip configured to aid in enabling a fluid tight seal with internal wall. It is to be appreciated, however, that theseptum114,214 can have other configurations.
• Referring toFIGS. 9A-11, in some versions,catheter hub104 and204 (or other types of catheter hubs) can include a two-way septum valve387.
• In some versions, a two-way septum valve387 can have afirst end388 and asecond end389, wherein the two-way septum valve387 is positioned within the firstinternal fluid passageway316 such that thefirst end388 of the two-way septum valve387 abuts up against thetransition step307. In some versions,septum retainer315 is at least partially insertable within the firstinternal fluid passageway316 of thecatheter hub body305 and is configured to secure the two-way septum valve387 in position within the firstinternal fluid passageway316. For example, theseptum retainer315 can have anouter wall324 shaped and sized to interlock with theinternal wall317 of thecatheter hub body305. Theseptum retainer315 can also have aninternal wall323 defining a secondinternal fluid passageway326.
• The two-way septum valve387 can be positioned between the firstinternal fluid passageway316 and the secondinternal fluid passageway326, and can be configured to control the flow of fluid between the two internal fluid passageways. When thecatheter302 is inserted into a patient's blood vessel the firstinternal fluid passageway316 is in uninterrupted fluid communication with the patient's blood vessel, wherein the patient's blood vessel has a venous blood pressure.
• In one version, the two-way septum valve387 is biased to a closed position, in which the flow of fluid between the firstinternal fluid passageway316 and the secondinternal fluid passageway326 is inhibited, but is configured to enable aneedle160 of a catheter insertion device to pass therethrough (as depicted inFIG. 9A). The two-way septum valve387 can additionally be configured to shift between various open and closed positions based on the differential pressure between the firstinternal fluid passageway316 and the secondinternal fluid passageway326. For example, in one version, the two-way septum valve387 is shiftable between a first open position (as depicted inFIG. 9B), a closed position (as depicted inFIG. 9C) and a second open position (as depicted inFIG. 9D).
• In the first open position, a first differential pressure between the venous blood pressure and pressure of fluid contained in the secondinternal fluid passageway326 enables a fluid flow towards the patient's blood vessel. For example, the first differential pressure is met when the pressure of fluid contained in the secondinternal fluid passageway326 exceeds the venous blood pressure. In the closed position, fluid flow through the fluid passageway of the two-way septum valve is inhibited. In the second open position, a second differential pressure between the venous blood pressure and pressure of fluid contained in the secondinternal fluid passageway326 enables a fluid flow away from the patient's blood vessel. For example, the second differential pressure is met when the venous blood pressure exceeds the pressure of fluid contained in the second internal fluid passageway by at least 8.5 inches of water. In some versions, the second differential pressure is met when the venous blood pressure exceeds the pressure of fluid contained in the secondinternal fluid passageway326 by at least 22 inches of water or at least 40 inches of water.
• Referring toFIG. 10, a cross-sectional view of an example embodiment of two-way septum valve387 is depicted. Two-way septum valve387 can be fixed to an overmoldedplastic ring390. Overmoldedplastic ring390 generally includes acylindrical portion391 and avalve engaging portion392. When the two-way septum valve387 is supported in the overmoldedplastic ring390, the overall diameter of the two-way septum valve387 is reduced, thus more readily permitting accommodation withincatheter hub104 and204.
• Referring toFIG. 11, the shape of two-way septum valve387 is depicted as being generally circular; this, however, should not be considered limiting, as other shapes can be used according to the disclosure. In one version, the two-way septum valve387 is a unitary structure, having acentral portion393, acircumferential flange394, aflexible membrane395 having one ormore valve openings396, and one or more circumferential living hinges397. In one version, there are two circumferential living hinges379A and379B. First livinghinge379A is located betweencircumferential flange394 and support.Second living hinge379B is located on thecentral portion393 between support andflexible membrane395.
• As discussed herein, two-way septum valve387 has a differential pressure response in that the pressure required to open two-way septum valve387 in a first direction (enabling fluid flow towards the patient's blood vessel) is substantially less than the pressure required to open two-way septum valve387 in the second direction (enabling fluid flow from the patient's blood vessel). Accordingly, two-way septum valve387 inhibits leakage of fluid under normal blood pressure while permitting IV fluid to flow, as well as enabling the aspiration of blood through two-way septum valve387 either by application of a reduced or negative pressure of fluid contained in the secondinternal fluid passageway326, or the or by insertion of a needle throughvalve opening396.
• In one version, thecentral portion393 is substantially dome shaped having adome peak399. In one version, the one ormore valve openings396 are in the form of at least one of an aperture, a single slit, a tri-slit, and a cross slit. In one version, the dome shapedcentral portion393 has an opening pressure in the first direction of about 15 mm of mercury which is equivalent to 0.3 pounds per square inch, and an aspiration pressure in the second direction of approximately 300 mm mercury or about 6 pounds per square inch. In one version, the two-way septum valve387 has an infusion flow rate at 40 inches of water pressure in the first direction of approximately 4,500 ml/hour (75 ml/min).
• Universal Wings
• Referring toFIG. 12, in some versions,catheter hub104,204 and304 can include one ormore wings484 that extend radially fromcatheter hub304. In one version, the one ormore wings484 generally extend outwardly from the central axis of thecatheter302 andcatheter hub304, so as to provide an adequate gripping surface for a user or clinician, as well as an extended surface for aid in securingcatheter hub304 in place on the patient. In one version, the one ormore wings484 are integrally molded onto a portion ofcatheter hub304.
• Universal Tubing, Clamp and Tube Connector
• Referring toFIGS. 12-13C, in some versions,intravenous catheter assembly100,200 and300 include at least one of ahollow tubing extension544, atubing clamp546 and atube connector548. In one version, thehollow tubing544 can be substantially transparent or translucent to enable the observation of fluid within thehollow tubing544. In one version, thetube clamp546 is constructed of a resilient material that can be deformed to selectively occludehollow tubing544 to restrict the passage of fluid.
• Tube connector548 is configured to connecthollow tubing544 to anfluid supply line558. In one version, thetube connector548 is a luer lock. In another version,tube connector548 is a needle-free connector, for example the connector described in U.S. Pat. No. 7,713,248 (depicting a needle-free connect, marketed by ICU Medical, Inc. under the Clave® trademark), which is hereby incorporated by reference. In one version, thetube connector548 is comprised of a conicalinternal conduit550 with one or morefluid path windows552, aflexible compression seal554 capable of selectively covering theconduit550, and ahousing556 substantially surroundingconduit550 andcompression seal554.Tube connector548 can guard against contamination of the fluid path. As depicted inFIG. 13B, whencompression seal554 is in its uncompressed state it extends over thefluid path window552 of conduit :550, thereby creating a fluid seal to restrict fluid from escaping fromtubing544. Conversely, as depicted in13C, when a portion of anfluid supply line558, such as a portion of a luer connector, is inserted intohousing556, compression seal545 is shifted to a compressed state, thereby exposing thefluid path windows552 to the fluid path of the IVfluid supply line558. In one version, thetube connector548 further includes a venting adapter (not shown) to vent trapped gas fromtubing544. Venting adapter can be comprised of a material that enables air to vent as blood or fluid fills thetubing544, but inhibits the fluid from passing through thetube connector548.
• Connection to Various Catheter Insertion Devices
• Referring toFIGS. 14A-20C in some versions, thesecond end130 of secondcatheter tub portion104B, or thesecond end220 and320 ofcatheter hub bodies205 and305 can be configured to receive a portion of acatheter insertion device600,700 and800. In some versions,second end130,220 is tapered to create a friction fit withneedle insertion device600,700 and800, thereby selectively couplingcatheter hub104,204 and304 toneedle insertion device600,700 and800.
• First Catheter Insertion Device
• Referring toFIGS. 14A-16B, in some versions,catheter insertion device600 generally includesneedle660 andneedle hub662.Needle660 can be a thin walled hollow tube, defining alumen663 along its central axis, with afirst end664 and asecond end666.First end664 can be defined by a sharpenedtip668 to reduce the insertion force required to penetrate the skin of a patient.Second end666 can be fixedly coupled toneedle hub662.
• In one version,needle hub662 has afirst end670 and asecond end672.First end674 ofneedle hub662 can be configured with a tapered blunt tip sized to create a friction fit with a portion ofcatheter hub304. In one version, theneedle hub662 includes aflash chamber674.
• Flash chamber674 can be configured as a cavity in fluid communication with thelumen663 ofhypodermic needle660 opposite sharpenedtip668.Flash chamber670 functions in cooperation with other elements of thecatheter insertion device600 so that blood from the user visibly flows into theflash chamber674 to positively indicate when theneedle660 has pierced a vein. In one version, theflash chamber674 can be constructed of a transparent or translucent material to enable a clinician to visually see when fluid enters theflash chamber674. The rear676 offlash chamber674 can be plugged with amicroporous flash plug678. Flash plug678 can be comprised of a material that enables air to vent from theflash chamber674 as fluid fills the chamber, but inhibit the fluid from passing from theflash chamber674. In other versions, plug678 can be non-microporous.
• In some versions,flash chamber674 can further include a diagnostic sampling port configured to enable selective access to fluid contained withinflash chamber674. Various needle assemblies having diagnostic sampling ports are disclosed in a concurrently filed application entitled “Needle Assembly with Diagnostic Analysis Provisions,” Attorney Docket No. 4176.178US02, which is incorporated by reference herein.
• In one version,needle hub662 can include at least onewing680 that extends outwardly from theneedle hub662. In one version, thewing680 is generally longitudinally aligned with the central axis of theneedle660.Wing680 can be configured with sufficient surface area to enable a user or clinician to easily grasp and maneuver thecatheter insertion device600, while providing the user or clinician an unobstructed view of theflash chamber674 during catheterization. In one version, thewider grip portion682 ofwing680 can be provided for this purpose. In one version, for better control of the catheter assembly,wing680 can extend forward of thefirst end670 ofneedle hub662 to overlap with theneedle660. In one version, thewing680 and the rest ofneedle hub662 are integrally formed of a plastic material. In another version,wing680 is formed as an extension offlash plug678.
• Second Catheter Insertion Device
• Referring toFIGS. 12 and 17A-18B, in some versions,catheter insertion device700 generally includesneedle housing718 andneedle hub720 coupled toneedle760.Needle housing718 has afirst end724 and asecond end726.First end724 ofneedle housing718 can be configured with a tapered blunt tip sized to create a friction fit with a portion ofcatheter hub104,204 and304. In some versions,first end724 can be at least partially inserted into a socket defined incatheter hub104,204 and304.First end724 can further define anaperture728 through which needle760 can pass.
• Needle hub720, which in some versions can be fixedly coupled to theneedle760, can be slideably coupled to theneedle housing718. For example, in one version, theneedle hub720 can have a “C” shapedcross section730 conformed to fit around the outer surface of theneedle housing718 in a manner that inhibits theneedle hub720 from readily separating from theneedle housing718, yet enables theneedle hub720 to slide along the longitudinal axis of theneedle housing718 with minimal resistance. In a further version, theneedle hub720 can be configured to slide along agroove734 defined in theneedle housing718 to restrict theneedle hub720 from rotating about the longitudinal axis of theneedle housing718. In one version, theneedle hub720 can include a protuberance736 (as depicted inFIGS. 18A-B) configured to fit within thegroove734 of theneedle housing718, thereby enabling linear movement of theneedle hub720 substantially parallel to the longitudinal axis of theneedle housing718, but restricting the rotational movement of theneedle hub720 relative to theneedle housing718.
• In one version, theneedle hub720 is slideable between a first position (as depicted inFIGS. 17A and 18A) and a second position (as depicted inFIGS. 17B and 18B). In the first position, a portion of theneedle760 extends throughneedle housing aperture728, thecatheter hub304 andcatheter lumen308, such that the sharpenedtip768 of theneedle760 protrudes slightly beyondfirst end310 ofcatheter302. In the second position, theneedle760 is withdrawn from thecatheter lumen308 and thecatheter hub304 and the sharpenedtip768 is sheathed byneedle housing718 in a manner intended to reduce or eliminate the likelihood of an inadvertent needle stick. In some versions,catheter insertion device700 can include a catheter hub coupling and release mechanism configured to couple tocatheter hub104,204, or304 in the first position, and release fromcatheter hub104,204,304 in the second position. Various catheter hub coupling and release mechanism are disclosed in a concurrently filed application entitled “Releaseable Catheter Hub Retainer,” Attorney Docket No. 4176.180US02, which is incorporated by reference herein.
• In one version, theneedle760 can be locked in position relative to theneedle housing718. Several different types of locking mechanisms can be used for this purpose. For example, in one version, thegroove734 of theneedle housing718 can have abottleneck738 defined in it, where thebottleneck738 portion ofgroove734 generally has a narrower width than the rest ofgroove734.Protuberance736 ofneedle hub720 can be triangular or wedge-like in shape (as depicted inFIGS. 18A-B) where the apex of the wedge faces thebottleneck738 when in the first position. When an external force is applied to theneedle hub720 in an effort to slide it into the second position, the apex of the wedge of theprotuberance736 comes into contact with thebottleneck738.Bottleneck738, which can have a width narrower than that of theprotuberance736 will initially resist movement of theprotuberance736 through thebottleneck738. However, with sufficient force the wedge-shape protuberance736 will cause thebottleneck738 to temporarily deform, thereby enabling theprotuberance736 to pass through thebottleneck738. Thereafter theprotuberance736 will be unable to pass back through thebottleneck738 in the opposite direction, and theneedle760 will be locked in position relative to theneedle housing718.
• In one version, themovable element720 further includes aflash chamber774.Flash chamber774 can be configured as a cavity in fluid communication with the lumen ofhypodermic needle760 opposite sharpenedtip768. In one version, theflash chamber774 can be constructed of a transparent or translucent material to enable a clinician to visually see when fluid entersflash chamber774. The rear726 offlash chamber774 can be plugged with amicroporous flash plug778. Flash plug778 can be comprised of a material that enables air to vent from theflash chamber774 as fluid fills the chamber, but inhibits the fluid from passing from theflash chamber774.
• Third Catheter Insertion Device
• Referring toFIGS. 19-20C, in some versions,catheter insertion device800 further includescap880.Cap880 is configured to cover a portion of theneedle housing818 proximate to thesecond end826 to reduce the likelihood of unwanted or uncontrolled movement of theneedle housing818 relative to theneedle hub820 by the user or clinician's palm or inside of their hand during catheter insertion.
• In one version, thecap880 is tubular in shape and has afirst end882 and asecond end884. In one version, thecap880 tapers slightly from thefirst end882 to thesecond end884.Second end884 can include awall886 extending radially inward to effectively close off thesecond end884. In one version, thewall886 can include anaperture888 for venting of the interior of thecap880.
• First end882 can be coupled to he needlehub820, so as to move along with theneedle hub820 and cover a portion of theneedle housing818. In one version, theneedle hub820 includes anarcuate rib890, and thecap880 includes a recess or groove892 sized to receive therib890, so that thecap880 can be coupled to themoveable element820 by joining therib890 to thegroove892. In other versions, thecap880 and theneedle hub820 can be attached by adhesive, ultrasonic bonding, or any other method.
• In one version, theneedle860 includes anotch894 defined proximate to the sharpenedtip868.Notch894 can be in fluid communication with theneedle lumen863. In one version, thecatheter302 is constructed of a transparent or translucent material, so that blood or other body fluid can be visible in thenotch894 when theneedle860 has pierced a vein.
• In some versions,catheter insertion device600,700, and800 can include at least one of a protective needle sheath, a self-contained antiseptic swab, and a tourniquet for treatment and/or preparation of a biological site of a patient. Various catheter insertion devices having protective needle sheaths, a self-contained antiseptic swabs, and/or tourniquets are disclosed in a concurrently filed application entitled “Antiseptic Sheath with Site Preparation Provisions,” Attorney Docket No. 4176.179US02, which is incorporated by reference herein.
• Operation of the Intravenous Catheter Assembly
• In operation, placement ofintravenous catheter assembly100,200, or300 generally includes preparation of the biological site of the patient. Often a tourniquet is applied proximal to the biological site and a variety of techniques can be used to dilate the patient's vein. While wearing disposable gloves, the clinician cleanses the biological site and a vein is retracted or anchored by placing a thumb over the vein about fifty to seventy-five mm distal to the site. Theneedle760 for instance andcatheter302 for instance are introduced into the vein by inserting the bevel of the sharpenedtip768 into the vein at about a twenty to thirty degree angle with the bevel facing up in order to pierce one wall of the vein. In some versions, during this process the clinician grips theneedle hub720 for optimum control.
• If successful, blood from the vein will flow through the lumen of theneedle760 and into theflashback chamber774, thereby indicating that the vein has been entered. To finish placement, thesafety catheter assembly600,700 or800 is lowered towards the skin to decrease the entry angle, and thecatheter302 is advanced slightly into the vein. Theneedle760 is loosened and thecatheter302 is gently advanced farther up into the vein until thecatheter hub304 is against the biological site.
• The tourniquet is loosened and theneedle760 is withdrawn from thecatheter302. Asneedle760 is withdrawn, the sharpenedtip768 is withdrawn throughcatheter lumen308,internal fluid passageway316 and valve or septum314. As the sharpenedtip768 passes through the valve or septum314, the self-sealing nature of the valve or septum314 closes any void left by the needle to create a fluid tight barrier.
• Thecatheter hub304 can be secured to the biological site by gauze and adhesive tape. In some versions, the added surface area of thecatheter hub wings484 is used when securing thecatheter302 to the biological site. The various versions of the disclosure enable an IVfluid supply line558 to be connected prior to catheterization. Once thecatheter assembly100,200 or300 is in place, clamp546 can be manipulated as desired to open or close the fluid path to IVfluid supply line558.
• Persons of ordinary skill in the relevant arts will recognize that embodiments may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Furthermore, it is intended also to include features of a claim in any other independent claim even if this claim is not directly made dependent to the independent claim.
• Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
• For purposes of interpreting the claims, it is expressly intended that the provisions ofSection 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims (10)

What is claimed is:

1. An intravenous catheter assembly, comprising:

a catheter having a first end for insertion into a biological site, a second end and a flexible wall defining a lumen extending therebetween; and

a catheter hub including—

a catheter hub body having a first end operably coupled to the second end of the catheter, a second end, and an internal wall defining an internal fluid passageway therebetween, the internal wall further defining a transition step within the internal fluid passageway between a smaller diameter portion of the internal fluid passageway proximal to the first end and a larger diameter portion of the internal fluid passageway proximal to the second end;

a septum having a first end and a second end, wherein the septum is positioned within the internal fluid passageway such that the first end of the septum abuts up against the transition step; and

a septum retainer at least partially insertable within the internal fluid passageway of the catheter hub body and configured to secure the septum in position within the internal fluid passageway, the septum retainer having a outer wall shaped and sized to interlock with the internal wail of the catheter hub body.

2. The intravenous catheter assembly ofclaim 1, wherein the internal wall of the catheter body further defines a side port, wherein the side port is in fluid communication with the internal fluid passageway.

3. The intravenous catheter assembly ofclaim 2, wherein the side port is configured to be connected to one or more lengths of hollow tubing so that the inside of the hollow tubing is in fluid communication with the internal fluid passageway.

4. The intravenous catheter assembly ofclaim 3, further including hollow tubing connected to the side port, the tubing including a tube connector configured to be connected to an IV fluid supply line.

5. The intravenous catheter assembly ofclaim 1, wherein the septum has an internal surface defining a slit passing from the first end to the second end, the slit configured to enable an insertion needle to pass therethough.

6. The intravenous catheter assembly ofclaim 1, wherein the septum has an internal surface defining an aperture passing from the first end to the second end, the aperture configured to enable an insertion needle to pass therethough.

7. The intravenous catheter assembly ofclaim 1, wherein the septum has an internal surface defining an aperture originating at the first end and passing through a first thickness, and a slit originating at the termination of the aperture and passing through the second end, the aperture and slit together configured to enable an insertion needle to pass therethough.

8. The intravenous catheter assembly ofclaim 1, wherein the catheter hub includes one or more wings extending radially outward from the catheter hub.

9. The intravenous catheter assembly ofclaim 8, wherein the wings are integrally molded onto the catheter hub.

10. The intravenous catheter assembly ofclaim 8, wherein the wings are coupled to catheter hub via a collar that at least partially surrounds the catheter hub.

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