EP4284479A1 - Procédés et dispositifs d'accès vasculaire - Google Patents

Procédés et dispositifs d'accès vasculaire

Info

Publication number
EP4284479A1
EP4284479A1 EP22757159.3A EP22757159A EP4284479A1 EP 4284479 A1 EP4284479 A1 EP 4284479A1 EP 22757159 A EP22757159 A EP 22757159A EP 4284479 A1 EP4284479 A1 EP 4284479A1
Authority
EP
European Patent Office
Prior art keywords
valve
wall portion
hub
barrier layer
valve assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22757159.3A
Other languages
German (de)
English (en)
Other versions
EP4284479A4 (fr
Inventor
Clint Solomon
Vincent LESKOWICH
Thomas Sutton
James Hale
Jacob HENTZLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IV Access Technology Inc
Original Assignee
IV Access Technology Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/307,766 external-priority patent/US11324939B2/en
Application filed by IV Access Technology Inc filed Critical IV Access Technology Inc
Publication of EP4284479A1 publication Critical patent/EP4284479A1/fr
Publication of EP4284479A4 publication Critical patent/EP4284479A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0626—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with other surgical instruments, e.g. endoscope, trocar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064—Slit-valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • Patent Number 10,406,326) which claims priority to U.S. Provisional Patent Application Number 62/552,663 filed August 31, 2017. This application is also a non-provisional of U.S. Provisional Application No. 63/151,562 filed February 19, 2021. The contents each of the above applications are incorporated herein by reference in their entirety.
  • the invention is directed to a valve assembly having improved ability to selectively control flow of fluids through the medical device and prevent leakage of fluids from the proximal end of the device that is positioned within a patient.
  • Such improved valve assemblies also prevent leakage of fluids after repeated insertion and removal of medical instruments through the valve, such as catheters introducers, tubes, lines, ports that can be used for vascular or other devices.
  • the valve assembly may also be used as a connection for needles (e.g., fistula needles), hemodialysis circuits, feeding tubes, urinary drain catheters, or any other suitable means.
  • catheters allow medical practitioners to administer infusion or removal of fluids from a patient.
  • catheters can function as a conduit that allows infusion of fluids, such as normal saline solution, therapeutic substances, and/or nutritional fluids into a patient.
  • catheters can withdraw fluids such as blood or other bodily fluids as required by the particular medical procedure.
  • the medical practitioner will look for a flow of blood back into the catheter (“flashback”) to verify placement of the catheter opening into a vessel.
  • flashback a flow of blood back into the catheter
  • the number of different catheter insertion procedures and techniques is great and may include the use of a needle, dilator, stylet, or other medical device within the catheter when placed.
  • the catheter’ s hub (or medical device positioned within the catheter) can be coupled to an adapter (typically a luer fitting) to enable fluid coupling of the catheter to the source of fluids or reservoir.
  • an adapter typically a luer fitting
  • the patient can bleed out or to entrain air that will lead to an embolism, both of which are potentially life-threatening for the patient.
  • Accidental disconnection can occur if the mating parts are not securely tightened. The mating parts can also become loose from patient movement, unwanted fidgeting, or other patient interference.
  • any blood-bome pathogen e.g., HIV, hepatitis, etc.
  • blood exposure for the caregiver is potentially lethal.
  • insertion of the catheter requires that the point of access remains sanitary.
  • the period between insertion of the catheter and coupling of an adaptor can cause bodily fluids to escape through the catheter, causing an unsanitary condition for the medical practitioner who must handle the catheter for coupling of the adapter and/or remove the medical device inserted through the catheter.
  • the caregiver often covers an open connection port with their finger to reduce the blood flow until making a mating connection. Since blood can be a medium for bacterial growth, infection chances can rise due to exposure at the time of catheter insertion.
  • valve assembly that permits controlled fluid flow that also reduces risk of infection.
  • valve assembly that slows blood loss to give the caretaker time to adequately clean the connection and wipe away any residual blood on the connection.
  • valve assembly is described below.
  • valve assemblies described herein can be used in any tubing assembly, especially medical tubing not only limited to catheter assemblies.
  • a valve assembly configured for use with a male luer having a distal end, a lateral surface, and a connector portion is provided.
  • the assembly can be used as part of a catheter assembly where the valve assembly fits within a catheter hub.
  • the valve assembly can be used in any assembly, especially those where valve deformation rather than fluid pressure opens the valve.
  • Such assemblies include but are not limited to medical assemblies. For convenience, the examples below are discussed in relation to catheter assemblies.
  • the catheter can comprise a catheter hub and a valve.
  • the catheter hub can be configured to receive the male luer in a proximal end.
  • the valve can be coupled to a chamber within the catheter hub and can comprise a barrier layer at a far end and a wall portion.
  • the wall portion can extend proximally from the barrier layer towards a near end of the valve.
  • the wall portion can define a valve cavity therein.
  • the barrier layer can have at least one slit extending therethrough.
  • An offset distance can be measured between a surface of the wall portion in the valve cavity and a surface of the chamber adjacent to barrier layer at the far end of the valve at the distal end. The offset distance can be less than a thickness of the barrier layer.
  • the valve can be configured for positioning in the catheter hub such that the wall portion can engaged a surface of a chamber within the catheter hub. Insertion of the male luer into the valve cavity can cause the distal end of the male luer to open the at least one slit to permit fluid flow through the barrier layer. The lateral surface of the male luer can engage the wall portion at an interior of the valve cavity, causing the wall portion to engage the surface of the chamber.
  • the at least one slit can form a plurality of leaflets in the barrier layer.
  • a perimeter of the at least one slit can be limited to the barrier layer such that the leaflets do not extend into the wall portion.
  • the at least one slit can be branched such that the plurality of leaflets comprises at least three leaflets.
  • a thickness of each of the plurality of leaflets can be the same.
  • An entire outer surface of the wall portion can contact an inner surface of the catheter hub.
  • the entire outer surface of the wall portion can comprise a cylindrical shape having a uniform outer diameter.
  • the valve assembly can further comprise a flange portion at a near portion of the valve.
  • the flange can extend out of the chamber of the catheter hub to engage a proximal surface of an exterior of the catheter hub where the connector portion of the male luer can directly engage the flange portion against the proximal surface of the catheter hub.
  • An outer diameter of the flange can be equal or less to an outer diameter of the proximal surface of the exterior of the catheter hub.
  • the flange can be located within a recess in the chamber of the catheter hub.
  • the flange can be located within a recess in a proximal surface of an exterior of the catheter hub.
  • the valve can be axially recessed within the catheter hub.
  • the wall portion can include at least one or more gaps to form at least one or more legs.
  • the valve assembly can further comprise an insert positioned within the valve.
  • the insert can be configured to receive the male luer.
  • the valve assembly can further comprise a raised surface positioned within the valve. Wherein upon insertion of the male luer, the raised surface can be configured to be pushed by the male luer to open the valve.
  • FIGS. 1A to IK illustrate examples of an improved valve for use with catheters or other medical devices/introducers.
  • FIGS. 2A and 2B show another cross-sectional view of another variation of a valve.
  • FIGS. 3 A and 3B illustrate a cross-sectional view of another variation of a catheter- valve assembly having a valve positioned within a recess within a wall of a chamber of a catheter hub.
  • FIGS. 4A and 4B illustrate additional partial cross-sectional views of valves within a chamber of a catheter hub to demonstrate a reduced wall thickness relative to a thickness of a barrier layer.
  • FIGS. 5A to 5G show cross-sectional views of a catheter valve assembly with a luer fitting being inserted into a valve located within a chamber to deliver fluids through the catheter tubing.
  • FIGS. 6 A to 6D illustrate partial cross-sectional views of additional variations of catheter assemblies having valves with various flange configurations.
  • FIGS. 7 A to 7D illustrate additional examples of improved valves for use with catheter assemblies as described herein.
  • the terms “a” or “an”, as used herein, are defined as one or as more than one.
  • the term “plurality”, as used herein, is defined as two or as more than two.
  • the term “another”, as used herein, is defined as at least a second or more.
  • the terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language).
  • the term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.
  • FIGS. 1A to 1C illustrate an improved valve for use with catheters or other medical devices/introducers.
  • a catheter 130 is used with a male luer (as described in FIGS. 5A-5G below).
  • the catheter 130 includes a catheter hub 134, having a chamber 140 with a proximal surface 138 defining an open proximal end.
  • the chamber 140 is in fluid communication with a catheter tubing 132 that is coupled to the catheter.
  • the tubing includes one or more lumens in fluid communication with the chamber 140.
  • the valve or septum valve 190 includes a barrier layer (or septum) 192 at a distal end.
  • the barrier layer 192 can have one or more slits 194.
  • the illustrated variation shows a barrier layer 192 with 3 slits 194 that form three leaflet structures 197 or flaps.
  • variations of the valve 190 include any number of slits forming any number of leaflets.
  • the barrier layer 192 generally includes a flexible or semi-flexible material that is compatible with exposure to blood, medicaments, and other fluids commonly encountered during catheterization/infusion procedure.
  • the valve includes a wall portion 196 extending proximally from the barrier layer 192 and defines a valve cavity 199.
  • the valve 190 includes a flange portion 198 that is formed around the wall 196 at a proximal end of the valve 190.
  • the flange portion 198 comprises a diameter greater than a diameter of the wall portion 196 for sealing against a proximal surface 138 of the catheter hub 134.
  • Variations of the valve 190 include a flange portion 198 that encircles the valve 190.
  • the flange portion 198 can include openings or segments such that it is not circumferentially continuous about the wall.
  • FIG. 1C shows the valve 190 coupled to the catheter hub 134 such that the flange portion 198 engages the proximal surface 138 of the catheter hub 134 and is exterior to the chamber 140 of the hub 134.
  • the wall portion 196 of the valve 190 engages a surface of the chamber.
  • the walls of the chamber 140 can be straight or can comprise any luer taper angle.
  • the walls of the valve can comprise a taper angle on the exterior and/or interior (e.g., the surface defining the cavity 199).
  • the valve 190 can be affixed to the catheter at various points.
  • variations of the assembly include a valve 190 that is only affixed to the catheter hub 134 at the flange portion 198 using an adhesive or joining material where the wall portion 196 is simply positioned against a wall of the chamber 140.
  • the valve 190 can be affixed to the catheter hub 134 at the exterior wall portion 196.
  • the valve 190 can simply be press-fit into the catheter hub 134. Any number of features known to those in the art can be used to facilitate seating of the valve 190 within the catheter hub 134 (e.g., pockets, ribs, increased frictional resistance of the surface of the valve or chamber, etc.)
  • valve 190 shown in FIGS. 1A to 1C also illustrate a valve 190 having a barrier layer 192 that is thicker than the wall portion 196.
  • a thicker wall on the slit 194 face was found to increase the sealing surface.
  • the increased thickness of the wall 192 along the slit 194 permits the slit 194 to return to a closed position rather than remaining deformed by insertion of a medical device (see e.g., FIGS. 5B and 5C).
  • the relatively thinner wall portion 196 shown in FIGS. 1A to 1C reduces an offset distance between the internal diameter of the valve cavity 199 and the internal wall 142 of the hub chamber 140.
  • a thickness of a wall 196 of a valve 190 must be selected such that the internal diameter of a valve cavity 199 is sufficiently large to allow insertion of a male luer into the cavity 199 when the valve is placed within the chamber 140 of the catheter hub.
  • a valve wall 196 is too thin, then the valve may suffer from an increased risk of failure (e.g., cracking or splitting) or a thin wall can present manufacturing difficulties in forming the valve.
  • valve 190 having sidewalls 196 that are thinner than the barrier layer 192 allows a slit 194 layer 192, having increased material thickness such that it is relatively more rigid, allowing the slit 194 to close fully and increases the likelihood that the slit returns to its original state to close the valve.
  • a barrier layer 192 i.e., the wall with the slit 194 formed therein
  • the thickness differential also allows deformation of the valve to occur at the septum rather than the wall portion.
  • FIGS. ID and IE show perspective and cross-sectional views of another variation of a catheter-valve assembly having an insert 170.
  • the insert 170 can be placed within valve 190.
  • the insert 170 can be made of a relatively harder durometer material as compared to the valve 190, which can be made from a softer durometer material.
  • the durometer material can be the same material used for the catheter hub 134 and the male luer 52.
  • the insert 170 has a standard luer taper to receive the male luer 52. As such, male luer 52 slides within and nests against a hard durometer material when attached to the valve 190.
  • both the insert 170 and valve 190 can comprise the same durometer material but each component can have different properties via a treatment, coating, additive, etc.
  • the insert 170 can include an insert flange 174 that is positioned against the back surface of the valve 190 or against the back surface 138 of the catheter hub 134.
  • the insert flange 174 can be configured to match or cover the flange portion 198 of valve 190, providing a secure connection to prevent leakage of fluid.
  • FIG. 1H illustrates a device similar to that shown in FIG. 1G but where the valve 190 and insert 170 is recessed with a proximal surface 138 of the catheter hub 134.
  • the valve 190 and insert 170 can be recessed within the catheter hub 134.
  • FIGS. II to IK illustrate another variation where a valve 190 is joined to an insert 170 to form a valve assembly having a durometer region selected to sufficiently hard and a distal relatively more elastic region.
  • additional variations include an insert 170 have any number of properties that are different from the valve portion (including, but not limited to differences in durometer).
  • FIG. 1J shows a partial cross-sectional exploded view of the catheter hub 134, valve 190 and insert 170 to demonstrate that the insert 170 can include a mating shape 175 that seats with a mating shape 180 in the valve 190.
  • Alternative variations of a valve assembly can include an insert joined with a valve in an end-to-end configuration and without a step or mating surface.
  • FIG. 1J shows a partial cross-sectional exploded view of the catheter hub 134, valve 190 and insert 170 to demonstrate that the insert 170 can include a mating shape 175 that seats with a mating shape 180 in the valve 190.
  • Alternative variations of a valve assembly can include an
  • IK illustrates a cross-sectional view of the assembled insert 170/valve 190 where both components include respective luer tapered surfaces 178 and 181 to provide a continuous luer taper in the joined assembly 170/190.
  • the valve 190 can include a configuration where the barrier layer/septum 192 is thicker than the largest width of the sidewall 196 that forms the valve cavity 199.
  • valve and insert can be joined using adhesives, welding, heat-forming, or any other joining process that allows dissimilar materials to be joined together.
  • one or both components can be sealingly joined to a wall of the catheter chamber 140.
  • the insert can comprise a first material and the valve can comprise a second material, wherein the first material and second material comprise different structural properties.
  • the materials are formed from different durometer polymers to provide the valve with a greater elasticity relative to the insert.
  • variations of the assembly include a luer surface that is smooth or continuous (meaning there are no steps or discontinuities in a surface of the luer forming the valve/insert cavity.
  • FIGS. 2A and 2B show another cross-sectional view of another variation of a valve 190 for use in a catheter hub 134.
  • this variation of a valve 190 does not include a flange member at the proximal end 191 of the valve.
  • the valve 190 can be positioned within a chamber 140 of the catheter hub 134 such that the proximal end 191 of the valve 190 is flush with a rear face 138 of the catheter hub 134.
  • Alternate variations include the proximal end 191 protruding from the rear face 138 of the hub 134 (not shown).
  • valve 190 can include a construction where a thickness 195 of the valve wall 196 is less than a thickness 193 of the barrier layer 192 that includes one or more slits 194.
  • FIG. 2B illustrates a variation of a valve 190 similar to that shown in FIG. 2A, where the valve 190 is axially recessed within a chamber of the catheter hub 134 by distance 180.
  • FIGS. 3 A and 3B illustrate a cross-sectional view of another variation of a catheter- valve assembly having a valve 190 positioned within a recess 144 within a wall 142 of a chamber 140 of a catheter hub 134. As shown, a valve 190 is positioned within a chamber 140 of a catheter hub 134. While both FIGS. 3A and 3B illustrate a valve 190 where a proximal end 191 of the valve 190 is spaced from a rear end 138 of the hub 134, variations of the assemblies can include any of the valve configurations described herein where the valve is positioned within a recess 144.
  • FIGS. 3A and 3B illustrate valves 190 where a side wall 196 has a thickness less than a thickness of a barrier wall 192 (as discussed above). However, positioning the valve 190 in a recess 144 located within the wall 142 allows for sizing the internal diameter of the valve cavity 199 closer to an internal diameter of the valve chamber 140 (as discussed below).
  • FIG. 3A illustrates a recess 144 that positions the valve wall 196 to be parallel to the chamber wall 142.
  • FIG. 3B shows a recess 144 that partially extends beyond the valve wall 196.
  • FIGS. 4A and 4B illustrate additional partial cross-sectional views of valves 190 within a chamber 140 of a catheter hub 134 relative to a thickness of a barrier layer.
  • the chamber 140 of the catheter hub 134 includes an inner diameter 146 adjacent to a barrier layer 192 of the valve 190.
  • FIG. 4A illustrates a configuration where a thickness 193 of the barrier wall 192 (i.e., the wall that opens upon insertion of a luer or other device) is greater than a thickness 195 of the sidewall of the valve 190. This allows for an increased inner diameter 188 of the cavity 199 relative to the inner diameter 146 of the catheter hub 134, which also allows a male luer (not shown) to be sufficiently inserted to open the valve.
  • the increased inner diameter 188 allows for minimizing an offset distance between a surface of the inner diameter 188 of the interior cavity 199 and a surface of the wall 142 of the chamber 140 of the catheter hub 134.
  • the offset distance is generally measured in a radial direction (i.e., perpendicular to the wall).
  • FIG. 4B illustrates an additional variation of a valve 190 where a thickness 195 of the sidewall 196 is close or equal to a thickness 193 of the barrier layer 192.
  • the variation shown in FIG. 4B includes a recess 144 within the catheter hub 134. This recess 144 allow for an increased internal diameter 188 of the valve cavity 199 relative to an internal diameter 146 of a chamber 140 of the catheter hub 134 to permit insertion of a male luer.
  • FIGS. 5 A to 5D show a cross-sectional view of a catheter valve assembly 130 to provide an example of a luer fitting 50 being inserted into a valve 190 located within a chamber 140 of the valve assembly 130 to deliver fluids through the catheter tubing 132.
  • the illustrated example shows a valve 190 where a proximal end 191 is flush with a proximal face 138 of the catheter hub 134.
  • the luer fitting 50 includes threading that engages threading on the catheter hub 134.
  • Variations of assemblies can include fittings without threading. Regardless, the male luer 52 of the luer fitting is inserted into the catheter hub 134 and valve 190.
  • FIG. 5B illustrates insertion of the male luer 52 into the cavity of the valve 190.
  • the wall portion 196 is compressed against a surface of the catheter chamber 140.
  • Further axial advancement of the male luer 52 against a barrier layer 192 causes leaflets 197 formed by the slit 194 in the barrier layer 192 to open in a distal direction, permitting fluid flow through the valve 190.
  • the male luer 52 causes leaflets 197 to deflect to an open position.
  • FIG. 5B illustrates insertion of the male luer 52 into the cavity of the valve 190.
  • insertion of the male luer 52 into the cavity of the valve 190 causes the distal end of the male luer 52 to a fully open position, while the lateral surface of the male luer 52 engages the wall portion 196 of the valve 190.
  • the leaflets 197 merely deflect to allow sufficient fluid flow.
  • the valve 190 is fabricated from a compliable and resilient material such that insertion of the male luer 52 causes the valve septum 192 to stretch and deform to open the leaflets 197.
  • the wall 196 of the valve 190 can be bonded to the interior of the hub.
  • a flange 198 shown in Fig. 1A can be used to bond or pinch the walls in position so the valve septum 192 stretches instead of moving forward in its normal shape.
  • the valve operates by elastic deformation rather than fluid pressure.
  • the thickness and elasticity of the septum wall 192 permits the valve to return to a closed position when the luer 52 is removed. Moreover, because the valve opens by physical deformation, the closed valve is not subject to leakage caused by the pressure of fluid flowing against the valve.
  • the connector portion 54 of the luer fitting 50 engages the proximal surface 138 of the catheter hub 134. Removal of the luer fitting 50 from the catheter hub 134 causes the leaflets 197 of the valve formed by the slit to return to a closed configuration.
  • FIG. 5E illustrates another variation of an assembly where a valve includes a material insert.
  • a variation where the wall and flange split between a hard interior top and soft exterior wall and top can be provided to enable the anchoring needed for the stretching of valve 190.
  • FIGS. 5F to 5G show cross-sectional views of another variation of a catheter- valve assembly having a protrusion 182.
  • the protrusion 182 can be a raised surface, such as a ring on the wall of the septum 192, or one or more protrusions arranged to receive the male luer 52, which in turn assists in opening the valve 190.
  • the ring can be configured with a slit (i.e., contiguous sections) to allow separation when the ring passes across different leaflets 197 of the valve 190.
  • the male luer 52 can be inserted into valve 190 and can push the protrusion 182 distally, stretching the valve 190 and causing the valve to pucker open.
  • the protrusion 182 may be used in combination with the insert 170 described in Figs. ID to 1G.
  • the male luer 52 will stop when wedged into the hard tapered surface of the insert 170.
  • the soft material of the valve can be molded over the harder material of the catheter hub 134 or the insert 170 to help anchor the proximal base of the soft valve. This anchoring can be important when the valve stretches and thins dimensionally due to insertion of the male luer 52.
  • the valve 190 can be stretched about 2mm or more.
  • the valve leaflets 197 are stretched open and folded to a certain point when the male luer 52 is inserted. After removal of the male luer 52, the valve leaflets 197 return to its original size and sealed position.
  • FIGS. 6 A to 6D illustrate partial cross-sectional views of additional variations of catheter assemblies 130 having valves 190 with various flange 198 configurations.
  • FIG. 6A illustrates a flange 198 positioned within a recess 148 located in the rear face 138 of the catheter hub 134. As shown, the proximal end 191 of the valve 190 extends beyond the rear face 138 of the catheter hub 134.
  • FIG. 6B illustrates another variation, where the flange 198 is positioned within a recess 148 located in the rear face 138 of the hub 134 but the proximal end 191 of the valve 190 is flush with the rear face 138 of the hub 134.
  • FIG. 6C and 6D illustrate a flange 198 that comprises a outer edge on an exterior surface of the valve 190.
  • the flange 198 is positioned within a recess 148 that is located within the catheter hub 134 such that the proximal end 191 of the valve 190 is also recessed from the back face 138 of the hub 134.
  • FIG. 6D illustrates a similar flange 198 where the proximal end 191 of the valve 190 extends beyond the rear face 138 of the hub 134 but the flange 191 does not entirely cover the rear face 138.
  • FIGS. 7 A to 7D illustrate additional examples of improved valves for use with catheter assemblies 130 as described herein.
  • the valve 190 is seated in the hub 134 of the catheter 130 and includes a barrier layer (or septum) 192 at a distal end that contains one or more slits 194 that define leaflets 197.
  • the valve includes a wall 196 that extends proximally from the barrier layer 192.
  • the wall 196 is divided into a number of legs 186 that extend to a segmented flange 198.
  • FIG. 7B illustrates a similar variation of a valve 190 with legs 186 that terminate without a flange.
  • FIG. 7C illustrates an example of a valve 190 where a wall 196 extends circumferentially about the valve but only partially along an axial length where legs 186 extend along a remaining distance of the valve 190.
  • an insert 170 can have legs 172 as shown in Fig. 7D. To form a barrier between the insert 170 and the catheter hub 134, the insert 170 can fill in the gaps between legs 186. When the insert 170 is placed within valve 190, the legs 186 can be sealed to prevent leakage of any fluid therethrough.
  • an insert 170 can have any number of properties that are different from the valve 190. The legs 172 of the insert 170 will minimize any gap that may form with the legs of the valve 190 when inserted.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne des ensembles valves ayant une capacité améliorée à réguler de manière sélective l'écoulement de fluides à travers le cathéter et à empêcher une fuite de fluides à partir de l'extrémité proximale d'un cathéter qui est positionné à l'intérieur d'un patient. De tels ensembles valves de cathéter améliorés empêchent également une fuite de fluides après insertion et retrait répétés d'instruments médicaux à travers la valve.
EP22757159.3A 2021-02-19 2022-02-15 Procédés et dispositifs d'accès vasculaire Pending EP4284479A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163151562P 2021-02-19 2021-02-19
US17/307,766 US11324939B2 (en) 2017-08-31 2021-05-04 Methods and devices for vascular access
PCT/US2022/070668 WO2022178506A1 (fr) 2021-02-19 2022-02-15 Procédés et dispositifs d'accès vasculaire

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EP4284479A1 true EP4284479A1 (fr) 2023-12-06
EP4284479A4 EP4284479A4 (fr) 2024-10-09

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EP (1) EP4284479A4 (fr)
JP (1) JP2024507167A (fr)
AU (1) AU2022222811A1 (fr)
BR (1) BR112023016573A2 (fr)
CA (1) CA3208826A1 (fr)
WO (1) WO2022178506A1 (fr)

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Publication number Priority date Publication date Assignee Title
US10406326B2 (en) 2017-08-31 2019-09-10 I-V Access Technology, Inc. Methods and devices for vascular access
US11607525B1 (en) 2022-06-30 2023-03-21 I-V Access Technology, Inc. Methods and devices for vascular access

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4341239A (en) * 1980-07-14 1982-07-27 Vernay Laboratories, Inc. Combination check-overpressure relief valve
US5114408A (en) * 1990-10-18 1992-05-19 Daig Corporation Universal hemostasis valve having improved sealing characteristics
US8092432B2 (en) * 2005-05-03 2012-01-10 Nordgren Corporation Outdwelling slit valves and assemblies for medical liquid flow through a cannula and related methods
US8628056B2 (en) * 2009-02-02 2014-01-14 Aptargroup, Inc. Dual sealing system for use with a probe
BR112014019419A2 (pt) * 2012-02-06 2017-06-27 I V Access Tech Inc válvula de cateter acionada por pressão
US10406326B2 (en) * 2017-08-31 2019-09-10 I-V Access Technology, Inc. Methods and devices for vascular access

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Publication number Publication date
CA3208826A1 (fr) 2022-08-25
EP4284479A4 (fr) 2024-10-09
BR112023016573A2 (pt) 2023-11-14
AU2022222811A1 (en) 2023-09-14
WO2022178506A1 (fr) 2022-08-25
JP2024507167A (ja) 2024-02-16

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