WO2024144888A1 - Fluid connector system - Google Patents

Fluid connector system Download PDF

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Publication number
WO2024144888A1
WO2024144888A1 PCT/US2023/037112 US2023037112W WO2024144888A1 WO 2024144888 A1 WO2024144888 A1 WO 2024144888A1 US 2023037112 W US2023037112 W US 2023037112W WO 2024144888 A1 WO2024144888 A1 WO 2024144888A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve plug
valve
extends
post
recess
Prior art date
Application number
PCT/US2023/037112
Other languages
English (en)
French (fr)
Inventor
Jason Andrew Wine
David Stockey
Leah Paige Gaffney
Siddarth K. Shevgoor
Original Assignee
Carefusion 303, 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 US18/089,310 external-priority patent/US20230139756A1/en
Application filed by Carefusion 303, Inc. filed Critical Carefusion 303, Inc.
Publication of WO2024144888A1 publication Critical patent/WO2024144888A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/261Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is increasing upon disconnection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument

Definitions

  • the present disclosure relates generally to medical fluid connectors and, more particularly, to fluid connector systems having valve assemblies that can be coupled together to form a fluid pathway.
  • a medical connection such as a medical fluid line
  • a caregiver such as by depriving the patient of a medicament, increasing the potential for infection to the patient, and exposing the caregiver to harmful medicaments.
  • a fluid connector system comprising: a first valve assembly comprising: a housing having a first end, a second end, wherein the second end is opposite to the first end, and an inner surface forming a cavity that extends through the second end toward the first end of the housing; a post having a proximal end portion and a distal end portion, wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing; a fluid passage that extends through the first end of the housing and the post; and a compressible valve positioned in the cavity, the compressible valve having a proximal end portion and a distal end portion, wherein the proximal end portion comprises a resilient member having an inner surface forming a recess, and wherein the distal end portion comprises a head having a slit that extends through the head to the recess; a second valve assembly comprising: a body having a first valve assembly comprising: a housing having a first
  • the present disclosure provides methods of providing a fluid connector system, the method comprising: providing a first valve assembly comprising a housing forming a cavity having a post therein and a compressible valve extending around the post; providing a second valve assembly comprising a body forming a bore having a valve plug therein; and inserting a second end of the body into the cavity of the housing such that a head of a compressible valve is biased toward a first end of the housing; and advancing the second end of the body into the cavity of the housing such that a distal end portion of the post extends through a slit of the head of the compressible valve and through a slit of the valve plug to fluidly couple a fluid passage of the first valve assembly and a fluid passage of the second valve assembly, and a protrusion of the housing is positioned between a wall of the body and a first end of the body, wherein engagement of the protrusion against the wall resists retraction of the second valve assembly from the first valve assembly.
  • the present disclosure provides a valve plug for a fluid connector system, the valve plug comprising a first end, a second end, and a longitudinal axis that extends between the first and second ends of the valve plug, an inner surface forming a recess that extends through the first end of the valve plug to a floor between the first and second ends of the valve plug, a slit that extends through the second end of the valve plug and the floor; and a first portion of the inner surface forming a ridge that extends into the recess toward the longitudinal axis, and a second portion of the inner surface forming a ramp wall, the ridge comprising a first engagement surface that extends radially inward, in a direction from the first end of the valve plug toward the longitudinal axis, to an apex of the ridge, and a second engagement surface that extends radially outward from the apex and in a direction away from the longitudinal axis, and the ramp wall extending from the second engagement surface to the floor.
  • a fluid connector system comprises a first valve assembly comprising a housing having a first end, a second end, wherein the second end is opposite to the first end, and an inner surface forming a cavity that extends through the second end toward the first end of the housing, a post having a proximal end portion and a distal end portion, wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing, and a fluid passage that extends through the first end of the housing and the post, and a second valve assembly comprising a body having a first end, a second end, wherein the second end is opposite to the first end, an inner surface forming a bore that extends through the second end toward the first end of the body, and a fluid passage that extends through the first end of the body to the bore, a valve plug positioned in the bore, the valve plug having a first end, a second end, and an inner surface forming
  • the present application addresses several operational challenges encountered in prior fluid connections and provides numerous improvements that enable the user to increase safety and efficacy, while more easily and precisely providing fluid connections.
  • Figure 1 illustrates a fluid connector system in use with an IV set coupled to a patient, in accordance with aspects of the present disclosure.
  • Figure 2 illustrates a perspective view of a fluid connector system, in accordance with aspects of the present disclosure.
  • Figures 3 A and 3B illustrate perspective views of the fluid connector system of Figure
  • Figure 4 illustrates a cross-sectional view of the fluid connector system of Figures 3 A and 3B, in accordance with aspects of the present disclosure.
  • Figure 5 illustrates a cross-sectional view of the fluid connector system of Figure 2, in accordance with aspects of the present disclosure.
  • Figure 6 illustrates a cross-sectional view of another embodiment of a fluid connector system, in accordance with aspects of the present disclosure.
  • Figure 7 illustrates a perspective view of another embodiment of a fluid connector system, in accordance with aspects of the present disclosure.
  • Figures 8 A and 8B illustrate perspective views of the fluid connector system of Figure 7, in accordance with aspects of the present disclosure.
  • Figure 9 illustrates a cross-sectional view of the fluid connector system of Figures 8A and 8B, in accordance with aspects of the present disclosure.
  • Figure 11 illustrates a perspective view of another embodiment of a valve plug, in accordance with aspects of the present disclosure.
  • Figure 12 illustrates a top plan view of the valve plug of Figure 11, in accordance with aspects of the present disclosure.
  • Figure 13 illustrates a bottom plan view of the valve plug of Figure 11, in accordance with aspects of the present disclosure.
  • Figure 14 illustrates a cross-sectional view of the valve plug of Figure 12, in accordance with aspects of the present disclosure.
  • Figure 15 illustrates a distribution of force on the valve plug of Figure 11 during use, in accordance with aspects of the present disclosure.
  • the present application discloses various features and advantages of a fluid connector system.
  • the fluid connector system can provide for efficient and safe maintenance of fluid connections, such as the connections used for transferring medical fluids toward or away from a patient.
  • the fluid connector system can maintain a fluid pathway by resisting unintended disconnection when a pulling or tension force is applied to the fluid connector system, such as when a patient moves or when the medical tubing is pulled away from the patient.
  • the fluid connector system can also prevent injury to a patient or a caregiver by permitting disconnection or separation between portions of the connector system when a pulling or tension force exceeds a threshold.
  • the fluid connector system can also prevent injury to a patient or a caregiver by obstructing the fluid pathway when disconnection or separation between portions of the connector system occurs. Further, the fluid connector system can provide for efficient and safe reestablishment of the fluid pathway, by permitting reassembly of portions of the system after a disconnection or separation occurs.
  • Figure 1 illustrates an example of a fluid connector system in use in accordance with aspects of the present disclosure.
  • the connector system 100 is coupled with tubing of an IV set, which is being used to direct a fluid to a patient 10.
  • the IV set can include a medicament bag 12, a drip chamber 14, tubing 16, and an IV catheter 18.
  • the connector system 100 includes a first valve assembly 110 and a second valve assembly 210, which are illustrated in Figure 2.
  • the first and second valve assemblies 110, 210 can be coupled together by inserting a portion of the second valve assembly 210 into the first valve assembly 110.
  • a fluid pathway is formed through the connector system 100.
  • each of the first and second valve assemblies 110, 210 can resist fluid flow by obstructing a fluid passage through their respective assemblies.
  • the compressible valve 114 is moved to a second position, wherein the fluid passage through the first valve assembly 110 is unobstructed to reduce the resistance to a fluid flow through the fluid passage of the first valve assembly 110.
  • first and second valve assemblies 110, 210 are coupled together, a portion of the first valve assembly 110 moves or biases the valve plug 214 to fluidly couple the fluid passage through the first valve assembly 110 with the fluid passage through the second valve assembly 210.
  • the post 120 can be configured as a needle that extends within the cavity and forms at least a portion of a fluid passage through the first valve assembly 110.
  • the post 120 can be formed unitarily with the housing 112 or another portion of the first valve assembly 110, or the post 120 can be coupled with the housing 112 or another portion of the first valve assembly 110.
  • the post 120 is formed from a material that includes any of a polymer and/or a metal.
  • engagement of the head 138 against the protrusion 144 can resist movement of the head 138 in the direction from the first end 116 toward the second end 118 of the housing. Engagement of the head 138 against the protrusion 144 can also form a seal between the head 138 and the housing 112.
  • the first valve assembly 110 is configured to couple with the second valve assembly 210 by inserting a portion of the second valve assembly 210 through the second end 118 of the housing 112 of the first valve assembly 110. The first valve assembly 110 and the second valve assembly 210 can then be moved toward each other to fluidly couple the first and second valve assemblies 110, 210.
  • Figure 4 also illustrates a cross-sectional view of the second valve assembly 210 separated from and spaced apart from the first valve assembly 110.
  • the second valve assembly 210 includes a body 212 having a first end 216 and a second end 218.
  • An inner surface of the body 212 form a bore 220 that extends through the second end 218 toward the first end 216 of the body.
  • the valve plug 214 includes a first end 236, a second end 238, and a slit 240 that extends through the first and second ends 236, 238 of the valve plug.
  • the second end 238 of the valve plug is aligned with the second end 218 of the body.
  • a common plane intersects the second end 238 of the valve plug and the second end 218 of the body.
  • the second end of the body 212 extends radially inward, in a direction toward the cavity.
  • the portion of the body 212 extends radially inward can engage against the valve plug 214 and resist movement of the valve plug 214 out of the bore 220.
  • the first end 216 of the body defines a male luer 242 structure that extends in a direction away from the second end 218 and forms at least portion of the fluid passage 226.
  • the first end 116, 216 of any of the first and second valve assemblies 110, 210 can include any of a bond pocket, a female luer, and/or a male luer.
  • the body 212 forms a wall 244 that is configured to engage against a portion of the first valve assembly 110 when the first and second valve assemblies 110, 210 are coupled together.
  • the wall 244 can be formed by a portion of the body 212 that extends away from the outer surface in a direction that is transverse, relative to a longitudinal axis A2 extending between the first and second ends 216, 218 of the body.
  • the wall 244 can be formed by a portion of the outer surface of the body 212 that is convex or concave relative to an adjacent portion of the outer surface of the body 212.
  • first and second valve assemblies 110, 210 can coupled together by inserting the second end 218 of the body for the second valve assembly 210 through the opening into the cavity at the second end 118 of the housing for first valve assembly 110, as illustrated in Figure 5.
  • any of the second end 218 of the body and/or the second end 238 of the valve plug engages against the distal end 140 of the compressible valve.
  • the resilient member formed by the proximal end portion 132 of the compressible valve is compressed and the head moves toward the first end 116. Movement of the head 138 toward the first end 116 of the housing causes the distal end portion 124 of the post to move through or pierce the slit 139 of the head and the slit 240 of the valve plug.
  • the body 212 is advanced toward the first end 116 of the housing until the protrusion 144 of the housing moves over and past the wall 244 of the body, such that the protrusion 144 is positioned between the wall 244 and the first end 216 of the body when the first and second valve assemblies 110, 210 are coupled together.
  • the distance between the wall 244 and the second end 218 of the body is configured to resist separation of the first and second valve assemblies 110, 210, while maintaining the fluid pathway through the first and second valve assemblies 110, 210.
  • the resist separation and maintaining the fluid pathway, the wall 244 is spaced apart from the second end 218 of the body is by a distance DI, where the distance D2 is approximately equal to or greater than a sum of the length LI of the slit 139 and the length L2 of the slit 240.
  • the opening through the distal end 127 of the post is positioned between the valve plug 214 and the first end 216 of the body so that the fluid passage 126 of the first valve assembly 110 is fluidly coupled with the fluid passage 226 of the second valve assembly 210.
  • the opening can be spaced apart from the distal end 127 of the post and can form a portion of the fluid passage 126 that extends in a directions that is aligned or parallel to the longitudinal axis A2.
  • the distal end 127 of the post has an outer surface that tapers to form a cross-sectional width that decreases in a direction from the proximal end portion 122 of the post to the distal end 127, and the opening extends through the tapered outer surface.
  • another portion of the inner surface of the valve plug 615 can form a recess 641 that extends through the first end 636 of the valve plug to a floor 643 between the first and second ends 636, 638 of the valve plug.
  • the slit 640 extends through the floor 643 thereby creating a pathway through the slit 640 and the recess 641, and entirely through the first and second ends 636, 638 of the valve plug.
  • a valve plug for a fluid connector system comprising: a first end, a second end, and a longitudinal axis that extends between the first and second ends of the valve plug; an inner surface forming a recess that extends through the first end of the valve plug to a floor between the first and second ends of the valve plug; a slit that extends through the second end of the valve plug and the floor; and a first portion of the inner surface forming a ridge that extends into the recess toward the longitudinal axis, and a second portion of the inner surface forming a ramp wall; the ridge comprising a first engagement surface that extends radially inward, in a direction from the first end of the valve plug toward the longitudinal axis, to an apex of the ridge, and a second engagement surface that extends radially outward from the apex and in a direction away from the longitudinal axis, and the ramp wall extending from the second engagement surface to the floor.
  • Clause 30 The valve plug of any of Clauses 22 to 29, wherein the second end of the valve plug comprises a concave surface extending into the valve plug, and the slit extends though the concave surface.
  • Clause 31 The valve plug of any of Clauses 22 to 30, wherein a distance from the first end of the valve plug to the floor of the recess is less than a distance from the floor of the recess to the second end of the valve plug.
  • a fluid connector system comprising: a first valve assembly comprising: a housing having a first end, a second end, wherein the second end is opposite to the first end, and an inner surface forming a cavity that extends through the second end toward the first end of the housing; a post having a proximal end portion and a distal end portion, wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing; and a fluid passage that extends through the first end of the housing and the post; a second valve assembly comprising: a body having a first end, a second end, wherein the second end is opposite to the first end, an inner surface forming a bore that extends through the second end toward the first end of the body, and a fluid passage that extends through the first end of the body to the bore; a valve plug positioned in the bore, the valve plug having a first end, a second end, and an inner surface forming a rece
  • any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses.
  • any of the clauses e.g., dependent or independent clauses
  • a claim may include some or all of the words (e.g., steps, operations, means or components) recited in a clause, a sentence, a phrase or a paragraph.
  • a claim may include some or all of the words recited in one or more clauses, sentences, phrases or paragraphs.
  • some of the words in each of the clauses, sentences, phrases or paragraphs may be removed.
  • additional words or elements may be added to a clause, a sentence, a phrase or a paragraph.
  • the subject technology may be implemented without utilizing some of the components, elements, functions or operations described herein. In one aspect, the subject technology may be implemented utilizing additional components, elements, functions or operations.
  • a phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology.
  • a disclosure relating to an aspect may apply to all configurations, or one or more configurations.
  • An aspect may provide one or more examples.
  • a phrase such as an aspect may refer to one or more aspects and vice versa.
  • a phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology.
  • a disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments.
  • An embodiment may provide one or more examples.
  • a phrase such an embodiment may refer to one or more embodiments and vice versa.
  • a phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology.
  • a disclosure relating to a configuration may apply to all configurations, or one or more configurations.
  • a configuration may provide one or more examples.
  • a phrase such a configuration may refer to one or more configurations and vice versa.
  • the term “coupled” or the like may refer to being directly coupled. In another aspect, the term “coupled” or the like may refer to being indirectly coupled. [0163] Terms such as “top,” “bottom,” “front,” “rear” and the like if used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/US2023/037112 2022-12-27 2023-11-09 Fluid connector system WO2024144888A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18/089,310 US20230139756A1 (en) 2021-06-30 2022-12-27 Fluid connector system
US18/089,310 2022-12-27

Publications (1)

Publication Number Publication Date
WO2024144888A1 true WO2024144888A1 (en) 2024-07-04

Family

ID=89222545

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/037112 WO2024144888A1 (en) 2022-12-27 2023-11-09 Fluid connector system

Country Status (2)

Country Link
CN (1) CN118253030A (zh)
WO (1) WO2024144888A1 (zh)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030209681A1 (en) * 2002-05-08 2003-11-13 Leinsing Karl R. Needle-free medical connector with expandable valve mechanism and method of fluid flow control
US8343113B2 (en) * 2010-10-12 2013-01-01 Charles Hokanson Medical valve assembly
US20170080203A1 (en) * 2015-09-21 2017-03-23 Carefusion 303, Inc. Priming device
US20230001172A1 (en) * 2021-06-30 2023-01-05 Carefusion 303, Inc. Fluid connector system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030209681A1 (en) * 2002-05-08 2003-11-13 Leinsing Karl R. Needle-free medical connector with expandable valve mechanism and method of fluid flow control
US8343113B2 (en) * 2010-10-12 2013-01-01 Charles Hokanson Medical valve assembly
US20170080203A1 (en) * 2015-09-21 2017-03-23 Carefusion 303, Inc. Priming device
US20230001172A1 (en) * 2021-06-30 2023-01-05 Carefusion 303, Inc. Fluid connector system

Also Published As

Publication number Publication date
CN118253030A (zh) 2024-06-28

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