CA2638744A1 - High flow rate needleless medical connector - Google Patents

High flow rate needleless medical connector Download PDF

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Publication number
CA2638744A1
CA2638744A1 CA002638744A CA2638744A CA2638744A1 CA 2638744 A1 CA2638744 A1 CA 2638744A1 CA 002638744 A CA002638744 A CA 002638744A CA 2638744 A CA2638744 A CA 2638744A CA 2638744 A1 CA2638744 A1 CA 2638744A1
Authority
CA
Canada
Prior art keywords
medical
medical device
medical connector
connector
seal element
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.)
Granted
Application number
CA002638744A
Other languages
French (fr)
Other versions
CA2638744C (en
Inventor
Thomas F. Fangrow, Jr.
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.)
ICU Medical Inc
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Priority to CA2783956A priority Critical patent/CA2783956A1/en
Publication of CA2638744A1 publication Critical patent/CA2638744A1/en
Application granted granted Critical
Publication of CA2638744C publication Critical patent/CA2638744C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • 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
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • 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
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • 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
    • 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
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection 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
    • A61M2039/0205—Access sites for injecting media
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/027—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
    • 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
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection

Abstract

A valve for selectively permitting a fluid flow between first and second medical implements is disclosed. The valve has a housing with an interface suitable for receiving a connector portion of a first medical device such as a catheter, and a seal made of a flexible material. The seal has a first end in fluid communication with the interface, a second end suitable for receiving the second medical device, and at least one slit in fluid communication with the first end and the second end. The slit defines a restricted fluid flow path and a relatively small interior volume when in an undisturbed state, defines an expanded fluid flow path and a larger interior volume upon the introduction of the second medical instrument into the slit, and retracts to define a restricted flow path and a small interior volume upon the withdrawal of the second medical device from the seal. The slit is constructed such that its upstream end initially is sealed as the second medical device is withdrawn. A fluid occupying the small interior volume of the slit is forced toward the downstream end of the slit.

Claims (26)

1. A high flow rate needleless medical connector having a downstream end for receiving a first medical device and an upstream end for receiving a second medical device having a standard medical Luer tip, the medical connector comprising:
a housing having an interface configured to receive a connector portion of the first medical device, the housing comprising a cavity extending from the upstream end of the medical connector to a lower inner surface of the housing, and a lead cannula extending from the lower inner surface toward the upstream end of the medical connector, the lead cannula having a substantially cylindrical outer surface and an inner diameter of the lead cannula being similar in size to an inner diameter of an end of the second medical device; and a seal element made of a flexible material, the seal element having a downstream end in fluid communication with the interface, an upstream end suitable for receiving the second medical device, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end of the seal element such that a substantial portion of the end of the second medical device is permitted to enter the passage when the second medical device is inserted into the medical connector;
wherein the upstream end and the downstream end of the medical connector are disposed on substantially the same axis to assist in providing a substantially straight fluid-flow path.
2. The medical connector of Claim 1, wherein the medical connector is configured to selectively permit a substantially unobstructed, smooth flow of fluid therethrough.
3. The medical connector of Claim 1, wherein the housing comprises a seal holder containing the seal element such that the interface is configured to be mateably coupled to the seal holder.
4. The medical connector of Claim 1, wherein the housing comprises an axial opening at an end opposite the interface and at least one side opening.
5. The medical connector of Claim 4, wherein the housing comprises two side openings circumferentially spaced apart at approximately 180 degrees from each other.
6. The medical connector of Claim 1, wherein the housing is configured to resist expansion in the radial direction upon insertion of a second medical device having a Luer lock into the seal element.
7. The medical connector of Claim 6, wherein the housing comprises two protrusions positioned near the end of the housing opposite the interface and configured to threadably engage the second medical device having the Luer lock.
8. The medical connector of Claim 1, wherein the interface of the housing comprises a Luer lock interface.
9. The medical connector of Claim 1, wherein the lead cannula comprises a lumen therethrough, and wherein the downstream end of the seal element is in fluid communication with the lumen of the lead cannula.
10. The medical connector of Claim 1, wherein upon insertion of the second medical device into the upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is similar in size to the height of the lead cannula.
11. The medical connector of Claim 1, wherein upon insertion of the second medical device into the upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is less than the height of the lead cannula.
12. The medical connector of Claim 1, wherein upon insertion of the second medical device into the upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is similar in size to the diameter of the end of the second medical device.
13. The medical connector of Claim 1, wherein the housing is substantially rigid.
14. The medical connector of Claim 1, wherein the seal element further comprises a substantially planar slit defining a highly restricted flow path in an undisturbed state, and a substantially unobstructed linear flow path when the second medical device is inserted into the passage.
15. The medical connector of Claim 1, wherein the seal element comprises a body made of flexible material and having a downstream end and an upstream end opposite the downstream end, a neck formed at the upstream end of the body, a transverse flange at an end of the neck opposite the transverse flange having at least one opening in fluid communication with the passage, and a lead lumen formed in the downstream end of the body and in fluid communication with the passage.
16. The medical connector of Claim 15, wherein an inner diameter of the lead lumen is about 0.040 inches.
17. The medical connector of Claim 1, wherein upon insertion of the second medical device into the upstream end of the passage, the seal element is moved downward onto the lead cannula such that at least a portion of the lead cannula extends into the passage.
18. The medical connector of Claim 1, wherein the seal element is made of silicone rubber.
19. The medical connector of Claim 1, wherein the seal element is made of synthetic polyisoprene.
20. The medical connector of Claim 1, wherein the housing comprises at least one slit extending generally vertically from an end of the housing opposite the interface toward the interface.
21. The medical connector of Claim 20, wherein the slit of the housing permits the housing to expand upon insertion of the second medical device into the seal element.
22. The medical connector of Claim 21, wherein the housing expands in a manner that permits the second medical device to be retained in the seal element.
23. The medical connector of Claim 22, wherein the second medical device comprises a medical device having a Luer slip connector.
24. The medical connector of Claim 20, wherein the housing comprises an axial opening at an end opposite the interface and at least one side opening.
25. The medical connector of Claim 24, wherein the at least one slit extends from the axial opening to the at least one side opening.
26. The medical connector of Claim 1, wherein upon removal of the second medical device from the seal element, substantially all fluid in the seal element is urged towards the downstream end of the seal element.
CA2638744A 2000-07-11 2001-07-11 High flow rate needleless medical connector Expired - Fee Related CA2638744C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2783956A CA2783956A1 (en) 2000-07-11 2001-07-11 Medical connector

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/614,001 US6695817B1 (en) 2000-07-11 2000-07-11 Medical valve with positive flow characteristics
US09/614,001 2000-07-11
CA002413728A CA2413728C (en) 2000-07-11 2001-07-11 Medical valve with positive flow characteristics

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA002413728A Division CA2413728C (en) 2000-07-11 2001-07-11 Medical valve with positive flow characteristics

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2783956A Division CA2783956A1 (en) 2000-07-11 2001-07-11 Medical connector

Publications (2)

Publication Number Publication Date
CA2638744A1 true CA2638744A1 (en) 2002-01-17
CA2638744C CA2638744C (en) 2012-08-28

Family

ID=24459496

Family Applications (3)

Application Number Title Priority Date Filing Date
CA002413728A Expired - Fee Related CA2413728C (en) 2000-07-11 2001-07-11 Medical valve with positive flow characteristics
CA2783956A Abandoned CA2783956A1 (en) 2000-07-11 2001-07-11 Medical connector
CA2638744A Expired - Fee Related CA2638744C (en) 2000-07-11 2001-07-11 High flow rate needleless medical connector

Family Applications Before (2)

Application Number Title Priority Date Filing Date
CA002413728A Expired - Fee Related CA2413728C (en) 2000-07-11 2001-07-11 Medical valve with positive flow characteristics
CA2783956A Abandoned CA2783956A1 (en) 2000-07-11 2001-07-11 Medical connector

Country Status (22)

Country Link
US (18) US6695817B1 (en)
EP (3) EP1299148B1 (en)
JP (1) JP2004516861A (en)
KR (1) KR100756081B1 (en)
CN (2) CN1287876C (en)
AT (1) ATE324137T1 (en)
AU (3) AU8051501A (en)
BR (1) BR0112402A (en)
CA (3) CA2413728C (en)
CZ (1) CZ301792B6 (en)
DE (1) DE60119112T2 (en)
ES (1) ES2261452T3 (en)
HK (1) HK1054337B (en)
HU (1) HUP0301556A2 (en)
IL (1) IL153646A0 (en)
MX (1) MXPA03000274A (en)
NO (1) NO334761B1 (en)
NZ (2) NZ533341A (en)
PL (1) PL365632A1 (en)
RU (1) RU2286808C2 (en)
SI (1) SI21083A (en)
WO (1) WO2002004065A2 (en)

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