Medical valve and method of use

• US 5,873,862 A
• Filed: 04/22/1997
• Issued: 02/23/1999
• Est. Priority Date: 12/18/1991
• Status: Expired due to Term

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Lopez, George A.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/841,408
• Time in Patent Office: 672 Days
• Field of Search: 604/30, 604/33, 604/246, 604/249, 604/283
• US Class Current: 604/249
• CPC Class Codes: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: F21K 2/00 Non-electric light sources using luminescence using excitation by radioactivity G21H3/02, H01J65/06, H01J65/08; using excitation by an external electromagnetic field or by external corpuscular radiation H01J65/04; Light sources using electrochemiluminescence
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A closed system, needleless valve device includes a generally tubular body defining an internal cavity. On the proximal end of the body there is an opening which is preferably sufficiently large to receive an ANSI standard tip of a medical implement. The distal end of the body has a generally tubular skirt. The valve also includes a hollow spike having a closed tip. The spike includes at least one longitudinal 18-gauge hole located distal the tip, and is seated inside the cavity such that the tip is below the proximal end of the body. An annular support cuff is connected to the spike which seals off a portion of the cavity of the body such that an upper cavity containing the tip is defined. The valve also includes a plastic, resilient silicone seal which fills the upper cavity and opening and covers the tip of the spike so as to present a flush surface. An adaptor enables the valve to be attached to a resealable container.

Claims

1. A method of transferring fluid from a remote source to a patient, comprising:

(a) connecting a medical valve to the patient, wherein the valve comprises a body including wall structure defining an internal cavity having a proximal end and a distal end, said proximal end having an opening sufficiently large to receive a delivery end of a medical implement which transfers fluid through said delivery end, a spike having a tip, at least one hole located at or near said tip, and a passageway in communication with the hole that allows fluid to flow through said hole, said spike being seated inside the cavity such that said tip is enclosed within the cavity, and a resilient seal having a proximal end and a distal end and adapted to be moved distally in the cavity into a compressed state upon insertion of the delivery end of the medical implement into said opening, said seal moving proximally in the cavity and returning to a decompressed state upon removal of said delivery end from said opening, said seal in the decompressed state having a section which fills essentially completely a portion of the cavity adjacent said opening, said seal section bearing against said wall structure near said opening to seal said opening, and in the compressed state said seal section being located in the cavity distal said opening, said seal being preslit at the proximal end thereof, wherein said seal has at least one horizontal groove to facilitate the movement of the seal;

(b) inserting the delivery end of the medical implement into said opening; and

(c) pushing said delivery end into the cavity to compress said seal sufficiently to allow fluid to flow from said medical implement through said valve to the patient.

2. A method of transferring fluid from a remote source to a patient, comprising:

(a) connecting a medical valve to the patient, wherein the valve comprises a body including wall structure defining an internal cavity having a proximal end and a distal end, said proximal end having an opening sufficiently large to receive a delivery end of a medical implement which transfers fluid through said delivery end, a spike having a tip, at least one hole located at or near said tip, and a passageway in communication with the hole that allows fluid to flow through said hole, said spike being seated inside the cavity such that said tip is enclosed within the cavity, and a resilient seal having a proximal end and a distal end and adapted to be moved distally in the cavity into a compressed state upon insertion of the delivery end of the medical implement into said opening, said seal moving proximally in the cavity and returning to a decompressed state upon removal of said delivery end from said opening, said seal in the decompressed state having a section which fills essentially completely a portion of the cavity adjacent said opening, said seal section bearing against said wall structure near said opening to seal said opening, and in the compressed state said seal section being located in the cavity distal said opening, said seal being preslit at the proximal end thereof, wherein said seal has at least one groove defined by at least two O-ring elements forming a portion of said seal to facilitate the movement of the seal;

(b) inserting the delivery end of the medical implement into said opening; and

(c) pushing said delivery end into the cavity to compress said seal sufficiently to allow fluid to flow from said medical implement through said valve to the patient.

3. The method of claim 2, wherein each succeeding O-ring element in the distal direction has a larger diameter than the preceding O-ring element.

4. A method of transferring fluid from a remote source to a patient, comprising:

(a) connecting a medical valve to the patient, wherein the valve comprises a body including wall structure defining an internal cavity wherein said body has a plurality of radial indentations in an interior wall of said body and said internal cavity has a proximal end and a distal end, said proximal end having an opening sufficiently large to receive a delivery end of a medical implement which transfers fluid through said delivery end, a spike having a tip, at least one hole located at or near said tip, and a passageway in communication with the hole that allows fluid to flow through said hole, said spike being seated inside the cavity such that said tip is enclosed within the cavity, and a resilient seal having a proximal end and a distal end and adapted to be moved distally in the cavity into a compressed state upon insertion of the delivery end of the medical implement into said opening, said seal moving proximally in the cavity and returning to a decompressed state upon removal of said delivery end from said opening, said seal in the decompressed state having a section which fills essentially completely a portion of the cavity adjacent said opening, said seal section bearing against said wall structure near said opening to seal said opening, and in the compressed state said seal section being located in the cavity distal said opening, said seal being preslit at the proximal end thereof, wherein said seal has a groove to facilitate the movement of the seal;

(b) inserting the delivery end of the medical implement into said opening; and

(c) pushing said delivery end into the cavity to compress said seal sufficiently to allow fluid to flow from said medical implement through said valve to the patient.

5. The method of claim 4, wherein said seal expands into said radial indentations upon distal compression of said seal.