Medical valve and method of use

• US 5,928,204 A
• Filed: 06/07/1995
• Issued: 07/27/1999
• 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): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/488,106
• Time in Patent Office: 1,511 Days
• Field of Search: 604/246, 604/249, 604/247, 604/256, 604/283, 604/216
• 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 seal for use in selectively opening and closing a fluid pathway through a medical connector comprising a resilient seal element having a wall having a top end and a bottom end, said wall including at least two generally arcuate segments each having an outwardly extending portion, said segments intersecting one another and defining at least one space between where said segments intersect and a line tangential to the outwardly extending portions of both segments, and at least one segment proximate to said bottom end having a larger maximum diameter than a second segment nearer to said top end of said element.

2. The seal element in accordance with claim 1, wherein said seal element has a centerline therethrough and a generally hollow interior, and wherein said outwardly extending portions of said arcuate segments extend in a direction perpendicular to said centerline.

3. The seal element in accordance with claim 1 wherein said seal element has a centerline therethrough and wherein said outwardly extending portions of said arcuate segments extend in a direction away from said centerline.

4. The seal element in accordance with claim 1, wherein said arcuate segments are defined by ring-elements, each ring element having a generally "c"-shaped cross-section with a top end and a bottom end and a central portion, said rings joined at their top and bottom ends, and said central portion defining said outwardly extending portions.

5. The seal element in accordance with claim 1, wherein said arcuate segments are defined by stacked ring elements, said ring elements having a generally circular cross-section and said outwardly extending portion comprising an outer surface of said ring element.

6. An element for use in selectively opening and closing a fluid flow path through a medical device, comprising:

a generally cylindrical member having a wall with a first end and a second end, said wall forming at said first end a unitary resealable opening, said member having an inner surface and an outer surface and a centerline extending between said ends, at least one of said surfaces having alternating radially inwardly and radially outwardly extending surfaces with respect to said centerline, said wall comprising a generally resilient material in at least the area of said alternating surfaces and said wall having at least two ring-shaped elements, each element having a diameter and an exterior surface and defining a central passage therethrough, said ring-shaped elements being joined to each other such that their central passages are aligned along said centerline, the diameter of each successive ring-shaped element increasing in a direction from said first end to said second end, and at least some portion of said alternating surfaces being defined by said exterior surfaces of said joined ring-shaped elements, whereby the application of a compressive force along said centerline decreases the length of said member, and when said force is removed, said member generally returns to its original length.

7. The element in accordance with claim 6, wherein said ring-shaped elements have a circular cross-section.

8. The element in accordance with claim 6, wherein at least one ring element has a "c"-shaped cross-section, said cross section having a top end, a bottom end, and a central portion, said ring element being joined to an adjacent ring element at said top end and another adjacent ring at said bottom end, and said central portion defining said exterior surface of said ring element.

9. A seal element for use in selectively opening and closing a fluid pathway through a medical connector comprising a resilient, generally conical seal element having a first end and a second end and a wall, said wall defining an inner surface and an outer surface of said element, said wall forming at said first end a resealable opening, said element having a centerline extending through said first and second ends thereof, and wherein the radial distance of at least one of said outer or inner surfaces from said centerline alternately varies from a first distance from said centerline to a second distance from said centerline which is different than said first distance moving in a direction from said first end to said second end.

10. The element in accordance with claim 9, wherein at least some portion of said element is comprised of a series of O-ring elements stacked together and connected to form a unitary structure.

11. A seal element for use in selectively opening and closing a fluid pathway through a medical connector comprising a resilient, generally frusto-conical seal element having a first end and a second end and a wall, said wall defining an inner surface and an outer surface of said element, said wall forming at said first end a resealable opening, said element having a centerline extending through said first and second ends thereof, and wherein the radial distance of at least one of said outer or inner surfaces from said centerline alternately varies from a first distance from said centerline to a second distance from said centerline which is different than said first distance moving in a direction from said first end to said second end.

12. The element in accordance with claim 11, wherein at least some portion of said element is comprised of a series of O-ring elements stacked together and connected to form a unitary structure.