Medical valve and method of use

• US 7,717,884 B2
• Filed: 05/03/2006
• Issued: 05/18/2010
• Est. Priority Date: 12/18/1991
• Status: Expired due to Fees

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Lopez, George A.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/381,526
• Publication Number:
  US 20060264892A1
• Time in Patent Office: 1,476 Days
• Field of Search: 604/246, 604/249
• 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 first medical implement to a second medical implement, comprising:

connecting a medical valve to a first medical implement, wherein the valve comprises a body including a 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 second medical implement, said cavity further including a rigid fluid conduit, and a resilient seal element having a proximal end and a distal end and adapted to be moved distally in the cavity from a first position to a second position upon insertion of the delivery end of the medical implement into the opening, the seal element moving proximally in the cavity and returning to the first position upon removal of the delivery end from the opening, the seal element in the first position having a section that fills essentially completely a portion of the cavity adjacent the opening, the seal element section contacting the wall structure near the opening to obstruct fluid flow through the opening, and in the second position the seal element section being located in the cavity distal the opening, the seal element having an orifice at the proximal end thereof, wherein the seal element has at least one substantially horizontal groove to facilitate the movement of the seal element and the rigid fluid conduit is located at least partially within the seal element;

inserting the delivery end of the second medical implement into the opening; and

pushing the delivery end into the cavity to move the seal element to the second position to allow fluid to flow from the medical implement through the valve and into the first medical implement.

2. The method in accordance with claim 1, wherein the proximal end of the seal element is substantially flush with the proximal end of the medical valve in the first position to facilitate antiseptic swabbing thereof.

3. The method in accordance with claim 1, wherein the shape of the proximal end of the seal is adapted to facilitate closure of the orifice when the seal element is in the first position.

4. The method in accordance with claim 1, wherein the orifice is made before the seal element is used to transfer fluid therethrough.

5. The method in accordance with claim 1, wherein the proximal end of the seal has a generally circular cross-section when the seal element is in the first position.

6. The method in accordance with claim 1, wherein at least a portion of the housing in a region of the internal cavity has a tapered interior surface.

7. The method in accordance with claim 1, wherein the valve provides substantially linear fluid flow from the medical implement through the valve.

8. The method in accordance with claim 1, wherein at least a portion of the seal element is corrugated.

9. The method in accordance with claim 1, wherein at least a portion of an outer surface of the seal element is an imperforate bellows.

10. The method in accordance with claim 1, wherein the seal element moves between the first and second positions in an accordion-like fashion.

11. The method in accordance with claim 1, wherein the housing is comprised of multiple, separately molded plastic structures configured to be joined together to define the internal cavity of the housing.

12. The method in accordance with claim 1, wherein the seal element comprises silicone rubber.

13. A method of transferring fluid from a first medical implement to a second medical implement, comprising:

connecting a medical valve to a first medical implement, wherein the valve comprises a body including a 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 second medical implement, a spike, and a resilient seal element having a proximal end and a distal end, the proximal end being adapted to be moved distally in the cavity from a first position to a second position upon insertion of the delivery end of the medical implement into the opening, the proximal end of the seal element moving proximally in the cavity and returning to the first position upon removal of the delivery end from the opening, the seal element in the first position having a section that fills essentially completely a portion of the cavity adjacent the opening, the seal element section contacting the wall structure near the opening to obstruct fluid flow through the opening, and in the second position the seal element section being located in the cavity distal the opening, the seal element having an orifice at the proximal end thereof, wherein the seal element has at least one substantially horizontal groove to facilitate the movement of the seal element and the spike is located at least partially within the seal element;

inserting the delivery end of the second medical implement into the opening; and

pushing the delivery end into the cavity to move the seal element to the second position to allow fluid to flow from the medical implement through the valve and into the first medical implement.

14. The method in accordance with claim 13, wherein the proximal end of the seal element is substantially flush with the proximal end of the medical valve in the first position to facilitate antiseptic swabbing thereof.

15. The method in accordance with claim 13, wherein the shape of the proximal end of the seal is adapted to facilitate closure of the orifice when the seal element is in the first position.

16. The method in accordance with claim 13, wherein the orifice is made before the seal element is used to transfer fluid therethrough.

17. The method in accordance with claim 13, wherein the proximal end of the seal has a generally circular cross-section when the seal element is in the first position.

18. The method in accordance with claim 13, wherein at least a portion of the housing in a region of the internal cavity has a tapered interior surface.

19. The method in accordance with claim 13, wherein the valve provides substantially linear fluid flow from the medical implement through the valve.

20. The method in accordance with claim 13, wherein at least a portion of the seal element is corrugated.

21. The method in accordance with claim 13, wherein at least a portion of an outer surface of the seal element is an imperforate bellows.

22. The method in accordance with claim 13, wherein the seal element moves between the first and second positions in an accordion-like fashion.

23. The method in accordance with claim 13, wherein the housing is comprised of multiple, separately molded plastic structures configured to be joined together to define the internal cavity of the housing.

24. The method in accordance with claim 13, wherein the seal element comprises silicone rubber.

25. The method in accordance with claim 13, wherein the spike includes a tip and at least one opening at or near the tip.

26. The method in accordance with claim 25, wherein the at least one opening is positioned distal from the tip.

27. The method in accordance with claim 25, wherein the spike includes one opening at the tip.

28. The method in accordance with claim 25, wherein the outer surface of the proximal end of the seal element in the second position is located in the cavity distal the tip of the spike.