Medical valve and method of use

• US 7,717,883 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:
  US11/381,524
• Publication Number:
  US 20060264891A1
• 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 establishing a fluid flow path through a medical connector having a housing with a hollow interior and a proximal end and a distal end, comprising:

providing a medical connector comprising a rigid element positioned within the interior and a seal element at least partially within the interior, the seal element having a proximal end and a distal end and a wall with inner and outer surfaces defining an internal cavity of the seal element, the seal element having a first position in which the proximal end of the seal element is substantially closed, obstructing fluid flow through the connector, at least a portion of the seal element near the seal element proximal end contacting a surface of the interior of the housing near the housing proximal end in the first position, and at least one of the surfaces in a cross-section along the longitudinal axis of the medical connector having alternating radially inwardly and radially outwardly extending surfaces, the seal element having a second position configured to permit fluid flow through the connector, the seal element further having a first axial height H1 when in the first position and a second axial height H2 when in the second position;

moving the seal element distally within the housing interior by inserting a medical implement having an end through the proximal end of the housing into the interior of the housing, the end of the medical implement contacting the seal element solely at the proximal end of the seal element upon insertion of the implement in the interior of the housing;

changing the height of the seal element from H1 to H2, where H1 is greater than H2; and

establishing fluid flow through the housing.

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 connector in the first position to facilitate antiseptic swabbing thereof.

3. The method in accordance with claim 1, wherein the proximal end of the seal element comprises an orifice extending through its proximal end into its hollow internal cavity.

4. The method in accordance with claim 3, 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.

5. The method in accordance with claim 3, wherein the orifice is made before the seal element is used to transfer fluid therethrough.

6. 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.

7. 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.

8. The method in accordance with claim 1, wherein the connector provides substantially linear fluid flow from its proximal end to its distal end..

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

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

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

12. 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.

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

14. The method in accordance with claim 1, the portion of the seal element near the seal element proximal end contacting the surface of the interior of the housing near the housing proximal end in the first position fills essentially completely an opening in the proximal end of the housing in a horizontal cross-sectional dimension.

15. A method of establishing a fluid flow path through a medical connector having a housing with a hollow interior and a proximal end and a distal end, comprising:

providing a medical connector comprising a spike within the housing extending toward the proximal end and a seal element at least partially within the interior, the seal element having a proximal end and a distal end and a wall with inner and outer surfaces defining an internal cavity of the seal element, the seal element having a first position in which the proximal end of the seal element is substantially closed, obstructing fluid flow through the connector, at least a portion of the seal element near the seal element proximal end contacting a surface of the interior of the housing near the housing proximal end in the first position, and at least one of the surfaces in a cross-section along the longitudinal axis of the medical connector having alternating radially inwardly and radially outwardly extending surfaces, the seal element having a second position configured to permit fluid flow through the connector, the seal element further having a first axial height H1 when in the first position and a second axial height H2 when in the second position;

moving the seal element distally within the housing interior by inserting a medical implement having an end through the proximal end of the housing into the interior of the housing, the end of the medical implement contacting the seal element solely at the proximal end of the seal element upon insertion of the implement in the interior of the housing;

changing the height of the seal element from H1 to H2, where Hi is greater than H2; and

establishing fluid flow through the housing.

16. The method in accordance with claim 15, wherein the proximal end of the seal element is substantially flush with the proximal end of the medical connector in the first position to facilitate antiseptic swabbing thereof.

17. The method in accordance with claim 15, wherein the proximal end of the seal element comprises an orifice extending through its proximal end into its hollow internal cavity.

18. The method in accordance with claim 17, 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.

19. The method in accordance with claim 17, wherein the orifice is made before the seal element is used to transfer fluid therethrough.

20. The method in accordance with claim 15, wherein the proximal end of the seal has a generally circular cross-section when the seal element is in the first position.

21. The method in accordance with claim 15, wherein at least a portion of the housing in a region of the internal cavity has a tapered interior surface.

22. The method in accordance with claim 15, wherein the connector provides substantially linear fluid flow from its proximal end to its distal end.

23. The method in accordance with claim 15, wherein at least a portion of the seal element is corrugated.

24. The method in accordance with claim 15, wherein at least a portion of an outer surface of the seal element is an imperforate bellows.

25. The method in accordance with claim 15, wherein the seal element moves between the first and second positions in an accordion-like fashion.

26. The method in accordance with claim 15, wherein the housing is comprised of multiple, separately molded plastic structures configured to be joined together to define the internal cavity of the housing.

27. The method in accordance with claim 15, wherein the seal element comprises silicone rubber.

28. The method in accordance with claim 15, the portion of the seal element near the seal element proximal end contacting the surface of the interior of the housing near the housing proximal end in the first position fills essentially completely an opening in the proximal end of the housing in a horizontal cross-sectional dimension.

29. The method in accordance with claim 15, wherein the spike includes a tip and at least one opening at or near the tip.

30. The method in accordance with claim 29, wherein the at least one opening is positioned distal from the tip.

31. The method in accordance with claim 29, wherein the spike includes one opening at the tip.

32. The method in accordance with claim 29, wherein the spike extends through the proximal end of the seal element when in the second position.