Medical valve and method of use

• US 6,572,592 B1
• Filed: 05/09/2000
• Issued: 06/03/2003
• 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): Casler, Brian L.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/569,712
• Time in Patent Office: 1,120 Days
• Field of Search: 604/244, 604/246, 604/249, 604/256, 604/905, 137/844, 137/845, 137/859
• US Class Current: 604/256
• 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 medical valve comprising:

a body including 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 have a tip and a passageway with a hole that allows fluid to flow through said passageway, and

a resilient seal which is adapted to be moved into a compressed state upon insertion of the of the medical implement into said opening to open the valve and returns to a decompressed state upon removal of said tip to close said valve,

said seal being pierced by the spike upon being compressed and having a proximal end including a pressure responsive element disposed on an inner surface of the seal adjacent said opening, said pressure responsive element in the decompressed state closing any orifice in the seal at said proximal end to provide an essentially fluid-tight seal while in the decompressed state.

2. The medical valve of claim 1 where said tip has a plurality of facets which meet within a recess.

3. The medical valve of claim 1 where the seal comprises a series of O-ring elements stacked together and connected to form a unitary structure.

4. The medical valve of claim 1 where the pressure responsive element is a section of the seal including an entryway into a precut orifice in the proximal end of the seal, said seal section being surrounded by a space which receives pressurized fluid.

5. The medical valve of claim 1 where the O-ring elements have increasing diameters, with the smallest diameter element being adjacent a proximal end of the seal.

6. The medical valve of claim 1 where there is a cavity in said body having a plurality of radial indentations in an interior wall that is adjacent the seal to accommodate the expansion of the seal upon compression of said seal.

7. The medical valve of claim 1 where the delivery end and the seal are adapted to engage so that when the tip of the spike pierces the seal there is essentially no dead space between said delivery end and the seal.

8. The medical valve of claim 1 where the proximal end of the seal has a centrally located, anti-vacuum, saucer like depression therein, and the pressure responsive element has an anti-tear element.

9. A valve, comprising:

a body having a cavity therein;

a spike located within said cavity in said body; and

a seal located on said spike, said seal comprising a series of O-ring elements.

10. The valve of claim 9, wherein said body includes a connector for connecting to a medical implement and an opening for transmission of fluid between said valve and said medical implement.

11. The valve of claim 10, wherein said spike includes a fluid passageway, an end, and one or more holes for providing fluid communication between said fluid passageway and said medical implement through said one or more holes.

12. The valve of claim 11, wherein said seal has a decompressed position and a compressed position, said seal preventing fluid communication between said fluid passageway and said medical implement when said seal is in said decompressed position and permitting fluid communication between said fluid passageway and said medical implement when said seal is in said compressed position, said seal being compressed to said compressed position when said medical implement is connected to said connector of said body and said seal returning to said decompressed position when said medical implement is disconnected from said connector of said body.

13. The valve of claim 12, wherein said end of said spike is pointed so that it can pierce said seal and enter into a portion of said medical implement when said medical implement is connected to said valve.

14. The valve of claim 13 wherein, fluid flows directly between said medical implement and said spike.

15. The valve of claim 12, wherein said seal is placed over said end of said spike so that said seal covers said end of said spike when said seal is in said decompressed position, but said end of said spike protrudes from said seal when said seal is in said compressed position.

16. The valve of claim 9, wherein the O-ring elements are connected to form a unitary structure.

17. A needleless connector valve comprising:

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, the opening being adapted to receive fluid through said delivery end;

a resilient seal which is adapted to be moved distally in the cavity into an axially compressed position upon insertion of the delivery end of the medical implement into said opening, said seal moving proximally in the cavity and returning to an axially uncompressed position upon removal of said delivery end from said opening, said seal in the axially uncompressed position bearing against said wall structure near said opening to seal said opening, said seal having at least one horizontal groove to facilitate movement of said seal between said axially compressed and said axially uncompressed positions, and in the axially compressed position said seal section being located in the cavity distal of said opening, wherein said seal in the uncompressed position has a proximal end substantially flush with the proximal end of said cavity of said body; and

a tube seated in the distal end of said cavity for permitting fluid to flow through the distal end of said cavity, said tube sized such that a portion of said seal fits snugly around the distal end of said tube.

18. The needleless connector valve of claim 17, wherein the distal end of the seal fits snugly within said wall structure.

19. The needleless connector valve of claim 18, wherein said proximal end of said seal is substantially flat.

20. The needleless connector valve of claim 17, wherein said seal moves between said compressed position and said uncompressed position in an accordion-like fashion.

21. The needleless connector valve of claim 17, wherein said seal is precut to form a tiny orifice therein, allowing fluid to pass through said orifice upon compression of said seal in the distal direction.

22. The needleless connector valve of claim 17, wherein the tube is formed integral with surrounding structure.

23. The needleless connecter valve of claim 17, wherein said valve further comprises a support member enabling said valve to be removably attached to a fluid dispenser.

24. The needleless connector valve of claim 17, wherein the distal end of said tube is formed integral with surrounding structure.

25. The needleless connector valve of claim 17, wherein said seal comprises an accordioned structure.

26. The needleless connector valve of claim 17, wherein said seal comprises a single rubber molding.

27. A valve, comprising:

a body having a cavity therein;

a spike located within said cavity, said spike having a proximal end and at least two holes located distal said proximal end; and

a seal located on said spike, said seal in a decompressed state extending proximal the proximal end of said spike.

28. The valve of claim 27, wherein said seal comprises a series of O-ring elements.

29. The valve of claim 28, wherein the O-ring elements are connected to form a unitary structure.

30. The valve of claim 27, wherein said seal in a compressed state is located distal said at least two holes in said spike.

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

positioning a tubular seal within said interior, said seal having a proximal end and a distal end and a tubular wall with inner and outer surfaces defining a passage through said seal along an axial centerline extending through said proximal and distal ends, said seal having an axially uncompressed position in which said passage is closed at said seal proximal end, obstructing fluid flow through said connector, at least a portion of said seal near said seal proximal end filling essentially completely a radial cross-section of said housing near said housing proximal end in said uncompressed position, and at least one of said surfaces having alternating radially inwardly and radially outwardly extending surfaces with respect to said centerline while said seal is in the uncompressed position, said seal having an axially compressed position in which said passage is open at said seal proximal end thereof and said passage is unobstructed, said seal having a first axial height H1 when in its uncompressed position and a second axial height H2 when said seal is in its compressed position;

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

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

opening said passage through said seal along said centerline when said seal is in its compressed position; and

establishing fluid flow through said housing from said housing proximal end to said housing distal end thereof.

32. The method of claim 31, wherein said wall comprises a plurality of ring elements, said ring elements having a 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 outwardly extending portions.

33. The method of claim 31, wherein said positioning step further comprises the step of positioning said proximal end of said seal flush with said proximal end of said medical connector.

34. The method of claim 31, wherein said seal comprises a single rubber molding.

35. A needleless connector valve comprising:

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 medical implement, the opening being adapted to receive fluid through said delivery end; and

a seal which is adapted to be moved distally in the cavity into an axially 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 an axially decompressed state upon removal of said medical implement from said opening, said seal substantially completely filling said opening and presenting a generally flush surface across said proximal end of said cavity of said body when said seal is in the decompressed position, said seal having a tubular, corrugated, imperforate wall accommodating axial compression of said seal, and said seal having a preslit orifice at the proximal end of the seal, said orifice being closed to prevent fluid from flowing through said seal when said seal is in said opening, and said orifice being open to allow fluid to flow through said seal when said seal is in the compressed state.

36. The needleless connector valve in accordance with claim 35, wherein said corrugated wall is defined by ring-elements, each of said ring elements having a 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.

37. The needleless connector valve of claim 35, wherein the valve further comprises a tube disposed within said seal near the junction of said seal and the distal end of said cavity, a distal portion of said seal fitting snuggly around a portion of said tube.

38. A needleless connector valve comprising:

a body including an 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; and

a seal which is adapted to be moved distally in the cavity into an axially 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 axially decompressed state upon removal of said medical implement from said opening, said seal substantially completely filling said opening and presenting a generally flush surface across said proximal end of said cavity of said body when said seal is in the decompressed position, said seal having resilient, imperforate bellows accommodating axial compression of said seal, and said seal having a preslit orifice at the proximal end of the seal, said orifice being closed to prevent fluid from flowing through said seal when said seal is in said opening, and said orifice being open to allow fluid to flow through said seal when said seal is in the compressed state.

39. The needleless connector valve of claim 38, wherein the valve further comprises a tube disposed within said seal near the junction of said seal and the distal end of said cavity, a distal portion of said seal fitting snuggly around a portion of said tube.

40. The needleless connector valve of claim 38, wherein said seal moves between said compressed state and said decompressed state in an accordion-like fashion.

41. 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, and a resilient seal having a proximal end and a distal end and adapted to be moved distally in the cavity into an axially 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 an axially 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 said seal having a proximal end substantially flush with the proximal end of said cavity of said body, 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, and said seal having a plurality of ring elements forming a portion of said seal to facilitate the movement of the seal, said ring elements having a 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 outwardly extending portions;

(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.

42. The method of claim 41, wherein said seal comprises a single rubber molding.

43. A medical valve including

a generally tubular body defining an internal cavity and having a proximal end and a distal end, said proximal end of said body having an opening sufficiently large to receive an ANSI standard tip of a medical implement,

a hollow spike having a closed tip, said spike including a plurality of holes located inward of said tip, said spike being seated inside the body such that said tip is inward of the proximal end of the body,

a support member connected to the spike which seals off a portion of the internal cavity of the body such that an upper cavity containing the tip of the spike is defined, and

a plastic, resilient silicone sealant which fills the upper cavity and covers the tip of the spike so as to present an essentially flush surface.

44. A valve for engaging a medical implement adapted to transfer fluid, comprising:

a hollow spike having a distal end and a proximal end, said spike having a tip at its proximal end and having at least 3 holes located inward of said tip, said holes being capable of being placed in fluid communication with said medical implement,

a seal adapted to fit over said spike and to reversibly seal said holes, said seal being adapted to reversibly unseal said holes when said medical implement is engaged with said connector valve; and

a housing at least partially containing said spike and said seal.

45. A method of transferring a predetermined amount of medication from a remote source to a patient, including

(a) connecting a medical valve to the patient where the valve includes an opening sufficiently large to receive a delivery end of a medical implement which transfers said predetermined amount of medication through said delivery end into the valve, said valve including an enclosed spike with a tip having a hole therein and a resilient seal which is adapted to be moved into a compressed state by the delivery end upon insertion of said delivery end of the medical implement into said valve and an returns to a decompressed state upon removal of said delivery end to close said valve, said delivery end and said seal being adapted to engage so that the tip of the spike pierces the seal and there is essentially no dead space between said delivery end and the seal;

(b) inserting the delivery end of the medical implement into said valve and pushing said delivery end against said seal to compress said seal sufficiently to allow said tip of the spike to pierce the seal and enter said delivery end, said seal and delivery end engaging to eliminate essentially any dead space;

(c) transferring from the remote source to the patient directly through said valve essentially the entire predetermined amount of medication, so that essentially none of said predetermined amount is collected in any dead space in the valve; and

(d) withdrawing the delivery end of the medical implement from the valve to enable the seal to return to the decompressed state to close the valve and maintain while in said decompressed state a fluid tight seal even at high pressures and repeated uses.

46. 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 resilient seal having a proximal end and a distal end and adapted to be moved distally in the cavity into an axially 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 an axially 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 and presenting a generally flush surface across said proximal end of said cavity of said body, and in the compressed state said seal section being located in the cavity distal said opening, said seal being pre-slit at the proximal end thereof, wherein said seal has at least one horizontal groove to facilitate the movement of the seal, and a tube disposed within said seal near the junction of said seal and the distal end of the cavity, the tube sized such that a portion of said seal fits snuggly around a portion of the tube near the distal end of the cavity;

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

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