IV catheter with in-line valve and methods related thereto

• US 7,695,458 B2
• Filed: 10/11/2006
• Issued: 04/13/2010
• Est. Priority Date: 10/11/2005
• Status: Active Grant

• Current Assignee: Kpr U.S., LLC (Cardinal Health, Inc.)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Belley, Richard A., Schrader, Eugene F., Fiser, Richard, Weilbacher, Eugene E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/546,752
• Publication Number:
  US 20070083157A1
• Time in Patent Office: 1,280 Days
• Field of Search: 604/246, 60416701-16704
• US Class Current: 604/246
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

Featured is a vascular access device such as an IV catheter device including a housing, a tubular member, a seal member, a compression member, and a securing mechanism. The housing includes a proximal and distal portion and a chamber that extends between the proximal and distal housings. The tubular member is coupled to the housing distal portion so it is fluidly coupled to the chamber. The seal member is disposed within the chamber and the securing mechanism secures the seal member distal end to the housing proximal portion so the seal member is sealingly and compressibly retained between a chamber proximal end and the securing mechanism. Such a seal member also forms a septum, which is compressed by the compression member to prevent seepage upon removal of a stylet.

Claims

1. An in-line valve IV catheter device comprising:

a housing defining a chamber;

a tubular member extending distally from the housing and defining a lumen therein that is fluidly coupled to the chamber;

a seal member disposed within the chamber and being movable between a first position sealingly engaged to a region of the housing and a second position to permit fluid flow through the housing, and wherein the seal member includes a septum configured to removably receive an introducer needle; and

a compression member coupled to the seal member at least partially about the septum, the compression member being configured and dimensioned to apply an inwardly directed force to assist re-sealing of the septum during and after withdrawal of the introducer needle from the septum.

2. The in-line valve IV catheter device of claim 1, further comprising a locking member positioned to retain the seal member within a proximal portion of the housing such that the seal member is sealingly and compressibly retained between a proximal end of the chamber and the locking member.

3. The in-line valve IV catheter device of claim 1, wherein the seal member includes at least one through-aperture extending between an inner cavity of the seal member and an outside surface of the seal member and the seal member is arranged in a proximal portion of the housing so that the seal member inner cavity is fluidly coupled to a portion of the chamber disposed in a distal portion of the housing.

4. The in-line valve IV catheter device of claim 3, wherein the seal member further includes a proximal end, a portion of the proximal end of the seal member having a sealing portion for sealing engagement with at least the proximal portion of the housing when the seal member is in the first position, and wherein the proximal portion of the housing further includes an opening that is fluidly coupled to a proximal end of the chamber, the opening being selectively fluidly coupled to the seal member inner cavity by moving the seal member to the second position, wherein the sealing portion is out of engagement with the proximal portion of the housing.

5. The in-line valve IV catheter device of claim 1, wherein the compression member is rigid.

6. The in-line valve IV catheter device of claim 1, wherein the compression member has an inner diameter smaller than an outer diameter of the septum.

7. The in-line valve IV catheter device of claim 1, wherein the compression member has at least one friction element on an inner diameter thereof.

8. The in-line valve IV catheter device of claim 1, wherein the compression member has a stop on one end for facilitating placement of the compression member on the septum.

9. A vascular access device comprising:

a housing including a housing proximal portion and a housing distal portion which define a chamber therein, the housing proximal portion having a distal reduced-diameter portion and a widened portion, the chamber having a proximal end positioned at a junction of the reduced-diameter portion and the widened portion;

a seal member movable from a first position to a second position, the seal member having a septum and a sealing portion and being disposed within the chamber to sealingly engage with at least a portion of the junction in the first position and permit fluid flow through the housing in the second position;

a compression member positioned at least partially about the septum and being configured and dimensioned to apply an inwardly directed force to apply pressure to the septum; and

an object that is arranged to pass through the septum.

10. The vascular access device as recited in claim 9, wherein the compression member surrounds and radially compresses the septum.

11. The vascular access device as recited in claim 9, wherein the compression member is a slotted ring.

12. The vascular access device as recited in claim 9, wherein the compression member has two opposing flat sides interconnected by semi-circular sections such that the opposing flat sides apply compression to the septum.

13. The vascular access device as recited in claim 12, wherein the septum defines an elongated slit having a height substantially parallel to the two opposing flat sides.

14. The vascular access device as recited in claim 9, wherein the compression member is a substantially circular asymmetrical ring with a substantially flattened portion.

15. The vascular access device as recited in claim 9, wherein the compression member is a crimped ring.

16. The vascular access device as recited in claim 9, wherein the compression member has at least one rigid arcuate section retained against the septum by an elastic band.

17. The vascular access device as recited in claim 9, wherein the compression member is a split ring having end portions that overlap and protrude such that upon movement of the end portions, a diameter of the split ring increases.

18. The vascular access device as recited in claim 9, wherein the compression member is a U-shaped member, wherein upon placement of the compression member about the septum, each end of the U-shaped member is formed tightly around the septum.

19. The vascular access device as recited in claim 9, wherein the compression member is a U-shaped clip.

20. An in-line IV catheter device comprising:

a housing defining a chamber having a proximal portion and a distal portion;

an elongated cannula removably extending through the housing and defining an axis;

a seal member positioned within the proximal portion of the chamber for sealing engagement with housing and, thereby, preventing fluid flow through the in-line valve IV catheter device, the seal member having sidewalls that extend along the axis and defining a proximal cavity and a septum, wherein the elongated cannula can be selectively passed through the septum; and

a compression member at least partially surrounding the septum, the compression member being configured and dimensioned to apply an inwardly directed force to the septum such that the septum seals when the elongated cannula is removed;

wherein when fluid flow in either direction through the in-line valve IV device is desired, the seal member can be selectively displaced from the proximal portion of the chamber to establish an open fluid flow path within the housing.

21. The in-line IV catheter device as recited in claim 20, wherein the seal member is constructed of a generally resilient material.

22. The in-line LV catheter device as recited in claim 20, wherein the seal member includes at least one raised section extending proximally from the sidewalls to form at least one channel fluidly coupled with the chamber.

23. The in-line IV catheter device as recited in claim 22, wherein the seal member includes a sealing portion, the sealing portion being positioned within the proximal portion of the chamber such that when the sealing portion of the seal member is displaced from the proximal portion of the chamber, at least one flow path is established via the at least one channel through the in-line valve LV catheter device.

24. The in-line IV catheter device as recited in claim 20, wherein the sidewalls are arranged so as to form a shape selected from the group consisting of cylindrical, triangular, square, pentagonal, hexagonal, septogonal, octagonal and polygonal.

25. The in-line IV catheter device as recited in claim 20, wherein the sidewalls extend distally beyond the septum so as to create a collar portion.

26. The in-line IV catheter device as recited in claim 20, further comprising a ring member for retaining the seal member within the proximal portion of the chamber in sealing engagement with the housing.

27. The in-line IV catheter device as recited in claim 26, wherein the seal member and the ring member combine to operate as a valve.

28. The in-line IV catheter device as recited in claim 20, wherein the septum has a preformed slit for receiving the cannula.

29. The in-line IV catheter device as recited in claim 20, wherein the compression member has an inner diameter relatively smaller than an outer diameter of the septum.

30. The in-line IV catheter device as recited in claim 29, wherein the septum has an outer diameter of approximately 0.150 inch and the compression member has an inner diameter in a range of 0.120 to 0.145 inch.

31. The in-line IV catheter device as recited in claim 20, wherein the compression member is fabricated from a material selected from the group consisting of plastic, polycarbonates, stainless steel, an elastic material, a semi-resilient material and combinations thereof.

32. An in-line valve IV catheter device comprising:

a housing including an inner wall defining a chamber;

a tubular member extending distally from the housing and defining a lumen therein that is fluidly coupled to the chamber;

a seal member disposed within the chamber and including a septum configured to removably receive an introducer needle, wherein the septum is spaced from the inner walls of the housing; and

a compression member coupled to the seal member and being positioned at least partially about the septum spaced from the inner wall of the housing, the compression member being configured and dimensioned to apply an inwardly directed force to the seal member to assist re-sealing of the septum during and after withdrawal of the introducer needle from the septum.

33. The in-line IV catheter device as recited in claim 32, wherein the seal member is movable within the housing between a first position, in which the seal member is sealingly engaged to a region of the housing, and a second position, wherein the seal member is spaced apart from the region of the housing, to permit fluid flow through the housing.