Catheter Priming System

• US 20090270815A1
• Filed: 04/29/2008
• Published: 10/29/2009
• Est. Priority Date: 04/29/2008
• Status: Abandoned Application

• Current Assignee: Infraredx Incorporated (Nipro Corporation)
• Original Assignee: Infraredx Incorporated (Nipro Corporation)
• Inventors: McNeil, Robert, Stamp, Andrea, Caplan, Jay, Gambale, Richard, Brightbill, Jerry
• Application Number:
  US12/111,457
• Publication Number:
  US 20090270815A1
• Time in Patent Office: Days
• US Class Current: 604/249
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• 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 2039/2426 Slit valve
• CPC Class Codes: A61M 2039/244 Hinged closure member, e.g. flap valve
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 25/0075 Valve means
• 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 39/0693 including means for seal penetration
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A catheter includes a longitudinally extending catheter body having proximal and distal ends. The catheter body defines a lumen extending longitudinally from a first port defined at the proximal end, through the body, to a second port defined at the distal end. The catheter includes a valve for controlling fluid flow through the second port.

Claims

1. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port defined at the proximal end, through the body, to a second port defined at the distal end; and

a valve for controlling fluid flow through the second port.

2. The catheter of claim 1, wherein the valve comprises:

a valve element pivotally attached to the catheter body and extending into the lumen; and

a valve seat defined by the catheter body in the lumen and configured to receive the valve element;

wherein the valve element is configured to transition between a first state in sealing engagement with the valve seat, and a second state spaced from the valve seat for permitting fluid flow through the second port in response to pressure in the lumen.

3. The catheter of claim 2, wherein the valve element is biased to maintain the first state.

4. The catheter of claim 1, wherein the valve comprises:

a compliant flap secured to the catheter body in the lumen; and

a valve seat defined by the catheter body in the lumen and configured to receive the flap;

wherein the flap is configured to maintain a first state in sealing engagement with the valve seat and to elastically deflect into a second state spaced from the valve seat for permitting fluid flow through the second port when pressure in the lumen exceeds a threshold pressure.

5. The catheter of claim 1, wherein the valve comprises at least first and second compliant flaps secured opposite each other in the lumen, the flaps being elastically deformable to move between a first state in sealing engagement with each other, inhibiting fluid flow through the second port, and a second state allowing fluid flow through the second port out of the lumen when pressure in the lumen exceeds a threshold pressure.

6. The catheter of claim 5, wherein the first and second compliant flaps each have proximal and distal ends with a broad side extending therebetween, the proximal ends of the flaps secured circumferentially to the inner wall of the lumen, the flaps extending toward each other and meeting along the broad sides when in the first position.

7. The catheter of claim 1, wherein the valve comprises an elastic tube surrounding the catheter body in a first state in sealing engagement with an outer surface of the catheter body to temporarily seal the second port, the tube being configured to distend into a second state that allows fluid flow out of the second port when pressure in the lumen exceeds a threshold pressure.

8. The catheter of claim 7, wherein the elastic tube has proximal and distal ends, the distal end being secured to the catheter body.

9. The catheter of claim 1, wherein the valve comprises

a valve element disposed in the lumen for movement;

a valve seat defined by the catheter body in the lumen; and

a spring for biasing the valve element toward a first position in sealing engagement with the valve seat;

wherein the valve element is operable to move from the first position in sealing engagement with the valve seat to a second position spaced from the valve seat for permitting fluid flow through the second port.

10. The catheter of claim 9, wherein the valve element moves from the first position to the second position when pressure in the lumen exceeds a threshold pressure.

11. The catheter of claim 1, wherein the valve comprises first and second compliant bladders mounted opposite each other in the lumen and disposed in a first position in sealing engagement with each other to inhibit fluid flow through the second port, wherein the first and second compliant bladders move to a second position for permitting fluid flow between the bladders and through the second port when pressure in the lumen exceeds a threshold pressure.

12. The catheter of claim 1, wherein the valve comprises a membrane disposed across the lumen, the membrane defining an aperture configured to remain closed in a first position to inhibit fluid flow through the second port, the aperture opening to a second position for permitting fluid flow through the second port when pressure in the lumen exceeds a threshold pressure.

13. The catheter of claim 1, wherein the catheter body defines at least one axial groove in a wall of the lumen, the groove extending from the proximal end of the catheter body to the distal end of the catheter body.

14. The catheter of claim 1, wherein the catheter body defines at least one axial protrusion in a wall of the lumen, the protrusion extending from the proximal end of the catheter body to the distal end of the catheter body.

15. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a first lumen extending longitudinally between a first port, defined at the proximal end, and a second port, defined at the distal end, and a second lumen extending from a side of the catheter body to the distal end of the catheter body, the second port providing fluid communication between the first and second lumens; and

an elastomeric tube disposed in the second lumen in a first state in sealing engagement with a wall of the second lumen to inhibit fluid flow through the second port;

wherein the tube elastically deflects to a second state spaced from the wall of the second lumen for permitting fluid flow through the second port when pressure in the first lumen exceeds a threshold pressure.

16. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a filter disposed in the lumen for controlling fluid flow through the second port.

17. The catheter of claim 16, wherein the filter defines fluid passageways therethrough having a diameter less than about 8 microns.

18. The catheter of claim 16, wherein the filter is configured to prevent blood flow therethrough.

19. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end, and a valve seat; and

a valve in fluid communication with the second port controls fluid flow through the second port, the valve having;

a valve element disposed within the lumen for transition between a first state in sealing engagement with the valve seat to inhibit fluid flow through the second port, and a second state spaced from the valve seat for permitting fluid flow through the second port; and

a valve element operator that, when engaged by a deliverable instrument received by the lumen, causes a transition of the valve element from the first position to the second position.

20. The catheter of claim 19, wherein the valve element is secured in the lumen to the catheter body and extends circumferentially along a wall of the lumen over the second port to a distal tip, the valve element being torsionally biased against the lumen wall in sealing engagement with the valve seat defined by the lumen wall, wherein circumvolution of the valve element operator disposed at the distal tip of the valve element causes the valve element to elastically deform from the first position to the second position, permitting fluid flow through the second port.

21. The catheter of claim 19, wherein a distal tip of the received deliverable instrument is configured to engage the valve element operator, such that torsional movement of the received deliverable instrument is translated to the valve element operator.

22. The catheter of claim 19, wherein the valve seat comprises an orifice defined by the catheter body in the lumen, the valve element being disposed distally of the orifice and spring biased toward sealing engagement with the valve seat to occlude the orifice.

23. The catheter of claim 22, wherein the valve element operator extends through the orifice for actuation of the valve by the received deliverable instrument.

24. The catheter of claim 19, wherein the valve element comprises a lumen plug slidably disposed within the lumen for movement between a first position that permits fluid flow through the second port, and a second position in sealing engagement with the valve seat defined by a wall of the lumen, occluding the lumen.

25. The catheter of claim 24, wherein the lumen plug defines a fluid channel extending from a longitudinal proximal end of the lumen plug to a lateral side of the lumen plug, the fluid channel being in fluid communication with the second port when the lumen plug is in the first position.

26. The catheter of claim 24, wherein the lumen plug is biased by a spring toward sealing engagement with the valve seat.

27. The catheter of claim 19, wherein the valve element comprises a gate pivotally attached to the catheter body in the lumen, the gate swinging from the first position, in sealing engagement with the valve seat, to the second position when moved by the received deliverable instrument.

28. The catheter of claim 27, wherein a side wall of the catheter body defines the second port, the valve element extending along a wall of the lumen for sealing engagement with the valve seat defined by the lumen wall, the valve element operator extending at least partially across the lumen for actuation by the received deliverable instrument.

29. The catheter of claim 19, wherein the valve element is disposed in the lumen and elastically deformed by the deliverable instrument when moved from the first position, in sealing engagement with the valve seat, to the second position, permitting fluid flow through the second port.

30. The catheter of claim 19, wherein the valve element comprises an ovular tube having inner and outer walls, a portion of the inner wall of the tube defining the valve element operator, the received deliverable instrument engaging the valve element operator to elastically alter a geometry of the tube to the second position for permitting fluid flow though the second port.

31. The catheter of claim 19, wherein the valve element comprises an inflatable bladder disposed in the lumen, the bladder being operable to distend between a first position in sealing engagement with the valve seat and the second position for allowing fluid flow through the second port.

32. The catheter of claim 31, wherein the catheter body defines a bladder inflation channel in fluid communication with the bladder to control bladder inflation.

33. The catheter of claim 19, wherein the catheter body defines at least one axial groove in a wall of the lumen, the groove extending from the proximal end of the catheter body to the distal end of the catheter body.

34. The catheter of claim 19, wherein the catheter body defines at least one axial protrusion in a wall of the lumen, the protrusion extending from the proximal end of the catheter body to the distal end of the catheter body.

35. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a valve for controlling fluid flow through the second port, the valve having;

an elastic tube surrounding the catheter body in a first state for sealing an outer surface of the catheter body to inhibit fluid flow through the second port; and

at least one projection extending radially inwardly from an inner surface of the tube, the projection extending into the lumen through an aperture defined by the catheter body, the projection being configured to be displaced in a radially outward direction by a deliverable instrument received by the lumen, thereby pushing a portion of the tube away from the outer surface of the catheter body to a second position to permit fluid flow through the second port.

36. The catheter of claim 35, wherein the aperture comprises the second port.

37. The catheter of claim 35, wherein the tube has first and second ends, the first end disposed distally of the second end on the catheter body and secured to the catheter body.

38. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a self-sealing fluid barrier disposed in the lumen for controlling fluid flow through the second port, the self-sealing fluid barrier configured to be pierced a deliverable instrument.

39. The catheter of claim 38, wherein the self-sealing fluid barrier extends across the lumen.

40. The catheter of claim 38, wherein the received deliverable instrument defines a lumen therethrough that allows fluid flow.

41. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a valve for controlling fluid flow through the second port, the valve including first and second compliant bladders mounted opposite each other in the lumen and disposed in a first position in sealing engagement to inhibit fluid flow through the second port, the bladders being configured to receive a deliverable instrument therebetween.

42. The catheter of claim 41, wherein the received deliverable instrument defines a lumen therethrough that allows fluid flow.

43. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a means for selectively controlling fluid flow through the second port.

44. A catheter system comprising:

a catheter including;

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end; and

a valve for controlling fluid flow through the second port, the valve having;

a valve element disposed within the lumen for transition between a first state in sealing engagement with a valve seat defined by the catheter body to inhibit fluid flow through the second port, and a second state in which the valve element is spaced from the valve seat to permit fluid flow through the second port; and

a valve element operator defined by the valve element and configured for engagement by a deliverable instrument received by the lumen to cause a transition of the valve element between the first state to the second state; and

a catheter primer in fluid communication with the catheter lumen, the catheter primer comprising;

a barrel having open proximal and distal ends;

a plunger receivable in the barrel and movable therealong;

a shank attached to the plunger and configured to actuate the plunger;

a handle secured to the barrel; and

a spring for biasing the shank toward the distal end of the barrel.

45. The catheter system of claim 44, wherein the catheter primer further comprises a spring retainer coupled to the proximal end of the barrel and configured to retain the spring.

46. The catheter system of claim 44, wherein the valve element is secured in the lumen to the catheter body and extends circumferentially along a wall of the lumen over the second port to a distal tip, the valve element being torsionally biased against the lumen wall in sealing engagement with the valve seat defined by the lumen wall, wherein circumvolution of the valve element operator disposed at the distal tip of the valve element causes the valve element to elastically deform from the first position to the second position, permitting fluid flow through the second port.

47. The catheter system of claim 44, wherein a distal tip of the received deliverable instrument is configured to engage the valve element operator, such that torsional movement of the received deliverable instrument is translated to the valve element operator.

48. The catheter system of claim 44, wherein the valve seat comprises an orifice defined by the catheter body in the lumen, the valve element being disposed distally of the orifice and spring biased toward sealing engagement with the valve seat to occlude the orifice.

49. The catheter system of claim 44, wherein the valve element operator extends through the orifice for actuation of the valve by the received deliverable instrument.

50. The catheter system of claim 44, wherein the valve element comprises a lumen plug slidably disposed within the lumen for movement between a first position that permits fluid flow through the second port, and a second position in sealing engagement with the valve seat defined by a wall of the lumen, occluding the lumen.

51. The catheter system of claim 50, wherein the lumen plug defines a fluid channel extending from a longitudinal proximal end of the lumen plug to a lateral side of the lumen plug, the fluid channel being in fluid communication with the second port when the lumen plug is in the first position.

52. The catheter system of claim 50, wherein the lumen plug is biased by a spring toward sealing engagement with the valve seat.

53. The catheter system of claim 44, wherein the valve element comprises a gate pivotally attached to the catheter body in the lumen, the gate swinging from the first position, in sealing engagement with the valve seat, to the second position when moved by the received deliverable instrument.

54. The catheter system of claim 53, wherein a side wall of the catheter body defines the second port, the valve element extending along a wall of the lumen for sealing engagement with the valve seat defined by the lumen wall, the valve element operator extending at least partially across the lumen for actuation by the received deliverable instrument.

55. The catheter system of claim 44, wherein the valve element is disposed in the lumen and elastically deformed by the deliverable instrument when moved from the first position, in sealing engagement with the valve seat, to the second position, permitting fluid flow through the second port.

56. The catheter system of claim 44, wherein the valve element comprises an ovular tube having inner and outer walls, a portion of the inner wall of the tube defining the valve element operator, the received deliverable instrument engages the valve element operator to elastically alter a geometry of the tube to the second position for permitting fluid flow though the second port.

57. The catheter system of claim 44, wherein the valve element comprises an inflatable bladder disposed in the lumen, the bladder being operable to distend between a first position in sealing engagement with the valve seat and the second position for allowing fluid flow through the second port.

58. The catheter system of claim 57, wherein the catheter body defines a bladder inflation channel in fluid communication with the bladder to control bladder inflation.

59. The catheter system of claim 44, wherein the catheter body defines at least one axial groove in a wall of the lumen, the groove extending from the proximal end of the catheter body to the distal end of the catheter body.

60. The catheter system of claim 44, wherein the catheter body defines at least one axial protrusion in a wall of the lumen, the protrusion extending from the proximal end of the catheter body to the distal end of the catheter body.

61. A catheter comprising:

a longitudinally extending catheter body having proximal and distal ends, the catheter body defining a lumen extending longitudinally from a first port, defined at the proximal end, through the body to a second port, defined at the distal end;

wherein a distal portion of the body defines a valve for controlling fluid flow through the second port, the distal portion of the body being formed in a substantially U-shaped cross-section having first and second substantially U-shaped flaps joined along lateral edges; and

wherein the flaps are configured to move between a first state permitting fluid flow through the second port and a second state in sealing engagement with each other when pressure in the lumen drops below a threshold pressure.

62. The catheter of claim 61, further comprising a guide wire tube disposed over the body and positioned to define a guide wire opening with a transition section of the body in between the valve and a main section of the body.

63. The catheter of claim 61, further comprising a reinforcing member embedded in the body at least along the distal portion of the body.

64. The catheter of claim 63, wherein the reinforcing member comprises a rail disposed substantially along the lateral edges of the flaps.

65. The catheter of claim 63, wherein the reinforcing member comprises a coil.

66. The catheter of claim 63, wherein the reinforcing member comprises braids.