Syringe system

• US 20030009132A1
• Filed: 09/28/2001
• Published: 01/09/2003
• Est. Priority Date: 04/13/2001
• Status: Active Grant

• Current Assignee: Tricardia Ventures LLC
• Original Assignee: Tricardia Ventures LLC
• Inventors: Schwartz, Robert S., Holmes, David R., Tassel, Robert A. Van
• Granted Patent: US 6,969,373 B2
• Time in Patent Office: Days
• US Class Current: 604/152
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0091 the single injection needle being fixed
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

A medical device is provided having a needle or a catheter, insertable into a living body, which defines a plurality of holes in fluid communication with a central lumen. The holes may be of various patterns located and angled to create a desired injectate cloud pattern when an injectate is forced through the central lumen and through the plurality of holes. One embodiment provides various designs including a moveable sheath or stylet used to selectively occlude one or more of the holes while in use, thereby providing an operating physician a way to manipulate the cloud pattern anytime during the introduction of the injectate. A reducer may be used in conjunction with these needles which provides an increased degree of control when injecting very small quantities of fluid.

Claims

1. An in-line volumetric reducer useable to advance a predetermined volume of liquid to an open end of a fluid-delivery catheter comprising:

a rigid housing defining;

a proximal opening attachable to a distal end of a hydraulic pressure line, said line having a proximal end in fluid communication with a plunger, whereby said proximal opening is in fluid communication with said pressure line when attached thereto;

a first inner chamber extending distally from said proximal opening and having a predetermined, substantially uniform, cross-sectional area along a predetermined linear axis;

a distal opening attachable to a proximal end of a catheter such that said distal opening is in fluid communication with said catheter when attached thereto; and

,

a second inner chamber extending proximally from said distal opening and having a predetermined, substantially uniform cross-sectional area along a predetermined linear axis, wherein said cross-sectional area of said second inner chamber is smaller than said cross-sectional area of said first inner chamber;

a piston assembly including;

a first piston operably disposed within said first inner chamber and having a proximal side and a distal side, said first piston forming a substantially liquid-tight seal with said rigid housing such that pressurized liquid on said proximal side of said first piston is not able to pass around said first piston to said distal side of said first piston; and

,

a second piston operably disposed within said second inner chamber and having a proximal side and a distal side, said second piston forming a substantially liquid-tight seal with said rigid housing such that liquid on said distal side of said second piston is not able to pass around said second piston to said proximal side of said second piston;

wherein said first piston is operably attached to said second piston such that when said first piston is moved linearly a predetermined distance, said second piston moves linearly an equal distance to said predetermined distance.

2. The reducer of claim 1 wherein said first piston is rigidly connected to said second piston.

3. The reducer of claim 1 wherein said housing is constructed and arranged such that a portion of said housing that defines said first inner chamber is integral with a portion of said housing that defines said second inner chamber and said housing further defines at least one vent constructed and arranged to allow a fluid to escape from said first inner chamber when said first piston is moved distally.

4. The reducer of claim 1 wherein said first piston comprises a circular cross-section.

5. The reducer of claim 4 wherein said first piston circular cross section lies in a plane which is normal to said predetermined first chamber linear axis.

6. The reducer of claim 1 wherein said second piston comprises a circular cross-section.

7. The reducer of claim 6 wherein said second piston circular cross section lies in a plane which is normal to said predetermined second chamber linear axis.

8. The reducer of claim 1 wherein said predetermined second chamber linear axis is aligned with said predetermined first chamber linear axis.

9. The reducer of claim 1 wherein said first piston and said second piston comprise parallel circular discs.

10. The reducer of claim 1 further comprising a member rigidly connecting said first piston distal side with said second piston proximal side.

11. The reducer of claim 1 further comprising a stop extending inwardly from said housing constructed and arranged to limit said predetermined linear distance which said pistons may move.

12. The reducer of claim 11 wherein said stop comprises a protuberance.

13. The reducer of claim 11 wherein said stop comprises an inwardly extending wall, formed by said housing, and defining a distal extent of said first inner chamber.

14. The reducer of claim 12 wherein said inwardly extending wall defines a vent constructed and arranged to allow a fluid to escape from said first inner chamber when said first piston is moved distally.

15. The reducer of claim 1 wherein said housing further defines a threaded connector surrounding said proximal opening connectable to a complimentarily threaded fitting on said distal end of said hydraulic pressure line.

16. The reducer of claim 1 wherein said housing further defines a threaded connector surrounding said distal opening connectable to a complimentarily threaded fitting on said proximal end of said catheter.

17. The reducer of claim 1 wherein said housing further defines a luer lock connector surrounding said proximal opening connectable to a complimentary connector on said distal end of said hydraulic pressure line.

18. The reducer of claim 1 wherein said housing further defines a luer lock connector surrounding said distal opening connectable to a complimentary connector on said proximal end of said catheter.

19. The reducer of claim 1 further comprising a quick connect coupling operably disposed around said proximal opening and connectable to a complimentary coupling on said distal end of said hydraulic pressure line.

20. The reducer of claim 1 further comprising a quick connect coupling operably disposed around said distal opening and connectable to a complimentary coupling on said proximal end of said catheter.

21. The reducer of claim 1 wherein said rigid housing comprises a first part defining said first inner chamber and a second part defining said second inner chamber.

22. The reducer of claim 21 wherein said first part is removably attached to said second part.

23. The reducer of claim 22 wherein said second part, second piston, and a needle assembly are provided as a single cartridge filled with a predetermined quantity of injectate.

24. The reducer of claim 1 further comprising a base plate to which said first cylinder is operably attached and to which said second cylinder is operably attached, said base plate fixing said first cylinder and said second cylinder relative to each other.

25. The reducer of claim 1 further comprising a bleed valve operably attached to said second cylinder and useable to vent air therefrom.

26. The reducer of claim 1 further comprising a vial attachment port operably attached to said second cylinder, and in fluid communication therewith, constructed and arranged to receive a vial of medicament.

28. The reducer of claim 27 wherein said first piston is rigidly connected to said second piston.

29. The reducer of claim 27 wherein said first cylinder distal end is integral with said second cylinder proximal end and said first cylinder further defines at least one vent constructed and arranged to allow a fluid to escape from inside said first cylinder when said first piston is moved distally.

30. The reducer of claim 27 wherein said first and second cylinders are axially aligned.

31. The reducer of claim 28 further comprising a member rigidly connecting said first piston with said second piston.

32. The reducer of claim 27 wherein said first cylinder comprises a stop extending inwardly constructed and arranged to limit said predetermined linear distance which said pistons may travel.

33. The reducer of claim 32 wherein said stop comprises a protuberance.

34. The reducer of claim 32 wherein said stop comprises an inwardly extending wall, integrally connected said first cylinder distal end with said second cylinder proximal end.

35. The reducer of claim 34 wherein said inwardly extending wall defines a vent constructed and arranged to allow a fluid to escape from said first inner chamber when said first piston is moved distally.

36. The reducer of claim 27 wherein said second cylinder is removably attachable to said first cylinder.

37. The reducer of claim 36 wherein said first piston comprises a distal end and a member extending distally from said distal end and constructed and arranged to abut against a proximal end of said second piston when said second cylinder is attached to said first cylinder.

38. The reducer of claim 36 wherein said second piston comprises a proximal end and a member extending proximally from said proximal end and constructed and arranged to abut against a distal end of said first piston when said second cylinder is attached to said first cylinder.

79. The in-line volumetric reducer of claim 28 further comprising a base rigidly connected to said first cylinder and said second cylinder, whereby said base fixes said first and second cylinders relative to each other, and whereby said first and second cylinders are located on said base such that said cylinders are axially aligned.

27. An in-line volumetric reducer useable to advance a predetermined volume of liquid to an open end of a fluid delivery lumen comprising:

a first cylinder having a proximal end defining a proximal opening and a distal end defining a distal opening;

a second cylinder having a proximal end defining a proximal opening and a distal end defining a distal opening, said second cylinder having a smaller diameter than said first cylinder;

a first piston operably disposed in said first cylinder;

a second piston operably disposed in said second cylinder;

wherein said first cylinder distal end is operably connected to said second cylinder proximal end;

wherein said first piston is operably connected with said second piston such that when said first piston travels a predetermined distance within said first cylinder, said second piston travels a distance within said second cylinder which is substantially equal to said predetermined distance.

39. A method of releasing a predetermined output volume from an output of a lumen of a catheter for a given input volume introduced to an input of said lumen comprising:

providing a flow reducer in line with said catheter between said input and said output, said reducer having a first piston distal said input and a second piston proximal said output, said first piston constructed and arranged such that when said first piston travels a predetermined distance, said second piston travels a distance substantially equal to said predetermined distance, said first piston having a first diameter and said second piston having a second diameter;

filling that portion of said catheter which extends from said second piston to said output with a desired output fluid;

injecting a predetermined amount of input fluid into said catheter input, thereby moving said first piston a predetermined distance and second piston a distance substantially equal to said predetermined distance;

thereby causing said predetermined output volume of output fluid to exit said catheter output, said output volume equal to the squared ratio of the second diameter to the first diameter.

40. A method of injecting a predetermined quantity of injectate comprising:

providing a catheter having a proximal end attached to a supply of pressurized fluid and a distal end in fluid communication with a first component operably containing a first piston;

attaching a second component to a distal end of the first component, the second component operably containing a second piston which is constructed and arranged to move with the first piston, said second piston having a smaller cross sectional area than the first piston, said second component defining a chamber on a distal side of said second piston containing said predetermined quantity of injectate, said second component having a distal end which is operably attached to a hypodermic device;

forcing a predetermined quantity of said pressurized fluid through said catheter to cause said first piston and said second piston to move a predetermined linear distance in a distal direction, thereby forcing said predetermined quantity of injectate out of said hypodermic device.

41. The method of claim 40 whereby attaching a second component to a distal end of the first component comprises providing said second component as a prepackaged unit containing said injectate and integral with said hypodermic device.

42. A medical device capable of creating a cloud of injectate, in tissue, having a predetermined shape, size and concentration, the device comprising:

an elongate member having a side wall defining a central lumen and having a distal end and a proximal end, the proximal end operably attachable to an injectate providing catheter such that said catheter is in fluid communication with said lumen;

a plurality of holes defined by said side wall and extending from said lumen to an exterior of said side wall;

wherein each of said holes is constructed and arranged to act in concert with each of the other holes to create said shaped cloud when said injectate is forced through said lumen.

43. The medical device of claim 42 wherein said elongate member comprises a hypodermic needle, said distal end sharpened to provide skin piercing or tissue entry capability.

44. The medical device of claim 42 wherein said elongate member comprises a catheter.

45. The medical device of claim 44 wherein said plurality of holes is axially displaced from said distal end.

46. The medical device of claim 42 wherein said distal end defines at least one hole of a predetermined diameter extending to said lumen.

47. The medical device of claim 42 wherein said distal end comprises a solid end wall.

48. The medical device of claim 42 wherein said plurality of holes are linearly aligned to form a single line of holes parallel to a longitudinal axis of said member.

49. The medical device of claim 42 wherein said plurality of holes are linearly aligned to form a single line of holes which forms an angle to a longitudinal axis of said member such that said line of holes wraps around said member to create a spiral pattern therearound.

50. The medical device of claim 42 wherein said plurality of holes progressively increase in diameter such that proximal holes are smaller than distal holes, thereby providing a relatively common flow rate to each of said holes.

51. The medical device of claim 42 wherein said plurality of holes progressively decrease in diameter such that proximal holes are larger than distal holes, thereby providing a greater flow rate through said proximal holes than said distal holes.

52. The medical device of claim 42 wherein said holes have central axes which are perpendicular to a central axis of said elongate member.

53. The medical device of claim 42 wherein at least one of said plurality of holes has a central axis which projects distally from said lumen and forms an acute angle with a central axis of said elongate member.

54. The medical device of claim 42 wherein at least one of said plurality of holes has a central axis which projects proximally from said lumen and forms an obtuse angle with a central axis of said elongate member.

55. The medical device of claim 42 further comprising a sheath slideably disposed over said member, said sheath slideable from a proximal position whereby an open distal end of said sheath is proximally displaced from said holes to a distal position whereby said distal end of said sheath is distally displaced from said plurality of holes, said sheath constructed and arranged to occlude said holes when positioned thereover.

56. The medical device of claim 55 wherein said sheath defines at least one opening positionable over one or more of said plurality of holes such that during an operation whereby injectate is being administered, predetermined holes may be selected, opened and reoccluded, thereby changing the shape of the cloud as desired.

57. The medical device of claim 55 wherein said sheath comprises a tapered distal end enabling said sheath to slide relative to and under surrounding tissue without imparting damage thereto.

58. The medical device of claim 42 further comprising an elongate stylet slideably disposed within said central lumen and defining its own central lumen and an opening leading thereto, said stylet having a proximal end attachable to said injectate providing catheter such that said member is in fluid communication therewith, said stylet slideable relative to said member from a proximal position, whereby a distal end of said stylet is proximally displaced from said holes, to a distal position, whereby said distal end of said stylet is distally displaced from said plurality of holes, said stylet constructed and arranged to interact with said holes when positioned thereunder.

59. The medical device of claim 58 wherein said stylet comprises a closed distal end such that as the stylet is advanced distally through said elongate member, the resulting cloud grows in a distal direction as holes become aligned with said opening.

60. The medical device of claim 58 wherein said stylet opening is defined by said stylet distal end such that when said stylet is in said proximal position, fluid flows to all of said plurality of holes and the cloud assumes a longest possible shape and as the stylet is advanced distally, said holes are progressively occluded such that the cloud shortens from a proximal end.

61. The medical device of claim 58 wherein said stylet defines at least one opening in fluid communication with said stylet inner lumen and positionable under one or more of said plurality of holes such that during an operation whereby injectate is being administered, predetermined holes may be selected, opened and reoccluded, thereby changing the shape of the cloud as desired.

62. The medical device of claim 58 further comprising an elongate key protruding from said stylet operably received by an elongate groove defined by an inside wall of said member, said key and said groove constructed and arranged to allow relative sliding between said stylet and said member and to prevent rotation by said stylet relative to said member.

63. The medical device of claim 42 further comprising an elongate stylet rotatably disposed within said central lumen and defining its own central lumen, said stylet rotatable from a closed position, whereby an outer surface of said stylet occludes all of said holes, to an open position, whereby an opening defined by said stylet and leading to said own central lumen aligns with at least one of said holes, allowing injectate to flow therethrough.

64. The medical device of claim 63 whereby said opening is angled relative to said holes such that as said stylet is rotated from said closed position, an increasing number of holes become aligned with said opening.

65. The medical device of claim 63 further comprising an indicator operably displayed on said member showing the relative position between said member and said stylet.

66. The medical device of claim 65 wherein said indicator is constructed and arranged to display the number of holes aligned with said opening for a given angular position.

67. The medical device of claim 55 further comprising an indicator operably displayed on said member showing the relative position between said member and said sheath.

68. The medical device of claim 67 wherein said indicator is constructed and arranged to display the number of holes which are not occluded by said sheath.

69. The medical device of claim 58 further comprising an indicator operably displayed on said stylet showing the relative position between said stylet and said member.

70. The medical device of claim 69 wherein said indicator is constructed and arranged to display the number of holes which are aligned with said opening in said stylet.

71. The medical device of claim 42 further comprising a sheath rotatably disposed over said member, said sheath rotatable from a closed position whereby said holes are occluded by said sheath, to an open position whereby at least one hole is aligned with an opening defined by said sheath.

72. The medical device of claim 71 wherein said opening is angled relative to said holes such that as the sheath is rotated from the closed position, an increasing number of holes are aligned with said opening.

73. The medical device of claim 71 further comprising an indicator operably displayed on said sheath and said member, showing the relative position between said sheath and said member.

74. The medical device of claim 73 wherein said indicator is constructed and arranged to display the number of holes which are aligned with said opening.

75. The medical device of claim 42 wherein the elongate member comprises a scored outer surface such that injectate back pressure is minimized while injecting a liquid into tissue which is in contact with the outer surface of the member.

83. The medical device of claim 42 wherein said distal end comprises a material which is softer than a material forming said side wall.

84. The medical device of claim 83 wherein said distal end further comprises a self-sealing material capable of accommodating a guidewire passing therethrough, and capable of forming a substantially leak-free barrier between said inner lumen and a location immediately distal of said distal end, when fluid is introduced into said inner lumen.

76. A method of introducing an injectate into tissue comprising:

providing a device having a holed member and an occluding member slideably attached to said holed member and capable of selectively occluding and uncovering predetermined holes leading to a central lumen in fluid communication with said injectate;

determining a target site in vivo;

determining a desired injectate cloud shape;

introducing said device to said target site;

providing pressurized injectate to said central lumen;

slideably manipulating said occluding member relative to said holed member, thereby uncovering predetermined holes and allowing injectate to be released in the tissue to form the desired cloud shape.

77. A method of creating a cloud of injectate in tissue having a predetermined size and shape comprising:

determining a target site in vivo;

determining said predetermined cloud size and shape;

providing a device having an elongate member defining a plurality of holes constructed and arranged to create a variety of cloud shapes in tissue, each of said shapes dependent on a pressure at which injectate is forced through said holes, at least one of said cloud shapes resembling said predetermined cloud shape;

determining said injectate pressure which results in said desired cloud shape;

determining an injectate quantity which results in said desired cloud size;

forcing said determined quantity of injectate through said holes of said elongate member at said determined pressure.

80. The in-line volumetric reducer of claim 79 further comprising a rigid member connecting said first piston to said second piston such that said first piston is fixed relative to said second piston.

81. The reducer of claim 79 further comprising a bleed valve operably attached to said second cylinder and useable to vent air therefrom.

82. The reducer of claim 79 further comprising a vial attachment port operably attached to said second cylinder, and in fluid communication therewith, constructed and arranged to receive a vial of medicament.

78. An in-line volumetric amplifier useable to advance a predetermined volume of liquid to an open end of a fluid delivery lumen comprising:

a first cylinder having a proximal end defining a proximal opening and a distal end defining a distal opening;

a second cylinder having a proximal end defining a proximal opening and a distal end defining a distal opening, said second cylinder having a larger diameter than said first cylinder;

a first piston operably disposed in said first cylinder;

a second piston operably disposed in said second cylinder;

wherein said first cylinder distal end is operably connected to said second cylinder proximal end;

wherein said first piston is operably connected with said second piston such that when said first piston travels a predetermined distance within said first cylinder, said second piston travels a distance within said second cylinder which is substantially equal to said predetermined distance.