Direct Stream Hydrodynamic Catheter System

• US 20110015564A1
• Filed: 03/20/2009
• Published: 01/20/2011
• Est. Priority Date: 03/20/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Bayer Medical Care Inc. (Bayer AG)
• Inventors: Morris, David B., Kozak, Debra M., Weisel, Stephen E., Prather, Richard R., Ball, Douglas J., Thor, Eric J., Bonnette, Michael J.
• Granted Patent: US 8,647,294 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A direct stream hydrodynamic catheter system is provided for the removal of thrombus, lesions and the like including provisions for the infusion of drugs, lysing fluids and the like into a blood vessel. Physician controlled high powered direct fluid jet streams emanate from a fluid jet emanator in the form of robust radially directed fluid jet streams to impinge upon and ablate difficult and strong thrombus or lesions within a blood vessel. Effluent aspiration is controlled by an exhaust regulator in the form of a roller pump, but effluent removal can be assistingly influenced by the fluid pressure associated with the radially directed fluid jet streams.

Claims

1. A direct stream hydrodynamic catheter system comprising a manifold having a central elongated tubular body with a proximal end and a distal end, an elongated flexible catheter tube having a proximal end and a distal end, said proximal end of said catheter tube extending into and distally from said distal end of said central tubular body of said manifold, a tapered flexible tip having a proximal end and a distal end, said tapered flexible tip having a central passageway extending therethrough, said elongated flexible catheter tube having an elongated distal section, said elongated distal section of said catheter tube having a proximal end and a distal end, said distal end of said elongated distal section being attached to said proximal end of said tapered flexible tip, a tubular fluid jet emanator positioned within said elongated distal section proximal to said proximal end of said tapered flexible tip, one or more inflow orifices in said distal section proximal to said tubular fluid jet emanator, said tubular fluid jet emanator having a proximal end and a distal end, a plurality of spaced, radially directed, fluid jet orifices around a peripheral surface of said tubular fluid jet emanator, said spaced, radially directed, fluid jet orifices being adjacent said proximal end of said tubular fluid jet emanator, a plurality of holes in said elongated distal section and in corresponding alignment with said plurality of spaced, radially directed, fluid jet orifices, an elongated, flexible, high pressure tube having a proximal end and a distal end, said elongated, flexible, high pressure tube extending from said manifold, through said elongated flexible catheter tube, and terminating within said tubular fluid jet emanator, and a high pressure fluid source delivering pressurized fluid into said proximal end of said elongated, flexible, high pressure tube.

2. The direct stream hydrodynamic catheter system of claim 1, wherein said tubular fluid jet emanator is fixed within said elongated distal section of said elongated flexible catheter tube.

3. The direct stream hydrodynamic catheter system of claim 2, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of spaced, radially directed, fluid jet orifices and said central passageway.

4. The direct stream hydrodynamic catheter system of claim 3, wherein said tubular fluid jet emanator has an outer annular groove therein, said distal section of said elongated flexible catheter tube has a first circular marker band surrounding an outer surface of said distal section and opposite said annular groove of said tubular fluid jet emanator, said first circular marker band compressing said outer surface within said annular groove of said tubular fluid jet emanator.

5. The direct stream hydrodynamic catheter system of claim 4, wherein an internal support ring is positioned within said proximal end of said elongated distal section and said elongated, flexible, high pressure tube is fixed thereto.

6. The direct stream hydrodynamic catheter system of claim 5, wherein a second circular marker band surrounds an outer surface near said proximal end of said elongated distal section, said second circular marker band being opposite to said internal support ring, said second circular marker band clamping said outer surface to said internal support ring.

7. The direct stream hydrodynamic catheter system of claim 6, wherein said first and second circular marker bands are radiopaque marker bands.

8. The direct stream hydrodynamic catheter system of claim 1, wherein said central elongated tubular body has a tubular connection branch attached thereto at an angle facing towards said proximal end of said central elongated tubular body, a Luer connector connected to the free end of said tubular connection branch, a high pressure fluid connection port having a proximal end and a distal end, said Luer connector being connected to said distal end of said high pressure fluid connection port, a high pressure fluid pump connected to said proximal end of said high pressure connection port, a high pressure fluid source connected to said high pressure fluid pump and said proximal end of said elongated flexible high pressure tube being in fluid communication with said distal end of said high pressure fluid connection port through said Luer connector.

9. The direct stream hydrodynamic catheter system of claim 8, wherein said pressurized fluid is saline or another suitable fluid.

10. The direct stream hydrodynamic catheter system of claim 8, wherein a tubular exhaust branch is connected to a side of said tubular connection branch, an exhaust regulator is connected to said tubular exhaust branch and a collection chamber is connected to said exhaust regulator.

11. The direct stream hydrodynamic catheter system of claim 8, wherein said manifold includes a self-sealing hemostasis valve positioned internally of said central elongated tubular body near said proximal end thereof, a hemostasis nut having a proximal end and a distal end, said distal end of said hemostasis nut being connected to said proximal end of said central elongated tubular body and fixing said hemostasis valve within said central elongated tubular body.

12. The direct stream hydrodynamic catheter system of claim 8, wherein said distal end of said central elongated tubular body has a strain relief tube connected thereto by means of a Luer fitting and wherein said proximal end of said elongated flexible catheter tube passes into said strain relief tube and is fixed therein.

13. The direct stream hydrodynamic catheter system of claim 8, wherein said elongated flexible high pressure tube is made from stainless steel or another suitable flexible material.

14. The direct stream hydrodynamic catheter system of claim 8, wherein said elongated flexible catheter tube is made from a flexible plastic material and has a hydrophilic coating along its outer surface.

15. The direct stream hydrodynamic catheter system of claim 1, wherein said pressurized fluid has a velocity between 1 m/s and 250 m/s and a pressure between 50 psi and 20,000 psi.

16. The direct stream hydrodynamic catheter system of claim 1, wherein said catheter system is used in conjunction with an elongated flexible guidewire passing through said central elongated tubular body of said manifold, through said elongated flexible catheter tube, and through said passageway of said tapered flexible tip.

17. The direct stream hydrodynamic catheter system of claim 1, wherein a solution of one or more drugs is delivered into said proximal end of said elongated flexible high pressure tube.

18. The direct stream hydrodynamic catheter system of claim 1, wherein said radially directed, fluid jet orifices have diameters between 0.001 inch to 0.040 inch.

19. The direct stream hydrodynamic catheter system of claim 2, wherein said tubular fluid jet emanator has a proximal face and a plurality of spaced, proximally directed, fluid jet orifices in said proximal face.

20. The direct stream hydrodynamic catheter system of claim 19, wherein the diameter of each of said plurality of spaced, radially directed, fluid jet orifices is smaller than the diameter of each of said plurality of spaced, proximally directed, fluid jet orifices.

21. The direct stream hydrodynamic catheter system of claim 20, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of spaced, radially directed, fluid jet orifices, said plurality of spaced, proximally directed, fluid jet orifices, and said central passageway.

22. The direct stream hydrodynamic catheter system of claim 21, wherein said pressurized fluid is saline or another suitable fluid.

23. The direct stream hydrodynamic catheter system of claim 22, wherein said pressurized fluid has a velocity of between 1 m/s and 250 m/s and a pressure of between 50 psi and 20,000 psi.

24. The direct stream hydrodynamic catheter system of claim 23, wherein said radial directed, fluid jet orifices and said proximally directed, fluid jet orifices have diameters between 0.001 inch and 0.040 inch.

30. The direct stream hydrodynamic catheter system of claim 23, wherein said plurality of spaced, proximally directed, fluid jet orifices and said plurality of spaced, distally proximally directed, fluid jet orifices have diameters between 0.001 inch and 0.040 inch.

25. A direct stream hydrodynamic catheter system comprising a manifold having a central elongated tubular body with a proximal end and a distal end, an elongated flexible catheter tube having a proximal end and a distal end, said proximal end of said catheter tube extending into and distally from said distal end of said central tubular body of said manifold, a tapered flexible tip having a proximal end and a distal end, said tapered flexible tip having a central passageway extending therethrough, said elongated flexible catheter tube having an elongated distal section, said elongated distal section of said catheter tube having a proximal end and a distal end, said distal end of said elongated distal section being attached to said proximal end of said tapered flexible tip, a tubular fluid jet emanator positioned within said elongated distal section proximal to said proximal end of said tapered flexible tip, one or more inflow orifices in said distal section proximal to said tubular fluid jet emanator, said tubular fluid jet emanator having a proximal face and a distal face, said proximal face has a plurality of spaced, proximally directed, fluid jet orifices and said distal face has a plurality of spaced, distally directed, fluid jet orifices, said elongated flexible catheter tube has one or more outflow orifices located between said distal end of said distal section and said proximal end of said tapered flexible tip, an elongated, flexible, high pressure tube having a proximal end and a distal end, said elongated, flexible, high pressure tube extending from said manifold, through said elongated flexible catheter tube, and terminating within said tubular fluid jet emanator, and a high pressure fluid source delivering pressurized fluid into said proximal end of said elongated, flexible, high pressure tube.

26. The direct stream hydrodynamic catheter system of claim 25, wherein said tubular fluid jet emanator is fixed within said elongated distal section of said elongated flexible catheter tube.

27. The direct stream hydrodynamic catheter system of claim 26, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of spaced, proximally directed, fluid jet orifices, said plurality of spaced, distally directed, fluid jet orifices, and said central passageway.

28. The direct stream hydrodynamic catheter system of claim 27, wherein said pressurized fluid is saline or another suitable fluid.

29. The direct stream hydrodynamic catheter system of claim 28, wherein said pressurized fluid has a velocity of between 1 m/s and 250 m/s and a pressure of between 50 psi and 20,000 psi.

31. A direct stream hydrodynamic catheter system comprising a manifold having a central elongated tubular body with a proximal end and a distal end, an elongated flexible catheter tube having a proximal end and a distal end, said proximal end of said catheter tube extending into and distally from said distal end of said central tubular body of said manifold, said elongated flexible catheter tube having an elongated distal section, said elongated distal section of said catheter tube having a proximal end and a distal end, said distal end of said elongated distal section coinsiding substantially with said distal end of said elongated flexible catheter tube, a tubular fluid jet emanator positioned within said distal end of said elongated distal section, one or more inflow orifices in said distal section proximal to said tubular fluid jet emanator, said tubular fluid jet emanator having a proximal face and a distal face, a plurality of spaced, proximally directed, fluid jet orifices in said proximal face of said tubular fluid jet emanator, a plurality of spaced, distally directed, fluid jet orifices in said distal face of said tubular fluid jet emanator, an elongated, flexible, high pressure tube having a proximal end and a distal end, said elongated, flexible, high pressure tube extending from said manifold, through said elongated flexible catheter tube, and terminating within said tubular fluid jet emanator, and a high pressure fluid source delivering pressurized fluid into said proximal end of said elongated, flexible, high pressure tube.

32. The direct stream hydrodynamic catheter system of claim 31, wherein said tubular fluid jet emanator is fixed within said elongated distal section of said elongated flexible catheter tube.

33. The direct stream hydrodynamic catheter system of claim 32, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of spaced, proximally directed, fluid jet orifices, said plurality of spaced, distally directed, fluid jet orifices, and said central passageway.

34. The direct stream hydrodynamic catheter system of claim 33, wherein said pressurized fluid is saline or another suitable fluid.

35. The direct stream hydrodynamic catheter system of claim 34, wherein said pressurized fluid has a velocity of between 1 m/s and 250 m/s and a pressure of between 50 psi and 20,000 psi.

36. The direct stream hydrodynamic catheter system of claim 35, wherein said plurality of spaced, proximally directed, fluid jet orifices and said plurality of spaced, distally directed, fluid jet orifices have diameters between 0.001 inch and 0.040 inch.

59. The direct stream hydrodynamic catheter system of claim 33, wherein said catheter system is used in conjunction with an elongated flexible guidewire passing through said central elongated tubular body of said manifold, through said elongated flexible catheter tube, and through said central passageway of said tubular fluid jet emanator.

37. A direct stream hydrodynamic catheter system comprising a manifold having a central elongated tubular body with a proximal end and a distal end, an elongated flexible catheter tube having a proximal end and a distal end, said proximal end of said catheter tube extending into and distally from said distal end of said central tubular body of said manifold, a tapered flexible tip having a proximal end and a distal end, said tapered flexible tip having a central passageway extending therethrough, said elongated flexible catheter tube having an elongated distal section, said elongated distal section of said catheter tube having a proximal end and a distal end, said distal end of said elongated distal section being attached to said proximal end of said tapered flexible tip, a tubular fluid jet emanator positioned within said elongated distal section proximal to said proximal end of said tapered flexible tip, one or more inflow orifices in said distal section proximal to said tubular fluid jet emanator, said tubular fluid jet emanator having a proximal end and a distal end, a plurality of spaced, proximally directed, fluid jet orifices in said proximal end of said tubular fluid jet emanator, a plurality of spaced, radially directed, fluid jet orifices around a peripheral surface of said tubular fluid jet emanator, said spaced, radially directed, fluid jet orifices being adjacent said proximal end of said tubular fluid jet emanator, a plurality of holes in said elongated distal section and in corresponding alignment with said plurality of spaced, radially directed, fluid jet orifices, said elongated distal section including and forming a self inflating balloon as an intregal part thereof, said self inflating balloon being located proximal to said proximal end of said tubular fluid jet emanator, an elongated, flexible, high pressure tube having a proximal end and a distal end, said elongated, flexible, high pressure tube extending from said manifold, through said elongated flexible catheter tube, and terminating within said tubular fluid jet emanator, and a high pressure fluid source delivering pressurized fluid into said proximal end of said elongated, flexible, high pressure tube.

38. The direct stream hydrodynamic catheter system of claim 37, wherein said distal section forming said self inflating balloon has a wall thickness less than the wall thickness of the extended portions of said elongated, flexible, catheter tube.

39. The direct stream hydrodynamic catheter system of claim 38, wherein said tubular fluid jet emanator is fixed within said elongated distal section of said elongated flexible catheter tube.

40. The direct stream hydrodynamic catheter system of claim 39, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of spaced, radially directed, fluid jet orifices, said plurality of spaced, proximally directed, fluid jet orifices, and said central passageway.

41. The direct stream hydrodynamic catheter system of claim 37, wherein said elongated flexible high pressure tube is made from stainless steel or another suitable flexible material.

42. The direct stream hydrodynamic catheter system of claim 37, wherein said elongated flexible catheter tube is made from a flexible plastic material and has a hydrophilic coating along its outer surface.

43. The direct stream hydrodynamic catheter system of claim 37, wherein said pressurized fluid has a velocity between 1 m/s and 250 m/s and a pressure between 50 psi and 20,000 psi.

44. The direct stream hydrodynamic catheter system of claim 37, wherein said catheter system is used in conjunction with an elongated flexible guidewire passing through said central elongated tubular body of said manifold, through said elongated flexible catheter tube, and through said passageway of said tapered flexible tip.

45. The direct stream hydrodynamic catheter system of claim 37, wherein a solution of one or more drugs is delivered into said proximal end of said elongated flexible high pressure tube.

46. The direct stream hydrodynamic catheter system of claim 37, wherein said radially and proximally directed, fluid jet orifices have diameters between 0.001 inch to 0.040 inch.

47. The direct stream hydrodynamic catheter system of claim 37, wherein said pressurized fluid is saline or another suitable fluid.

48. A direct stream hydrodynamic catheter system comprising a manifold having a central elongated tubular body with a proximal end and a distal end, an elongated flexible catheter tube having a proximal end and a distal end, said proximal end of said catheter tube extending into and distally from said distal end of said central tubular body of said manifold, a tapered flexible tip having a proximal end and a distal end, said tapered flexible tip having a central passageway extending therethrough, said elongated flexible catheter tube having an elongated distal section, said elongated distal section of said catheter tube having a proximal end and a distal end, said distal end of said elongated distal section being attached to said proximal end of said tapered flexible tip, a tubular fluid jet emanator positioned within said elongated distal section proximal to said proximal end of said tapered flexible tip, one or more inflow orifices in said distal section proximal to said tubular fluid jet emanator, said tubular fluid jet emanator having a proximal face and a distal face, a plurality of spaced, proximally directed, fluid jet orifices in said proximal face of said tubular fluid jet emanator, a plurality of spaced, distally directed, fluid jet orifices in said distal face of said tubular fluid jet emanator, a plurality of spaced, radially directed, fluid jet orifices around a peripheral surface of said tubular fluid jet emanator, said radially directed, fluid jet orifices being adjacent said proximal face of said tubular fluid jet emanator, a plurality of holes in said elongated distal section and in corresponding alignment with said plurality of radially directed, fluid jet orifices, said elongated distal section including and forming a self inflating balloon as an intregal part thereof, said self inflating balloon being located proximal to said proximal end of said tapered flexible tip, one or more balloon inflation orifices in said elongated distal section located proximally to said self inflating balloon and distally to said tubular fluid jet emanator, an elongated, flexible, high pressure tube having a proximal end and a distal end, said elongated, flexible, high pressure tube extending from said manifold, through said elongated flexible catheter tube, and terminating within said tubular fluid jet emanator, and a high pressure fluid source delivering pressurized fluid into said proximal end of said elongated, flexible, high pressure tube.

49. The direct stream hydrodynamic catheter system of claim 48, wherein said distal section forming said self inflating balloon has a wall thickness less than the wall thickness of the extended portions of said elongated, flexible, catheter tube.

50. The direct stream hydrodynamic catheter system of claim 49, wherein said tubular fluid jet emanator is fixed within said elongated distal section of said elongated flexible catheter tube.

51. The direct stream hydrodynamic catheter system of claim 50, wherein said tubular fluid jet emanator has a central passageway therethrough and an internal manifold communicating with said distal end of said elongated, flexible, high pressure tube, said plurality of radially directed, fluid jet orifices, said plurality of spaced, proximally directed, fluid jet orifices, said plurality of spaced, distally directed, fluid jet orifices, and said central passageway.

52. The direct stream hydrodynamic catheter system of claim 48, wherein said elongated flexible high pressure tube is made from stainless steel or another suitable flexible material.

53. The direct stream hydrodynamic catheter system of claim 48, wherein said elongated flexible catheter tube is made from a flexible plastic material and has a hydrophilic coating along its outer surface.

54. The direct stream hydrodynamic catheter system of claim 48, wherein said pressurized fluid has a velocity between 1 m/s and 250 m/s and a pressure between 50 psi and 20,000 psi.

55. The direct stream hydrodynamic catheter system of claim 48, wherein said catheter system is used in conjunction with an elongated flexible guidewire passing through said central elongated tubular body of said manifold, through said elongated flexible catheter tube, and through said passageway of said tapered flexible tip.

56. The direct stream hydrodynamic catheter system of claim 48, wherein a solution of one or more drugs is delivered into said proximal end of said elongated flexible high pressure tube.

57. The direct stream hydrodynamic catheter system of claim 48, wherein the diameter of each of said spaced, radially directed, fluid jet orifices is smaller than the diameter of each of said plurality of spaced, proximally directed, fluid jet orifices.

58. The direct stream hydrodynamic catheter system of claim 48, wherein said radially, proximally and distally directed, fluid jet orifices have diameters between 0.001 inch to 0.040 inch.