Direct stream hydrodynamic catheter system

• US 8,647,294 B2
• Filed: 03/20/2009
• Issued: 02/11/2014
• Est. Priority Date: 03/20/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J., Kozak, Debra M., Ball, Douglas J., Weisel, Stephen E., Morris, David B.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US12/933,520
• Publication Number:
  US 20110015564A1
• Time in Patent Office: 1,789 Days
• Field of Search: 604/22, 604/93.01, 604/95.02, 604/181, 604/264, 604/266, 60410201-10203, 604/107, 604/167, 604/190, 606/107, 606/167, 606/190
• 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 general flow characteristics A61M2206/10
• 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 section and a distal section, said proximal section having a proximal end extending into and distally from said distal end of said central elongated tubular body of said manifold, and said distal section having an open distal end coincident with a longitudinal axis of the distal section;

a tubular fluid jet emanator positioned within said distal section of said elongated flexible catheter tube adjacent to said open distal end, said tubular fluid jet emanator having a proximal face and a distal face, said proximal face having a plurality of proximal fluid jet orifices that are proximally directed, and said distal face having a plurality of distal fluid jet orifices aligned with and laterally recessed from an inner edge of the open distal end such that fluid jet streams distally directed from the plurality of distal fluid jet orifices extend through said open distal end;

one or more inflow orifices in said elongated flexible catheter tube proximal to said tubular fluid jet emanator, wherein the one or more inflow orifices are configured to receive a fluid flow provided by the fluid jet streams extending through the open distal end;

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 a 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 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 proximal fluid jet orifices, said plurality of distal fluid jet orifices, and said central passageway.

4. The direct stream hydrodynamic catheter system of claim 1, wherein said pressurized fluid is saline or another suitable fluid.

5. The direct stream hydrodynamic catheter system of claim 1, 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.

6. The direct stream hydrodynamic catheter system of claim 1, wherein the one or more inflow orifices in said elongated flexible catheter tube proximal to said tubular fluid jet emanator are radially directed relative to the longitudinal axis of the distal section of the catheter tube.

7. The direct stream hydrodynamic catheter system of claim 1, wherein said plurality of proximal fluid jet orifices and said plurality of distal fluid jet orifices have diameters between 0.001 inch and 0.040 inch.

8. A direct stream hydrodynamic catheter system comprising:

a manifold having an elongated tubular body with a proximal end and a distal end;

an elongated flexible catheter tube having a proximal section and a distal section, said proximal section having a proximal end extending into and distally from said distal end of said elongated tubular body of said manifold, and said distal section having an open distal end coincident with a longitudinal axis of the distal section;

a fluid jet emanator positioned within said distal section of said elongated flexible catheter tube near said open distal end, said fluid jet emanator having a proximal face and a distal face, said proximal face having a plurality of proximal fluid jet orifices that are proximally directed, and said distal face having a plurality of distal fluid jet orifices that are distally directed, wherein fluid jet streams distally directed from the plurality of said distal fluid jet orifices extend through said open distal end;

one or more inflow orifices in said elongated flexible catheter tube proximal to said fluid jet emanator, wherein the one or more inflow orifices are configured to receive a fluid flow provided by the fluid jet streams extending through the open distal end;

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 coupled with said fluid jet emanator; and

a high pressure fluid source configured to deliver a pressurized fluid into said proximal end of said elongated flexible high pressure tube;

wherein in an operation mode of the catheter system, the distal fluid jet orifices are configured to provide a direct fluid stream along the longitudinal axis of the distal section of the elongated flexible catheter tube and through the open distal end of the elongated flexible catheter tube.

9. The direct stream hydrodynamic catheter system of claim 8, wherein said fluid jet emanator is fixed within said distal section of said elongated flexible catheter tube.

10. The direct stream hydrodynamic catheter system of claim 9, wherein said 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 proximal fluid jet orifices, said plurality of distal fluid jet orifices, and said central passageway.

11. The direct stream hydrodynamic catheter system of claim 8, wherein said pressurized fluid is saline.

12. The direct stream hydrodynamic catheter system of claim 8, 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.

13. 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 an outer surface.

14. The direct stream hydrodynamic catheter system of claim 8, further comprising an elongated flexible guidewire passing through said elongated tubular body of said manifold and through said distal section of said elongated flexible catheter tube.

15. The direct stream hydrodynamic catheter system of claim 14, wherein said elongated flexible guidewire further comprises a balloon deployed distally from said distal section of said elongated flexible catheter tube.

16. The direct stream hydrodynamic catheter system of claim 8, wherein in an operation mode of the catheter system, the proximal fluid jet orifices and the distal fluid jet orifices are pressurized together by said pressurized fluid provided by the high pressure fluid source.