RHEOLYTIC THROMBECTOMY CATHETER WITH SELF-INFLATING PROXIMAL BALLOON WITH DRUG INFUSION CAPABILITIES

• US 20090171267A1
• Filed: 12/18/2008
• Published: 07/02/2009
• Est. Priority Date: 12/26/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Kozak, Debra M., Bonnette, Michael J., Thor, Eric J.
• Granted Patent: US 8,439,878 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 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02

Abstract

The present disclosure involves a rheolytic thrombectomy catheter with a self-inflating proximal balloon having drug infusion capabilities. A self-inflating balloon having a plurality of outflow orifices located about the peripheral circumference thereof is located proximal to an inflow gap or orifices and a fluid jet emanator and which balloon is inflated and expanded by internal operating pressures to uniformly space and position the outflow orifices of the self-inflating balloon in close proximity to or in intimate contact with the thrombus or walls of the blood vessel. Devices of the present disclosure can be used for the purposes of thrombectomies, embolectomies, thrombus or vessel dilation and for the delivery of drugs to a thrombus or vessel site.

Claims

1. A thrombectomy catheter 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 elongated 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 proximal end of said elongated distal section being spaced from said distal end of said elongated flexible catheter tube by an inflow gap interposed between the elongated flexible catheter tube and the elongated distal section;

said elongated flexible catheter tube further having a section adjacent said distal end, said section forming a self-inflating balloon having a periphery with a plurality of outflow orifices in said periphery;

a fluid jet emanator having a plurality of spaced jet orifices, said fluid jet emanator secured within said proximal end of said elongated distal section;

an elongated flexible high pressure tube having a proximal end in fluid communication with a fluid source and the fluid jet emanator; and

wherein the self-inflating balloon is pressurized into an expanded configuration by a proximal flow of fluid from the fluid jet emanator.

2. The thrombectomy catheter of claim 1, wherein said elongated flexible catheter tube has a predetermined wall thickness and said self-inflating balloon has a wall thickness less than said predetermined wall thickness.

3. The thrombectomy catheter of claim 1, wherein said elongated flexible catheter tube has a predetermined wall thickness and said self-inflating balloon is formed of a material with a wall thickness less than said predetermined wall thickness.

4. The thrombectomy catheter of claim 1, wherein said central elongated tubular body has a tubular connection branch attached thereto, a high pressure fluid connection port having a proximal end and a distal end, a high pressure fluid pump connected to said proximal end of said high pressure fluid connection port, the fluid source connected to said high pressure fluid pump and said proximal end of said elongated flexible high pressure tube in fluid communication with said distal end of said high pressure fluid connection port.

5. The thrombectomy catheter of claim 1, wherein said fluid source is selected from the group saline, a solution of one or more drugs and a combination of saline and a solution of one or more drugs.

6. The thrombectomy catheter of claim 1, wherein said self-inflating balloon has an approximate length between 2 mm and 200 mm.

7. The thrombectomy catheter of claim 1, wherein said self-inflating balloon has an approximate maximum inflated diameter between 2 mm and 20 mm at a pressure up to 20 ATM.

8. The thrombectomy catheter of claim 1, wherein said self-inflating balloon is pressurized into an expanded configuration by the proximal flow of fluid from the fluid jet emanator and an entrained fluid from the inflow gap.

9. A thrombectomy catheter 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 portion, said proximal end of said catheter tube extending into and distally from said distal end of said central elongated tubular body of said manifold;

said elongated flexible catheter tube continuous with an elongated distal section, said elongated distal section of said catheter tube having a proximal portion and a distal end;

a fluid jet emanator having a plurality of spaced jet orifices, said fluid jet emanator secured between the proximal portion of the elongated distal section and the distal portion of the elongated flexible catheter tube;

said distal portion of the elongated flexible catheter tube having an inflow orifice;

said distal portion of the elongated flexible catheter tube having a self-inflating balloon having a periphery proximal to the inflow orifice, said self-inflating balloon having a plurality of outflow orifices in said periphery;

an elongated flexible high pressure tube having a proximal end in fluid communication with a fluid source and the fluid jet emanator; and

wherein the self-inflating balloon is pressurized into an expanded configuration by a proximal flow of fluid from the fluid jet emanator.

10. The thrombectomy catheter of claim 9, wherein said elongated flexible catheter tube has a predetermined wall thickness and said self-inflating balloon has a wall thickness less than said predetermined wall thickness.

11. The thrombectomy catheter of claim 9, wherein said elongated flexible catheter tube has a predetermined wall thickness and said self-inflating balloon is formed of a material with a wall thickness less than said predetermined wall thickness.

12. The thrombectomy catheter of claim 9, wherein said fluid jet emanator has a periphery and the plurality of spaced jet orifices in said fluid jet emanator includes rearwardly directed orifices and radially directed spaced orifices in the periphery of said fluid jet emanator, said radially directed spaced orifices in alignment with corresponding holes in said elongated flexible catheter tube.

13. The thrombectomy catheter of claim 9, wherein said fluid source is selected from the group saline, a solution of one or more drugs and a combination of saline and a solution of one or more drugs.

14. The thrombectomy catheter of claim 9, wherein said self-inflating balloon has an approximate length between 2 mm and 200 mm.

15. The thrombectomy catheter of claim 9, wherein said self-inflating balloon has an approximate maximum inflated diameter between 2 mm and 20 mm at a pressure up to 20 ATM.

16. The thrombectomy catheter of claim 9, wherein said self-inflating balloon is pressurized into an expanded configuration by a proximal flow of fluid from the fluid jet emanator and an entrained fluid from the inflow orifice.