Rheolytic thrombectomy catheter with self-inflating distal balloon

• US 8,303,538 B2
• Filed: 12/17/2008
• Issued: 11/06/2012
• Est. Priority Date: 12/17/2007
• 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.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US12/336,750
• Publication Number:
  US 20090156983A1
• Time in Patent Office: 1,420 Days
• Field of Search: 604/97.01, 604/97.02, 604/97.03, 604/98.01, 604/99.01, 604/102.01, 604/102.02, 604/102.03, 604/103.06
• US Class Current: 604/102.01
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving

Abstract

The devices of the present disclosure are rheolytic thrombectomy catheters with a self-inflating distal balloon. A self-inflating balloon is located distal to an inflow gap or orifice and distal to a fluid jet emanator, which self-inflating balloon is inflated and expanded by the utilization of internal operating forces consisting of forwardly directed high velocity fluid jet streams and/or entrained thrombus particulate therein. The self-inflating balloon, when inflated, impinges on the wall of the blood vessel to isolate sections of the blood vessel distal and proximal to the inflated balloon in order to prevent flow of thrombus particulate, fluids and the like distal to the self-inflating balloon and to provide a stagnant nonflow region proximal to the self-inflating balloon. The devices of the present disclosure also provide for a uniform spacing of the catheter tube with respect to the thrombus and/or wall of the blood vessel.

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 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 elongated distal section having a first inflow orifice near said proximal portion thereof and distal relative to the secured fluid jet emanator;

said elongated flexible catheter tube having a second inflow orifice near said distal portion thereof and proximal relative to the secured fluid jet emanator;

a self-inflating balloon interposed between said first inflow orifice and said distal end of said elongated distal section; and

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

wherein the first inflow orifice is interposed between and in communication with the fluid jet emanator and the self-inflating balloon, and the self-inflating balloon is pressurized into an expanded configuration by a distal 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 of said elongated distal section 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 the plurality of spaced jet orifices in said fluid jet emanator includes forwardly directed orifices and rearwardly directed orifices.

5. The thrombectomy catheter of claim 1, wherein said fluid source is selected from a group consisting of 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 a distal flow of fluid from the fluid jet emanator and an entrained fluid from the first inflow orifice.

9. The thrombectomy catheter of claim 1, further comprising an outflow orifice that is smaller than both the first and second inflow orifices and is located proximal to the second inflow orifice.

10. 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 elongated distal section having a first inflow orifice near said proximal portion thereof and distal relative to the secured fluid jet emanator;

said elongated flexible catheter tube having a second inflow orifice near said distal portion thereof and proximal relative to the secured fluid jet emanator;

a self-inflating balloon interposed between said first inflow orifice and said distal end of said elongated distal section; and

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

wherein the first inflow orifice is interposed between and in communication with the fluid jet emanator and the self-inflating balloon, and the self-inflating balloon is pressurized into an expanded configuration by a distal flow of an entrained fluid from the first inflow orifice and the fluid jet emanator.