Rheolytic thrombectomy catheter with self-inflating proximal balloon with drug infusion capabilities

• US 8,439,878 B2
• Filed: 12/18/2008
• Issued: 05/14/2013
• Est. Priority Date: 12/26/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J., Kozak, Debra M.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/338,376
• Publication Number:
  US 20090171267A1
• Time in Patent Office: 1,608 Days
• Field of Search: 60410201-10203, 60410301-10302
• US Class Current: 604/165.02
• 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

A thrombectomy catheter with a self-inflating proximal balloon having drug infusion capabilities is described. A self-inflating balloon is formed from an inflatable thin walled section of a flexible catheter tube. The self-inflating balloon includes a plurality of outflow orifices located about the peripheral circumference thereof and located proximal to an inflow gap interposed between a fluid jet emanator and the self-inflating balloon. The self-inflating balloon is inflated and expanded by internal operating pressures by proximal composite flow of fluid from the fluid jet emanator and entrained fluid from the inflow gap to uniformly space and position the outflow orifices of the self-inflating balloon in close proximity to the thrombus or vessel walls of a blood vessel. The thrombectomy catheter may be used for, among other things, 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 elongated flexible 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 elongated flexible 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 formed of a first material and further having an inflatable thin walled section adjacent to said distal end and proximal relative to the inflow gap, said inflatable thin walled section forming a self-inflating balloon in communication with the inflow gap, the inflatable thin walled section formed from the first material and 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, the inflow gap being interposed between the fluid jet emanator and the self-inflating balloon; 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 self-inflating balloon is pressurized into an expanded configuration by a proximal composite flow of fluid from the fluid jet emanator and entrained fluid from the inflow gap, whereby the plurality of outflow orifices are in close proximity to a vessel wall or thrombus along the vessel wall according to the expanded configuration of the self-inflating balloon, the proximal composite flow of fluid crossing the inflow gap to the self-inflating balloon.

2. 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.

3. The thrombectomy catheter of claim 1, wherein said fluid source is selected from at least one of:

saline, a solution of one or more drugs and a combination of saline and a solution of one or more drugs.

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

5. 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.

6. The thrombectomy catheter of claim 1, wherein the plurality of outflow orifices extend from an interior of the self-inflating balloon to an exterior of the self-inflating balloon, and the proximal composite flow of fluid from the fluid jet emanator passes from the interior to the exterior of the self-inflating balloon through the outflow orifices.

7. The thrombectomy catheter of claim 1, wherein the elongated flexible high pressure tube is retained within a catheter lumen of the elongated flexible catheter tube, the inflow gap and the plurality of outflow orifices are in communication with the catheter lumen, and the proximal composite flow of fluid is directed distally through the catheter lumen to inflate the self-inflating balloon.

8. The thrombectomy catheter of claim 1, wherein the fluid jet emanator is distal relative to the inflow gap and the self-inflating balloon.