Exhaust-pressure-operated balloon catheter system

• US 8,162,878 B2
• Filed: 12/05/2005
• Issued: 04/24/2012
• Est. Priority Date: 12/05/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Bonnette, Michael John, Thor, Eric Joel, Ball, Douglas James, Kozak, Debra M.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US11/294,006
• Publication Number:
  US 20090149807A1
• Time in Patent Office: 2,332 Days
• Field of Search: 604/96.01, 604/97.01, 604/97.02, 604/97.03, 604/98.01, 604/99.01, 60410001-10003, 604/101.01
• US Class Current: 604/98.01
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An exhaust-pressure-operated balloon catheter system which is a cross stream thrombectomy catheter, such as, but not limited to, an Angiojet® catheter with a flexible and expandable balloon, wherein the balloon is formed from and is continuous with the catheter tube which, in part, forms the cross stream thrombectomy catheter, wherein the balloon is deployable and expandable about the distal region of the cross stream thrombectomy catheter to act as an occluder device, and wherein the balloon is located proximal to the fluid jet emanator and inflow and outflow orifices upstream of ablative cross stream flows. The balloon is expandably deployed by the exhaust or back pressure created by the operation of the cross stream flows as generated by the fluid jets of the operating exhaust-pressure-operated balloon catheter system.

Claims

1. An exhaust-pressure-operated balloon catheter thrombectomy system for use within a vessel comprising:

a. a manifold including;

(1) a central tubular body;

(2) a high pressure branch including an integral threaded connector port extending angularly from the central tubular body;

(3) an exhaust branch including an integral threaded connector port extending angularly from the high pressure branch; and

,

(4) a cavity body, having a hemostatic nut assembly, extending proximally from the central tubular body;

b. a catheter tube formed from a first material, including an exhaust lumen, extending distally from the manifold through a strain relief and toward a distally located tapered tip;

c. a plurality of outflow and inflow orifices on the catheter tube and in communication with the exhaust lumen in close proximity to the tapered tip;

d. a high pressure tube connectively extending from the high pressure branch, through the manifold and through the catheter tube to a fluid jet emanator located distal to the plurality of outflow and inflow orifices, and a fluid distally carried under high pressure from the manifold to the fluid jet emanator;

e. an inflatable thin walled section balloon formed from the first material of the catheter tube and aligned between two sections of full wall catheter tube proximal to the plurality of outflow and inflow orifices, where the outflow and inflow orifices are between the fluid jet emanator and the thin walled section balloon, and the outflow and inflow orifices are in communication with the thin walled section balloon and the emanator through the exhaust lumen; and

f. the exhaust lumen of the catheter tube communicating with the thin walled section balloon, the exhaust lumen and thin walled section balloon of the catheter tube being sustainably pressurized by a proximal exhaust flow of the fluid from the fluid jet emanator and an entrained fluid from the inflow and outflow orifices, the proximal exhaust flow crossing the inflow and outflow orifices between the emanator and the thin walled section balloon and combining with the entrained fluid, and the proximal exhaust flow including the fluid from the fluid jet emanator and the entrained fluid inflating the thin walled section balloon into an expanded configuration.

2. The exhaust-pressure-operated balloon catheter system of claim 1, further including opposed radiopaque marker bands distal and proximal of the thin walled section balloon.

3. The exhaust-pressure-operated balloon catheter system of claim 2, further including support rings adjacent to the thin walled section balloon.

4. The exhaust-pressure-operated balloon catheter system of claim 1, wherein the hemostatic nut assembly engages the cavity body.

5. The exhaust-pressure-operated balloon catheter system of claim 4, wherein the cavity body includes dimples protruding inwardly on the cavity body for engagement with an annular lip on the hemostatic nut assembly.

6. The exhaust-pressure-operated balloon catheter system of claim 1, wherein the thin walled section balloon is deployable and expandable about a distal region of the catheter tube to act as an occlusive device when an exhaust pressure control device is operated.

7. The exhaust-pressure-operated balloon catheter system of claim 1, wherein the fluid jet emanator and inflow and outflow orifices define a location for ablative cross stream flows generated by the fluid from the fluid jet emanator, and wherein the thin walled section balloon is located proximal to the location of such ablative cross stream flows.

8. The exhaust-pressure-operated balloon catheter system of claim 1, wherein the exhaust branch of the manifold includes an exhaust regulator, and the exhaust regulator is configured to cooperate with the proximal exhaust flow to control inflation pressure at the thin walled section balloon.

9. A method of occluding a location in vasculature comprising:

a. providing an exhaust-pressure-operated balloon catheter including;

a manifold comprising a high pressure branch having a high pressure connector, and an exhaust branch,

a full wall catheter tube formed from a first material and having an exhaust lumen, the catheter tube extending distally from the manifold, and the catheter tube includes inflow and outflow orifices in communication with the exhaust lumen,

a high pressure tube communicating with the high pressure connector and extending through the manifold and through the catheter tube to a fluid jet emanator, and a fluid distally carried under high pressure from the manifold to the fluid jet emanator,

an integral, flexible, expandable, and inflatable thin wall section balloon aligned between two sections of the full wall catheter tube, the outflow and inflow orifices are between the fluid jet emanator and the expandable balloon, and the outflow and inflow orifices are in communication with the expandable balloon and the emanator through the exhaust lumen;

b. positioning the balloon at the location in the vasculature; and

c. sustainably inflating the balloon into an expanded configuration by supplying high pressure flow to a fluid jet emanator and restricting the exhaust outflow, wherein sustainably inflating the balloon includes;

directing the high pressure flow proximally through the fluid jet emanator and across one or more of inflow and outflow orifices, the one or more inflow and outflow orifices are between and in communication with the balloon and the fluid jet emanator,

entraining and combining fluid from the one or more of inflow and outflow orifices with the proximal high pressure flow as a proximal exhaust flow, and

delivering the proximal exhaust flow to the balloon for sustainable inflation.

10. The method of claim 9, wherein the exhaust-pressure-operated balloon catheter includes the one or more inflow and outflow orifices situated distally from the balloon, and further comprising:

generating a cross stream ablative jet.

11. The method of claim 10, further comprising:

stopping the cross stream ablative jet and deflating the balloon.

12. The method of claim 11, further comprising:

repositioning the deflated balloon at another location in the vasculature; and

,

reinflating the balloon by resupplying high pressure flow and re-restricting the exhaust outflow and generating another cross stream ablative jet.

13. An exhaust-pressure-operated balloon catheter thrombectomy system comprising:

a. a manifold comprising a high pressure branch having a high pressure connector, and an exhaust branch;

b. a catheter tube formed from a first material and having an exhaust lumen, the catheter tube extending distally from the manifold, and the catheter tube includes inflow and outflow orifices in communication with the exhaust lumen;

c. a high pressure tube communicating with the high pressure connector and extending through the manifold and through the catheter tube to a fluid jet emanator, and a fluid distally carried under high pressure from the manifold to the fluid jet emanator;

d. a thin walled section formed from the first material of the catheter tube located between two sections of thicker walled catheter tube formed from the first material, where the thin walled section is an expandable balloon, the outflow and inflow orifices are between the fluid jet emanator and the expandable balloon, and the outflow and inflow orifices are in communication with the expandable balloon and the emanator through the exhaust lumen; and

e. the exhaust lumen of the catheter tube communicating with the expandable balloon, the exhaust lumen of the catheter tube being sustainably pressurized by a proximal exhaust flow of the fluid from the fluid jet emanator and an entrained fluid from the inflow and outflow orifices, the proximal exhaust flow crossing the inflow and outflow orifices between the emanator and the expandable balloon and combining with the entrained fluid, and the proximal exhaust flow including the fluid from the fluid jet emanator and the entrained fluid sustainably inflating the expandable balloon into an expanded configuration.

14. The exhaust-pressure-operated balloon catheter system of claim 13, further comprising an exhaust regulator.

15. The exhaust-pressure-operated balloon catheter system of claim 14, wherein the exhaust regulator is in the exhaust branch, and the exhaust regulator is configured to cooperate with the proximal exhaust flow to control inflation pressure at the thin walled section balloon.

16. An exhaust-pressure-operated balloon catheter system comprising:

a. a manifold comprising a high pressure branch having a high pressure connector, and an exhaust branch;

b. a catheter tube formed from a first material and having an exhaust lumen, the catheter tube extending distally from the manifold, and the catheter tube includes inflow and outflow orifices in communication with the exhaust lumen;

c. a high pressure tube communicating with the high pressure connector and extending through the manifold and through the catheter tube to a fluid jet emanator, and a fluid distally carried under high pressure from the manifold to the fluid jet emanator;

d. an expandable balloon, the outflow and inflow orifices are between the fluid jet emanator and the expandable balloon, and the outflow and inflow orifices are in communication with the expandable balloon and the emanator through the exhaust lumen; and

e. the exhaust lumen of the catheter tube communicating with the expandable balloon, the exhaust lumen of the catheter tube configured for sustainably pressurizing by a proximal exhaust flow along a composite exhaust path extending from the fluid jet emanator to the expandable balloon, the composite exhaust path configured to receive fluid from the fluid jet emanator and an entrained fluid from the inflow and outflow orifices to form the proximal exhaust flow, the composite exhaust path extends through the inflow and outflow orifices between the emanator and the expandable balloon, the proximal exhaust flow in the composite exhaust path is configured to sustainably inflate the expandable balloon into an expanded configuration.

17. The exhaust-pressure-operated balloon catheter system of claim 16, wherein the expandable balloon is deployable and expandable about a distal region of the catheter tube to act as an occlusive device when an exhaust pressure control device is operated.

18. The exhaust-pressure-operated balloon catheter system of claim 16, wherein the exhaust branch of the manifold includes an exhaust regulator, and the exhaust regulator is configured to cooperate with the proximal exhaust flow to control inflation pressure at the expandable balloon.

19. The exhaust-pressure-operated balloon catheter system of claim 16, wherein the fluid jet emanator and inflow and outflow orifices define a location for ablative cross stream flows generated by the fluid from the fluid jet emanator, and wherein the expandable balloon is located proximal to the location of such ablative cross stream flows.