METHOD AND APPARATUS FOR CONTROLLED VESSEL OCCLUSION

• US 20100191220A1
• Filed: 02/12/2010
• Published: 07/29/2010
• Est. Priority Date: 12/20/2005
• Status: Active Grant

• Current Assignee: August R. Yambao, William E. Webler
• Original Assignee: August R. Yambao, William E. Webler
• Inventors: Webler, William E., Yambao, August R.
• Granted Patent: US 8,419,714 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device. The balloon may have tapered ends and a cylindrical center portion so that it increases by more equal increments in outer diameter in response to incremental equal increases in inflation volume.

Claims

1. An apparatus comprising:

a flexible tube comprising;

a first end to attach and seal the tube to an output of a syringe tube;

a second end to couple the tube to an input adapter of a catheter;

an inner diameter sufficient to communicate fluid between the syringe tube and the input adapter to cause a volume of fluid to inflate a balloon attached to the catheter to occlude a blood vessel at a region of interest;

an inner material;

an outer material surrounding and extruded over the inner material;

wherein the inner material has a modulus greater than a modulus of the outer material.

2. The apparatus of claim 1, further comprising a stopcock having an input adapter attached and sealed to the second end and an output adapter attached and sealed to the input adapter of the catheter.

3. The apparatus of claim 1, wherein the inner material and the outer material are miscible and are co-extruded, the inner diameter of the inner material is less than or equal to 0.035 inches and the outer diameter of an outer material is greater than or equal to 0.13 inches.

4. The apparatus of claim 1, further comprising a third intermediate adhesive polymer attaching the inner material to the outer material.

5. An apparatus comprising:

a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal and a distal end;

a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated the balloon will expand in size to a plurality of relatively equally increasing outer diameters when inflated with a plurality of equally increasing inflation volumes over a range of outer diameters.

6. The apparatus of claim 5, wherein the relatively equally increasing outer diameters define an approximately cylindrical shape extending along a longitudinal axis of the cannula between two tapered ends of the balloon when inflated with a first inflation volume and define an elliptical or curved shape between the two tapered ends with respect to the axis when inflated with a second inflation volume, wherein the second inflation volume is greater than the first inflation volume.

7. The apparatus of claim 6, wherein at least one of the tapered ends is attached to the cannula at a position toward the mid-point of the balloon.

8. The apparatus of claim 5, wherein the balloon is a first balloon and the cannula is a first cannula, and further comprising:

a second balloon axially coupled to an exterior surface of a second cannula at or adjacent the distal end of the second cannula, the second balloon comprising a property such that when inflated the balloon will expand in size to a plurality of relatively equally increasing outer diameters when inflated with a plurality of equally increasing inflation volumes over a range of outer diameters, the second balloon having a lower outer diameter at the bottom of its inflation range of outer diameters than the first balloon and having a longer cylindrical length than a cylindrical length of the first balloon, wherein the first balloon and the second balloon will expand in size by a relatively equal increase in outer diameter when inflated by an equal increase in inflation volume.

9. A system of claim 8, wherein a portion of the outer diameter range of the first balloon overlaps with a portion of the outer diameter range of the second balloon.

10. A method comprising:

advancing a catheter percutaneously through a blood vessel to a region of interest, the catheter having a proximal end, a distal end, and an exterior surface at or adjacent the distal end of the catheter axially coupled to a balloon;

locking a latch in a first position to locate a plunger at a first location in a syringe tube;

pushing the plunger to a second location in the syringe tube to inflate the balloon to an inflation diameter;

transitioning the latch to a second position to locate the plunger at a different third location in the syringe tube to deflate the balloon.

11. The method of claim 10, wherein locking and pushing cause the plunger to push an inflation volume of fluid out of the syringe tube;

and wherein transitioning includes unlocking the plunger from the second location in the syringe tube and moving the plunger proximally within the syringe tube to cause the plunger to retract a deflation volume of fluid into the syringe tube.

12. The method of claim 10, wherein pushing includes dialing a knob to select a volume of fluid to be pushed by the plunger to inflate the balloon sufficiently to occlude the blood vessel at the region of interest, and transitioning includes deflating the balloon sufficiently to allow fluid to flow in the blood vessel at the region of interest.

13. A method of claim 10, further comprising:

after transitioning the latch to a second position, transitioning the latch to the first position to returns the plunger to the second location in the syringe tube to inflate the balloon to the inflation diameter; and

then

transitioning the latch to the second position to returns the plunger to the third location in the syringe tube to deflate the balloon.

14. The method of claim 13, wherein transitioning the latch to the first position includes inflating the balloon for a first period of time, and transitioning the latch to the second position includes deflating the balloon for a second period of time;

and further comprising;

transitioning the latch to re-locate the plunger at the second location; and

infusing a treatment agent to the region of interest distal or proximal to the balloon prior during the first period of time; and

transitioning the latch to the second position to relocate the plunger at the third position for at least the second period of time.

15. The method of claim 14, wherein transitioning the latch to the first position, infusing and transitioning the latch to the second position is repeated at least once.

16. The method of claim 10, wherein, locking the latch in a first position includes first placing the latch in a mid-position, between the first and second latch positions, to locate the plunger at a fourth location in the syringe tube and transitioning the latch from the mid-position to the first position to inflate the balloon with a selected volume of fluid.

17. The method of claim 10, wherein, pushing includes rotating the cowling with respect to a longitudinal axis of one of a proximal housing coupled to the latch and a distal housing coupled to the latch to cause a threaded attachment between the cowling and the housing to move an inner surface of the cowling over an outer surface of the housing and to move the plunger along a length of the syringe tube along the longitudinal axis to push a volume of fluid into the balloon.

18. The method of claim 17 wherein, the volume of fluid pushed into the balloon is adjusted to produce a selected pressure of fluid in the balloon.

19. The method of claim 10, wherein, pushing includes rotating the a knob with respect to the longitudinal axis of a housing coupled to the latch to cause a threaded attachment between the knob and the housing to move one of the syringe tube and the plunger to cause the plunger to move along a length of the syringe tube along the longitudinal axis to push a volume of fluid into the balloon.