Method and apparatus for controlled occlusion

• US 8,936,568 B2
• Filed: 02/25/2013
• Issued: 01/20/2015
• Est. Priority Date: 12/20/2005
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Webler, William E., Yambao, August R.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/776,579
• Publication Number:
  US 20130165903A1
• Time in Patent Office: 694 Days
• Field of Search: 604 9601- 9701, 604/99.01, 604/100.01, 604/100.03, 604/103.06, 60410311-10314, 604/103.07
• US Class Current: 604/103.07
• 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 cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal and a distal end; and

a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a first property such that when inflated the balloon will expand in size to a plurality of predictable and linear relatively equally increasing outer diameters of between 0.12 and 0.25 millimeters (mm), over a range of outer diameters having a maximum designed outer diameter of less than 10 mm, when inflated with a plurality of equally increasing inflation volumes of between 0.005 and 0.05 cubic centimeters (cc), the balloon being a compliant balloon, the compliant balloon comprising a second property such that when deflated the balloon will not return to its original un-inflated outer diameter after inflation to its maximum designed outer diameter, wherein the plurality of 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.

2. The apparatus of claim 1, wherein at least one of the tapered ends is attached to the cannula at a position toward the mid-point of the balloon.

3. The apparatus of claim 1, wherein the balloon is a first balloon, the cannula is a first cannula, and the plurality of relatively equally increasing outer diameters, over a range of outer diameters, when inflated with a plurality of equally increasing inflation volumes are a first plurality of relatively equally increasing outer diameters, over a first range of outer diameters, when inflated with a first plurality of equally increasing inflation volumes;

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 second balloon will expand in size to a second plurality of relatively equally increasing outer diameters, over a second range of outer diameters, when inflated with a second plurality of equally increasing inflation volumes, 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 a first plurality of increases in outer diameter of the first balloon for the first plurality of relatively equally increasing outer diameters are relatively equal to a second plurality of increases in outer diameter of the second balloon for the second plurality of relatively equally increasing outer diameters, when the first and second balloon are inflated by equal increases in inflation volume.

4. The apparatus of claim 3, wherein a portion of an outer diameter range of the first plurality of relatively equally increasing outer diameters of the first balloon overlaps with a portion of an outer diameter range of the second plurality of relatively equally increasing outer diameters of the second balloon.

5. The apparatus of claim 1, the balloon comprising a third property such that the balloon has an initial, pre-insertion inner diameter that is larger than the outer diameter of the cannula.

6. The apparatus of claim 1, the balloon being folded to hug the outer diameter of the cannula during the percutaneous advancement through a blood vessel.

7. The apparatus of claim 1, the balloon comprising a third property such that the balloon has an initial, pre-insertion inner diameter that closely fits the outer diameter of the cannula.

8. The apparatus of claim 1, wherein the maximum designed outer diameter is between 3.5 mm and 4.5 mm.

9. The apparatus of claim 8, wherein the balloon has a nominal range in outer diameter of between 3.0 and 4.5 mm;

or of between 4.0 mm and 5.5 mm.

10. The apparatus of claim 1, wherein the balloon has a maximum inflation volume of between 0.05 and 1.5 cubic centimeters (cc).

11. The apparatus of claim 1, wherein the plurality of equally increasing inflation volumes includes up to 20 increments of equally increasing inflation volumes.

12. 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; and

a compliant balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a first property such that when inflated the balloon will expand in size to a plurality of predictable and linear relatively equally increasing outer diameters of between 0.12 and 0.25 millimeters (mm), over a range of outer diameters having a maximum designed outer diameter of less than 10 mm, when inflated with a plurality of equally increasing inflation volumes of between 0.005 and 0.05 cubic centimeters (cc), the balloon comprising a second property such that when inflated the balloon will expand in size from a cylindrical un-inflated shape to a spherical inflated shape.

13. The apparatus of claim 12, the balloon comprising a material and a thickness of the material such that when inflated the balloon will expand in size to form a plurality of relatively increasing outer diameters and will expand to an inflated outer diameter that defines a spherical outer diameter shape.

14. 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; and

a compliant balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a first property such that when inflated the balloon will expand in size to a plurality of predictable and linear relatively equally increasing outer diameters of between 0.12 and 0.25 millimeters (mm), over a range of outer diameters having a maximum designed outer diameter of less than 10 mm, when inflated with a plurality of equally increasing inflation volumes of between 0.005 and 0.05 cubic centimeters (cc), the balloon being a compliant balloon, the compliant balloon comprising a second property such that when deflated the balloon will not return to its original un-inflated outer diameter after inflation to its maximum designed outer diameter, the balloon comprising a third property such that when inflated the balloon will expand in size from a cylindrical un-inflated shape to a spherical inflated shape.

15. The apparatus of claim 14, the balloon comprising a fourth property such that the balloon has an initial, pre-insertion inner diameter that is larger than the outer diameter of the cannula.

16. The apparatus of claim 14, the balloon being folded to hug the outer diameter of the cannula during the percutaneous advancement through a blood vessel.

17. The apparatus of claim 14, the balloon comprising a fourth property such that the balloon has an initial, pre-insertion inner diameter that closely fits the outer diameter of the cannula.

18. The apparatus of claim 14, the balloon comprising a material and a thickness of the material such that when inflated the balloon will expand in size to form a plurality of relatively increasing outer diameters and will expand to an inflated outer diameter a defines a spherical outer diameter shape.

19. 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; and

a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a first property such that when inflated the balloon will expand in size to a plurality of predictable and linear relatively equally increasing outer diameters of 0.25 mm or less, over a range of outer diameters having a maximum designed outer diameter of less than 10 mm, when inflated with a plurality of equally increasing inflations volumes between 0.005 and 0.02 cubic centimeters (cc), the balloon being a compliant balloon comprising a second property such that when deflated the balloon will not return to its original un-inflated outer diameter after inflation to its maximum designed outer diameter, wherein the plurality of relatively equally increasing outer diameters define an approximately cylindrical shape extending alone 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.