Precalibrated inflation device for balloon catheter

• US 20040019323A1
• Filed: 04/23/2003
• Published: 01/29/2004
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Skerven, Gregory J., Carter, Matthew P.
• Granted Patent: US 7,314,461 B2
• Time in Patent Office: Days
• US Class Current: 604/97.03
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

A medical device including an inflation element, such as a syringe, and a balloon catheter in which the inflation element includes a series of indicia to which an operative portion of the inflation device can be aligned. The indicia directly correspond to a particular balloon diameter. A method of inflating a balloon to at least two desired diameters in a body lumen and determining the inflation diameter of the balloon within the body lumen. A method of calibrating the inflation device to allow a user to inflate a balloon to a desired diameter.

Claims

1. A medical device, comprising:

a balloon inflatable to at least two inflated diameters;

an inflation element adapted to inflate the balloon, wherein the inflation element includes

at least two markings displayed on the inflation element, each of the markings corresponding to each of the at least two inflated diameters, and

an indicator movable to a plurality of positions relative to the at least two markings, wherein the inflated diameter is directly ascertainable by reference to the position of the indicator relative to the at least two markings.

2. The medical device of claim 1, wherein the inflation element is a syringe comprising a distal tip and a barrel, and the indicator is a plunger movable within the barrel.

3. The medical device of claim 2, wherein the distal tip is attachable to a luer fitting.

4. The medical device of claim 3, further comprising a stopcock operably connected to the luer fitting.

5. The medical device of claim 2, wherein the barrel comprises a protuberance adapted to selectively lock the plunger at a predetermined position within the barrel relative to one of the markings.

6. The medical device of claim 1, wherein the markings each comprise a numerical dimension representative of the inflated diameter of the balloon.

7. The medical device of claim 6, wherein each of the plurality of markings comprises a predetermined diameter measurement in millimeters.

8. The medical device of claim 6, wherein the inflation element includes at least three markings displayed thereon, and further wherein each adjacent pair of markings comprise a different spacing therebetween.

9. The medical device of claim 1, further comprising:

a catheter having a longitudinal shaft extending between a distal end and a proximal end, and

a passageway extending along the longitudinal shaft from the proximal end to the distal end, wherein a proximal end of the passageway is operably connected to the inflation element and the distal end of the passageway is operably connected to the balloon.

10. The medical device of claim 1, wherein the indicator is adapted to control the inflated diameter of the balloon.

11. The medical device of claim 1, wherein the at least two markings are printed on the inflation element.

12. The medical device of claim 1, wherein the at least two markings are etched on the inflation element.

13. The medical device of claim 1, wherein the at least two markings are embossed on the inflation element.

14. The medical device of claim 1, wherein the balloon is formed of an elastomeric material.

15. The medical device of claim 14, wherein the elastomeric material is latex.

16. The medical device of claim 14, wherein the elastomeric material is silicone.

17. A medical device, comprising:

a balloon inflatable to at least two balloon diameters; and

a syringe operably connected to the balloon, the syringe comprising an indicator and at least two distinct markings, whereby a measurement of the balloon diameter is directly ascertainable by reference to the indicator relative to one of the at least two distinct markings, each of the markings comprising numerical dimensions representative of one of the balloon diameters.

18. The medical device of claim 17, further comprising:

a catheter having a longitudinal shaft extending between a distal end and a proximal end; and

a passageway extending along the longitudinal shaft from the proximal end to the distal end, wherein a proximal end of the passageway is operably connected to the inflation element and the distal end of the passageway is operably connected to the balloon.

19. A medical device, comprising:

a balloon inflatable to at least two inflated diameters;

an inflation element adapted to inflate the balloon, comprising;

at least two markings displayed on the inflation element, each of the markings corresponding to one of the at least two inflated diameters; and

an indicator movable to a plurality of positions relative to the at least two markings, wherein the inflated diameter is directly ascertainable by reference to the position of the indicator relative to the at least two markings;

a catheter having a longitudinal shaft extending between a distal end and a proximal end;

a first passageway extending along the longitudinal shaft from the proximal end to the distal end, a proximal end of the passageway being operably connected to the inflation element and a distal end of the passageway being operably connected to the balloon, wherein the balloon is inflatable remotely by the inflation element.

20. The medical device of claim 19, wherein the inflation element is a syringe comprising a distal tip and a barrel, and the indicator is a plunger movable within the barrel.

21. The medical device of claim 20, wherein the syringe further comprises a secondary set of markings representative of a volume of fluid dispensed from the barrel by the plunger.

22. The medical device of claim 19, wherein each of the at least two markings comprises a predetermined diameter measurement in millimeters.

23. The medical device of claim 19, further comprising:

a dual function passageway extending along the longitudinal axis from the proximal end to the distal end, comprising

a syringe port provided at the proximal end of the dual function passageway, and a wireguide port provided at the proximal end of the dual function passageway, wherein the syringe port is adapted to receive a syringe and the wireguide port is adapted to receive a wireguide.

24. A method for determining the inflation diameter of a balloon within a body lumen, comprising the steps of:

a) providing a medical device comprising;

a balloon inflatable to at least two inflated diameters;

an inflation element adapted to inflate the balloon, the inflation element comprising;

at least two markings displayed on the display surface, each of the markings corresponding to each of the at least two inflated diameters;

an indicator movable to a plurality of positions relative to the at least two markings, wherein the inflated diameter is directly ascertainable by reference to the position of the indicator relative to the at least two markings; and

a catheter having a longitudinal shaft between a distal end and a proximal end, the proximal end being operably connected to the inflation element and the distal end being operably connected to the balloon, wherein the balloon is inflatable remotely by the inflation element;

b) inserting a distal portion of the catheter into the body lumen;

c) operating the inflation element to inflate the balloon within the body lumen;

d) ascertaining the position of the indicator relative to one of the at least two distinct markings; and

e) adjusting the indicator to a position adjacent to one of the at least two distinct markings.

25. A method of calibrating a syringe for use with a balloon, comprising the steps of:

a) operably attaching the balloon to the syringe, the syringe containing a fluid;

b) dispensing a first quantity of the fluid from the syringe and into the balloon until a first desired balloon diameter is obtained, the fluid being dispensed by pushing a plunger into a barrel of the syringe;

c) marking the location of the plunger relative to the barrel of the syringe at a first point corresponding with the first desired balloon diameter;

d) dispensing a second quantity of the fluid from the syringe and into the balloon until a second desired balloon diameter is obtained, the second quantity of fluid being dispensed by pushing a plunger into a barrel of the syringe; and

e) marking the location of the plunger relative to the barrel of the syringe at a second point corresponding with the second desired balloon diameter.

26. The method of claim 25, wherein steps c) and e) each comprise marking the location of the plunger with an alphanumeric symbol that is representative of the diameter of the balloon.