Flexible low compliance extension tubing for balloon inflation

• US 8,419,714 B2
• Filed: 02/12/2010
• Issued: 04/16/2013
• Est. Priority Date: 12/20/2005
• Status: Expired due to Fees

• 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): SHUMATE, VICTORIA PEARL
• Application Number:
  US12/705,556
• Publication Number:
  US 20100191220A1
• Time in Patent Office: 1,159 Days
• Field of Search: 604 9601- 9702, 604/264, 604/523, 604/524, 604/533, 604/538
• US Class Current: 604/538
• 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 having a length dimension for positioning between a syringe tube and an input adaptor of a catheter, the flexible tube consisting essentially of;

a first end having a first connector adapted to attach and seal the flexible tube to an output of the syringe tube;

a second end having a second connector to couple the flexible tube to the input adapter of the catheter;

an inner material defining a lumen having 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 outer material surrounding and extruded over the inner material;

wherein the inner material has a modulus of elasticity greater than a modulus of elasticity of the outer material, and wherein the inner material thickness and the outer material thickness are chosen depending upon the modulus of the inner material and the modulus of the outer material to provide the flexible tube with a selected flexibility and low compliance, wherein the inner material and the outer material are miscible and are co-extruded, and wherein the inner diameter of the inner material is less than or equal to 0.035 inches, and the outer diameter of the outer material is greater than or equal to 0.13 inches.

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

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

4. The apparatus of claim 1, wherein the inner material is one of nylon and HDPE;

wherein the outer material is one of a non-elastomeric polymer and LDPE;

wherein the outer material is miscible with inner material; and

wherein the inner material has thickness less than a thickness of the outer material.

5. The apparatus of claim 1, wherein the inner material has a high modulus to provide low compliance and low volume change properties of the flexible tube;

and the outer material has a low modulus to provide support to the inner material to provide kink resistance and to increase the flexible tube outer diameter to and outer diameter accepted by conventional extension tubing connectors, while maintaining an acceptable level of flexibility.

6. The apparatus of claim 1, wherein the inner material is bonded to the outer material by a bonding agent or due to their being miscible, to facilitate the attachment of the first connector to the first end and the second connector to the second end.

7. The apparatus of claim 1, wherein the flexible tube has a low compliance, such that it does not exhibit a substantial change in a volume of fluid within the inner diameter in response to (1) bends, curves, or movement of the tube, (2) grasping or holding the tube such as by a human hand, or (3) pressure changes of the fluid within the tube, when the flexible tube is used to inflate the balloon.

8. The apparatus of claim 1, comprising a syringe tube attached to the first connector, the syringe tube to provide a pressure of fluid to 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.

9. The apparatus of claim 1, wherein the second connector comprises a rotating male luer attached to the second end.

10. The apparatus of claim 1, further comprising a syringe tube attached to the first connector, and a catheter attached to the second connector, the syringe tube to provide a pressure of fluid to 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.

11. The apparatus of claim 1, wherein the inner material and the outer material are translucent materials.

12. A system comprising:

a syringe tube attached and sealed to a first connector on a first end of a flexible tube, the syringe tube to provide a pressure of fluid to 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;

a catheter attached and sealed to a second connector on a second end of the flexible tube, the catheter having 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;

the flexible tube consisting essentially of;

an inner material defining a lumen having an inner diameter sufficient to communicate fluid between the syringe tube and the catheter 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 outer material surrounding and extruded over the inner material;

wherein the inner material has a modulus of elasticity greater than a modulus of elasticity of the outer material, and wherein the inner material thickness and the outer material thickness are chosen depending upon the modulus of the inner material and the modulus of the outer material to provide the flexible tube with a selected flexibility and low compliance, wherein the inner material and the outer material are miscible and are co-extruded, and wherein the inner diameter of the inner material is less than or equal to 0.035 inches, and the outer diameter of the outer material is greater than or equal to 0.13 inches.

13. The apparatus of claim 12, further comprising a stopcock having an input adapter attached and sealed to the second connector and an output adapter attached and sealed to the catheter.

14. The apparatus of claim 13, wherein the stopcock is a two way stopcock and has another input adapter attached and sealed to an aspiration syringe.

15. The apparatus of claim 12, wherein the inner material and the outer material are translucent materials.

16. A system comprising:

a syringe tube coupled to a first connector on a first end of a flexible tube, the syringe tube to provide a pressure of fluid to 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;

a catheter coupled to a second end of the flexible tube, the catheter having 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;

the flexible tube comprising;

an inner material defining a lumen having an inner diameter sufficient to communicate fluid between the syringe tube and the catheter 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 outer material surrounding and co-extruded over the inner material;

wherein the inner material has a modulus of elasticity greater than a modulus of elasticity of the outer material, and wherein the inner material thickness and the outer material thickness are chosen depending upon the modulus of the inner material and the modulus of the outer material to provide the flexible tube with a selected flexibility and low compliance, wherein the inner material and the outer material are miscible and are co-extruded, and wherein the inner diameter of the inner material is less than or equal to 0.035 inches, and the outer diameter of the outer material is greater than or equal to 0.13 inches.

17. The apparatus of claim 16, further comprising a stopcock having an input adapter attached and sealed to the second connector and an output adapter attached and sealed to the catheter.

18. The apparatus of claim 17, wherein the stopcock is a two way stopcock and has another input adapter attached and sealed to an aspiration syringe.

19. The apparatus of claim 16, wherein the inner material and the outer material are translucent materials.

20. An apparatus comprising:

a flexible tube having a length dimension for positioning between a syringe tube and an input adaptor of a catheter, the flexible tube comprising;

a first end having a first connector adapted to attach and seal the flexible tube to an output of the syringe tube;

a second end having a second connector to couple the flexible tube to the input adapter of the catheter;

an inner material defining a lumen having 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 outer material surrounding and co-extruded over the inner material;

wherein the inner material has a modulus of elasticity greater than a modulus of elasticity of the outer material, and wherein the inner material thickness and the outer material thickness are chosen depending upon the modulus of the inner material and the modulus of the outer material to provide the flexible tube with a selected flexibility and low compliance, wherein the inner material and the outer material are miscible and are co-extruded, and wherein the inner diameter of the inner material is less than or equal to 0.035 inches, and the outer diameter of the outer material is greater than or equal to 0.13 inches.

21. The apparatus of claim 20, further comprising a stopcock having an input adapter attached and sealed to the second connector and an output adapter attached and sealed to the input adapter of the catheter, the stopcock having 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.

22. The apparatus of claim 20, wherein the inner material and the outer material are translucent materials.