Integrated balloon catheter inflation system

• US 9,919,137 B2
• Filed: 08/27/2014
• Issued: 03/20/2018
• Est. Priority Date: 08/28/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chen, Harvey H., Phung, Andrew, Chien, Thomas, Chang, Da-Yu
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/469,978
• Publication Number:
  US 20150066137A1
• Time in Patent Office: 1,301 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves

Abstract

An inflation system having two pressure vessels integrated into a balloon catheter. A pressurized chamber and a vacuum chamber are integrally attached to proximal end of the balloon catheter and activated by a common valve or switch. Pressure or vacuum is selectively transmitted to the balloon depending on the valve/switch position. The working fluid may be air, or a combination of air and saline with an intermediate piston/cylinder assembly. The balloon catheter may be a part of a heart valve delivery system with a balloon-expandable heart valve crimped onto the balloon.

Claims

1. A balloon catheter system having an integrated inflation subsystem, comprising:

a manifold having internal passages;

a sealed pressurized vessel permanently attached to an inflation port in the manifold, wherein the pressurized vessel is attached to the manifold in a manner selected from the group consisting of adhesion and thermal welding;

a sealed vacuum vessel permanently attached to a vacuum port in the manifold in a manner selected from the group consisting of adhesion and thermal welding;

a balloon catheter having a balloon on a distal end in fluid communication with an inflation lumen extending through the catheter;

a balloon port in the manifold in fluid communication with and permanently connected to the balloon catheter inflation lumen, wherein the manifold with connected vessels is assembled and packaged with the balloon catheter; and

a control valve on the manifold configured to selectively open and close fluid communication between the balloon port and the inflation port so that a positive pressure differential from the pressurized vessel inflates the balloon, wherein the control valve is also configured to selectively open and close fluid communication between the balloon port and the vacuum port so that a negative pressure differential from the vacuum vessel deflates the balloon.

2. The system of claim 1, wherein the balloon catheter system is part of a prosthetic heart valve delivery system including a balloon-expandable heart valve crimped onto the balloon.

3. The system of claim 1, further including a one-way valve attached to a deflation port in the manifold separate from the inflation port, wherein the control valve is also configured to selectively open and close fluid communication between the balloon port and the deflation port to enable passive deflation of the balloon pressure to the atmosphere.

4. The system of claim 1, wherein the manifold opens to just the balloon port, inflation port and vacuum port, and the control valve is a stopcock mounted for rotation on the manifold into three positions.

5. The system of claim 1, further including a pressure regulator located between the control valve and the balloon to limit a balloon pressure to a predetermined maximum.

6. The system of claim 1, wherein the pressurized vessel holds air.

7. The system of claim 6, further including a piston/cylinder assembly incorporated into the manifold on which the pressurized air acts and further including saline in the system distal to the piston/cylinder assembly for inflating the balloon.

8. The system of claim 1, further including an indicator printed, inscribed or embossed on the control valve that conveys information to a user regarding whether there is open fluid communication between the balloon port and the inflation port.

9. The system of claim 8, wherein the indicator is selected from the group consisting of:

a plus sign; and

the color green.

10. A manufactured balloon catheter system, comprising:

a balloon catheter having a balloon on a distal end in fluid communication with an inflation lumen extending through the catheter;

an integrated inflation system assembled and packaged with the balloon catheter, the integrated inflation system having;

a manifold having internal passages;

a sealed pressurized vessel permanently attached to an inflation port in the manifold;

a sealed vacuum vessel permanently attached to a vacuum port in the manifold, wherein the pressurized vessel and the vacuum vessel are attached to the manifold in a manner selected from the group consisting of adhesion and thermal welding;

a balloon port in the manifold in fluid communication with and permanently connected to the balloon catheter inflation lumen; and

a control valve on the manifold configured to selectively open and close fluid communication between the manifold internal passages and one or the other of the pressurized vessel and vacuum vessel.

11. The system of claim 10, wherein the balloon catheter system is part of a prosthetic heart valve delivery system including a balloon-expandable heart valve crimped onto the balloon.

12. The system of claim 10, wherein the manifold opens to just the balloon port, inflation port and vacuum port, and the control valve is a stopcock mounted for rotation on the manifold into three positions.

13. The system of claim 10, further including a pressure regulator located between the control valve and the balloon to limit a balloon pressure to a predetermined maximum.

14. The system of claim 10, wherein the pressurized vessel holds air.

15. The system of claim 14, further including a piston/cylinder assembly incorporated into the manifold on which the pressurized air acts and further including saline in the system distal to the piston/cylinder assembly for inflating the balloon.

16. The system of claim 10, further including indicators printed, inscribed or embossed on the control valve that convey information to a user regarding whether there is open fluid communication between the manifold port and the pressurized vessel or vacuum vessel.

17. The system of claim 16, wherein the indicators are selected from the group consisting of:

a plus sign for the pressurized vessel and a minus sign for the vacuum vessel; and

the color green for the pressurized vessel and the color red for the vacuum vessel.

18. The system of claim 10, further including indicators printed, inscribed or embossed on the pressurized vessel and vacuum vessel selected from the group consisting of:

the word “

Pressure”

for the pressurized vessel and the word “

Vacuum”

for the vacuum vessel; and

the word “

Inflate”

for the pressurized vessel and the word “

Deflate”

for the vacuum vessel.