FLOW REGULATION VALVE FOR CONTROLLING INFLATION RATE OF A BALLOON DEPLOYING A SCAFFOLD

• US 20160158046A1
• Filed: 02/04/2016
• Published: 06/09/2016
• Est. Priority Date: 05/14/2012
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Pacetti, Stephen D., Wang, Yunbing
• Granted Patent: US 10,441,448 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2039/2413 designed to reduce and or shut-off the flow when a certain maximum flow limit is exceeded
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

An apparatus and method for controlling inflation pressure, pressurization rate, and volumetric flow rate of a balloon during deployment of a stent or scaffold is disclosed.

Claims

1. A flow regulator for regulating flow of an inflation fluid to a balloon catheter, comprising:

a valve body enclosing a control chamber comprising a passageway for fluid flow;

a distal end of the valve body with a distal flow orifice for connection with the balloon catheter,

a proximal end of the valve body with a proximal flow orifice for connection with a catheter in fluid communication an inflation device,

a slidable restrictor body positioned within the control chamber to allow fluid flow distally or proximally through the restrictor body;

a valve seat positioned distal to the restrictor body comprising a valve seat orifice which allows fluid to flow out of the distal flow orifice,

wherein the slidable restrictor body is operable to slide distally in response to fluid flow in the distal direction toward the valve seat during inflation of the balloon, wherein as a distal end of the restrictor body approaches the valve seat they cooperate to increase restriction to fluid flow which controls the pressurization rate of the balloon to within a specified range.

2. The flow regulator of claim 1, further comprising a biasing element that applies a biasing force that opposes the distal sliding of the restrictor body.

3. The flow regulator of claim 1, wherein the restrictor body comprises a conduit positioned within the control chamber to allow fluid flow along its axis.

4. The flow regulator of claim 3, wherein a distal end of the conduit comprises a piston with an opening to allow fluid flow distally or proximally.

5. The flow regulator of claim 3, wherein a proximal end of the conduit is open to allow unrestricted flow distally or proximally.

6. The flow regulator of claim 1, wherein a distal end of the restrictor body comprises wall with at least one opening to allow fluid flow distally or proximally.

7. The flow regulator of claim 6, wherein the wall restricts the fluid flow and the openings are positioned with respect to the valve seat orifice to allow some fluid flow when the wall engages the valve seat.

8. The flow regulator of claim 1, wherein the restriction of fluid flow is a maximum when a distal end of the restrictor body engages the valve seat.

9. The flow regulator of claim 1, wherein the slidable restrictor body is operable to slide proximally in response to fluid flow in the proximal direction during deflation of the balloon without increasing restriction of the proximal fluid flow.

10. The flow regulator of claim 1, wherein the valve body and slidable restrictor body have a cylindrical cross section.

11. The flow regulator of claim 1, wherein the valve body and slidable restrictor body have a square or rectangular cross section.

12. A flow regulator for regulating flow of an inflation fluid to a balloon catheter, comprising:

a valve body enclosing a control chamber comprising a passageway for fluid flow;

a distal end of the valve body with a distal flow orifice for connection with the balloon catheter,

a proximal end of the valve body with a proximal flow orifice for connection with a catheter in fluid communication an inflation device,

a flexible restrictor membrane positioned within the control chamber comprising an opening which allows fluid to flow distally or proximally through the membrane;

a valve seat positioned within the control chamber distal to the membrane comprising an opening for fluid to flow distally and proximally;

wherein the membrane is operable to flex distally in response to fluid flow in the distal direction toward the valve seat during inflation of the balloon, wherein as the membrane flexes toward the valve seat restriction to fluid flow increases which controls the pressurization rate of the balloon to within a specified range.

13. The flow regulator of claim 12, wherein the membrane and valve seat are positioned so that as the membrane flexes toward the valve seat, restriction of flow around the valve seat increases.

14. The flow regulator of claim 12, wherein when the valve seat comprises a plate fixed within a path of the fluid flow.

15. The flow regulator of claim 12, wherein the flexing membrane is operable to engage the valve seat resulting in a maximum restriction of fluid flow.

16. The flow regulator of claim 12, wherein the membrane is operable to flex proximally in response to fluid flow in the proximal direction during deflation of the balloon without an increase in restriction of the proximal fluid flow.

17. A flow regulator for regulating flow of an inflation fluid to a balloon catheter, comprising:

a valve body enclosing a control chamber comprising a passageway for fluid flow;

a distal end of the valve body with a distal flow orifice for connection with the balloon catheter,

a proximal end of the valve body with a proximal flow orifice for connection with a catheter in fluid communication an inflation device,

a slidable restrictor body positioned within the control chamber to allow fluid flow distally or proximally through the restrictor body; and

a valve seat extending proximally from a distal end of the valve body, wherein the valve seat comprises a valve seat orifice at its distal end which allows fluid to flow out of the distal flow orifice,

wherein the slidable restrictor body is operable to slide distally in response to fluid flow in the distal direction during inflation of the balloon, wherein as a proximal end of the restrictor body approaches the valve seat orifice, the proximal end of the restrictor body and the valve seat cooperates to increase restriction to fluid flow which controls the pressurization rate of the balloon to within a specified range.

18. The flow regulator of claim 17, wherein the restrictor body comprises a conduit positioned within the control chamber to allow fluid flow along its axis, wherein a distal end of the conduit comprises a piston with an opening to allow fluid flow distally or proximally and a distal end of the conduit is open to allow flow distally or proximally through the restrictor body.

19. The flow regulator of claim 18, wherein the piston restricts the fluid flow and the opening is positioned with respect to the valve seat orifice to allow some fluid flow when the wall engages the distal end of the valve seat.

20. The flow regulator of claim 19, further comprising a spring within the conduit that applies a biasing force that opposes the distal sliding of the conduit.

21. The flow regulator of claim 17, wherein the slidable restrictor body is operable to slide proximally in response to fluid flow in the proximal direction during deflation of the balloon without increasing restriction of the proximal fluid flow.