DIASTOLIC CORONARY STENT DEPLOYMENT SYSTEM FOR PRECISE BIFURCATION LESION STENTING

• US 20140094893A1
• Filed: 03/28/2013
• Published: 04/03/2014
• Est. Priority Date: 03/30/2012
• Status: Active Grant

• Current Assignee: Elliot M. Gerber
• Original Assignee: Elliot M. Gerber
• Inventors: Gerber, Elliot M.
• Granted Patent: US 9,999,530 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

A system is provided for precise stent deployment in synchronization with the cardiac cycle. The system comprises a cable set having a first connector for connection to a source of a signal that is indicative of the status of the cardiac cycle, and a second connector for connection to a processor. A processor is provided for converting cardiac cycle data into a control signal for controlling inflation of a balloon catheter such that the balloon catheter reaches inflation at a point within the range of from about 55% to about 85% into the R-R interval. An inflation pump is provided, for inflating a balloon responsive to the control signal. A third connector is provided in communication with the inflation pump, for releasable connection to a balloon catheter. The system may also comprise a balloon catheter, in communication with the inflation pump via the third connector.

Claims

1. A method of precise stent deployment in synchronization with the cardiac cycle, comprising the steps of:

obtaining a transduced intracoronary arterial pressure curve;

determining balloon inflation characteristics that will cause a balloon to reach an inflation endpoint at a predetermined point during diastole; and

initiating balloon inflation in accordance with the determined inflation characteristics such that the balloon reaches inflation at the predetermined inflation endpoint;

wherein the predetermined endpoint is at a vascular bifurcation with a positional accuracy of within about +/−

1 mm.

2. A method of precise stent deployment as in claim 1, wherein the transduced intracoronary arterial pressure curve is obtained from a guiding catheter placed in an ostium of a coronary artery undergoing treatment.

3. A method of precise stent deployment as in claim 1, wherein the predetermined point is within the range of from about 55% to about 85% into the R-R interval.

4. A method of precise stent deployment as in claim 3, wherein the predetermined point is within the range of from about 65% to about 75% into the R-R interval.

5. A method of precise stent deployment in synchronization with the cardiac cycle, comprising the steps of:

providing a system having a processor for generating a control signal for controlling inflation of a balloon catheter in response to a transduced intracoronary arterial pressure curve such that inflation is reached at a predetermined point during diastole;

connecting the processor to a source of cardiac cycle data;

connecting a balloon catheter to the system; and

deploying a stent from the balloon in response to the control signal, to a site adjacent a vascular bifurcation with a positional accuracy of within about +/−

1 mm.

6. A method of precise stent deployment as in claim 5, wherein the site is a Left Main ostial lesion.

7. A method of precise stent deployment as in claim 5, wherein the site is a Right Coronary ostial lesion.

8. A system for precise stent deployment in synchronization with the cardiac cycle, comprising:

a cable set having a first connector for connection to a source of a signal that is indicative of the status of the cardiac cycle, and a second connector for connection to a processor;

a processor for converting cardiac cycle data into a control signal for controlling inflation of a balloon catheter such that the balloon catheter reaches inflation at a point within the range of from about 55% to about 85% into the R-R interval;

an inflation pump, for inflating a balloon responsive to the control signal; and

a third connector in communication with the inflation pump, for releasable connection to a balloon catheter.

9. A system as in claim 8, wherein the source of a signal that is indicative of the status of the cardiac cycle comprises a source of a surface EKG signal.

10. A system as in claim 8, wherein the source of a signal that is indicative of the status of the cardiac cycle comprises a source of arterial pressure waveform data.

11. A system as in claim 8, further comprising a balloon catheter, in communication with the inflation pump via the third connector.