ENDOVENTRICULAR INJECTION CATHETER SYSTEM WITH INTEGRATED ECHOCARDIOGRAPHIC CAPABILITIES

• US 20110021911A1
• Filed: 07/16/2010
• Published: 01/27/2011
• Est. Priority Date: 07/23/2009
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: Silicon Valley Medical Instruments, Inc.
• Inventors: Waters, Kendall R., Zelenka, Robert, Moore, Thomas C., Zalesky, Paul
• Granted Patent: US 8,876,722 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An endoventricular injection catheter with integrated echocardiographic capability enables injections into heart tissue under visualization. The catheter includes an elongated body having a distal end and an imaging core arranged to be inserted into a heart. The imaging core is arranged to transmit ultrasonic energy and to receive reflected ultrasonic energy at the distal end to provide electrical signals representing echocardiographic images to enable cardiac visualization. The catheter further includes an injector carried on the elongated body with the imaging core. The injector is arranged to inject a therapeutic agent into tissue of the heart visualized by the imaging core.

Claims

1. An endoventricular injection catheter with integrated echocardiographic capability, comprising:

an elongated body having a distal end and an imaging core arranged to be inserted into a heart, the imaging core being arranged to transmit ultrasonic energy and to receive reflected ultrasonic energy at the distal end to provide electrical signals representing echocardiographic images to enable cardiac visualization; and

an injector carried on the elongated body with the imaging core, the injector being arranged to inject a therapeutic agent into tissue of the heart visualized by the imaging core.

2. The catheter of claim 1, wherein the elongated body includes a telescoping section to permit longitudinal positioning of the imaging core.

3. The catheter of claim 1, wherein the imaging core is a mechanically rotating imaging core.

4. The catheter of claim 1, further comprising a deflection system that causes the elongated body distal end to deflect in a desired direction.

5. The catheter of claim 4, wherein the deflection system includes a steerable guide sheath.

6. The catheter of claim 4, wherein the deflection system includes a deflection section sheath, a steering ring, at least one steering wire, and a deflection control knob.

7. The catheter of claim 1, wherein the elongated body includes a guide wire lumen for receiving a guide wire.

8. The catheter of claim 7, wherein the guide wire lumen is at the distal end of the elongated body of the catheter.

9. The catheter of claim 7, wherein the guide wire lumen extends along the elongated body of the catheter proximal to the distal end.

10. The catheter of claim 1, wherein the elongated body includes an imaging core lumen and an outer circumferential surface, and wherein the imaging core lumen and the outer surface define a substantially uniform wall thickness of the elongated body over a portion of the elongated body circumference.

11. The catheter of claim 1, wherein the imaging core comprises a plurality of transducers.

12. The catheter of claim 1, further comprising a cannula lumen and wherein the injector includes a cannula received by the cannula lumen and an injection needle within the cannula.

13. The catheter of claim 12, wherein the cannula is formed of a super-elastic material.

14. The catheter of claim 12, further comprising an injection system including the injector, the injection system including a proximal handle, the injection handle including injection controls for extending the cannula, advancing the injection needle, limiting advancement of the injection needle beyond the cannula, and torquing the cannula.

15. The catheter of claim 12, wherein the injection needle includes an end stop that limits advancement of the injection needle within the cannula.

16. The catheter of claim 12, further comprising an injection system including the injector, the injection system further including a reservoir within the cannula and a plunger that forces therapeutic agent into the needle.

17. The catheter of claim 12 wherein the injector comprises a pair of injection needles.

18. The catheter of claim 17 wherein the injector further comprises a fiber optic bundle and an ultraviolet light source for photocrosslinking an injected bioabsorbable polymer solution.

19. A method of providing image-guided transendocardial injection of a therapeutic agent into a left ventricular wall of a heart, comprising:

providing an endoventricular injection catheter having integrated echocardiographic capability, comprising an elongated body having a distal end and an imaging core arranged to be inserted into a heart, the imaging core being arranged to transmit ultrasonic energy and to receive reflected ultrasonic energy at the distal end to provide electrical signals representing echocardiographic images to enable cardiac visualization and an injector carried on the elongated body with the imaging core, the injector being arranged to inject a therapeutic agent into tissue of the heart visualized by the imaging core;

delivering the endoventricular injection catheter into the left ventricle of the heart;

visualizing the left ventricular wall of the heart using the imaging core;

identifying infarct regions of the left ventricle; and

injecting a therapeutic agent into the visualized infarcted regions of the left ventricle using the injector.

20. The method of claim 19, including the further step of injecting a bioabsorbable agent with the injector to prevent back flow of the therapeutic agent.