Device and method for needle-less interstitial injection of fluid for ablation of cardiac tissue

• US 7,118,566 B2
• Filed: 02/03/2003
• Issued: 10/10/2006
• Est. Priority Date: 05/16/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jahns, Scott E.
• Primary Examiner(s): Gibson, Roy D.
• Assistant Examiner(s): Roane, Aaron
• Application Number:
  US10/356,909
• Publication Number:
  US 20030216724A1
• Time in Patent Office: 1,345 Days
• Field of Search: 606 41- 52, 607/96, 607/98
• US Class Current: 606/41
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00809 measured thermochromatically
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes

Abstract

Methods and apparatus for delivering precise amounts of fluid under pressure into cardiac tissue for the purpose of facilitating ablation of the tissue along a desired lesion line. One method injects fluid under pressure through a discharge orifice in a needle-less injection device. The injected fluid can be a cytotoxic fluid and/or a highly conductive fluid injected in conjunction with radio frequency ablation to create an ablative virtual electrode. The injected fluid can provide deeper and narrower conduction paths and resulting lesions. Radio frequency ablation can be performed at the same time as the fluid injection, using the injection device as an electrode, or subsequent to the fluid injection, using a separate device. In some methods, the injected fluid is a protective fluid, injected to protect tissue adjacent to the desired lesion line. Fluid delivery can be endocardial, epicardial, and epicardial on a beating heart. The present methods find one use in performing maze procedures to treat atrial fibrillation.

Claims

1. A needle-less tissue ablative injector device for injecting a fluid into cardiac tissue, the device comprising:

a housing having a lumen within for containing the fluid;

a distal surface operably coupled to the housing for contacting cardiac tissue;

at least one discharge orifice disposed near the distal surface and in fluid communication with the fluid lumen;

a pressure applicator in communication with the fluid lumen for imparting sufficient pressure to the fluid lumen to inject the fluid into myocardium from an epicardial surface;

a pressure applicator switch operably coupled to the pressure applicator for controllably imparting pressure from the pressure applicator to the fluid lumen when the pressure applicator switch is activated;

a first electrode disposed to contact at least one of the tissue and the fluid lumen;

an electrical connector in electrical continuity with the first electrode for providing ablative electrical energy to the cardiac tissue;

an electrical switch operably coupled to the electrical connector for controllably providing the ablative electrical energy to the cardiac tissue when the electrical switch is activated; and

a switch member operably configured to first activate the pressure applicator switch to cause fluid to be injected into the myocardium and subsequently to activate the electrical switch to cause ablative electrical energy to be provided to the cardiac tissue having the injected fluid within, wherein depressing a portion of the switch member to a first position activates the pressure applicator switch and further depressing the same portion of the switch member to a more depressed second position activates the electrical switch.

2. A needle-less tissue ablative injector device as in claim 1, further comprising a radio-frequency current source electrically coupled to the electrical connector.

3. A needle-less tissue ablative injector device as in claim 1, further comprising a fluid supply connector coupled to the fluid lumen.

4. A needle-less tissue ablative injector device as in claim 1, wherein the pressure applicator includes a reciprocating piston, wherein the reciprocating piston is disposed within the fluid lumen.

5. A needle-less tissue ablative injector device as in claim 4, further comprising a spring urging the piston to travel distally.

6. A needle-less tissue ablative injector device as in claim 4, further comprising a gas pressure source urging the piston to travel distally.

7. A needle-less tissue ablative injector device as in claim 1, further comprising a distal tip coupled to the device distal region, wherein the at least one discharge orifice numbers at least two and the orifices are disposed in the tip, wherein the tip includes a tip fluid lumen in fluid communication with the device fluid lumen and the tip discharge orifices, wherein the distal surface is located on the distal tip, such that fluid can be injected through at least two discharge orifices simultaneously.

8. A needle-less tissue ablative injector device as in claim 7, wherein the distal tip is removable from remaining portions of the injector device.

9. A needle-less tissue ablative injector device as in claim 1, wherein the device further comprises a second electrode electrically isolated from the first electrode to form a bi-polar tissue ablating device.

10. A needle-less tissue ablative injector device as in claim 1, wherein the fluid is capable of being delivered to the myocardium in a predetermined, metered amount.

11. A needle-less tissue ablative injector device as in claim 1, wherein the device is adapted to be used epicardially on a beating heart.

12. A needle-less tissue ablative injector device as in claim 1, wherein the device is capable of injecting fluid into at least half the thickness of the myocardium.

13. A needle-less tissue ablative injector device as in claim 1, wherein the fluid is a conductive fluid.

14. A needle-less tissue ablative injector device as in claim 1, wherein the switch member is a two-position switch member.

15. A needle-less tissue ablative injector device as in claim 14, wherein the two-position switch member is a two-position trigger.

16. An ablation device for ablating cardiac tissue, the device comprising:

a housing having a lumen within for containing a conductive fluid;

a distal surface operably coupled to the housing for contacting tissue to be ablated;

a discharge orifice disposed near the distal surface and in fluid communication with the fluid lumen;

a pressure applicator operably coupled to the fluid lumen for applying sufficient pressure to the conductive fluid to inject the conductive fluid into tissue;

a pressure applicator switch operably coupled to the pressure applicator for controllably applying pressure from the pressure applicator to the conductive fluid when the pressure applicator switch is activated;

a first electrode disposed to contact at least one of the tissue and the fluid lumen;

a radio-frequency current source operably coupled to the first electrode for providing ablative electrical energy to the cardiac tissue; and

an electrical switch operably coupled to the electrical connector for controllably providing the ablative electrical energy to the cardiac tissue when the electrical switch is activated, wherein the electrical switch is operably coupled to the pressure applicator switch to cause ablative electrical energy to be provided to the cardiac tissue following the injection of conductive fluid into tissue; and

a switch member operably coupled to the pressure applicator switch and the electrical switch, wherein depressing a portion of the switch member to a first position activates the pressure applicator switch and further depressing the same portion of the switch member to a more depressed second position activates the electrical switch.