SYSTEM AND METHOD FOR ADVANCING, ORIENTING, AND IMMOBILIZING ON INTERNAL BODY TISSUE A CATHETER OR OTHER THERAPEUTIC DEVICE

• US 20070249999A1
• Filed: 03/30/2007
• Published: 10/25/2007
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Electrophysiology Frontiers S.P.A.
• Original Assignee: Automated Medical Instruments, Inc.
• Inventors: Ring, Howard, Sklar, Martin
• Granted Patent: US 8,535,304 B2
• Time in Patent Office: Days
• US Class Current: 604/101.50
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 34/72 Micromanipulators
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

This invention provides a system and method that allows a therapeutic device, such as an atrial fibrillation microwave ablation catheter or ablation tip to be guided to a remote location within a body cavity and then accurately immobilized on the tissue, including that of a moving organ, such as the heart. In various embodiments, the system and method also enables accurate movement and steering along the tissue, while in engagement therewith. Such movement and engagement entails the use of vacuum or microneedle structures on at least two interconnected and articulated immobilizers that selectively engage to and release from the tissue to allow a crawling or traversing walking across the organ as the therapeutic catheter/tool tip applies treatment (AGE devices). In further embodiments that lack a movement capability (AID devices), the immobilizers allow a predetermined position for the introduced device to be maintained against the tissue while a treatment is applied to the location adjacent thereto. In the exemplary AID devices, variety of steering mechanisms and mechanisms for exposing and anchoring a catheter against the underlying tissue can be employed. In the exemplary AGE devices, a variety of articulation and steering mechanisms, including those based upon pneumatic/hydraulic bellows, lead screws and electromagnetic actuators can be employed.

Claims

1. A system for minimally invasive surgery using a therapeutic catheter comprising:

a proximal immobilizer;

a distal immobilizer;

an actuation mechanism that allows the proximal immobilizer and the distal immobilizer to move axially with respect to each other;

a steering mechanism that allows a pointing direction of the distal immobilizer to be changed; and

a proximal immobilizer lumen passing through the proximal immobilizer and a distal immobilizer lumen passing through at least a proximal portion of the distal immobilizer, constructed an arranged to allow the catheter to pass therethrough, the catheter being slidably arranged with respect to one of the proximal immobilizer lumen and the distal immobilizer lumen being held stationary to one of the distal immobilizer lumen and the proximal immobilizer lumen, respectively.

2. The system as set forth in claim 1 wherein the catheter comprises a microwave ablation catheter that extends proximally out of the proximal immobilizer.

3. The system as set forth in claim 1 wherein the actuation mechanism comprises a pressure and vacuum-driven bellows assembly located between the proximal immobilizer and the distal immobilizer.

4. The system as set forth in claim 3 wherein the bellows assembly surrounds the catheter.

5. The system as set forth in claim 4 wherein the bellows assembly comprises a plurality of discrete bellows, each in communication with a pressure lumen positioned at predetermined locations with respect to a perimeter of each of the proximal immobilizer and the distal immobilizer.

6. The system as set forth in claim 5 wherein the steering assembly is constructed and arranged to variably apply pressure or vacuum to each of the plurality of bellows to cause the distal immobilizer to steer with respect to the proximal immobilizer.

7. The system as set forth in claim 1 wherein one of the proximal immobilizer lumen and the distal immobilizer lumen includes an inflatable balloon constructed and arranged to selectively inflate to bias the catheter against a lumen wall so as to frictionally restrict axial movement of the catheter with respect to the one of the proximal immobilizer and the distal immobilizer.

8. The system as set forth in claim 1 wherein one of the proximal immobilizer lumen and the distal immobilizer lumen includes a mechanically deployable contact surface constructed and arranged to selectively bias the catheter against a lumen wall so as to frictionally restrict axial movement of the catheter with respect to the one of the proximal immobilizer and the distal immobilizer.

9. The system as set forth in claim 1 wherein the actuation mechanism includes a helical drive screw that rotates in each of a first rotational direction and a second opposing rotational direction to move the proximal immobilizer and the distal immobilizer away from each other and toward each other, respectively.

10. The system as set forth in claim 9 wherein the helical drive screw is flexible to allow steering of the distal immobilizer with respect to the proximal immobilizer.

11. The system as set forth in claim 9 wherein the helical drive screw is substantially rigid and includes a flexible joint that allows steering of the distal immobilizer with respect to the proximal immobilizer in a region of the flexible joint.

12. The system as set forth in claim 9 wherein the helical drive screw is substantially rigid so that each of the proximal immobilizer and the distal immobilizer are maintained in a substantially axial alignment therebetween, the proximal immobilizer including a selectively tissue-engageable, pivoting hold-down assembly and the steering mechanism being constructed and arranged to cause the proximal immobilizer to steer about the pivoting hold-down mechanism.

13. The system as set forth in claim 12 wherein the pivoting hold-down mechanism comprises a suction cup in communication with a vacuum source.

14. The system as set forth in claim 1 wherein the actuation mechanism includes a plurality of electromagnet assemblies arranged axially between the proximal immobilizer and the distal immobilizer, wherein adjacent of the assemblies are aligned with each other, each of the assemblies including a plurality of electromagnets disposed about a respective perimeter thereof, the electromagnets in each of adjacent assemblies opposing each other when energized so as to cause the adjacent assemblies to move selectively toward and away from each other.

15. The system as set forth in claim 14 wherein opposing electromagnets are constructed and arranged to be individually energized so as to cause steering between the adjacent assemblies.

16. The system as set forth in claim 1 wherein at least one of the proximal immobilizer and the distal immobilizer includes a tissue-engaging immobilizer base that selectively applies a vacuum suction to immobilize the immobilizer with respect to an underlying tissue surface.

17. The system as set forth in claim 16 wherein the immobilizer base includes a vacuum port disposed within a suction cup, the top of the suction cup including projections around the vacuum port to create a gap for transmitting vacuum thereby with respect to tissue drawn toward the vacuum port.

18. The system as set forth in claim 1 wherein at least one of the proximal immobilizer and the distal immobilizer includes a tissue-engaging immobilizer base that selectively applies a plurality of needle projections into an underlying tissue surface to thereby adhere the immobilizer base to the tissue surface.

19. The system as set forth in claim 18 wherein the needle projections are each arranged on a plurality of independently movable bases that are each biased by pressure to a predetermined, variable distance of extension below a base plane of the immobilizer base and into engagement with the tissue surface.

21. The system as set forth in claim 19 wherein the surgical too comprises one of a deployable fluid-injecting needle, in communication with a fluid delivery lumen, a biopsy blade that deploys into a vacuum chamber that draws tissue thereinto for cutting, and a dissection blade that extends into underlying tissue.

24. The system as set forth in claim 19 wherein the surgical tool comprises a plurality of conductive microspikes on a base that are selectively deployed into the tissue and that are interconnected with an electrical conduit adapted to communicate with a remote system.

20. A system for minimally invasive surgery comprising:

a proximal immobilizer;

a distal immobilizer;

an actuation mechanism that allows the proximal immobilizer and the distal immobilizer to move axially with respect to each other;

a steering mechanism that allows a pointing direction of the distal immobilizer to be changed; and

a deployable surgical tool that moves from an enclosed location upon actuation by a remote control system to a deployed location to perform a surgical procedure on internal tissue.

22. The system as set forth in claim 20 wherein the surgical tool comprises a plurality of microneedles on a base that are selectively deployed into the tissue and that are interconnected with a fluid source adapted to deliver fluid to the tissue.

23. The system as set forth in claim 22 wherein the source is interconnected to the base via a tube.

25. A system for treating atrial fibrillation using a microwave ablation catheter comprising:

a flexible, elongated structure defining a top, a base, and a lumen located above the base that receives the ablation catheter therein;

an immobilization structure defined in the base that selectively applies a hold-down force to an underlying tissue; and

a central base portion facing the lumen constructed and arranged to be slid proximally so as to expose the lumen to the underlying tissue.

26. The system as set forth in claim 25 further comprising a plurality of steering wires that are anchored within the top at locations about a perimeter of the top and a steering wire anchored in the central base portion.

27. The system as set forth in claim 25 further comprising an inflatable balloon in communication with a pressure source located on a top portion of the lumen constructed and arranged to bias the catheter toward the underlying tissue when the pressure source inflates the balloon.

28. The system as set forth in claim 25 herein the base includes a plurality of vacuum ports on opposing sides of the central base portion disposed along a length thereof, each of the ports being interconnected with a lumen that transmits a vacuum from a vacuum source.

29. The system as set forth in claim 25 wherein the flexible, elongated stricture comprises a plurality of immobilization segments that are spaced at length intervals and interconnected by a vacuum tube in communication with immobilizing vacuum ports on the base with respect to each of the segments.

30. A system for minimally invasive surgery using a therapeutic catheter comprising:

a proximal immobilizer;

a distal immobilizer;

an actuation mechanism that allows the proximal immobilizer and the distal immobilizer to move axially with respect to each other;

wherein the actuation mechanism comprises an electromagnetic actuator that is selectively energized with a predetermined polarity to move the proximal immobilizer toward and away from the distal immobilizer.

31. The system as set forth in claim 30 further comprising a steering mechanism located between the proximal immobilizer and the distal immobilizer, the steering mechanism being constructed and arranged to direct the distal immobilizer in a steering direction with respect to the proximal immobilizer, and wherein the actuation mechanism comprises a coil assembly and a magnetic shaft that slidably moves with respect to the coil assembly, and wherein the actuation mechanism includes a flexible joint.

32. The system as set forth in claim 30 wherein the actuation assembly includes plurality of electromagnet assemblies arranged axially between the proximal immobilizer and the distal immobilizer, and wherein adjacent of the assemblies are aligned with each other, each of the assemblies including a plurality of electromagnets disposed about a respective perimeter thereof, the electromagnets in each of adjacent assemblies opposing each other when energized so as to cause the adjacent assemblies to move selectively toward and away from each other.

33. The system as set forth in claim 32 wherein opposing electromagnets are constructed and arranged to be individually energized so as to cause steering between the adjacent assemblies.

34. A method for performing a minimally invasive procedure for treating atrial fibrillation comprising the steps of:

inserting a microwave catheter to a location adjacent to a heart, the catheter being supported by a structure having a proximal immobilizer and a distal immobilizer;

traversing a surface of the heart by alternately removably securing the proximal immobilizer and the distal immobilizer to the surface while the proximal immobilizer and the distal immobilizer move toward and away from each other with the catheter slidably mounted with respect to one of the proximal immobilizer and the distal immobilizer and fixedly mounted with respect to one of the distal immobilizer and the proximal immobilizer, respectively;

steering the distal immobilizer to point the distal immobilizer in a predetermined direction while traversing the surface; and

applying ablation energy from the microwave catheter at predetermined intervals as the catheter traverses the surface.