Apparatus and methods for placing leads using direct visualization

• US 10,368,910 B2
• Filed: 06/07/2016
• Issued: 08/06/2019
• Est. Priority Date: 05/30/2002
• Status: Expired due to Term

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Inventors: Eversull, Christian S., Leeflang, Stephen A., Mourlas, Nicholas J.
• Primary Examiner(s): Kasztejna, Matthew J
• Application Number:
  US15/175,601
• Publication Number:
  US 20160287287A1
• Time in Patent Office: 1,155 Days
• Field of Search: 600104, 600114-115, 600117-118, 600153-156
• CPC Class Codes: A61B 1/00073 with externally grooved shaft
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/051 Details of CCD assembly
• CPC Class Codes: A61B 1/053 being detachable
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 : Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 : Anchoring means

Abstract

A system for delivering a lead comprises an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon. The outer balloon is concentric with the inner balloon. The expandable distal end includes a channel defined between the inner balloon and the outer balloon. The imaging device further comprises a lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end. The system further comprises an elongate rail comprising a proximal end and a distal end positionable through the lumen of the imaging device and the channel. The elongate rail comprises a fixation element on the distal end. The system also comprises a lead comprising a proximal end, a distal end introduced through the lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

Claims

1. A system for delivering a lead into a body cavity of a patient, comprising:

an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon, the outer balloon being concentric with the inner balloon, the expandable distal end including a channel defined between the inner balloon and the outer balloon, the imaging device further comprising at least one lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end while the distal end is in a fully expanded configuration and manipulated relative to a tissue wall;

an elongate rail comprising a proximal end and a distal end positionable through the at least one lumen of the imaging device and the channel, the elongate rail comprising a fixation element on the distal end for securing the distal end to a delivery location on the tissue wall; and

a lead comprising a proximal end, a distal end arranged for introduction through the at least one lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

2. The system of claim 1, wherein the expandable distal end includes a transparent membrane through which the imaging assembly captures images of the tissue wall.

3. The system of claim 1, wherein the elongate rail comprises a guidewire.

4. The system of claim 1, wherein the lead is configured to advance over the elongate rail.

5. The system of claim 1, wherein the fixation element comprises at least one of a helical screw, an adhesive, a hook, a pincher, and a barb.

6. The system of claim 1, wherein the imaging device is removable after the distal end of the elongate rail is secured to the delivery location.

7. The system of claim 1, wherein the imaging device is removable before the lead is introduced through the at least one lumen.

8. The system of claim 7, wherein the elongate rail comprises a tubular member sized to advance over the imaging device.

9. The system of claim 8, wherein the lead is sized to advance through the tubular member to the delivery location.

10. The system of claim 1, wherein the imaging device further includes a steering element coupled to the expandable distal end to steer the expandable distal end in at least one degree of freedom.

11. The system of claim 1 wherein the imaging assembly includes an optical image element.

12. The system of claim 11 wherein the optical image element includes an optical fiber bundle extending between the proximal and distal ends of the imaging device.

13. The system of claim 11 wherein the optical image element includes a CMOS sensor disposed at the distal end of the imaging device.

14. The system of claim 11 wherein the optical image element includes a CCD sensor disposed at the distal end of the imaging device.

15. The system of claim 11 wherein the imaging device includes a light source.

16. The system of claim 1 wherein the expandable distal end includes an inflatable member.

17. The system of claim 1 wherein the expandable distal end includes a radially expandable frame.