IN-SITU GRAFT FENESTRATION

• US 20090228020A1
• Filed: 03/06/2009
• Published: 09/10/2009
• Est. Priority Date: 03/06/2008
• Status: Abandoned Application

• Current Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Stahler, Gregory J., Wallace, Daniel T.
• Application Number:
  US12/399,912
• Publication Number:
  US 20090228020A1
• Time in Patent Office: Days
• US Class Current: 606/130
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/508 with releasable brake mechanisms
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/37 Master-slave robots A61B34/35 takes precedence
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 : with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 : Y-shaped blood vessels
• 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 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Assemblies, systems, and methods related to in-situ graft fenestration are described. Subsequent to placement of a graft or stent graft into a lumen, such as a blood vessel, a steerable catheter platform is utilized to create fenestrations, or holes, into the material comprising the graft to facilitate flow of fluids, such as blood, out of the holes and into other structures, such as side branch vessels. The catheter platform preferably comprises one or more fenestration elements located distally and configured to controllably create the fenestrations through common graft materials, such as Dacron®. The catheter also may be utilized to size and/or locate side branching structures, confirm fenestration sizes and/or locations, and deploy additional grafts through the fenestrations into other branching structures.

Claims

1. A robotic system for deploying a medical lumen graft, comprising:

A. a remotely steerable flexible instrument having proximal and distal ends and a graft fenestration element coupled to its distal end, the graft fenestration element configured to controllably create a fenestration through a wall of a deployed graft;

B. a controller in communication with a master input device; and

C. an instrument driver operatively coupled to the controller and the proximal end of the flexible instrument, the instrument driver configured to cause controlled steering movement of the flexible instrument in accordance with input signals received by the controller from the master input device.

2. The system of claim 1, wherein the graft fenestration element comprises a resistive element configured to heat to a cutting temperature upon application of a current to said resistive element.

3. The system of claim 2, wherein the resistive element comprises a wire loop.

4. The system of claim 3, wherein the wire loop comprises nichrome material.

5. The system of claim 1, wherein the graft fenestration element comprises a non-resistive discrete heat source.

6. The system of claim 5, wherein the non-resistive discrete heat source dissipates energy from a laser light source or an ultrasound transducer source.

7. The system of claim 1, wherein the graft fenestration element comprises a mechanical fenestration tip.

8. The system of claim 7, wherein the mechanical fenestration tip comprises a corkscrew tip or a mechanical dilation tip.

9. The system of claim 1, wherein the flexible instrument defines a lumen along the length of the flexible instrument.

10. The system of claim 9, further comprising a vacuum element coupled to the flexible instrument and configured to controllably provide vacuum through the lumen to assist in engagement of the flexible instrument with other nearby structures.

11. The system of claim 9, wherein the lumen is configured to facilitate controllable passage of a branch lumen graft through said lumen.

12. The system of claim 1, further comprising an elongate sheath instrument having a base, distal end portion, and a lumen through which the instrument is coaxially disposed, the instrument driver further comprising a sheath instrument interface operatively coupled to the sheath instrument base.

13. The system of claim 11, wherein the elongate sheath instrument comprises a controllably lockable spine.

14. The system of claim 9, wherein the lumen is a working lumen configured to accommodate elongate instruments inserted therethrough.

15. The system of claim 14, further comprising a force sensing apparatus coupled to the instrument driver and configured to sense forces applied distally to instruments inserted through the working lumen.

16. The system of claim 1, further comprising a localization sensor coupled to the flexible instrument, the localization sensor configured to determine the spatial position of at least a portion of the flexible instrument.

17. The system of claim 16, wherein the localization sensor is selected from the group consisting of an electromagnetic localization sensor, a potential difference localization sensor, and a fiber-bragg localization sensor.

18. The system of claim 1, further comprising an ultrasound transducer coupled to the distal end portion of the flexible instrument, the ultrasound transducer having a field of view configured to be able to capture reflected sound information pertinent to a side branch vessel location and geometry.

19. A method for deploying a lumen graft, comprising:

a. deploying a parent lumen graft in a parent lumen;

b. determining one or more locations to create fenestrations in the deployed parent lumen graft by utilizing a electromechanically-controlled catheter system configured to determine position information pertinent a distal tip of a steerable catheter comprising the catheter system; and

c. creating one or more fenestrations in the parent lumen graft by utilizing a fenestration element coupled to the distal tip of the steerable catheter.

20. The method of claim 19, wherein determining locations comprises utilizing a kinematic relationship established for the steerable catheter to determine a position of the distal tip of said steerable catheter.

21. The method of claim 19, wherein determining locations comprises utilizing a localization system selected from the group consisting of an electromagnetic localization sensing system, a potential difference localization sensing system, and a fiber-bragg localization sensing system.

22. The method of claim 19, wherein the fenestration element comprises a resistive heating element, and wherein creating fenestrations comprises controllably providing electrical current to said resistive heating element.

23. The method of claim 19, wherein the fenestration element comprises a non-resistive discrete heat source selected from the group consisting of a laser light source or an ultrasound transducer source, and wherein creating fenestrations comprises controllably providing electrical current to said source.

24. The method of claim 19, wherein the fenestration element comprises a mechanical fenestration tip selected from the group consisting of a corkscrew tip and a mechanical dilation tip, and wherein creating fenestrations comprises advancing such tip through a wall of the lumen graft.

25. The method of claim 19, further comprising applying vacuum through a lumen defined through the steerable catheter to encourage coupling of said catheter to other nearby structures.

26. The method of claim 19, further comprising confirming the location or size of the one or more fenestrations.

27. The method of claim 26, wherein confirming comprises utilizing a kinematic relationship established for the steerable catheter to determine a position of the distal tip of said steerable catheter when positioned adjacent the one or more fenestrations.

28. The method of claim 26, wherein confirming comprises utilizing a localization sensor disposed at least in part at the distal tip of the steerable catheter, the localization sensor selected from the group consisting of an electromagnetic localization sensor, a potential difference localization sensor, and a fiber-bragg localization sensor.

29. The method of claim 26, wherein confirming comprises utilizing an ultrasound transducer coupled to the distal portion of the steerable catheter to capture an image of the one or more fenestrations.

30. The method of claim 26, wherein confirming comprises utilizing a contrast agent disbursal adjacent the location of the one or more fenestrations, along with fluoroscoping imaging, to locate and size the one or more fenestrations.

31. The method of claim 26, wherein confirming comprises utilizing a force sensor to locate and size the or more fenestrations.

32. The method of claim 19, further comprising deploying a child lumen graft through one of the one or more fenestrations utilizing the steerable catheter.

33. The method of claim 32, further comprising utilizing an inflatable balloon element to mechanically seat the child lumen graft relative to the parent lumen graft.

34. The method of claim 19, further comprising confirming the location or size of the one or more child lumens intersecting with the parent lumen.

35. The method of claim 34, wherein confirming comprises utilizing a kinematic relationship established for the steerable catheter to determine a position of the distal tip of said steerable catheter when positioned adjacent the one or more fenestrations.

36. The method of claim 34, wherein confirming comprises utilizing a localization sensor disposed at least in part at the distal tip of the steerable catheter, the localization sensor selected from the group consisting of an electromagnetic localization sensor, a potential difference localization sensor, and a fiber-bragg localization sensor.

37. The method of claim 34, wherein confirming comprises utilizing an ultrasound transducer coupled to the distal portion of the steerable catheter to capture an image of the one or more fenestrations.

38. The method of claim 34, wherein confirming comprises utilizing a contrast agent disbursal adjacent the location of the one or more fenestrations, along with fluoroscoping imaging, to locate and size the one or more fenestrations.

39. The method of claim 34, wherein confirming comprises utilizing a force sensor to locate and size the or more fenestrations.