Devices, Systems, and Methods Using a Steerable Stylet and Flexible Needle

• US 20170095234A1
• Filed: 10/08/2015
• Published: 04/06/2017
• Est. Priority Date: 04/02/2014
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Inventors: Prisco, Giuseppe Maria, Simi, Massimiliano
• Granted Patent: US 10,779,803 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2061 using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• 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 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/35 for telesurgery
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms

Abstract

What is described is a minimally invasive system comprising an elongate instrument and a stylet slidably disposed within the lumen of the elongate instrument. The instrument includes a flexible proximal portion fixedly coupled to a rigid distal portion, and a lumen extending from a proximal end to a distal end through the flexible proximal portion and the rigid distal portion and defining a longitudinal axis of the instrument. The stylet includes a flexible body fixedly coupled to a steerable portion and a sensor element extending through the flexible body. The stylet is movable within the instrument between a retracted condition in which the steerable portion is retracted within the instrument and an extended configuration in which the steerable portion at least partially extends from the rigid distal portion of the instrument.

Claims

1. A minimally invasive system comprising:

an elongate instrument extending from a proximal end to a distal end and including;

a flexible proximal portion;

a rigid distal portion, the flexible proximal portion fixedly coupled to the rigid distal portion; and

a lumen extending from the proximal end to the distal end through the flexible proximal portion and the rigid distal portion and defining a longitudinal axis of the instrument; and

a stylet slidably disposed within the lumen of the elongate instrument, the stylet including a flexible body fixedly coupled to a steerable portion and a sensor element extending through the flexible body, the stylet being movable within the elongate instrument between a retracted condition in which the steerable portion is retracted within the elongate instrument and an extended configuration in which the steerable portion at least partially extends from the rigid distal portion of the elongate instrument.

2. The minimally invasive system of claim 1, wherein the sensor element is configured to measure the shape of at least a portion of the stylet.

3. The minimally invasive system of claim 1, wherein the sensor element is configured to measure the position of at least a portion of the stylet.

4. The minimally invasive system of claim 1, wherein the sensor element extends into the steerable portion of the stylet.

5. The minimally invasive system of claim 1, wherein the stylet includes an outer diameter that closely approximates an inner diameter of the elongate instrument such that the stylet blocks the lumen of the elongate instrument when the stylet is received within the lumen of the elongate instrument.

6. The minimally invasive system of claim 1, wherein the stylet includes a sensor conduit configured to maintain the axial position of the sensor element in substantially parallel alignment with a longitudinal axis of the elongate instrument.

7. The minimally invasive system of claim 1, further including a plurality of actuation cables extending through the flexible body of the stylet and terminating in the steerable portion of the stylet.

8. The minimally invasive system of claim 7, further including a plurality of actuation conduits within the flexible body of the stylet and a plurality of actuation channels within the steerable portion of the stylet, wherein each of the plurality of actuation cables extend through a discrete actuation conduit of the plurality of actuation conduits and anchor within a discrete actuation channel of the plurality of actuation channels.

9. The minimally invasive system of claim 8, wherein each actuation conduit comprises a flexible microcoil.

10. The minimally invasive system of claim 8, wherein each actuation conduit of the plurality of actuation conduits is positioned immediately adjacent a neighboring actuation conduit of the plurality of actuation conduits.

11. The minimally invasive system of claim 10, wherein the stylet includes a sensor conduit configured to maintain the axial position of the sensor element in substantially parallel alignment with a longitudinal axis of the elongate instrument, and the plurality of actuation conduits are arranged circumferentially around the sensor conduit.

12. The minimally invasive system of claim 7, wherein each of the plurality of actuation cables maintains its radial position relative to the longitudinal axis of the stylet as the actuation cable extends from the flexible body into the steerable portion.

13. The minimally invasive system of claim 7, wherein the steerable portion of the stylet comprises a bend-resistive section and a bendable section, the bendable section including a plurality of articulable sections linked by the actuation cables.

14. The minimally invasive system of claim 13, wherein the bendable section includes a plurality of joint pivots disposed between adjacent articulable segments.

15. The minimally invasive system of claim 14, wherein the bendable section includes a first joint pivot between a first articulable segment and a second articulable segment, and a second joint pivot between the second articulable segment and a third articulable segment.

16. The minimally invasive system of claim 15, wherein the first joint pivot allows the first articular segment to bend in a first plane relative to the second articulable segment, and the second joint pivot allow the second articulable segment to bend in a second plane relative to the third articulable segment, the first plane being different than the second plane.

17. The minimally invasive system of claim 1, wherein the rigid distal portion of the elongate instrument comprises a partially conical, non-beveled, and annular cutting tip.

18. A minimally invasive system comprising:

an actuator;

a needle including a lumen extending from a proximal end to a distal end and defining a longitudinal axis of the needle;

a stylet slidably disposed within the lumen of the needle, the stylet including a proximal flexible body, a distal steerable portion including a bend-resistive tip, and a sensor element extending through the flexible body, the stylet being movable within the needle between a retracted condition in which the steerable portion is retracted within the lumen of the needle and an extended configuration in which the steerable portion of the stylet at least partially extends from the distal end of the needle; and

a plurality of actuation cables extending from the actuator through the flexible body of the stylet and terminating in the steerable portion of the stylet.

19. The minimally invasive system of claim 18, wherein the sensor element is configured to measure the shape of at least a portion of the stylet.

20. The minimally invasive system of claim 18, wherein the sensor element is configured to measure the position of at least a portion of the stylet.

21. The minimally invasive system of claim 18, wherein the sensor element extends into the steerable portion of the stylet.

22. The minimally invasive system of claim 18, wherein the stylet includes an outer diameter that closely approximates an inner diameter of the lumen of the needle such that the sensor element is substantially aligned with the longitudinal axis of the needle when the stylet is received within the lumen of the needle.

23. The minimally invasive system of claim 18, further including a plurality of actuation conduits extending through the flexible body and a plurality of actuation channels extending through the steerable portion, wherein each of the plurality of actuation cables extend through one of the plurality of actuation conduits and anchor within one of the plurality of actuation channels.

24. The minimally invasive system of claim 23, wherein each actuation conduit of the plurality of actuation conduits comprises a flexible microcoil.

25. The minimally invasive system of claim 18, further including a plurality of actuation conduits extending through the flexible body and a plurality of actuation channels extending through the steerable portion, wherein each of the plurality of actuation cables extend through a one of the plurality of actuation conduits and return through another of the plurality of actuation conduits.

26. The minimally invasive system of claim 23, wherein each of the plurality of actuation cables maintains its radial position relative to the longitudinal axis of the stylet as the actuation cable extends from the flexible body into the steerable portion.

27. The minimally invasive system of claim 18, wherein the steerable portion of the stylet comprises a plurality of articulable sections linked by the actuation cables and separated by a plurality of joint pivots disposed between adjacent articulable segments.

28. The minimally invasive system of claim 27, wherein a first joint pivot of the plurality of joint pivots allows a first articulable segment to bend in a first plane relative to a second articulable segment, and a second joint pivot of the plurality of joint pivots allows the second articulable segment to bend in a second plane relative to a third articulable segment, wherein the first plane is different than the second plane, the first joint pivot is disposed between the first articulable segment and the second articulable segment, and the second joint pivot is disposed between the second articulable segment and the third articulable segment.

29. The minimally invasive system of claim 18, wherein the distal end of the needle comprises a partially conical, non-beveled, and annular cutting tip.

30. A method of evaluating a target area in a patient, comprising:

advancing a needle system into the patient toward the target area, the needle system comprising a stylet slidably positioned within a lumen of an elongate medical instrument, the stylet including a flexible body, a distal steerable portion, and a sensor element configured to detect characteristics of the stylet;

advancing the steerable portion of the stylet distal to a distal end of the elongate medical instrument;

acquiring characteristics of the stylet from the sensor element as the stylet advances toward the target area;

determining a position of the stylet and the elongate medical instrument relative to the target area based on the acquired characteristics ;

steering the steerable portion of the stylet toward the target area based on the determined position; and

advancing the elongate medical instrument over the stylet into the target area.

31. The method of claim 30, further comprising withdrawing the stylet from the lumen of the elongate medical instrument and obtaining a biopsy from the target area into the lumen of the elongate instrument.

32. The method of claim 30, wherein acquiring characteristics of the stylet comprises detecting a shape of at least a portion of the stylet.

33. The method of claim 30, wherein acquiring characteristics of the stylet comprises detecting a position of at least a portion of the stylet relative to the target area.