Flexible and steerable elongate instruments with shape control and support elements

• US 10,363,103 B2
• Filed: 02/05/2016
• Issued: 07/30/2019
• Est. Priority Date: 04/29/2009
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Auris Health, Inc. (Johnson & Johnson)
• Inventors: Alvarez, Jeffery B., Romo, Enrique, MacNamara, Francis
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US15/017,147
• Publication Number:
  US 20160151122A1
• Time in Patent Office: 1,271 Days
• CPC Class Codes: A61B 1/00078 with stiffening means
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• 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 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00305 Constructional details of the flexible means
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• 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 2034/303 specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

An instrument having a flexible and elongated body includes at least a lumen and a flex member disposed within the lumen. The flex member may be capable of providing steering control to a first portion of the elongate body while providing load bearing support to a second portion of the elongate body. A pull wire may be disposed within the flex member, and at least a distal portion of the pull wire may be coupled to the elongate body and a proximal portion of the pull wire may be operatively coupled to a control unit. The control unit may be coupled to a proximal portion of the elongate body. In addition, a control member may be operatively coupled to the control unit such that a distal portion of the control member may be positioned near a proximal portion of the flex member. The control member may be configured to support the flex member and control the movement or displacement of the flex member. Furthermore, the flex member may be configured to selectively decouple articulation or steering forces of a first portion of the elongate body away from a second portion of the elongate body; thereby, preventing compression of the second portion of the elongate body while maintaining elasticity or flexibility of the second portion of the elongate body.

Claims

1. A steerable elongate instrument, comprising:

an elongate body, comprising;

a proximal portion;

a distal portion;

a first lumen extending through the proximal portion and the distal portion; and

multiple secondary lumens extending through the proximal portion and the distal portion;

multiple flex tubes disposed within the secondary lumens within the proximal portion of the elongate body, wherein a proximal portion of each flex tube is slideable into and out of the elongate body at a proximal end of the elongate body, wherein a distal end of each flex tube is fixedly coupled to a distal end of the proximal portion of the elongate body, and wherein, when the elongate body is placed in a bend such that a first side of the elongate body contracts and a second side of the elongate body stretches, one of the flex tubes located in the first side slides at least partially out of the secondary lumen in which it is disposed, and another of the flex tubes located in the second side slides at least partially into the secondary lumen in which it is disposed;

multiple pull wires, wherein each of the flex tubes has a different one of the pull wires disposed therein; and

a control unit positioned proximal to the elongate body,

wherein a distal portion of each of the pull wires is coupled to the distal portion of the elongate body, and wherein a proximal portion of each of the pull wires is operatively coupled to the control unit.

2. The elongate instrument of claim 1, wherein the distal portion of each of the pull wires is coupled to the elongate body via a control ring fixedly coupled to the elongate body.

3. The elongate instrument of claim 1, further comprising multiple liners, wherein each of the liners is disposed within each of the secondary lumens between the secondary lumen and the flex tube and comprises a slidable surface for the flex tubes to slide within the secondary lumens.

4. The elongate instrument of claim 1, configured such that a tension applied to the pull wires via the control unit results in articulation of the distal portion of the elongate instrument.

5. The elongate instrument of claim 1, wherein each of the flex tubes is a coil tube.

6. The elongate instrument of claim 1, wherein each of the flex tubes is a ring.

7. The elongate instrument of claim 1, wherein each of the flex tubes is a spirally cut tube.

8. The elongate instrument of claim 1, wherein the flex tubes are configured to support articulation forces that steer the distal portion of the elongate body while decoupling the articulation forces from the proximal portion of the elongate body.

9. The elongate instrument of claim 1, wherein the flex tubes are configured to support articulation forces that steer the distal portion of the elongate body such that the proximal portion of the elongate body remains flexible while the articulation forces are applied.

10. The elongate instrument of claim 1, wherein a proximal end of each of the flex tubes is fixedly coupled to the control unit or other structural element such that outward sliding of one of the flex tubes from the elongate body forms a buffer loop that maintains a constant path length for the respective pull wire for accurate articulation as the elongate instrument is steered through a patient'"'"'s anatomy.

11. The elongate instrument of claim 1, wherein the control unit is a splayer.

12. A steerable elongate instrument, comprising:

an elongate body, comprising;

a proximal portion;

a distal portion;

a first lumen extending through the proximal portion and the distal portion; and

a secondary lumen extending through the proximal portion and the distal portion;

a flex tube disposed within the secondary lumen within the proximal portion of the elongate body, wherein a proximal end of the flex tube is free to slide such that a proximal portion of the flex tube is slideable into and out of the elongate body at a proximal end of the elongate body, wherein a distal end of the flex tube is fixedly coupled to a distal end of the proximal portion of the elongate body, and wherein, when the elongate body is placed in a bend oriented such that the flex tube is positioned in a contracted side of the elongate body, the proximal portion of the flex tube slides at least partially out of the secondary lumen, and when the bend is oriented such that the flex tube is positioned in a stretched side of the elongate body, the proximal portion of the flex tube slides at least partially into the secondary lumen;

a pull wire disposed within the flex tube; and

a control unit positioned proximal to the elongate body,

wherein a distal portion of the pull wire is coupled to the distal portion of the elongate body, and a proximal portion of the pull wire is operatively coupled to the control unit.

13. The elongate instrument of claim 12, wherein the distal portion of the pull wire is coupled to the elongate body via a control ring fixedly coupled to the elongate body.

14. The elongate instrument of claim 12, further comprising a liner disposed within the secondary lumen between the secondary lumen and the flex tube and comprising a slidable surface for the flex tube to slide within the secondary lumen.

15. The elongate instrument of claim 12, configured such that a tension applied to the pull wire via the control unit results in articulation of the distal portion of the elongate instrument.

16. The elongate instrument of claim 12, wherein the flex tube is configured to support an articulation force that steers the distal portion of the elongate body while decoupling the articulation force from the proximal portion of the elongate body.

17. The elongate instrument of claim 16, wherein the flex tube is configured to prevent compression of the proximal portion of the elongate body from the articulation forces while maintaining flexibility of the distal portion of the elongate body.

18. The elongate instrument of claim 12, wherein the proximal end of the flex tube is fixedly coupled to the control unit or other structural element such that outward sliding of the flex tube from the elongate body forms a buffer loop that maintains a constant path length for the pull wire for accurate articulation as the elongate instrument is steered through a patient'"'"'s anatomy.

19. The elongate instrument of claim 12, wherein the control unit is a splayer.

20. The elongate instrument of claim 12, wherein the flex tube is selected from the group consisting of a coil tube, a ring tube, and a spirally cut tube.