Devices, system, and methods for guiding an operative tool into an interior body region

• US 10,357,230 B2
• Filed: 03/16/2016
• Issued: 07/23/2019
• Est. Priority Date: 11/28/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/071,501
• Publication Number:
  US 20160193450A1
• Time in Patent Office: 1,224 Days
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A guide device establishes a guide passage through a guide tube, through which an operative tool can be deployed into an interior body region for use. A steering assembly, in use, deflects or bends the distal end region of the guide tube, so that the operative tool can be placed in a desired orientation with respect to tissue. The steering assembly is desirable configured for single handed operation by the clinician. The steering assembly is also desirably configured to provide a mechanical advantage sufficient to translate relatively small increments of clinician control into relatively larger increments of guide tube deflection. In one arrangement, the steering assembly includes a rack and pinion linkage system. In another arrangement, the steering assembly includes a pivoting lever system.

Claims

1. A guide device comprising:

a flexible guide tube comprising a main lumen defining a guide passage and at least one control lumen separate from the main lumen, the guide tube further comprising a tip reinforcing element comprising a uniform ring;

a handle coupled to the guide tube, the handle comprising a proximal opening in communication with the guide passage through which a separate operative tool can be advanced; and

a steering assembly comprising;

a deflecting element at least partially within the control lumen and coupled to a distal end region of the flexible guide tube to apply a deflecting force to bend the distal end region, the deflecting element making a continuous loop completely around the tip reinforcing element,

an actuator configured to rotate about the longitudinal axis of the guide device and rotatable by a single-handed operation, and

a linkage system coupling the actuator to the deflecting element to apply the deflecting force in response to operation of the actuator, the linkage system including a slider and a pivoting lever arm, the slider having a threaded portion adapted to mate with a threaded portion of the actuator, the pivoting lever arm directly coupled to a proximal end of the deflecting element at a first end portion and pivotally attached to the handle at a second end portion and adapted to be contacted by the slider to translate rotation of the actuator into linear movement of the slider into pivotal movement of the lever arm to apply the deflecting force to the deflecting component, wherein the linkage system is positioned within the handle and amplifies the amount of deflecting force.

2. The device according to claim 1 further comprising at least one additional deflecting element.

3. The guide device according to claim 1 further comprising at least two control lumens.

4. The guide device according to claim 3 wherein the control lumens are oriented 180 degrees apart.

5. The guide device according to claim 1 wherein the distal end region of the guide tube comprises radiopaque markers.

6. A system comprising:

a guide device as defined in claim 1, and

an operative tool that applies one or more fasteners to tissue.

7. A method comprising:

providing a guide device as defined in claim 1,

deploying the guide device into an interior tissue region, and

operating the steering assembly to bend the distal end region of the guide tube.

8. A method comprising:

providing a system as defined in claim 6,

deploying the guide device into an interior tissue region,

operating the steering assembly to bend the distal end region of the guide tube,

passing the operative tool through the guide device, and

operating the operative tool while residing in the guide device to apply at least one fastener to tissue.