STEERABLE INTRODUCER ASSEMBLY FOR FIRST PERCUTANEOUSLY IDENTIFYING TARGET TISSUE AND THEN DEFINING A PERCUTANEOUS PATH TO THE TARGET TISSUE FOR AN IMPLANTABLE MEDICAL DEVICE

• US 20170252064A1
• Filed: 05/19/2017
• Published: 09/07/2017
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Staunton, Douglas A.
• Granted Patent: US 10,463,398 B2
• Time in Patent Office: Days
• 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: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An assembly for both targeting a location in a living being at which an implantable medical device is to be inserted and defining a percutaneous path to the target location. The assembly includes a guidewire with electrodes that is inserted percutaneously into the living being. Electrodes on the guidewire source and sink current to facilitate the identification of the target location. A dilator encased in a reinforced sleeve is disposed over the guidewire. Steering wires in the sleeve facilitate the advancement of the sleeve and the guidewire. Once the dilator and sleeve are advanced to the target location, the dilator is removed from the sleeve. The lumen in sleeve functions as the lumen in the living being through which the implantable device is delivered to the target location.

Claims

1. An assembly for percutaneously inserting an implantable assembly in a living body, said assembly including:

a guidewire dimensioned to be inserted in the lumen of a needle, the needle dimensioned to be inserted percutaneously into tissue, said guidewire being flexible and having;

at least one electrode through which current is sourced or sunk to determine the location of target tissue over which an implantable assembly is to be employed;

for flexing said guidewire;

an introducer including;

a dilator having a bore dimensioned to receive said guidewire so said dilator can be advanced over said guidewire;

a sleeve disposed over said dilator, said sleeve having a longitudinally extending lumen that is dimensioned to receive said dilator so the sleeve can be advanced over said guidewire with said dilator wherein said sleeve is formed from material that at least partially resists compression so that, when said guidewire and said dilator are removed from said sleeve, the lumen remains defined in said sleeve so that the lumen is able to receive the implantable assembly; and

at least one steering wire embedded in said sleeve; and

a steering unit located outside of the living body that is attached to said at least one steering wire for displacing said at least one steering wire so that said at least one steering wire displaces said sleeve and said dilator disposed in said sleeve.

2. The assembly of claim 1, wherein:

said sleeve has a proximal end located outside of a living being into which said sleeve is inserted and the proximal end of said sleeve is attached to a sleeve hub; and

said steering unit includes a steering member that is moveably attached to said sleeve hub to which said at least one steering wire is attached so that the displacement of said steering member results in the displacement of said at least one steering wire.

3. The assembly of claim 1, wherein:

said sleeve has a proximal end located outside of a living being into which said sleeve is inserted and the proximal end of said sleeve is attached to a sleeve hub, said sleeve hub having opposed distal and proximal ends wherein said sleeve extends forward from the distal end of said sleeve hub and a bore that extends longitudinally between the distal and proximal ends of said sleeve hub;

said steering unit includes a steering member that is moveably attached to said sleeve hub to which said at least one steering wire is attached so that the displacement of said steering member results in the displacement of said at least one steering wire;

said dilator has a proximal end located outside of the living being that is connected to dilator hub located adjacent the proximal end of said sleeve hub; and

a coupling assembly releasably holds said dilator hub to said sleeve hub so that, said dilator and said sleeve can be inserted in the living being as a single unit, and upon decoupling of said coupling assembly, said dilator hub can be withdrawn away from said sleeve hub so as to withdraw said dilator from said sleeve.

4. The assembly of claim 1 wherein:

plural said steering wires are embedded in said sleeve; and

said plural steering wires are attached to said steering unit.

5. The assembly of claim 1, wherein sleeve is formed from a plastic that includes internal reinforcing braids.

6. The assembly of claim 1, wherein said sleeve is oval in shape.

7. The assembly of claim 1, wherein said guidewire is formed with a lumen dimensioned to receive a stylet so that, upon insertion of the stylet in the lumen of said guidewire, said guidewire assumes a defined shape.