ASSEMBLY FOR PERCUTANEOUSLY INSERTING AN IMPLANTABLE MEDICAL DEVICE, STEERING THE DEVICE TO A TARGET LOCATION AND DEPLOYING THE DEVICE

• US 20140121674A1
• Filed: 11/25/2013
• Published: 05/01/2014
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Staunton, Douglas A.
• Granted Patent: US 9,655,645 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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 implanting a medical device such as an electrode array. The assembly includes a sheath that is disposed over the medical device and a core that supports the device. The sheath and core are connected to, respectively, first and second slides in a handpiece. An single actuator first moves one slide, typically the slide to which the sheath is attached. Once the first slide at least partially displaced both slides are moved to simultaneously retract the sheath and core away from the implantable medical device. The assembly includes a steering assembly for steering the sheath and implantable medical device. Some of the components forming the steering assembly are disposed on at least one of the slides. Tensioners prevent the steering cables of the steering assembly from being exposed to excessive force.

Claims

1. An assembly for percutaneously inserting an implantable medical device, the assembly including:

a handpiece shaped to be held in a single hand;

a sheath, said sheath having a distal portion in which the implantable medical device is disposed and a proximal portion that extends rearwardly from the distal portion so the proximal portion can extend out of the living being in which the sheath is inserted, the proximal portion of said sheath being moveably attached to said handpiece so that the sheath can be retracted away from the medical device;

at least one steering cable is connected to either to said sheath or the medical device or said sheath for steering the device and said sheath with the device is disposed in said sheath, said steering cable extending to said handpiece;

a steering unit attached to said handpiece, wherein said at least one steering cable is attached to said steering unit and said steering unit selectively controls said at least one steering cable and said steering unit has a manually actuated control member that is manipulated to control said at least one steering cable, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece; and

a first retraction unit attached to said handpiece, wherein said sheath is attached to said retraction unit so that the actuation of said first retraction unit results in the retraction of said sheath proximally away from the implantable medical device, said first retraction unit having a manually actuated control member that actuates said first retraction unit, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece.

2. The assembly of claim 1, further including:

a core for supporting the implantable medical device (30) wherein the medical device and the core are encased in the sheath; and

wherein,

a second retraction unit is disposed in said handpiece and said core is connected to said second retraction unit, said second retraction unit configured to, when actuated, retract said core proximally away from the implantable device, said second retraction unit having a manually actuated control member that actuates said second retraction unit, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece.

3. The assembly of claim 2, wherein said first retraction unit and said second retraction unit are collectively configured so that a single manually actuated control member actuates both said retraction units.

4. The assembly of claim 3, wherein said first retraction unit and said second retraction unit are collectively configured so that said second retraction unit is not actuated after said first retraction unit initially at least partially retracts the sheath away from the medical device.

5. The assembly of claim 2, wherein said first and second retraction units are collectively configured so that the actuation of one of said retraction units results in the simultaneous actuation of the other one of the retraction units.

6. The assembly of claim 2, wherein:

said first retraction unit is a first slide that is moveably disposed in said handpiece; and

said second retraction unit is a second slide that is moveably disposed in said handpiece.

7. The assembly of claim 1, wherein said first retraction unit is a slide that is moveably disposed in said handpiece.

8. The assembly of claim 7 wherein said at least one steering cable and components of said steering unit are attached to said slide.

9. The assembly of claim 1, wherein:

plural said steering cables are connected to said sheath or the medical device; and

said steering unit is able to selectively tension the plural said steering cables.

10. The assembly of claim 9, wherein said steering unit includes a single said control member that is selectively manipulated to selectively tension the plural steering cables.

11. An assembly for percutaneously inserting an implantable medical device, the assembly including:

a core for supporting the implantable medical device;

a sheath, said sheath having a distal portion in which the implantable medical device and core are disposed and a proximal portion that extends rearwardly from the distal portion end so the proximal portion can extend out of the living being in which the sheath is inserted, the proximal portion of said sheath being moveably attached to said handpiece so that the sheath can be retractable away from the medical device;

at least one steering cable is connected to either to said sheath or the medical device or said sheath for steering the device and said sheath with the device is disposed in said sheath, said steering cable extending to said handpiece;

a handpiece, said handpiece shaped to be held in a single hand, wherein the proximal end of said sheath and said core are each connected to said handpiece;

a first retraction unit attached to said handpiece, wherein said sheath is attached to said retraction unit so that the actuation of said first retraction unit results in the retraction of said sheath proximally away from the implantable medical device, said first retraction unit having a manually actuated control member that actuates said first retraction unit, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece; and

a second retraction unit attached to said handpiece, wherein said core is attached to said retraction unit so that the actuation of said second retraction unit results in the retraction of said core proximally away from the implantable medical device, said second retraction unit having a manually actuated control member that actuates said second retraction unit, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece.

12. The assembly of claim 11, wherein said first retraction unit and said second retraction unit are collectively configured so that a single manually actuated control member actuates both said retraction units.

13. The assembly of claim 11, wherein said first retraction unit and said second retraction unit are collectively configured so that said second retraction unit is not actuated after said first retraction unit initially at least partially retracts the sheath away from the medical device.

14. The assembly of claim 13, wherein said first retraction unit and said second retraction unit are collectively configured so that a single manually actuated control member actuates both said retraction units.

15. The assembly of claim 11, wherein said first and second retraction units are collectively configured so that the actuation of one of said retraction units results in the simultaneous actuation of the other one of the retraction units.

16. The assembly of claim 11, wherein at least one of said retraction units is a slide that is moveably disposed in said handpiece.

17. The assembly of claim 11, wherein:

said first retraction unit is a first slide that is moveably disposed in said handpiece; and

said second retraction unit is a second slide that is moveably disposed in said handpiece.

18. The assembly of claim 11, wherein:

at least one steering cable is connected to either to said sheath or the medical device or said sheath for steering the device and said sheath with the device is disposed in said sheath and said steering cable extending to said handpiece; and

a steering unit is attached to said handpiece, wherein said at least one steering cable is attached to said steering unit and said steering unit selectively controls said at least one steering cable and said steering unit has a manually actuated control member that is manipulated to control said at least one steering cable, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece.

19. An assembly for percutaneously inserting an implantable medical device, the assembly including:

a sheath, said sheath having a distal portion in which the implantable medical device is disposed and a proximal portion that extends rearwardly from the distal portion so the proximal portion can extend out of the living being in which the sheath is inserted;

at least one steering cable fitted to said sheath;

a handpiece shaped to be held in the hand, wherein the proximal end of said sheath and said steering cable extend to said handpiece;

a slide moveably disposed in said handpiece, wherein;

the proximal end of said sheath and said at least one steering cable are connected in said slide; and

a control member is connected to said slide for moveably displacing said slide within said handpiece so that the displacement of said slide results in the retraction of said sheath away from the implantable medical device; and

a steering unit attached to said handpiece, wherein;

said at least one steering cable is attached to said steering unit and said steering unit selectively controls said at least one steering cable;

said steering unit has a manually actuated control member that is manipulated to control said at least one steering cable, said control member being positioned on said handpiece to be manipulated by the hand holding said handpiece; and

said steering unit has at least one additional component that is mounted to said slide.

20. The assembly of claim 19, wherein:

said handpiece includes a housing; and

said steering unit includes a control member that is mounted to said handpiece housing, said steering unit control member configured to engage the said steering unit component that is mounted to said slide.

21. The assembly of claim 19, wherein:

said steering unit is configured to impose a force on said at least one steering cable; and

a tensioner is disposed in said housing, said at least one steering cable is attached to said tensioner and said tensioner is configured to limit the amount of force said steering unit places on said at least one steering cable.

22. The assembly of claim 21, wherein said tensioner is mounted to said slide to move with said slide.

23. The assembly of claim 19, wherein a plurality of said steering cables extend from said sheath to said slide.

24. The assembly of claim 19, wherein said control member connected to said slide is pivotally connected to said handpiece.

25. The assembly of claim 19, wherein said slide and said control member connected to said slide are configured to:

move said slide in a first direction within said handpiece to cause the retraction of said sheath away from the implantable medical device; and

after said slide is moved in the first direction, inhibit movement of said slide in a second direction opposite the first direction.

26. The assembly of claim 19, further including:

a core disposed in said sheath for supporting the implantable medical device, said core being connected to said handpiece; and

a core retraction assembly disposed in said handpiece to which said core is attached, said core retraction assembly configured to, when actuated, retract said core away from the implantable medical device, wherein said slide and said core retraction device are at least partially able to be actuated independently of each other.