Tools and assemblies thereof for implantable medical devices

• US 10,300,286 B2
• Filed: 09/27/2013
• Issued: 05/28/2019
• Est. Priority Date: 09/27/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ward, Sean, Wood, Ronan, McMullin, Gwenda, McDonnell, Paula, Jamous, Aram
• Primary Examiner(s): Yabut, Diane D
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/040,110
• Publication Number:
  US 20150094735A1
• Time in Patent Office: 2,069 Days
• Field of Search: 606129
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A tool has an outer assembly, which includes a deployment tube, extending around, and moveable with respect to an inner assembly of the tool; the inner assembly includes a single pull wire and a distal member configured to engage an end of an implantable medical device. The deployment tube includes an articulating segment located just proximal to an enlarged distal-most portion, which contains the device and the distal member. Relatively soft and stiff sections of a composite sidewall define the articulating segment and extend alongside one another, such that, when the pull wire is actuated, the composite sidewall causes bending of the segment in two directions. A handle assembly of the tool includes a control member for the pull wire, and may further include a flushing subassembly that has a connector port located at an end of the handle assembly that is opposite a proximal port of the handle.

Claims

1. A tool facilitating deployment of an implantable medical device, the tool comprising:

a handle assembly including a first control member and a second control member;

an elongate inner assembly comprising a distal member and a single pull wire and defining a single lumen for the single pull wire, the single pull wire extending from the first control member of the handle assembly to an end of the single pull wire anchored adjacent to the distal member, and the distal member being configured to abut an end of the implantable medical device; and

an outer assembly comprising an elongate deployment tube extending around the inner assembly and being longitudinally moveable by means of the second control member of the handle assembly relative to the inner assembly between first and second positions, the deployment tube including an enlarged distal-most portion and an articulating segment, and a preformed curvature, the articulating segment being located proximal to the enlarged distal-most portion, the preformed curvature being located proximal to the articulating segment of the deployment tube, the distal member of the inner assembly being located within the enlarged distal-most portion, and the enlarged distal-most portion defining a distal opening of the deployment tube;

wherein the articulating segment of the deployment tube of the outer assembly is defined by a composite sidewall, the composite sidewall including a relatively soft section and a relatively stiff section, the sections extending alongside one another and along a length of the articulating segment and meeting along a line that is tangent to an outside of the preformed curvature such that when the single pull wire of the inner assembly is actuated in a single direction via the first control member the composite sidewall causes the articulating segment of the deployment tube to bend in a first direction and a second direction that is different than the first direction such that the articulating segment articulates in at least two geometric planes;

wherein the composite sidewall that defines the articulating segment of the deployment tube of the outer assembly comprises a first inner portion extending 360 degrees around the inner assembly to form the relatively soft section of the composite sidewall and a second outer portion extending approximately 180 degrees around the first inner portion to form the relatively stiff section of the composite sidewall;

wherein substantially an entirety of the implantable medical device is contained within the enlarged distal-most portion of the deployment tube when the deployment tube is in the first position and the end of the implantable medical device abuts the distal member; and

wherein the implantable medical device passes out through the distal opening of the deployment tube when the deployment tube is in the second position.

2. The tool of claim 1, wherein the preformed curvature extends about a radius of between approximately 9 centimeters (cm) and approximately 13 cm, and the enlarged distal-most portion of the deployment tube is oriented by the curvature at an angle of approximately 90 degrees with respect to a length of the deployment tube that extends proximally from the preformed curvature.

3. The tool of claim 1, wherein the length of the articulating segment of the deployment tube of the outer assembly is between approximately 5 centimeters (cm) and approximately 7 cm.

4. The tool of claim 1, wherein the enlarged distal-most portion of the deployment tube of the outer assembly comprises a metal foil radiopaque marker band sandwiched between layers of polyether block amide.

5. The tool of claim 1, wherein the outer assembly further comprises an outer stabilizing sheath surrounding the deployment tube, the stabilizing sheath having a proximal end secured to the handle assembly, and the deployment tube being longitudinally moveable relative to the stabilizing sheath.

6. The tool of claim 1, wherein:

the inner assembly further includes a multi-lumen tube to which the distal member is coupled, the multi-lumen tube including the single lumen in which the single pull wire extends and at least one other lumen in fluid communication with the distal opening of the deployment tube of the outer assembly, the at least one other lumen being configured to receive an elongate tether, the tether being secured to the end of the device; and

the handle assembly further includes a proximal port in fluid communication with the at least one other lumen, the proximal port allowing passage of the tether therethrough.

7. The tool of claim 6, wherein the handle assembly further includes a flushing subassembly, the flushing subassembly including a connector port and a flush lumen extending therefrom, the flush lumen being in fluid communication with the at least one other lumen of the multi-lumen tube.

8. The tool of claim 7, wherein the flush lumen is also in fluid communication with an interior of the deployment tube of the outer assembly that surrounds the multi-lumen tube.

9. The tool of claim 1, wherein:

the inner assembly further includes a multi-lumen tube to which the distal member is coupled, the multi-lumen tube including the single lumen in which the single pull wire extends and at least one other lumen in fluid communication with the distal opening of the deployment tube of the outer assembly;

the handle assembly further includes a flushing subassembly and a proximal port in fluid communication with the at least one other lumen; and

the flushing subassembly includes a connector port and a flush lumen extending therefrom, the flush lumen being in fluid communication with the at least one other lumen of the multi-lumen tube.

10. The tool of claim 9, wherein the multi-lumen tube further includes at least one port formed through a sidewall thereof to create fluid communication between the at least one other lumen and an interior of the deployment tube of the outer assembly that extends around the multi-lumen tube so that the flush lumen is also in fluid communication with the interior of the deployment tube.

11. The tool of claim 1, wherein the deployment tube is configured to retract relative to the implantable medical device in the enlarged distal-most portion when the deployment tube moves from the first position to the second position to cause the implantable medical device to pass out through the distal opening of the deployment tube.

12. A deployment tube for a tool that facilitates deployment of an implantable medical device, the deployment tube comprising:

a proximal end coupled to a control member of a handle assembly of the tool;

an enlarged distal-most portion defining a distal opening of the deployment tube and forming a container for the implantable medical device, the deployment tube being configured for assembly around an inner assembly of the tool that comprises a distal member and a single pull wire such that the distal member of the inner assembly fits together with the implantable medical device in the container;

a first segment having a preformed curvature; and

a second articulating segment that defines a single lumen for the single pull wire and extends between the first segment and the enlarged distal-most portion, the second articulating segment being defined by a composite sidewall, the composite sidewall including a relatively soft section and a relatively stiff section, the sections extending alongside one another and along a length of the second articulating segment and meeting along a line that is tangent to an outside of the preformed curvature such that when the deployment tube is assembled around the inner assembly of the tool and the single pull wire of the inner assembly of the tool is actuated in a single direction the composite sidewall causes the second articulating segment of the deployment tube to bend in two directions;

wherein the composite sidewall that defines the second articulating segment comprises a first inner portion extending 360 degrees around a longitudinal axis of the deployment tube to form the relatively soft section of the composite sidewall and a second outer portion extending approximately 180 degrees around the first inner portion to form the relatively stiff section of the composite sidewall.

13. The deployment tube of claim 12, wherein the preformed curvature of the first segment extends about a radius of between approximately 9 centimeters (cm) and approximately 13 cm, and the enlarged distal-most portion is oriented by the curvature at an angle of approximately 90 degrees with respect to a proximal length of the deployment tube that extends proximally from the first segment.

14. The deployment tube of claim 12, wherein the length of the second articulating segment is between approximately 5 centimeters (cm) and approximately 7 cm.

15. The deployment tube of claim 12, wherein the enlarged distal-most portion comprises a metal foil radiopaque marker band sandwiched between layers of polyether block amide.