SYSTEMS FOR DEPLOYING MEDICAL DIAGNOSTICS AND/OR THERAPY AND DELIVERY TOOLS THEREOF

• US 20160143758A1
• Filed: 11/20/2014
• Published: 05/26/2016
• Est. Priority Date: 11/20/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: GRENZ, Nathan A., GARDESKI, Kenneth C., SHEN, Xiaonan, LENERS, Michael R., RONNING, Lonnie D.
• Granted Patent: US 9,788,981 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A delivery tool of a system for deploying medical diagnostics and/or therapy includes a deployment member and a sheath. An elastic cantilever element secured to a tubular sidewall of the deployment member, in proximity to a distal opening of a lumen formed by the sidewall, is spring biased to extend outward from the sidewall. When the cantilever element is received within the sheath, a sheath sidewall pushes the cantilever element inward, against the spring bias thereof, and a radius of curvature of the cantilever element approximately conforms to that of an outer surface of the deployment member sidewall. A helical track for receiving passage of a medical device helix fixation element therein may extend around a perimeter of the deployment member lumen, wherein a distal terminal end of the track is located in close proximity to the distal opening and generally opposite a free end of the cantilever element.

Claims

1. A delivery tool for an implantable medical device, the tool comprising:

a deployment member comprising a tubular sidewall and an elastic cantilever element, the tubular sidewall defining an elongate lumen of the deployment member that extends along a longitudinal axis of the tool, from a proximal opening of the lumen to a distal opening of the lumen, the lumen being configured to receive passage of an elongate body of the medical device therethrough, and the elastic cantilever element being secured to the tubular sidewall in proximity to the distal opening of the lumen, the cantilever element being spring biased to extend outward from the sidewall, in a direction approximately orthogonal to the longitudinal axis; and

a sheath including a tubular sidewall, the sheath sidewall defining an elongate lumen of the sheath that extends along the longitudinal axis of the tool, from a proximal opening of the sheath lumen to a distal opening of the sheath lumen, the sheath lumen being configured to receive passage of both the tubular sidewall of the deployment member and the elastic cantilever member of the deployment member therethrough; and

wherein the elastic cantilever element of the deployment member has a radius of curvature that approximately conforms to a curvature of an outer surface of the tubular sidewall of the deployment member, when the cantilever element is received within the sheath sidewall and the sheath sidewall pushes the cantilever element inward, toward the longitudinal axis, against the spring bias of the element.

2. The tool of claim 1, wherein the cantilever element of the deployment member includes a radiopaque marker located in proximity to a free end thereof.

3. The tool of claim 1, wherein the sheath sidewall has a distal-most edge that defines the distal opening of the sheath lumen, the distal-most edge extending in a plane that forms an acute angle with respect to the longitudinal axis of the tool.

4. The tool of claim 1, wherein:

the deployment member sidewall has a distal-most edge that defines the distal opening of the deployment member lumen;

the deployment member further comprises a helical track extending around a perimeter of the deployment member lumen, within a distal segment of the deployment member sidewall, the distal segment being terminated by the distal-most edge; and

the helical track has a distal terminal end located in close proximity to the distal-most edge of the deployment member sidewall, the distal terminal end of the track being generally opposite a free end of the cantilever element, when the cantilever element extends outward from the deployment member sidewall according the spring bias thereof.

5. The tool of claim 4, wherein the deployment member includes a pair of helically extending side rails spaced longitudinally apart from one another to form the helical track along the distal segment of the deployment member sidewall, the side rails protruding inward from an inner surface of the deployment member sidewall, toward the longitudinal axis of the tool.

6. The tool of claim 5, wherein a first side rail of the pair of side rails extends around a first number of turns, and a second side rail of the pair of side rails extends around a second number turns, the second number of turns being less that the first number of turns such that a proximal terminal end of the helical track is formed by only the first side rail for between approximately one fourth of a turn and one turn.

7. The tool of claim 5, wherein the pair of side rails comprise a molded component, the distal segment of the deployment member sidewall being over-molded onto the molded component to form a subassembly, and the subassembly being attached to a remainder of the deployment member sidewall.

8. The tool of claim 7, wherein the subassembly further comprises the cantilever element insert molded together with the distal segment of the sidewall.

9. The tool of claim 4, wherein:

the distal-most edge of the deployment member sidewall includes a first section and a second section, the first section being recessed from the second section along the longitudinal axis of the tool such that a longitudinal gap between the first section and the second section is approximately one half a pitch length of the helical track; and

the distal terminal end of the helical track lies within the gap.

10. The tool of claim 1, wherein the deployment member further includes a hub defining the proximal opening of the lumen thereof, the hub including a handle that protrudes laterally therefrom in a direction that is approximately 90 degrees offset from the spring biased extension of the elastic cantilever element, about a circumference of the deployment member sidewall.

11. A system for deploying medical diagnostics and/or therapy, the system comprising an implantable medical device including an elongate body for delivery of the therapy therethrough and a helix fixation element coupled to the body, and a delivery tool for implanting the elongate body, the delivery tool comprising:

a deployment member comprising a tubular sidewall and an elastic cantilever element, the tubular sidewall defining an elongate lumen of the deployment member that extends along a longitudinal axis of the tool, from a proximal opening of the lumen to a distal opening of the lumen, the lumen being configured to receive passage of the elongate body therethrough, and the elastic cantilever element being secured to the tubular sidewall in proximity to the distal opening of the lumen, the cantilever element being spring biased to extend outward from the sidewall, in a direction approximately orthogonal to the longitudinal axis; and

a sheath including a tubular sidewall, the sheath sidewall defining an elongate lumen of the sheath that extends along the longitudinal axis of the tool, from a proximal opening of the sheath lumen to a distal opening of the sheath lumen, the sheath lumen being configured to receive passage of both the tubular sidewall of the deployment member and the elastic cantilever member of the deployment member therethrough; and

wherein the elastic cantilever element of the deployment member has a radius of curvature that approximately conforms to a curvature of an outer surface of the tubular sidewall of the deployment member, when then the cantilever element is received within the sheath sidewall and the sheath sidewall pushes the cantilever element inward, toward the longitudinal axis, against the spring bias thereof.

12. The system of claim 11, wherein the elastic cantilever element of the delivery tool deployment member includes a radiopaque marker located in proximity to a free end of the cantilever element.

13. The system of claim 11, wherein the tubular sidewall of the delivery tool sheath has a distal-most edge that defines the distal opening of the sheath lumen, the distal-most edge extending in a plane that forms an acute angle with respect to the longitudinal axis of the tool.

14. The system of claim 11, wherein:

the tubular sidewall of the delivery tool deployment member has a distal-most edge that defines the distal opening of the deployment member lumen;

the delivery tool deployment member further comprises a helical track extending around a perimeter of the deployment member lumen, within a distal segment of the deployment member sidewall, the distal segment being terminated by the distal-most edge, and the helical track being configured to receive passage of the helix fixation element therein; and

the helical track includes a distal terminal end located in close proximity to the distal-most edge of the delivery tool deployment member sidewall, the distal terminal end being generally opposite a free end of the elastic cantilever element of the delivery tool deployment member, when the cantilever element extends outward from the deployment member sidewall according the spring bias thereof.

15. The system of claim 14, wherein the delivery tool deployment member includes a pair of helically extending side rails spaced longitudinally apart from one another to form the helical track along the distal segment of the deployment member sidewall, the side rails protruding inward from an inner surface of the deployment member sidewall, toward the longitudinal axis of the tool.

16. The system of claim 15, wherein a first side rail of the pair of side rails extends around a first number of turns, and a second side rail of the pair of side rails extends around a second number turns, the second number of turns being less that the first number of turns such that a proximal terminal end of the helical track is formed by only the first side rail for between approximately one fourth of a turn and one turn.

17. The system of claim 15, wherein the pair of side rails of the delivery tool deployment member comprise a molded component, the distal segment of the deployment member sidewall being over-molded onto the molded component to form a subassembly, and the subassembly being attached to a remainder of the deployment member sidewall.

18. The system of claim 17, wherein the subassembly further comprises the cantilever element of the delivery tool deployment member insert molded together with the distal segment of the sidewall.

19. The system of claim 14, wherein:

the implantable elongate body includes a junction at which the helix fixation element is coupled, the junction having a helical profile;

the helix fixation element includes first, second, and third segments, the first segment being embedded within the junction, the second segment extending from the first segment to the third segment, the third segment being terminated by a distal-most piercing tip of the helix fixation element, and the helical profile of the junction matching a pitch of the second and third segments of the helix fixation element, and having an outer diameter greater than that of the second segment;

the third segment of the helix fixation element has an outer diameter greater than that of the second segment of the helix fixation element, and greater than or equal to that of the junction; and

the helical track of the delivery tool deployment member has an inner diameter approximately equal to the outer diameter of the third segment of the helix fixation element.

20. The system of claim 14, wherein:

the distal-most edge of the tubular sidewall of the delivery tool deployment member includes a first section and a second section, the first section being recessed from the second section along the longitudinal axis of the tool such that a longitudinal gap between the first section and the second section is approximately one half a pitch length of the deployment member helical track; and

the distal terminal end of the deployment member helical track lies within the gap.

21. The system of claim 11, wherein the delivery tool deployment member further includes a hub defining the proximal opening of the lumen thereof, the hub including a handle that protrudes laterally therefrom in a direction that is approximately 90 degrees offset from the spring biased extension of the elastic cantilever element of the delivery tool deployment member, about a circumference of the deployment member sidewall.

22. An assembly for an implantable medical device delivery tool, the subassembly comprising:

a tubular sidewall including an inner surface and a distal-most edge, the inner surface defining an elongate lumen that extends along a longitudinal axis of the subassembly from proximal opening of the lumen to a distal opening of the lumen, the distal opening of the lumen being defined by the distal-most edge of the sidewall, the lumen being configured to receive passage of an elongate body of an implantable medical device therethrough;

an elastic cantilever element secured to the tubular sidewall in proximity to the distal opening of the lumen, the cantilever element being spring biased to extend outward from the tubular sidewall in a direction approximately orthogonal to the longitudinal axis, and the cantilever element having a radius of curvature that approximately conforms to a curvature of the tubular sidewall when the element pushed inward, toward the longitudinal axis, against the spring bias thereof; and

a helical track extending along the inner surface of the tubular sidewall and around a perimeter of the lumen, the track including a distal terminal end located in close proximity to the distal-most edge of the tubular sidewall, the distal terminal end being generally opposite a free end of the elastic cantilever element, when the cantilever element extends outward from the sidewall according the spring bias thereof.

23. The assembly of claim 22, wherein:

the helical track is formed by a pair of helically extending side rails spaced longitudinally apart from one another and protruding inward from the inner surface of the deployment member sidewall, toward the longitudinal axis; and

a first side rail of the pair of side rails extends around a first number of turns, and a second side rail of the pair of side rails extends around a second number turns, the second number of turns being less that the first number of turns such that a proximal terminal end of the helical track is formed by only the first side rail for between approximately one fourth of a turn and one turn.

24. The subassembly of claim 22, wherein:

the distal-most edge of the tubular sidewall includes a first section and a second section, the first section being recessed from the second section along the longitudinal axis such that a longitudinal gap between the first section and the second section is approximately one half a pitch length of the helical track; and

the distal terminal end of the helical track lies within the gap.