INTERVENTIONAL MEDICAL SYSTEMS, DEVICES, AND COMPONENTS THEREOF

• US 20160059002A1
• Filed: 10/20/2014
• Published: 03/03/2016
• Est. Priority Date: 08/26/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Grubac, Vladimir, Anderson, Thomas A, Kuhn, Jonathan L, Swenson, Richard W., Campbell, Michael P
• Granted Patent: US 9,675,798 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A fixation member component, for example, employed by a relatively compact implantable medical device, includes a plurality of fingers; each finger includes a first segment extending from a fixed end of the corresponding finger, and a second segment extending from the corresponding first segment to a free end of the corresponding finger. Each first segment is elastically deformable from a relaxed to an extended condition, and from the relaxed to a compressed condition, and includes a peripheral portion and a central cut-out portion, framed by the peripheral portion. In the compressed condition, a free tip of the cut-out portion of some or all of the fingers may lodge against opposing tissue surfaces, via a spring force of the compressed fingers. Each second segment and cut-out portion is preferably configured to prevent penetration thereof within tissue at the implant site.

Claims

1. An interventional medical system comprising:

an implantable medical device comprising an electronic controller, a hermetically sealed housing containing the controller, a pacing electrode electrically coupled to the controller and mounted in proximity to a distal end of the housing, and a fixation member mounted to the distal end of the housing, the fixation member comprising a plurality of fingers spaced apart from one another around a perimeter of the distal end of the housing, and each finger comprising;

a first segment extending from a fixed end of the corresponding finger and being elastically deformable between a relaxed condition and an extended condition, and between the relaxed condition and a compressed condition, and each first segment including a peripheral portion and a central cut-out portion, the peripheral portion framing the central cut-out portion and having an inside edge spaced apart from an outside edge of the central cut-out portion, and the central cut-out portion extending from a fixed end thereof to a free tip thereof, the fixed end of the central cut-out portion being integral with the peripheral portion in proximity to the fixed end of the corresponding finger, and the central cut-out portion being configured to prevent penetration thereof within tissue at the implant site; and

a second segment extending from the corresponding first segment to a free end of the corresponding finger, the second segment being configured to prevent penetration thereof within tissue at an implant site, the second segment extending from the corresponding first segment in a proximal direction and outward from the device housing, when the first segment is in the relaxed condition, and the second segment extending distally from the distal end of the device housing, when the first segment is in the extended condition; and

a delivery tool comprising a handle, an elongate inner member and a deployment tube, the handle including a control member, the elongate inner member including a proximal end secured to the handle and a distal end configured to abut a proximal end of the device housing, and the deployment tube including a proximal end coupled to the control member of the handle, a distal-most portion, and a lumen extending from a proximal opening thereof to a distal opening thereof, the proximal opening being located in proximity to the proximal end of the deployment tube, and the distal opening terminating the distal-most portion, and the inner member extending within the lumen of the deployment tube such that the deployment tube is movable with respect to the inner member via the control member of the handle; and

wherein the distal-most portion of the deployment tube of the tool is sized to contain the distal end of the inner member together with an entirety of the device when the distal end of the inner member abuts the proximal end of the device housing and when the first segment of each finger of the fixation member is in the extended condition, being held in the extended condition by the distal-most portion.

2. The system of claim 1, wherein the central cut-out portion of the first segment of each finger of the device fixation member tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

3. The system of claim 1, wherein the first segment of each finger of the device fixation member, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

4. The system of claim 1, wherein the plurality of fingers of the device fixation member comprises six fingers spaced equally apart from one another around the perimeter of the device housing.

5. The system of claim 1, wherein:

the second segment of each finger of the device fixation member includes at least one peripheral portion and a corresponding central cut-out portion, each peripheral portion framing the corresponding central cut-out portion and having an inside edge spaced apart from an outside edge of the corresponding central cut-out portion; and

each central cut-out portion of each second segment extends from a fixed end thereof to a free tip thereof in a direction toward the free end of the corresponding finger, the fixed end of each central cut-out portion being integral with the corresponding peripheral portion, and each central cut-out portion being configured to prevent penetration thereof within tissue at the implant site.

6. The system of claim 5, wherein the central cut-out portion of the first segment of each finger of the device fixation member tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

7. The system of claim 5, wherein the first segment of each finger of the device fixation member, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

8. The system of claim 5, wherein the at least one peripheral portion and corresponding central cut-out portion of the second segment of each finger of the device fixation member comprises two peripheral portions and corresponding central cut-out portions spaced apart from one another along a length of the second segment.

9. The system of claim 5, wherein the plurality of fingers of the device fixation member comprises six fingers spaced equally apart from one another around the perimeter of the device housing.

10. The system of claim 1, wherein the device further includes a pacing extension on which the pacing electrode is mounted, the pacing extension extending distally from the distal end of the housing and electrically coupling the pacing electrode to the controller.

11. The system of claim 10, wherein:

the pacing electrode of the device is located in close proximity to a distal tip of the pacing extension of the device; and

the pacing extension of the device includes a pre-formed curvature in proximity to and proximal to the pacing electrode.

12. The system of claim 10, wherein the pacing electrode of the device is located distal to the free end of each finger of the device fixation member, when the proximal segment of each fixation finger is in the extended condition.

13. A relatively compact implantable medical device comprising an electronic controller, a hermetically sealed housing containing the controller, a pacing electrode electrically coupled to the controller and mounted in proximity to a distal end of the housing, and a fixation member mounted to the distal end of the housing, the fixation member comprising a plurality of fingers spaced apart from one another around a perimeter of the distal end of the housing, and each finger comprising:

a first segment extending from a fixed end of the corresponding finger and being elastically deformable between a relaxed condition and an extended condition, and between the relaxed condition and a compressed condition, and each first segment including a peripheral portion and a central cut-out portion, the peripheral portion framing the central cut-out portion and having an inside edge spaced apart from an outside edge of the central cut-out portion, and the central cut-out portion extending from a fixed end thereof to a free tip thereof, the fixed end of the central cut-out portion being integral with the peripheral portion in proximity to the fixed end of the corresponding finger, and the central cut-out portion being configured to prevent penetration thereof within tissue at the implant site; and

a second segment extending from the corresponding first segment to a free end of the corresponding finger, the second segment being configured to prevent penetration thereof within tissue at an implant site, the second segment extending from the corresponding first segment in a proximal direction and outward from the device housing, when the first segment is in the relaxed condition, and the second segment extending distally from the distal end of the device housing, when the first segment is in the extended condition

14. The device of claim 13, wherein the central cut-out portion of the first segment of each finger of the fixation member tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

15. The device of claim 13, wherein the first segment of each finger of the fixation member, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

16. The device of claim 13, wherein the plurality of fingers of the fixation member comprises six fingers spaced equally apart from one another around the perimeter of the housing.

17. The device of claim 13, wherein:

the second segment of each finger of the device fixation member includes at least one peripheral portion and a corresponding central cut-out portion, each peripheral portion framing the corresponding central cut-out portion and having an inside edge spaced apart from an outside edge of the corresponding central cut-out portion; and

each central cut-out portion of each second segment extends from a fixed end thereof to a free tip thereof in a direction toward the free end of the corresponding finger, the fixed end of each central cut-out portion being integral with the corresponding peripheral portion, and each central cut-out portion being configured to prevent penetration thereof within tissue at the implant site.

18. The device of claim 17, wherein the central cut-out portion of the first segment of each finger of the fixation member tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

19. The device of claim 17, wherein the first segment of each finger of the fixation member, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

20. The device of claim 17, wherein the at least one peripheral portion and corresponding central cut-out portion of the second segment of each finger of the fixation member comprises two peripheral portions and corresponding central cut-out portions spaced apart from one another along a length of the second segment.

21. The device of claim 17, wherein the plurality of fingers of the fixation member comprises six fingers spaced equally apart from one another around the perimeter of the housing.

22. The device of claim 13, further comprising a pacing extension on which the pacing electrode is mounted, the pacing extension extending distally from the distal end of the housing and electrically coupling the pacing electrode to the controller.

23. The device of claim 22, wherein:

the pacing electrode is located in close proximity to a distal tip of the pacing extension; and

the pacing extension includes a pre-formed curvature in proximity to and proximal to the pacing electrode.

24. The device of claim 22, wherein the pacing electrode is located distal to the free end of each finger of the fixation member, when the proximal segment of each fixation finger is in the extended condition.

25. A fixation member component for an implantable medical device comprising a base ring and a plurality of fingers integrally formed with the base ring, wherein each finger comprises:

a first segment extending from a fixed end of the corresponding finger where the finger joins to the base ring, the first segment being elastically deformable between a relaxed condition and an extended condition, and between the relaxed condition and a compressed condition, and the first segment including a peripheral portion and a central cut-out portion, the peripheral portion framing the central cut-out portion and having an inside edge spaced apart from an outside edge of the central cut-out portion, and the central cut-out portion extending from a fixed end thereof to a free tip thereof, the fixed end of the central cut-out portion being integral with the peripheral portion in proximity to the fixed end of the corresponding finger, and the central cut-out portion being configured to prevent penetration thereof within tissue at the implant site; and

a second segment extending from the corresponding first segment to a free end of the corresponding finger, the second segment being configured to prevent penetration thereof within tissue at an implant site, the second segment extending from the corresponding first segment in a proximal direction and outward from the base ring, when the first segment is in the relaxed condition, and the second segment extending distally from the base ring, when the first segment is in the extended condition

26. The component of claim 25, wherein the central cut-out portion of the first segment of each finger tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

27. The component of claim 25, wherein the first segment of each finger, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

28. The component of claim 25, wherein the plurality of fingers comprises six fingers spaced equally apart from one another around a perimeter of the base ring.

29. The component of claim 25, wherein:

the second segment of each finger includes at least one peripheral portion and a corresponding central cut-out portion, each peripheral portion framing the corresponding central cut-out portion and having an inside edge spaced apart from an outside edge of the corresponding central cut-out portion; and

each central cut-out portion of each second segment extends from a fixed end thereof to a free tip thereof in a direction toward the free end of the corresponding finger, the fixed end of each central cut-out portion being integral with the corresponding peripheral portion, and each central cut-out portion being configured to prevent penetration thereof within tissue at the implant site.

30. The component of claim 29, wherein the central cut-out portion of the first segment of each finger tapers from a first width at the fixed end thereof to a second width in proximity to the free tip thereof, the first width being greater than the second width, and the free tip being rounded and having a width greater than the second width.

31. The component of claim 29, wherein the first segment of each finger, when the finger is in the relaxed condition, extends in a compound curve, distally and outwardly from the corresponding fixed end, the curve enclosing an angle between approximately 135 degrees and 180 degrees.

32. The component of claim 29, wherein the at least one peripheral portion and corresponding central cut-out portion of the second segment of each finger comprises two peripheral portions and corresponding central cut-out portions spaced apart from one another along a length of the second segment.

33. The component of claim 29, wherein the plurality of fingers comprises six fingers spaced equally apart from one another around a perimeter of the base ring.