Interventional medical devices, device systems, and fixation components thereof
A fixation mechanism of an implantable medical device is formed by a plurality of tines fixedly mounted around a perimeter of a distal end of the device. Each tine may be said to include a first segment fixedly attached to the device, a second segment extending from the first segment, and a third segment, to which the second segment extends. When the device is loaded in a lumen of a delivery tool and a rounded free distal end of each tine engages a sidewall that defines the lumen, to hold the tines in a spring-loaded condition, the first segment of each tine, which has a spring-biased pre-formed curvature, becomes relatively straightened, and the third segment of each tine, which is terminated by the free distal end, extends away from the axis of the device at an acute angle in a range from about 45 degrees to about 75 degrees.
1. A tissue penetrating fixation component for an implantable medical device, the component comprising a base and a plurality of tines, the base defining a longitudinal axis of the component and being configured to be fixedly attached to the device so that a perimeter of the component extends around an electrode of the device, and so that the longitudinal axis of the component is generally aligned along a longitudinal axis of the device, the plurality of tines extending from the base and being spaced apart from one another around a perimeter thereof, and each tine comprising:
a proximal, spring portion being fixedly attached to the base and having a spring-biased pre-formed curvature, the pre-formed curvature, in proximity to the base, extending in a first direction, generally parallel to the axis of the component, and then sweeping laterally, outward from the axis; and
a distal portion including a proximal section, a hook section, and tip section terminated by a rounded free distal end, the proximal section extending from the proximal, spring portion and being pre-formed to extend in a second direction and along a relatively straight line to the hook section, the proximal section being oriented, by the spring-biased pre-formed curvature of the proximal, spring portion, so that the second direction is generally opposite the first direction, and the relatively straight line intersects the axis at an acute angle of between about 30 degrees and about 50 degrees, the hook section having a deformable pre-formed curvature that extends from the proximal section back toward the axis of the component, the tip section being pre-formed to extend along a relatively straight line from the hook section to the rounded free distal end, and the tip section being oriented by the pre-formed curvature of the hook section, when un-deformed, to extend toward the axis of the component, such that the tip section and the proximal section enclose an angle in a range from about 70 degrees to about 120 degrees; and
wherein, when the device, having the fixation component fixedly attached thereto, is loaded within a tubular sidewall of a delivery tool, so that the rounded free distal end of each tine of the component engages an inner surface of the sidewall in proximity to a distal opening of the tool, to hold the proximal, spring portion of each tine of the component in a spring-loaded condition, each tip section of the distal portion extends away from the axis of the component at an acute angle in a range from about 45 degrees to about 75 degrees for deployment of the corresponding rounded free distal end out from the distal opening of the tool tubular sidewall; and
upon deployment of the rounded free distal end of each tine, the tip section of each distal portion rotates away from the axis to approach an angle of 90 degrees, relative to the axis, in response to an initial release of the spring-loaded condition of the corresponding proximal, spring portion.
2. The component of claim 1 , wherein each tine has a constant thickness of about 0.005 inch and a width no less than about 0.02 inch.
3. The component of claim 2 , wherein the width of each tine tapers from a greater width in proximity to the base to a lesser width in proximity to the hook section of the distal portion.
4. The component of claim 3 , wherein the rounded free distal end of each tine has an enlarged width relative to a remainder of the tip section of the corresponding distal portion.
5. The component of claim 1 , wherein the spring-biased pre-formed curvature of the proximal, spring portion of each tine is defined by a single radius, the radius being between about 0.06 inch and about 0.08 inch.
6. The component of claim 1 , wherein the tip section of the distal portion of each tine has a length of about 0.06 inch.
7. The component of claim 1 , wherein the proximal section of the distal portion of each tine has a length of about 0.1 inch.
8. The component of claim 1 , wherein the deformable pre-formed curvature of the hook section of the distal portion of each tine is defined by a single radius, when un-deformed, the radius being about 0.05 inch.
9. The component of claim 1 , wherein the acute angle of the relatively straight line of the proximal section of the distal portion of each tine is about 45 degrees.
10. The component of claim 1 , wherein the deformable pre-formed curvature of the hook section of the distal portion of each tine, when un-deformed, orients the corresponding tip section to enclose, with the corresponding proximal section, an angle of no less than about 90 degrees.
11. The component of claim 1 , wherein:
the deformable pre-formed curvature of the hook section of the distal portion of each tine, when un-deformed, is defined by two radii and a straight length extending therebetween, the straight length being about 0.04 inch; and
the proximal section of the distal portion of each tine has a length of about 0.085 inch.
12. An implantable medical device having a longitudinal axis and including a housing, an electrode, and a fixation mechanism, the housing having a proximal end and a distal end, between which the longitudinal axis extends, the electrode being mounted in proximity to the housing distal end, and the fixation mechanism comprising a plurality of tines formed from an elastically deformable material, the tines being fixedly mounted and spaced from one another around a perimeter of the housing distal end, and wherein each tine of the fixation mechanism comprises:
a proximal, spring portion being fixedly attached to the device housing and having a spring-biased pre-formed curvature, the pre-formed curvature, in proximity to the housing, extending in a first direction, generally parallel to the axis of the device, and then sweeping laterally, outward from the axis; and
a distal portion including a proximal section, a hook section, and tip section terminated by a rounded free distal end, the proximal section extending from the proximal, spring portion and being pre-formed to extend in a second direction and along a relatively straight line to the hook section, the proximal section being oriented, by the spring-biased pre-formed curvature of the proximal, spring portion, so that the second direction is generally opposite the first direction, and the relatively straight line intersects the axis of the device at an acute angle of between about 30 degrees and about 50 degrees, the hook section having a deformable pre-formed curvature that extends from the proximal section back toward the axis of the device, the tip section being pre-formed to extend along a relatively straight line from the hook section to the rounded free distal end, and the tip section being oriented by the pre-formed curvature of the hook section, when un-deformed, to extend toward the axis of the device, such that the tip section and the proximal section enclose an angle in a range from about 70 degrees to about 120 degrees; and
wherein, when the device is loaded within a tubular sidewall of a delivery tool, so that the rounded free distal end of each tine of the fixation mechanism engages an inner surface of the sidewall in proximity to a distal opening of the tool, to hold the proximal, spring portion of each tine in a spring-loaded condition, each tip section of the distal portion extends away from the axis of the component at an acute angle in a range from about 45 degrees to about 75 degrees for deployment of the corresponding rounded free distal end out from the distal opening of the tool tubular sidewall; and
upon deployment of the rounded free distal end of each tine, the tip section of each distal portion rotates away from the axis to approach an angle of 90 degrees, relative to the axis, in response to an initial release of the spring-loaded condition of the corresponding proximal, spring portion.
13. The device of claim 12 , wherein each tine of the fixation mechanism has a constant thickness of about 0.005 inch and a width no less than about 0.02 inch, and the width of each tine tapers from a greater width in proximity to the device housing, where the tine is fixedly attached, to a lesser width in proximity to the hook section of the distal portion.
14. The device of claim 13 , wherein the rounded free distal end of each tine of the fixation mechanism has an enlarged width relative to a remainder of the tip section of the corresponding distal portion.
15. The device of claim 12 , wherein the spring-biased pre-formed curvature of the proximal, spring portion of each tine of the fixation mechanism is defined by a single radius, the radius being between about 0.06 inch and about 0.08 inch.
16. The device of claim 12 , wherein the tip section of the distal portion of each tine of the fixation mechanism has a length of about 0.06 inch.
17. The device of claim 12 , wherein the proximal section of the distal portion of each tine of the fixation mechanism has a length of about 0.1 inch.
18. The device of claim 12 , wherein the deformable pre-formed curvature of the hook section of the distal portion of each tine of the fixation mechanism is defined by a single radius, when un-deformed, the radius being about 0.05 inch.
19. The device of claim 12 , wherein the acute angle of the relatively straight line of the proximal section of the distal portion of each tine of the fixation mechanism is about 45 degrees.
20. The device of claim 12 , wherein the deformable pre-formed curvature of the hook section of the distal portion of each tine of the fixation mechanism, when un-deformed, orients the corresponding tip section to enclose, with the corresponding proximal section, an angle of no less than about 90 degrees.
21. The device of claim 12 , wherein:
the deformable pre-formed curvature of the hook section of the distal portion of each tine of the fixation mechanism, when un-deformed, is defined by two radii and a straight length extending therebetween, the straight length being about 0.04 inch; and
the proximal section of the distal portion of each tine of the fixation mechanism has a length of about 0.085 inch.
22. The device of claim 12 , wherein:
an intersection between the proximal, spring portion and the distal portion of each tine of the fixation mechanism is spaced distally from the housing distal end; and
the electrode is flush with, or spaced distally apart from the intersection between the proximal, spring portion and the distal portion of each tine by a distance in a range from about 0 mm to about 2 mm.
23. An implantable medical device having a longitudinal axis and including a housing, an electrode, and a fixation mechanism, the housing having a proximal end and a distal end, between which the longitudinal axis extends, the electrode being mounted in proximity to the housing distal end, and the fixation mechanism comprising a plurality of tines formed from an elastically deformable material, the tines being fixedly mounted and spaced from one another around a perimeter of the housing distal end, and wherein each tine of the fixation mechanism comprises:
a first segment fixedly attached to the device housing and extending therefrom;
a second segment extending from the first segment; and
a third segment, to which the second segment extends, the third segment having a rounded free distal end spaced from the perimeter of the device housing distal end; and
wherein the first segment has a spring-biased pre-formed curvature, the pre-formed curvature extending distally from the device housing distal end, and then sweeping laterally outward from the axis of the device and then proximally to the second segment;
the second segment is pre-formed to extend proximally along a relatively straight line to the third segment, the relatively straight line of the second segment being oriented, by the spring-biased preformed curvature of the first segment, to intersect the axis of the device at an acute angle of between about 30 degrees and about 50 degrees; and
the third segment has a deformable pre-formed curvature that extends back toward the axis of the device, such that, when the curvature of the third segment is un-deformed, the second and third segments enclose an angle in a range from about 70 degrees to about 120 degrees.
24. The device of claim 23 , wherein the acute angle of the relatively straight line of the second segment of each tine of the fixation mechanism is about 45 degrees.
25. The device of claim 23 , wherein the second and third segments of each tine of the fixation mechanism enclose an angle of no less than about 90 degrees, when the corresponding third segment is un-deformed.
26. The device of claim 23 , wherein:
an intersection between the first segment and the second segment of each tine of the fixation mechanism is spaced distally from the housing distal end; and
the electrode is flush with, or spaced distally apart from the intersection between the first segment and the second segment of each tine by a distance in a range from about 0 mm to about 2 mm.
27. A medical device system comprising an implantable medical device and a delivery tool, the device having a proximal end, a distal end and a longitudinal axis extending between the proximal and distal ends, the delivery tool including a tubular sidewall that defines a lumen into which the device may be loaded, the lumen having a distal opening through which the device may be deployed; and the device further comprising:
an electrode mounted in proximity to the distal end;
a fixation mechanism comprising a plurality of tines formed from an elastically deformable material, the tines being fixedly mounted and spaced from one another around a perimeter of the device distal end, and each tine comprising:
a first segment fixedly attached to the device and extending therefrom;
a second segment extending from the first segment; and
a third segment, to which the second segment extends, having a rounded free distal end spaced from the perimeter of the device distal end; and
wherein the first segment has a spring-biased pre-formed curvature, extending distally from the device distal end, and then sweeping laterally outward from the axis of the device and then proximally to the second segment;
the second segment is pre-formed to extend proximally along a relatively straight line to the third segment, the relatively straight line of the second segment being oriented, by the spring-biased preformed curvature of the first segment, to intersect the axis of the device at an acute angle of between about 30 degrees and about 50 degrees;
the third segment has a deformable pre-formed curvature that extends back toward the axis of the device such that, when the curvature of the third segment is un-deformed, the second and third segments enclose an angle in a range from about 70 degrees to about 120 degrees; and
the tines are each configured such that when the device is loaded in the lumen of the tool and the rounded free distal end of the third segment of each tine engages the delivery tool sidewall to hold the tines in a spring-loaded condition, the first segment of each tine becomes relatively straightened, and the third segment of each tine extends away from the axis of the device at an acute angle in a range from about 45 degrees to about 75 degrees.
28. The device system of claim 27 , wherein the tines are each configured such that, upon deployment of the third segments thereof, out from the distal opening of the tool, each third segment rotates away from the axis of the device to extend at an angle that approaches 90 degrees relative to the axis.
29. The device system of claim 27 , wherein the acute angle of the relatively straight line of the second segment of each tine of the device fixation mechanism is about 45 degrees.
30. The device system of claim 27 , wherein the second and third segments of each tine of the device fixation mechanism enclose an angle of no less than about 90 degrees, when the corresponding third segment is un-deformed.
31. The device system of claim 27 , wherein:
an intersection between the first segment and the second segment of each tine of the device fixation mechanism is spaced distally from the housing distal end; and
the electrode is flush with, or spaced distally apart from the intersection between the first segment and the second segment of each tine by a distance in a range from about 0 mm to about 2 mm.