Methods and apparatus for radially compressive shape memory implants
11678875 ยท 2023-06-20
Assignee
Inventors
Cpc classification
A61B17/10
HUMAN NECESSITIES
A61B17/0644
HUMAN NECESSITIES
A61B17/8085
HUMAN NECESSITIES
A61B2017/0641
HUMAN NECESSITIES
A61B17/068
HUMAN NECESSITIES
A61B17/0642
HUMAN NECESSITIES
A61B17/8019
HUMAN NECESSITIES
A61B17/8004
HUMAN NECESSITIES
A61B17/808
HUMAN NECESSITIES
A61B17/8014
HUMAN NECESSITIES
International classification
A61B17/68
HUMAN NECESSITIES
Abstract
A radially compressive implant, which includes a central vertical axis, is configured to transition between a natural shape and an insertion shape. A transition of the implant from the natural shape to the insertion shape facilitates the implant storing energy deliverable radially relative to the central vertical axis. A transition of the implant from the insertion shape toward the natural shape facilitates the implant delivering the energy stored therein radially relative to the central vertical axis. An implant delivery device in an implant engagement position is configured to engage the implant and constrain the implant in the insertion shape. The implant delivery device in an implant release position is configured to release the implant.
Claims
1. A radially compressive implant, comprising: a bridge including a central vertical axis, the bridge, comprising: a center section, a first bridge segment extending from the center section to an end thereof, the first bridge segment including an opening adjacent the end thereof, a second bridge segment extending from the center section to an end thereof, the second bridge segment including an opening adjacent the end thereof, a third bridge segment extending from the center section to an end thereof, the third bridge segment including an opening adjacent the end thereof, whereby the first bridge segment, the second bridge segment, and the third bridge segment at the ends thereof each define an interlock adapted to facilitate engagement of the implant with an implant delivery device, a first transition section located in the first bridge segment between the center section and the opening of the first bridge segment, a second transition section located in the second bridge segment between the center section and the opening of the second bridge segment, and a third transition section located in the third bridge segment between the center section and the opening of the third bridge segment; a first fixation member inserted through the opening of the first bridge segment at the end thereof; a second fixation member inserted through the opening of the second bridge segment at the end thereof; a third fixation member inserted through the opening of the third bridge segment at the end thereof; and the implant being transitionable between a natural shape and an insertion shape, wherein: a transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, and the third transition section being deformable to store energy whereby the first transition section, the second transition section, and the third transition section move the bridge from a natural form to an insertion form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, and the third transition section moves the third fixation member away from the central axis such that the first fixation member, the second fixation member, and the third fixation member diverge relative to the central axis as the first fixation member, the second fixation member, and the third fixation member progress from a natural position to an insertion position thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis, and a transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, and the third transition section delivering the energy stored therein whereby the first transition section, the second transition section, and the third transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, and the third transition section moves the third fixation member toward the central axis such that the first fixation member, the second fixation member, and the third fixation member converge relative to the central axis as the first fixation member, the second fixation member, and the third fixation member progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
2. The radially compressive implant of claim 1, wherein the first bridge segment, the second bridge segment, and the third bridge segment radially extend from the center section and are spaced symmetrically about the central vertical axis of the implant.
3. The radially compressive implant of claim 1, wherein the first bridge segment, the second bridge segment, and the third bridge segment are dimensionally identical.
4. The radially compressive implant of claim 1, wherein the first fixation member, the second fixation member, and the third fixation member are spaced symmetrically about the central vertical axis of the implant in both the natural position and the insertion position.
5. The radially compressive implant of claim 1, wherein: the first fixation member, the second fixation member, and the third fixation member in the natural position reside from the central vertical axis at a first distance; and the first fixation member, the second fixation member, and the third fixation member in the insertion position reside from the central vertical axis at a second distance that is greater than the first distance.
6. The radially compressive implant of claim 1, wherein the bridge defines an aperture at the central vertical axis of the implant.
7. The radially compressive implant of claim 1, wherein: the first fixation member, the second fixation member, and the third fixation member in the natural position reside from the central vertical axis at a first angle measured from a plane perpendicular to the central vertical axis; and the first fixation member, the second fixation member, and the third fixation member in the insertion position reside from the central vertical axis at a second angle measured from a plane perpendicular to the central vertical axis that is greater than the first angle.
8. The radially compressive implant of claim 1, wherein: the first fixation member comprises a first screw inserted through the opening of the first bridge segment at the end thereof; the second fixation member comprises a second screw inserted through the opening of the second bridge segment at the end thereof; and the third fixation member comprises a third screw inserted through the opening of the third bridge segment at the end thereof.
9. The radially compressive implant of claim 8, wherein: the transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, and the third transition section being deformable to store energy whereby the first transition section, the second transition section, and the third transition section move the bridge from the natural form to the insertion form, further whereby the first transition section moves the first screw, the second transition section moves the second screw, and the third transition section moves the third screw away from the central axis such that the first screw, the second screw, and the third screw diverge relative to the central axis as the first screw, the second screw, and the third screw progress from the natural position to the insertion position thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis; and the transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, and the third transition section delivering the energy stored therein whereby the first transition section, the second transition section, and the third transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first screw, the second transition section moves the second screw, and the third transition section moves the third screw toward the central axis such that the first screw, the second screw, and the third screw converge relative to the central axis as the first screw, the second screw, and the third screw progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
10. The radially compressive implant of claim 1, the implant, comprising: the bridge, comprising: a fourth bridge segment extending from the center section to an end thereof, the fourth bridge segment including an opening adjacent the end thereof, a fifth bridge segment extending from the center section to an end thereof, the fifth bridge segment including an opening adjacent the end thereof, whereby the first bridge segment, the second bridge segment, the third bridge segment, the fourth bridge segment, and the fifth bridge segment are spaced symmetrically about the central vertical axis of the implant, a fourth transition section located in the fourth bridge segment between the center section and the opening of the fourth bridge segment, and a fifth transition section located in the fifth bridge segment between the center section and the opening of the fifth bridge segment; a fourth fixation member insertable through the opening of the fourth bridge segment at the end thereof; a fifth fixation member insertable through the opening of the fifth bridge segment at the end thereof; and the implant being transitionable between the natural shape and the insertion shape, wherein: the transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section being deformable to store energy whereby the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section move the bridge from the natural form to the insertion form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, the third transition section moves the fourth fixation member, the fourth transition section moves the fourth fixation member, and the fifth transition section moves the fifth fixation member away from the central axis such that the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member diverge relative to the central axis as the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member progress from the natural position to the insertion position thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis, and the transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section delivering the energy stored therein whereby the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, the third transition section moves the third fixation member, the fourth transition section, and the fifth transition section moves the fifth fixation member toward the central axis such that the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member converge relative to the central axis as the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
11. The radially compressive implant of claim 10, wherein the fourth bridge segment and the fifth bridge segments at the ends thereof each define an interlock adapted along with the interlocks of the first bridge segment, the second bridge segment, and the third bridge segment to facilitate engagement of the implant with an implant delivery device.
12. A radially compressive implant, comprising: a bridge including a central vertical axis, the bridge, comprising: a center section, a first bridge segment extending from the center section to an end thereof, the first bridge segment including an opening adjacent the end thereof, a second bridge segment extending from the center section to an end thereof, the second bridge segment including an opening adjacent the end thereof, a third bridge segment extending from the center section to an end thereof, the third bridge segment including an opening adjacent the end thereof, a first transition section located in the first bridge segment between the center section and the opening of the first bridge segment, a second transition section located in the second bridge segment between the center section and the opening of the second bridge segment, and a third transition section located in the third bridge segment between the center section and the opening of the third bridge segment; a first fixation member inserted through the opening of the first bridge segment at the end thereof; a second fixation member inserted through the opening of the second bridge segment at the end thereof; a third fixation member inserted through the opening of the third bridge segment at the end thereof; and the implant being transitionable between a natural shape and an insertion shape, wherein: a transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, and the third transition section being deformable to store energy whereby the first transition section, the second transition section, and the third transition section move the bridge from a natural form to an insertion form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, and the third transition section moves the third fixation member away from the central axis such that the first fixation member, the second fixation member, and the third fixation member diverge relative to the central axis as the first fixation member, the second fixation member, and the third fixation member progress from a natural position whereby the first fixation member, the second fixation member, and the third fixation member reside from the central vertical axis at a first angle measured from a plane perpendicular to the central vertical axis to an insertion position whereby the first fixation member, the second fixation member, and the third fixation member reside from the central vertical axis at a second angle measured from the plane perpendicular to the central vertical axis that is greater than the first angle thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis, and a transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, and the third transition section delivering the energy stored therein whereby the first transition section, the second transition section, and the third transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, and the third transition section moves the third fixation member toward the central axis such that the first fixation member, the second fixation member, and the third fixation member converge relative to the central axis as the first fixation member, the second fixation member, and the third fixation member progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
13. The radially compressive implant of claim 12, wherein the first bridge segment, the second bridge segment, and the third bridge segment radially extend from the center section and are spaced symmetrically about the central vertical axis of the implant.
14. The radially compressive implant of claim 12, wherein the first bridge segment, the second bridge segment, and the third bridge segment are dimensionally identical.
15. The radially compressive implant of claim 12, wherein the first fixation member, the second fixation member, and the third fixation member are spaced symmetrically about the central vertical axis of the implant in both the natural position and the insertion position.
16. The radially compressive implant of claim 12, wherein: the first fixation member, the second fixation member, and the third fixation member in the natural position reside from the central vertical axis at a first distance; and the first fixation member, the second fixation member, and the third fixation member in the insertion position reside from the central vertical axis at a second distance that is greater than the first distance.
17. The radially compressive implant of claim 12, wherein the bridge defines an aperture at the central vertical axis of the implant.
18. The radially compressive implant of claim 12, wherein the first bridge segment, the second bridge segment, and the third bridge segment at the ends thereof each define an interlock adapted to facilitate engagement of the implant with an implant delivery device.
19. The radially compressive implant of claim 12, wherein: the first fixation member comprises a first screw inserted through the opening of the first bridge segment at the end thereof; the second fixation member comprises a second screw inserted through the opening of the second bridge segment at the end thereof; and the third fixation member comprises a third screw inserted through the opening of the third bridge segment at the end thereof.
20. The radially compressive implant of claim 19, wherein: the transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, and the third transition section being deformable to store energy whereby the first transition section, the second transition section, and the third transition section move the bridge from the natural form to the insertion form, further whereby the first transition section moves the first screw, the second transition section moves the second screw, and the third transition section moves the third screw away from the central axis such that the first screw, the second screw, and the third screw diverge relative to the central axis as the first screw, the second screw, and the third screw progress from the natural position to the insertion position thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis; and the transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, and the third transition section delivering the energy stored therein whereby the first transition section, the second transition section, and the third transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first screw, the second transition section moves the second screw, and the third transition section moves the third screw toward the central axis such that the first screw, the second screw, and the third screw converge relative to the central axis as the first screw, the second screw, and the third screw progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
21. The radially compressive implant of claim 12, the implant, comprising: the bridge, comprising: a fourth bridge segment extending from the center section to an end thereof, the fourth bridge segment including an opening adjacent the end thereof, a fifth bridge segment extending from the center section to an end thereof, the fifth bridge segment including an opening adjacent the end thereof, whereby the first bridge segment, the second bridge segment, the third bridge segment, the fourth bridge segment, and the fifth bridge segment are spaced symmetrically about the central vertical axis of the implant, a fourth transition section located in the fourth bridge segment between the center section and the opening of the fourth bridge segment, and a fifth transition section located in the fifth bridge segment between the center section and the opening of the fifth bridge segment; a fourth fixation member insertable through the opening of the fourth bridge segment at the end thereof; a fifth fixation member insertable through the opening of the fifth bridge segment at the end thereof; and the implant being transitionable between the natural shape and the insertion shape, wherein: the transition of the implant from the natural shape to the insertion shape includes the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section being deformable to store energy whereby the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section move the bridge from the natural form to the insertion form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, the third transition section moves the fourth fixation member, the fourth transition section moves the fourth fixation member, and the fifth transition section moves the fifth fixation member away from the central axis such that the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member diverge relative to the central axis as the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member progress from the natural position to the insertion position thereby facilitating the implant storing energy deliverable radially relative to the central vertical axis, and the transition of the implant from the insertion shape toward the natural shape includes the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section delivering the energy stored therein whereby the first transition section, the second transition section, the third transition section, the fourth transition section, and the fifth transition section move the bridge from the insertion form toward the natural form, further whereby the first transition section moves the first fixation member, the second transition section moves the second fixation member, the third transition section moves the third fixation member, the fourth transition section, and the fifth transition section moves the fifth fixation member toward the central axis such that the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member converge relative to the central axis as the first fixation member, the second fixation member, the third fixation member, the fourth fixation member, and the fifth fixation member progress from the insertion position toward the natural position thereby facilitating the implant delivering the energy stored therein radially relative to the central vertical axis.
22. The radially compressive implant of claim 21, wherein the first bridge segment, the second bridge segment, the third bridge segment, the fourth bridge segment, and the fifth bridge segments at the ends thereof each define an interlock adapted to facilitate engagement of the implant with an implant delivery device.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(50) As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Figures are not necessarily to scale, and some features may be exaggerated to show details of particular components or steps.
(51)
(52) The implant 5 in the first embodiment includes a bridge 8 defining an aperture 9 at a central vertical axis 10 of the implant 5. The bridge 8 includes a center section 11 defining the aperture 9 at the central vertical axis 10 and a first bridge segment 12 extending from the center section 11 to an end 15 thereof, a second bridge segment 13 extending from the center section 11 to an end 16 thereof, and a third bridge segment 14 extending from the center section 11 to an end 17 thereof. The bridge 8 of the implant 5 according to the first embodiment includes a transition section 18 located in the first bridge segment 12 at the end 15 thereof, a transition section 19 located in the second bridge segment 13 at the end 16 thereof, and a transition section 20 located in the third bridge segment 14 at the end 17 thereof. The first bridge segment 12, the second bridge segment 13, and the third bridge segment 14 in the first embodiment are symmetrical in that the first, second, and third bridge segments 12-14 radially extend from the center section 11 and are spaced about the central vertical axis 10 equidistant or at least substantially equidistant in order for the implant 5 to provide optimal radial compression. Moreover, the symmetry of the first bridge segment 12, the second bridge segment 13, and the third bridge segment 14 includes the first, second, and third bridge segments 12-14 being dimensionally identical or at least substantially, dimensionally identical; particularly with respect to length.
(53) The implant 5 in the first embodiment includes a fixation member in the form of a leg 25 extending from the transition section 18 of the first bridge segment 12 at its end 15, a fixation member in the form of a leg 26 extending from the transition section 19 of the second bridge segment 13 at its end 16, and a fixation member in the form of a leg 27 extending from the transition section 20 of the third bridge segment 14 at its end 17. In the first embodiment, the leg 25 is formed integrally with the first bridge segment 12 at the transition section 18, the leg 26 is formed integrally with the second bridge segment 13 at the transition section 19, and the leg 27 is formed integrally with the third bridge segment 14 at the transition section 20. The fixation members in the form of the legs 25-27 in the first embodiment, due to the configuration of the bridge 8 whereby the first, second, and third bridge segments 12-14, which include the transition sections 18-20, respectively, at the ends 15-18, are spaced apart substantially equidistant about the central vertical axis 10, also are spaced about the central vertical axis 10 equidistant or at least substantially equidistant. Each leg 25-27, which has a respective tip 28-30, may include barbs thereon that improve the pull-out resistance of the implant 5. The implant 5 includes the fixation members in the form of the legs 25-27 in order to facilitate a securing of the implant 5 with bone, bones, or bone pieces whereby the bridge 8 between the legs 25-27 traverses a fixation zone central relative to the bone, bones, or bone pieces such that the implant 5, after its insertion and attempted transition from the insertion shape 7 to the natural shape 6, delivers energy to the bone, bones, or bone pieces at their centrally located fixation zone.
(54) Referring to
(55) Since the insertion shape 7 is not the regular inherent shape of the implant 5, the implant 5 typically is mechanically constrained using an implant delivery device that maintains the bridge 8 in its insertion form and the legs 25-27 in their insertion position. The bridge 8 includes the aperture 9 in order to facilitate engagement of an implant delivery device of the present invention with the implant 5. Upon deformation of the transition sections 18-20, the implant delivery device passes through the aperture 9 while also engaging the legs 25-27 adjacent the transition sections 18-20 thereby constraining the legs 25-27 and thus the deformed transition sections 18-20 such that the implant delivery device maintains the implant 5 in its insertion shape 7.
(56) After implantation of the implant 5 in its insertion shape 7 into bone, bones, or bone pieces and a release thereof, including, if necessary, a heating of the implant 5, the implant 5 in an attempted transition to its natural shape 6 delivers the energy stored in the transition sections 18-20, resulting in the bridge 8, due to the transition sections 18-20, attempting to transition from its insertion form to its natural form. The legs 25-27, accordingly, attempt to move from their insertion position to their natural position whereby the implant 5 affixes the bone, bones, or bone pieces through an application of a radial compressive force thereto. More particularly, each transition section 18-20 attempts to move a respective leg 25-27 appended thereto linearly toward the central vertical axis 10 such that the implant 5 through this attempted convergence of the legs 25-27 imparts a radial compressive force to the bone, bones, or bone pieces.
(57) The implant 5 in the first embodiment applies a continuously compressive radial force to the bone, bones, or bone pieces at a central fixation zone thereby facilitating a fixation thereof due to the symmetrical arrangement of the bridge segments 12-14 about the central vertical axis 10 and the transition sections 18-20 that impart, respectively, linear movement to the legs 25-27 relative to the central vertical axis 10. In accordance therewith, the legs 25-27 diverge from the central vertical axis 10 when transitioning from their natural position to their insertion position and converge toward the central vertical axis 10 when transitioning from their insertion position to their natural position such that the legs 25-27 are spaced apart substantially equidistant about the central vertical axis 10 in both their natural and insertion positions. Consequently, upon implantation of the implant 5 in its insertion shape 7 into the bone, bones, or bone pieces with the bridge 8 traversing a central fixation zone of the bone, bones, or bone pieces followed by a release of the implant 5, the transition sections 18-20, respectively, impart the energy stored therein to the legs 25-27 such that the legs 25-27 attempt linear movement resulting in an attempted convergence of the legs 25-27 toward the central vertical axis 10 whereby the implant 5, via the attempted transition from its insertion shape 7 to its natural shape 6 due to the transition sections 18-20 and the attempted convergence of the legs 25-27, applies a continuously compressive radial force to the bone, bones, or bone pieces at the central fixation zone in order to fixate the bone, bones, or bone pieces at the central fixation zone.
(58)
(59) The implant 50 in the second embodiment includes a bridge 53 defining an aperture 54 at a central vertical axis 55 of the implant 50. The bridge 53 includes a center section 56 defining the aperture 54 at the central vertical axis 55 and a first bridge segment 57 extending from the center section 56 to an end 61 thereof, a second bridge segment 58 extending from the center section 56 to an end 62 thereof, a third bridge segment 59 extending from the center section 56 to an end 63 thereof, and a fourth bridge segment 60 extending from the center section 56 to an end 64 thereof. The bridge 53 of the implant 50 according to the second embodiment includes a transition section 65 located in the first bridge segment 57 at the end 61 thereof, a transition section 66 located in the second bridge segment 58 at the end 62 thereof, a transition section 67 located in the third bridge segment 59 at the end 63 thereof, and a transition section 68 located in the fourth bridge segment 60 at the end 64 thereof. The first bridge segment 57, the second bridge segment 58, the third bridge segment 59, and the fourth bridge segment 60 in the second embodiment are symmetrical in that the first, second, third, and fourth bridge segments 57-60 radially extend from the center section 56 and are spaced about the central vertical axis 55 equidistant or at least substantially equidistant in order for the implant 50 to provide optimal radial compression. Moreover, the symmetry of the first bridge segment 57, the second bridge segment 58, the third bridge segment 59, and the fourth bridge segment 60 includes the first, second, third, and fourth bridge segments 57-60 being dimensionally identical or at least substantially, dimensionally identical; particularly with respect to length.
(60) The implant 50 in the second embodiment includes a fixation member in the form of a leg 69 extending from the transition section 65 of the first bridge segment 57 at its end 61, a fixation member in the form of a leg 70 extending from the transition section 66 of the second bridge segment 58 at its end 62, a fixation member in the form of a leg 71 extending from the transition section 67 of the third bridge segment 59 at its end 63, and a fixation member in the form of a leg 72 extending from the transition section 68 of the fourth bridge segment 60 at its end 64. In the second embodiment, the leg 69 is formed integrally with the first bridge segment 57 at the transition section 65, the leg 70 is formed integrally with the second bridge segment 58 at the transition section 66, the leg 71 is formed integrally with the third bridge segment 59 at the transition section 67, and the leg 72 is formed integrally with the fourth bridge segment 60 at the transition section 68. The fixation members in the form of the legs 69-72 in the second embodiment, due to the configuration of the bridge 53 whereby the bridge segments 57-60, which include the transition sections 65-68, respectively, at the ends 61-64, are spaced apart substantially equidistant about the central vertical axis 55, also are spaced about the central vertical axis 55 equidistant or at least substantially equidistant. Each leg 69-72, which has a respective tip 73-76, may include barbs thereon that improve the pull-out resistance of the implant 50. The implant 50 includes the fixation members in the form of the legs 69-72 in order to facilitate a securing of the implant 50 with bone, bones, or bone pieces whereby the bridge 53 between the legs 69-72 traverses a fixation zone central relative to the bone, bones, or bone pieces such that the implant 50, after its insertion and attempted transition from the insertion shape 52 to the natural shape 51, delivers energy to the bone, bones, or bone pieces at their centrally located fixation zone.
(61) Referring to
(62) Since the insertion shape 52 is not the regular inherent shape of the implant 50, the implant 50 typically is mechanically constrained using an implant delivery device that maintains the bridge 53 in its insertion form and the legs 69-72 in their insertion position. The bridge 53 includes the aperture 54 in order to facilitate engagement of an implant delivery device of the present invention with the implant 50. Upon deformation of the transition sections 65-68, the implant delivery device passes through the aperture 54 while also engaging the legs 69-72 adjacent the transition sections 65-68 thereby constraining the legs 69-72 and thus the deformed transition sections 65-68 such that the implant delivery device maintains the implant 50 in its insertion shape 52.
(63) After implantation of the implant 50 in its insertion shape 52 into bone, bones, or bone pieces and a release thereof, including, if necessary, a heating of the implant 50, the implant 50 in an attempted transition to its natural shape 51 delivers the energy stored in the transition sections 65-68, resulting in the bridge 53, due to the transition sections 65-68, attempting to transition from its insertion form to its natural form. The legs 69-72, accordingly, attempt to move from their insertion position to their natural position whereby the implant 50 affixes the bone, bones, or bone pieces through an application of a radial compressive force thereto. More particularly, each transition section 65-68 attempts to move a respective leg 69-72 appended thereto linearly toward the central vertical axis 55 such that the implant 50 through this attempted convergence of the legs 69-72 imparts a radial compressive force to the bone, bones, or bone pieces.
(64) The implant 50 in the second embodiment applies a continuously compressive radial force to the bone, bones, or bone pieces at a central fixation zone thereby facilitating a fixation thereof due to the symmetrical arrangement of the bridge segments 57-60 about the central vertical axis 55 and the transition sections 65-68 that impart, respectively, linear movement to the legs 69-72 relative to the central vertical axis 55. In accordance therewith, the legs 69-72 diverge from the central vertical axis 55 when transitioning from their natural position to their insertion position and converge toward the central vertical axis 55 when transitioning from their insertion position to their natural position such that the legs 69-72 are spaced apart substantially equidistant about the central vertical axis 55 in both their natural and insertion positions. Consequently, upon implantation of the implant 50 in its insertion shape 52 into the bone, bones, or bone pieces with the bridge 53 traversing a central fixation zone of the bone, bones, or bone pieces followed by a release of the implant 50, the transition sections 65-68, respectively, impart the energy stored therein to the legs 69-72 such that the legs 69-72 attempt linear movement resulting in an attempted convergence of the legs 69-72 toward the central vertical axis 55 whereby the implant 50, via the attempted transition from its insertion shape 52 to its natural shape 51 due to the transition sections 65-68 and the attempted convergence of the legs 69-72, applies a continuously compressive radial force to the bone, bones, or bone pieces at the central fixation zone in order to fixate the bone, bones, or bone pieces at the central fixation zone. Although the implant 5 according to the first embodiment discloses three legs 25-27 and the implant 50 according to the second embodiment discloses four legs 69-72, one of ordinary skill in the art will recognize an implant including more than four legs will function to continuously and radially compresses bone, bones, or bone pieces to promote a fusion thereof.
(65)
(66) The implant 80 in the third embodiment includes a bridge 83 defining an aperture 84 at a central vertical axis 85 of the implant 80. The bridge 83 includes a center section 86 defining the aperture 84 at the central vertical axis 85 and a first bridge segment 87 extending from the center section 86 to an end 92 thereof, a second bridge segment 88 extending from the center section 86 to an end 93 thereof, a third bridge segment 89 extending from the center section 86 to an end 94 thereof, a fourth bridge segment 90 extending from the center section 86 to an end 95 thereof, and a fifth bridge segment 91 extending from the center section 86 to an end 96 thereof. The bridge 83 of the implant 80 according to the third embodiment includes an opening 97 disposed in the first bridge segment 87 adjacent the end 92 thereof, an opening 98 disposed in the second bridge segment 88 adjacent the end 93 thereof, an opening 99 disposed in the third bridge segment 89 adjacent the end 94 thereof, an opening 100 disposed in the fourth bridge segment 90 adjacent the end 95 thereof, and an opening 101 disposed in the fifth bridge segment 91 adjacent the end 96 thereof. The openings 97-101 in the third embodiment each include an interlock feature in the form of threads that facilitate an engagement of the openings 97-101 with a fixation member. The bridge 83 of the implant 80 according to the third embodiment includes a transition section 102 located in the first bridge segment 87 between the center section 86 and the opening 97, a transition section 103 located in the second bridge segment 88 between the center section 86 and the opening 98, a transition section 104 located in the third bridge segment 89 between the center section 86 and the opening 99, a transition section 105 in the fourth bridge segment 90 between the center section 86 and the opening 100, and a transition section 106 in the fifth bridge segment 91 between the center section 86 and the opening 101. Each of the first, second, third, fourth, and fifth bridge segments 87-91 at their respective ends 92-96 includes an interlock 107 that facilitates engagement of the implant 80 with an implant delivery device. The interlocks 107 in the third embodiment each include an engagement interface 108, which is a flat surface in the respective ends 92-96 of the bridge segments 87-91, and a detent 109 disposed beneath the engagement interface 108. The first bridge segment 87, the second bridge segment 88, the third bridge segment 89, the fourth bridge segment 90, and the fifth bridge segment 91 in the third embodiment are symmetrical in that the first, second, third, fourth, and fifth bridge segments 87-91 radially extend from the center section 86 and are spaced about the central vertical axis 85 equidistant or at least substantially equidistant in order for the implant 80 to provide optimal radial compression. Moreover, the symmetry of the first bridge segment 87, the second bridge segment 88, the third bridge segment 89, the fourth bridge segment 90, and the fifth bridge segment 91 includes the first, second, third, fourth, and fifth bridge segments 87-91 being dimensionally identical or at least substantially, dimensionally identical; particularly with respect to length.
(67) The implant 80 in the third embodiment includes a fixation member in the form of a screw 110 configured to insert through the opening 97 disposed in the first bridge segment 87 adjacent the end 92 thereof while also engaging the interlock feature of the opening 97, a fixation member in the form of a screw 111 configured to insert through the opening 98 disposed in the second bridge segment 88 adjacent the end 93 thereof while also engaging the interlock feature of the opening 98, a fixation member in the form of a screw 112 configured to insert through the opening 99 disposed in the third bridge segment 89 adjacent the end 94 thereof while also engaging the interlock feature of the opening 99, a fixation member in the form of a screw 113 configured to insert through the opening 100 disposed in the fourth bridge segment 90 adjacent the end 95 thereof while also engaging the interlock feature of the opening 100, and a fixation member in the form of a screw 114 configured to insert through the opening 101 disposed in the fifth bridge segment 91 adjacent the end 96 thereof while also engaging the interlock feature of the opening 101. The screws 110-114 in the third embodiment comprising the fixation members may include any suitable screw such as a non-locking or locking bone screw including a self-tapping bone screw. The fixation members in the form of the screws 110-114 in the third embodiment, due to the configuration of the bridge 83 whereby the bridge segments 87-91, which include the transition sections 102-106, respectively, between the center section 86 and the ends 92-96, are spaced apart substantially equidistant about the central vertical axis 85, also are spaced about the central vertical axis 85 equidistant or at least substantially equidistant. The implant 80 includes the fixation members in the form of the screws 110-114 in order to facilitate a securing of the implant 80 with bone, bones, or bone pieces whereby the bridge 83 between the screws 110-114 traverses a fixation zone central relative to the bone, bones, or bone pieces such that the implant 80, after its insertion and attempted transition from the insertion shape 82 to the natural shape 81, delivers energy to the bone, bones, or bone pieces at their centrally located fixation zone. Although the third embodiment of the implant 80 discloses the bridge 83 as including the first, second, third, fourth, and fifth bridge segments 87-91 with respective openings 97-101 disposed therein that receive a respective screw 110-114 therethrough, one of ordinary skill in the art will recognize the bridge 83 of the implant 80 will function to continuously and radially compresses bone, bones, or bone pieces to promote a fusion thereof utilizing only a first bridge segment, a second bridge segment, and a third bridge segment that are symmetrical whereby the first, second, and third bridge segments radially extend from the center section 86 and are spaced about the central vertical axis 85 equidistant or at least substantially equidistant. Moreover, one of ordinary skill in the art will recognize the bridge 83 of the implant 80 will function to continuously and radially compresses bone, bones, or bone pieces to promote a fusion thereof utilizing more than five bridge segments.
(68) Referring to
(69) Since the insertion shape 82 is not the regular inherent shape of the implant 80, the implant 80 typically is mechanically constrained using an implant delivery device that maintains the bridge 83 in its insertion form and thus the screws 110-114 in their insertion position. The bridge 83 at the respective ends 92-96 of the bridge segments 87-91 includes the interlocks 107 in order to facilitate engagement of an implant delivery device of the present invention with the implant 80. Upon deformation of the transition sections 102-106, the implant delivery device engages the bridge segments 87-91 via the interlocks 107 at the ends 92-96 thereby constraining the bridge 83 and thus the deformed transition sections 102-106 such that the implant delivery device maintains the implant 80 in its insertion shape 82.
(70) After implantation of the implant 80 in its insertion shape 82 into bone, bones, or bone pieces and a release thereof, including, if necessary, a heating of the implant 80, the implant 80 in an attempted transition to its natural shape 81 delivers the energy stored in the transition sections 102-106, resulting in the bridge 83, due to the transition sections 102-106, attempting to transition from its insertion form to its natural form. The screws 110-114, accordingly, attempt to move from their insertion position to their natural position whereby the implant 80 affixes the bone, bones, or bone pieces through an application of a radial compressive force thereto. More particularly, each transition section 102-106 attempts to move a respective screw 110-114 inserted through a respective opening 97-101 linearly toward the central vertical axis 85 such that the implant 80 through this attempted convergence of the screws 110-114 imparts a radial compressive force to the bone, bones, or bone pieces.
(71) The implant 80 in the third embodiment applies a continuously compressive radial force to the bone, bones, or bone pieces at a central fixation zone thereby facilitating a fixation thereof due to the symmetrical arrangement of the bridge segments 87-91 about the central vertical axis 85 and the transition sections 102-106 that impart, respectively, linear movement to the screws 110-114 relative to the central vertical axis 85. In accordance therewith, the screws 110-114 diverge from the central vertical axis 85 when transitioning from their natural position to their insertion position and converge toward the central vertical axis 85 when transitioning from their insertion position to their natural position such that the screws 110-114 are spaced apart substantially equidistant about the central vertical axis 85 in both their natural and insertion positions. Consequently, upon implantation of the implant 80 in its insertion shape 82 into the bone, bones, or bone pieces with the bridge 83 traversing a central fixation zone of the bone, bones, or bone pieces followed by a release of the implant 80, the transition sections 102-106, respectively, impart the energy stored therein to the screws 110-114 such that the screws 110-114 attempt linear movement resulting in an attempted convergence of the screws 110-114 toward the central vertical axis 85 whereby the implant 80, via the attempted transition from its insertion shape 82 to its natural shape 81 due to the transition sections 102-106 and the attempted convergence of the screws 110-114, applies a continuously compressive radial force to the bone, bones, or bone pieces at the central fixation zone in order to fixate the bone, bones, or bone pieces at the central fixation zone.
(72)
(73) The implant delivery device 125 about at a central vertical axis 130 thereof includes a barrel 131 with a first finger 132, a second finger 133, and a third finger 134 extending therefrom and a plunger 135 integrated with the barrel 131 and the first, second, and third fingers 132-134. The plunger 135 includes a shaft 136 with a head 137 atop a first or top end 138 of the shaft 136 and a protrusion 139 at a second or bottom end 140 of the shaft 136 and further a rod 141 extending from the protrusion 139 at a bottom 142 thereof. The plunger 135 includes the head 137 to restrict movement of the shaft 136 relative to the barrel 131 and the first, second, and third fingers 132-134. The plunger 135 includes the protrusion 139, which is preferably of a bulbous shape distended at the bottom 142, in order to facilitate an interface of the plunger 135 with the first, second, and third fingers 132-134. The plunger 135 includes the rod 141 to facilitate an interface of the plunger 135 with the first, second, and third fingers 132-134 and with an implant 5 according to the first embodiment.
(74) The barrel 131 includes a first or top end 143, a second or bottom end 144, and a channel 145 therebetween configured to receive therethrough the plunger 135 at the shaft 136. The first finger 132 extends from the second or bottom end 144 of the barrel 131 to a tip 146, the second finger 133 extends from the second or bottom end 144 of the barrel 131 to a tip 147, and the third finger 134 extends from the second or bottom end 144 of the barrel 131 to a tip 148. The extension of the first, second, and third fingers 132-134 from the second or bottom end 144 of the barrel 131 to a respective tip 146-148 forms a passageway 149 interior of the first, second, and third fingers 132-134 configured to receive therethrough the plunger 135 at the shaft 136, the protrusion 139, and the rod 141. More particularly, the first finger 132 includes a bend 150 beginning at a first or upper end 153 and stopping at a second or lower end 156, the second finger 133 includes a bend 151 beginning at a first or upper end 154 and stopping at a second or lower end 157, and the third finger 134 includes a bend 152 beginning at a first or upper end 155 and stopping at a second or lower end 158 in order to create an expansion 159 in the passageway 149 configured for the protrusion 139 of the plunger 135. The first finger 132, the second finger 133, and the third finger 134 preferably are symmetrical in that the first, second, and third fingers 132-134 are spaced about the central vertical axis 130 and the barrel 131 equidistant or at least substantially equidistant in order to facilitate interfacing of the first, second, and third fingers 132-134 with an implant 5. Moreover, the symmetry of the first, second, and third fingers 132-134 includes the first, second, and third fingers 132-134 being dimensionally identical or at least substantially, dimensionally identical; particularly with respect to length.
(75) The first finger 132 at the tip 146 thereof includes an abutment 160, the second finger 133 at a tip 147 thereof includes an abutment 161, and the third finger 134 at a tip 148 thereof includes an abutment 162. The abutments 160-162 preferably extend perpendicular to or at least substantially perpendicular to the first, second, third fingers 132-134, respectively, at the tips 146-148 thereof. The abutment 160 includes a rod interface 163 that faces toward the central vertical axis 130 and an implant interface 166 that resides opposite to the rod interface 163 and thus faces away from the central vertical axis 130. The abutment 161 includes a rod interface 164 that faces toward the central vertical axis 130 and an implant interface 167 that resides opposite to the rod interface 164 and thus faces away from the central vertical axis 130. The abutment 162 includes a rod interface 165 that faces toward the central vertical axis 130 and an implant interface 161 that resides opposite to the rod interface 165 and thus faces away from the central vertical axis 130. The abutments 160-162 include the rod interfaces 163-165 to facilitate an engagement of the abutments 160-162 in an abutting relationship with the rod 141 of the plunger 135 and the implant interfaces 166-168 to facilitate an engagement of the abutments 160-162 in an abutting relationship with the implant 5, and, in particular, respectively, with the legs 25-27 of the implant 5, such that the implant delivery device 125 constrains the implant 5 in the insertion shape 7. The rod interfaces 163-165 and the implant interfaces 166-168 of the abutments 160-162, preferably, and due to the symmetry of the first, second, and third fingers 132-134, are spaced about the central vertical axis 130 and the barrel 131 equidistant or at least substantially equidistant in order to facilitate engagement of the rod interfaces 163-165 with the rod 141 of the plunger 135 and the implant interfaces 166-168 with an implant 5, and, in particular, respectively, with the legs 25-27 of the implant 5.
(76) In integrating the plunger 135 with the barrel 131 and the first, second, and third fingers 132-134, the plunger 135 at the shaft 136 inserts through the channel 145 of the barrel 131 and into the passageway 149 defined by the first, second, and third fingers 132-134 while the head 137 atop the shaft 136 remains above the barrel 131 at the first or top end 143 thereof. The shaft 136 includes a length that locates the protrusion 139 of the plunger 135 in the expansion 159 of the passageway 149 created by the bends 150-152 of the first, second, and third fingers 132-134. Moreover, the rod 141 of the plunger 135 includes a length that permits the rod to interface with an implant 5 and with the abutments 160-162 of the first, second, and third fingers 132-134 at the rod interfaces 163-165.
(77) When the implant delivery device 125 resides in the implant release position 126 as illustrated in
(78) Conversely, when the implant delivery device 125 resides in the implant engagement position 127 as illustrated in
(79) In order for the implant delivery device 125 to transition between the implant release position 126 and the implant engagement position 127, the implant delivery device 125 includes the transitional position 128 illustrated in
(80) The implant delivery device 125, when loaded with an implant 5 according to the first embodiment whereby the implant delivery device 125 in the implant engagement position 127 as illustrated in
(81) The implant delivery device 125, when residing in the implant release position 126 as illustrated in
(82) As illustrated in
(83) The fourth finger 176 extends from the second or bottom end 144 of the barrel 131 to a tip 177. The extension of the first, second, third, and fourth fingers 132-134 and 176 from the second or bottom end 144 of the barrel 131 to a respective tip 146-148 and 177 forms the passageway 149 interior of the first, second, third, and fourth fingers 132-134 and 176 configured to receive therethrough the plunger 135 at the shaft 136, the protrusion 139, and the rod 141. More particularly, the fourth finger 176 includes a bend 178 beginning at a first or upper end 179 and stopping at a second or lower end 180 in order to create with the bends 150-152 of the first, second, and third fingers 132-134 the expansion 159 in the passageway 149 configured for the protrusion 139 of the plunger 135. The first finger 132, the second finger 133, the third finger 134, and the fourth finger 176 preferably are symmetrical in that the first, second, third, and fourth fingers 132-134 and 176 are spaced about the central vertical axis 130 and the barrel 131 equidistant or at least substantially equidistant in order to facilitate interfacing of the first, second, third, and fourth fingers 132-134 and 176 with an implant 50. Moreover, the symmetry of the first, second, third, and fourth fingers 132-134 and 176 includes the first, second, third, and fourth fingers 132-134 and 176 being dimensionally identical or at least substantially, dimensionally identical; particularly with respect to length.
(84) The fourth finger 176 at the tip 177 thereof includes an abutment 181 that preferably extends perpendicular to or at least substantially perpendicular to the fourth finger 176 at the tip 177 thereof. The abutment 181 includes a rod interface 182 that faces toward the central vertical axis 130 and an implant interface 183 that resides opposite to the rod interface 182 and thus faces away from the central vertical axis 130. The abutment 181 includes the rod interface 182 to facilitate an engagement of the abutment 181 in an abutting relationship with the rod 141 of the plunger 135 and the implant interface 183 to facilitate an engagement of the abutment 181 in an abutting relationship with the implant 50, and, in particular, with one of the legs 69-72 of the implant 50, such that the implant delivery device 175 constrains the implant 50 in the insertion shape 52. The rod interfaces 163-165 and 182 and the implant interfaces 166-168 and 183 of the abutments 160-162 and 181, preferably, and due to the symmetry of the first, second, third, and fourth fingers 132-134 and 176, are spaced about the central vertical axis 130 and the barrel 131 equidistant or at least substantially equidistant in order to facilitate engagement of the rod interfaces 163-165 and 182 with the rod 141 of the plunger 135 and the implant interfaces 166-168 and 183 with an implant 50, and, in particular, respectively, with the legs 69-72 of the implant 50.
(85) In integrating the plunger 135 with the barrel 131 and the first, second, third, and fourth fingers 132-134 and 176, the plunger 135 at the shaft 136 inserts through the channel 145 of the barrel 131 and into the passageway 149 defined by the first, second, third, and fourth fingers 132-134 and 176 while the head 137 atop the shaft 136 remains above the barrel 131 at the first or top end 143 thereof. The shaft 136 includes a length that locates the protrusion 139 of the plunger 135 in the expansion 159 of the passageway 149 created by the bends 150-152 and 178 of the first, second, third, and fourth fingers 132-134 and 176. Moreover, the rod 141 of the plunger 135 includes a length that permits the rod to interface with an implant 50 and with the abutments 160-162 and 181 of the first, second, third, and fourth fingers 132-134 and 176 at the rod interfaces 163-165 and 183.
(86) The implant delivery device 175, when loaded with an implant 50 according to the second embodiment whereby the implant delivery device 175 in the implant engagement position 127 as illustrated in
(87) The implant delivery device 175, when residing in the implant release position 126 as illustrated in
(88) Based upon the foregoing, the implant delivery device 175 differs from the implant delivery device 125 primarily in that the implant delivery device 175 includes the fourth finger 176. In accordance therewith, the implant delivery device 175 is substantially similar in design and operation relative to the implant delivery device 125, except that the implant delivery device 175 is engageable with an implant 50 having the four legs 69-72.
(89)
(90) The implant delivery device 185 includes an implant holding ring 188 with a top 189, a bottom 190, an inner wall 191, and an outer wall 192. The implant holding ring 188 includes a split 193 whereby the implant holding ring 188 terminates in a first end 194 and a second end 195. The implant holding ring 188 includes a first or upper projection 196 with an aperture 198 therethrough extending from the first end 194 of the implant holding ring 188 at the top 189 thereof into the split 193 as well as away from the outer wall 192. The implant holding ring 188 includes a second or lower projection 197 with an aperture 199 therethrough, preferably threaded, extending from the second end 195 of the implant holding ring 188 at the bottom 190 thereof into the split 193 as well as away from the outer wall 192. The positioning of the first or upper projection 196 at the top 189 and the second or lower projection 197 at the bottom 190 permits a vertical alignment of the apertures 198 and 199. The implant holding ring 188 in the inner wall 191 at the bottom 190 includes an implant holding surface 200 configured to engage the first, second, third, fourth, and fifth bridge segments 87-91 of the implant 80 at their respective ends 92-96. More particularly, the implant holding surface 200 engages the interlocks 107 such that the implant holding surface 200 abuts the engagement interfaces 108 while the bottom 190 abuts the detents 109. The implant holding ring 188 includes a pivot member 201 across from the split 193 at the bottom 190 of the implant holding ring 188. The pivot member 201, which is produced by a slot 202 created in the implant holding ring 188 at the top 189 thereof, divides the implant holding ring 188 into first and second ring sections 203 and 204.
(91) The implant holding ring 188 and the pivot member 201 in particular preferably are manufactured from a resilient metal or plastic material that allows flexing of the implant holding ring 188 about the pivot member 201 in order to facilitate an expansion and a contraction of the implant holding ring 188. The implant holding ring 188 includes an open position 205 as illustrated in
(92) The implant delivery device 185 as illustrated in
(93) The implant delivery device 185, when loaded with an implant 80 according to the third embodiment whereby the implant delivery device 185 in the implant engagement position 187 as illustrated in
(94) The implant delivery device 185, when residing in the implant release position 186 as illustrated in
(95)
(96) The surgeon as illustrated in
(97) After withdrawing the implant delivery device 125 from the implant 5, the surgeon tamps the implant 5 at the bridge 8 until the implant 5 at the bridge 8 seats completely flush atop the first, second, and third bones 215-217 with the bridge 8 spanning the fusion zone 218. With the legs 25-27 respectively fully inserted into the first, second, and third bones 215-217 via the first, second, and third holes 219-221 and the bridge 8 seated completely flush atop the first, second, and third bones 215-217 across the fusion zone 218 as illustrated in
(98)
(99) The surgeon as illustrated in
(100) After securing the implant 80 atop the bones 225 using the screws 110-114, the surgeon transitions the implant delivery device 185 from the implant engagement position 187 to the implant release position 186 as previously described with reference to
(101) With the screws 110-114 fully inserted into the bones 225 and the bridge 83 seated atop the bones 225 across the fusion zone 226 as illustrated in
(102) Although the present invention has been described in terms of the foregoing preferred embodiments, such description has been for exemplary purposes only and, as will be apparent to those of ordinary skill in the art, many alternatives, equivalents, and variations of varying degrees will fall within the scope of the present invention. That scope, accordingly, is not to be limited in any respect by the foregoing detailed description; rather, it is defined only by the claims that follow.