Expanding implant with hinged arms

Abstract

An implant (500, 600) includes first and second arms (14a, 14b) hinged to a base (12) at spaced-apart locations. An actuator (18, 22a, 22b, 602, 604, 606) is deployed to rotate the arms from an initial position in opposing angular motion towards a final position. A rigid bridging element (28) bridges between the arms so that deployment of the arms towards the final position displaces the bridging element away from the base. Engagement between the bridging element and at least one of the arms is via a double pin-in-slot engagement in which two non-collinear pins (30, 40) are engaged in respective non-parallel slots (32, 42).

Claims

1. An implant comprising: (a) a base; (b) a first arm hinged to said base at a first hinge location and extending from said first hinge location in a direction of extension; (c) a second arm hinged to said base at a second hinge location and extending from said second hinge location in a direction of extension, said first and second arms assuming an initial state, and wherein said directions of extension of said first and second arms being convergent; (d) an actuator operatively linked to said first and second arms and operable to rotate said first and second arms from said initial state in opposing angular motion towards a final state, wherein said actuator comprises: a first actuator linkage hinged to said first arm; and a second actuator linkage hinged to said second arm, such that rotation of said actuator causes displacement of said first and second actuator linkages to generate motion of said first and second arms; (e) a rigid bridging element bridging between said first arm and said second arm such that deployment of said first and second arms from said initial state towards said final state displaces said bridging element away from said base, wherein engagement between said bridging element and at least one of said first arm and/or said second arm is via a double pin-in-slot engagement with two non-collinear pins engaged in respective non-parallel slots; and wherein said first arm further comprises a rear projection projecting beyond said hinge location in a direction away from said direction of extension, the implant further comprising a displaceable portion engaged with said rear projection such that rotation causes displacement of said bridging element in a first direction and of said displaceable portion in a second direction generally opposite to said first direction, and wherein said displaceable portion is pivotally linked to said base.

2. An implant comprising: (a) a base; (b) a first arm hinged to said base; (c) a second arm hinged to said base; (d) an actuator operatively linked to said first and second arms and operable to rotate said first and second arms; (e) a first actuator linkage hinged to said first arm; (f) a second actuator linkage hinged to said second arm, such that rotation of said actuator causes displacement of said first and second actuator linkages to generate motion of said first and second arms; and (g) a bridging element bridging between said first arm and said second arm, wherein said bridging element is a rigid bridging element engaged with said first and second arms by a pin-in-slot engagement; (h) wherein each of said first and second arms is hinged to said base at a hinge location, and extends from said hinge location in a direction of extension, said directions of extension of said first and second arms being convergent, wherein said first arm further comprises a rear projection projecting beyond said hinge location in a direction away from said direction of extension, the implant further comprising a displaceable portion engaged with said rear projection such that rotation causes displacement of said bridging element in a first direction and of said displaceable portion in a second direction generally opposite to said first direction, and wherein said displaceable portion is pivotally linked to said base.

3. An implant comprising: (a) a base having a length; (b) a first arm hinged to said base at a hinge location and extending from said hinge location in a first direction of extension, said first arm assuming an initial state in which said first direction of extension is at a first angle to said length, said first arm further comprising a rear projection projecting beyond said hinge location in a direction away from said first direction of extension; (c) a second arm hinged to said base at a second hinge location and extending from said second hinge location in a second direction of extension, said second arm assuming an initial state in which said second direction of extension is at a first angle to said length; (d) an actuator operatively linked to said first arm and said second arm and operable to rotate said first arm and said second arm from said initial state towards a deployed state in which said first direction of extension and said second direction of extension are at a second angle to said length greater than said first angle; (e) a bridging element bridging between said first arm and said second arm; (f) a displaceable portion engaged with said rear projection such that rotation of said first arm from said initial state towards said deployed state causes displacement of said displaceable portion relative to said base in a first direction and displacement of said bridging element relative to said base in a second direction opposite to said first direction; and (g) wherein at least one pin-in-slot engagement engages said bridging element to at least one of said first arm and/or said second arm.

4. The implant of claim 3, wherein said displaceable portion is pivotally linked to said base.

5. The implant of claim 3, wherein said first direction of extension of said first arm and said second direction of extension of said second arm converge in said initial state, said actuator being configured to rotate said second arm in an angular direction opposite to rotation of said first arm.

6. The implant of claim 3, wherein said second arm further comprises a rear projection projecting beyond said second hinge location in a direction away from said second direction of extension, and wherein said displaceable portion is engaged with said rear projection of said second arm.

7. The implant of claim 3, wherein said displaceable portion is implemented as a casing at least partially encompassing said base.

8. The implant of claim 3, wherein said bridging element is substantially parallel to said displaceable portion when said first arm is in said initial state and said deployed state.

9. The implant of claim 3, wherein said displaceable portion displaces a first distance in said first direction and said bridging element displaces a second distance in said second direction, wherein said first distance is less than said second distance.

10. The implant of claim 3, wherein said rear projection is a projecting tab.

11. The implant of claim 10, wherein said displaceable portion includes a recess, wherein said projecting tab engages said recess.

12. The implant of claim 3, wherein said actuator includes one or more actuator linkages hingedly connected to at least one of said first arm and/or said second arm.

13. The implant of claim 3, wherein two of said pin-in-slot engagements engage said bridging element to at least one of said first arm and/or said second arm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

(2) FIGS. 1A-1C are isometric views of an implant, constructed and operative according to an embodiment of the present invention, shown in a low-profile insertion state, a partially-expanded state and a fully-expanded state, respectively;

(3) FIGS. 2A-2C are cross-sectional views taken through the implant of FIGS. 1A-1C in the states of FIGS. 1A-1C, respectively;

(4) FIG. 2D is an enlarged view of the region of FIG. 2C identified by dashed rectangle “D”

(5) FIG. 3 is an exploded isometric view showing the parts of the implant of FIGS. 1A-1C;

(6) FIGS. 4A-4C are views similar to FIGS. 2A-2C illustrating a first variant implementation of the implant of FIGS. 1A-1C having asymmetric expansion;

(7) FIG. 5A is an isometric view of a second variant implementation of the implant of FIGS. 1A-1C;

(8) FIGS. 5B and 5C are cross-sectional views taken through the implant of FIG. 5A, shown in a low-profile insertion state and a fully-expanded state, respectively;

(9) FIGS. 6A and 6B are cross-sectional views taken through a further variant of the implant of FIG. 5A, shown in a partially-expanded state and a fully-expanded state, respectively;

(10) FIGS. 7A and 7B are schematic side views of a further variant implementation of an expanding implant shown in a partially-expanded state and a fully-expanded state, respectively;

(11) FIGS. 8A-8C are side views of a modified version of the implant of FIGS. 1A-1C illustrating a further aspect of the present invention for limiting sliding of a bridging element bridging between the arms, the implant being shown in a low-profile insertion state, a partially-expanded state and a fully-expanded state, respectively;

(12) FIG. 9A is a cross-sectional view taken along the line A-A in FIG. 8B;

(13) FIGS. 98 and 9C are cross-sectional views taken along the line B-B in FIG. 9A with the implant shown in a partially-expanded state and a fully-expanded state, respectively;

(14) FIGS. 10A-10C are side views of an expanding implant employing the arrangement for limiting sliding of a bridging element in the context of a worm-gear-actuated implant, the implant being shown in a low-profile insertion state, a partially-expanded state and a fully-expanded state, respectively;

(15) FIG. 11A is a cross-sectional view taken along the line A-A in FIG. 101; and

(16) FIGS. 11B and 11C are cross-sectional views taken along the line B-B in FIG. 11A with the implant shown in a partially-expanded state and a fully-expanded state, respectively.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(17) The present invention is an expanding implant with hinged arms.

(18) By way of introduction, reference is made to a range of implants described in PCT Patent Application Publication No. WO2015087285 in which one or more arms are pivotally connected to a base and are deployable to expand the implant from an initial state for insertion to an expanded state within the body. The WO2015087285 publication, which is commonly owned with the present invention and was unpublished at the priority date of this application, is not admitted as prior art except where defined as such under the applicable local law.

(19) The present invention relates to a number of variations, additions or improvements to the expanding implants described in the WO2015087285 publication particularly in three aspects, which are each of utility when used alone, but which may also be used to advantage in various combinations. A first aspect, exemplified herein with reference to the embodiments of FIGS. 1A-7B, relates to a deployment mechanism based on a threaded bolt arrangement. A second aspect relates to an additional displacement part (shown as a casing) which is deployed by rearward projections from the arms. This second aspect is also exemplified herein with reference to the embodiments of FIGS. 1A-71. A third aspect of the invention relates to an arrangement of pin-in-slot engagements between the arms and a bridging element between the arms. This third aspect is relevant to all embodiments illustrated herein, and is illustrated herein in the context of two exemplary embodiments in FIGS. 8A-11C.

(20) Turning now to the drawings, FIGS. 1A-3 illustrate an implant, generally designated 10, constructed and operative according to the teachings of an embodiment of the present invention. In general terms, implant 10 has a base 12, a first arm 14a hinged to the base at a hinge location 16a, and a second arm 14b hinged to the base at a hinge location 16b. According to a first aspect of the present invention, actuation of motion of the two arms is achieved by an actuator including a threaded bolt 18 extending within base 12 and mounted so as to be rotatable about a central axis 20 of threaded bolt 18. A first actuator linkage 22a is hinged to first arm 14a at a pivot point 24a and to a first threaded rider 26a engaged with threaded bolt 18. Similarly, a second actuator linkage 22a is hinged to second arm 14b at a pivot point 24b and to a second threaded rider 26b engaged with threaded bolt 18. In the configuration shown here, threaded bolt 18 includes a first portion 18a with a left-handed thread and a second portion 18b with a right-handed thread. These two portions may either be integrally formed as a single bolt, or bolt 18 may be assembled from two separate interlocked parts (as illustrated here). Rotation of threaded bolt 18 thus causes displacement of the first and second riders 26a. 26b in opposite directions. This motion displaces first and second actuator linkages 22a, 22b and hence generates motion of the first and second arms, reversibly, through the range of positions illustrated in FIGS. 1A-1C and 2A-2C.

(21) It should be noted that the use of a threaded-bolt actuator in this context may offer considerable advantages of simplicity, reliability, reversibility and/or capacity to bear loads. However, in the case of a pair of arms, the range of motion for each rider is inherently limited to less than half the length of base 12, and in practical terms, may be limited to not significantly more than a quarter of the base length. The geometry of connection of actuator linkages 22a and 22b is therefore preferably chosen according to the teachings of certain embodiments of the present invention to achieve mechanical amplification, i.e., where the end portion of each arm moves a greater distance than motion of the corresponding rider along the bolt.

(22) Specifically, referring to FIG. 21), a length L.sub.1 from hinge location 16a to pivot point 24a is preferably less than half a length L.sub.2 from hinge location 16a along a direction of extension of arm 14a to the end of the arm. Additionally, L is preferably less than the length L.sub.3 of actuator linkage 22a between its pivotal connection at pivot point 24a and its pivotal connection to rider 26a. The degree of mechanical amplification can be selected by suitable choice of the ratios of L.sub.1, L.sub.2 and L.sub.3, and will vary according to the intended application, the range of motion required, the load expected to be encountered, the load that can be applied to turn the bolt, and the strength of the materials used. In certain particularly preferred implementations, a ratio of L.sub.1 to L.sub.3 in the range of 50%-95% is used. Where greater mechanical amplification is required, ratios in the range of 20%-50%, or in the range of 20%-33%, or in the range of 10%-25%, each provide particular advantages for a corresponding set of applications. For the sake of precision, it is noted that pivot point 24a does not necessarily lie on the dashed line illustrating the “extensional direction” of the arm. The dimensions used to define L.sub.1 and L.sub.3 are specifically the inter-axis distances.

(23) Clearly, these considerations apply equally to the second arm 14b and its corresponding actuating components. In implant 10 as illustrated here, dimensions L.sub.1, L.sub.2 and L.sub.3 are the same for both arms 14a and 14b and the thread pitch of the two portions of bolt 18 is the same, resulting in symmetrical opening of the two arms. Referring briefly to FIGS. 4A-4C, these show an alternative implementation of an implant, generally designated 100, which is generally structurally and functionally similar to implant 10, with analogous elements labeled similarly. In this case, second actuator linkage 22b is shorter than first actuator linkage 22a, resulting in lesser mechanical amplification of the opening of second arm 14b and a corresponding asymmetric opening of implant 100, as seen in FIGS. 4B and 4C. It should be noted that the degree of mechanical amplification can additionally, or alternatively, be varied by moving the location of pivot point 24b along arm 14b and/or employing arms of differing lengths.

(24) The actuator configuration described thus far is applicable to a range of implant forms, particularly where a base supports at least two arms which are deployed simultaneously in opposite angular motions, including cases where the arms are initially convergent or divergent, and including cases with and without bridging elements extending between the arms. In one particularly preferred set of applications as exemplified by the drawings herein, a rigid bridging element 28 bridges between first arm 14a and second arm 14b. In this case, bridging element 28 is preferably engaged with arms 14a and 14b via a pin-in-slot engagement, here shown as a pin 30 associated with an end portion of each arm that engages a slot 32 formed in bridging element 28. Most preferably, a double-pin-in-slot engagement is provided, with two pins engaged in non-parallel slots, as will be described in detail below with reference to FIGS. 8A-11C.

(25) It should be noted that references herein to “arms”, “linkages” etc. refer to functional elements which may, for design purposes, be implemented as either single or double structures. For example, referring to the exploded view of FIG. 3, it will be noted that arms 14a and 14b are shown as single elements while linkages 22a and 22b are bilaterally attached pairs of linkages on either side of the arms. Similarly, base 12 and bridging element 28 are shown here as two-sided elements internally connected. These structures could be reversed, for example, employing a pair of arms for each “arm” structure and a single linkage for each of linkages 22a and 22b, as will be appreciated by one ordinarily skilled in the art.

(26) As also best seen in FIG. 3, mounting of bolt 18 within base 12 is preferably achieved at least in part by a rotary bearing 19 which is inserted into the distal end of base 12. For simplicity of assembly, rotary bearing 19 may itself have an external thread which engages a corresponding threaded region within the distal end of base 12. At the other end, bolt 18 is preferably inset from a proximal opening of the implant sufficiently to leave an open channel for introduction of filler material into an inner volume of the implant after expansion.

(27) Turning now again to FIGS. 1A-3, a second aspect of the present invention is independent of the actuator mechanism employed to displace the arms and relates to a case in which at least one arm 14a is hinged to base 12 at a hinge location 16a and extends from the hinge location in a direction of extension that initially forms a first angle, in this case close to zero, to a length of base 12. First arm 14a has a rear projection 34 projecting beyond the hinge location in a direction away from the direction of extension. The rear projection 34 engages a displaceable portion 36 of the implant so that, when an actuator is operated to rotate first arm 14a from its initial state towards a deployed state at a second, larger angle to the length, rear projection 34 causes displacement of displaceable portion 36 relative to base 12.

(28) In the example of implant 10 (FIGS. 1A-3) and implant 100 (FIGS. 4A-4C), both arms 14a and 14b are formed with rear projections 34 engaging displaceable portion 36 to that the rotation of the arms generates displacement of displaceable portion 36 at both ends of the implant. In the case of implant 10, the symmetrical rotation of the arms results in symmetrical displacement of displaceable portion 36, as best seen in FIGS. 1C and 2C. In the case of implant 100, the asymmetric rotation of the arms typically generates asymmetric displacement of displaceable portion 36, unless this asymmetry is compensated for, for example by employing a longer rear projection (not shown).

(29) Engagement between rear projections 34 and displaceable portion 36 may be any suitable form of mechanical engagement. In the particularly simple implementation illustrated here, rear projections 34 are a simple projecting tab with a rounded end that engages a suitably shaped recess (slot or pocket) in displaceable portion 36. Other forms of engagement, such as one or more gear teeth engaging a rack, or a pin-in-slot engagement, may also be used, but this simple tab-in-socket engagement is believed to be sufficient for many implementations.

(30) FIGS. 5A-6B show further variant implementations of an implant differing from those above by the deployment of displaceable portion 36. Specifically, in these implementations, displaceable portion 36 is pivotally linked to base 12 at a hinge, in this case implemented by engagement with an extended hinge pin 38 forming the hinged connection between second arm 14b and base 12 at hinge location 16b (see FIG. 5A). In this case, only arm 14a is formed with rear projection 34, and displacement of displaceable portion 36 is a rotary motion. In the case of implant 200 of FIGS. 5A-5C, the remainder of the mechanism is a symmetrical mechanism, equivalent to that of implant 10 above. In the case of implant 300 of FIGS. 6A and 6B, the remainder of the mechanism is an asymmetrical mechanism, equivalent to that of implant 100 above. In all other respects, implants 200 and 300 are fully analogous in structure and function to the implants described above.

(31) In FIGS. 1A-6B, displaceable portion 36 is shown implemented as a casing, at least partially encompassing base 12. It should be noted that this form is non-limiting and that, depending upon the intended application, displaceable portion may be implemented in various different forms. For example, in various cases, an open frame may be superior to allow bone ingrowth into the deployed implant.

(32) Additionally, it should be noted that the same operational principles may be applied to implants with very different geometry. For example, in contrast to the above embodiments in which rear projections 34 are short (typically less than 20%, and preferably less than 10% of the length of the corresponding arm), an alternative implementation illustrated schematically in FIGS. 7A and 7B employs rear projections that extend to a length greater than the inward-directed part of the arms. In this case, both bridging element 28 and displaceable element 36 are preferably significantly longer than base 12, and engagement between rear projections 34 and displaceable element 36 are implemented as pin-in-slot engagements.

(33) Turning now to a third aspect of the present invention, in the above embodiments, as well as other implant structures in which a bridging element bridges between two arms hingedly mounted to a base, engagement between the bridging element and the arms is typically achieved through a pin-in-slot engagement. In a fully-closed, low-profile state and a fully-open state, the pins are typically at the end of the slots and the position of the bridging element is well defined. However, at partially-deployed intermediate positions, there is potential for sliding motion of the bridging element parallel to the length of the base.

(34) In applications where such freedom of sliding motion is undesirable, a third aspect of the present invention serves to limit such sliding motion. Referring specifically to FIGS. 8A-9C, these illustrate an implant 500 which is similar in structure and function to implant 10 described above, with analogous elements labeled similarly. Thus, implant 500 includes a base 12, hinged arms 14a and 14b, and an actuator (bolt 18 not visible in these views and actuator linkages 22a and 22b) operatively linked to the arms and operable to rotate the first and second arms from their initial state in opposing angular motion towards a final state. Rigid bridging element 28 bridges between first arm 14a and second arm 14b such that deployment of the first and second arms from the initial state towards the final state displaces the bridging element away from the base.

(35) Implant 500 differs from implant 10 in that engagement between bridging element 28 and at least the first arm 14a is via a double-pin-in-slot engagement with two non-collinear pins engaged in non-parallel slots. Thus, in addition to pin 30 that projects from arm 14a to engage slot 32 in bridging element 28, bridging element 28 also features a projecting pin 40 that is engaged with a slot 42 formed in arm 14a, as best seen in the cross-sectional view of FIGS. 9B and 9C.

(36) It will be noted that the desired relative motion of the arms and the bridging element as the implant expands is a compound motion made up of displacement plus rotation. As a result, the trace of each point on the arm passing across the surface of the bridging element follows a unique path, and vice versa for points on the bridging element passing across the surface of the arm. By forming an additional pin projecting from one of these surfaces, and a complementary slot corresponding to the desired path to be followed by that pin on the facing surface, it is possible to limit, and typically substantially eliminate, unwanted sliding motion of the bridging element. The slots are necessarily of different shapes, and thus inherently “non-parallel”.

(37) The above principle may be implemented in numerous ways, including providing both pins projecting from the arm and a corresponding pair of non-parallel slots in the bridging element. However, it has been found particularly effective for certain implementations of the present invention to provide pin 40 projecting (in this case inwards) from bridging element 28, at or near a lower edge of the bridging element. This position helps to ensure overlap with arm 14a during most if not all of the range of motion. The corresponding shape of slot 42 is a generally arcuate channel of non-uniform curvature, as may be derived in a straightforward manner from trigonometric calculations over the range of angular motion of arm 14a. Pin 40 need not be circular, and in fact is shown here as a flattened rhombus shape, chosen for reasons of ease of manufacture.

(38) In principle, provision of this double pin-in-slot engagement on only one of arms 14a and 14b would be sufficient to eliminate the undesired sliding. However, where motion of the two arms is synchronous in a fixed proportion (symmetrically or asymmetrically), it is typically preferable to provide double pin-in-slot engagement between bridging element 28 and each of arms 14a and 14b, as illustrated here. In cases of individually adjustable arms (such as certain examples mentioned in the aforementioned WO2015087285 publication), the double pin-in-slot engagement should be used on only one arm.

(39) Although certain reference numerals have been omitted in order to increase intelligibility of the drawings, implant 500 also includes all features and functionality described above with reference to implant 10, including the threaded-bolt actuator with mechanical amplification, and the rear projections actuating the displaceable element. All such features will be fully understood by reference to the drawings and description above in the context of implant 10.

(40) Turning now to FIGS. 10A-11C, these illustrate the application of the double pin-in-slot engagement in the context of an implant 600 actuated by a worm-gear engagement between a worms 602 formed in a worm-rod 604 engaging teeth 606 associated with each of two arms 14a and 14b. Further details of various implants of this type may be found in WO2015087285. The features defining the double pin-in-slot engagement for one or both of arms 14a and 14b are identical to those described in the context of implant 500 above, including pin 30 in slot 32 and pin 40 in slot 42, all as described above.

(41) It should be noted that the various implants described herein may be used in any and all orthopedic applications in which an expanding implant is required, and are particularly suitable for various minimally invasive spinal surgery (MISS) techniques, for intra-body or inter-body placement, and in various orientations and approach directions. Without detracting from the generality of the above, various applications of particular significance employ the implants deployed intervertebrally oriented so as to expand axially, thereby achieving restoration of intervertebral height and/or correction of lordotic angle or scoliosis misalignment. Other applications of particular significance employ the implant deployed intervertebrally with expansion within the plane of the disc. In each case, the appropriate surfaces are modified according to the intended application by addition of bone-purchase features, windows for filling with biocompatible filler and/or osseous integration, all as will be clear to a person having ordinary skill in the art.

(42) It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible within the scope of the present invention as defined in the appended claims.