Intervertebral implants and systems expandable by conical screw elements
By combining an internal cylindrical thread structure with a conical screw element, the design of expandable intervertebral implants is simplified, solving the problems of complexity and high cost in existing technologies, and achieving the effects of simplified operation and cost reduction.
Patent Information
- Application Number
- CN202380042761.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-08-19
- Filing Date
- 2023-04-11
- Publication Date
- 2025-01-10
AI Technical Summary
Existing expandable intervertebral implants are complex in design, rely on intricate mechanical mechanisms, have high manufacturing and operating costs, and are difficult to simplify.
An expandable implant with first and second bone engagement surfaces is used. The expansion and adjustment of the implant are achieved by combining an internal cylindrical thread structure and a conical screw element, utilizing the deformability of the interconnected structure, which simplifies the design and reduces complexity.
This allows for a simplified intervertebral implant design, reducing manufacturing costs and operational complexity, while maintaining effective support and correction for the spine.
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Figure CN119300779A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to International Patent Application No. PCT / IB2022 / 053530 filed on April 14, 2022, the entire contents of which are incorporated herein by reference. This application also claims priority to International Patent Application No. PCT / IB2022 / 057789 filed on August 19, 2022, the entire contents of which are incorporated herein by reference. Technical Field
[0003] The present disclosure relates to surgical procedures for spinal surgery and devices and systems for treating spinal diseases. In particular, various embodiments relate to expandable and adjustable intervertebral implants or cages, and surgical instruments, systems and methods for inserting and operating expandable and adjustable intervertebral implants. More particularly, the present disclosure relates to devices, systems and methods for correcting lordosis and / or other spinal abnormalities. Background Art
[0004] Several intervertebral implants, spacers, spinal cages or spinal fusion devices have been proposed which can be expanded, for example to increase their thickness, or in which the orientation of the superior vertebral engaging surface can be modified relative to the inferior vertebral engaging surface, for example to change the lordotic angle between adjacent vertebrae.
[0005] For example, U.S. Pat. No. 9,839,528 describes an expandable fusion device having a first end plate and a second end plate, and also including first and second ramps configured to mate with both the first and second end plates. The first ramp has a mating feature having a first angle relative to a vertical axis, and the second ramp has a mating feature having a second angle relative to the vertical axis, such that the first angle is different from the second angle. In particular, the first and second ramps can be configured to provide symmetrical expansion of the first and second end plates of the expandable fusion device.
[0006] As another example, U.S. Patent Publication No. 2021 / 0085486 describes an implant device comprising an expandable shell, a first drive mechanism and a second drive mechanism, and the first drive mechanism comprises a first pair of cam members and a first shaft engaged with the first pair of cam members. The second drive mechanism may include a second pair of cam members and a second shaft engaged with the second pair of cam members. In addition, the first and second pairs of cam members may each include an external helical thread having a thickness configured to fit in a gap between adjacent individual riser members.
[0007] However, all prior art expandable intervertebral implants require complex manufacturing and rely on relatively complex mechanical mechanisms for expansion and angular orientation changes, requiring several complex components. Therefore, in view of these defects of the prior art, a strongly improved intervertebral implant is strongly desired to simplify its design and operation and reduce complexity and manufacturing costs. Summary of the invention
[0008] According to one aspect of the present invention, there is provided an expandable implant with an insertion direction (ID) to be placed in an intervertebral space. Preferably, the expandable implant comprises a first segment having a first bone engaging surface; a second segment having a second bone engaging surface arranged opposite to the first segment, the first and second bone engaging surfaces being arranged parallel or substantially parallel to the insertion direction; an interconnection structure interconnecting the first segment and the second segment, at least a portion of the interconnection structure being deformable to allow a change in the distance and / or orientation between the first segment and the second segment; and a first partially internal cylindrical threaded structure arranged between the first segment and the second segment, the first partially internal cylindrical threaded structure having a first thread axis, the first thread axis being inclined at a first angle relative to the insertion direction.
[0009] The expandable implant may also include a first inclined surface, which faces the opening section of the inner cylindrical thread structure of the first portion and is arranged between the first segment and the second segment, wherein the distance between the first inclined surface and the inner cylindrical thread structure of the first portion measured in a direction perpendicular to the first and second bone-engaging surfaces decreases along the insertion direction.
[0010] The first inclined surface may form a cylinder segment surface having a cylinder axis inclined at a second angle α2 relative to the insertion direction.
[0011] The expandable implant may also include a second-part internal cylindrical thread structure, which is arranged between the first segment and the second segment and arranged to face the first-part internal cylindrical thread structure, so that the first pitch of the first-part internal cylindrical thread structure and the second pitch of the second-part internal cylindrical thread structure match, and the second-part internal cylindrical thread structure has a second thread axis, and the second thread axis is inclined at a second angle α2 relative to the insertion direction.
[0012] The expandable implant may also include a third-part internal cylindrical thread structure, which is arranged between the first segment and the second segment, extending close to the first-part internal cylindrical thread structure, and the third-part internal cylindrical thread structure has a third thread axis, and the third thread axis is inclined at a third angle relative to the insertion direction.
[0013] The expandable implant may also include a second inclined surface, which faces the opening section of the inner cylindrical thread structure of the third part and is arranged between the first section and the second section, wherein the distance between the second inclined surface and the inner cylindrical thread structure of the third part measured in a direction perpendicular to the first and second bone engaging surfaces decreases along the insertion direction.
[0014] The second inclined surface may form a cylinder segment surface having a cylinder axis inclined at a fourth angle relative to the insertion direction.
[0015] The expandable implant may also include a fourth-part internal cylindrical thread structure, which is arranged between the first segment and the second segment and arranged to face the third-part internal cylindrical thread structure, so that the third pitch of the third-part internal cylindrical thread structure and the fourth pitch of the fourth-part internal cylindrical thread structure match, and the fourth-part internal cylindrical thread structure has a fourth thread axis, and the fourth thread axis is inclined at a fourth angle relative to the insertion direction.
[0016] The interconnecting structure may be deformably attached to the upper section to form a first hinge element, and the interconnecting structure may be deformably attached to the lower section to form a second hinge element.
[0017] The expandable implant may also include a first conical screw element having a first external thread configured for threading engagement (engagement by threading engagement) with the first partially internal cylindrical thread structure.
[0018] The expandable implant may further include a second conical screw element having a second external thread configured for threaded engagement with the third portion internal cylindrical thread structure (50).
[0019] When the first conical screw element is threadedly engaged with the first partially internal cylindrical thread structure, a first distance between the first and second sections will increase by deformation of at least a portion of the interconnection structure to push the first and second sections apart.
[0020] The interconnection structure may be arranged diagonally between the first and second sections, with the first and second hinge elements being arranged at opposite side edges of the first and second sections respectively, or the interconnection structure comprises a plurality of spring elements arranged between the first and third partial inner cylindrical thread structures.
[0021] The first partial internal cylindrical thread structure may be formed in a surface of the interconnection structure facing the first section.
[0022] The third portion of the internal cylindrical thread structure may be formed in a surface of the interconnection structure facing the second section.
[0023] The interconnection structure may include a plurality of first elastic interconnection elements, which are arranged at one side close to the inner cylindrical thread structure of the first portion and between the first and second segments; and a plurality of second elastic interconnection elements, which are arranged at the other side close to the inner cylindrical thread structure of the first portion and between the upper segment and the lower segment.
[0024] At least one of the first elastic interconnection elements and at least one of the second elastic interconnection elements may include a first tab having a first oblique direction and a second tab having a second oblique direction, the first and second oblique directions being different.
[0025] The interconnecting structure may be deformable to allow expansion of the distance between the upper and lower sections when the conical screw element is threadedly engaged with the first portion inner cylindrical thread structure.
[0026] When the conical screw element is threadedly engaged with the first internal thread, the plurality of first elastic interconnecting elements and the plurality of second elastic interconnecting elements may be deformable to change a relative angle between the first oblique direction and the second oblique direction to allow expansion of a distance between the upper and lower sections.
[0027] The expandable implant may also include an expansion mechanism constructed for linear displacement relative to the implant, and the expansion mechanism may include at least one wedge-shaped element for engaging with at least one inclined surface of one or both of the first and second segments. The expansion mechanism may be rotatably connected to the first conical screw element so that the threaded engagement of the first conical screw element with the cylindrical thread structure within the first portion causes the expansion mechanism to be linearly displaced.
[0028] According to another aspect of the present invention, there is provided an expandable implant having an insertion direction (ID) to be placed in an intervertebral space. The expandable implant preferably includes a first element for engaging with a first vertebra; a second element for engaging with a second vertebra; a flexible device interconnecting the first element and the second element to allow a distance D between the first and second elements to be changed; and a device for increasing the distance D between the first and second elements by applying at least one of an expansion force or a bending force to the flexible device.
[0029] The means for increasing the distance may be configured to convert a rotational threaded engagement motion into a translational motion to change the distance D by deforming at least a portion of the flexible means.
[0030] The means for increasing the distance may be configured to perform the transformation without the use of a linear slidable joint or without the use of a means for performing a linear translation without rotation.
[0031] The means for increasing the distance may comprise a conical screw element and an at least partially internal cylindrical thread.
[0032] According to another aspect of the present invention, there is provided an expandable implant to be placed in an intervertebral space. Preferably, the expandable implant comprises four corner elements extending parallel to the insertion direction; and four groups of multiple deformable interconnecting elements, each elastic interconnecting element is arranged between two adjacent corner elements, and at least one corner element comprises a partial internal cylindrical thread, the at least one partial internal cylindrical thread forms a discontinuous thread having a thread axis, the thread axis being inclined relative to the insertion direction, the discontinuous thread being configured to threadably receive a conical screw element.
[0033] At least two of the four corner elements may comprise a partial internal cylindrical thread.
[0034] When the conical screw element is threadedly engaged with the non-continuous thread, the deformable interconnecting element may be deformable to allow expansion of the distance between the upper and lower sections of the two corner elements and simultaneous expansion of the distance between the left and right sections of the two corner elements.
[0035] At least one of the deformable interconnecting elements may include a first tab having a first oblique direction and a second tab having a second oblique direction, the first and second oblique directions being different.
[0036] According to yet another aspect of the present invention, a three-dimensional printing method for manufacturing an expandable implant is provided, for manufacturing an implant body and a conical screw element.
[0037] According to another aspect of the present invention, an expandable implant system is provided, which includes an intervertebral implant and an implant manipulation device. Preferably, the implant manipulation device includes: a dual-function retainer for removably retaining the implant and for guiding and injecting a bone graft into the implant; a dual-function pusher that can be inserted into the retainer, for acting like a piston or as a piston to push the bone graft through the retainer into the implant, and for disengaging the retainer from releasable engagement with the implant; one or more screwdrivers; and a screwdriver guide that can be attached to the retainer or can be formed integrally with the retainer, the screwdriver guide having at least one guide hole extending in the insertion direction ID, for guiding one or more screwdrivers to engage and rotate with one or more conical screw elements accordingly.
[0038] According to another aspect of the present invention, a spinal implant system is provided. The spinal implant system may include a spinal plate or device, and an interconnecting screw for attaching the spinal plate or device to the implant via the connection interface of the implant. The spinal plate or device are configured to receive one or more bone screws, which are used to implant in the spinal column or vertebrae, so as to provide support for maintaining the implant in the spinal column or between the vertebrae once implanted. The spinal implant system may also include the one or more bone screws.
[0039] According to another aspect of the present invention, a spinal implant system is provided, which may include one or more of an implant holding instrument, a screwdriver, a removable bone graft inserter, an injection syringe, and a slap hammer.
[0040] The implant retaining instrument may be a straight implant retaining instrument, or may be an angled implant retaining instrument.
[0041] According to another aspect of the present invention, an implant holding instrument is provided, which may be a straight implant holding instrument or an angled implant holding instrument.
[0042] Described implant holding instrument can comprise slender body, and described slender body comprises the handle part at proximal end and the implant interface head at distal end.Described main body can comprise the axle extending between described handle part and described implant interface head.Described main body can comprise the central passage that is configured to receive and keep tubular implant connector.
[0043] The tubular implant connector can include a shaft having an elongated hollow tube and an implant interface device located at the distal end of the shaft. The tubular implant connector and the implant interface device include a hollow tubular coupling element that includes an external thread configured to cooperate or engage with an implant to be attached to the implant.
[0044] The tubular implant connector can be positioned in the implant retaining instrument so that the shaft is received in the central channel and the implant interface device can be received inside the implant interface head, wherein the connecting element extends from the implant interface head and protrudes outwardly through its central orifice for connecting with the implant to attach the implant to the tubular implant connector.
[0045] The tubular implant connector may be arranged to rotate within the central passage and the implant interface head.
[0046] The implant holding instrument may also include a first screwdriver guide channel extending from the proximal end to the distal end and a second screwdriver guide channel extending from the proximal end to the distal end. The first screwdriver guide channel may be a partially closed channel formed by a proximal closure section included in the handle portion and a distal closure section included in the implant interface head, and may also include an open support extending between the proximal closure section and the distal closure section. The second screwdriver guide channel may similarly include an open support extending between the proximal closure section and the distal closure section.
[0047] The tubular implant connector may include such a flexible interconnector. The flexible interconnector may include a main body, wherein the main body includes a plurality of strips and a plurality of grooves, and the material of the main body does not exist or is removed in the plurality of grooves. The strip may be located between the grooves. The plurality of strips and grooves may be arranged so that the distal end of the implant holding device is elastically bent away from the central axis of the implant holding device.
[0048] The above and other objects, features and advantages of the present invention and the manner in which they are accomplished will become more apparent, and the invention itself will be best understood by studying the following description with reference to the accompanying drawings which illustrate some preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0049] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate presently preferred embodiments of the invention, and together with the general description given above and the detailed description given below, serve to explain the features of the invention.
[0050] Figures 1A to 1GAn intervertebral implant 100 according to a first embodiment of the present invention is shown, the implant 100 having a partially internal cylindrical thread structure 40 for threaded engagement with a conical screw element 60, Figure 1A A top perspective view of an implant 100 is shown having a conical screw element 60 threadedly engaged therewith, Figure 1B shows a perspective cross-sectional view with a vertical cut position along its central axis, Figure 1C shows a perspective cross-sectional view with a horizontal cutting position along its central axis, Figure 1D A front view and a top view are shown, Figure 1E A side view thereof is shown, Figure 1F A side cross-sectional view thereof is shown, and Figure 1G Shown as Figure 1C , and also showing two (2) further cross-sectional views with cutting planes A and B arranged perpendicular to the insertion direction ID;
[0051] Figures 2A to 2G An intervertebral implant 200 according to a second embodiment of the invention is shown, the implant 200 having two partially internal cylindrical thread structures 40, 46, which face each other and have aligned and matching thread pitches for threaded engagement with a conical screw element 60, wherein Figure 2A shows a top perspective view of an implant 200 having a conical screw element 60 threadedly engaged therewith, Figure 2B shows a perspective cross-sectional view with a vertical cut position along its central axis, Figure 2C shows a perspective cross-sectional view with a horizontal cutting position along its central axis, Figure 2D A front view and a top view are shown, Figure 2E A side view thereof is shown, Figure 2F A side plan view is shown, and Figure 2G A front view is shown;
[0052] FIG. 3A to FIG. 3N An intervertebral implant 300 according to a third embodiment of the invention is shown, the implant 300 having two partially inner cylindrical thread structures 40, 50 arranged close to each other, each partially inner cylindrical thread structure extending substantially with an angular offset in the insertion direction (ID), each configured for threaded engagement with a conical screw element 60, 70, wherein Figure 3A A rear perspective view of the implant 300 without the screw elements 60, 70 is shown, Figure 3B A rear perspective view of an implant 300 is shown having screw elements 60, 70 threadedly engaged with the partially internal cylindrical threaded structures 40, 50, Figure 3C shows a rear view of the implant 300 without the screw elements 60, 70, Figure 3DA rear view of the implant 300 is shown in a non-expanded or non-extended state with screw elements 60, 70 threadedly engaged with the partially internal cylindrical threaded structures 40, 50, Figure 3E is a side cross-sectional view with a cut through a vertical plane arranged coincident with the third thread axis TA3 of the partially internal cylindrical threaded structure 50, showing the implant 300 without the screw element 70, Figure 3F is a side cross-sectional view with a cut through a vertical plane coinciding with the first thread axis TA1 of the partially internal cylindrical threaded structure 40, showing the implant 300 without the screw element 70, Figure 3G is a side cross-sectional view showing an implant 300 with a screw element 70, Figure 3H shows a top view of the implant 300 without the conical screw elements 60, 70, Fig. 3I shows a top view of an implant 300 with conical screw elements 60, 70, Figure 3J A front view of an implant 300 is shown in a partially expanded state expanded to a distance D1 by using a conical screw element 60, the bone engaging surfaces 12, 22 are arranged at an angle β1, the first section 10 is pivoted about a first hinge element 15 as a deformable part of the interconnection structure 30, Figure 3K A side cross-sectional view of an implant 300 is shown with a conical screw element 60 fully screwed into the end of a partially internal cylindrical thread structure 40, Figure 3L A top perspective view of an implant 300 is shown with a conical screw element 60 fully screwed into the end of a partially internal cylindrical threaded structure 40, as can be seen through the transverse opening TO, Figure 3M A front view of the implant 300 is shown in a fully expanded state by using conical screw elements 60, 70 which are fully screwed into the partially internal cylindrical threaded structures 40, 50, respectively, to pivot the first and second sections 10, 20 with the first and second hinge elements 15, 25 relative to the interconnecting section 30, and Figure 3N A top perspective view thereof is shown.
[0053] 4A to 4F An intervertebral implant 400 according to a fourth embodiment of the invention is shown, the implant 400 having four corner elements 110, 120, 130, 140 extending longitudinally in the insertion direction ID, wherein the threaded engagement of the conical screw element 60 with the internal threads arranged at one or more of the four corner elements 110, 120, 130, 140 causes the implant body 5 to expand in the z-direction to have a variable dimension for the distance D1 and in the y-direction to have a variable dimension for the distance D2, thereby expanding in height and width, wherein Figure 4AAn exemplary top perspective view of implant 400 is shown in a non-expanded state, Figure 4B shows a perspective cross-sectional view with a cutting plane arranged horizontally through the center of the body 5 and the conical screw element 60 along the insertion direction, Figure 4C Shows front view, top view, perspective view, Figure 4D shows a side view, Figure 4E A top side view is shown, and Figure 4F A front view is shown;
[0054] Figure 5 A top perspective view of a spinal implant system according to yet another aspect of the present invention is shown, showing an exemplary intervertebral implant 300 that can be removably interconnected to an implant manipulation device 505, the implant manipulation device 505 comprising: a retainer 530, exemplarily formed by a hollow cylindrical body, having the dual functions of removably retaining the implant 300 and guiding and injecting a bone graft into the implant 300; a pusher 510 that can be inserted into the hollow body of the retainer 530, having the dual functions of acting like a piston to push the bone graft through the retainer 530 into the implant 300 and for disengaging the retainer 530 from releasable engagement with the implant 300; one or more screwdrivers 540 each having a torque instrument 544; a screwdriver guide 520 that can be attached to or integrally formed with the retainer 530, having at least one guide hole extending in the insertion direction ID for guiding the one or more screwdrivers 540 to engage and rotate with the one or more conical screw elements 60, 70 accordingly;
[0055] FIG. 6A to FIG. 6D Different top and side cross-sectional views of the implant 300 and the retainer 530 having a hollow body (eg, a cylindrical element) are shown in disengaged and engaged states, wherein Fig. 6A Since then, Figure 5 The cross-sectional top view in the z direction referenced in FIG. 3 shows the implant 300 and the retainer 530 in a disengaged state, and also depicts an exemplary flexible coupling 534 having two symmetrically arranged flexible clips 336, 338, which may be part of or formed together with the interconnection structure 30 of the implant, Figure 6B The cross-sectional side view in the y direction shows the implant 300 and the retainer 530 in the disengaged state. Figure 6CThe implant 300 and the retainer 530 are shown in an engaged state in the z direction, wherein the clips 336, 338 have been engaged with corresponding locking cavities or holes 536, 538 arranged in the side walls of the retainer 530, and the distal end of the retainer 530 forming a bone graft outlet 532 is also shown, and the bone graft outlet reaches the body 5 of the implant 300, the distal end of the retainer 530, thereby resulting in a traversing opening TO for bone graft injection into the opening TO, and the distal end of the retainer 530 also has a groove 534 to allow insertion into the implant 300 to form a flexible connection, Fig.6D The cross-sectional side view from the y-direction shows the implant 300 and the retainer 530 in an engaged state;
[0056] FIG. 7A to FIG. 7D Four (4) different views of an intervertebral implant 600 according to a fifth embodiment of the present invention are shown, wherein the implant 600 uses two (2) conical screw elements 660, 670, each having two (2) conical screw segments 664, 666 and 674, 676 arranged at the distal and proximal ends of the respective screw elements 660, 670, and the implant body 5 has two pairs of partially internal cylindrical thread structures 644, 646 and 654, 656, which are arranged to allow the screw element 660 having the two conical screw segments 664, 666 to be engaged with the corresponding internal cylindrical thread structures on one side of the implant 600. The separate threaded engagement of the cylindrical thread structures 644, 646, and the separate threaded engagement of the screw element 670 having two conical screw segments 674, 676 with the corresponding internal cylindrical thread structures 654, 656 on the other side of the implant 600 provide improved pressure and weight distribution for the body 5 when pressurized or loaded along the z-direction, wherein the four (4) conical screw segments 664, 666, 674, 676 and the corresponding partial internal cylindrical thread structures 644, 646, 654, 656 are arranged at the corners of the implant 600 when viewed in the z-direction, wherein Fig. 7A A front view toward the insertion direction ID is shown, wherein the implant 600 is in a non-expanded state, Figure 7B shows a side cross-sectional view along the axis of a conical screw element 660 in a non-expanded state, the conical screw element having front and rear conical screw sections 664, 666 interconnected to each other by a rod or shaft 662, Figure 7C A top cross-sectional view of implant 600 is shown, and Fig.7D A top perspective view thereof is shown;
[0057] FIG. 8A to FIG. 8CDifferent views of an intervertebral implant 700 according to a sixth embodiment of the invention are shown, the implant 700 having an implant body 5 with an interconnection structure 730 formed by a plurality of spring elements 732.1 to 732.6, in an exemplary variant, six (6) spring elements 732.1 to 732.6 are arranged along a central section of the body 5, at least partially arranged in a transverse opening TO, the spring element 732 interconnecting the first and second sections 10, 20 and being arranged along the insertion direction ID between two openings having two partially internal cylindrical threaded structures 40, 50, respectively, wherein Fig. 8A shows a front view in the direction of insertion direction ID, Figure 8B A top perspective view is shown, and Figure 8C A top view thereof is shown;
[0058] 9A to 9D Different views of an intervertebral implant 800 according to a seventh embodiment of the present invention are shown, wherein Fig.9A A front view and a top view are shown, Fig. 9B Another front view from a different perspective is shown. Fig. 9C shows a front view of the implant 800 in a non-expanded state, Fig.9D shows a front view of the implant 800 in a fully expanded state, and Fig.9E , wherein the implant 800 is in a partially expanded state, wherein the first section 10 and the second section 20 of the implant 800 have an oblique angle therebetween;
[0059] Fig. 10A and Fig. 10B A simplified top view of an intervertebral implant 900 according to an eighth embodiment of the present invention is shown, wherein Fig. 10A A top view showing the symbol layout of the expansion mechanism and the main body 5 in a non-expanded state, Fig. 10B Another top view of the expansion mechanism in an expanded state is shown, preferably for transforaminal lumbar interbody fusion (TLIF) applications;
[0060] FIG. 11A to FIG. 11D Aspects of an intervertebral implant 1000 according to a ninth embodiment of the present invention are shown, wherein Fig.11A A top perspective view thereof is shown, Fig. 11B A top perspective view and a transparent view thereof are shown to illustrate the different elements of the implant 1000, Fig. 11C shows a cross-sectional view defined by a cutting plane coinciding with the axis of rotation of the rotatable expansion mechanism 1060, and Fig.11DShown in a top view thereof, implant 1000 utilizes an expansion mechanism that combines aspects of utilizing a conical screw segment 1064 and linear sliding of one or more wedges 1072, 1074 relative to inclined surfaces 1014, 1024 and inclined surfaces 1016, 1026, respectively;
[0061] FIG. 12A to FIG. 12D Aspects of an intervertebral implant 1100 according to a tenth embodiment of the present invention are shown, wherein Fig. 12A A top perspective view thereof is shown, Fig. 12B Shows top view perspectives from different directions, Fig. 12C shows a cross-sectional view defined by a cutting plane coinciding with the two (2) rotational axes of the rotatable expansion mechanisms 1160, 1170, and Fig.12D A top view of the implant 1100 is shown placed into the intervertebral space; and
[0062] FIG. 13A to FIG. 13D Aspects of an intervertebral implant 1200 according to an eleventh embodiment of the present invention are shown, wherein Fig.13A A top perspective view thereof is shown, Fig. 13B A front view is shown against the insertion direction ID to show its distal end DE, and also shows Fig. 13C The cross-sectional view of the cutting surface AA shown in, Fig. 13C A top view thereof is shown, Fig.13D The eleventh embodiment is shown in a side view and a cross-sectional view of the cutting surface BB. FIG. 7A to FIG. 7D A variation of the fifth embodiment shown in .
[0063] FIG. 14A to FIG. 14F Aspects of an intervertebral implant 1400 according to a twelfth embodiment of the present invention are shown, wherein Fig.14A A top perspective view thereof is shown, Fig. 14B A side perspective and cross-sectional view thereof are shown, Fig. 14C shows a side view of the implant 1400 in a non-expanded state, Fig.14D shows a side view of the implant 1400 in an expanded state, Fig.14E A side view and a cross-sectional view of implant 1400 are shown; Fig.14F The implant 1400 and the screw element 1470 are shown in side and cross-sectional views; the twelfth embodiment is FIG. 7A to FIG. 7D The fifth embodiment shown in FIG. 13A to FIG. 13D A variation of the eleventh embodiment shown in .
[0064] Fig.15A A perspective view of a spinal implant system 1500 according to yet another aspect of the present disclosure is shown and Fig. 15BShown are side views and partial cross-sectional views of an exemplary intervertebral implant 1400 which may be attached or connected to a spinal plate or device 1501 via interconnecting screws 1505, the spinal plate or device 1500 being configured to receive bone screws 1510, 1515 for implantation in the spine, thereby providing support for maintaining the implant 1400 in the spine or between vertebrae once implanted.
[0065] Fig.16A A perspective view of another spinal implant system 1600 according to yet another aspect of the present disclosure is shown, illustrating an exemplary intervertebral implant 1400, an implant retaining instrument 1605, a screwdriver 1610, a removable bone graft inserter 1615, an injection syringe 1620, and a slap hammer 1625; Fig. 16B Shows Fig.16A An enlarged perspective view of the implant holding instrument 1605 shown in FIG. Fig. 16C A top view of an implant retaining instrument 1605 is shown; Fig.16D A cross-sectional view of the cage holder 1605 taken along BB is shown; Fig.16E Shows Fig.16A An enlarged perspective view of a screwdriver 1610, a removable bone graft inserter 1615, an injection syringe 1620, and a slap hammer 1625 are shown in FIG.
[0066] Fig.17A A perspective view of another spinal implant system 1700 according to yet another aspect of the present invention is shown, showing an exemplary intervertebral implant 1400, an angled implant retaining instrument 1705, a screwdriver 1710, a removable bone graft inserter 1715, an injection syringe 1720, and a slap hammer 1725; Fig. 17B Shows Fig.17A An enlarged perspective view of the angled implant retaining instrument 1705 shown in FIG.
[0067] Fig. 17C Shows Fig.17A An enlarged perspective view of a screwdriver 1710, a removable bone graft inserter 1715, an injection syringe 1720, and a slap hammer 1725 are shown in FIG. FIG. 17D to FIG. 17F An enlarged perspective view and an enlarged top view of an angled implant retaining instrument 1705 are shown; Figure 17G Details of the distal end of the tubular implant connector of the implant retaining instrument 1705 are shown, and Fig.17H An angled implant retention instrument 1705 is shown.
[0068] Herein, where possible, the same reference numerals are used to denote the same elements that are common to the figures. In addition, for illustrative purposes, the images are simplified and may not be drawn to scale. DETAILED DESCRIPTION
[0069] According to a first embodiment of the present invention, an expandable implant 100 is provided, such as Figures 1A to 1G As shown in the example. The expandable implant 100 has or includes an implant body 5 forming an insertion direction ID, and the insertion direction ID is the direction in which the implant 100 is inserted into the intervertebral space or the intervertebral space, for example, the insertion direction for lateral lumbar intervertebral fusion (LLIF) between two adjacent vertebrae of the biological spine. The expandable implant 100 forms an implant body 5, which has an insertion end or distal end DE that will point to the intervertebral space during insertion and an operating end or proximal end PE that can hold the implant 100, and the expandable implant 100 includes a first or upper segment 10 having a first bone engaging surface 12 and a second or lower segment 20 having a second bone engaging surface 22, and the second segment 20 is arranged opposite to the first segment 10. The first and second segments 10, 20 may be implemented in different ways, for example to form first and second plates, discs or other types of planar structures, which are arranged to be substantially parallel to each other at least before insertion into the intervertebral space, with porous, trabecular or other types of surface or body structures at the bone engaging surfaces 12, 22, which may promote attachment and fusion with bone structures (e.g. with the bone surfaces of vertebrae). The first and second segments 10, 20 may extend in a plane parallel or substantially parallel to the insertion direction ID, for example within a certain angular tolerance range, for example less than ±5°, more preferably less than ±2.5°.
[0070] In a variation, the surfaces 12, 22 that will face the bone and engage with the bone can have a structure for increasing the friction between the implant 100 and the bone structure with which the implant 100 will engage, such as, but not limited to, corrugations, ridges, cones, hooks, knobs, tabs, ramps, spheres, peaks. For example, it is possible to form a ridge, track or other type of longitudinal structure that is arranged parallel to the insertion direction ID on the surface 12, 22 to provide some guidance when the implant 100 is inserted into the intervertebral space. In addition, it is also possible that the surfaces 12, 22 are not completely flat, but have a convex structure, such as in the form of a dome or a ridge, which can match the end plate surfaces of two adjacently arranged vertebrae, the end plate surfaces facing each other. For example, it is possible that the surfaces 12, 22 are specifically manufactured by three-dimensional printing for patient-specific construction to provide a shape complementary to the existing end plate surfaces. In addition, the bone engaging surfaces 12, 22 of the first and second segments 10, 20 may include one or more openings that can be filled with bone graft and bone fusion promoter for fusion of adjacent vertebrae with the implant 100, such as an opening leading to the inner hollow volume of the implant 100, not shown in this embodiment. Preferably, when viewed from the top or from the bottom, the first and second segments 10, 20 have rounded and smooth corners to prevent damage and facilitate insertion of the implant into the intervertebral space. In addition, the distal end DE of the implant 100 can be shaped as a circle or spherical shape, or have the curvature of a cylindrical surface, or can be pointed to facilitate insertion.
[0071] Furthermore, the implant 100 is provided with an interconnection structure 30 interconnecting the first section 10 and the second section 20, at least a portion of the interconnection structure 30 being deformable to allow a distance and / or orientation between the first section 10 and the second section 20 to be changed. Figures 1A to 1G In the first embodiment shown, only a change in the distance D between the first and second sections 10, 20 is possible to expand the distance D between the sections 10, 20. The distance D between the first and second sections 10, 20 may be, for example, the distance between the outer surface of the first section 10 and the outer surface of the second section 20, such as Figure 1E. However, the distance D may be measured, for example, between any first position on the first segment 10 and any second position on the second segment 20, which are subjected to relative displacement by the interconnection structure 30. In general, the interconnection structure or element 30 may have a geometry, material characteristics or properties, structure or other arrangement that allows the interconnection structure or element 30 to deform when an expansion force (e.g., a force that moves the segments 10, 20 away from each other) is applied. In addition, it is possible that the interconnection structure 30 allows the distance D to be reduced by an elastic force that moves the segments 10, 20 closer to each other, so that at least a portion of the interconnection structure or element 30 has elastic properties. In this regard, when the distance D is expanded to a higher value, if the expansion force is released, a tension force that can allow the contraction or reduction of the distance D may be emitted by the interconnection structure or element 30. In a variant, it is also possible that at least a portion of the interconnection structure 30 has plastic properties and once deformed to increase the distance between the segments 10, 20, there is no tension or only a small tension emitted by the interconnection structure or element 30 for contraction.
[0072] In the illustrated variation, the interconnection structure or element 30 is formed as a plurality of first elastic interconnection elements 32 arranged at a first side of the implant 100 and a plurality of second elastic interconnection elements 34 arranged at another second side of the implant body 5, the first side being opposite to the second side, interconnecting the first and second sections 10, 20 (e.g., interconnecting the edge posts or struts 14 of the first section 10 with the edge posts or struts 24 of the second section 20 on the first side, and interconnecting the edge posts or struts 16 of the first section 10 with the edge posts or struts 26 of the second section 20 on the other second side), thereby forming two laterally arranged elastic interconnection elements 32. For example, at least one of the first and second elastic interconnection elements 32, 34 may include a first tab, rod, post, support, strut, plate or column 36 arranged in a first oblique direction relative to the insertion direction ID, and a second tab, rod, post, support, strut, plate or column 38 connected to the first tab 36, which has a second oblique direction relative to the insertion direction ID, the first oblique direction and the second oblique direction being different. Therefore, the first and second tabs 36, 38 are arranged to form a V-shape, which can open its V angle to increase the distance D between the segments 10, 20, and the first and second inclination angles between the tabs 36, 38 and the insertion direction can be, but not limited to, an angle range between 30° and 60°. In addition, the first and second elastic interconnecting elements 32, 34 can be embodied in a variety of different structural arrangements that allow deformation as the distance D increases, such as a circular, oval, diamond, arc or other shape that allows deformation of the interconnecting elements 32, 34 to allow the distance D between the segments 10, 20 to increase.
[0073] It is also possible that the interconnection structure 30 can be configured so that expansion of the implant body 5 in the z-direction is advantageous, more particularly, deformation of the interconnection structure 30 to expand in the z-direction is advantageous, and deformation in another direction is substantially prevented or reduced, for example resulting in displacement of the first segment 10 relative to the second segment 20 relative to or along the insertion direction ID, or displacement of the segments 10, 20 relative to the y-direction, the transverse or lateral direction, or deformation of the segments 10, 20 around the angular displacement of the z-direction. Figure 1A and Figure 1D In the variation shown, this is accomplished, for example, by an arrangement of V-shaped elements that can be bent to provide expansion, but also provide contraction in the z-direction because the width of the tab-like elements 36, 38 is substantially greater than the thickness of the tab-like elements 36, 38 (e.g., having a ratio of 1 to 3 or even 1 to 5).
[0074] In addition, the implant body 5 includes a first portion of an inner cylindrical thread structure 40 arranged between the first section 10 and the second section 20. Figure 1B and Figure 1C As shown in, in the variation shown, the partially internal cylindrical threaded structure 40 has a partially internal thread formed as a surface of a section of a cylinder, wherein the rotation axis of the cylinder coincides with the first thread axis TA1 of the partially internal cylindrical threaded structure 40, and can be machined, formed or otherwise provided into the inner surface of the second segment 20, the second segment 20 being formed as a rectangular plate. The first thread axis TA1 or the rotation axis of the cylinder extends substantially in the insertion direction ID, but is inclined at a small angle relative to the insertion direction ID, the small angle being defined as a first angle α1. Preferably, the first angle α1 is between 1° and 30°, more preferably between 1° and 15°, and even more preferably within an angular range between 3° and 15° relative to the insertion direction. In addition, the first thread axis TA1 of the threaded structure 40 is preferably substantially located in a plane placed parallel to the insertion direction ID and is placed in the middle between the first and second side walls of the implant body 5, for example between the first and second interconnecting elements 32, 34 of the interconnecting structure 30, for example substantially in the middle between the first and second interconnecting elements 32, 34 of the interconnecting structure 30. Thus, the partial internal cylindrical thread structure 40 may be located between and substantially in the middle between the interconnecting elements 32, 34, extending therebetween at a small inclined first angle α1 relative to the insertion direction ID. Figure 1B and Figure 1C As shown in the variation, the partially internal cylindrical thread structure 40 can extend from the proximal end PE to the distal end DE, and due to the inclined arrangement of the first thread axis TA1 at an inclined first angle α1, the width of the cavity or concave cavity of the cylindrical segment measured from the inner surface of the second segment 20 in a direction perpendicular to the insertion direction decreases from the proximal end PE toward the distal end DE.
[0075] In addition, the implant 100 can also include a screw element 60, for example, a conical screw element 60, which defines a front insertion side IS and a rear operating side OS, has a length L, and includes an external thread 62 and a torque application structure 64, the external thread is configured to be threadedly engaged with a portion of the internal cylindrical thread structure 40 of the implant body 5. Preferably, the torque application structure 64 is arranged on the operating side OS of the screw element 60, such as but not limited to a plum blossom socket, a hexagonal socket, a Philips-type socket or other types of torque application structures, for removably engaging with a torque tool, as further explained below. In the illustrated variation, the screw element 60 is hollow and traversed by a hole (e.g., a conical hole narrowing toward the insertion direction), but can also be made solid. The external thread 62 has a thread radius or diameter that decreases from the operating side OS of the screw element 60 to the insertion side IS, thereby forming a conical or tapered shape and a conical thread. The thread diameter is, for example, the distance from the external thread on one side of the screw element 60 to the external thread on the other opposite side, or, for example, a major diameter. The thread radius is half the value of the thread diameter. Preferably, the maximum thread radius of the external thread 62 at the operating side is such that it corresponds or matches the constant thread radius of the partially internal cylindrical thread structure 40, thereby allowing threaded engagement with the partially internal cylindrical thread structure 40, while the thread radius of the screw element 60 decreases constantly and linearly from the operating side OS to the insertion side IS. In contrast, the thread radius of the cylindrical thread structure 40 is constant, for example the structure 40 has a constant effective thread radius or diameter. In this regard, although the largest section of the screw element 60 can be fully threadedly engaged with the cylindrical thread structure 40, due to the nature of the tapered or conical shape of the screw element 60, only partial contact of the threads between the thread 62 and the thread structure 40 will occur at a narrower section closer to the front side or insertion side IS of the screw element 60, such as Figure 1C and Figure 1G In this regard, Figure 1G Two further (2) cross-sectional views with cutting planes AA and BB arranged perpendicular to the insertion direction ID are shown, showing a cross-sectional view of the screw element 60 and the body 5 close to the opening 80, wherein the outer radius of the screw element 60 is only slightly smaller than the radius of the cylindrical thread structure 40, and on the right showing a cross-sectional view of the screw element 60 and the body 5 near the middle between the proximal end PE and the distal end DE, wherein the outer radius of the screw element 60 is approximately half the radius of the cylindrical thread structure 40. This also allows threadable displacement of the conical screw element 60 along the axis of the cylindrical thread structure 40 (approximately parallel to the insertion direction ID).
[0076] About internal thread and external thread, pitch can preferably in the scope between 0.5mm to 5mm, can have circle, square, trapezoid, triangle shape or other shapes, and can have the thread form of sharp V, metric, sawtooth, unified, square, Whitworth, trapezoid, circle or Dadezhu formula thread.In shown modification, only have a thread, but also can have and be used for external thread 62 and internal thread structure 40 and surpass a thread, for example double thread, three threads or more threads, to change the torque transmission between screw element 60 and the implant body 5.
[0077] In addition, preferably, the taper, vertex or cone angle of the conical screw element 60 and the external thread 62 is substantially the same as the inclined first angle α1 of the cylindrical thread structure 40, such as Figure 1B and Figure 1F . In addition, the conical screw element 60 can make it removable from the implant 100, for example, by the threaded engagement of the external thread 62 with the threaded structure 40 and the removal and insertion via the opening 80 provided at the proximal end PE. In the example shown, the circular opening has a radius greater than the maximum outer radius of the screw element 60. In a variant, the conical screw element 60 cannot be removed from the implant, for example by selecting an opening 80 that hinders the removal of the screw element 60, such as, but not limited to, an opening 80 that is smaller than the maximum cross-section of the screw element 60 when viewed in the insertion direction ID. In addition, the length L of the conical screw element 60 is less than the extension length of the cylindrical internal thread structure 40 in the insertion direction ID or the entire length of the implant 100, so that the screw element 60 can be threadedly displaced within a certain range relative to the partial internal cylindrical thread structure 40 and the implant 100, and still be completely located inside the implant 100. In the variant shown, the length L is about 50% of the length of the implant 100. Preferably, in order to well support the first and second segments 10, 20 through direct or indirect contact between the first and second segments 10, 20 and the outer surface of the screw element 60, the conical screw element 60 is not less than 30% of the entire length of the implant body 5 or the extension length of the cylindrical internal thread structure 40 in the insertion direction ID.
[0078] As described above, the implant 100 is configured to be variable in size, and in this embodiment, the distance D between the first and second sections 10, 20 can be varied by the interaction between the conical screw element 60 and the inner cylindrical thread 60 in combination with the deformability of the interconnecting structure 30. For example, Figure 1B , Figure 1C , Figure 1F and Figure 1GThe screw element 60 is shown in a first initial position after being inserted into the implant 100. Thereafter, after the first conical screw element 60 is threadedly engaged with the first partially internal cylindrical threaded structure 40, the screw element 60 can be threadedly rotated to linearly advance in a linear direction corresponding to the insertion direction ID toward the distal end DE of the implant 100, for example, using a torque instrument removably attached to the torque applying structure 64, for example, in a clockwise direction. Thus, the screw element 60 acts as a wedge-shaped or conical element that gradually moves along the insertion direction and applies an expansion force to the first and second segments 10, 20, forcing these elements to expand away from each other. In other words, this threaded rotation and linear advancement of the element 60 will generate an expansion force toward the first and second segments 10, 20, which will push the first and second segments 10, 20, thereby moving the segments 10, 20 apart and increasing the first distance D between the first and second segments 10, 20, wherein at least a portion of the interconnection structure 30 is deformed, for example, by bending to increase the V angle between the tabs 36, 38 of the interconnection elements 32, 34. In this regard, the interconnection structure 30 can provide a reaction force to the expansion force, which can maintain the first and second sections 10 , 20 in operable direct or indirect contact with the conical screw element 60 .
[0079] Furthermore, in order to further assist the expansion of the segments 10, 20 by the threaded engagement of the conical screw element 60 with the partially inner cylindrical threaded structure 40, an inclined surface 44 facing and aligned with the opening section of the first partially inner cylindrical threaded structure 40 may optionally be provided, the inclined surface 44 being arranged between the first segment 10 and the second segment 20. Figure 1B In the variation shown, the inclined surface 44 forms part of the inner surface of the first upper section 10, while the threaded structure 40 is formed in the inner surface of the second lower section 20, but this arrangement may be reversed (see for example Figure 1F ). The orientation angle of the plane defining the inclined surface 44 relative to the insertion direction ID can be defined as a second angle α2, and preferably, the absolute value of the second angle α2 is equal to or substantially equal to the first angle α1, but in the opposite direction or with a different sign value. Thus, a plurality of contact points CP of the apex of the external thread 62 can contact the inclined surface 44 to provide an expansion force to the second segment 20, such as Figure 1F As shown in , or providing an expansion force to the first section 10, such as Figure 1BAs shown in . With this arrangement, the distance between the inclined surface 44 and the partially internal cylindrical thread structure 40 measured in a direction perpendicular to the first and second bone engaging surfaces 12, 22 decreases along the insertion direction ID to form a hollow portion having a narrowing opening toward the distal end DE, the opening angle being about two (2) times the first angle α1. The inclined surface 40 can be a continuous surface, or an interrupted surface with an opening, or alternatively can be a narrow slope extending only to a limited width to reduce the use of implant material, which is arranged roughly in the middle of the implant 100 and is arranged to ensure contact with the apex of the thread of the conical screw element 60 having a contact point CP.
[0080] In this regard, threaded engagement and advancement of the conical screw element 60 into the narrowed opening by the inclined surface 44 and the first partially internal cylindrical thread structure 40 exerts an expansion force on the first and second sections 10, 20 for expansion and increasing the distance D. The inclined surface 44 may be flat, but in order to increase the surface area of the contact point CP, preferably, the inclined surface 44 is a segment of a cylindrical surface having a radius corresponding to or equal to or slightly greater than the maximum external thread radius of the conical screw element 60 at its operating side OS. Furthermore, preferably, the cylindrical axis of the cylindrical segment of the inclined surface 44 is inclined at a second angle α2 relative to the insertion direction ID, for example having a cylindrical axis CA that may coincide with the thread axis TA1 at or around the region of the opening 80, as shown in FIG. Figure 1F as shown in .
[0081] Using implant 100, a simplified design is provided for intervertebral or intervertebral implants or spinal cages, allowing the components used to be reduced and having reduced complexity. In the variation shown above, only two components are required, namely the implant body 5 and the conical screw element 60 of implant 100, and the adjustability of the implant design can still be maintained without the need for complex components and multiple moving parts. Thus, operational failures can be prevented and manufacturing costs can be reduced. In a preferred embodiment, the implant body 5, the conical screw element 60 or both can be manufactured by three-dimensional printing, for example, by using an electron melting beam 3D printer system and by using biocompatible Ti6Al4V metal powder. Other types of 3D printing techniques can be used, such as metal powder bed melting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), metal binder jetting or molding jetting.
[0082] With regard to the manufacturing method by using 3D printing technology, the implant body 5 and one or more conical screw elements 60, 70 can be printed at the same time as the 3D printing step, for example, by building the body 5 and one or more conical screw elements 60, 70 together layer by layer. The implant can, for example, include titanium or be composed of titanium, or include plastic or be composed of plastic, such as polyetheretherketone (PEEK). The implant can be produced by 3D printing technology, and for example, include titanium or be composed of titanium, or include plastic or be composed of plastic, such as polyetheretherketone (PEEK). Thereafter, one or more heating and / or surface treatment steps can be performed to obtain the desired specific surface and core material properties. For example, once the body 5 and one or more screw elements 60, 70 are formed, a hot isostatic pressing (HIP) treatment step can be performed with the heating chamber of a furnace and under high pressure to improve mechanical properties, such as improving the elasticity and deformability of the material, providing the isotropic properties of the material, densifying the material, and thereby providing better fatigue resistance. Next, a pickling step for surface treatment can be performed, such as using a gas mixture of hydrofluorine (HF) and nitric acid (HNO3), which can improve the surface properties of the body 5 and one or more conical screw elements 60, 70 to reduce the friction of the threaded engagement. In addition, after the pickling step, an anodizing step can be performed to improve usability, and optionally further reduce the friction surface properties or improve lubricity, such as a type 3 titanium coloring anodizing step. Optionally, the anodizing step can also include a type 2 titanium anodizing step to reduce the friction or lubricity of the surface. Preferably, no additional processing steps of the implant body 5 and one or more conical screw elements 60, 70, such as by a milling machine or a lathe, are required, and since the body 5 and one or more screw elements 60, 70 are the only components of the implant described herein, no additional assembly steps are required.
[0083] Using 3D printing, complex trabecular or porous structures can be produced at reduced cost, shorter manufacturing time and reduction of material used. In addition, deformable complex elements for the interconnecting structure 30 can be manufactured, such as a certain number of tabs 36, 38 arranged adjacent to each other, for example to form two rows of interconnecting elements 32, 34 on each lateral side. In addition, by providing areas or volumes or other elements of the interconnecting structure 30 with a certain degree of porosity, a certain degree of cavity, a certain degree of hollow volume, or by providing thinned walls, tabs, rods, etc., specific areas or volumes can be made to be designated as deformable or bendable areas or volumes of the interconnecting structure 30, as further explained below. For example, in Figures 1A to 1FIn the context of the first embodiment, the volume in which the tab 38 contacts the first upper section 10, the volume in which the tabs 36, 38 are interconnected, and the volume in which the tab 36 contacts the second lower section 20 can be made thinner, or can be made with a certain degree of porosity to facilitate deformation or bending in those areas.
[0084] In addition, the interconnection structure 30 can be characterized as a device that can allow for a change in the distance D between the first element or device 10, 12 for engagement with the first vertebra and the second element 20, 22 for engagement with the second vertebra due to its mechanical deformation properties, and the partially internal cylindrical threaded structure 40 and the conical screw element 60 can cooperate to form a device, apparatus or system that can increase the distance D between the first and second elements 10, 12, 20 and by applying an expansion force to the interconnection structure 30 (e.g., an expansion force applied via the first and second elements 10, 12, 20, 22). In this regard, the device, subassembly, device or system that can increase the distance D between the first and second elements 10, 12, 20, 22 embodied by the structure 40 and the element 60 is configured to convert the rotational threaded engagement motion of the conical screw element 60 relative to the threaded structure 40 into a translational motion along the z-direction to change the distance D by deforming at least a portion of the interconnection structure 30. In addition, the device, subassembly, apparatus or system that can increase the distance D between the first and second elements 10, 12, 20, 22 can be configured to perform a conversion of the rotation-threaded motion to the translational motion to cause the expansion of the distance D without performing a linear slidable engagement of two inclined surfaces, for example, without performing a slidable linear engagement of two inclined structures without any rotation of the inclined structures, or other types of slidable linear elements, for example, with different types of cam and thread combinations. In addition, a threaded cylindrical shaft is not required to move the cam member or the inclined structure along the insertion direction, for example, by using two different sections along the cylindrical shaft, which have right-handed and left-handed threads, requiring an arrangement of multiple moving parts.
[0085] Figures 2A to 2GAn exemplary second embodiment of the present invention is shown, in which an expandable implant 200 is provided, which has a body 5 and a conical screw element 60. The expandable implant 200 and its body 5 form an insertion direction ID, which is the insertion direction of the implant 200. In contrast to the first embodiment in which the first inclined surface 40 is provided in the form of a plane or a cylindrical segment surface, a second portion inner cylindrical thread structure 46 is provided, which is arranged between the first upper segment 10 and the second lower segment 20. In addition, the second portion inner cylindrical thread structure 46 is arranged to face the first portion inner cylindrical thread structure 40, so that the first pitch of the first portion inner cylindrical thread structure 40 and the second pitch of the second portion inner cylindrical thread structure 46 match, thereby allowing the conical screw element 60 and both the first portion inner cylindrical thread structure 40 and the second portion inner cylindrical thread structure 46 to be threadedly engaged with the upper and lower segments 10, 20, respectively, at the same time. Preferably, the first and second partially internal cylindrical threaded structures 40, 46 may be separated by an expandable gap that expands as the conical screw element 60 is threadedly engaged with the partially threaded structures 40, 46, such as Figure 2A As shown in the example. In addition, the second partial internal cylindrical thread structure 46 has a second thread axis TA2, which is arranged to be inclined at a second angle α2 relative to the insertion direction (1D), preferably, the absolute value of the second angle α2 is equal to the first angle α1, but is arranged in the opposite direction or arranged to a different sign value. The thread axes TA1 and TA2 are configured to intersect at a position for providing matching threads, wherein there is an angle α1+α2 between the axes TA1 and TA2. As a result, there is a mirror-symmetrical arrangement of the cylindrical segments forming the first and second partial internal cylindrical thread structures 40, 46. In this embodiment, the contact surface of the contact point CP can be further increased, and considering the symmetry provided between the two partial thread structures 40, 46, a more symmetrical expansion force application can also be provided, and a smoother thread engagement can also be provided. In addition, due to the simultaneous threaded engagement with the first upper and second lower segments 10, 20, the segments 10, 20 can be prevented from shifting relative to each other in the insertion direction ID or in a direction transverse to the insertion direction.
[0086] In this embodiment, it is also possible that the first and second segments 10, 20 are interconnected to each other by a tearable or releasable structure (e.g., as an additional part of the interconnection structure 30) or another separate part (e.g., an interconnection that can be torn or separated on the expansion segment 10, 20, such as a force established by the threaded engagement of the conical screw element 60 with the first and second part inner cylindrical thread structures 40, 46 of the implant body 5 and the expansion of the segments 10, 20). The tearable structure can be, for example, but not limited to, a tearable layer, such as a porous or otherwise weakened interconnection layer, a tearable adhesive, or an adhesive between the contact surfaces of the segments 10, 20 facing each other. In such an embodiment, it is possible that before any expansion of the first and second segments 10, 20 occurs, the first and second part inner cylindrical thread structures 40, 46 can be initially interconnected together without a gap between the first and second segments 10, 20 at the interface.
[0087] FIG. 3A to FIG. 3N An intervertebral implant 300 according to a third embodiment of the invention is shown, the implant 300 having two partially internal cylindrical threaded structures 40, 50 arranged adjacent to each other in the body 5, each structure 40, 50 extending substantially in the insertion direction (ID) with an angular offset, and each structure being configured to threadedly engage with a conical screw element 60, 70. In the variant shown, the implant body 5 can be expanded at two different locations for increasing the distance D1 at a first transverse side of the body 5 and for increasing the distance D2 at a second transverse side of the body 5 opposite to the first side by using two substantially parallel arranged partially internal cylindrical threaded structures 40, 50 threadedly cooperating with two corresponding conical screw elements 60, 70. The distance D1 at the first transverse side of the body 5 can be, for example, the distance between the outer surface of the first segment 10 and the outer surface of the second segment 20. However, the distance D1 can be measured, for example, between any first position on the first segment 10 and any second position on the second segment 20, which undergo a relative displacement by the screw elements 60, 70. The distance D2 at the second lateral side of the body 5 may be, for example, the distance between the outer surface of the first segment 10 and the outer surface of the second segment 20. However, the distance D2 may be measured, for example, between any first position on the first segment 10 and any second position on the second segment 20, which are subjected to a relative displacement by the screw elements 60, 70. This allows, for example, to change the angular orientation between the first and second segments 10, 20 to an angle β (see, for example Figure 3J and Figure 3M), for example, by threading the conical screw element 60 into the main body 5 at a certain penetration distance, the distance D1 at one side is increased by a certain first height without changing the distance D2 at the other side; or by threading the conical screw element 70 into the main body 5 at a certain penetration distance, the distance D2 at the other side is increased by a certain second height without changing the distance D1; or by increasing the distance D1 to D2 to different heights, there are different penetration distances between the screw elements 60 and 70.
[0088] In the third embodiment, in addition to the partial internal cylindrical thread structure 40, another partial internal cylindrical thread structure 50 is arranged between the first section 10 and the second section 20, extending close to the partial internal cylindrical thread structure 40, and the other or third partial internal cylindrical thread structure 50 forms Figure 3E The third thread axis TA3 shown in FIG. 1 is inclined at a third angle α3 relative to the insertion direction ID. The third angle α3 may be, for example, the same or substantially the same as the absolute value of the first angle α1 defined by the first thread axis TA1 of the first part internal cylindrical thread structure 40, as described with respect to the previous embodiment. In addition, a second inclined surface 54 may be provided (see, for example, Figure 3E and Figure 3G ), the second inclined surface faces the opening section of the third part inner cylindrical thread structure 50 and is opposite thereto, and can be arranged between the first section 10 and the second section 20, for example, in a mirror-symmetrical arrangement. This arrangement can be similar to the arrangement of the first inclined surface 44, which faces the opening section of the first part inner cylindrical thread structure 40 and is aligned therewith. The second inclined surface 54 can be formed as a cylindrical segment surface having a cylindrical axis inclined at a fourth angle α4 relative to the insertion direction (ID), and preferably, the absolute values of the third angle α3 and the fourth angle α4 are the same or approximately the same. In this regard, the distance measured between the second inclined surface 54 and the cylindrical surface segment of the third part inner cylindrical thread structure 50, measured in a direction perpendicular to the first and second bone engaging surfaces 12, 22, decreases along the insertion direction ID.
[0089] In another variation, it is possible that a fourth partial internal cylindrical thread structure 56 (not shown) is arranged between the first and second sections 10, 20 and arranged to face the third partial internal cylindrical thread structure 50, rather than facing the second inclined structure 54 without threads, so that the third pitch of the third partial internal cylindrical thread structure 50 and the fourth pitch of the fourth partial internal cylindrical thread structure 56 match, for example by a mirror-symmetrical arrangement of the structures 50, 56. In addition, the fourth partial internal cylindrical thread structure 56 can define a fourth thread axis TA4, which is arranged to be inclined at a fourth angle α4 relative to the insertion direction (ID). Again, preferably, the absolute values of the third angle α3 and the fourth angle α4 are the same.
[0090] In addition, if Figure 3C and Figure 3D As shown in , the interconnection structure 30 in this embodiment forms a transverse structure, for example in the form of a plate, which is arranged diagonally between the first and second segments 10, 20, for example from one side edge of the first segment 10 to the opposite side edge of the second segment 20 when viewed in the insertion direction ID, and the interconnection structure 30 can be deformably attached to the first segment 10 at one edge to form the first hinge element 15, and the interconnection structure 30 can be deformably attached to the second segment 20 at the other opposite side edge to form the second hinge element 25. In addition, in this variation, the partial inner cylindrical thread structure 40 can be arranged to extend at a first position on the side of the interconnection structure 30 facing the first segment 10, and the inclined surface 44 (for example, a cylindrical surface) or the second partial inner cylindrical thread structure 46 is arranged to be formed in the portion of the first segment 10 facing the thread structure 40. Similarly, the partial internal cylindrical thread structure 50 can be arranged to extend at a second position on the opposite side of the interconnection structure 30 facing the second segment 20, while the inclined surface 54 (e.g., a cylindrical surface) or a fourth partial internal cylindrical thread structure 56 is arranged to be formed within the portion of the first segment 10 facing the thread structure 40.
[0091] Furthermore, the interconnection structure 30 may have two curved surface elements 33, 37, which are curved, have a substantially cylindrical segment shape, with the cylindrical axis thereof being parallel to the insertion direction ID, the surface element 37 being arranged on the side of the interconnection structure 30 opposite to the partially internal cylindrical thread structure 40, and the surface element 33 being arranged on the opposite side of the partially internal cylindrical thread structure 50. The two surface elements 33, 37 may face the two curved surface elements 18, 28 of the first section 10 and the second section 20, respectively, also having a substantially cylindrical segment shape. In the non-expanded or non-extended shape, the two curved surface elements 33, 37 and the two curved surface elements or components 18, 28, respectively, may be in contact with each other, or there may be a gap that may be formed between the two curved surface elements 33, 37 and the two curved surface elements 18, 28, respectively.
[0092] In addition, for the third embodiment, a transverse opening or transverse cavity T0 is arranged, which can form a first cavity in the middle area of the first section 10, a second cavity in the middle area of the interconnection structure 30, and a third cavity in the middle area of the second section 20, as shown in FIG. Figure 3A , Figure 3B , Figure 3G and Figure 3H As shown in . By placing such a transverse opening or cavity between the structure of the partial inner cylindrical thread structure 40, 50 and the inclined surface 44, 54, a bone graft or other functional material can be filled or otherwise provided therein.
[0093] Figures 3J to 3N The implant 300 is shown in two different expanded states to illustrate its operation and different configuration possibilities. Figure 3J A front view of an implant 300 in a partially expanded state by using a conical screw element 60 which has been fully threadedly engaged with the thread structure 40 to its end, at a maximum penetration depth or distance away from the opening 80, resulting in an expanded state in which one of the lateral sides is expanded to a maximum value of the distance D1. In contrast, the conical screw element 70 is still in the initial starting position at the opening 90. Thereby, the bone engaging surfaces 12, 22 are arranged at a first bending angle β1, because the first section 10 has pivoted about the first hinge element 15 as a deformable part of the interconnection structure 30. By this maximum thread penetration depth or distance of the screw element 60, by means of the deformation of the first hinge element 15 of the interconnection structure 30, a maximum extension of the distance D1 has been reached, preferably 50% or more of the initial non-extended distance D1 (e.g. 150% or more of the initial non-extended distance D1). In addition, a maximum obtainable angle between the bone engaging surfaces 12, 22 has been reached, preferably about 12°, more preferably about 18° or more. Figure 3K A side cross-sectional view of an implant 300 is shown, wherein a conical screw element 60 is fully screwed into the end of a partially internal cylindrical threaded structure 40, wherein vertically arranged cutting surfaces pass through the axes TA1, TA2, showing that the conical screw element 60 reaches the end of the partially internal cylindrical threaded structure 40 at the tip or apex of the screw element 60, and Figure 3L A top perspective view of the implant 300 is shown with the conical screw element 60 fully screwed into the end of the partial inner cylindrical thread structure 40, visible through the transverse opening TO.
[0094] Figure 3MA front view of an implant 300 is shown in a fully expanded state by using two conical screw elements 60, 70 which have been fully threadedly engaged with the threaded structures 40, 50 to their ends with a maximum penetration depth or distance resulting in a fully expanded state in which the two lateral sides are expanded to a maximum value of the distances D1, D2. Thus, the bone engaging surfaces 12, 22 are arranged parallel or substantially parallel to each other, since the first segment 10 has been pivoted around the first hinge element 15 as a deformable part of the interconnection structure 30 at a first bending angle β1, and the second segment 20 has been pivoted around the second hinge element 25 as a deformable part of the interconnection structure 30 at a first or second bending angle β2, through equal penetration depths or distances of the screw elements 60, 70. By means of this maximum thread penetration depth or distance of the screw elements 60, 70, a maximum extension of the two distances D1, D2 has been reached by means of deformation of the first and second hinge elements 15, 25 of the interconnection structure 30, and again preferably 50% or more of the initial non-extended distances D1, D2 (for example, 150% or more of the initial non-extended distance and 150% or more of the initial non-extended distance D2). Figure 3N A top perspective view of the fully expanded body 5 of the implant 300 is shown.
[0095] For the third embodiment, the angle between the first upper and second lower sections 10, 20 is allowed to vary so as to reach their bone engaging surfaces 12, 22, and the implant 300 can be adjusted to provide the desired scoliosis, lordosis or kyphosis angle for correction thereof. For example, for a coronal plane balanced restoration, the lateral height can be adjusted by the independently adjustable distances D1 and D2, and the coronal plane correction angle can be adjusted within a certain range.
[0096] 4A to 4FAspects of a fourth embodiment of the invention are shown, showing an implant 400 having a plurality of corner elements, for example, four corner elements 110, 120, 130, 140 extending longitudinally in the insertion direction ID, wherein the threaded engagement of the conical screw element 60 with one or more internal threads arranged at one or more of the four corner elements 110, 120, 130, 140, respectively, causes the implant body 5 to expand in the z direction to have a variable size over a distance D1, and simultaneously expand in the y direction to have a variable size over a distance D2, thereby forming an implant 400 that expands in height and width. Furthermore, in the variant shown, the implant 400 has a slightly rectangular cross-sectional area when viewed in the insertion direction ID. To allow expansion in the z and y directions perpendicular to each other, the corner elements of one side of the common implant body 5 are interconnected with a deformable interconnection structure, thereby having a plurality or four sets of a plurality of deformable interconnection elements 115, 125, 135, 145, wherein the interconnection element 115 is formed between the corner elements 110, 120, the interconnection element 125 is formed between the corner elements 120, 130, the interconnection element 135 is formed between the corner elements 130, 140, and the interconnection element 145 is formed between the corner elements 140, 110. In the illustrated variation, the deformable interconnection elements 115, 125, 135, 145 include a plurality of links or tabs having a V shape. For example, each of the deformable interconnection elements 115, 125, 135, 145 is formed by pairs of tabs or links 117, 119, 127, 129, 137, 139 and 147, 149 arranged at different angles.
[0097] Furthermore, at least one (or more) corner elements 110, 120, 130, 140 comprises a partial internal cylindrical thread 112, 122, 132, 142, at least one partial internal cylindrical thread 112, 122, 132, 142 forming a discontinuous thread, the thread axis of which is inclined relative to the insertion direction ID, the discontinuous thread being configured for threadably receiving the conical screw element 60. In the variant shown, each corner element 110, 120, 130, 140 has a corresponding internal cylindrical thread 112, 122, 132, 142, but it is also possible that there is only one, while the other corner elements have an inclined surface arranged at an oblique angle to the insertion direction ID, or have a cylinder segment surface having a cylinder axis inclined relative to the insertion direction ID, as described above. Preferably, at least two corner elements facing each other (for example, corner elements 110, 130 or corner elements 120, 140) include partial internal cylindrical threads 112, 132 or 122, 142, while the other two corner elements can be equipped with inclined surfaces arranged at an inclined angle to the insertion direction ID, or cylindrical segment surfaces arranged at an inclined angle to the insertion direction ID.
[0098] The deformable interconnecting elements 115, 125, 135, 145 are deformable to allow expansion of the distance D1 between the upper and lower segments of two corner elements 110, 120 and 130, 140 arranged on the same side, and simultaneous expansion of the distance D2 between the left and right segments of the two corner elements 120, 130 and 110, 140 arranged on the same side when the conical screw element 60 is threadedly engaged with a non-continuous thread that can be formed by one or more partial internal cylindrical threads 112, 122, 132, 142, because the progressive thread engagement of the conical screw element 60 will cause the conical screw element 60 to advance in the insertion direction to engage with the narrower segments of one or more of the obliquely arranged internal cylindrical threads 112, 122, 132, 142 to spread the four corner elements 110, 120, 130, 140 so that the distance between adjacent corner elements will increase.
[0099] Figure 5 A top perspective view of a spinal implant system 500 according to yet another aspect of the present invention is shown, showing an exemplary intervertebral implant 300 that can be removably interconnected to an implant manipulation device or system 505 to form a spinal implant system 500 having a triple function, a first function for holding and inserting the implant 300 into the intervertebral space between two adjacently positioned vertebrae, a second function for adjusting the implant 300 by two screwdrivers 540 that can rotate the first and second conical screw elements 60, 70 to expand and tilt the first and second sections 10, 20, and a third function for injecting or otherwise providing bone graft into the transverse opening or another type of cavity of the spinal implant 300. The intervertebral implant 300 is exemplary only, and other intervertebral implants as described herein can be used in conjunction with the implant manipulation device 505.
[0100] The implant manipulation device or system 505 includes a holder 530, which is exemplarily formed by a hollow cylinder having a dual function. First, the holder 530 can be used to removably hold the implant 300, and secondly, the holder 530 can be used to guide and inject a bone graft into the implant 300 via its hollow body. The guiding and injection of the bone graft can be formed by a pusher 510, which has a shape complementary to the inner volume of the holder 530, is configured to slidably engage with the inner volume, and is displaceable along the insertion direction ID. Furthermore, the pusher 510 itself may also have a dual function, firstly to act like a piston to push the bone graft through the inner volume retainer 530 into the implant 300 via the bone graft discharge opening or port 532 arranged at the distal end of the retainer 530, directed toward the transverse opening TO of the implant body 5, and secondly to release the implant by disengaging the flexible coupling (or clip) 334 configured to releasably engage the retainer 530 with the implant body 5 of the implant 300. This may be embodied by the distal end of the pusher 510 having a hollow cylindrical section forming a circular wall, which, when the pusher 510 is relatively slidably engaged with the retainer 530 in the insertion direction ID, allows the two clips 336, 338 to bend inwardly to engage with the inclined surfaces 337, 339 of the clips 336, 338, respectively (see, e.g. Fig. 6A ) engages to release them from the locking cavities 536, 538 of the retainer 530. In addition, the front end or distal end of the retainer 530 also includes locking cavities or openings 536, 538 arranged in the side walls of the retainer 530, and the flexible connector 334 having two symmetrically arranged flexible clips 336, 338 can be a part of the interconnection structure 30 of the implant 300 or formed together with it.
[0101] In addition, the implant manipulation device or system 505 may also include one or more screwdrivers 540, each having a torque instrument 544 arranged at its distal end, the torque instrument being configured to transmit torque to a corresponding one of the first and second torque applying structures 64, 74 of the first and second conical screw elements 60, 70, respectively; and a screwdriver guide 520, which may be attached to the holder 530 or may be formed integrally therewith, and in the illustrated variation has two (2) guide holes 522, 524 extending in the insertion direction ID for guiding the two (2) screwdrivers 540 to engage and rotate with the one or more conical screw elements 60, 70, respectively. The guide holes 522, 524 of the screwdriver guide 520 each have a hollow cylindrical shape, which is sized to accommodate the shaft of the screwdriver 540, and their cylindrical axes are configured to be spaced apart and arranged so that they coincide with the rotational axes of the conical screw elements 60, 70 arranged in the body 5 of the implant 300.
[0102] FIG. 6A to FIG. 6D Different top and side cross-sectional views of the implant 300 and a retainer 530 having a hollow body (e.g., a cylindrical element) are shown, illustrating the operation, interconnection, and release of the retainer 530 from the implant body 5, showing the retainer 530 and the body 5 in a disengaged state (in Fig. 6A and Figure 6B ) and in the engaged state (shown in Figure 6C and Fig.6D ), depicting an exemplary flexible coupling 334 of an implant 300 having two symmetrically arranged flexible clips 336, 338 that may be part of or formed with the interconnection structure 30 of the implant, such as two clips 336, 338 cut out of a plate forming the interconnection structure 30. Each clip 336, 338 has an inclined or ramped surface 337, 339 that is inclined relative to the insertion direction ID, so that the clips 336, 338 can be bent radially inwardly by the distal end of the retainer 530 for engagement between the retainer 530 and the implant 300, and can also be bent radially inwardly by engagement with the cylindrical wall of the pusher 510 for disengagement or release of the retainer 530 and the implant 300. In this regard, it should be noted that the direction in which the implant 300 is inserted into the intervertebral space and the direction in which the retainer 530 is inserted into the implant are generally the same direction. In addition, a flexible connector 534 at the distal end of the retainer and locking cavities or holes 536, 538 arranged in the side wall of the retainer 530 are shown, the flexible connector having a cylindrical section cut through a groove, which is configured to flex or bend in a radial direction away from and toward the central axis of the retainer 530. Figure 6C The implant 300 and the retainer 530 are shown in an engaged state, wherein the clips 336, 338 are bent radially inwardly and have engaged with corresponding locking cavities or holes 536, 538 arranged in the side wall of the retainer 530. In addition, the distal end of the retainer 530 forms a bone graft outlet 532, which can reach into the body 5 of the implant 300, so that the distal end of the retainer 530 leads to traverse the opening TO to inject the bone graft into the opening TO. This can be done by a pusher 510, which acts like a piston within the hollow body or volume of the retainer 530 to push the bone graft located inside the retainer 530 into the body 5 of the implant 300 via the bone graft outlet 532. Preferably, the inner hollow volume of the retainer 530 is cylindrical, and the pusher 510 has a corresponding cylindrical shape, but other cross-sectional shapes are also possible.
[0103] FIG. 7A to FIG. 7DFour (4) different views of an intervertebral implant 600 according to a fifth embodiment of the present invention are shown, which uses two (2) conical screw elements 660, 670, each screw element having two (2) conical screw parts 664, 666 and 674, 676 arranged at the distal and proximal ends of the corresponding screw elements 660, 670, and the implant body 5 has two pairs of partial internal cylindrical thread structures 644, 646 and 654, 656, which are arranged to allow the screw element 660 having two conical screw parts 664, 666 to engage with the threads of the corresponding partial internal cylindrical thread structures 644, 646 at one side of the implant 600, and to allow the screw element 670 having two conical screw parts 674, 676 to engage with the threads of the corresponding partial internal cylindrical thread structures 654, 656 at the other side of the implant 600, and the two screw elements 660, 670 are arranged to be roughly parallel to each other. By this arrangement, it is possible to provide an improved pressure and weight distribution for the body 5 when compressed or loaded in the z-direction, and it is also possible to provide an improved parallelism of the upper and lower sections 10, 20 when expanding the implant 600, for example to ensure that the upper and lower surfaces 12, 22 remain parallel to the insertion direction ID by minimizing the deformation that may be caused by the expansion of the conical screw elements 660, 670. In the variant shown, there are two (2) conical screw elements 660, 670, but it is also possible that the implant is provided with only one (1) conical screw element 660, which has a front and a rear conical screw part 664, 666. In addition, it is also possible to provide more than two (2) screw parts 664, 666 on one screw element 660 or 670.
[0104] In the variation shown, four (4) conical screw components 664, 666, 674, 676 and corresponding partially internal cylindrical thread structures 644, 646, 654, 656 are arranged at the corners of the implant 600 when viewed in the z-direction to provide improved load bearing and stability of the implant 300, but other configurations may be selected. For example, in a variation, the implant 600 may have one screw element 660 or 670 with two conical screw components 664, 666 or 674, 676 at one side and a conical screw element 60 with only one conical thread element at the opposite side, such as Figures 1A to 1GAs exemplarily shown in , so as to have three (3) mechanical support positions. When viewed from the z-direction, such an embodiment will also allow the manufacture of an implant having a triangular or trapezoidal profile, for example by having a first and second section 10, 20 having a triangular or trapezoidal shape, wherein the conical screw element 60 is located at the short base of the trapezoidal shape or at the corner of the triangular shape, and a longitudinal screw element 660 or 670 is arranged at or along the long base of the trapezoidal shape, or arranged at the opposite side of the triangular shape. In addition, the screw element 660 includes a shaft or bolt 662, which has two conical screw components 664, 666 arranged at its two ends, and the screw element 670 includes a shaft or bolt 672, which has two conical screw components 674, 676 arranged at its two ends. As Fig.7D As shown in , the space between the first and second sections 10, 20 is increased by substantially extending the interconnection structure 30 in the z direction to place the screw elements 660, 670 into their respective openings, and the screw elements 660, 670 can be placed into the implant 600 to their operative positions. In the present disclosure, the interconnection structure 30 may include any of the interconnection structures 30 discussed herein. As described in the previous embodiments, a partially internal cylindrical threaded structure 644, 646, 654, 656 may be included in the first section 10 or the second section 20 (formed or disposed in its inner surface). Figure 7B In the illustrated variation, a partially internal cylindrical thread structure 644, 646, 654, 656 is included in the first section 10. As previously disclosed in previous embodiments, each partially internal cylindrical thread structure 644, 646, 654, 656 has a thread axis TA or a rotation axis of the cylinder, which extends in the insertion direction but is at an inclination angle αTA relative to the insertion direction, which inclination angle αTA may be, for example, the same or substantially the same as the first angle α1. The inclination angle α of each partially internal cylindrical thread structure 644, 646, 654, 656 may be the same or substantially the same. The partially internal cylindrical thread structure 644, 646, 654, 656 or each of them may have an inclined surface 695, 696, 697, 698 facing it or positioned opposite it. The inclined surfaces 695, 696, 697, 698 are formed, arranged and disposed relative to the partial internal cylindrical thread structures 644, 646, 654, 656 in the same manner as described in the previous embodiments, and as previously described, each has a cylindrical axis inclined at an angle αR relative to the insertion direction ID. The absolute value of the angle αR may be the same or substantially the same as the absolute value of the angle αTA of the partial internal cylindrical thread structure located (directly) opposite the inclined surface.
[0105] In addition, for the intervertebral implant 600, the cylindrical surface elements 680, 690 can be arranged to engage or cooperate with the surface of the corresponding shaft or bolt 662, 672, each cylindrical surface element 680, 690 having a first cylindrical segment 682, 692 and a second cylindrical segment 684, 694 facing each other, for providing guidance of the rotation performed by the longitudinal screw element 660, 670 relative to the implant body 5. The corresponding radius or diameter of the cylindrical segment formed by the surface 682, 684 and the surface 692, 694 should be selected to be slightly larger than the radius or diameter of the corresponding shaft or bolt 662, 672 to allow easy but guided rotation. The first cylindrical segment 682, 692 can be integrally formed with the first segment 10, be a part of it or be attached to it, and the second cylindrical segment 684, 694 can be integrally formed with the second segment 20, be a part of it or be attached to it. In the first unexpanded state or position of the implant 600, the two segments 682, 692 and 684, 694 of the cylindrical surface element 680, 690 can be constructed and arranged so that their cylindrical axes coincide or share with adjacent segments 682, 684 and 692, 694, and can also coincide with the axis of rotation of the shaft or bolt 662, 672, thereby forming a generally cylindrical cavity or volume between adjacent segments 682, 684 and 692, 694. This arrangement allows for improved guidance during rotation of the longitudinal screw element 660 or 670, in particular at the beginning of expansion of the implant 600. This in turn can prevent blocking of the conical thread, such as blocking of the conical screw components 664, 666 and 674, 676. As the first and second segments 10, 20 expand, the cavity or volume between adjacent segments 682, 684 and 692, 694 will be stretched and will therefore no longer be cylindrical, but may still provide some lateral guidance in the y direction. In a variant, it is also possible that the cylindrical surface elements 680, 690 are not made of two cylindrical surface segments facing each other as described above, but each form a generally cylindrical hole or cavity in the block for accommodating a shaft or bolt 662, 672 therein, and are arranged to be suspended between the first and second segments 10, 20, for example by using expandable elements or connecting rods arranged between the cylindrical surface elements 680, 690 and the first element 10 and between the cylindrical surface elements 680, 690 and the second element 20. These expandable elements can be part of the different interconnecting structures 30 discussed herein, or can be an integral part thereof, or embedded in the interconnecting structure 30, and can be made of similar or identical elements thereof, such as but not limited to bendable tabs, connecting rods, V-shaped elements, circular or oval elements, W-shaped elements, and combinations thereof.This variation would provide a suspended cylindrical surface element 680 , 690 between the first and second elements 10 , 20 so that the rotational guidance by the shaft or bolt 662 , 672 would not change with the expansion and increased distance between the first and second elements 10 , 20 .
[0106] FIG. 8A to FIG. 8C Different views of an intervertebral implant 700 according to a sixth embodiment of the invention are shown, the implant 700 having an implant body 5 with an interconnection structure 730 formed by a plurality of spring elements 732.1 to 732.6, in an exemplary variant, six (6) spring elements 732.1 to 732.6 arranged along a central section of the body 5, at least partially arranged in a transverse opening TO, the spring element 732 interconnecting the first and second sections 10, 20 and arranged along the insertion direction ID between two openings, the two openings respectively having two partially internal cylindrical threaded structures 40, 50. In the variant shown, no transverse plate-like element is shown or is not present, for example Figure 3A In the embodiment shown in FIG. 7 , the spring element is a deformable structure, such as an elastically deformable structure that can extend in the z direction in the middle or central section of the implant 700, and in the variation shown, an M-shaped or W-shaped structure with four legs, each leg slightly bent. In addition, the orientation of the M-shaped or W-shaped structure in the transverse or y-direction is selected to alternate for each spring element 732.1 to 732.6 to provide a generally symmetrical arrangement, thereby minimizing any lateral forces when the implant 700 expands in the z-direction.
[0107] 9A to 9D Different views of an intervertebral implant 800 according to a seventh embodiment of the present invention are shown, wherein Fig.9A A front view and a top view are shown, Fig. 9B Another front view from a different perspective is shown. Fig. 9C shows a front view of the implant 800 in a non-expanded state, Fig.9D shows a front view of the implant 800 in a fully expanded state, and Fig.9E, wherein the implant 800 is in a partially expanded state, wherein there is an oblique angle between the first section 10 and the second section 20 of the implant 800. The implant 800 may include a first section 10 having a first bone engaging surface 12 (e.g., having one or more openings therein), a second section 20 having a second bone engaging surface 22, a transverse middle section 830 disposed between the first section 10 and the second section 20, one end of the transverse middle section 830 being articulatably attached to the first section 10, e.g., attached to the first section 10 along a side edge or end of the first section 10, and the other end of the transverse middle section 830 being articulatably attached to the second section 20, e.g., a diagonally opposite side edge or end of the second section 20.
[0108] In addition, the implant 800 may also include a first rotatable bolt 860, which is configured to be arranged between the first section 10 and the transverse middle section 830 and defines a first rotation axis that is preferably parallel to or approximately parallel to the insertion direction (ID); and a second rotatable bolt 870, which is arranged between the transverse middle section 830 and the second section 20, and has a second rotation axis that is preferably parallel to or approximately parallel to the insertion direction (ID). The outer surfaces 862, 872 formed around their respective rotation axes of the first and second rotatable bolts 860, 870, and the first surface 832 facing the first section 10 and the second surface 834 facing the second surface 20 of the transverse middle section 830 are configured to grip or interlock with each other, such as by having mutually engaging surface structures, so that when at least one of the first and second rotatable bolts 860, 870 is rotated around the first or second rotation axis, at least one of the first and second rotatable bolts 860, 870 can roll on the first or second surface 832, 834, respectively, with increased grip. The inner surface 19 of the first section 10 may have a flat surface or other smooth surface that allows the bolt 860 to slide or glide rotatably on the surface 19 when it rotates and contacts the inner surface 19, and the inner surface 29 of the second section 20 may also have a flat surface or other smooth surface that allows the bolt 870 to slide or glide rotatably on the surface 29 when it rotates and contacts the inner surface 19.
[0109] In a variation, both the inner surface 19 of the first section 10 and the first surface 832 of the transverse middle section 830 may have interengaging surface structures for engaging with the outer surface 862 of the first rotatable bolt 860, and similarly, both the inner surface 29 of the second section 20 and the second surface 834 of the transverse middle section 830 may have interengaging surface structures for engaging with the outer surface 872 of the second rotatable bolt 870. In another variation, the first surface 832 of the transverse middle section 830 may have a flat surface or other smooth surface that allows the bolt 860 to rotatably slide or glide on the first surface 832 when rotating and contacting the first surface 832, and the second surface 834 of the transverse middle section 830 may have a flat surface or other smooth surface that allows the bolt 870 to rotatably slide or glide on the second surface 834 when rotating and contacting the second surface 834. Thus, in this variation, the inner surface 19 of the first section 10 may have an interengaging surface structure for engaging with the outer surface 862 of the first rotatable bolt 860, and similarly, the inner surface 29 of the second section 20 may have an interengaging surface structure for engaging with the outer surface 872 of the second rotatable bolt 870.
[0110] With this construction, by imparting rotation to the first rotatable bolt 860, such as clockwise rotation of the first rotatable bolt 860 as viewed from the front surface through engagement of the surface 862 of the bolt 860 with any one or both of the surfaces 19, 832, the first rotatable bolt 860 will move in the positive y-direction, thereby applying an expansion force between the first section 10 and the transverse section 830, and thereby also applying a bending force to the first bendable or pivotable attachment link 836, causing the first section 10 to pivot relative to the transverse section 830, and Fig. 9C and Fig.9E This transition from a first non-expanded state to a second expanded state is shown, showing two states when the first rotatable bolt 860 is rotated and displaced. In this regard, the first section 10 and the transverse section 830 can be interconnected to each other via a first bendable or pivotable attachment link 836 (e.g., an elastically bendable element of the transverse section 830) to allow the first section 10 to pivot relative to the transverse section 830. The bendable or pivotable attachment link 836 can be embodied as an edge portion between the transverse section 830 and the first section 10, and can be made of a reversibly bendable material or structural construction. Due to the reversible bendability of the bendable or pivotable attachment link 836, when the first rotatable bolt 860 is rotated in a counterclockwise direction, the first rotatable bolt 860 can move in the negative y direction to move back to the position as shown in FIG. Fig. 9C , and the first section 10 will be able to move back to the initial non-expanded position.
[0111] Similarly, the second section 20 and the transverse section 830 can be interconnected to each other via a second bendable or pivotable attachment link 838 to achieve a reversible pivotable interconnection between the second section 20 and the transverse section 30. In the illustrated embodiment, an edge portion is arranged between the transverse section 830 and the second section 20, and a second rotatable bolt 870 can perform a reversible pivotal expansion between the second section 20 and the transverse section 830, for example by a clockwise rotation for expansion and a counterclockwise rotation for retraction.
[0112] Preferably, the surface structure of the first surface 862 of the first bolt 860, the second surface 872 of the second bolt 870, and the surface structure of any one of the first surface 832 of the transverse middle section 830, the second surface 834 of the transverse middle section 830, the inner surface 19 and the inner surface 29 can be such that it allows for discrete positions of the first and second bolts 860, 870 along the y-axis. For example, the first and second surfaces 862, 872 of the first and second rotatable bolts 860, 870 include alternating grooves 864 and ridges 866 (see, e.g. Fig. 9C ), in the exemplary variation, three (3) such alternating grooves 864 and ridges 866 are shown. The grooves 864 and ridges 866 are arranged parallel to the rotation axis of the first bolt 860. In addition, the surface structure of the transverse middle section 830 may include ridges 836 and grooves 838 of complementary shapes, so that the ridges 866 of the bolt 860 can cooperate with the grooves 838 of the transverse middle section 830. In the example shown, the ridges 866 of the bolt 860 are rounded to engage with the complementary rounded grooves 838 of the transverse middle section 830. As shown in FIG. FIG. 9C to FIG. 9E As shown in , with this configuration, the first bolt 860 can adopt discrete positions where the contact surface between the bolt 860 and the transverse middle section 830 is increased, thereby providing a higher load carrying rating and better weight distribution. The bolt 870 and the second surface 834 of the transverse middle section 830 can be similarly configured with grooves 874 and ridges 876 of the bolt 870 and complementary grooves 837 and ridges 835.
[0113] With this configuration, the first and second rotatable bolts 860, 870 can form a cam-type device that allows discrete displacement positions along the y-direction by applying rotation to a respective one of the first or second bolts 860, 870. This allows for the provision of an expandable implant device 800, wherein if the same amount of rotation is applied to both bolts 860, 870, the first and second bone engaging surfaces 12 and 22 of the first and second sections 10, 20, respectively, can expand to remain parallel to each other, thereby performing the same amount of linear displacement along the y-direction in opposite directions for the respective bolts 860, 870. This is Fig. 9C and Fig.9D It is shown in Fig. 9CThe implant 800 is shown in a non-expanded state, wherein two bolts 860, 870 are arranged near or at respective sides of the implant body 5 in an initial position, and Fig.9D The implant is shown in the most expanded state, wherein the two bolts 860, 870 are rotated the same distance relative to the y direction to the innermost position of the implant body 5 to provide the maximum expansion of the surfaces 12, 22. In addition, by rotating the first rotatable bolt 860 and the second rotatable bolt 870 to different positions along the y direction, as shown in FIG. Fig.9E As shown in FIG. 8 , the innermost position of bolt 860 and the outermost position of bolt 870 may achieve different angles between surfaces 12 , 22 .
[0114] For additional load bearing and weight distribution, the expandable implant device 800 may include a first longitudinal protrusion or ridge 815 extending in the insertion direction ID on the first surface 832 of the transverse middle section 830, and a second longitudinal protrusion or ridge 825 also extending in the insertion direction ID on the second surface 834 of the transverse middle section 830. In addition, for example, Fig. 9C In the non-expanded position shown, the inner surface 19 of the first segment 10 may include a corresponding groove 15G for receiving and contacting the first longitudinal protrusion or ridge 815, and the inner surface 29 of the second segment 20 may include a corresponding groove 25G for receiving and contacting the second longitudinal protrusion or ridge 825. In addition, for example at the front thereof, the first and second rotatable bolts 860 and 870 may include first and second torque application structures 869, 879, which allow removable engagement with a torque instrument (such as a screwdriver or torque tool). In addition, the first and second rotatable bolts 860 and 870 may include central transverse or non-transverse bores 865, 875, respectively, thereby allowing tool guidance rods or instruments, such as but not limited to K-wires, K-wires or rods. Preferably, the expandable implant device 800 has two (2) such rotatable bolts 860 and 870, rather than just one, to provide various structural positions of the bone engaging surfaces 12, 22, and also to allow parallel displacement or expansion of the first and second bone engaging surfaces 12, 22. As Fig.9A , Fig. 9B and Fig. 9C As shown in, in the non-expanded position or state, the surface wall of the first and second rotatable bolts 860 and 870 can form a part of the side wall of the implant device 800 and can contact tissue or bone. As shown, a part of the outer surface 862, 872 of the first and second rotatable bolts 860, 870 can be provided with a surface that promotes bone or tissue ingrowth, such as a trabecular surface structure, a porous structure or other types of surface structures known to promote bone or tissue ingrowth.
[0115] In the context of the seventh embodiment, the implant device 800 comprises a flexible assembly or flexible means provided by a first bendable or pivotable attachment link 836, a second bendable or pivotable attachment link 838 and a transverse intermediate section 830, which interconnects the first and second elements 10, 20 and allows to change the distance D between the first and second elements 10, 20, and further allows to change the angle between the first and second elements 10, 20. In addition, the implant device 800 comprises an assembly or means for increasing the distance D between the first and second elements 10, 20, in particular by means of first and second rotatable bolts 860, 870, which are configured to apply a bending force to the first and second bendable or pivotable attachment links 836, 838 to allow reversible expansion.
[0116] Fig. 10A and Fig. 10B A simplified top view of an intervertebral implant 900 according to an eighth embodiment of the present invention is shown, wherein Fig. 10A A top view of an expansion mechanism 960 having two (2) conical screw sections 964, 966 and a symbolic layout of the body 905 in a non-expanded state are shown, Fig. 10B Another top view of an expansion mechanism 960 in an expanded state is shown, which is preferably used for transforaminal lumbar interbody fusion (TLIF) applications. However, some or all aspects of this embodiment may also be used for other spinal implant application types. In this embodiment, an expansion mechanism 960 based on a conical screw is provided, in which a torque application structure 984 of a head portion 980 can only rotate relative to the body 905 of an implant 900, but does not move along the insertion direction ID when rotating. For this variation, a sliding mechanism 970 is provided, which has a sleeve element 972 and a sliding shaft 974, the sleeve element having an open inner hole attached to or integrally formed with a rotatable bolt 962, the sliding shaft being configured to be slidably accommodated inside the sleeve element 972, and, for example, attached to or integrally formed with a torque application structure 984 via another shaft element or interconnector 982. The inner surface of the open inner bore of the sleeve element 972 and the outer surface of the sliding shaft 974 are configured so that sliding, gliding or other relative movement along the rotation axis of the rotatable bolt 962 is possible, while relative rotation of the sleeve element 972 relative to the sliding shaft 974 is blocked. This rotation blocking can be achieved by complementary surface structures on the inner surface of the open inner bore of the sleeve element 972 and the outer surface of the sliding shaft 974, for example by alternating grooves and ridges extending along the rotation axis, such as Fig. 10BAs shown in . The head portion 980 attached to or integrally formed with the interconnector 982 and the sliding shaft 974 can be rotatably arranged in the cylindrical cavity at the proximal end PE of the body 905 of the implant 900, so that the user can insert a torque tool into the torque applying structure 984 to expand and retract the implant 900, and the head portion 980 can be rotated relative to the cylindrical cavity. The rotation and torque of the torque applying structure 984 applied to the head portion 980 will transmit the rotation and torque to the rotatable bolt 962 via the sliding mechanism 970, and thereby the conical screw segments 964, 966 can engage with a corresponding one of the thread structures in the partial inner cylindrical thread structure, for example Figure 7B and Figure 7C Due to the sliding mechanism 970, linear translation relative to the body 905 in the direction of the axis of rotation is not transmitted to the head portion 980. This engagement of the conical screw sections 964, 966 with the thread structure will cause the first and second sections 10, 20 of the body 905 to expand.
[0117] FIG. 11A to FIG. 11D Aspects of an intervertebral implant 1000 according to a ninth embodiment of the present invention are shown, wherein Fig.11A A top perspective view thereof is shown, Fig. 11B A top perspective view and a transparent view thereof are shown to illustrate the different elements of the implant 1000, Fig. 11C shows a cross-sectional view defined by a cutting plane coinciding with the axis of rotation of the rotatable expansion mechanism 1060, and Fig.11D Shown is its top view, implant 1000 uses expansion mechanism, described expansion mechanism combination uses conical screw element 1064 and one or more wedges 1072,1074 respectively with respect to the linear sliding aspect of inclined surface 1014,1024 and inclined surface 1016,1026.Implant 1000 can be used for anterior lumbar interbody fusion (ALIF) application.However, some or all aspects of this embodiment can also be used for other spinal implant application types.
[0118] like Fig. 11BAs shown in , an expansion mechanism is provided, which includes a rotation expansion mechanism 1060 that is rotatably interconnected or attached to a translation expansion mechanism 1070 that is disposed between first and second segments 1010, 1010 having bone engaging surfaces 1012, 1022. The rotation expansion mechanism 1060 may include a head portion having a torque applying structure 1084; a conical screw element 1064 configured to threadably engage with one or more partially internal cylindrical thread structures 1044 that may be disposed at the inner side of the first segment 1010, the second segment 1020, or both of the first and second segments 1010, 1020; a shaft or bolt 1062; and a rotatable attachment mechanism 1077 configured to rotatably attach the rotation expansion mechanism 1060 to the translation expansion mechanism 1070. The rotatable attachment mechanism 1077 can be embodied by circularly arranged recesses or grooves around a portion 1069 of an axis or bolt 1062 located within a cylindrical cavity or hole 1079 of the translational expansion mechanism 1070 and by a closing cap or plate 1068, so that when the rotational expansion mechanism 1060 is linearly moved back and forth along its rotational axis or along the insertion direction ID for expansion and retraction of the implant 1000, the rotatable attachment mechanism 1077 or portion 1069 is securely retained within the cylindrical cavity or hole 1079.
[0119] The translational expansion mechanism 1070 may include one or more wedge-shaped elements 1072, 1074, and in the illustrated variation, two (2) wedge-shaped elements 1072, 1074 are disposed at the distal end of a transverse rod or beam 1078, which is rotatably attached at its center to a shaft or bolt 1062 of the rotational expansion mechanism 1060, for example, by using a transverse cylindrical bore or hole 1079. It is also possible to arrange additional wedge-shaped elements along the transverse rod 1078. The first and second segments 1010, 1020 are interconnected to each other by an elastic interconnection structure 1030, which is illustrated as having one or more elastic interconnection elements 1031, 1032, 1033, 1034, 1035, and 1036, which are arranged at the center of the transverse rod 1078. Fig.11D In the exemplary variation shown in the top view of FIG. 1 , there are six (6) elastic interconnecting elements that can elastically hold the first and second sections 1010, 1020 together, allowing expansion and retraction of the implant 1000. In the variation shown, the elastic interconnecting elements 1031-1036 are formed as wave spring elements, but can have different shapes, as explained above with respect to the different structures of the interconnecting structure 1030 that can be used in various embodiments described herein.
[0120] The wedge-shaped elements 1072, 1074 can push the first and second pairs of inclined surfaces 1014, 1024 (e.g., the top surface 1014 of the first segment 1010 and the relative bottom surface 1024 of the second segment 1020) and the inclined surfaces 1016, 1026 (e.g., the top surface 1016 of the first segment 1010 and the relative bottom surface 1026 of the second segment 1020) of the first and second segments 1010, 1020 respectively when they move linearly along the insertion direction ID (which can be initiated by the threaded engagement and rotation of the rotational expansion mechanism 1060, for example, by applying torque to the torque applying structure 1084 with a torque tool), thereby generating two expansion forces or pressure areas to expand or push apart the first and second segments 1010, 1020 of the implant body 1005. This is due to the rotatable interconnection with the rotatable attachment mechanism 1077 between the rotational and translational expansion mechanisms 1060 and 1070. Preferably, the inclined surfaces 1014, 1024, 1016, 1026 are treated, coated or otherwise manufactured to have a low coefficient of friction (COF) therebetween. In addition, in the variant shown, the two surfaces 1014, 1024 and 1016, 1026 facing each other are inclined, which means that they are inclined relative to the insertion direction ID. However, it is also possible that only one of the surfaces 1014, 1024 and 1016, 1026 is inclined, and thus one or more wedge-shaped elements 1072, 1074 also have only one corresponding inclined surface. These expansion forces or pressures in turn cause the first and second sections 1010, 1020 to expand away from each other to increase the distance therebetween, thereby resisting the contraction force issued by the interconnection structure 1030. At the same time, the rotational threaded engagement of the conical screw element 1064 of the rotary expansion mechanism 1060 with one or more partially inner cylindrical thread structures 1044 will also generate an expansion force or pressure area to expand or push apart the first and second sections 1010, 1020 of the implant body 1005. When the threaded engagement is released and the rotational expansion mechanism 1060 is rotated in the reverse rotational direction, the wedge elements 1072, 1074 will be pulled back in the direction opposite to the insertion direction ID, thereby allowing the force issued by the interconnection structure 1030 to pull the first and second sections 1010, 1020 together to retract, and at the same time, the conical screw element 1064 will rotate the thread to move against the insertion direction ID to reduce the distance between the first and second sections 1010, 1020, and retract again by the force issued by the interconnection structure 1030. By combining two expansion mechanisms, one in line with the wedge elements 1072, 1074 and one rotated using the conical screw element 1064, less mechanical resistance to the expansion process of the segments 1010, 1020 may be provided.
[0121] With implant 1000, for example, for all ALIF surgical procedures, only one entry point for applying torque is provided, thereby still having at least three expansion forces or pressure areas to expand segments 1010, 1020, with a centrally arranged torque application structure 1084 at the proximal end of implant 1000, thereby providing a device that can be more easily used in a surgical environment without requiring multiple entry points for implant construction. The rotational expansion mechanism 1060 may also include a cavity or hole coinciding with its axis of rotation for removably accommodating a guide wire, such as a Kirschner wire, a Kirschner wire, or other guide structures for guiding a torque tool during surgery. In this article, implant 1000 is shown as having a rectangular profile when viewed from the top or in the z direction. However, because the exemplary implant 1000 has three (3) or more expansion force or pressure zones having one (1) conical screw element 1064 and two (2) wedge elements 1072, 1074 arranged in a triangle, the implant 1000 can be designed to have a triangular shape, a trapezoidal shape, or other shapes.
[0122] FIG. 12A to FIG. 12D Aspects of an intervertebral implant 1100 according to a tenth embodiment of the present invention are shown, wherein Fig. 12A A top perspective view of implant 1100 is shown, Fig. 12B Shows top view perspectives from different directions, Fig. 12C shows a cross-sectional view defined by horizontally arranged cutting planes coinciding with the two (2) rotational axes of the rotatable expansion mechanisms 1160, 1170, and Fig.12D A top view of an implant 1100 placed in the intervertebral space on top of a vertebra V is shown. The implant 1100 may be used in an oblique lateral interbody fusion (OLIF) application. However, some or all aspects of this embodiment may also be used in other spinal implant application types.
[0123] Implant 1100 is similar to FIG. 3A to FIG. 3NThe implant shown in , but uses two parallel arranged rotational expansion mechanisms 1160, 1170 of different lengths, whose rotation axes are arranged approximately parallel to each other, wherein conical screw elements 1164 and 1174 are arranged at diagonally opposite first and second corners of the implant body 1105, respectively. The first, longer rotational expansion mechanism 1160 has a first torque applying structure 1184 accessible by a torque tool at the proximal end PE, wherein the first conical screw element 1164 is arranged at the other distal end DE to form a first force or pressure area 1161 at the first corner of the body 1105. The torque applying structure 1184 and the conical screw element 1164 are interconnected to each other by a bolt or shaft 1162. In addition, the second, shorter rotational expansion mechanism 1170 has a second torque applying structure 1194 at the proximal end PE, and also has a second conical screw element 1174 arranged at a second corner of the proximal end PE to form a second force or pressure area 1171 at the second corner of the body 1105 (see, e.g. Fig.12D ), the second force or pressure region is arranged diagonally opposite to the first corner, such as Fig.12D . With this arrangement, the proximal side of the implant 1100 has two torque applying structures 1184, 1194, which are arranged adjacent to each other, but allow the implant body 1105 to be expanded, with first and second sections 1110, 1120 at two opposite corners of the body 1105, with first and second pressure areas or zones 1161, 1171. The elastic interconnection structure 1130 can be arranged between the first and second sections 1110, 1120, for example, the elastic interconnection element 1135 is arranged in the form of a V-shaped connecting rod, for example, at the extension area of the rotation axis of the second shorter rotation expansion mechanism 1170. A plurality of interconnection elements 1135B can also be included, for example, between the first rotation expansion mechanism 1105 and the second rotation expansion mechanism 1170. In addition, a diagonally shaped transverse opening TO is arranged in the first and second sections 1110, 1120, extending along a virtual line extending midway between the first and second pressure regions or zones 1161, 1171, and also extending diagonally between the first and second opposing corners of the implant body 1105. At the respective first and second diagonally arranged corners, the first and second partially internal cylindrical threaded structures 1144 and 1154 can be arranged on either or both of the inner face of the first section 1110, the inner face of the second section 1120, allowing the threaded engagement of the respective one of the first and second conical screw elements 1164 and 1174 to generate an expansion force on the regions 1161, 1171, respectively.
[0124] FIG. 13A to FIG. 13D Various aspects of an intervertebral implant 1200 according to an eleventh embodiment of the present invention are shown, wherein Fig.13A A top perspective view thereof is shown, Fig. 13BA front view is shown against the insertion direction ID to show its distal end DE, and also shows the Fig. 13C The cross-sectional view of the cutting surface AA shown in, Fig. 13C A top view thereof is shown, Fig.13D The eleventh embodiment is shown in a side view and a cross-sectional view of the cutting surface BB. FIG. 7A to FIG. 7D A variation of the fifth embodiment shown in . In this variation, the elastic interconnection structure 1230 elastically interconnecting the first and second sections 10, 20 comprises a plurality of spring elements 1232, for example three (3) different spring elements, wherein the first and second spring elements 1232.1, 1232.2 are arranged around the shaft or bolt 1262, 1272 of the respective conical screw elements 1260, 1270, and the third spring element 1232.3 is arranged at the distal end DE, approximately in the middle between the two sides of the implant 1200. Furthermore, in this embodiment, the transverse opening TO is shown as having a cavity or volume to receive and hold a bone graft, arranged between the screw elements 1260, 1270, and having a filling port FP at the proximal end. The filling port FP may have a transverse opening, for example a cavity hole or a hole leading from the external environment to the cavity of the transverse opening TO, allowing the graft to be filled into the TO with a tool, for example as Figure 5 The tool shown in the embodiment of , for example, has a flexible coupling mechanism 334, 534 configured to removably interconnect the implant 1200 with the tool, for example Figure 5 The details and operation are shown in FIG. 6A to FIG. 6D The implant manipulation device or system 505 shown in FIG. Fig. 13B As shown in the cross-sectional view of , the first and second spring elements 1232.1 and 1232.2 include open loops arranged around the respective bolts or shafts 1262, 1272 of the conical screw elements 1260, 1270, and each also has two bent or folded arms, which interconnect the ends of the open loops with the upper and lower segments 10, 20, respectively. The central third spring element 1232.3 is formed as a wavy or wave-like structure interconnecting the first and second segments 10, 20. The upper and lower segments 10, 20 and one or more spring elements 1232.1, 1232.2, 1232.3 can be integrally formed by three-dimensional printing.
[0125] FIG. 14A to FIG. 14F Various aspects of an intervertebral implant 1400 according to a twelfth embodiment of the present disclosure are shown, wherein Fig.14A A top perspective view thereof is shown, Fig. 14B A side perspective view and a cross-sectional view thereof are shown, Fig. 14C shows a side view of the implant 1400 in a non-expanded state, Fig.14D shows a side view of the implant 1400 in an expanded state, Fig.14EA side view and a cross-sectional view of implant 1400 are shown, Fig.14F The implant 1400 and the screw element 1470 are shown in side and cross-sectional views; the twelfth embodiment is FIG. 7A to FIG. 7D A variation of the fifth embodiment shown in FIG. 13A to FIG. 13D A variation of the eleventh embodiment shown in .
[0126] In this variant, similar to the previous variant, in particular FIG. 7A to FIG. 7D The fifth embodiment shown in FIG. 13A to FIG. 13D In a variation of the twelfth embodiment shown in , an implant 1400 comprises a first section 10 having a first bone engaging surface 12; and a second section 20 arranged opposite the first section 10 and having a second bone engaging surface 22; and an interconnection structure 1430 interconnecting the first section 10 and the second section 20 and being deformable to allow a change in the distance and / or orientation between the first section 10 and the second section 20. The elastic interconnection structure 1230 elastically interconnecting the first and second sections 10, 20 similarly comprises one or more spring elements 1432, such as three (3) different spring elements, having first and second spring elements 1432.1, 1432.2 arranged around shafts or bolts 1462, 1472 of respective conical screw elements 1460, 1470; and a third spring element 1432.3 arranged at a distal end DE between the two sides of the implant 1400, such as in the middle or approximately in the middle between the two sides of the implant 1400.
[0127] and FIG. 13A to FIG. 13D Similar to the eleventh embodiment, the first and second spring elements 1432.1 and 1432.2 may comprise an open ring arranged around the respective bolt or shaft 1462, 1472 of the conical screw element 1460, 1470 and each further having two bent or folded arms interconnecting the ends of the open ring with the upper and lower segments 10, 20, respectively (see for example Fig. 13B ). The central third spring element 1432.3 may be formed as a wavy or corrugated structure interconnecting the first and second sections 10, 20. The upper and lower sections 10, 20 and the one or more spring elements 1232.1, 1232.2, 1232.3 may be integrally formed by three-dimensional printing. The interconnection structure 1430 may alternatively include the previously described FIG. 7A to FIG. 7D The interconnection structure disclosed in the fifth embodiment shown may consist of or be composed thereof.
[0128] FIG. 7A to FIG. 7D The fifth embodiment shown in and / or FIG. 13A to FIG. 13D Other features of the eleventh embodiment shown in FIG. 14 may be similarly included in the present embodiment.
[0129] The implant 1400 includes a transverse opening TO, which includes or defines a cavity or volume for receiving and holding a bone graft, the cavity or volume being arranged between the screw elements 1460, 1470, and having a filling port FP at the proximal end PE. The filling port FP can have a transverse opening, such as a cavity hole or a hole leading from the external environment to the cavity of the transverse opening TO, allowing the graft to be filled into the transverse opening TO and the cavity with a tool, such as Fig.16A and Fig. 16C The tools shown in the system of the illustrated embodiment are described in further detail below. In contrast to the previous embodiments, in this twelfth embodiment, the filling port FP includes internal threads 1450 on the inner surface of the implant 1400, which define or define a cavity or hole leading from the external environment to the cavity across the opening TO. The internal threads 1450 are configured to be connected to the spinal plate (in Fig.15A and Fig. 15B ) or provided on the external threaded mating or engagement at the distal end of the tubular implant connector of the holding instrument or tool, as described below with respect to Fig.16A and Fig. 16C as well as Fig.17A and Fig. 17B The systems 1600, 1700 of the embodiments shown in Figure 1 are described in further detail. Either the first section 10 or the second section 20 comprises a filling port FP, and in the illustrated variation, the second section 20 comprises a filling port FP.
[0130] In this variation, a plurality of implant partial inner cylindrical thread structures 1444, 1446, 1454, 1456 or each of them provided in the first or second section 10, 20 have an opposing partial inner cylindrical thread structure 1495, 1496, 1497, 1498 (rather than an inclined structure) facing it or positioned opposite thereto, so as to provide a double-threaded screw guide SG for each of the conical screw components 1464, 1466, 1474, 1476 arranged at the distal and proximal ends of the corresponding conical screw elements 1460, 1470. Thus, a plurality of double-threaded screw guides SG are provided, thereby allowing a more stable expansion of the implant 1400 to be ensured.
[0131] Each relative partial inner cylindrical thread structure 1495, 1496, 1497, 1498 is formed or disposed in the inner surface of the first segment 10 or the second segment 20, and is arranged to face the implant partial inner cylindrical thread structure 1444, 1446, 1454, 1456 of the double-threaded screw guide SG, so that, for example, through the mirror-symmetrical arrangement of the implant partial inner cylindrical thread structure 1444, 1446, 1454, 1456 and the relative partial inner cylindrical thread structure 1495, 1496, 1497, 1498, the pitch of the implant partial inner cylindrical thread structure 1444, 1446, 1454, 1456 and the pitch of the relative partial inner cylindrical thread structure 1495, 1496, 1497, 1498 match or allow cooperation with the conical screw component 1464, 1466, 1474, 1476. Each relative partial inner cylindrical thread structure 1495,1496,1497,1498 can define a thread axis TA, and the thread axis is arranged to be inclined at an angle αTA relative to the insertion direction ID. The absolute value of the angle αTA of each relative partial inner cylindrical thread structure 1495,1496,1497,1498 can be the same or approximately the same as the absolute value of the angle αTA of the (directly) relatively positioned implant partial inner cylindrical thread structure 1444,1446,1454,1456.
[0132] The conical screw components 1464 , 1466 , 1474 , 1476 arranged at the distal and proximal ends of the respective conical screw elements 1460 , 1470 are thus guided by the resulting double-threaded screw guide SG to provide a more stable expansion of the implant 1400 .
[0133] The implant 1400 of this modification can also include at least one or more elongated fixing elements or pins 1475 to improve the fixation of the spinal endplate. However, multiple elongated fixing elements 1475 can also be included in the implant of any one embodiment of the present disclosure. The elongated fixing pins 1475 are attached to the first bone engagement surface 12 and / or the second bone engagement surface 22, and the pins 1475 are away from the bone engagement surface and extend in a direction away from the insertion direction ID or in a direction opposite thereto to facilitate the insertion of the implant, and extend in a direction that helps to prevent the implant from being expelled once implanted. The elongated fixing pins 1475 (or each elongated fixing pin 1475) can include or define an elongated tapered structure that tapers to a reduced thickness or width in a direction extending away from the bone engagement surface. The elongated fixing element 1475 can include an outer end, and the outer end includes or defines a surface in the form of a hook, which includes a curved portion directed toward or toward the distal end DE of the implant 1400, and extends to a capture or serrated surface directed toward or toward the proximal end PE of the implant 1400. The elongated fixation pin 1475 may extend at an angle from the first bone engaging surface to define an acute angle Δ relative to the bone engaging surface (e.g., see Fig.14E ) which extends between the bone engaging surface and the lateral wall LW of the pin 1475 facing the proximal end of the implant 1400.
[0134] The implant 1400 of this variation may also include at least one or more lateral guide or retention tabs / winglets 1486 attached to and extending from a lateral side LS of the implant 1400 that is located between or extends between the first section 10 and the second section 20. The winglets 1486 are preferably located on each lateral side LS of the implant 1400.
[0135] The first section 10 and / or the second section 20 may include a lateral winglet 1486 extending therefrom. The lateral winglet 1486 is located on the lateral side LS of the implant 1400 so that when the implant 1400 is in an expanded state (e.g., Fig.14D) and / or during rotation of the screw elements 1460, 1470 when the screw elements 1460, 1470 have been advanced to a deep position inside the implant 1400, the conical screw components 1464, 1466, 1474, 1476 adjacent to or flanking the conical screw elements 1460, 1470. When the implant 1400 is in an expanded state or a fully expanded state, the lateral winglets 1486 extend to at least partially close the lateral spacing between the first section 10 and the second section 20. Lateral movement of the screw elements 1460, 1470 is corrected by the lateral winglets 1486 contacting the conical screw components and realigning the screw elements 1460, 1470 to advance along the thread axis. The conical screw elements 1460, 1470 provide further guidance during advancement in the implant 1400 to allow the screw elements 1460, 1470 to be realigned or maintained aligned along their thread axis TA and / or retained within the implant 1400, thereby ensuring that the implant 1400 is more stable during deployment to the expanded state and in the expanded state.
[0136] In the embodiment shown, Fig.14D As shown in , the implant 1440 includes an upper or first transverse winglet 1486A, which extends at a certain angle away from the first segment 10 and toward the second segment 20, and is positioned adjacent to or flanking the conical screw component 1466 of the conical screw element 1470, and the implant 1440 includes a lower or second transverse winglet 1486B, which extends at a certain angle away from the first segment 20 and toward the first segment 10, and is positioned adjacent to or flanking the conical screw component 1464 of the conical screw element 1470. Another lower transverse winglet 1486C is located below the upper or first transverse winglet 1486A and extends from the second segment 20 away from the first segment 10. Another upper transverse winglet 1486D is located above the lower or second transverse winglet 1486B and extends from the first segment 10 away from the second segment 20. As shown in Fig. 14C and Fig.14D , to facilitate closure of the implant 1400 in the non-expanded state, the upper or first transverse winglet 1486A can extend at the same or substantially the same angle as the other lower transverse winglet 1486C relative to the transverse side LS of the implant 1400, and the lower or second transverse winglet 1486B can extend at the same or substantially the same angle as the other upper transverse winglet 1486D relative to the transverse side LS of the implant 1400. The transverse winglets 1486 can, for example, have or define a triangular form, and can include or define a serrated or concave outer peripheral surface.
[0137] Fig.15A A perspective view of a spinal implant system 1500 according to yet another aspect of the present disclosure is shown, and Fig. 15BA side view and a partial cross-sectional view thereof are shown. System 1500 includes a vertebra or spinal plate (or device) 1501 and an intervertebral implant 1400 of a twelfth embodiment, which can be attached or connected to the spinal plate 1501 via an interconnecting screw 1505. Interconnecting screw 1505 includes an external thread configured to cooperate or engage with an internal thread 1450 of a filling port FP of implant 1400 to attach implant 1400 to spinal plate 1501. Interconnecting screw 1505 may include a central traverse or may be cannulated to allow a tool guide rod or instrument (such as, but not limited to, a Kirschner wire, a Kirschner wire, or a rod) to be received therein and passed through interconnecting screw 1505. Interconnecting screw 1505 can slide or shift along a tool guide rod or instrument alone or together with spinal plate 1501 to facilitate connection to or engagement with the internal thread 1450 of implant 1400. Similarly, a hollow screwdriver can also be connected to the interconnecting screw 1505, for example by being slidably attached to the interconnecting screw 1505 along a tool guide rod or instrument, thereby allowing the interconnecting screw 1505 to be guided into the internal threads 1450 of the implant 1400 and screwed into the internal threads 1450 of the implant 1400, thereby attaching the interconnecting screw 1505 and the spinal plate 1501 to the implant 1400.
[0138] The spinal plate 1501 includes a central transverse hole 1520 in which the interconnecting screw 1505 is received and passes through the central transverse hole to connect to the filling port FP and the implant 1400. The central transverse hole 1520 includes an outer section 1521 having a larger diameter or width than an inner section 1522, the outer section 1521 being configured to receive a screw head of the interconnecting screw 1505, and the inner section 1522 receiving a shaft of the interconnecting screw 1505. The diameter of the screw head is wider than the diameter of the inner section 1522 of the central transverse hole 1520, allowing the interconnecting screw 1505 to be retained or held by the spinal plate 1501 and the implant 1400 to be attached to the spinal plate 1501. The spinal plate 1501 also includes first and second bone screw transverse holes 1525, 1530 located on either side or opposite sides of the central transverse hole 1520. The first and second bone screw transverse holes 1525, 1530 are configured to receive the bone screws 1510, 1515 so that once implanted, they are inserted into the upper and lower vertebrae or the first and second vertebrae located on either side of the implant 1400. Each of the bone screw transverse holes 1525, 1530 similarly includes an outer section 1531 and an inner section (not shown), the outer section 1531 having a larger diameter or width than the inner section. The outer section 1531 is configured to receive the screw head of the bone screw 1510, 1515, wherein the inner section is configured to receive the shaft of the bone screw 1510, 1515. The diameter of the screw head is wider than the inner section of the transverse holes 1525, 1530, thereby allowing each bone screw 1510, 1515 to be retained or held by the spine plate 1501, and the spine plate 1501 is attached or fixed to the vertebrae and the spine. The spine plate 1500 is thus configured to receive bone screws 1510, 1515 for implantation into the spine so as to provide support for holding or retaining the implant 1400 in the spine or between vertebrae once implanted. The spine plate 1500 may also include a flexible blocking element 1550 extending through and / or into the outer section 1531 of the bone screw transverse holes 1525, 1530 to serve as an outer stop or abutment to block the bone screw from leaving the plate 1501. The flexible blocking element 1550 may, for example, be located at the outer edge of the outer section 1531 and include a flexible blade or spring extending in front of the bone screw head to allow contact with the screw head in the event that the bone screw is displaced in a direction away from the plate 1501 over time. The plate 1501 may include, for example, a recess 1551 that communicates with the outer section 1531 of the bone screw transverse hole or is included in a wall defining the bone screw transverse hole, the recess 1551 containing a flexible barrier element 1550 extending therefrom into the outer section 1531. The recess 1551 is configured to receive the flexible barrier element 1550 therein during insertion and rotation of the bone screw so as not to interfere with implantation of the bone screw. Fig.15AOne flexible barrier element 1550 is shown, but the plate 1501 may comprise, for example, at least one flexible barrier element 1550 for each bone screw of the plate 1501. The plate 1501 may also be produced, for example, by 3D printing. The plate 1501 may also be produced, for example, by 3D printing, and comprise or consist of titanium.
[0139] Fig.16A A perspective view of another spinal implant system 1600 according to yet another aspect of the present disclosure is shown. System 1600 includes intervertebral implant 1400, intervertebral implant retaining instrument or tool 1605, at least one screwdriver 1610, a removable separate bone graft inserter 1615, an injection syringe 1620, and a slap hammer 1625. Fig. 16B Shows Fig.16A An enlarged perspective view of the implant retaining instrument 1605 is shown in FIG. Fig. 16C A top view of an implant retaining instrument 1605 is shown, and Fig.16D A cross-sectional view of the implant retaining instrument 1605 taken along BB is shown. Fig.16E Shows Fig.16A An enlarged perspective view of a screwdriver 1610, a removable bone graft inserter 1615, an injection syringe 1620, and a slap hammer 1625 are shown in FIG.
[0140] Implant holding instrument 1605 extends from the proximal end PE1 of the instrument to the distal end DE1 in a (roughly) straight or straight manner. Implant holding instrument 1605 comprises an elongated body 1632, which comprises a handle portion 1633 at the proximal end PE1 and an implant interface head 1636 at the distal end DS1. Main body 1632 comprises an axis 1638 extending between handle portion 1633 and implant interface head 1636. Main body 1632 comprises a central channel 1640, which extends from the proximal end PE1 to the distal end DE1 and is configured to receive and hold a tubular implant connector 1630.
[0141] The tubular implant connector 1630 includes a shaft 1642 having an elongated hollow tube (i.e., flexible, for example), a knob 1644 at the proximal end, and an implant interface device 1646 at the distal end of the shaft 1642. The tubular implant connector 1630 and the implant interface device 1646 include a hollow tubular coupling element 1634 that includes an external thread configured to cooperate or engage with an internal thread 1450 of a filling port FP of the implant 1400 to attach the implant 1400 to the tubular implant connector 1630.
[0142] The hollow tubular coupling element 1634 comprises, for example, a hollow cylindrical rod, the outer surface of which is provided with an outer thread for cooperating with the inner thread 1450 of the filling port FP. The elongated body 1632 comprises or defines a cavity 1652 configured to hold the knob 1644. The tubular implant connector 1630 is positioned in the implant holding instrument 1605 so that the knob 1644 is received in the cavity 1652, the shaft 1642 is received in the central channel 1640, and the implant interface device 1646 is received inside the implant interface head 1636, wherein the coupling element 1634 extends and protrudes outwardly from the implant interface head 1636, passes through its central orifice CO, to connect to the inner thread 1450 of the filling port FP of the implant 1400, thereby attaching the implant 1400 to the tubular implant connector 1630. The tubular implant connector 1630 is arranged to rotate inside the central channel 1640 and the implant interface head 1636, for example, by the rotation of the knob 1644 around the central axis R, thereby allowing the external thread of the coupling element 1634 to cooperate or engage with the internal thread 1450 of the filling port FP to attach the implant 1400 to the tubular implant connector 1630. The implant holding instrument 1605 may include a removable cap 1654 that can be removed from the proximal end PE1 to allow the tubular implant connector 1630 to be inserted or replaced. The implant holding instrument 1605 and the removable cap 1654 may be produced, for example, by plastic injection molding.
[0143] Implant holding instrument 1605 is for example made of plastic or polymer, including plastic or polymer, or consisting of plastic or polymer. Implant holding instrument 1605 is for example made of polyvinyl chloride (PVC), polyethylene, polyester, polycarbonate, polyetheretherketone (PEEK), ultra-high molecular weight polyethylene (UHMWPE) or polyacrylamide, including it or consisting of it. The knob 1644 of tubular implant connector 1630 can be made of the aforementioned materials, including the aforementioned materials or consisting of the aforementioned materials, but can also be made of metal, including metal or consisting of metal, such as stainless steel, or titanium, or tantalum, or platinum, or palladium or aluminum. The remaining elements of tubular implant connector 1630 can also be made of such metal, including such metal or consisting of such metal, or made of such plastic / polymer material, including such plastic / polymer material or consisting of such plastic / polymer material.
[0144] The implant retaining instrument 1605 extends completely in a (substantially) rectilinear or straight manner from the proximal end PE1 to the distal end DE1 of the instrument, and the implant 1400 is positioned or attached thereto in alignment with the rectilinear extension direction of the implant retaining instrument 1605 .
[0145] The implant holding instrument 1605 also includes a first screwdriver guide channel 1656 extending from the proximal end PE1 to the distal end DE1 and a second screwdriver guide channel 1658 extending from the proximal end PE1 to the distal end DE1. The first screwdriver guide channel 1656 is a partially closed channel formed by a proximal closure section 1660A included in the handle portion 1633 and a distal closure section 1662A included in the implant interface head 1636 and an open support 1664A extending between the proximal closure section 1660A and the distal closure section 1662A. The second screwdriver guide channel 1658 similarly includes an open support 1664B extending between the proximal closure section 1660B and the distal closure section 1662B.
[0146] The screwdriver 1610 includes an elongated shaft 1666 (i.e., for example, flexible), a knob 1667 at the proximal end, and an implant interface device 1668 at the distal end. The implant interface device 1668 includes a torque instrument 1669 disposed at the distal end and configured to transmit torque to the torque applying structure of the first and second screw elements 1460, 1470 of the implant 1400, which can have any of the torque applying structures previously described with respect to the first embodiment of the present disclosure.
[0147] The knob 1667 of the screwdriver 1610 can be made of, include or consist of the aforementioned plastic / polymer material. The remaining elements of the screwdriver 1610 can be made of, include or consist of metal, such as stainless steel, or titanium, or tantalum, or platinum, or palladium or aluminum.
[0148] The screwdriver 1610 is received by the implant holding instrument 1605 through the first aperture OF1A, passes through the proximal closure segment 1660A of the handle portion 1633, along the open support 1664A and through the distal closure segment 1662A of the implant interface head 1636, so that the torque instrument 1669 exits through the second aperture OF2A of the implant holding instrument 1605 and the implant interface head 1636 to be connected to the torque applying structure of the screw element 1470. The screwdriver 1610 can be connected to the torque applying structure of the screw element 1460 via the third aperture OF1B, the proximal closure segment 1660B of the handle portion 1633, the open support 1664B and the distal closure segment 1662B, and the fourth aperture OF2B of the implant interface head 1636 in a similar manner.
[0149] Fig.16EAn enlarged perspective view of a screwdriver 1610 and a removable bone graft inserter 1615, an injection syringe 1620, and a slap hammer 1625 are shown. The implant holding instrument 1605 includes a slap hammer attachment mechanism 1670 at its proximal end, which is configured to connect to an attachment mechanism 1671 located at the distal end of the slap hammer 1625. The attachment mechanisms 1670, 1671 can be configured to engage each other using a bayonet mount or fitting, for example, the attachment mechanism 1670 includes a slot configured to receive a pin attachment mechanism 1671. Alternatively, a threaded mount can be used, for example.
[0150] The independent bone graft inserter 1615 comprises, for example, an elongated flexible hollow tube 1671 and a connecting device 1672, the connecting device comprising a first connector (e.g., a threaded connector 1673 configured to engage or cooperate with a corresponding threaded connector 1674 of an injection syringe 1620) and a second connector 1674 configured to be connected at its proximal end to a connecting mechanism 1670 of an implant holding instrument 1605. The second connector 1674 may, for example, comprise a bayonet mount or fitting, or a threaded connector as previously described with respect to the slap hammer 1625. The threaded connector 1673 of the connecting device 1672 and the corresponding threaded connector 1674 of the injection syringe 1620 are, for example, configured to implement a Luer lock.
[0151] The flexible elongated hollow tube 1671 has a diameter and length such that it can be received within the central passage 1640 of the implant holding instrument 1605 and extend therethrough and into the filling port FP of the implant 1400 to inject the bone graft into the implant 1400. The central passage 1640 guides the independent bone graft inserter 1615 into the filling port FP and can be fixed at its proximal end PE1 to the attachment mechanism 1670 of the implant holding instrument 1605. The injection syringe 1620, when it is attached to the independent bone graft inserter 1615, allows the bone graft or demineralized bone matrix to be injected into the implant 1400 through the elongated flexible hollow tube 1671. The independent bone graft inserter 1615 uses the implant holding instrument 1605 as a guide to backfill the implant 1400 with the bone graft. The injection syringe 1620 and the independent bone graft inserter 1615 are made of, including or consisting of polyvinyl chloride (PVC), polyethylene, polyester, polycarbonate, polyetheretherketone (PEEK), ultra-high molecular weight polyethylene (UHMWPE) or polyacrylamide, for example. The slap hammer 1625 can also be made of, including or consisting of such materials or the metals mentioned previously.
[0152] Fig.17AA perspective view of another spinal implant system 1700 according to yet another aspect of the present invention is shown, showing an exemplary intervertebral implant 1400, an angled implant retaining instrument 1705, a screwdriver 1710, a separate removable bone graft inserter 1715, an injection syringe 1720, and a slap hammer 1725; Fig. 17B Shows Fig.17A An enlarged perspective view of the angled implant retaining instrument 1705 shown in FIG. Fig. 17C Shows Fig.17A An enlarged perspective view of a screwdriver 1710, a separate removable bone graft inserter 1715, an injection syringe 1720, and a slap hammer 1725 are shown in FIG. FIG. 17D to FIG. 17F An enlarged perspective view and an enlarged top view of an angled implant retaining instrument 1705 are shown; Figure 17G Details of the distal end of the flexible tube of the cage holder 1705 are shown, and Fig.17H Angled implant retention instrument 1705 is also shown.
[0153] System 1700 is similar to that previously described and FIG. 16A to FIG. 16E The spinal implant system 1600 shown in FIG. 1 is the same as that shown in FIG. 1 , except that the implant retaining instrument is an angled implant retaining instrument 1705, such as Fig. 17B and FIG. 17D to FIG. 17F as well as Fig.17H As shown in . The implant retaining instrument does not extend completely from the proximal end PE1 of the instrument to the distal end DE1 in a straight line or straight manner. Instead, the angled implant retaining instrument 1705 first extends in a straight line or straight manner and then extends in a curved manner. The implant interface head 1736 is inclined or angled at an angle θ relative to the central axis R1 extending in the extension direction of the proximal segment PS of the implant retaining instrument 1705. For this purpose, the proximal segment PS can be defined as extending between the outermost proximal end or proximal tip PT of the instrument 1705 and the midpoint MD of the instrument 1705, the midpoint MD being located at a distance of half the maximum length value MLV of the instrument 1705 (see, e.g. Fig.17H ). Angle θ can be, for example, between 5° and 45°. The implant interface head 1736 has, for example, a first lateral side FLS that is longer in length than a second lateral side SLS that is positioned opposite the first lateral side FLS (see, for example Fig.17F ), thereby limiting the angular deviation θ of the instrument 1705. The curvature direction of the distal end of the instrument 1705 or the implant interface head 1736 can be in the transverse direction, such as FIG. 17D to FIG. 17F , to the left or right relative to the extension direction of the central axis R1, or alternatively downward or upward relative to the extension direction of the central axis R1. The angled implant retaining instrument 1705 is configured to continuously or permanently maintain an angled orientation.
[0154] The tubular implant connector 1730 is identical to the tubular implant connector 1630 described above, and includes a shaft 1742 having an elongated hollow tube, a knob 1744 at the proximal end, and an implant interface device 1746 located at the distal end of the shaft 1742. The tubular implant connector 1730 and the implant interface device 1646 include a hollow tubular coupling element 1734 as described above. The implant interface device 1746 also includes a flexible interconnector 1790 interconnecting the distal end of the shaft 1742 and the tubular coupling element 1734. The flexible interconnector 1790 can, for example, include a hollow body 1791, the hollow body including a plurality of strips 1792 and a plurality of slots 1792, in which the material of the body 1791 is absent or removed. Each strip 1792 is, for example, located between two slots 1793. The plurality of strips 1792 and the grooves 1792 are arranged so that the distal end of the implant holding instrument 1705 is elastically bent in all directions away from the central axis CA1 of the implant holding instrument 1705. This allows the distal end of the tubular implant connector 1730 received in the implant interface head 1736 of the implant holding instrument 1705 to be elastically bent and guided to the filling port FP of the implant 1400 for connection therewith by, for example, a threaded connection via rotation of the tubular implant connector 1730, as FIG. 17D to FIG. 17F The previously described tubular implant connector 1630 may, for example, also optionally include such a flexible interconnect 1690.
[0155] In addition, similar to the screwdriver 1610 previously described with respect to the system 1600, the screwdriver 1710 includes an elongated shaft 1766, a knob 1767 at the proximal end, and an implant interface device 1768 at the distal end. The implant interface device 1768 includes a torque instrument 1769 disposed at the distal end and configured to transmit torque to the first and second screw elements 1460, 1470 of the implant 1400. The implant interface device 1746 also includes a flexible interconnector 1790 interconnecting the distal end of the shaft 1766 with the torque instrument 1769. The flexible interconnector 1790 can be the same as the flexible interconnector of the tubular implant connector 1730, or can be implemented differently. The flexible interconnector 1790 allows the screwdriver 1710 received in the implant interface head 1736 of the implant holding instrument 1705 to be elastically bent and guided so that the torque instrument 1769 leaves through the orifices OF2A, OF2B of the implant holding instrument 1705 and the implant interface head 1736 to be connected to the torque applying structure of the screw elements 1460, 1470. Rotating the torque applying structure by the screwdriver 1710 allows the implant 1400 to expand. The screwdriver 1610 described previously may also, for example, optionally include such a flexible interconnector 1790.
[0156] The spinal implant systems 1600 , 1700 thus provide straight and angled disposable implant retention instruments for lateral, ATP, and iliac crest 1705 approaches.
[0157] Although described with respect to spinal implant systems 1600, 1700, implant retaining instruments 1605, 1705 are each related to additional independent aspects of the present invention.
[0158] Although the present invention has been disclosed with reference to certain preferred embodiments, many modifications, changes and variations of the described embodiments and their equivalents are possible without departing from the scope and range of the present invention. For example, an aspect of an embodiment may be incorporated into another of several embodiments. As a non-limiting example, it should be understood that the sliding mechanism 970 of the eighth embodiment may also be an aspect of other embodiments using conical screw elements to maintain the position of the torque applying structure in a specific position and to avoid linear displacement along the axis of rotation defined by the corresponding conical screw elements. As another example, the implant manipulation device or the element of the system 505 of the spinal implant system 500 may also be a part or element of other embodiments of the spinal implant described herein. In addition, the manufacturing technology described herein may be used for or applied to any embodiment described herein. Therefore, it is intended that the present invention is not limited to the described embodiments, and the language of the attached claims is given the broadest reasonable interpretation.
Claims
1. An expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) having an insertion direction (ID) to be placed in an intervertebral space, the expandable implant comprising: a first section (10) having a first bone engaging surface (12); a second section (20) having a second bone engaging surface (22) arranged opposite to the first section (10), the first and second bone engaging surfaces (12, 22) being arranged substantially parallel to the insertion direction (ID); an interconnection structure (30) interconnecting the first segment (10) and the second segment (20), at least a portion of the interconnection structure (30) being deformable to allow a change in the distance and / or orientation between the first segment (10) and the second segment (20); as well as A first partial internal cylindrical thread structure (40) is arranged between the first section (10) and the second section (20), wherein the first partial internal cylindrical thread structure (40) has a first thread axis (TA1), and the first thread axis (TA1) is inclined at a first angle α1 relative to the insertion direction (ID).
2. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, further comprising: A first inclined surface (44), the first inclined surface facing the opening section of the first partial internal cylindrical thread structure (40) and arranged between the first section (10) and the second section (20), wherein the distance between the first inclined surface (44) and the first partial internal cylindrical thread structure (40) measured in a direction perpendicular to the first bone engaging surface and the second bone engaging surface (12, 22) decreases along the insertion direction (ID).
3. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 2, wherein: The first inclined surface (44) forms a cylindrical segment surface having a cylindrical axis inclined at a second angle α2 relative to the insertion direction (ID).
4. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, further comprising: A second-part internal cylindrical thread structure (46), wherein the second-part internal cylindrical thread structure is arranged between the first section (10) and the second section (20) and is arranged to face the first-part internal cylindrical thread structure (40), so that a first pitch of the first-part internal cylindrical thread structure (40) and a second pitch of the second-part internal cylindrical thread structure (46) match, and the second-part internal cylindrical thread structure (46) has a second thread axis (TA2), and the second thread axis (TA2) is inclined at a second angle α2 relative to the insertion direction (ID).
5. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, further comprising A third-part internal cylindrical thread structure (50) is arranged between the first section (10) and the second section (20), and extends close to the first-part internal cylindrical thread structure (40). The third-part internal cylindrical thread structure (50) has a third thread axis (TA3), and the third thread axis (TA3) is inclined at a third angle relative to the insertion direction (ID).
6. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 5, further comprising: A second inclined surface (54), the second inclined surface faces the opening section of the third portion internal cylindrical thread structure (50) and is arranged between the first section (10) and the second section (20), wherein the distance between the second inclined surface (54) and the third portion internal cylindrical thread structure (50) measured in a direction perpendicular to the first bone engaging surface and the second bone engaging surface (12, 22) decreases along the insertion direction (ID).
7. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 6, wherein: The second inclined surface (54) forms a cylindrical segment surface having a cylindrical axis inclined at a fourth angle relative to the insertion direction (ID).
8. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 5, further comprising: A fourth-part internal cylindrical thread structure (56), wherein the fourth-part internal cylindrical thread structure is arranged between the first section (10) and the second section (20) and is arranged to face the third-part internal cylindrical thread structure (50), so that the third pitch of the third-part internal cylindrical thread structure (50) and the fourth pitch of the fourth-part internal cylindrical thread structure (56) match, and the fourth-part internal cylindrical thread structure (56) has a fourth thread axis (TA4), and the fourth thread axis (TA4) is inclined at a fourth angle relative to the insertion direction (ID).
9. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, wherein: The interconnection structure (30) is deformably attached to the upper section (10) to form a first hinge element (15), and the interconnection structure (30) is deformably attached to the lower section (20) to form a second hinge element (25).
10. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, further comprising: A first conical screw element (60) having a first external thread (62) configured for threaded engagement with the first partially internal cylindrical thread structure (40).
11. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 5, further comprising: A second conical screw element (70) having a second external thread (72) configured for threaded engagement with the third partial internal cylindrical thread structure (50).
12. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 10, wherein: When the first conical screw element (60) is threadedly engaged with the first partially internal cylindrical thread structure (40), the first section and the second section (10, 20) are pushed apart by deformation of at least a portion of the interconnection structure (30), and a first distance (D1) between the first section (10) and the second section (20) is increased.
13. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 5, wherein: The interconnection structure (30) is arranged diagonally between the first segment and the second segment (10, 20), and the first hinge element and the second hinge element (15, 25) are arranged at opposite side edges of the first segment and the second segment (10, 20) respectively, or the interconnection structure (30) includes a plurality of spring elements (632) arranged between the first portion inner cylindrical thread structure and the third portion inner cylindrical thread structure (40, 50).
14. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 13, wherein: The first portion of the internal cylindrical thread structure (40) is formed in a surface of the interconnection structure (30) facing the first section (10).
15. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 13, wherein: The third portion of the internal cylindrical thread structure (50) is formed in a surface of the interconnection structure (30) facing the second section (20).
16. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, wherein The interconnect structure (30) comprises: a plurality of first elastic interconnecting elements (32), the plurality of first elastic interconnecting elements being arranged at one side close to the first portion internal cylindrical thread structure (40) and between the first section and the second section (10, 20); and A plurality of second elastic interconnecting elements (34) are arranged near the other side of the first portion internal cylindrical thread structure (40) and between the upper section (10) and the lower section (20).
17. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 16, wherein At least one of the first elastic interconnection elements (32) and at least one of the second elastic interconnection elements (34) comprises a first tab (36) having a first oblique direction and a second tab (38) having a second oblique direction, the first oblique direction and the second oblique direction being different.
18. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 1, wherein When the conical screw element (70) is threadedly engaged with the first partially internal cylindrical thread structure (40), the interconnection structure (30) is deformable to allow expansion of the distance D between the upper and lower sections (10, 20).
19. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) according to claim 17, wherein: When the conical screw element (50) is threadedly engaged with the first internal thread (40), the plurality of first elastic interconnecting elements (32) and the plurality of second elastic interconnecting elements (34) can be deformed to change the relative angle between the first inclined direction and the second inclined direction to allow expansion of the distance D between the upper section and the lower section (10, 20).
20. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) of claim 10, further comprising: An expansion mechanism (1070) is constructed for linear displacement relative to the implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400), the expansion mechanism (1070) comprising at least one wedge-shaped element (1072, 1074) for engaging with at least one inclined surface (1014, 1024, 1016, 1026) of one or both of the first segment and the second segment (10, 20), the expansion mechanism (1070) being rotatably connected to the first conical screw element (60) so that threaded engagement of the first conical screw element (60) with the first portion inner cylindrical thread structure (40) causes linear displacement of the expansion mechanism (1070).
21. An expandable implant (400) to be placed in an intervertebral space, the expandable implant comprising: four corner elements (110, 120, 130, 140) extending parallel to the insertion direction (ID); as well as Four groups of multiple deformable interconnecting elements (115, 125, 135, 145), each elastic interconnecting element is arranged between two adjacent corner elements (110, 120), (120, 130), (130, 140), (140, 110), Wherein, at least one corner element (110, 120, 130, 140) includes a partial internal cylindrical thread (112, 122, 132, 142), and the at least one partial internal cylindrical thread (112, 122, 132, 142) forms a discontinuous thread having a thread axis, and the thread axis is inclined relative to the insertion direction (ID), and the discontinuous thread is configured to threadably receive a conical screw element (60).
22. The expandable implant (400) of claim 21, wherein: At least two of the four corner elements (110, 120, 130, 140) include partial internal cylindrical threads (112, 122, 132, 142).
23. The expandable implant (400) of claim 21, wherein: When the conical screw element (60) is threadedly engaged with the non-continuous thread, the deformable interconnecting elements (115, 125, 135, 145) can be deformed to allow the expansion of the distance D1 between the upper and lower sections of the two corner elements (110, 120) (130, 140) and the simultaneous expansion of the distance D2 between the left and right sections of the two corner elements (120, 130) and (110, 140).
24. The expandable implant (400) of claim 21, wherein: At least one of the deformable interconnecting elements (115, 125, 135, 145) comprises a first tab having a first oblique direction and a second tab having a second oblique direction, the first oblique direction and the second oblique direction being different.
25. An expandable implant (100, 200, 300, 400, 600, 700, 800, 900, 1000, 1100, 1200, 1400) having an insertion direction (ID) to be placed in an intervertebral space, the expandable implant comprising: a first member (10, 12, 110, 120) for engaging a first vertebra; a second member (20, 22, 130, 140) for engaging a second vertebra; a flexible device (30, 125, 145, 730, 830, 836, 838) interconnecting the first element (10, 12, 110, 120) and the second element (20, 22, 130, 140) to allow a distance D between the first element and the second element (10, 12, 110, 120, 20, 22, 130, 140) to be varied; as well as Means (40, 60, 860, 870) for increasing the distance between the first element and the second element (10, 12, 110, 120, 20, 22, 130, 140) by applying at least one of an expansion force or a bending force to the flexible means (30, 125, 145, 830, 836, 838).
26. The expandable implant (100, 200, 300, 400, 600, 700, 800, 900, 1000, 1100, 1200, 1400) according to claim 25, wherein The means (40, 60) for increasing the distance is configured to convert the rotational threaded engagement motion into a translational motion to change the distance D by deforming at least a portion of the flexible means (30, 125, 145, 730).
27. The expandable implant (100, 200, 300, 400, 600, 700, 800, 900, 1000, 1100, 1200, 1400) of claim 25, wherein: The means (40, 60) for increasing the distance is configured to perform the transformation without the use of a linear slidable joint or without the use of a means for performing a linear translation without rotation.
28. The expandable implant (100, 200, 300, 400, 600, 700, 900, 1000, 1100, 1200, 1400) of claim 25, wherein: The means (40, 60) for increasing the distance comprises a conical screw element (60) and an at least partially internal cylindrical thread (40).
29. An expandable implant system (500), comprising: Intervertebral implants (100, 200, 300, 400, 600, 700); as well as An implant manipulation device or system (505), Wherein, the implant manipulation device or system (500) comprises, A dual-function holder (530) for removably holding the implant (100, 200, 300, 400, 600, 700) with couplings (534, 536, 538) and for guiding and injecting bone graft into the implant (100, 200, 300, 400, 600, 700) via a bone graft outlet (532); a dual-function pusher (510) insertable into the retainer (530) for acting like or as a piston to push a bone graft through the retainer (530) into the implant (100, 200, 300, 400, 600, 700) and for disengaging the retainer (530) from releasable engagement with the implant (100, 200, 300, 400, 600, 700), Screwdriver (540), and A screwdriver guide (520) can be attached to the holder (530) or can be formed integrally with the holder, the screwdriver guide (520) having a guide hole (522) extending in the insertion direction ID for guiding the screwdriver (540) to engage and rotate with the conical screw element (60).
30. A three-dimensional (3D) printing method for manufacturing the expandable implant according to claim 1.
Citation Information
Patent Citations
Surgical instrument for operating spinal implant system with dual axis adjustability and method of operating same
US20210085486A1
Variable lordosis spacer and related methods of use
US9839528B2
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