Instruments and methods for treating spinal discs and sacroiliac joints

Abstract

Devices and methods for preparing spaces in a spine and / or sacroiliac joint. The devices and methods include reciprocating disruption heads and / or devices with tissue disruption members and tissue removal members. The devices and methods also include side-to-side moving disruption heads.

Description

Instruments and Methods For Treating Spinal Discs And Sacroiliac JointsThe present application claims the benefit of and prior to U.S. Patent Application No. 63 / 616,070, filed on December 29, 2023, which is hereby incorporated by reference.FIELD OF DISCLOSURE

[0001] This application relates to devices and instruments for the treatment of the spine. In particular, this application relates to devices and instruments for treating collapsed disc spaces and Sacroiliac joint (SI) spaces. More particularly, this application relates to the instruments and methods for cleaning and expanding disc spaces.BACKGROUND

[0002] Spinal fusion is one of the primary treatment options for a variety of spinal conditions due to various degenerative, neoplastic, traumatic, and infectious processes. In general, achieving spinal fusion requires bony growth between two or more adjacent spinal vertebrae. A collapsed disc is a subset of the general spinal fusion and may require specialized instrumentation due to the nature of the collapsed condition where no disc material might be present. Treating SI joint spaces may use similar instrumentation.

[0003] Therefore, there is a need for instruments and methods that facilitate, simplify, and streamline the preparation of the site for fusion.SUMMARY

[0004] In one aspect, cleaning the disc space or tight joint is facilitated with a reciprocating motion of a double action rasp head having a two-sided grit pattern that cleans the superior and inferior part of the space at the same time. The head portion can also be expanded and deployed to act as an implant for bone fusion.

[0005] In another aspect, a reciprocating double rasp instrumentation system for the cleaning of the bony growth and irregular surface of a collapsed disc space.

[0006] In yet another aspect, various instruments and methods are provided to generate reciprocating motion for cleaning out collapsed disc or joint spaces. In one example, the instruments include gear mechanisms that facilitate operation under power at high RPMs.

[0007] In another aspect, the instrument includes a reciprocating rasp configured to be expandable in the vertical direction, which increases the material-removing ability in the axial direction in a controlled manner.

[0008] In another aspect, the rasp blades serve as a spacer that keeps the disc or joint spaced apart during the injection of fusion material.

[0009] In a further aspect, the instrument includes the addition of spike anchors on the superior and inferior sides of the deployable portion / implant for better anchoring of the implant.

[0010] In yet another aspect, the disruption head has the ability to move in a side- to-side motion about a pivot point. The disruption head could be a single unit or a dual unit.

[0011] In another aspect, the side-to-side motion is a single back-and-forth motion or reciprocation motion with a single-action arm or double-action arms.

[0012] A device for preparing a space between adjacent bone segments includes a disruption head having a first disruption member and a second disruption member, wherein the first and second disruption members reciprocate relative to one another. The adjacent bone segments may be vertebral bones, and the disruption head may be sized and configured to be inserted between the vertebral bones. The adjacent bone segments may be bones of a sacroiliac joint, and the disruption head may be sized and configured to be inserted between the bone segments of the sacroiliac joint.

[0013] In yet another aspect, a device for preparing a space between adjacent bone segments includes a delivery instrument, a tissue disruption member, and a tissue removal member. The tissue disruption member may include an elongated body with openings and the tissue removal member may be located within a lumen of the elongated body.BRIEF DESCRIPTION OF DRAWINGS

[0014] Fig. 1 a is a side view of one embodiment of a reciprocating double rasp device, in accordance with the present disclosure.

[0015] Fig. 1 b is a partial cross-sectional view showing the reciprocating device with a yoke and worm gear system in a neutral position.

[0016] Fig. 1 c is a partial cross-sectional view showing the reciprocating device with a yoke and worm gear system in an offset position.

[0017] Fig. 1 d is a side view showing a schematic illustration of another embodiment of a reciprocating device with arm leverage and a miter gear system in a neutral position.

[0018] Fig. 1 e is a top view showing a schematic illustration of the reciprocating device of Fig. 1 d with arm leverage and a miter gear system in a neutral position.

[0019] Fig. 1 f is a side view showing a schematic illustration of the reciprocating device of Fig. 1 d with arm leverage and a miter gear system in an offset position.

[0020] Fig. 1 g is a side view showing a schematic illustration of the reciprocating device of Fig. 1 d with arm leverage and a miter gear system in an offset position.

[0021] Fig. 2a is an isometric view of the reciprocating device of Fig. 1 d with arm leverage and a miter gear system in a neutral position with a cutaway view showing the internal mechanisms.

[0022] Fig. 2b is an isometric view of the reciprocating device of Fig. 1 b with a yoke and worm gear system in a neutral position with a cutaway view showing the internal mechanisms.

[0023] Fig. 3a is a cross-sectional side view of another reciprocating double rasp device using a yoke and a drive belt mechanism, in accordance with the present disclosure.

[0024] Fig. 3b is a cross-sectional top view of the reciprocating double rasp device of Fig. 3a with the belt drive system and the yoke activation mechanism.

[0025] Fig. 3c is an isometric view of the reciprocating double rasp device of Fig. 3a with a transparent outer shell to show the internal mechanisms.

[0026] Fig. 4a is a cross-sectional side view of yet another reciprocating rasp device using a spur gear and rotating arm activation mechanism.

[0027] Fig. 4b is a top view of the reciprocating rasp device of Fig. 4a with a cutaway view to show the internal mechanism in a neutral position.

[0028] Fig. 4c is a side view of the reciprocating rasp device of Fig. 4a, with a cutaway view showing the internal mechanism in an offset position.

[0029] Fig. 5 is a side view of adjacent vertebral bodies with the reciprocating device inserted and operating in a collapsed or relatively tight disc space.

[0030] Fig. 6 is a side view of a device having a disruption head and connecting arms.

[0031] Fig. 7 is a close-up side view of the disruption head and connecting arms of Fig. 6.

[0032] Fig. 8 is an exploded, isometric view of the connector for the detachable arms of Fig. 6.

[0033] Fig. 9 is an isometric view of the disruption head elements with different height configurations.

[0034] Fig. 10 is an exploded, isometric view of the coupling distal connecting arms of the disruption heads.

[0035] Fig. 11 a is an exploded, isometric view of the disruption head shown with its locking element.

[0036] Fig. 11 b is an isometric view of the locking element.

[0037] Fig. 12a is a side view of an embodiment of the disruption head with additional side spike anchors.

[0038] Fig. 12b is a side cross-sectional view of the assembly of the disruption head with the side spike extended vertically in the superior and inferior directions.

[0039] Fig. 13 is an isometric view of the disruption head assembly with the spike anchors.

[0040] Fig. 14 is an isometric view of a single monobloc disruption head having a side-to-side motion.

[0041] Fig. 15 is a left lateral side view of the single monobloc disruption head of Fig. 14.

[0042] Fig. 16 is a right lateral side view of the single monobloc disruption head of Fig. 14, having a side-to-side motion.

[0043] Fig. 17 is an isometric view of a dual-member disruption head having a side-to-side motion.

[0044] Fig. 18 is a left lateral side view of the dual member disruption head of Fig. 17 with side-to-side motion.

[0045] Fig. 18a is a cross-sectional back view taken along plane A-A of the dual member disruption head with a side-to-side motion of Fig. 18.

[0046] Fig. 18b is a cross-sectional back view taken along plane B-B of the dual member disruption head with a side-to-side motion of Fig. 18.

[0047] Fig. 19 is an isometric view of the full handle using a lead screw drive mechanism.

[0048] Fig. 20 is a schematic view of a worm gear and yoke system to drive the side-to-side motion of a single unit disruption head.

[0049] Fig. 21 is a schematic view of a worm gear and yoke system to drive the side-to-side motion of a dual unit disruption head.

[0050] Fig. 22 is a perspective view of one embodiment of a discectomy / fusion instrument.

[0051] Fig. 23 is a perspective view of the distal end of the instrument shown in Fig. 22.

[0052] Fig. 24 is a perspective view of the distal end of the device of Fig. 22, shown without the grabbing arms and the drive shaft mechanism of the deployment device.

[0053] Fig. 25 is a perspective view of a distal end of a tissue disruption instrument in accordance with the present disclosure.

[0054] Fig. 26 is a perspective view of the distal end of the tissue disruption instrument of Fig. 25.

[0055] Fig. 27 is an exploded perspective view of the tissue disruption member of Fig. 25.

[0056] Fig. 28 is a perspective view of the tissue disruption member of the instrument shown in Fig. 25.

[0057] Fig. 29 is a perspective view of the distal end portion of the tissue removal member of the instrument, as shown in Fig. 25.

[0058] Fig. 30 is a perspective view of a portion of the tissue removal member of the instrument shown in Fig. 25.

[0059] Fig. 31 is a perspective view of the tissue removal member of the instrument shown in Fig. 25.

[0060] Fig. 32 is a perspective view of the proximal end portion of the tissue removal member of the instrument, as shown in Fig. 25.

[0061] Fig. 33 is a perspective view of the tissue disruption instrument of Fig. 25.DETAILED DESCRIPTION

[0062] While the subject matter of the present disclosure is susceptible to embodiments in various forms, there will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words "a" or "an" are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0063] It is understood that the foregoing merely illustrates the principles of the various embodiments of the systems, devices, and methods disclosed herein. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein.

[0064] The devices and methods disclosed herein generally relate to cleaning and preparing tight or collapsed disc spaces, as this might require a different set of tools than needed for standard discs. A collapsed or tight disc space might not have much intervertebral disc material left, and therefore, curettes and pituitaries are not as useful as in a standard diseased disc. A tool that can smooth out the irregularities of the endplate and remove the cartilage is useful for providing some bleeding bone to achieve the desired bony fusion.

[0065] It is also understood that not only tight or collapsed disc spaces would benefit from the devices / instruments and methods disclosed herein, but also other tight joints that might need a fusion for the given disease condition, and such joint could be the Sacroiliac joint (SI) for instance, where a fusion stabilization would be desired due to pain related syndrome that cannot be treated with less invasive means.

[0066] In some embodiments of the devices with a reciprocating tissue disruption head, the reciprocating head can be locked, detachable, and deployed like an interbody cage system, similar to those previously disclosed in US Patent Application Publication US2021 / 0212712, filed January 7, 2021 , and / or provisional application 63 / 498,913, filed April 28, 2023, where lockable, detachable and deployable devices are described following discectomy with the same device.

[0067] It is also understood that the present devices and systems can be motorized for ease of use and effectiveness. The devices can also be adapted for robotically guided systems that use computer systems that employ imaging such as CT scan, MRI, or other image modalities to plan and execute the proper trajectory. The imaging can aid in proper positioning within the disc or other joint space that might require a lot more fluoroscopic imaging during that procedure in a manual method.

[0068] Now, turning to the Figs. 1 a-1 g, Fig. 1a shows a device 1 for preparing a space between two bone segments. Device 1 and the other devices disclosed herein may be particularly, but not exclusively, useful in preparing a tight space between two bones. For example, device 1 may be used to prepare a collapsed disc space between adjacent vertebral bodies or the SI joint space. Device 1 has a body 2, which may also serve as a housing or handle the user can grip. Body 2 may have ergonomic features 3, e.g., over-molding surfaces for better hand grip. Optionally, features 3 of body 2 may include, for example, dimples, recesses, finger patterns, or the like, as well as directional indicators. A rotating knob 4 is located at the proximal end of the handle. Rotating knob 4 is operatively connected to reciprocating distal ends 5 and 5' of arms 7 and 7', respectively, and thus, rotating knob 4 is also connected to arms 7 and 7'. Rotating knob 4 activates the mechanisms of device 1 to move the distal ends 5 and 5' forward and backward like hands being rubbed together front to back. Distal ends 5 and 5' of arms 7 and 7' move proximally and distally when activated. Optionally, the distal ends 5 and 5' may also have a side-to-side motion, as described below. The distal ends 5 and 5' include or define tissue disruption heads 13 and 13', which may be rasps or shaver heads. Tissue disruption heads 13 and 13' cut, scrape, rip, grasp, detach, or otherwise disrupt tissue. Tissue disruption heads 13 and 13' may include protrusions extending from at least the outer or outwardfacing surfaces of the disruption heads. The protrusions may be sharp or teethlike features or textures configured to cut, scrape, rip, grasp, detach, or otherwise disrupt tissue.

[0069] Distal end 5 / disruption head 13 are separated or spaced from distal end 57disruption head 13' by a small gap 6 therebetween. As described in more detailbelow, each disruption head 13 and 13' may be operatively connected to a mechanism that moves or activates the disruption head 13 and 13'. In some alternatives, each disruption head 13 and 13' may be operatively connected to a separate mechanism, such as different or separate gears. Connecting arms 7 and 7' operatively connect the disruption heads 13 and 13' to the internal mechanism inside the handle 2 and translate motion therebetween.

[0070] Fig. 1 b shows a side view of an example of device or instrument 1 having a system or mechanism 8 with a double yoke activation arm 9 and 9' and a worm gear system 10 in a neutral position. The yoke activation may be a Scotch yoke gear. Connecting arm 1 1 activates disruption head 13 on the top side (in the figure), and connecting arm 12 activates disruption head 13' on the bottom side. Connecting points 20 and 20' located on the yokes 9 and 9' are both at the 6 o'clock position (the center of the clock being the center axis about which the yoke rotates; for the purpose of this description, 12 o'clock being at the top of the page) within the worm gear system 10. Worm gear system 10, which is an activation member, includes a shaft 14. A worm gear 17 is at the distal end of the shaft 14, and a knob 15 is at the proximal end of the shaft 14.

[0071] Fig. 1 c illustrates an example of the operation of device 1 with system 8. Upon rotating the knob 15 in a clockwise direction (CW) 16, worm gear 17 rotates in its bearing housing (not shown), which prevents axial translation of the worm gear. Turning worm gear 17 rotates worm wheel 18 in a counterclockwise direction (CCW) 19. On the other hand, worm wheel 18' rotates in a CW direction 19'. With the respective rotating motions, connection point 20 will move to a 3 o'clock position, which will translate to a retracting or backward motion of the disruption head 13 in the direction of arrow 21 from its original neutral position, as shown in Fig. 1 b. At the same time, connecting point 20' will move to a 9 o'clock position, which will translate to a forward or advancing motion of disruption head 13' in the direction of arrow 21 ' and move away from its original neutral position as shown in Fig. 1 b. In the illustrated embodiment, connecting point 20 moves proximally relative to the neutral position, and connecting point 20' moves distally relative to the neutral position.

[0072] Upon continuing to rotate knob 15 in the CW direction, connection point 20 of yoke mechanism 9 will be traveling from the 3 o'clock position to the 12 o'clock position, to the 9 o'clock position until it reaches the 6 o'clock position making a complete CCW revolution and a one back-and-forth motion of the disruption head 13. Additional rotation will create many back-and-forth motions, and it will be the same for connection point 20' of yoke mechanism 9', traveling from the 9 o'clock to the 12 o'clock, to the 3 o'clock and finally to the 6 o'clock position for a complete revolution in the CW direction. Multiple rotations of the knob 15 and worm gear 17 will translate the disruption head 13' back and forth multiple times, creating the reciprocating movement.

[0073] Once the instrument is inserted into the collapsed disc space, for example, in the preparation of the disc space before fusion, the reciprocation motions of the top and bottom disruption heads 13 and 13' will disrupt disc material with the teeth-like pattern at its tip in a more consistence manner than by a manual rasp.

[0074] T urning to Fig. 1 d, a schematic side view of an alternative activation mechanism to create the reciprocating motion for the disruption heads 13 and 13' is shown. Device 1 a uses a miter gear system 22 with a gear pinion 23 and two side gears 24 and 24'. Each side gear is connected to drive arms 25 and 25' via connecting primary rotating points 27 and 27' and secondary rotation points 28 and 28'. Connecting arms 26 and 26' connect secondary rotation points 28 and 28' to disruption heads 13 and 13'. The embodiment shown in Fig. 1 d is in a neutral position where the disruption heads 13 and 13' are aligned with one another. Fig. 1 e shows a top view of device 1 a and system 22. This figure illustrates the angular side gears 24 and 24' and connecting arms 25 and 25'. Optionally, a shaft operatively connects knob 15 to pinion gear 23. In the illustrated embodiment, side gears 24 and 24' include gear teeth that mesh or engage with gear teeth of pinion gear 23.

[0075] Fig. 1f and Fig. 1g show device 1a and system 22 in motion with reciprocating disruption heads 13 and 13'. As knob 15 rotates CW, pinion gear 23 drives side gear 24 to turn in a CW direction and side gear 24' to turn in a CCW direction. The turning of the side gears 24 and 24' drives the primary pivot points 27 and 27' away from their initial neutral position and in opposite directionsrelative to each other, as seen in these two figures. Turning gears 24 and 24' in opposite directions results in disruption heads 13 and 13' reciprocating back and forth in an oscillating motion.

[0076] The gear ratios of the worm gear 17, shown in Fig. 1 b, and the gear pinion 23, shown in Fig. 1 e, may be selected so that the devices can be used with a power driver or drill at high RPMs.

[0077] Additionally, the primary rotating pivot points 27 and 27' and the secondary rotating pivoting points 28 and 28' may be located and configured to rotate so drive arms 25 and 25' move smoothly, as the connecting arms 26 and 26' are locked in a horizontal position and travel in an axial direction to create the reciprocating motion. Each pivot point may be a shaft contained in a sleeve bearing, bushing, or the like.

[0078] Other gear and drive mechanisms may create the desired reciprocating motion. Such systems could include a belt drive mechanism or a planetary gear system. The systems can also be adapted to have a yoke-type mechanism or pivoting arm mechanism.

[0079] Fig. 2a shows an isometric view of device 1 a and system 22 described in Fig. 1d-g. Disruption heads 13 and 13' include protrusions 29, such as small tooth-like protrusion, in a pattern that can be fine or coarse based on the type of discectomy or bone preparation needed. The cutaway view 30 renders visible the mechanism previously described where the pinion gear 23 and the two angular side gears 24 and 24' are visible. A connecting arm support 31 is located between the two side gears to hold the gear shaft 32. The two connecting arms 26 and 26' are held together in a stable position. For example, nose cone 33 may hold the connecting arms 26 and 26' together and in a stable position while allowing the arms to move in the axial direction shown by arrow 34. The nose cone 33 may also act as a sliding bushing.

[0080] Fig. 2b shows an isometric view of the reciprocating device 1 of Figs. 1 b- 1 c. This figure has a cutaway view 35 for better visibility inside the handle 2 with the double yoke activation system 8 and the connecting arms 1 1 and 12. The top yoke arm 9 engages sliding pin 36 that will travel from one end to the other of groove 37 based on the rotational axis of pivot point 20. As wheel 18 rotates, arm1 1 translates the back-and-forth motion to disruption head 13. The bottom yoke arm 9' will do the same motion in the opposite direction as previously described. A U-shaped bracket 38 holds the two worm wheels / gears 18 and 18' as well as the worm gear 17. Similar to the device shown in Fig. 2a, nose cone piece 39 holds the connecting arms 11 and 12 steady and stable but allows the arms to move in the axial direction so they can slide back and forth.

[0081] Moving to Fig. 3a, this figure shows a cross-sectional side view of yet another embodiment of a reciprocating motion of a double-action disruption head. In this configuration, device 1 b uses a drive belt system 40 and a yoke-type mechanism 41 . Drive belt system 40 is enclosed in a handle body 2, similar to previously described devices. The drive knob 42 activates a geared pully 43 that is supported by a holding bracket 44 and a belt 45, which may be toothed. Belt 45 is connected with the front gear 46 that drives the top yoke arm 47 and the bottom yoke arm 47'. The yoke mechanism 41 operates similarly to that previously described in Figs. 1 b and 1c, as well as Fig. 2b. A tension mechanism 48 creates sufficient tension in the belt system to drive the yoke activation mechanism. A fixed tension bracket 49 is located inside of the handle and attached to the handle via screws or bonding, or other means, as known in the art for attaching elements together. The movable tension bracket 50 supports the yoke activation mechanism 41 and is adjusted with screw tensioners 51 during assembly of the device. Once the selected tension is obtained, movable bracket 50 may be attached to the body handle similarly to the fixed bracket. The disruption heads 52 and 52' and the connecting arms 53 and 53' are similar as previously described by all other devices.

[0082] T uring to Fig. 3b, this figure shows a cross-sectional top view of the belt drive system with the geared pully 43, the front gear 46, and the driving belt 45, as well as the tensioning mechanism 48.

[0083] Fig. 3c shows an isometric view wherein the body is transparent to show the belt-driven system and internal mechanism. This figure illustrates knob 42, the geared pully 43, the driving belt 45, the yoke activation mechanism 41 , and the disruption heads 52 and 52'.

[0084] Figs. 4a-4c illustrate another embodiment of a reciprocating device 1c with a spear gear system. The driving gear 54 is positioned proximally in the handle 2 and connected to knob 59 (shown in Fig. 4b). The driving gear 54 engages the double-driven gears 55, which are held by a central connector 56 that includes the center axis shaft 60. In this embodiment, the disruption heads 52 and 52' are activated via connecting arms 58 and 58' and drive arms 57 and 57', which are connected to the rotating double spear gear 55. The drive arms pivot at rotating points 61 and 62 to carry out the reciprocating motion as previously described in Figs. 1 d-1 g, as well as in Fig. 2a.

[0085] Fig. 4b is a top view of the system with a cutaway view 63) showing the drive system with the double driven gear 55 supported by central connector 56 and in contact with driving gear 54.

[0086] Fig. 4c shows a side view of the device with a cutaway view 64 to show the internal gears 54 and 55, the drive arms 57 and 57', and the connecting arms 58 and 58' in an activated position. In this figure, knob 59 has been rotated a quarter turn to move the disruption heads 52 and 52' from a neutral position to an offset position.

[0087] Fig. 5 shows an example of a device of the present disclosure being used in a collapsed disc. After creating access to the spine, the user grasps handle 2 to maneuver the device and introduces disruption heads 65 and 65' into the disc space. The access may be minimally invasive or open. Using the reciprocating device 1 via tubular access is also possible, as used for MIS access (not shown). The device is introduced by manually advancing the disruption heads 65 and 65' into the disc or with light tapping with a mallet. Once in the disc, the device is activated, for example, by rotating the knob, resulting in the oscillation of the disruption head back and forth, which cleans and / or prepares the disc space. Positioning may be controlled by using fluoroscopy or the surgeon's tactile feel. The device is retrieved once the disc space is prepared, and the surgery can proceed.

[0088] Turning to Fig. 6, device 1 d includes a disruption head portion 65 and connecting arms 66. The disruption head portion 65 may be deployable and expandable. The device includes a coupling section 69 that allows disconnectionand expansion of the disruption head portion 65 in the vertical direction and an upward action, as shown by arrow 70. Also, the disruption head portion 65 may be releasably attached to the arms at location 67. After being placed into the desired site within a patient, the disruption head portion 65 may be separated from the device or arms at location 67 to deploy the disruption head within the site, as represented by arrows 68.

[0089] Fig. 7 shows an enlarged side view of the reciprocating device's distal end 71 . A coupling 76 connects the two sections of the connecting arms 73 and 73' on the distal end and the two sections of connecting arms 74 and 74' at the proximal side. Coupling 76 includes two U-channel elements 72 and 72', that releasably secure together the two connecting arms 73 and 74 on the superior side and the two connecting arms 73' and 74' on the inferior side. It is also understood that the two coupling sections 72 and 72' could be made as one piece. Additionally, any suitable coupling may be used to couple arms 73 and 74 with connecting arms 73' and 74'. Furthermore, there could be additional features like screws or lock levers to improve the locking of the coupling elements onto the connecting arms.

[0090] In addition, the disruption heads 65' and 65" of disruption head portion 65 may be securely attached to connecting arms 73 and 73' at point 67 via a pair of long screws 75.

[0091] Fig. 8 shows an enlarged, exploded, isometric view of coupling 76. U- channel members 72 and 72' each have a T-slot 77 and 77'. The proximal end of connecting arm 73 abuts the distal end of connecting arm 74 at the location 81 to form or define T-Key 78. Similarly, the proximal end of connecting arm 73' abuts the distal end of connecting arm 74' at location 81 to form or define T-Key 78'. In other words, each T-Key is split in the middle 81 , with one-half of the section being part of the connecting arms 73 and 73' on the distal side and the other half being part of connecting arms 74 and 74' on the proximal side. T-Keys 78 and 78' are received into T-slots 77 and 77', respectively.

[0092] Optionally, the connecting arm 73 may have a guide slot 79, and connecting arm 73' may have a corresponding guide 80, which may be a rail or other protrusion. The guide slot allows the reciprocating motion to stay in line andguide the superior connecting arm 73 and the inferior connecting arm 73' along the axial direction.

[0093] Fig. 9 shows an isometric view of different sized elements to permit different disruption heights, such as different shaving heights, for the reciprocating device. For example, the surgeon may determine the desired height for a particular procedure. The surgeon may then choose between element 83, which has a particular-sized X of the head 85, or element 82, with a different-sized Y of the head 85'. In some embodiments, during the procedure, the surgeon may use element 83 and then swap it out for element 82 and vice versa. The heads 85 and 85' may not only be different heights, but they may also have different configurations in size, angles, sharpness, edges, shape, patterns, etc. Element 82 could also have an angle along the disruption head 85' section to create lordosis at the implant site.

[0094] The height X of the disruption head 85 can range from 1 mm to 8mm, depending on the application. For example, a range from 1 mm to 3mm or 4mm may be preferable for non-detachable / nondeployable embodiments, and 3mm to 8mm or more on the detachable / deployable heads 85'.

[0095] Fig. 10 shows an isometric view of the system with connecting arms 73 and 73' that can be coupled to the disruption heads 85 and 85' with screws 75 that are passed through passageways 87 and 87' and securely tied to corresponding threaded holes 88 and 88' of heads 85 and 85'. In order to keep the disruption heads 85 and 85' in the desired orientation, a pair of guide pins 86 and 86' on the connecting arms side 73 and 73' are inserted into corresponding holes 89 and 89' on the disruption heads' 85 and 85' sides.

[0096] T urning to Fig. 1 1 a, there is a matting feature 90 and 90' in the form of a V- angled slot that can accept an insert 91 with the same shape to securely keep the superior and inferior portions of the disruption heads 85 and 85' together. Insert 91 and its backstop 92 can be attached via a pair of screws 93 inserted in and through holes 94 and into corresponding tapped holes 88 and 88' on the disruption heads' rear side.

[0097] Fig. 1 1 b shows the other side of the insert 91 and the location of pins 95 on the backstop 92. Insert 91 has a dedicated double V-angled slot 96 that isinserted into the disruption heads 85 and 85' to securely keep the different components that make up the head portion 65 together. It is understood that head portion 65 could have a lordotic angle for use in a situation where lordosis needs to be restored.

[0098] Fig. 12 is a cross-sectional side view of an example implant with disruption heads 85 and 85' having internal spike anchors 97 and 97'. The number of spike anchors 97 and 97' may be determined by the device's size and could range from 2 to 10 or more. Each spike anchor may have a pointed tip 98 on the outer section that can anchor into the bone. Spike anchors 97 and 97' may be tapered or have a ramp-like structure 99 on the inside section that will be pushed out of the head upon introduction of the insert 91 . The insert has a tapered or sloped front-loading section 100 that will push each spike anchor toward the outside and into the bone tissue. It is also understood that insert 91 could create a vertical expansion of the head portion with a slightly thicker body height that moves the head 85 and 85' apart as the insert advances into the head portion to push the spike anchors.

[0099] Fig. 12b shows a side view of the assembled disruption heads 85 and 85' that define an implant. The disruption heads are shown after insert 91 has pushed all the side spike anchors 97 and 97' outward and into the bone structure for anchoring. Fig. 13 shows an isometric view of the implant with side spike anchors 97 and 97' on the top and inferior surfaces. It is also understood that other anchor shapes could be used with different insertion methods without departing from the present disclosure.

[0100] T urning to Fig. 14, this figure shows the side-to-side motion of a monobloc disruption head 101 , which may be a rasp or shaver head. The monobloc disruption head is a single piece with teeth on the top 102 and on the bottom 103, as shown in Fig. 15 and Fig. 16. The monobloc device is held in place by support or bracket 104 and is attached to the bracket by pin 105. Bracket 104 is connected to the handle and may be of rigid construct. Monobloc disruption head 101 moves from side to side by moving side arm 106. Side arm 106 is connected to the monobloc disruption head 101 on the side of the back edge by pin 107. As the side arm 106 advances or retracts per arrow 108, it moves the monoblocdisruption head 101 by pivoting the head 101 about the axis of pin 105 as indicated by arrow 109. The motion of the disruption head 101 is from a retracted position 10T through a neutral position to an extended position 101", as shown with the dotted outlines.

[0101] Fig. 15 is a side view of the monobloc disruption head 101 and its connecting bracket 104 with pin 105. Optionally, disruption head 101 may include a tapered tip 110 and teeth on the superior side 102 and / or inferior side 103. The teeth may be sized and shaped and / or in a pattern configured to disrupt tissue (i.e., cut, scrape, rip, etc.). Fig. 16 illustrates the other side view of monobloc disruption head 101 with side arm 106 connected to pin 107 within a recess 111 to optimize the profile.

[0102] T urning to Fig. 17, a dual member disruption head 112 is shown. The disruption head includes a superior member 113 and an inferior member 114, and both of them are connected and stabilized by connecting bracket 115 and pin 116. The superior member 113 has a movable side arm 117 connected via pin 1 18, and inferior member 114 also has a movable side arm 119 connected via pin 118'. As bracket 115 is held stationary, the superior and inferior members pivot about the axis of pin 116. Therefore, when movable side arm 117 is retracted, as shown by arrow 120, the superior member 113 of assembly 112 will move to a position shown by the dotted line of member 113'. Similarly, when movable side arm 119 is retracted as indicated by arrow 120', the inferior member 1 14 will move in the opposite direction as outlined with the dotted line of member 114'. This creates a side-to-side motion of the dual member disruption head 1 12 similar to the reciprocating motion of disruption head 52. The disruption heads prepare the disc space for fusion by creating / preparing the necessary space for receiving an implant and its associated bone graft material.

[0103] Fig. 18 shows a lateral view of the dual-member disruption head 112 with similar features as previously described. Disruption head 112 includes a tapered tip 110 that is split between the superior member 113 and the inferior member 1 14. The superior member 113 and inferior member 114 also have a set of teethlike features 102a. A pin 116 engages connecting bracket 115, and in this view, the side arm 119 is moving side to side with connecting pin 1 18.

[0104] Fig. 18a shows a back view of the superior member 113 and inferior member 114, which have several pockets or recesses to accommodate the connecting of movable arm 117 on the superior side and of movable arm 119 on the inferior side with both engaging into each respective recess 122 and 123. The connecting and stabilizing bracket 115 has engagements 115' and 115" in both disruption head members 113 and 114 with accommodating recesses 121 and 121 '. The recesses provide a low profile. Turning to Fig. 18b, this figure illustrates a cross-section located more proximally toward the handle (not shown). This figure shows the connecting and stabilizing bracket 1 15 as well as the two moving side arms 117 and 119 that are connected into superior member 113 and inferior member 114, respectively.

[0105] T urning now to Fig. 19, this figure shows an isometric view showing the disruption head 101 of Fig. 14. Handle 123' houses activation mechanism 127, which includes, on the proximal side, the knob 124 having a leadscrew shaft 125 engaging with the corresponding thread at the handle site 128. On the distal end of the leadscrew is connecting recess with shoulder 129, which holds bushing connector 126. This translates a rotating motion (Z) of the leadscrew to a back- and-forth motion (Y), which moves side arm 106 in a back-and-forth motion. Side arm 106 is connected at the proximal end to bushing connector 126 and on the distal end to the disruption head 101 via pin 107. Connecting bracket 104 will hold the disruption head 101 via pin 105.

[0106] As side arm 106 is moving back and forth, disruption head101 ) pivots in a swivel motion (X) about the axis (W), which is the location of pin 105. This back- and-forth action of side arm 106 will translate into a side-to-side motion of the disruption head as desired.

[0107] Fig. 20 shows another alternative of moving a disruption head 101 in a side-to-side motion (V). The device uses a yoke and worm gear system, as previously described, but only one side is used in this instance. For example, the knob 130 is rotated in one direction. This is contrary to the previous embodiment (Fig. 19), where knob 124 is rotated in a series of CW and CCW motions to have disruption head 101 move from side to side. In the alternative illustrated in Fig. 20, only one rotational direction is needed to provide the side-to-side motion (V) ofdisruption head 101 since the combination of stationary worm gear 131 , worm wheel 132 and yoke 133 will result in the disruption head 101 moving in a one side-to-side motion with one revolution of worm wheel 132. This could translate to one or more revolutions of knob 130 based on the chosen gear ratio in the worm gear system. Because connecting bracket 104 is fixed, the of moving side arm 106 will advance back-and-forth as shown by arrow 134 and make the disruption head 101 pivot at the point of pin 105 along an arc (X). As will any of the embodiments disclosed herein, this device could be configured for a motorized drive to make the motion and could also be robotically controlled.

[0108] Now looking at the dual unit system as previously described in Fig. 17 and Fig. 18, we can see in Fig. 21 that the above yoke and worm gear system that both sides are used as previously described in Fig. 1 b and Fig. 1 c. Therefore, upon rotation of knob 130 in a CW direction, worm wheel 132 will rotate in a CCW direction while worm wheel 132' will rotate in a CW direction, driving yoke position 133 to a position shown as point 136 and likewise, yoke position 133' will move to position shown as point 136'. This will translate a forward motion 137 and 137' to movable side arm 117 and 119, resulting in a side motion of superior member 113 in the direction pointed by arrow 135 while the inferior member 114 will have a side motion in the opposite direction as shown by arrow 134.

[0109] It is understood that other mechanisms could be used, such as the ones already presented in the application and it is also feasible that disruption heads 101 , 113 and 114 could also be changed and replaced with different thicknesses as well as deployed and implanted as presented with any suitable reciprocating device or system. It is also understood that several permutations could be contemplated, or additional embodiments developed to enhance the usability of the reciprocating device based on the described systems, devices, and methods.

[0110] Figs. 22-24 illustrate an exemplary embodiment of a discectomy / implant instrument 200, which includes a deployment device 204 and detachable head 202. Such devices are described in International Application Pub. No. WO 2024 / 2269906, filed April 26, 2024, which is hereby incorporated by reference, in its entirety, herein. Instrument 200 may be used to prepare the disc space by disrupting and removing tissue. Additionally, head 202 may be detached frominstrument 200 and a new or different head for disrupting tissue may be attached to the instrument. Head 202 may also be detached and left in the disc space to serve as an implant.[01 1 1] The tissue disruption and removal instruments of Figs. 25-33 and described in more detail below may be used with the discectomy / implant instruments described in the ‘906 application or with any other suitable discectomy or implant instruments. Alternatively, the tissue disruption / removal instruments shown in Figs. 25-33 and described below may be used on their own.

[0112] T urning to Fig. 22, the instrument with its head 202 is generally designated by reference numeral 200. Instrument 200 may be a discectomy instrument and / or an implant delivery instrument. For example, instrument 200 may be used as a discectomy instrument to evacuate tissue from the disc space and / or a delivery instrument to implant head 202 into the disc space.

[0113] Head 202 is located at the distal end 203 of instrument 200 and is operatively connected to deployment device 204. The proximal end portion 205 of deployment device 204 includes a controlling section 206 and a handle 208. In addition, deployment device 204 (and thus instrument 200) includes an interface 210 at the proximal end of the drive shaft 212 for connection to a handle (not shown) or a robotic system for manipulating and controlling instrument 200. Deployment device 204 includes a shaft assembly with an outer sleeve 214, a grabbing sleeve 216 and a drive shaft 218. The outer sleeve 214, grabbing sleeve 216, and drive shaft 218 are concentrically positioned relative to one another.

[0114] Fig. 23 shows head 202 with deployment device 204 having outer sleeve 214, distal prongs 220 of the grabbing sleeve 216 and rotating drive shaft 218. Turing to Fig. 24, detachable head 202 includes recess 222, latches 224 and hole 226 for insertion of the distal end 219 of the rotating drive shaft 218.

[0115] Turning to Figs. 25 and 26, head 202 (Fig. 23) has been removed from the outer sleeve 214 of deployment device 204. A tissue disruption member 228 has been connected to the outer sleeve 214 of deployment device 204. In some alternatives, the tissue disruption instrument is a standalone instrument that includes a deployment device and the tissue disruption member 228. Tissuedisruption member 228 includes a body 230, which may be a box or elongated body. Body 230 may be generally cylindrical, cuboidal or a prism of various cross- sectional shapes. Furthermore, body 230 may have a top 233, bottom 235 and opposed sides 237, 239. In the illustrated embodiment, the body 230 is generally cylindrical. Body 230 also has a lumen 240 extending therethrough. Body 230, and thus tissue disruption member 228, is connected to deployment device 204 via grabbing sleeve 232 with the outer sleeve 214 and the distal prongs 234. Tissue disruption member 228 also includes a tissue removal member 236 extending within sleeve 214 of deployment device 204. If deployment device 204 is the same device used in Figs. 22-24, the drive shaft 218 may be removed and replaced with removal member 236. Removal member 236 may be a screw pump, such as an Archimedes screw. Tissue removal member 236 extracts disc material that enters the disruption member 228 as it is inserted into the disc space and / or disrupts tissue within the disc space.

[0116] Removal member 236 extends within sleeve 214 and the distal end of removal member 236 extends or is located within lumen 240 of body 230 of tissue disruption member 228. Sleeve 214, optionally, includes windows or opening 238 through which the user or surgeon can visual portions 242 of the removal member 236. The surgeon is able to visually check if the removal member 236 is filled or clogged with tissue, in which case, the removal member 236 can be removed, cleaned, and repositioned within deployment device 204. For example, when the removal member 236 is a screw, such as an Archimedes screw, the surgeon can visually inspect the spaces between the screw threads to determine if they are filled with tissue.

[0117] Fig. 27 is an exploded perspective view of the tissue disruption instrument assembly, which is shown separate in three sections: the tissue disruption member 228, the deployment device 204, and the tissue removal member 236.

[0118] T urning Fig. 28, tissue disruption member 228 includes a distal end portion 244, a proximal end portion 246, a top 233, a bottom 235 and opposed sides 237, 239. The distal portion 244 includes a distal or front hole 248 with a sharp cutting edge 250 that is configured to cut through disc material during insertion into the disc space. In the illustrated embodiment, the cutting edge 250 defines front hole248. Lumen 240 of tissue disruption member 228 is in communication with the front hole 248. As illustrated in Figs. 25 and 26, tissue removal member 236, such as the illustrated Archimedes screw, is positioned in lumen 240 of tissue disruption member 228. Tissue disruption member 228 includes a plurality of openings or hole in communication with lumen 240. The openings allow tissue to enter disruption element 228 and be disrupted and removed from the disc space. The top and bottom 233 and 235 of tissue disruption member 228 each include an elongated opening 252 and 254, respectively, in communication with lumen 240. Each of the sides 237 and 239 includes an opening 256 and 258, respectively, which in the illustrated embodiment are shorter in length than the elongated openings 252 and 254 in the top and bottom 233 and 235. Elongated opening 252 and 254 are at least partially defined by sharp edges 260, and shorter opening 256 and 258 in the sides 237 and 239 are at least partially defined by sharp edges 262. Sharp edges 260 and 262 are configured to disrupt disc and or end plate tissue when the tissue disruption member 228 is rotated in either in a CW direction or CCW direction within the disc space to disrupt tissue.

[0119] In the illustrated embodiment, the proximal end portion 246 of tissue disruption member includes a guide 266 that engages the outer sleeve 214 for positioning of the disruption member 228 on the deployment device 204. In the illustrate embodiment, the guide 266 is a cylindrical protrusion or peg. Proximal end portion 246 also includes an opening 268 that provides clearance for the grabbing sleeve 232 (Figs. 25 and 26) while edge connector or catches 270 allows the distal prongs 234 (Figs. 25 and 26) to securely attached the tissue disruption member 228 to deployment device 204 in a similar arrangement as to hold head 202, as shown in Figs. 22-24.

[0120] T urning to Fig. 29, the illustrate tissue removal member 236, such as the illustrated Archimedes screw, has a leading edge 270 and a helical thread 272 surrounding central cylindrical shaft 274. Referring to Fig. 30, at least a portion shaft 274 includes a helical portion 282. In the illustrated embodiment, shaft 274 includes a helical portion 282 and a portion 284 without the helical thread 272. When turned in a CCW fashion, disc tissue trapped at the distal tip 276 will be moved in the arrow direction 278 along thread 272 until it has filled the entirelength 280 of the threaded portion 282 as shown in Fig. 30. At that point, the tissue removal member can be removed for the deployment device, cleaned, and repositioned for additional cleaning passes. Different sized tissue disruption members can be used based on the height of the disc space and the intent of the treatment for disc height restoration.

[0121] Fig. 31 and 32 show a perspective view of the tissue removal member 236, which includes a connecting assembly 288 connected to the shaft 274 of the tissue removal member 236. The proximal end 290 of the connecting apparatus assembly 288 includes a drive shaft 292 and an interface 294 at its most proximal end. Interface 294 may be connected to a T-handle (not shown) or a robotic guidance and motion control (not shown) for automation of the discectomy process.

[0122] Drive shaft 292 is connected to central cylindrical shaft 274, of a portion of which has helical thread 272. In the illustrated embodiment, the helical portion 282 extends along about half of the length of the shaft 274. In other alternatives, the helical portion 282 could extend more or less than half of shaft 274. In the illustrated embodiment, at the very distal tip 296 for the Archimedes screw is the leading edge 270 as previously explained. Drive shaft 292 is directly connected to shaft 274 through the housing 298. Housing 298 is the section of the connecting apparatus assembly 288 that is coupled to the proximal end of deployment device 204 with an orienting section 300 that includes serrated teeth 302 that are used to lock the tissue removal member 236 by flipping the toggle switch 304 seen in Fig. 33, conical section 306 of housing 298 can be moved axially to show the "L" for lock position 308 to unlock.

[0123] Fig. 33 shows the instrument with the tissue disruption member 228, which may include an Archimedes screw assembly and proximal connecting apparatus assembly 288. The instrument may be used to clear up disc material from the disc space in order to create an opening large enough and clean enough to accept the insertion of disruption / implant instrument 200 which include head 202 for further discectomy work before the appropriate head size can be deploy as an implant.

[0124] The systems and methods described herein provide several benefits, such as, but not limited to: 1 ) providing a more accurate way to complete a discectomy in a collapsed disc or tight space, 2) providing a more controlled manner to smooth out the disc cartilage for future placement of an implant, 3) permitting the operator to complete the procedure in less time reducing the risk of anesthesia for the patient, 4) minimizing the nerve manipulation required to prepare the majority of the disc space to accept the spinal fusion implant, 5) combining the joint / disc space preparation tool with the fusion implant the sterilization burden to the facility would be reduced, 6) vertical expansion method permits the surgeon to restore the normal anatomic alignment to the disc space also permitting indirect decompression of the neural structures, 7) placing an angle on the member that creates the vertical expansion permits the introduction of lordosis into the device.

[0125] It is understood that the foregoing merely illustrates the principles of the various embodiments of the systems, device and methods disclosed herein. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein.

Claims

Claims1 . A device for preparing a space between adjacent bone segments, comprising: a disruption head having a first disruption member and a second disruption member, wherein the first and second disruption members reciprocate relative to one another.

2. The device of claim 1 , wherein the first disruption member is connected to a first arm and the second disruption member is connected to a second arm.

3. The device of claim 2, further including a gear system operatively connected to the first and second arms.

4. The device of claim 3, wherein the gear system comprises a first yoke, a second yoke and a worm gear.

5. The device of claim 4, wherein when the worm gear is turned, the first arm moves in one direction and the second arm in an opposite direction.

6. The device of claim 3, wherein the gear system comprises a first side gear, a second side gear and a pinion gear.

7. The device of any one of claims 1-6, wherein the first disruption member and the second disruption member are configured to move apart from one another so as to expand the space being prepared.

8. The device of any one of claims 1-6, wherein the first disruption member and the second disruption member serve as a spacer that keeps a disc or joint spaced apart during an injection of fusion material.

9. The device of any one of claims 1-8, wherein the first disruption member and the second disruption member include spike anchors on superior and inferior sides disruption head.

10. The device of any one of claims 1 -9, wherein the disruption head is configured to move side to side.11 . The device of claim 10, wherein the first and second disruption members move as a single unit.

12. The device of claim 10, wherein the first disruption member moves in a first direction and the second disruption member moves in a second direction.

13. The device of any one of claims 1 -12, wherein the adjacent bone segments comprise vertebral bones and the disruption head is sized and configured to be inserted between the vertebral bones.

14. The device of any one of claims 1 -12, wherein the adjacent bone segments comprise bones of a sacroiliac joint and the disruption head is sized and configured to be inserted between the bone segments of the sacroiliac joint.

15. A device for preparing a space between adjacent bone segments, comprising a delivery instrument; a tissue disruption member; and a tissue removal member.

16. The device of claim 15, wherein the tissue removal member comprises a shaft.

17. The device of any one of claims 15-16, wherein the tissue removal member comprises a screw pump.

18. The device of claim 17, wherein the tissue removal member comprises an Archimedes screw.

19. The device of any one of claims 16-19, wherein the tissue removal member includes a helical portion.

20. The device of claim 19, wherein the helical portion comprises a helical thread.21 . The device of claim 20, wherein the helical thread is configured to move disrupted tissue along the threads.

22. The device of any one of claims 15-21 , wherein the tissue disruption member is releasably attached to a distal end of the delivery instrument.

23. The device of any one of claims 15-22, wherein the tissue disruption member comprises an elongated body having a lumen therethrough.

24. The device of claim 23, wherein the tissue removal member extends within the lumen of the tissue disruption member.

25. The device of claim 24, wherein the tissue removal member extends within the delivery instrument.

26. The device of any one of claims 23-25, wherein the body of the tissue disruption member includes a proximal end, a distal end, a top, a bottom and opposed sides.

27. The device of claim 26, wherein the body of the tissue disruption member includes a hole in a distal end portion of the body, wherein the hole is in communication with the lumen.

28. The device of claim 27, wherein the hole in the distal end portion is defined by a sharp edge.

29. The device of any one of claims 26-28, wherein the body of the tissue disruption member includes an opening in the top.

30. The device of claim 29, wherein the opening in the top is defined by a sharp edge.31 . The device of any one of claims 26-30, wherein the body of the tissue disruption member includes an opening in the bottom.

32. The device of claim 29, wherein the opening in the bottom is defined by a sharp edge.

33. The device of any one of claims 26-32, wherein the body of the tissue disruption member includes an opening in each of the opposed sides.

34. The device of claim 33, wherein the openings in each side are defined by sharp edges.

35. The device of any one of claims 25-34, wherein the delivery instrument includes windows configured to allow visualization of the tissue removal member.

Images