INTERVERTEBRAL PROSTHETIC DISC PLACEMENT AND REMOVAL SYSTEMS
20220087832 ยท 2022-03-24
Inventors
Cpc classification
A61F2002/4625
HUMAN NECESSITIES
A61F2002/443
HUMAN NECESSITIES
A61F2002/4627
HUMAN NECESSITIES
A61F2/4637
HUMAN NECESSITIES
A61F2002/4628
HUMAN NECESSITIES
International classification
Abstract
Embodiments of the disclosure provide systems and methods of removing a core from an intervertebral prosthetic disc. The method may include: securing a multipart prosthetic disc to a distal end of a removal instrument by grasping at least a portion of the multipart prosthetic disc between a pair of core removal arms on the placement instrument; inserting the pair of core removal arms between two prosthetic disc plates of the intervertebral prosthetic disc to distract the plates away from one another; and removing the core from the intervertebral prosthetic disc with the removal instrument. The removal instrument may include: an inner shaft connected to the pair of core removal arms; and an outer shaft movable with respect to the inner shaft and including an activation mechanism for causing the arms to grasp the core for removal.
Claims
1. A method of removing a core from an intervertebral prosthetic disc, the method comprising: securing a multipart prosthetic disc to a distal end of a removal instrument by grasping at least a portion of the multipart prosthetic disc between a pair of core removal arms on the placement instrument, wherein the arms are each tapered from a thinnest portion at their distal ends to a thicker portion at some distance from the distal end; inserting the pair of core removal arms between two prosthetic disc plates of the intervertebral prosthetic disc to distract the plates away from one another; and removing the core from the intervertebral prosthetic disc with the removal instrument, the removal instrument including: an inner shaft connected to the pair of core removal arms; and an outer shaft movable with respect to the inner shaft and including an activation mechanism for causing the arms to grasp the core for removal, the outer shaft having an axial channel shaped to slidably engage an outer surface of the pair of core removal arms at the thicker portion thereof, such that the pair of core removal arms are selectively seated within the outer shaft.
2. The method of claim 1, wherein the thicker portion is at least two times as thick as the thinnest.
3. The method of claim 2, wherein the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core.
4. The method of claim 1, wherein the pair of core removal arms are shaped to correspond substantially to an outer perimeter of the core.
5. The method of claim 1, wherein distal motion of the inner shaft within the outer shaft causes the pair of core removal arms causes the two prosthetic disc plates of the intervertebral prosthetic disc to abut an outer housing at the distal end of the outer shaft.
6. A method of removing a core from an intervertebral prosthetic disc, the method comprising: securing a multipart prosthetic disc to a distal end of a removal instrument by grasping at least a portion of the multipart prosthetic disc between a pair of core removal arms on the placement instrument, wherein the arms are each tapered from a thinnest portion at their distal ends to a thicker portion at some distance from the distal end; inserting the pair of core removal arms between two prosthetic disc plates of the intervertebral prosthetic disc to distract the plates away from one another; and removing the core from the intervertebral prosthetic disc with the removal instrument, the removal instrument including: a pair of distraction wedges, each wedge being tapered from a thinnest portion at a distal end of a respective one of the pair of core removal arms to a thicker portion at some distance from the distal end, the thicker portion extending outward along an axis perpendicular to an axial orientation of the pair of removal arms; and a core removal instrument handle connected to the pair of core removal arms and the distraction wedge, the handle configured to move the arms with respect to one another to grasp the core for removal and configured to advance the distraction wedge from a distal end of the core removal handle to allow the core to be removed.
7. The method of claim 6, wherein the distraction wedge is formed integral with the core removal arms.
8. The method of claim 6, wherein the pair of core removal arms are shaped to correspond substantially to an outer perimeter of the core.
9. The method of claim 6, wherein removing the from the intervertebral prosthetic disc includes simultaneously actuating the pair of core removal arms and the distraction wedge.
10. The method of claim 6, wherein distal motion of the inner shaft within the outer shaft causes the pair of core removal arms causes the two prosthetic disc plates of the intervertebral prosthetic disc to abut an outer housing at the distal end of the outer shaft.
11. A system for removing a core from an intervertebral prosthetic disc, the system comprising: a core removal instrument including: a pair of core removal arms having inner surfaces shaped to correspond substantially to a shape of an outer perimeter of a prosthetic disc core, wherein the arms are each tapered from a thinnest portion at their distal ends to a thicker portion at some distance from the distal end such that insertion of the arms between two prosthetic disc plates distracts the plates away from one another to allow the core to be removed; and an inner shaft connected to the pair of core removal arms; an outer shaft movable with respect to the inner shaft and including an activation mechanism for causing the arms to grasp the core for removal, the outer shaft having an axial channel shaped to slidably engage an outer surface of the pair of core removal arms at the thicker portion thereof, such that the pair of core removal arms are selectively seated within the outer shaft; and a prosthetic disc comprising: an upper plate and a lower plate, wherein the upper and lower plates are configured to articulate with respect to one another and wherein the pair of core removal arms are configured to grasp the upper and lower plates in the non-articulating configuration.
12. The system of claim 11, wherein the thicker portion of the pair of core removal arms is at least two times as thick as the thinnest portion and the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core.
13. The system of claim 11, wherein the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core.
14. The system of claim 11, wherein the activation mechanism includes one of a knob, a lever, a cam, or a ratchet.
15. The system of claim 11, wherein the prosthetic disc further includes: the upper plate having an upper vertebra contacting surface and a lower surface having a bearing surface thereon; the lower plate having a lower vertebra contacting surface and an upper surface having a bearing surface thereon, wherein the upper and lower plates are configured to articulate with respect to one another; first and second notches in lateral surfaces of the upper plate and third and fourth notches in lateral surfaces of the lower plate, wherein the first and third notches are aligned with one another, the second and fourth notches are aligned with one another and the core removal arms are configured to grasp the upper and lower plates in the non-articulating configuration by engaging the first, second, third and fourth notches.
16. A system for removing a core from an intervertebral prosthetic disc, the system comprising: a core removal instrument including: a pair of core removal arms having inner surfaces shaped to correspond substantially to a shape of an outer perimeter of a prosthetic disc core; a pair of distraction wedges, each wedge being tapered from a thinnest portion at a distal end of a respective one of the pair of core removal arms to a thicker portion at some distance from the distal end, the thicker portion extending outward along an axis perpendicular to an axial orientation of the pair of removal arms, such that insertion of the distraction wedge between two prosthetic disc plates of the prosthetic disc distracts the plates away from one another to allow the core to be removed; and a core removal instrument handle connected to the pair of core removal arms and the distraction wedge, the handle configured to move the arms with respect to one another to grasp the core for removal and configured to advance the distraction wedge from a distal end of the core removal handle and distract the plates away from one another to allow the core to be removed; and a prosthetic disc comprising: an upper plate and a lower plate, wherein the upper and lower plates are configured to articulate with respect to one another and wherein the pair of core removal arms are configured to grasp the upper and lower plates in the non-articulating configuration.
17. The system of claim 16, wherein the distraction wedge is formed integral with the core removal arms.
18. The system of claim 16, wherein the core removal instrument is configured to hold the plates in place as the pair of core removal arms withdraw the core from between the plates by activation of the core removal instrument.
19. The system of claim 16, further comprising an activation mechanism coupled to the pair of core removal arms for pulling of the core out from between the plates.
20. The system of claim 16, wherein the prosthetic disc further includes: the upper plate having an upper vertebra contacting surface and a lower surface having a bearing surface thereon; the lower plate having a lower vertebra contacting surface and an upper surface having a bearing surface thereon, wherein the upper and lower plates are configured to articulate with respect to one another; first and second notches in lateral surfaces of the upper plate and third and fourth notches in lateral surfaces of the lower plate, wherein the first and third notches are aligned with one another, the second and fourth notches are aligned with one another and the pair of core removal arms are configured to grasp the upper and lower plates in the non-articulating configuration by engaging the first, second, third and fourth notches.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
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DETAILED DESCRIPTION OF THE INVENTION
[0033] Positioning of an intervertebral prosthetic disc properly in the spine is an important part of a successfully total disc arthroplasty (TDR) procedure. The position of the implant in the intervertebral space can influence the range of motion, implant behavior and clinical result. Proper position in the anterior/posterior direction between the vertebral bodies is particularly important but can be difficult due to surrounding anatomy. Surgeon experience, surgeon training, use of imaging modalities and patient anatomy are all factors which can influence accuracy of prosthetic disc placement.
[0034] An intervertebral prosthetic disc placement system according to the present invention includes a multi-part prosthetic disc and an associated placement instrument. The placement instrument holds the prosthetic disc securely for placement into an intervertebral disc space and quickly releases the disc within the disc space at a desired position between the vertebral bodies. The quick release is facilitated by providing the instrument with an ejector which helps disengage the prosthetic disc from the instrument.
[0035] One example of an intervertebral prosthetic disc for insertion between adjacent vertebrae includes an upper plate, a lower plate and a core between the upper and lower plates, such as the prosthetic discs described in U.S. Pat. Nos. 8,808,384 and 10,206,785, which are incorporated herein by reference in their entirety. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core. The upper and lower plates are provided with a side groove, notch, slot, channel or other feature which can be grasped by the placement instrument.
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[0037] A prosthetic disc ejector 30 on the distal end of the instrument shaft 12 moves distally with respect to the pair of grasping jaws 24 to contact the prosthetic disc to fully disengage the prosthetic disc from the placement instrument 10. The activation mechanism 20 includes the nut 32 used to open and close the jaws 24 and a thumb activated button 34 used to advance the ejector 30.
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[0042] When the ejector 30 is in the ejecting position shown in
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[0044] Similar to the embodiment of
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[0048] A method for inserting an intervertebral prosthetic disc with the placement instruments 10, 100 described herein involved securing the prosthetic disc to the instrument by tightening the instrument jaws, inserting the prosthetic disc to a desired location between the vertebrae, releasing the instrument jaws from the prosthetic disc, ejecting the disc from the instrument and removing the instrument from the patient. The intervertebral prosthetic disc is surgically implanted between adjacent spinal vertebrae in place of a damaged disc. Those skilled in the art will understand that the damaged disc is partially or totally removed according to known procedures and the adjacent vertebrae are forcibly separated from one another prior to inserting the prosthetic disc to provide the necessary space for insertion of the disc.
[0049] To connect the prosthetic disc securely in the placement instrument 10, 100, the tabs of the instrument jaws are seated in the upper and lower plate notches formed at the sides of the plates. The placement instrument is tightened around the disc by tightening the activation knob or other activation mechanism which may be at the proximal end of the handle or at another location on the handle. Once the prosthetic disc is loaded and tightened on the placement instrument the disc is inserted between the vertebral bodies with the patient lying flat on the operating table and the instrument straight up and down, perpendicular to the body. If the prosthetic disc includes fins or teeth requiring slots to be cut in the vertebral bodies, the disc is inserted with the fins or teeth aligned with the precut slots. Using lateral imaging and a mallet to tap the distal end of the placement instrument, the prosthetic disc is inserted into the space between vertebral bodies until the upper and lower plates are at or within about 1 mm of the posterior margin of the vertebral bodies. When the prosthetic disc is in the proper position as verified by X-ray or fluoroscopic imaging, the placement instrument is removed by activation of the activation mechanism. In one embodiment, the activation nut is rotated counter-clockwise until the upper and lower plates are released by the jaws. If the placement instrument is loose after releasing the jaws, the instrument can be removed. Slight side to side motion can be used to remove the instrument. However, if the instrument is not easily removed, the ejector is activated to press the implant off of the instrument. Preferably, the activation mechanism for the ejector is manually activated without the need for a mallet. The ejector in the ejecting position shown in
[0050] In another version of a method for placement of a prosthetic disc, the placement instrument is tightened around the disc in the manner described above. Once the prosthetic disc is loaded and tightened on the placement instrument the disc is inserted between the vertebral bodies with the fins or teeth aligned with the precut slots. Using lateral imaging and a mallet to tap the distal end of the placement instrument, the prosthetic disc is inserted into the space between vertebral bodies until the disc is about half way into the space as viewed on lateral fluoroscopy, just past 50% of the anterior/posterior depth or until the jaws come into contact with the vertebral body. When the prosthetic disc is in the proper position as verified by X-ray or fluoroscopic imaging, the placement instrument is removed. The ejector in the ejecting position shown in
[0051] The activation mechanisms used for both the jaws and the ejectors in each of the embodiments of the placement instrument can include any of the known handle mounted activator mechanisms for instruments including one or more rotatable knobs, movable levers or other known mechanisms.
[0052] The prosthetic disc can be inserted laterally, from an anterior side, or from a posterior or posterior/lateral side of the patient's spine. In the embodiment shown, the disc is designed for insertion anteriorly into an intervertebral space. Although the disc has been described herein as inserted anteriorly and is shown in a size appropriate for the cervical spine, the system can be modified to accommodate other locations in the spine, such as the lumbar spine, and other implantation approaches.
[0053] Occasionally an implanted intervertebral prosthetic disc needs to be surgically removed from a patient. Currently intervertebral prosthetic discs are removed with a variety of different instruments and techniques. Often disc removal surgery involves removing each plate from the vertebrae separately. One challenge with this known technique is that the plates are difficult to remove without significantly distracting the vertebrae. Excessive distraction of the vertebra is undesirable because of the stretching and damage to the adjacent ligaments and structures. The plates are much easier to remove from the vertebrae and distraction is minimized if the core is first removed from between the plates. A core removal instrument 300 is shown in
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[0055] The arms 302, 304 of the core removal tool 300 are connected to an inner shaft 306 of the core removal tool 300 which slides within an outer shaft 308. Any known activation mechanism can be used to move the inner and outer shafts with respect to one another including knobs, levers, cams, ratchets or the like. Distal motion of the inner shaft 306 within the outer shaft 308 to the position shown in
[0056] In an alternative embodiment, the core removal tool arms and distraction wedge can be separate members which move with respect to one another and can be activated sequentially or simultaneously to grasp the core and separate the plates. In one embodiment, the core removal tool sequentially allows the surgeon to grasp the core, distract the plates and then pull out the core from between the plates. The pulling of the core out from between the plates can be performed by an activation mechanism of the handle or manually by the surgeon with the core grasped by the core removal tool arms.
[0057] Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the invention disclosure.