Patent ID: 12232971

DETAILED DESCRIPTION

Referring now to the figures, there is shown inFIG.1a side, perspective view of the physical guidance device10of the present disclosure.FIG.2shows top, perspective view of physical guidance device10. As described herein, physical guidance device10includes an upper portion12, with, in some embodiments, indicia or markings13thereon, a platform or lower portion14, and a plurality of legs16extending downward from platform14. Upper portion12forms a cylindrical shape with an aperture18therein. Aperture18is sized to receive and guide a bone removal instrument, as described herein. Although not shown inFIGS.1and2, aperture18can be advantageously angled in order to allow guidance device10to receive a bone removal instrument and guide the instrument at an angle either partially or completely through the vertebral body. As explained in further detail below, the ability to assist a surgeon in guiding the bone removal instrument through (or partially through) the vertebral body at one or more angles is invaluable in surgical procedures.

FIGS.1and2show one embodiment where physical guidance device10has an irregular outer perimeter. The shape of the outer perimeter of physical guidance device10can be designed to receive a handle, which, as discussed herein, can be used to grip and hold physical guidance device10and apply downward pressure or other holding functions. It is within the scope of the present disclosure to provide a physical guidance device10with various types of dimensions, outer circumferential shapes and contours, to accommodate differently sized bone removal instruments, and/or differently shaped handles.

In some embodiments, the markings13on the visible portion of upper portion12of guidance device10represent indicia to give the surgeon additional flexible guidance if the surgeon decides to, for example, shift guidance device10in one direction or another (e.g., up, down, side to side) thus altering the path the bone removal instrument will follow. As guidance device10itself cannot be changed intraoperatively, the angle can be adjusted by shifting the position of guidance device10per indicia13. Thus, indicia13provides additional guidance for the surgeon before, and/or during the removal of bone from the vertebra.

FIGS.3and4show physical guidance device10of the present disclosure and anterior and posterior views, respectively of the cervical vertebra20with angled void26extending partially through cervical vertebra20. As described herein, physical guidance device10is used to assist a surgeon in guiding a bone removal instrument within a void26created in the vertebral body of a cervical vertebra which is a central portion24of cervical vertebra20between the two endplates22of the cervical vertebra20. In this embodiment, void26extends partially through center portion24of cervical vertebra20. In other embodiments, void26extends completely through center portion24. As described herein, a vertebral body replacement device may be placed within void26and between endplates22. In one embodiment, the vertebral body replacement device has been given a PLR product code from the FDA.

As shown inFIGS.3and4, the angled aperture18of guidance device10has created an angled void26partially through vertebral body20. Thus,FIGS.3and4show the results of guidance device10and an angled aperture18of guidance device10used to direct the angle of the bone removal instrument in order to create an angled void26within cervical vertebra20.

FIG.5is a top view of the physical guidance device10of the present disclosure and an anterior perspective view of the cervical vertebra20with an alternately angled void26partially through the cervical vertebra20. As can be seen inFIG.5, the void26is angled in a different orientation than the void26shown inFIG.3. Thus, physical guidance device10can be used by the surgeon to assist in inserting the bone removal instrument in the cervical vertebra20in any variety of different angles, orientations, and depths.

FIG.6shows physical guidance device10with an angled aperture18and a posterior view of cervical vertebra20showing the angle of void26that was created by the bone removal instrument with the use of guidance device10.

FIG.7is a perspective view of a handle28, which in some embodiments may be used with physical guidance device10, as described herein. In one embodiment, handle28a detachable handle separate from physical guidance device10. Handle28is used to hold the physical guidance device10and apply downward pressure or other holding functions.

FIG.8is an axial perspective view of physical guidance device10being used to guide a bone removal instrument30within the void26in cervical vertebra20. In this embodiment, handle28is used to assist the guidance process. As explained herein, the performance of a partial vertebrectomy procedure requires a complex range of angles, single and compound, and depth and length characteristics for the surgeon to consider, which generally depends on the pathologies that are addressed by the partial vertebrectomy procedure. Advantageously, and as can be seen inFIG.8(andFIG.10), the aperture18(not labeled) of guidance device10is sized to allow bone removal instrument to be angled during the partial vertebrectomy procedure. Depending upon the angle needed to perform the procedure, the surgeon can select one of a series of guidance devices10, each with its own uniquely sized and/or angled aperture18to properly guide bone removal instrument30. The guidance device10of the present disclosure is not limited to allowing bone removal instrument30to be inserted within the guide10and in cervical vertebra20at only the angle shown inFIG.8. Depending upon the size and dimensions of guidance device10and its aperture18, bone removal instrument30may be guided to enter cervical vertebra20with the assistance of guidance device10at virtually any angle. Throughout this disclosure, the various exemplary angles that are discussed are defined as angles with respect to the vertical dashed line shown inFIGS.8-11.

FIG.9is an axial perspective view of physical guidance device10being used to guide a bone removal instrument30part of the way through the void26in cervical vertebra20. In this embodiment, handle28is not being used in the guidance process. In bothFIG.8andFIG.9, void26(not labeled) only extends partially through cervical vertebra20.

FIG.10is an axial view of physical guidance device10and a bone removal instrument30inserted at an angle within the void26(not labeled) within cervical vertebra20. Again, the angle taken by bone removal instrument30shown inFIG.10is exemplary only. The surgeon is free to use one or more guidance devices10from a series of guidance devices10to assist in the surgical procedure depending upon a variety of factors explained herein. Again, in this embodiment, the void extending only partially within the cervical vertebra20.

FIG.11is an axial view of physical guidance device10and a bone removal instrument30inserted within the void in cervical vertebra20. Again, physical guidance device10allows bone removal instrument30to be inserted within the void at various angles depending on the guide selected, including the exemplary angle shown inFIG.11. In this embodiment, the void26extends completely through cervical vertebra20, thus allowing bone removal instrument30to extend through and out the bottom of cervical vertebra20.

FIG.12is an anterior view of cervical vertebra20showing different pathways that can be achieved by using a selection of guidance devices10.FIG.13shows a posterior view of the cervical vertebra20with the different pathways into vertebral body20achieved by using a selection of guidance devices10. The dark ring inFIG.12shows an exemplary starting point on the front of cervical vertebra20for all the voids26.FIG.13shows the terminus of each of the channels, i.e. voids26. Thus, although the starting point is represented by the dark circle, the terminus of each of these voids26need not pass all the way through cervical vertebra20and can pass through at various angles, at the surgeon's discretion.

In use, the surgeon could create a single angle or a compound angle within cervical vertebra20with just a single pass through guidance device10. This is because, in one embodiment, when manufactured, aperture18in guidance device10can be drilled as either a single angle or a compound angle. Thus, in use, the surgeon places guidance device10on the front of cervical vertebra20, passes bone removal tool instrument30through aperture18and the void26is created at the surgeon's desired angle in one pass. The surgeon need only choose the depth of void26and decide whether to pass the bone removal instrument30either part way into cervical vertebra20or through cervical vertebra20.

FIGS.14and15represent a top view of physical guidance device10showing indicia or markings13. As shown inFIG.14, guidance device10has an aperture18at a particular internal angle. Each guidance device10can have an aperture with a particular internal angle to assist the surgeon insert the bone removal instrument at a particular angle in cervical vertebra20.

It should noted that the arrangement of indicia13shown in these figures as well asFIGS.1and2are exemplary only. Different arrangements of indicia13can be used. The primary goal of these markings13on the upper portion12, i.e., visible portion of guidance device10is to give the surgeon a reference point to better enable the surgeon to use guidance device10during the operative process.

FIGS.16-19represent side views of a series of physical guidance device10, each with varying height profiles. For example,FIG.16shows guidance device10with a relatively short profile, for example, 6 millimeters or less. InFIG.17, the height profile of guidance device10is higher than the device10shown inFIG.16. Here, the height profile could be, for example, 10 millimeters or less.FIG.18shows guidance device10with a height profile of, for example, 15 millimeters or less, andFIG.19a guidance device10with a height profile of, for example, 20 millimeters or less. As seen inFIGS.16-19, the differences in height profiles could be due to, for example, an increase in height and dimensions of upper portion12of guidance device10(i.e., the guidance device10shown inFIG.17), an increase in the height and dimensions of platform14(i.e., the guidance device10shown inFIG.18), or an increase in the height and dimensions of support legs16(i.e., the guidance device10shown inFIG.19). The height profiles and dimensions listed above for each guidance device10are exemplary only and other height profiles may be used.

FIG.20shows a front perspective view of vertebral body20with an implant32inserted therein within void26. Implant32is discussed in further detail below. The use of an implant32is optional and is upon the surgeon's discretion.

Disclosed herein is a method of reducing excess bone removal and reducing time in the operating room while improving surgical accuracy and patient outcomes in the performance of a partial vertebrectomy procedure. This disclosure presents an inventive method of planning and performing a partial vertebrectomy procedure and this disclosure includes the necessary device or devices to perform the method. In an anterior cervical spinal surgical procedure called a partial vertebrectomy procedure, a portion of the vertebra must be removed. Prior to this disclosure, when performing a partial vertebrectomy procedure, which is a clearly defined and well understood procedure by those skilled in the art of cervical spine surgery, the surgeon begins by removing an intervertebral disc and then bone until the location of the pathologic bone or tissue is reached. This means that in comparison to the method disclosed in this application, in the cases performed by the current traditional approach, the direction to the pathologic bone or tissue will be indirect. The word “indirect” in this case means, for example, that if the single focal surgical target the surgeon has in mind is in the middle of the vertebral body20, in accordance with this disclosure, the removal of the intervertebral disc and the vertebral endplate22and one half of the vertebral body20is unnecessary since this is removed only for access to the middle of the vertebral body20. In light of inventive method disclosed herein, this would be considered excess bone and tissue removal, not to mention time consuming, since the surgeon is working in direct proximity to the spinal cord. Consequently, this excess bone and tissue removal is not without risk. If the target is in in the center of the vertebral body20, removing disc tissue, a vertebral endplate22and bone purely for access to the center of the vertebral body20increases the risk to the patient and decreases the benefit to the patient as well as increasing pain and recovery time. Prior to this disclosure, there has been no alternative.

The methods disclosed in this application describe, in one embodiment, a method of preoperative planning, a surgical method and a physical guidance device10, or depending on surgeon preference, a series of guidance devices10to choose from, in order to make a more direct approach through or into a cervical vertebra20towards a surgical target within, upon, or in proximity to, the subject cervical vertebra20.

In one embodiment, the guidance devices10of the present disclosure are single-use and/or disposable guidance devices10.

In another embodiment, the guidance devices10of the present disclosure are custom made, i.e., made-to-order guidance devices.

In another embodiment, the guidance devices10of the present disclosure are prescription devices, i.e., a prescription is required to purchases the guidance devices10.

As will become apparent in the detailed description of this inventive method of performing a partial vertebrectomy procedure, this procedure attempts to, in addition to minimized bone, endplate, and disc removal, also minimize or avoid altogether the retraction of delicate soft tissues such as the longus colli muscles. Retraction of the longus colli muscles is performed routinely and without much consideration, as current surgical methods do not provide an alternative prior to this disclosure.

The methods of this disclosure allow a surgeon to avoid the need to perform the excess bone, endplate and disc removal that requires the use of a cervical plate and fusion when avoiding this is determined by the surgeon to be in the patient's best interest. While those schooled in the art of anterior cervical spine surgery take the placement of an anterior cervical plate for granted, a reading of the steps involved in the placing of the plate reveals a time-consuming procedure that is not without short- and long-term risk to the patient. The drilling of screw holes and the plating procedure has been going on for a long period of time and it has become a natural and necessary step in anterior cervical spine surgery. But in view of the methods and devices of this disclosure, it no longer has to be.

The following will illustrate several use-cases of the methods and apparatuses of the present disclosure.

In accordance with one embodiment, the method of the present disclosure will typically begin with an image study (CT scan, MRI Scan, X-Rays, or any combination of these). The combined image studies are analyzed by a skilled radiologist and a qualified orthopedic or neuro-spine surgeon skilled and trained in anterior cervical spine surgery. The surgeon will then compare the symptoms disclosed by the patient to what is revealed in the image studies and the radiologist's report.

In this embodiment, we will use, as an example, a small abnormal bone growth called osteophyte which is a bony excrescence (any abnormal growth from the surface of a part) or outgrowth of bone. The osteophyte, in this example, is compressing the neural anatomy and causing the patient to suffer pain and weakness in the extremities. In accordance with the methods and apparatuses in this disclosure, instead of planning to automatically remove an intervertebral disc, vertebral endplates22, and a large portion of the vertebra20, the surgeon will as part of the preoperative planning of the present disclosure to minimize excess bone removal, the surgeon will use a surgical planning software to measure the angles or angulation from the point of entry to the desired ultimate point of contact with the surgical target. With this method, the surgeon may prefer use a template or a simple manual instrument to measure the distance and the angle of the surgical target, the osteophyte in this case, in relation to a point on the front of the vertebral body selected for entry.

At this point, using the software or a static image, the surgeon will track or map out the point of the pathology, the osteophyte, and to the ideal point on the vertebral body20in which the surgeon could enter the vertebral body20. With the angles noted, the surgeon measures the distance from the clinically ideal entry point to the point of contact to the osteophyte (target). In this example, we will say the distance is approximately 15 millimeters. Next, the surgeon measures the angle of the most clinically ideal entry point upon the vertebral body20and trace it back to the osteophyte. At this point, the surgeon will closely assess the angle of the chosen approach path. In this example, we will say the angle is 14 degrees. In some cases, it may very well be a compound angle but for this example we will say a simple 14-degree approach with a depth of 15 millimeters is ideal.

Disclosed herein is a physical guidance device10. In this disclosure, a physical guidance device10is differentiated from an image guided device. An image guidance device is a method of guidance using one or more computers and one or more images obtained by radiological methods, i.e., X-Ray, MRI, CT, etc., and merging such image or images onto one or more computer screens with a computer-generated image of an instrument or an implant. When the radiologic images are merged together with a computer-guided image of an instrument or an implant which is tracked in the operating room by computers and/or camera arrays, the combined images can be used as a method of guidance for a surgeon.

In one preferred embodiment disclosed herein, physical guidance device10is provided wherein the surgeon relies upon the physical guidance device10to direct the pathway of the bone removal instrument30. In this embodiment, the surgeon may use intraoperative radiological methods such as an X-Ray to confirm or follow bone removal instrument30but this is following the physical bone removal instrument30and not a virtual image generated solely by a computer array tracking the instrument.

Physical guidance device10of the present disclosure physically guides bone removal instrument30along a direction selected by the surgeon for the surgery. The surgeon may use or may not use a form of intraoperative radiology such as X-Ray to follow the progress of the bone removal instrument30but with or without X-Ray imaging, physically guiding a bone removal instrument30is distinctly different than utilizing a virtual computer-based image guidance system. While the physical guidance device10of the present disclosure is not connected directly to a computer or any type of guidance system, a surgeon may be free to provide a separate bone removal tool that may or may not be connected to other virtual guidance systems.

In this example, the surgeon uses guidance device10that has, for example, a 14-degree guide angle in the direction the surgeon has requested from his pre-operative analysis and planning. Furthermore, the surgeon will request a bone-removal instrument30dimensionally compatible with this guidance device10, for example, a trephine, or another bone removal tool which may or may not be associated with this guidance device10. In the present example, the surgeon will set a depth for the bone removal tool of, for example, 15 millimeters. The surgeon will then place the selected guidance device10upon the anterior facing surface or anterolateral surface of the vertebral body. The guidance device10provides a direct line of direction and guidance of depth for the removal of bone, i.e., the partial vertebrectomy procedure.

At this point, the surgeon will use a bone removal instrument30, and with the aid of guidance device10and the bone removal instrument30selected by the surgeon, the surgeon will pass into the vertebral body20from the point of entry selected during the pre-operative planning stage and continue on into the vertebral body20removing bone and therefore performing the partial vertebrectomy procedure as the bone removal tool passes into the vertebral body20toward the surgeon's target.

When the surgeon's bone removal tool arrives at the selected target, the partial vertebrectomy procedure has been performed. If, at this point, the partial vertebrectomy procedure itself has not completely removed the surgical target, i.e., in this example, the osteophyte, the surgeon may remove any remaining osteophyte and begin to conclude the surgery at this time. The surgeon may decide to use an implant32or not to use an implant32depending upon the surgeon's determination of the patient's bone quality and of the state of the vertebral body20at the end of the bone-removing partial vertebrectomy procedure. Regarding the depth of the partial vertebrectomy procedure or the targeted pathology, the surgeon may pass all way through the vertebral body20if necessary or stop before passing through the vertebral body20. These decisions are made at the surgeon's discretion as to what is in the patient's best interest and what increases the benefit of the procedure to the patient and what reduces risk to the patient. The result in the example above is that the partial vertebrectomy procedure was performed by the surgeon with directional precision only removing a portion of bone in the smallest diameter required by the pathologic surgical target as determined by the surgeon. The intervertebral disc and end plates22and the rest of the vertebral body20remain intact.

In another example, a surgical target prompting the performance of the partial vertebrectomy procedure may be one of the other pathologies listed in the indications for use for a partial vertebrectomy procedure where the surgical target may be located within or near the center of the vertebral body20. In this case, the surgeon would ideally preoperatively plan the trajectory into the vertebral body20beginning at the anterior or anterolateral starting point with a bone removal plan intended to stop in the center or near-center of the vertebral body20.

Instead of automatically removing the intervertebral disc and then beginning to remove bone by necessarily beginning at the top or bottom of the vertebral body20where an intervertebral disc has been removed, the method and device of this disclosure allows the surgeon, when beneficial to the patient, to begin and complete bone removal using the shortest pathway possible from outside the vertebral body20and into the vertebral body20and halting at the point in which the surgical target has been removed. This would include a surgical target within and/or without the subject vertebral body20.

When the method and device of this disclosure are used in the performance of a partial vertebrectomy procedure, the result is that the minimum amount of bone will be removed, the minimum amount of retraction of soft tissue will be used, and the minimum amount of time will be required and, in many cases, the intervertebral discs and the vertebral endplates22will be functionally preserved. This result is a partial vertebrectomy procedure that does not begin with the removal of intervertebral disc and end plate22. This method will permit the surgeon to preserve the functional aspects of the intervertebral discs and the vertebral endplates22even if a small amount of disc and/or endplate22are removed or manipulated. Leaving the intervertebral discs and vertebral endplates22functionally intact will reduce patient recovery time and preserve motion for the patient's spinal segment.

By utilizing the present disclosure, a partial vertebrectomy procedure may be performed with greater accuracy, which will reduce unnecessary bone removal and limit bone removal to the surgeon's determination as to what is in the patient's best interest. What is described herein is a method of performing a procedure called a partial vertebrectomy procedure that creates a bone removal procedure directed toward a patient's particular need. Therefore, unlike following a manufacture's recommendation for ideal application and use of an implant32, the surgeon will be following a patient's clinical needs and the amount of bone removed and the direction of removal will be based upon the surgeon's determination of the patient's need and best interest. This means the surgeon will use this method to remove a widely varying amount of bone and using supplied disclosed devices which will provide the surgeon guidance with a number of different angles of approach to the surgical target.

In the example above of the surgeon desiring to reach a pathological target at the center of the vertebral body20, during the planning phase, the surgeon will have a variety of image options available from many different sources such as CT scan, MRI, etc., to review two-dimensional or computer-generated three-dimensional images of the cervical vertebral body20the surgeon wants to enter. The surgeon will select the preferred or ideal point of entry and measure the distance to the target which will be the termination point, in this case example, the center of the vertebral body20. The surgeon will also measure the angle or compound angles from the entry point to the termination point. By carefully studying the entry point and the termination point, the surgeon will be able to determine the precise distance to be traveled and the single angle or compound angle to follow to arrive at the targeted point. The surgeon will select guidance device10of this disclosure that matches or most closely matches the angle the surgeon determined was optimal for the patient's partial vertebrectomy procedure. It is intended that the surgeon will chose from a variety of guidance devices10, where the guidance devices10may include single angles, compound angles, or no angles. Surgeons have personal preferences that must be respected and patients have widely varying anatomy and pathologies. For this purpose, it is intended that a wide variety of guidance devices10will be provided in a series to match the needs of both patient and surgeon. Some guidance devices10will be simple whereas others may be complex and include computer assisted image guidance with images updated intraoperatively as the complex procedure progresses. This disclosure anticipates custom guidance devices10being made for patients where the surgeon determines a custom guidance device10would provide a benefit to the patient undergoing a partial vertebrectomy procedure.

The present disclosure introduces guidance devices10and methods of use to be used for partial vertebrectomy procedures upon the anterior cervical spine. The guidance devices10disclosed herein may be pre-configured, or pre-configured in a series, may include electronics with or without computer/software capabilities, and/or may be mechanical.

Some partial vertebrectomy procedures are rather straight forward while other partial vertebrectomy procedures are more complex. The intent of the present disclosure is to provide guidance devices10and uses of these guidance devices10to suit the preferences of the surgeon as well as the needs of each patient. The disclosed method of providing guidance devices10and methods of use to the partial vertebrectomy procedure will allow this otherwise ignored procedure to enter into the family of procedures that are considered minimally disruptive and/or minimally invasive. Providing the disclosed guidance method will permit a surgeon to customize the pathway to the patient's pathology by pre-operative analysis revealing the most direct or otherwise least disruptive pathway to the patient's surgical target. This is in contrast to the partial vertebrectomy of today that follows the routine of first removing the intervertebral disc, then removing the vertebral endplate22, and then systematically removing portions of the vertebral body20until the surgical target is reached. Having a guidance device10and a guidance methodology that provides a trajectory directly to the surgical target through the shortest path will reduce excess bone, vertebral endplate22, and disc removal and will speed up patient recovery along with the surgery itself.

In another exemplary use case, the surgeon has a target internal to the vertebral body20, posterior and lateral to the center, and the surgeon has decided that an ideal point of entry into the vertebral body20is centered on the front of the vertebral body20. To perform the partial vertebrectomy with minimal bone removal by using this disclosed method, the most direct access might be achieved be by using a guide set at, for example, a primary angle of approximately 17 degrees and a secondary angle of approximately 8 degrees (i.e., 17°×8°) and to a depth of 13 mm). After the performance of the exemplary partial vertebrectomy procedure within the vertebral body20, the surgeon determines whether or not to place implant32into the space created by the removal of bone, i.e., the partial vertebrectomy procedure. This determination made by the surgeon depends on numerous factors such as, for example, bone quality, volume of removed bone, pathology of the target, presence of or risk of infection, among others. If a surgeon is to perform a partial vertebrectomy procedure within a cervical spine, the surgeon may have many options for implant sizes etc., but any implant32placed during a partial vertebrectomy procedure within a cervical spine must necessarily include a PLR product code from the FDA. This means the implant32has been disclosed, tested, and validated as a partial vertebrectomy procedure implant called a Partial Vertebral Body Replacement Device. If implant32does not have a PLR product code from the FDA this necessarily means the device is not a Partial Vertebral Body Replacement Device. It may be many other things but it is not a vertebral body replacement device for placement during the performance of a partial vertebrectomy of a vertebral body20resected or excised for the treatment of tumors, trauma/fracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

The present disclosure relates to guidance devices10and methods that are used for a specific procedure, namely a partial vertebrectomy procedure performed upon an anterior cervical spine. The performance of a partial vertebrectomy procedure will require a complex range of angles, single and compound, and depth/length characteristics specific to the variety of pathologies that are addressed by a partial vertebrectomy procedure. As the method of guidance and the guidance devices10disclosed herein are not paired to a specific implant32or set of implants32, the range of guidance devices10must necessarily be matched to the variety of pathologies that exist in the cervical spine that can be treated by the performance of an anterior cervical partial vertebrectomy procedure. This includes requiring a variety of dimensions such as diameters, widths and heights, in addition to the angles, compound angles, trajectories, and lengths/depths to address the needs a surgeon may have when performing an anterior cervical partial vertebrectomy procedure. As disclosed previously, the range of pathologies that may be addressed by a partial vertebrectomy procedure and the methods of performing such procedure may include, per the FDA, as described in the indications for use of the partial vertebrectomy procedure vertebral body replacement device, partial vertebrectomy of a vertebral body20resected or excised for the treatment of tumors, or trauma/fracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

It is understood why an anterior cervical partial vertebrectomy guidance device10has not previously been made available. Guidance devices usually require the attachment of reference devices, or possibly an implantable device in order to function as a reference device, in proximity or upon the area of anatomy requiring guiding reference. The disclosed guidance device10and its method of use can be performed with or without reference devices, while providing guidance to perform the bone removal procedure described as a Partial Vertebrectomy Procedure.

The method and guidance device10of the present disclosure provides benefits such as but not limited to, a reduction in operating time, a reduction in the retraction of the delicate soft tissues anterior to the anterior cervical spine, and a greater accuracy in targeting. Greater accuracy in targeting and therefore accuracy in locating and intraoperatively reaching the pathology that created the need for surgery in the first place allows for a very important reduction in unnecessary bone removal.

In another exemplary use embodiment, a surgical target that the surgeon must access is off the center of a vertebral body20of a cervical spine. Prior to this disclosure, using previously-known methods, the surgeon would, after gaining exposure to the spine, begin by removing one of the intervertebral discs adjacent to the vertebra20and then begin removing bone from the vertebral body20by beginning at the endplate22(the hard cortical bone that makes up the top and bottom of a vertebral body, which is the vertebra's point of contact to the intervertebral disc prior to removal of said disc) and continuing removing the vertebral body20until the target is reached.

Using the method disclosed in this disclosure, the surgeon would first make an image of the patient's vertebral body20available for review. This image, depending on the type of pathology and the surgeon's preference could be an X-Ray, an MRI, a CT, or another combined image study. The location of the surgical target will be noted and the preferred entry point of what will become the starting point of a surgical direction into the vertebral body20will be selected and noted by the surgeon. This will usually be, but not always, the shortest distance to a targeted pathology within or without a vertebral body20. For clinical reasons, the surgeon may determine the best approach may be closer to the endplate22instead of the shortest distance. The point being the surgeon will choose the optimum route to the targeted pathology. Contrary to the traditional method where the default starting point is the disc and endplate22, with this disclosure the surgeon has broad new options when choosing the starting point.

In accordance with the methods disclosed herein, the surgeon will have the ability to mark out the target, the optimum entry point, and measure the distance and angle from the entry point to the target. This will now become the optimum trajectory to the pathologic target. For this example, the surgeon may desire to enter the vertebral body20just above the inferior vertebral endplate22and terminate the removal of bone directly at the target. At this point, the surgeon will determine the size and shape of the required bone removal. The actual size and shape of bone removal the surgeon creates, i.e., circular, cylindrical, squared, rectangular, etc., will vary depending upon clinical requirements of the patient and surgical preferences of the surgeon.

In this exemplary use case, the surgeon chooses a cylindrical pathway. The surgeon now has an entry point, a termination point, and a shape of the pathway needed. Next, the surgeon will determine the diameter of the pathway. For this example, the surgeon chooses an eight-millimeter (8 mm) diameter, although the surgeon can choose any diameter that best benefits the patient.

Having determined the preference is to enter close to the inferior endplate22, the surgeon will now determine where in the front of the vertebral body20, close to the endplate22will be the ideal point of entry. For this example, the surgeon finds the center of the front of the vertebral body20one millimeter (e.g., 1 mm) just above the inferior endplate22because this pathway will require the minimum of retraction of soft tissue including leaving the longus colli muscle in place, helping reduce post operative pain and discomfort which reduces post operative need for pain medications and a shortened recovery timeline.

The surgeon will then map out an approximately 8 mm cylindrical pathway from the center of the vertebral body20, beginning approximately 1 mm above the inferior endplate22to the surgical target. The surgeon then measures the distance from the entry point to the desired target within the vertebral body20. In this example, the target is within the vertebral body20and the distance from the point of entry to the target is approximately 9 millimeters. Using the method of this disclosure, the surgeon determines the pathway from the entry point at the centerline of the vertebral body20approximately 1 mm above the inferior endplate22with an approximately 8 mm diameter and will need to pass through the vertebral body20at a ten-degree (+10° degree) angle for a distance of approximately 9 mm. At this point, the surgeon will be confident that an 8 mm diameter pathway, beginning 1 mm above the inferior endplate22at the center of the vertebral body20directed at a +10° angle for a distance of 9 mm will put the surgeon directly upon the surgical target within the vertebral body20with the absolute minimum required bone removal and soft tissue retraction. Targets can be located within a vertebral body20, upon a vertebral body20as in a mass growing on a vertebral body20, or a target may be located beyond the vertebral body20. In this example, the target will is described as being at the terminus of the guided removal of bone. This means the removal of bone, i.e., the performance of the partial vertebrectomy procedure, captures the surgical target and allows the surgeon to successfully conclude the surgery and begin closing the case.

In this disclosure, a series of guidance devices10is provided to assist the surgeon in the performance of the disclosed method. The disclosed guidance devices10form part of a series of directional guidance devices10hat the surgeon can choose from to create the desired pathway. The guidance devices10can take various forms, thus allowing for variances in surgeon preference and patient-related variables.

In another example, after gaining surgical access to the anterior cervical spine, the surgeon will ask for an 8 mm diameter cutting device and a guidance device10with a +8° angle. With the +8°-angle guidance device10and the 8 mm diameter cutting device, the surgeon will cut a pathway into the vertebral body2012 mm in length from the point of entry. The surgeon will then perform the treatment upon the surgical target and then terminate the surgery.

It is possible that the surgeon determines it is in the patient's best interest to repair the surgical pathway of removed bone, in which case the surgeon would choose from a variety of PLR vertebral body replacement devices from various manufacturers, or the surgeon may determine it is in the patient's best interest not to repair the surgical pathway of removed bone and allow the bone to heal without an implant32. It is important to note that if a partial vertebrectomy procedure is performed and a manufacturer or provider of implants32wants to label the procedure and implant32as such, promote or teach the repair of the partial vertebrectomy void, the FDA requires the implant32to be officially designated a vertebral body replacement device with an official PLR product code from the FDA. For an implant manufacturer to promote or teach the use of a non-PLR implant would be in direct violation of FDA rules and requirements and laws and regulations. If implant32does not have a PLR product code from the FDA, implant32is not a vertebral body replacement device. A vertebral body replacement device is the only device that can be used for the repair of a vertebrectomy or a partial vertebrectomy.

Patient bone quality and potential for bone growth to repair the surgical bone removal void by regrowing bone varies from patient to patient and opinions and preferences vary from surgeon to surgeon. Disclosed herein is a method for carefully determining an optimum pathway to a surgical target within or around a cervical vertebral body and providing guidance devices10to aid the surgeon in performing a less destructive partial vertebrectomy procedure. The performance of such a partial vertebrectomy procedure has never been performed and is counterintuitive. The performance of a partial vertebrectomy procedure is associated with a comparably unrefined removal of bone, and bone removal only after the removal of an intervertebral disc. In this partial vertebrectomy procedure, the surgeon may choose to remove an intervertebral disc or may choose not to remove an intervertebral disc. In this partial vertebrectomy procedure the surgeon is able to determine a more precise removal of bone thus greatly reducing the amount of bone removal required and the amount of tissue retraction required in the performance of the partial vertebrectomy procedure.

Many surgeons and published clinical papers believe the retraction of the soft tissues is often the cause of one of the most common of post operative problems associated with anterior cervical spine surgery; dysphagia. Dysphagia describes the inability to swallow or difficulty in swallowing. This improved procedure and planning method of the present disclosure permits a very strategic analyzation of the amount of bone to be removed, the direction of bone removal, and how to plan bone removal to minimize soft tissue distraction during the performance of a partial vertebrectomy procedure.

It is possible and common that a surgical target of a partial vertebrectomy procedure is not in the center of a vertebral body20. Surgical targets requiring a partial vertebrectomy procedure vary considerably and may occur anywhere within or without a vertebral body20. Disclosed herein is a method that can be used for a variety of pathologies requiring the performance of a partial vertebrectomy procedure.

In the present example, the pathology rested in the vertebral body20. It is possible and even likely the pathology will not reside in the direct center of the body. If the surgical target was in the posterior third of the vertebral body20and in the right quarter of the vertebral body20, the surgeon may need a guidance device10that provides a compound angle. As this disclosure describes a selection of guidance devices10and methods to address the varying patient needs it is anticipated that a compound angle will be provided for. For example, guidance device10could be provided with a cephalad +8° angle with a right +15° angle.

It is anticipated that the performance of the partial vertebrectomy procedure may create a pathway into a vertebral body20of the cervical spine or it may create a pathway through a vertebral body20of the cervical spine. The pathway may enter the spinal canal the pathway may not enter the spinal canal. The goal of the guidance method and guidance devices10disclosed herein are to provide directional guidance to the surgeon during the performance of a partial vertebrectomy procedure in which the procedure requires the removal of bone associated with the partial vertebrectomy. This is unique as the guidance devices10provided for this procedure are not necessarily associated with an implant32to be attached to or into a vertebral body20as is the case with bone plates and associated implants32. The partial vertebrectomy procedure may be performed independent of an implanted device32, with the use of implants32left to the discretion of the surgeon and independent of the use of the guidance method and device10of this disclosure. Furthermore, this disclosure is unique in that it is applied to the partial vertebrectomy procedure and the methods of surgical planning and devices for implementing such a surgical plan are designed specifically for the partial vertebrectomy procedure and to minimize the amount of bone removal performed during the course of such a procedure. Prior to this disclosure, this method and the described guidance devices10have not been described, disclosed or used in the performance of a partial vertebrectomy procedure upon an anterior cervical vertebral body20.

To clarify and formalize the independence and uniqueness of the partial vertebrectomy procedure as being unlike other orthopedic or neurosurgical procedures, as referred to earlier, the FDA has a unique identifier code for implants32used during the performance of a partial vertebrectomy procedure. If the method and the guidance devices10of this disclosure are to be distributed and taught to be used in conjunction with an implant32because the surgeon determined an implant32would be beneficial to the patient, the provider would necessarily be required to select an implant32that carries the FDA product code PLR. If the surgeon chose a manufactured implant that did not have a PLR product code the surgeon would be using a device off label. The use of the methods and guidance devices10of this disclosure do not require the use of an implant32for the performance of a partial vertebrectomy procedure but if a partial vertebrectomy procedure is performed and repaired with an implant32provided by a manufacturer for repairing a partial vertebrectomy void, the implant must be a PLR implant32.

For the purposes of this disclosure, the term “cervical spine” follows the usual guidance of the FDA, which when referring to vertebral body replacement devices, includes the second cervical vertebra (C2) through the first vertebra of the Thoracic spine (T1). This is commonly expressed as (C2-T1) which means the second through the seventh cervical vertebrae and the first and most superior of the thoracic vertebrae. In the present disclosure, unless otherwise specified, when discussing implants or implantable devices the term “implantable device” or “device” may be used interchangeably with the terms “implant” or “medical instrument.”

The FDA defines a Vertebral Body Replacement device as:

Device—Spinal Vertebral Body Replacement device—CervicalRegulatory Description—Spinal intervertebral body fixation orthosisDefinition—Vertebral body replacement in the cervical spinePhysical State—Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.Technical Method—Provides structural support for the indicated populationTarget Area—Cervical spineProduct Code—PLR

As described herein, in order for a device to be given clearance to be used as a vertebral body replacement device in the cervical spine and receive the product code PLR from the FDA, the device has to be submitted to rigorous testing. To date, there is not a PLR predicate that has been associated with a guidance method and a guidance device10as disclosed herein and this is for fairly direct reasons.

Prior to the guidance methods and guidance devices10as disclosed herein, a vertebral body replacement device with a PLR code from the FDA has historically been associated with a broad-based bone removal procedure beginning with the intervertebral disc and vertebral endplates22. Disclosed herein is a method of preoperative planning and guidance devices10that will promote performing a minimally disruptive partial vertebrectomy procedure. The devices10and associated methods of its use disclosed herein will allow a surgeon to remove only the necessary amount of bone required to be removed and no more. While an implant32is not required to perform a partial vertebrectomy procedure an implant32may be used at a surgeon's discretion. Therefore, disclosed herein is a method of performing a partial vertebrectomy procedure upon a cervical vertebral body20during the course of performing an anterior cervical surgical procedure to a cervical spine and utilizing guidance device10to aid in the creation of the partial vertebrectomy void26. An implant32may be placed into the partial vertebrectomy void26, wherein the implant32has received a PLR code from the FDA.

With the introduction of guidance devices10to the partial vertebrectomy procedure as disclosed herein comes the ability to introduce a multi-aperture method of performing the partial vertebrectomy procedure. The introduction of the guidance devices10and methods of this disclosure allows the surgeon greater precision in the preoperative planning and performance of the surgical procedure. This can allow as surgeon to create one pathway to a pathology and an additional pathway or pathways to other pathologies or for example the introduction of additional instruments to treat one or more pathologies. A simplified example of this would be the placement of a second partial vertebrectomy void26next a first void26or directed to the terminus of the first void26. This second void26could be used for the introduction of an endoscope for greater visualization or an instrument for the treatment of the surgical target. Surgical planning as disclosed using the methods disclosed herein can allow for the introduction of one, two, or several partial vertebrectomy voids26into a cervical vertebral body20for the treatment of a pathologic tissue or a target a surgeon has determined should be removed. These singular or plural voids26may be repaired or may not be repaired, or one or more may be repaired while one of more is not repaired based upon the decision of the surgeon. The partial vertebrectomy void or voids26may be created into the vertebral body20of the cervical spine or they may be created through the vertebral body20or a combination of both.

The introduction of multiple apertures or voids26allows for separate partial vertebrectomy voids to be created. The most anterior aspect of a cervical vertebral body20is considered by many to be the area of the vertebral body20to carry the greatest loads and therefore maintaining anterior integrity can be a preference for some surgeons. Multiple apertures26created through the front of the vertebral body20could converge posteriorly creating a larger void26close to the spinal canal while having smaller voids26in the anterior portion of the vertebral body20.

Another option anticipated with this method and guidance devices10with single and compound angles would allow for more than one partial vertebrectomy void26to be created using a second angle guide using the same entry point on the front of the body20. This would maintain a greater percentage of the integrity of the anterior aspect of the vertebral body20will creating more room at the terminus of the void26, or the combined voids26. This and other methods become possible by the unique method of preoperative planning and use of the guidance devices10of this disclosure. The planning and precision gained by using guidance devices10allows for very precise creation of the partial vertebrectomy void or voids26. The placement of the entry points along with the angle and often angles of the partial vertebrectomy voids26allows for the introduction of new options for the surgeons.

This disclosure also introduces a new type of guidance device10for use in the anterior cervical spine for the performance of the partial vertebrectomy procedure. In one embodiment, guidance device10has lower profiles with single angle and in other embodiments, compound angles. These may be provided in a series of guide devices10with a selection of guide devices10for the surgeon to choose from based upon the surgeons preoperative planning associated with the performance of the disclosed partial vertebrectomy procedure. In one embodiment, it is anticipated that a unique detachable handle28as shown inFIG.7may be provided where the handle28is separate from the guidance device10and the guidance function is uniquely performed within the guidance device10separate from the handle28. If handle28is used, it is used to hold the separate guidance device10and apply downward pressure or other holding functions. In one embodiment, guidance device10may contain a single angle or compound angles wherein the guidance device10has a profile of height that is less than twenty millimeters, a profile of height that is less than fifteen millimeters, a profile of height that is less than ten millimeters, and a profile of height that is less than six millimeters.

The handle28used with guidance device10is a separate instrument that may or may not be used at the surgeon's discretion. This is because different than other directional bone drill guide devices for use in bone related surgery, the angle of direction is performed or directed within the instrument itself. Thus, the outside dimensions of the guidance device10including the angles and outside features of the device10remain unchanged as does the angle if placement upon the bone. The internal aspect of the guidance device10contains the angle or angles. This allows for lower profiles of height than is typically used in a bone application, particularly the anterior cervical spine. This also allows for handle28to be in some embodiments attached, and in some embodiments not attached to guidance devices10with significantly different angle presentations because the angles are internal to the guidance device10and the external dimensions of this embodiment remain constant.

This also allows for custom angles to be requested by a surgeon. The guide blanks may be mass produced with all the devices10carrying the same external dimensional characteristics with the internal guidance angle or angles placed into the guide device10as requested by a surgeon for a patient need. In one example, a circular guidance device10may be provides with an outside diameter of approximately fourteen millimeters and a profile of height of just over six millimeters. This provides an internal area in which to place the angle or angles for the bone removal instrument30to follow as the partial vertebrectomy procedure is performed.

Ideally, care is given to minimize the size of the incision and exposure created to access the anterior cervical spine in addition to limiting the retraction of the soft tissues during the anterior cervical spine surgery. For this reason, a range of low-profile and/or low-mass and/or low-bulk guidance devices10for use in performing a partial vertebrectomy procedure are herein disclosed. As different patients have different needs and different surgeons have different preferences, a series of more than one guidance device10having differing angles and differing height profiles is herein disclosed. Some surgeons will prefer a low-mass or low-profile guidance device10in order to avoid disrupting adjacent tissues or obstructing clear visualization for example. Therefore, it is anticipated and disclosed herein that the guidance device10of this embodiment may be presented as part of a series of guidance devices10which may provide a range of directional angles and may contain a range of different height profiles.

Disclosed herein, in one embodiment, is a guidance device10for use in the performance of a partial vertebrectomy of a cervical vertebra during the performance an anterior cervical spinal surgical procedure, wherein the guidance device10has a height profile of less than 20 millimeters. A height profile for the purpose of this disclosure is defined as the measurement of the guidance device10from the underside of the guidance device10which is placed upon the cervical vertebral body20to the highest point of height of the guidance device10.

Also disclosed herein, in one embodiment, is a guidance device10for use in the performance of a partial vertebrectomy of a cervical vertebra20during the performance an anterior cervical spinal surgical procedure wherein the guidance device20has height profile of less than 15 millimeters.

Also disclosed herein, in one embodiment, is a guidance device10for use in the performance of a partial vertebrectomy of a cervical vertebra20during the performance an anterior cervical spinal surgical procedure wherein the guidance device10has height profile of less than 10 millimeters.

Also disclosed herein, in one embodiment, is a guidance device10for use in the performance of a partial vertebrectomy of a cervical vertebra20during the performance an anterior cervical spinal surgical procedure wherein the guidance device10has height profile of less than 6 millimeters.

Disclosed herein, in one embodiment, is a series of guidance devices10for use in the performance of a partial vertebrectomy of a cervical vertebra20during the performance an anterior cervical spinal surgical procedure where the guidance devices10provided in the series of guidance devices10can offer a range of variations including various angles and/or height profiles. The surgeon is able to select one or more guidance devices10from the series of guidance devices10provided in this disclosure.

In another embodiment, a handle28used to aid in the holding and placing of the guidance device10is disclosed, wherein the handle28may be a separate instrument and removable from the guidance device10.

Operatively, it is clear to the surgeon when a partial vertebrectomy procedure will be or has been performed. The FDA also provides guidance by providing indications as to when a PLR implant may be cleared to be used, as PLR implants are indicated only to be used during the performance of a partial or complete vertebrectomy. For example, according to the typical FDA guidance for the use of a PLR device which would mean for a partial or complete corpectomy, the indications would include a vertebral body20resected or excised for the treatment of tumors, or trauma/fracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. This is guidance which manufacturers of implants are required to follow and surgeons are very strongly encouraged to follow.

When a surgeon schedules a surgical case, the surgeon will define the case. For example, if a surgeon schedules the case as a partial vertebrectomy, the surgeon will inform the hospital so the hospital can prepare the room and instruments along with adequate time for a partial vertebrectomy. Furthermore, the surgeon and the hospital will preoperatively notify and gain clearance or authorization with which ever organization is paying for the surgery, an insurance company or Medicare for examples. It is possible and not altogether uncommon that a surgeon starts out intending to perform a lesser or smaller procedure than a partial vertebrectomy, but upon conducting the surgical procedure the surgeon may find that a broader procedure such as a partial vertebrectomy is required in order to properly and completely address the patient's condition successfully. When this is the case, the surgeon will, upon completion of the surgical procedure, dictate detailed notes on the surgical case including declaring, defining, and describing the case as a partial or possible a complete vertebrectomy including the use of a PLR implant if one was used. The surgeon's declaration of the surgery being a partial or a complete corpectomy is authoritative as this information will also be reviewed by the hospital and the insurance provider etc., and is formally recorded and officially documented. It is therefore known that when a partial vertebrectomy has been performed and when such a procedure has been performed, the surgeon will formally and, on the record, describe and define the case as a partial vertebrectomy.

The use of the disclosed guidance device10for a partial vertebrectomy procedure with the disclosed features will permit the surgery to be completed with less unnecessary bone removal and preservation of the functionality of the vertebral endplates22of the subject vertebral body20and the functionality of the adjacent intervertebral discs. This provides a direct benefit to the patient.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.