The present invention relates generally to orthopedic implants used for correction of spinal injuries or deformities, and more specifically, but not exclusively, to holding apparatus, systems and methods for preparing spinal implants for insertion into a patient.
In the field of spinal surgery, it is known to place implants into vertebrae for a number of reasons, including (a) to correct an abnormal curvature of the spine, including a scoliotic curvature, (b) to maintain appropriate spacing and provide support to broken or otherwise injured vertebrae, and (c) to perform other therapies on the spinal column.
Some treatments involve the removal of a disk, distraction of the disk space, and the insertion of an interbody device between two adjacent vertebrae. In some cases, it may be desirable to load the interbody device with bone or other material to promote bony ingrowth or fusion. To do so, the surgeon often must remove the implant from its sterile packaging, find a flat, sterile surface on which to place the implant, and thereafter pack the implant with the desired material, all while trying to keep the implant from sliding around or falling to the floor. Improvements are desired.
The present invention provides spinal implant systems, apparatus, and methods of use. In one embodiment, an apparatus for holding an implantable spinal device according to the present invention includes a base having a generally flat first surface and a second surface spaced apart from the first surface to define a base thickness. The base has a third surface between the first and second surfaces and generally orthogonal to at least one of the first and second surfaces. The base further includes a fourth surface spaced apart from the third surface. At least one cavity is provided in the base, with the cavity being accessible through the base second and fourth surfaces, and adapted to receive the implantable spinal device. In some embodiments, the spinal implant has an opening accessible through the fourth surface when the spinal device is positioned in the cavity. In this manner, bony growth-promoting substances may be inserted into the implant when the implant is positioned in the apparatus.
In one aspect, the third surface is generally orthogonal to both the first and second surfaces. In another aspect, the base includes at least three spaced apart cavities, with each of the cavities accessible through the second and fourth surfaces, and inaccessible through the first and third surfaces. In alternative embodiments, at least two of the three cavities have a different size, a different width, and/or a different depth. Further, the cavity may have a shape which is adapted to frictionally engage the implantable spinal device. In still another aspect, the cavity further includes a lip extending over a portion of the cavity and generally aligned with the second surface. The lip may, for example, operate to help maintain the implant in the cavity.
The present invention further provides spinal implant systems. In one such embodiment, the system includes a loading block having a generally flat first surface and a second surface spaced apart from the first surface. The loading block has a third surface between the first and second surfaces, and a fourth surface spaced apart from the third surface. The loading block further includes a chamber disposed therein, with the chamber being open through the base second and fourth surfaces. A spinal implant is disposed in the chamber. The implant has a cavity therein for receiving a bone growth-promoting substance, with the cavity generally aligned with the chamber opening through the fourth surface.
In one aspect, the loading block and spinal implant are adapted to be sterilized in a same process. The system may further comprise additional instruments, including, a packing instrument adapted for packing the bone growth-promoting substance in the implant cavity when the implant is disposed in the chamber, and an implant removal instrument adapted to remove the spinal implant from the chamber. The spinal implant, in one aspect, includes a tool engaging recess generally aligned with the chamber opening through the second surface. The recess is adapted to engage the removal instrument.
The present invention further provides methods, including methods of preparing a spinal implant for insertion in a patient. In one such embodiment, the method includes providing a generally rectangular loading block having a chamber therein, inserting a spinal implant into the chamber, and sterilizing the combined loading block and spinal implant. The method includes positioning the loading block on a first side thereof and inserting a material, such as a bone growth-promoting substance, into the spinal implant. The loading block is positioned on a second side thereof and the spinal implant is engaged with an instrument adapted for removing the spinal implant from the loading block.
In some aspects, the first and second loading block sides are generally orthogonal. The chamber may define an opening through third and fourth sides of the loading block generally opposite the first and second sides, respectively. In one aspect, the material is inserted through the chamber opening in the third side for packing into the spinal implant. Engagement of the spinal implant may occur through the chamber opening in the fourth side. In some aspects, the engagement of the spinal implant includes threadingly engaging the spinal implant with the instrument. In other aspects, the spinal implant is removed from the loading block through the chamber opening in the fourth side. The instrument used to remove the implant from the loading block, in some embodiments, is the same instrument used to insert the spinal implant into a patient.
Other features and advantages of the invention will appear from the following description in which the preferred embodiment has been set forth in detail in conjunction with the accompanying drawings.
Reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of embodiments of the invention as illustrated therein, being contemplated as would normally occur to one skilled in the art to which the invention relates.
Turning now to
Loading block 100 depicted in
As best seen in
Loading block 100 preferably comprises a material which lends itself to being sterilized. For example, loading block 100 may comprise a metal, ceramic, polymer, or the like. In this manner, loading block 100 may be used in sterile procedures and/or with implantable devices requiring a high degree of cleanliness. Further, in some embodiments, loading block 100 can be preloaded with an implantable medical device and sterilized therewith. As a result, the implant and loading block 100 can be delivered to the surgical site, operating room or the like, in a sterile condition.
In one embodiment, loading block 100, and more preferably cavities 110, are adapted to receive a medical implant 200 such as the spinal implant 200 shown in
In one embodiment of the present invention, implant 200 is placed in cavity 110 of loading block 100. Preferably, the dimensions of at least one cavity 110 generally corresponds to the outer dimensions of implant 200. For example, an implant having an 11 mm by 11 mm width and depth may be positioned in a similarly dimensioned cavity 110. In one embodiment, one or more walls of cavity 110 acts to frictionally engage corresponding side surfaces of implant 200. In this manner, cavity 110 holds implant 200 therein to avoid unwanted or premature removal of implant 200. In an alternative embodiment, one or more cavities 110 include one or more lips 120. In the embodiment shown in
One advantage of the present invention involves loading block 100 having cavities 110 which allow access thereto from two sides of loading block 100. For example, as shown in
Once implant 200 is sufficiently packed, in one embodiment loading block 100 is placed on first side 102. Placing first side 102 on a firm surface, such as a tray or surgical table, provides a stable environment for implant 200 during subsequent processes. In doing so, second side 104 is exposed to, for example, a tool or instrument 420 adapted for removing implant 200 from loading block 100. Instrument 420 may engage recess 220 in implant 200 to remove implant 200 from loading block 100. In one embodiment, the removal of implant 200 from loading block 100 includes threadingly engaging instrument 420 into recess 200, and sliding implant 200 along cavity 100 until implant 200 passes out of cavity 110 through the opening in fourth side 108. This may be useful, for example, in embodiments utilizing the loading block 100 shown in
In this manner, a single loading block 100 may be used for delivering a sterile implant 200 to the operating site, for holding implant 200 while bone growth-promoting material (or other material, medicine, etc.) is inserted into implant 200, and/or for providing a stable platform to hold implant 200 while implant 200 is coupled to an instrument (such as instrument 420). In one embodiment, instrument 420 not only removes implant 200 from loading block 100, but also is the instrument or a portion of the instrument used to insert implant 200 into the patient.
Turning now to
As shown in
While the above description generally describes embodiments of the present invention, it would be appreciated by those skilled in the art that several alternatives exist within the scope of the present invention. For example, implant 200 depicted in
Bone growth-promoting substances may include a wide range of materials within the scope of the present invention. For example, the material may include an allograft, an autograft, bone morphogenic protein (BMP), as well as a product sold under the trademark INFUSE⢠by Medtronic Sofamor Danek, Inc. Other bone growth-promoting substances, proteins, organic materials, inorganic materials and the like also may be used. In one embodiment, loading block 100 comprises a metal, a ceramic, a polymer, or the like, which is capable of being sterilized through using known or future sterilization processing. The sterilization may include, for example, sterilized solutions, autoclaves, or the like.
Components of the described embodiments, including loading block 100 may be made from a variety of materials compatible for use with the human body, including without limitation metals (e.g., titanium, nitinol, stainless steel), ceramics, polyethylene, PEEK, and other materials.
Having described several embodiments, it will be recognized by those skilled in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Accordingly, the above description should not be taken as limiting of the scope of the present invention.