The present disclosure relates generally to the field of spinal surgery. In particular, the present disclosure relates to devices and instruments for use with spinal implants, and methods of using spinal implant devices and instruments.
A wide variety of intervertebral implants and associated instruments have been utilized for stabilizing adjacent vertebral elements and facilitating the development of bone union between the vertebral elements. In some configurations, the intervertebral implants are adjustable. That is, the intervertebral implants are designed to expand from a first height to a second height. An example of an expandable intervertebral implant is disclosed in U.S. Pat. No. 5,489,307.
A number of devices and instruments are required to prepare for, handle, and operate expandable implants during a surgical procedure. In general, improvement has been sought with respect to such devices, instruments, and methods.
In one aspect, the present disclosure relates to a box chisel having a hollow structure. The hollow structure includes a first surface and a second opposite surface, each of the first and second surfaces having a cutting edge. The hollow structure also includes a rasping structure formed in one of the first and second surface.
In another aspect, the present disclosure relates to a chisel instrument having an elongated structure. The elongated structure includes a cutting edge and a first side facing in an opposite direction from a second side. The elongated structure also includes rasping structure formed in at least one of the first and second sides adjacent a distal end of the elongated structure.
In still another aspect, the present disclosure relates to a surgical instrument for expanding an expandable implant. The surgical instrument includes a sliding member and an instrument structure having an implant mounting arrangement. The mounting arrangement includes first and second portions adapted for insertion into the expandable implant. The sliding member is configured to slide relative to the instrument structure and expand the implant mounting arrangement such that the first and second portions expand the implant in an expansion direction.
In yet another aspect, the present disclosure relates to a surgical instrument for expanding an expandable implant. The surgical instrument includes a mounting structure configured for receipt of the expandable implant, a handle, and an actuator. The instrument is configured such that expansion of the mounting structure in a linear direction causes an expandable implant mounted on the mounting structure to expand from a non-expanded configuration to an expanded configuration.
In another aspect, the present disclosure relates to a surgical instrument for expanding an expandable implant. The surgical instrument includes a body defining a longitudinal axis extending between a proximal end and a distal end. The body defines a channel. The surgical instrument also includes a handle, an actuator configured to slide within the channel, and mounting structure having first and second members. When the actuator is slid toward the distal end of the body, the first and second members become spaced apart from one another.
In still another aspect, the present disclosure relates to a surgical instrument for expanding an expandable implant. The surgical instrument includes, an elongated housing, a rail member, and a channel defined by the elongated housing and the rail member. The surgical instrument also includes an actuator positionable within the channel, and configured to space apart the elongated housing and the rail member to thereby expand an expandable implant from a non-expanded configuration to an expanded configuration.
In yet another aspect, the present disclosure relates to a surgical instrument including a body, mounting structure located at a distal end of the body, a handle located at a proximal end of the body, and a moveable sleeve positioned between the handle and the mounting structure. The mounting structure is configured to insert within an opening of an implant and includes first and second member. When the sleeve moves toward the distal end of the body, the first and second members move toward one another.
In another aspect, the present disclosure relates to a surgical instrument including an engagement member having first and second cantilevers, and a sleeve positioned to slide along the engagement member. The sleeve is positionable at first and second positions. At the first position, the first and second cantilevers are spaced apart from one another a first distance. At the second position, the first and second cantilevers are spaced apart from one another a second distance, the second distance being less than the first distance.
In still another aspect, the present disclosure relates to a surgical instrument having a scissor arrangement. The scissor arrangement includes a first arm connected to a second arm at a pivot location. The surgical instrument also includes mounting structure located at a distal end of the scissor arrangement, the mounting structure being defined by shaped tips of the first and second arms. The mounting structure is configured to insert within an opening of an implant, and the shaped tips are configured to grasp structure formed within the opening of the implant. When the first and second arms, are pivoted, the shaped tips also pivot towards one another to cause a mounted implant to collapse from a first height to a reduced height.
In yet another aspect, the present disclosure relates to a kit. The kit includes at least one box chisel configured to prepare an implant site, an expandable implant, a first instrument configured to expand the expandable implant from a non-expanded configuration to an expanded configuration, and a second instrument having tips to engage the expandable implant to orient the expandable implant in a non-expanded configuration.
A variety of examples of desirable product features or methods are set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practicing various aspects of the disclosure. The aspects of the disclosure may relate to individual features as well as combinations of features. It is to be understood that both the foregoing general description and the following detailed description are explanatory only, and are not restrictive of the claimed invention.
Reference will now be made in detail to various features of the present disclosure that are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
I. Kit Generally
The illustrated kit 10 generally includes one or more embodiments of a box chisel (e.g. 14, 16), one embodiment of an inserter/expander (e.g. 18), and one or more embodiments of an implant assembling/collapsing instrument (e.g. 20, 22). Each of the instruments of the kit 10 is configured for use with a two-piece ratcheting-type implant, such as the expandable implant 12 shown.
II. Expandable Implant
Referring now to
Referring now to
The illustrated implant 12 also includes an implant handling arrangement 42. Some of the surgical instruments of the kit 10 are designed to engage the implant handling arrangement 42 to handle and manipulate the implant 12 during a surgical procedure. The implant handling arrangement 42 of the illustrated embodiment is located on the internal member 26 and includes implant handling structures 44 formed on the inside walls surfaces 46, 48 of the first and second walls 38, 40. The handling structures 44 include a projection 50 defining a hole 52. The hole 52 is configured to receive an end of a surgical instrument.
When the internal and external members 24, 26 are assembled, openings 54 are formed at each of a first end 56 and second end 58 of the implant 12 (
III. Box Chisel
Prior to placement of an expandable implant at an implant site, the implant site between the two vertebral elements V1, V2 is first prepared. Preparation includes forming an implant site corresponding to the shape of the non-expanded implant. The box chisels 14, 16 shown in
Referring now to
Referring to
A tapered region 76 is located adjacent to the proximal end 66 of the box chisel 14. Attachment structure 77 is located adjacent to the tapered region 76. The attachment structure 77 may include, for example, a threaded member 78 extending outward from the tapered region 76. A handle (not shown) can be attached to the threaded member 78 for manipulation and operation of the box chisel 14 during site preparation. In alternative embodiments, the box chisel 14 can include other types of attachment structure, such as a threaded hole formed in the tapered region, for attaching a handle.
Still referring to
In the illustrated embodiment, the perimeter cutting edge 86 also includes an arcuate region 88. The acruate region extends upward from the first planar surface 62 and has a second height H2 greater than the first height H1. The arcuate region 88 is formed by a curvature 90 formed in the first planar surface 62. In the illustrated embodiment, the curvature 90 extends along the longitudinal axis B-B of the box chisel 14 (
In general, the width W1, the first height H1, and the second height H2, of the box chisel 14 are sized to correspond to the size and configuration of the expandable implant 12, although the disclosed principles can be applied in a variety of sizes and applications. The width W1 of the box chisel 14 is generally defined between first and second sides 98, 100 of the box chisel, and is preferably between 0.375 and 0.750 inch; more preferably about 0.512 inches. The first height H1 of the box chisel 14 is generally defined between the first and second planar surfaces 62, 64, and is preferably between 0.250 and 0.500 inches; more preferably about 0.296 inches. The second height H2 of the box chisel 14 is generally defined between the second planar surface 64 and the curvature 134 formed in the first planar surface 62, and is preferably between 0.270 and 0.520 inches; more preferably about 0.316 inches.
To cut different sized channels, a set of chisels can be available for providing incrementally different sizes of cutting edges corresponding to a particular size implant. For example, chisels 14 having different widths W1 and heights H1, H2 can be made available to permit the surgeon to select a cutting edge corresponding to a particular implant configuration.
In the illustrated box chisel embodiment 14, the scraping arrangement 80 includes rasping structures or elements, such as teeth 82, 84 formed in each of the first and second planar surfaces 62, 64. The teeth 82, 84 of the box chisel 14 are designed to scrape the vertebral elements V1, V2 for further site preparation of the implant site.
The teeth 82, 84 of the scraping arrangement 80 illustrated in
The teeth 82, 84 of the scraping arrangement 80 extend across each of the planar surfaces 62, 64 from the first side 98 of the box chisel 14 to the second side 100. The teeth 82 located on the first planar surface 62 also include curvatures 90 formed in a central portion 102 of each of the teeth (
As shown in
Referring now to
The box chisel 14 also includes an aperture 104. The aperture 104 extends through the working portion 70 of the box chisel 14 and is in communication with the interior space 74 of the hollow construction 72. The aperture 104 is oriented generally transverse to the longitudinal axis B-B of the box chisel. That is, the aperture 104 extends from the first planar surface 62, through the working portion 70, to the second planar surface 64. The aperture is located between the last of the teeth 82, 84 of the scraping arrangement 80 and the tapered region 76 of the box chisel 14. In use, the aperture 104 provides an opening for removal of material scraped from the vertebral elements, and to facilitate cleaning between and at the rasping structures.
Referring now to
The box chisel 16 also includes a width and first and second heights that are substantially the same as the previous box chisel embodiment 14. A tapered region 124 is located adjacent to the proximal end 114 of the box chisel 16. Attachment structure 126 is located adjacent to the tapered region 124 for attachment to a handle (not shown).
The box chisel 16 also has a perimeter cutting edge 127 and a surface texture or scraping arrangement 128. The scraping arrangement 128 includes rasping structure such as first and second roughening surfaces 130, 131 formed in each of the first and second planar surfaces 110, 112.
Similar to the previous embodiment, the roughening surface 130 also defines an arcuate region 132 that extends upward from the first planar surface 110. The arcuate region 132 is formed by a curvature 134 formed in the first planar surface 110 and extends along the longitudinal axis C-C of the box chisel 16. The curvature 134 is configured to correspond to the curved portion 92 of the implant 12.
The roughening surfaces 130, 131 in the illustrated embodiment each include a knurled or cross-hatched pattern construction 136. The cross-hatched pattern construction 136 functions to scrape the vertebral elements V1, V2 for further site preparation of the implant site. In particular, the roughening surfaces 130 of the scraping arrangement 128 are configured for detailed site preparation. That is, the cross-hatched pattern construction 136 is configured to rasp or roughen the surfaces of each of the vertebral elements V1, V2 to promote growth between the vertebral elements and the implant.
The cross-hatched pattern constructions 136 extend across each of the planar surfaces 110, 112 from a first side 138 of the box chisel 16 to a second side 140. Similar to the previous embodiment, the curvature 134 of the box chisel 16 extend through the cross-hatched pattern construction 136 located on the first planar surface 110.
Referring back to
IV. Inserter/Expander
Once the implant site has been prepared, the expandable implant can be inserted between the two vertebrae V1, V2.
The placement instrument 18, as shown in
As shown in
Referring to
Referring to
A longitudinal and axial projection 176 is located at the distal end 166 of the housing 154. In particular, the projection 176 extends outward from the upper housing portion 170 of the housing 154. The projection includes shoulders 178 formed at a base 179. In the illustrated embodiment, the base 179 includes an arcuate region 181 (
In the illustrated embodiment, the distal end 166 of the housing 154 also includes a flared region 180. The flared region 180 has shoulder surfaces 182 located adjacent the base 179 of the projection 176. As will be discussed in greater detail, the shoulder surfaces 182 locate and maintain positioning of the rail 156 when the rail 156 and the housing 154 are assembled.
The sides 172 of the housing 154 include extended regions 184, 185. The extended regions generally define a maximum distance of separation allowed between the housing 154 and the rail 156 when the rail and housing are assembled. In particular, the proximal extended region 184 is interconnected to the lower housing portion 174. The intermediate extended region 185 includes tabs 187. The lower housing portion 174 and the tabs 187 hold the rail 156 in relation to the housing 154 during use (
Referring again to
Referring now to
A collar 196 and mounting tip 198 are located at the distal end 194 of the rail 156. The collar 196 includes proximal surfaces 200 extending upward along sides 204 of the rail. When assembled, the proximal surfaces 200 of the collar 196 abut the shoulder surfaces 182 of the housing 154 to locate and maintain the position of the rail 156 relative to the housing 154 (
As shown in
In addition, the hook 206 can be used during a pull test. In particular, once the implant 12 is inserted and expanded at the implant site, the surgeon can pull the implant 12 by the hook 206 of the instrument 18 to ensure that the implant is securely positioned or placed.
Referring back to
As shown in
Referring again to
Referring now to
Referring now to
Referring back to
In use, the varied widths of the placement instrument 18 components limit the depth at which the actuator rod 158 can be advanced within the channel 160. In particular, a tapered region 221 (
Referring again to
In use, the placement instrument 18 is configured to place or insert the expandable implant 12 between the two vertebrae V1, V2. The installation procedure includes mounting the expandable implant 12 onto the mounting structure 152 of the placement instrument 18. At this point in the procedure, the external member 24 and the internal member 26 of the implant are assembled together and have a first non-expanded height (
The implant 12 is inserted between two vertebral elements V1, V2 in the non-expanded configuration having a first non-expanded height (
To remove the placement instrument 18 once the implant 12 is expanded, the actuator rod 158 is first removed from the channel 160. The housing 154 is then removed by sliding the housing 154, relative to the rail 156, out from the opening 54 of the implant. The opening 171 (
The placement instrument 18 provides several advantages. For example, the placement instrument is designed to easily insert the implant with minimal instrument adjustments. The placement instrument 18 also minimizes the detrimental effect on surrounding anatomy. In particular, the placement instrument 18 does not require interchanging multiple instruments to expand the implant from the non-expanded configuration to the expanded configuration. The actuator rod 158 is configured to easily slide and includes an enlarged palm area or head 216 to reduce stress on the surgeon's hand. The instrument 18 is also designed to fit within the opening 54 of the implant and does not extend beyond the profile of the implant; thereby the instrument 18 is less invasive and reduces trauma to the surrounding anatomy.
In addition, the double ramp/incline design of the instrument 18 (i.e. first and second ramped section 214, 215 of the rail 156 and first and second incline surfaces 223, 224 of the rod 158) maintains the parallelism of expansion between the housing 154 and the rail 156. This in turn, ensures that the implant 12 is equally and properly expanded at each end 56, 58. That is, the instrument 18 is designed so that both the proximal and distal ends 146, 148 of the instrument equally separate during operation. This design eliminates the possibility of unintended angular separation (i.e. the distal end 148 having a greater separation than the proximal end 146), which could cause the implant to ratchet or expand more at one end than the other.
Also, the placement instrument 18 includes three components. The components can be quickly assembled and disassembled for ease of use and cleaning.
Overall, the placement instrument 18 of
Specifically,
The linkage assembly 230 of
The actuator 228 includes a threaded end 244. The threaded end 244 engages a threaded hole (not shown) in each of the brackets 238. As the actuator 228 is turned, the first and second members 232, 234 linearly separate or expand in opposite directions (represented by arrows). In particular, as a surgeon rotates or threads the actuator 228 into the brackets 238, the brackets axially move apart from one another (by means of a left-handed and a right-handed thread arrangement, for example). When the brackets 238 axially move apart, the link arms 236 rotate from a first angular orientation to a more vertical orientation; and in turn, drive the first and second members 232, 234 apart from one another. Separation of the first and second members 232, 234 accordingly expands a mounted implant.
To remove the insert/expander 225 once the implant has been expanded, the actuator 228 can be turned in an opposite direction to cause the brackets 238 to axially move toward one another, thereby collapsing the linkage assembly 230 and returning the first and second members 232, 234 to an initial position. The insert/expander 224 can then be removed from the opening 54 of the expanded implant 12.
Referring to
The first and second members 260, 262 are configured to linearly separate or expand in opposite directions (represented by arrows). In particular, as a surgeon axially pulls the actuator 250, the link arms 254 pivot and drive into the slots 258 to axially move the first and second members 260, 262 apart from one another. When the actuator 250 is axially pulled, the link arms 254 rotate from a first angular orientation to a more vertical orientation. Rotating the link arms 254 to a more vertical orientation drives the first and second members 260, 262 apart from one another, and accordingly, expands a mounted implant.
To remove the insert/expander 246 once the implant has been expanded, the actuator 250 can be pushed in the opposite direction to collapse the linkage assembly 252 and cause the first and second members 260, 262 to return to an initial position. The insert/expander 246 can then be removed from the opening 54 of the expanded implant 12.
Referring to
The wedge 268 has a conical or tapered region 270 at a first end 272. The expansion piece 266 in this embodiment may include a sheath 267 configured and sized for receipt within the opening 54 of the implant 12. The sheath 267 may include mounting structure similar to the previous embodiment to retain an implant during insertion and placement.
Preferably, the sheath 267 includes an expandable outer construction 271 defining an interior 273. When the sheath is positioned within the opening 54 of the implant, a user can slidably insert the wedge 268 into the interior 273 of the outer construction 271 to cause the sheath 267 to expand and thereby expand the mounted implant 12.
In general, the inserter/expander embodiments include a structure upon which an expandable implant is mounted. Each embodiment includes an actuator arranged to expand the structure in an expansion direction. The expansion direction in the illustrated inserter/expander embodiments is generally linear; however, the disclosed principles may be applied to provide expansion in a non-linear expansion direction. Expansion of the structure, in turn, expands the mounted implant from a non-expanded configuration to an expanded configuration. As can be understood, each of the embodiments is designed to structurally withstand expansion forces. In particular, the embodiments are structurally designed to created enough force to distract the disc space as well as expand the implant device.
V. Assembling/Collapsing Instrument
In use, the internal and external members 24, 26 of the implant 12 are assembled in relation to one another prior to insertion at an implant site.
In addition, the implant 12 is configured so that expansion from the non-expanded configuration to the expanded configuration is not permanent; that is, the surgeon can reduce the expansion height or can altogether collapse and remove the implant 12 after an installation and expansion procedure. The assembling/collapsing instruments of
In particular, the locking arrangement 28 (
Disengagement of the locking arrangement 28 is accomplished by inserting one of the assembling/collapsing instruments into the holes 52 of the implant handling structure 44, and flexing the walls 38, 40 together. When the first and second interlocking teeth structures 30, 32 have been disengaged, the external and internal members 24, 26 can be compressed to non-expanded configuration. The external and internal member 24, 26 may be compressed prior to installation (i.e. for assembly purposes) or while installed. In some situations, for example, a surgeon may determine after installation and expansion that the expanded height of the implant is too great. The surgeon can then disengage the interlocking teeth structures 30, 32 and permit the implant 12 to ratchet from the expanded configuration to a second, reduced expanded configuration.
Referring now to
The engagement structure 284 of the instrument 20 includes projections 286 that engage the holes 52 of the implant handling structures 44 of the implant 12. In use, the engagement structure 284 is inserted within the opening 54 of the implant 12. A stop piece 288 is located a distance from the distal end 278 of the instrument 20. The distance is configured to limit insertion of the instrument 20 and provide an indication to the surgeon that the instrument 20 is fully engaged with the implant 12. The stop piece 288 of
Referring now to
The handle 274 in the illustrated embodiment is ergonomically designed for easy handling. Likewise, the moveable sleeve 280 is ergonomically designed, including a bulb-like region 292, for easy handling and sliding.
Referring now to
The configuration of the aperture 308 and the center gap 306 provides a spring-type arrangement 310. In a relaxed state, the first and second cantilever members 296, 298 of the spring-type arrangement 310 are spaced apart from one another (
The stop piece 288 of the instrument 20 is defined by first and second stop sections 312, 314 formed on each of the first and second cantilever members 296, 298. The stop sections 312, 314 extend outward from the cantilever members. Shoulders 338, 340 of the stop section 312, 314 limit insertion of the instrument 20 in the implant 12. The shoulders 338, 340 prevent the distal end 278 of the instrument from extending through the implant and possibly causing unintended tissue, nerve, or bone contact.
Referring now to
Referring to
The distal end 320 includes shaped tips 330 sized for receipt within the holes 52 of the implant. The shaped tips 320 each include a necked region 332 leading to a shoulder 334, and a projection 336 extending outward from the shoulder 334. The necked region 332 is shaped so that the shaped tip 330 fits within the openings defined by the implant. The projections 336 are sized for receipt within the holes 52 of the implant 12. The shoulders 334 are configured to contact the handling structures 44 of the implant 12 when the shaped tips 330 are properly inserted into the holes 52 of the implant 12.
In use, a surgeon inserts the each of the shaped tip 330 into one of the holes 52 of the implant handling arrangement 42 of the implant. In this initial position, the shaped tips of the instrument 22 are spaced apart from one another. To draw the walls 38, 40 of the internal member 26 together, the surgeon squeezes the finger loops 324 to draw the shaped tips 330 inward, thereby disengaging the locking arrangement 28 of the implant 12. The implant 12 can then be collapsed for removal or the height reduced as needed.
The above specification provides a complete description of the INSTRUMENTS FOR USE WITH EXPANDABLE IMPLANTS, AND METHODS. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, certain aspects of the invention reside in the claims hereinafter appended.