The present disclosure relates generally to surgical access systems, and more particularly, to a surgical access system for accessing, dilating, and retracting tissue in a surgical site, and methods of using the same.
Disease, the effects of aging, or physical trauma resulting in damage to the spine has been treated in many instances by fixation or stabilization of the effected vertebra. A wide variety of spinal fixation apparatuses have been employed in surgical procedures for correcting spinal injuries and the effects of spinal diseases.
After a partial or complete discectomy, the normally occupied space between adjacent vertebral bodies is subject to collapse and/or misalignment due to the absence of all or a part of the intervertebral disc. In such situations, the physician may insert one or more prosthetic spacers between the affected vertebrae to maintain normal disc spacing and/or the normal amount of lordosis in the affected region.
Typically, a prosthetic implant is inserted between the adjacent vertebrae and may include pathways that permit bone growth between the adjacent vertebrae until they are fused together. As is typical, the intervertebral spaces are accessed anteriorly, posteriorly, or laterally. It would be desirable to access the intervertebral spaces via an approach that provides greater access to the surgical area while applying the least amount of stress to the surrounding tissue.
In accordance with an aspect of the present disclosure, a dilator includes a main body and a cross brace assembly. The main body includes a pair of body members movable in parallel relationship with respect to each other between a closed position and an open position. The cross brace assembly includes two linkage assemblies, with each linkage assembly having a pair of arms arranged in an X configuration. Each arm includes at least one slidable connection point with the respective body member to which the arm is coupled to facilitate movement of the body members relative to each other.
Each body member may include a post releasably engageable with a retractor device that is configured to move the body members to the open position. In embodiments, each body member includes a flange extending laterally from a proximal portion thereof, and the post extends proximally from the flange. Each post may include a shaft and an enlarged head. Each body member may include a distal portion having a tapered edge.
The dilator may include a threaded pin having an elongated body removably disposed within a throughhole defined in the main body. In embodiments, the elongated body of the threaded pin includes an enlarged proximal end and a threaded distal end that extends distally beyond distal portions of the body members when the threaded pin is disposed in the throughhole. In some embodiments, each body member includes an inner surface having a recess defined therein that together define the throughhole of the main body when in the closed position, and at least one of the recesses is configured to retain the threaded pin therein when the body members are in the open position.
Each body member of the main body may include proximal slots and distal apertures, and each arm of the cross brace assembly may have a proximal region including a proximal pin and a distal region including a distal pin. The proximal pins may be slidably disposed within the proximal slots and the distal pins may be rotatably disposed within the distal apertures. In some embodiments, the proximal slots and the distal apertures are disposed in side surfaces of the body members.
Each body member of the main body may include distal slots, and each arm of the cross brace assembly may have a barb. The barbs may be movable within the distal slots such that when the main body is disposed in the closed position, the barbs are disposed within the distal slots and when the main body is in the open position, the barbs extend laterally through the distal slots. In some embodiments, the distal slot is defined through inner and outer surfaces of each body member, and the barb is disposed at a distal-most end of each arm.
In accordance with another aspect of the present disclosure, a kit includes a dilator, a retraction device, and a scalpel. The dilator includes a main body having a pair of body members movably coupled to one another and movable in parallel relationship with respect to each other between a closed position and an open position. The retraction device is configured to engage the dilator and move the body members towards the open position.
In embodiments, the dilator further includes a cross brace assembly including two linkage assemblies. Each linkage assembly has a pair of arms arranged in an X configuration, and each arm includes at least one slidable connection point with the respective body member to which the arm is coupled to facilitate movement of the body members relative to each other.
In accordance with yet another aspect of the present disclosure, a method of accessing and retracting tissue includes pushing a main body of a dilator that is disposed in a closed position into an incision, and opening the main body of the dilator to an open position to retract the surrounding tissue. The main body of the dilator includes a pair of body members movably coupled to one another and movable in parallel relationship with respect to each other between the closed and open positions.
In embodiments, pushing the main body of the dilator may include advancing the main body into tissue until distal ends of the body members are disposed adjacent a vertebral body.
The method may include passing a threaded pin through a throughhole defined in the main body of the dilator and into the vertebral body, prior to opening the main body of the dilator.
In embodiments, opening the main body of the dilator includes connecting a retraction device to posts extending from the body members of the dilator, and operating the retraction device to move the body members to the open position.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure, wherein:
Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. The term “clinician” refers to a doctor (e.g., a surgeon), a nurse, or any other care provider, and may include support personnel. Throughout this description, the term “proximal” refers to a portion of a system, device, or component thereof that is closer to a clinician, and the term “distal” refers to the portion of the system, device, or component thereof that is farther from the clinician.
A surgical access system in accordance with the present disclosure includes a scalpel 100 (
As shown in
Referring now to
The threaded pin 250 includes an elongated body 252 having an enlarged proximal end 252a configured to facilitate driving the threaded pin 250 distally into bone, and a threaded distal end 252b terminating in a sharp distal tip 252c that is configured to penetrate or pierce bone. The proximal end 252a of the threaded pin 250 may include, for example, a hex shaped recess 253 configured to mate with an insertion instrument or driving tool (not shown), as is within the purview of those skilled in the art. The threaded pin 250 may be slid distally into the channel 211 of the main body 210 such that, as shown in
The dilator 200 is configured for use with a variety of retraction devices, such as hand-held retraction devices, like a Gelpi retractor, as shown, for example, in U.S. Pat. No. 7,846,093, the entire contents of which are hereby incorporated by reference herein, and retraction frames (e.g., table-mountable retraction frames), such as those shown in U.S. Pat. No. 8,449,463, the entire contents of which are hereby incorporated by reference herein.
As shown in
The Gelpi retractor 300 facilitates movement of the body members 220 of the dilator 200 laterally relative to the longitudinal axis “X” (
Moving the finger rings 312 towards each other pivots the arms 310 away from each other and urges the body members 220 away from each other, thereby separating tissue and enlarging a passageway therethrough. Consequently, movement of the finger rings 312 away from each other pivots the arms 310 towards each other, allowing the dilator 200 to return to the closed position. In embodiments, an outside force, such as pressure from the surrounding tissue or manual movement, aid in moving the body members 220 of the dilator 200 towards the closed position. In some embodiments, additional structure such as, for example, a biasing mechanism coupled to the body members 220 of the dilator 200 or fingers of a retraction device that engage outer surfaces or encircle the posts 224 of the body members 220, move the body members 220 of the dilator 200 to the closed position.
With continued reference to
The inner surface 220c of each body member 220 includes a pair of longitudinally extending grooves 221 defined therein. Each groove 221 is disposed adjacent a side surface 220e of the body member 220. As shown in
Referring again to
The cross brace assembly 230 includes two linkage assemblies 231. Each linkage assembly 231 includes arms 232. Each arm 232 has a proximal region 232a including a proximal pin 234, and a distal region 232b terminating in a barb 236 and including a distal pin 238. The proximal region 232a of each arm 232 is positioned within a groove 221 of a body member 220 with the proximal pin 234 inserted into, and slidable within, the respective proximal slot 222. The distal region 232b of each arm 232 is positioned within the groove 221 of the other of the body members 220 such that the arms 232 cross in an “X” configuration. The distal pin 238 of each arm 232 is inserted into the respective distal aperture 223 and rotatable about an axis of the distal pin 238, and the barb 236 of each arm 232 is inserted into, and slidable within, the respective distal slot 228. Accordingly, the arms 232 are rotatably fixed to the body members 220 about the distal pins 238, and movable about the proximal pins 234, which ride in the proximal slots 222 of the body members 220.
The barbs 236 of the arms 232 are movable in the distal slots 228 of the body members 220. The barbs 236 are configured to grab and engage tissue, providing an anchor for the dilator 200 when the dilator 200 is in the open position. As shown, for example, in
In a method of use, the blade portion 120 of the scalpel 100 is utilized to create an incision or pathway in tissue for the dilator 200. The scalpel 100 is removed, and the main body 210 of the dilator 200, in the closed configuration, is pushed into the incision and through the created pathway until the distal portions 220b of the body members 220 of the dilator 200 are positioned adjacent to bone, such as a vertebral body.
Optionally, as shown in
After inserting the main body 210 of the dilator 200 adjacent the bone, the threaded pin 250 is inserted into the throughhole 211 of the dilator 200 and into the bone to facilitate retention of the dilator 200 therein. The pin 250 may be positioned, for example, adjacent a pedicle, an anterior face, or a lateral side of a vertebral body as shown. Other locations on a vertebral body are also contemplated. The posts 224 of the dilator 200 are then engaged, by a retraction device 300 (
With the tissue separated, a clinician has increased visualization of the surgical site for performing a desired surgical procedure, such as a discectomy.
In another method of use, as shown in
In embodiments, the threaded pin 250′ includes depth markings thereon at predetermined lengths to aid a clinician in determining the depth at which the threaded pin 250′ is inserted into the vertebral body “V.” The depth markings also indicate a distance between a distal tip of the threaded pin 250′ and an outer surface of body tissue. In some embodiments, additional cannulae (not shown) of increasing diameters may be subsequently inserted over one another to increase the size of the opening of the surgical site.
As shown in
The spinal access system may be provided in a kit. The kit is an assembled package including a scalpel, a dilator, and a retraction device. In embodiments, the kit may include a plurality of scalpels, dilators, and/or retraction devices. For example, the scalpels may be cannulated or non-cannulated, have different blade configurations and/or different lengths, the dilators may have different sized body members and/or different open diameters, and/or the retractors may have different handle and/or finger configurations, to allow a clinician to pick and choose instruments for use in a desired surgical procedure.
Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. For example, the surgical access system of the present disclosure, and devices thereof, may be utilized to access and/or retract tissue at a surgical site in a variety of orthopedic surgery applications. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.
This application claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 62/237,607, filed on Oct. 6, 2015, the entire contents of which are hereby incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US16/55676 | 10/6/2016 | WO | 00 |
Number | Date | Country | |
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62237607 | Oct 2015 | US |