Modular surgical instrument system and method for shank-based retraction and distraction

A surgical device includes at least one retractor blade. Each retractor blade includes a blade body having a lateral side, a medial side opposite the lateral side and a bottom end. The bottom end has an inverted-arch curvature. The inverted-arch curvature includes a lowest point in proximity to a midline of the blade body. Each retractor blade includes a connector integrated into a mid-section on the medial side of the blade body and a leg interface configured to mate and/or pair with a leg of a distractor. The at least one retractor blade may include two retractor blades configured as mirror images of each other. Each blade is configured to pair with a respective one distractor.

FIELD

The present technology is generally related to systems and methods using modular retractor blade and distractors to provide retraction and distraction at the same time for use in a mini-open transforaminal lumbar interbody fusion (TLIF) spine surgery.

BACKGROUND

Spinal disorders may result in pain, nerve damage, and loss of mobility. While, non-surgical treatments may be effective to treat some spine disorders, others will require surgical treatments, such as without limitation, spinal fusions. During, a mini-open transforaminal lumbar interbody fusion (TLIF) spine surgery, an incision can be made off the midline to access both disc space and pedicles. Other spine surgeries may place the incision in a different location. Various tools are used to perform retraction with blades to expose a portion of the spine or boney structures through the incision. Other instruments are used to perform distraction. The interchange of these different instruments may increase the length of time required to perform the surgery. This disclosure describes methods and systems directed to addressing the problems described above, and/or other issues.

SUMMARY

The techniques of this disclosure generally relate, for example, to a modular surgical instrument system using modular retractor blade and distractors to provide retraction and/or distraction, which may be provided at the same time for use, for example, in an open, mini-open transforaminal lumbar interbody fusion (TLIF) spine surgery, or other applicable procedures.

In one aspect, the present disclosure provides a surgical device comprising at least one retractor blade. Each retractor blade may include a blade body having a lateral side, a medial side opposite the lateral side, and a bottom end. The bottom end may include an inverted-arch curvature. The inverted-arch curvature may include a lowest point in proximity to a midline of the blade body. Each retract blade may include a connector integrated into a mid-section on the medial side of the blade body. The connector may include a leg interface configured to mate with a leg of a distractor.

In another aspect, the disclosure provides a modular surgical instrument system that may include a medial-lateral distractor rack tool having first and second parallel arms. The modular surgical instrument system may include first and second leg-docking members connected to the first and second parallel arms. The modular surgical instrument system may include a first distractor having a first distractor leg configured to be docked with the first leg-docking member. The modular surgical instrument system may include a second distractor having a second distractor leg configured to be docked with the second leg-docking member. The modular surgical instrument system may include a retractor blade pair. Each retractor blade of the blade pair comprises a blade body having a lateral side, a medial side opposite the lateral side and a bottom end. The bottom end may include an inverted-arch curvature. The inverted-arch curvature may include a lowest point in proximity to a midline of the blade body. Each blade may include a connector integrated into a mid-section on the medial side of the blade body. The connector may include a leg interface configured to mate with the first distractor leg or the second distractor leg.

In another aspect, the disclosure provides a method that may include providing the modular surgical instrument system and driving a shank of a bone fastener into a pedicle. The method may include sliding a retractor blade over a distractor leg of a distractor to pair the retractor blade and distractor together and attaching in situ, the distractor to the shank of the bone fastener. The method may include attaching a medial-lateral distractor rack tool to the distractor leg to assemble the system and performing distraction and retraction with the assembled system using the paired retractor blade and the distractor.

DETAILED DESCRIPTION

The embodiments of a surgical instrument system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical instrument system and a method for treating a spine. In some embodiments, the system includes at least one modular surgical device with a retraction blade and distractor pair for both shank-based retraction and distraction and related methods of use that can create a distraction in the disc space while retracting fascia and/or muscles during spine surgery.

The disclosure is directed, for example, to surgical tools used to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures.

The following discussion includes a description of a modular surgical instrument system including at least one modular surgical device and related components and methods of employing the surgical instrument system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures.

Turning toFIG. 1A, a perspective view that illustrates components of a modular surgical instrument system100for shank-based retraction and distraction with the retraction blades separated is shown.FIG. 1Bis a rear view that illustrates the components of the modular surgical instrument system100.

Various components of the system100may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of the system100, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of the system100may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

The system100may be employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical techniques. In one embodiment, the components of the system100may be configured to distract and/or retract to fix a bone fastener, such as a pedicle screw, for a surgical treatment to treat various spine pathologies, such as those described herein. The system100may be configured to create a distraction in the disc space while retracting fascia and/or muscles during spine surgery.

The bone fastener may include a head portion that defines an implant cavity and a penetrating portion or shank configured for penetrating tissue. As used in this disclosure, shank-based retraction may relate to, for example, to applying force to the shank or shaft, for example, associated with a bone fastener or may further relate to other posts, shafts, shanks or sleeves or other extensions implanted or embedded in a portion of the spine or other bony structures. The bone fastener may be coated with an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenic protein for enhanced bony fixation. Bone fastener can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. Metallic or ceramic radiomarkers, such as tantalum beads, tantalum pins, titanium pins, titanium endcaps, and platinum wires can be used.

It is contemplated that the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. It is further contemplated that the disclosed surgical system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the thoracic, lumbar, sacral, cervical, and pelvic sections of the spinal column. The system100of the present disclosure may also be used on animals, simulated spinal bone models or other non-living substrates, such as, without limitations for use in testing and training.

The system100will be described in relation toFIGS. 1A-1BandFIGS. 2A and 2B.FIGS. 2A-2Bare lateral side and medial side views that illustrate the components of the modular surgical instrument system100. The modular surgical instrument system100may include a medial-lateral distractor rack tool101having first and second parallel arms107A,107B. The system100may include first and second leg-docking members109A,109B connected to the first and second parallel arms107A,107B.

The medial-lateral distractor rack tool101may include a knob102that may be configured to be rotated clockwise or counter-clockwise. Rotating the knob102in a first direction may close the tool101such that the spacing between the first and second parallel arms107A,107B is decreased. By way of non-limiting example, the first direction may be clockwise. Alternately, rotating the knob102in a second direction may open the tool101such that the spacing between the first and second parallel arms107A,107B is increased. By way of non-limiting example, the second direction may be counter-clockwise.

The medial-lateral distractor rack tool101may include a rack of teeth104(FIG. 1B) interfaced with the first and second parallel arms107A,107B so that as the knob102is rotated in the second direction, at least one of the arms moves relative to the other arm to increase the distance between the arms107A,107B. An example rack tool for retraction is described in U.S. Patent Application Publication 2014/0024900, titled “SURGICAL RETRACTOR AND METHOD OF USE,” assigned to Warsaw Orthopedic, Inc., which is incorporated herein in its entirety. Another example, rack tool for retraction is described in U.S. Patent Application Publication 2011/0098537, titled “TISSUE MASSAGE RETRACTOR,” to Warsaw Orthopedic, Inc., which is incorporated herein in its entirety. Another rack tool for retraction is described in U.S. Pat. No. 7,976,463, titled “INSTRUMENTS AND METHODS FOR MINIMALLY INVASIVE TISSUE RETRACTION AND SURGERY,” assigned to Warsaw Orthopedic, Inc., which is incorporated herein by reference in its entirety. A rack tool for retraction is also described in U.S. Pat. No. 6,945,933, titled “INSTRUMENTS AND METHODS FOR MINIMALLY INVASIVE TISSUE RETRACTION AND SURGERY,” assigned to SDGI Holding, Inc., which is incorporated herein by reference in its entirety.

Since each of the first and second leg-docking members109A,109B are essentially the same, only one leg-docking member109A will be described. The leg-docking member109A may include a yoke111and a connector pin112configured to connect to a respective one arm107A. The yoke111of the leg-docking member109B may be configured to connect to arm107B. The first leg-docking member109A may include a hollow tubular member114having a first end117integrated with the yoke111and a second end119. The second end119is at an opposite the first end117. The yoke111may be arranged at an angle relative to the first end117of the hollow tubular member114. The angle between the hollow tubular member114and the yoke111may be 90° or an obtuse angle that may be less than 180°.

The system100may include at least modular surgical device120A,120B. The modular surgical device120A may include a retractor blade130A that may be a standalone retractor blade. The modular surgical device120A may include a distractor180A. The standalone retractor blade130A may be paired with a distractor180A to form a retractor blade and distractor pair. The retractor blade130A may be paired with a distractor180A with a connector137integrated into a medial side of the blade130A. The system100may include a second modular surgical device120B that may include a retractor130B and distractor180B. The retractor blade130B may be paired with a distractor180B with a connector137integrated into a medial side of the blade130B.

In various embodiments, the distractors180A and180B may be essentially the same. Therefore, only one distractor180A will be described in detail with additional distractor details provided in relation toFIG. 5. With reference specifically toFIGS. 1A and 1B, the distractor180A may include a distractor leg182and hook190. The leg182may be configured to be docked with the first leg-docking member109A. The distractor leg182of distractor180B may be configured to be docked with the second leg-docking member109B. This docking may occur with the assistance of a robotic system and/or with the aid of surgical navigation techniques. The system100may include a plurality of distractors that may be selected to assist with distraction during spine surgery. By way of non-limiting example, distractors may have different hook types, as will be described in more detail in relation toFIGS. 5-6. The distractor leg182has a longitudinal axis LA (FIG. 1B).

In various embodiments, the system100may include a plurality of standalone retractor blades of different sizes that may be selected for a pairing with a distractor. For example, the retractor blades may have different longitudinal lengths, diameters or thicknesses. In various embodiments, the plurality of standalone retractor blades may include a retractor blade pair125, denoted in the dashed box.

FIG. 3Ais a top view of the modular surgical devices120A,120B installed in first and second leg-docking members109A,109B.FIG. 3Bis a bottom view of the modular surgical device120A,120B installed in the first and second leg-docking members109A,109B. The first and second leg-docking members109A,109B are shown attached to arms107A,107B. The retractor blade pair125may include a first retractor blade130A and a second retractor blade130B that is a mirror image of the first retractor blade130A. The system100may be configured to position the medial sides of the first retractor blade130A and a second retractor blade130B facing each other. The hook190of the distractor180A,180B may have an opening199that may open in a direction toward the medial side of the retractor blade. Additionally, the hook190may be offset in a direction of a front side of the blade. In this disclosure, the term “front side” of the blade is in a direction that when installed is farthest from the tool101. A retractor blade will be described in more detail in relation toFIGS. 4A-4D.

Referring now toFIGS. 4A-4D, the retractor blade430will be described. Specifically,FIG. 4Ais a rear view that illustrates the retractor blade430.FIG. 4Bis a bottom end view that illustrates the retractor blade430ofFIG. 4A.FIG. 4Cis a first (lateral) side perspective view that illustrates the retractor blade430ofFIG. 4A.FIG. 4Dis a second (medial) side perspective view that illustrates the retractor blade430ofFIG. 4A. Each retractor blade430(i.e., retractor blade130A or130B) may include a blade body432having a lateral side434and a medial side436opposite the lateral side434. The blade body432may include a bottom end440having an inverted-arch curvature445, as best seen inFIG. 4D. The lowest point on the inverted-arch curvature445may be positioned at or in proximity to the center C or a midline of the blade body432. In some embodiments, the inverted-arch curvature445may be a bullet nose curvature. An inverted-arch curvature445or bullet nose curvature may aid the surgeon with placement into an incision. Each retractor blade430may include a connector437(i.e., connector137ofFIG. 2B) integrated into a mid-section on the medial side436of the blade body432. The connector437may include a leg interface438that may be configured to mate with a leg182of the distractor180, as best seen inFIG. 2B.

Referring still toFIGS. 4A-4D, the blade body432may include a first body portion402and a second body portion404. The first body portion402may include a top end412, a bottom end414and a first longitudinal length between the top end and the bottom end. The second body portion404may include a top end422, a bottom end424and a second longitudinal length that is less than the first longitudinal length between the top end422and the bottom end424of the second body portion404. The top end412of the first body portion402may be elevated above the top end422of the second body portion404.

The bottom end414of the first body portion402decreasingly slopes from a first free end431toward the center C or midline of the blade430to a first portion446A of the inverted-arch curvature445. The bottom end424of the second body portion404decreasingly slopes from a second free end433toward the center C or midline of the blade430to second portion446B of the inverted-arch curvature445. The first body portion402and the second body portion404together form a longitudinally, arch shape, as best seen inFIGS. 4A-4B. The second body portion404has a cutout so that the blade clears structures radiating from the tool101. When installed, the second body portion404may be closest to the tool101.

The leg interface438includes a band450having a projection452that may be received in the guide channel192(FIG. 2B) and configured to slide along the guide channel192to pair the projection452with the guide channel end194(FIG. 2B). In operation, the leg interface438may have a poka-yoke configuration so that the modular attachment and interchange of retractor blade to a distractor provides essentially an error free interchange and attachment mechanism. The poka-yoke configuration may ensure that the blade can always be attached to the distractor leg in direction of retraction. The connection of the leg182to the leg interface448may be a non-rotational connection. The shaft section188of the leg182has a square cross-section. As best seen inFIG. 4B, the interior orifice455of the leg interface448may be essentially square shaped.

FIG. 5is a side view that illustrates a distractor580(i.e., distractor180A or180B). The leg582(i.e., leg182) may have a first distal end584and a second distal end586with a shaft section588between the first distal end584and second distal end586. The distractor580may include a hook590(i.e., hook190) at the second distal end586of the leg582. The leg582has a longitudinal length and may include a guide channel592formed along a portion of the longitudinal length. The guide channel592may include a guide channel end594. In the illustration, the hook590may be integrated with the second distal end586and the hook may be generally 90° relative to a longitudinal axis of the leg to orient a center of the hook opening generally parallel to the longitudinal axis. The distractor580may include concaved elements581for the placement of fingers or a thumb. The concaved elements581may be diametrically opposing each other on the distractor leg582. In various embodiments, the leg582has a square shape. The guide channel592may be on a first side of the leg while the concaved elements581may be on sides that are essentially perpendicular to the side of the guide channel592. In various embodiments, the leg592may include two guide channels592that are diametrically opposing each other.

InFIG. 6, the distractor680may include a leg682having a shaft section688having a first distal end684and a second distal end686. The distractor580may include a hook or eyelet690at the second distal end686of the leg682. The leg682has a longitudinal length and may include a guide channel692formed along a portion of the longitudinal length. The guide channel692may include a guide channel end694. In the illustration, the hook or eyelet690may be integrated with the second distal end686. The second distal end686includes a first angled portion686A that may form an obtuse angle with the longitudinal axis of the shaft section688. The second distal end686includes a second angled portion686B that may form a straight portion that may be generally parallel with the longitudinal axis of the shaft section688but offset. The center of the hook or eyelet690may be parallel to the longitudinal axis of the shaft section688.

The distractor680may include at least one concaved element681for the placement of fingers or a thumb. In various embodiments, the leg682has a square shape. However, other geometric shapes may be used. The guide channel692may be on a first side of the leg while the concaved element681may be on a side that are essentially perpendicular to the side of the guide channel692. The distractor may be configured to different hook shape or eyelet shapes.

The hook590or hook/eyelet690may have an opening which may be positioned in a plane below the bottom end440(FIGS. 4A and 4C-4D) of the blade or proximal the lowest point of the inverted-arch curvature.

FIGS. 7A-7Dare perspective side views that illustrate steps for assembling the components of the modular surgical instrument system.FIGS. 7A-7Billustrate the steps for pairing a respective one retractor blade730with a respective one distractor780. The projection752, shown in phantom, may be received in the guide channel792of the leg782. The projection752may slide down or along the guide channel792to the guide channel end (not shown). This may orient the hook790at a plane below or proximal the lowest point of the inverted-arch curvature745and in a direction toward the bottom end414(FIGS. 4C-4D) of the first body portion402(FIGS. 4C-4D). The leg interface (i.e., connector737) may be a docking stop member to stop a docking motion of the hollow tubular member714that is being docked onto the leg782of the distractor780.

FIG. 8is a flowchart that illustrates a method800of retracting and distracting with the system100ofFIG. 1A. The method800will be described in relation toFIGS. 1A-1B and 7A-7D. The method steps may be performed in the order shown or a different order. One or more of the steps may be performs contemporaneously. Furthermore, one or more steps may be added or omitted in an iteration. An example, application of the system100for the treatment of the spine is described in “MAST QUADRANT® Unilateral and Bilateral Techniques,” by Medtronic Safemor Danek USA, Inc., copyright date 2006, and incorporated herein by reference in its entirety.

At801, the method800may include providing and/or using the system100. At802, the patient's anatomy, such as the spine or portions of the boney structures of the spine may be measured. In some embodiments, measurement associated with a patient's height and weight may be used. The measurements of the spine or boney structures may be made using medical imaging devices, such as without limitation, a magnetic resonance imaging (MRI) device, electromagnetic radiation device or X-ray device, computed tomography (CT) scan device and/or manual surgical measuring tools. At804, the blade for the size of the anatomy of the patient may be selected. The order of steps801,802and804may be varied. Step802may be performed during surgery or as pre-operative testing and/or measuring. In some embodiments, the selection of the blade at804may be performed during surgery or during a surgery planning phase.

At806, the method800may include driving a shank of a bone fastener into a (first) pedicle. In some embodiments, the implantation of the bone fastener may have taken place using a different surgery or the same surgery and other surgical tools, such as without limitation, those described in “MAST QUADRANT® Unilateral and Bilateral Techniques,” by Medtronic Safemor Danek USA, Inc., copyright date 2006. At808, the method800may include sliding a retractor blade730or over a distractor leg782of a distractor780to pair the retractor blade730and distractor780together, as best seen inFIGS. 7A-7B. At808, the sliding the retractor blade130over the distractor leg182to pair the retractor blade130and the distractor180together may include orienting a distractor hook790at a plane below or proximal the lowest point of an inverted-arch curvature of the retractor blade730, as best seen inFIG. 7B.

At810, the method800may include attaching in situ, the distractor780to the shank of the bone fastener. At812, the method800may include attaching a medial-lateral distractor rack tool101(FIG. 1A-1B) to the distractor leg782to assemble the system100, as best seen inFIGS. 7C-7D. At812, the attaching the medial-lateral distractor rack tool101may include docking a leg-docking member709of the medial-lateral distractor rack tool101to the distractor leg782, as shown inFIG. 7C-7D.

At816, the method800may include performing distraction and retraction with the assembled system100using the paired retractor blade730and the distractor780. The modular surgical device120A (FIG. 1A-1B) may be used with a retraction blade and distractor pair for both shank-based retraction and distraction and related methods of use that can be create a distraction in the disc space while retracting fascia and/or muscles during spine surgery.

The system100may include a second retractor blade (i.e.,130B) and second distractor (i.e.,180B) pair that need pairing and attachment to the tool101. Accordingly, steps806,808,810, and812may be repeated, for example. The method may include using another bone fastener.

At814, a determination may be made whether the assembly of the system100is complete. If the determination is “YES,” the method800continues to step816. If the determination is “NO,” the method800may include repeating steps806,808,810, and812using a second bone fastener to be driven into a second pedicle or portion of the boney structures of the spine in proximity to the first pedicle, at806. In such an instance, at808, the method800may include sliding a second retractor blade130B over a second distractor leg182of a second distractor180B to pair the second retractor blade130B and second distractor180B, in the same manner as described and shown in relationFIGS. 7A-7B. In various embodiments, at808, the sliding the second retractor blade130B over the second distractor leg182to pair the second retractor blade130B and the second distractor180B together may include orienting a distractor hook190at a plane below or proximal the lowest point of an inverted-arch curvature of the retractor blade130B, as best seen inFIG. 7B.

At810, the method800may include attaching in situ, the second distractor180B to the second shank of the second bone fastener. At812, the method800may include attaching the medial-lateral distractor rack tool101to the second distractor leg182to assemble the system100, in a similar manner as described and shown in relation toFIGS. 7C-7D. At816, the method800may include performing distraction and retraction with the assembled system100using the paired second retractor blade130and the second distractor180.

In various embodiments, at812, the attaching of the medial-lateral distractor rack tool101to the second distractor leg182may include docking a second leg-docking member109B of the medial-lateral distractor rack tool101to the second distractor leg182, in a similar manner as described and shown in relation toFIGS. 7C-7D.