TLIF Extension and Laminectomy

Abstract

To provide distractor and retractor systems and methods of using the same.SOLUTION: A pedicle-based distractor assembly may include a base supporting a distraction rack, a pair of moveable arms coupled to the distraction rack, a connector at the end of each arm, each connector having a through-opening, and a pair of distractor elements each configured to attach to a pedicle screw. Each distractor element may be positioned through the through-opening in the respective connector. The distractor elements are modular such that different types of distractor elements, such as headless posts, pre-assembled posts, or minimally invasive towers, are interchangeable with the connectors. The assembly may also include a retractor assembly with a medial retractor blade for retracting soft tissue. The medial retractor blade may distally have one or more translating components for retracting soft tissue.SELECTED DRAWING: Figure 22

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. Patent Application No. 17 / 752,346, filed May 24, 2022, which is hereby incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates generally to devices and systems for performing pedicle-based surgical distraction and / or retraction and methods of use thereof. [Background technology]

[0003] Many types of spinal irregularities cause pain, limit range of motion, or damage the nervous system within the spinal column. These irregularities may result from, but are not limited to, trauma, tumors, disc degeneration, and disease. Often, these irregularities are treated through surgical procedures that may include, for example, fixing a portion of the spine. These treatments may involve, for example, replacing the damaged disc with an intervertebral implant and / or fixing the adjacent vertebrae with, for example, a combination of screws and rods. For example, to correct a collapsed disc causing impingement of one or more nerve roots, the disc space may be restored to or close to its original height, and the collapsed disc may be replaced with a device and / or bone graft material.

[0004] To perform these procedures, a surgical opening is created and a device such as a retractor may be used to enlarge the opening to facilitate access to the surgical site. Retractors typically include one or more blades that may be adjusted to establish, provide, and / or maintain a suitable opening that minimizes trauma to the surrounding tissue. For example, a distractor may be used to distract the disc space by placing a portion of the distractor between the vertebral bodies or by using pedicle screws at adjacent levels.

[0005] By using a pedicle-based system, the assembly can perform the functions of both a distractor and a retractor. For example, the pedicle screw may be configured to simultaneously facilitate distraction of the disc space, and the blade may provide soft tissue retraction. However, there is a need for an improved distractor / retractor that provides pedicle-based distraction and / or soft tissue retraction. Summary of the Invention

[0006] To meet this and other needs, devices, systems, and methods are provided for performing pedicle-based surgical distraction and / or retraction. In particular, a modular pedicle-based distraction assembly may include interchangeable distractor elements, such as a headless post, a pre-assembled post, or a minimally invasive tower. The pedicle-based distractor is configured to widen the collapsed disc space, thereby enlarging the disc space. Pedicle-based distraction also serves as a landmark method to pinpoint a surgical safe zone. In pedicle-based distraction, tissue retraction may be used to view and access the surgical site. For example, a retractor assembly may be attached to the distraction assembly. The retractor assembly may include an inner retractor blade configured to retract soft tissue.

[0007] According to one embodiment, a pedicle-based distractor and retractor system includes a distraction rack supporting a pair of side arms and a central arm, a connector at an end of each side arm, and a pair of distractor elements engaged to the connectors, each distractor element configured to be attached to a pedicle screw to provide pedicle-based distraction. The distractor and retractor system further includes a medial retractor blade coupled to the central arm, the medial retractor blade including a blade body, a blade connector, a first translation component, and a second translation component. The blade connector is coupled to a proximal end of the blade body and configured to engage the central arm. The first translation component and the second translation component are configured to engage soft tissue and each configured to move independently from a first position to a second position.

[0008] According to one embodiment, a pedicle-based distractor and retractor system includes a distraction rack supporting a pair of side arms and a central arm, a connector at an end of each side arm, and a pair of distractor elements engaged to the connectors, each distractor element configured to be attached to a pedicle screw to provide pedicle-based distraction, the central arm including a click-in connector. The distractor and retractor system further includes a medial retractor blade coupled to the central arm, the medial retractor blade including a blade body, a blade connector, a first translation component, and a second translation component. The blade connector is coupled to a proximal end of the blade body and configured to engage the central arm via the click-in connector. The first translation component and the second translation component are configured to engage soft tissue and each configured to move independently from a first position to a second position. [Brief description of the drawings]

[0009] The present embodiments will become more fully understood from the detailed description and the accompanying drawings, wherein: [Figure 1] FIG. 1 illustrates a pedicle based distractor system according to one embodiment. [Diagram 2] 2 illustrates a pair of headless post distraction elements for use with the distractor system of FIG. 1 according to one embodiment. [Figure 3A] 1A-1C are cross-sectional and distal views, respectively, of a headless post capturing the head of a pedicle screw at an open section and a contoured section, according to one embodiment, and a cross-sectional view of the headless post with a driver instrument engaged with the screw head. [Figure 3B] 1A-1C are cross-sectional and distal views, respectively, of a headless post capturing the head of a pedicle screw at an open section and a contoured section, according to one embodiment, and a cross-sectional view of the headless post with a driver instrument engaged with the screw head. [Figure 3C]1A-1C are cross-sectional and distal views, respectively, of a headless post capturing the head of a pedicle screw at an open section and a contoured section, according to one embodiment, and a cross-sectional view of the headless post with a driver instrument engaged with the screw head. [Figure 3D] 1A-1C are cross-sectional and distal views, respectively, of a headless post capturing the head of a pedicle screw at an open section and a contoured section, according to one embodiment, and a cross-sectional view of the headless post with a driver instrument engaged with the screw head. [Figure 4A] 1A-1C illustrate one embodiment of a headless post distraction assembly in an open position and a locked position, respectively. [Figure 4B] 1A-1C illustrate one embodiment of a headless post distraction assembly in an open position and a locked position, respectively. [Diagram 5] FIG. 13 is an exploded view of a headless post distraction assembly, according to one embodiment. [Figure 6A] 13A-13D are diagrams illustrating the locking interaction of the outer sleeve and screw head clamp of the headless post distraction assembly in the open and locked positions, respectively. [Figure 6B] 13A-13D are diagrams illustrating the locking interaction of the outer sleeve and screw head clamp of the headless post distraction assembly in the open and locked positions, respectively. [Figure 7A] FIG. 13 illustrates the thread angulation capabilities of the headless post distraction assembly when in the locked position. [Figure 7B] FIG. 13 illustrates the thread angulation capabilities of the headless post distraction assembly when in the locked position. [Figure 8A] 13A-13C show an MIS cap suitable for attaching the proximal end of a distraction post to an MIS sleeve adapter, according to one embodiment. [Figure 8B] 13A-13C show an MIS cap suitable for attaching the proximal end of a distraction post to an MIS sleeve adapter, according to one embodiment. [Figure 8C]13A-13C show an MIS cap suitable for attaching the proximal end of a distraction post to an MIS sleeve adapter, according to one embodiment. [Figure 9] 2 illustrates a pair of pre-assembled post distraction elements for use with the distractor system of FIG. 1 according to one embodiment. [Figure 10A] 10A-10C are perspective and cross-sectional views of the pre-assembled post of FIG. 9 threaded into the tulip of a pedicle screw according to one embodiment. [Figure 10B] 10A-10C are perspective and cross-sectional views of the pre-assembled post of FIG. 9 threaded into the tulip of a pedicle screw according to one embodiment. [Figure 10C] 10A-10C are perspective and cross-sectional views of the pre-assembled post of FIG. 9 threaded into the tulip of a pedicle screw according to one embodiment. [Figure 11] 2 illustrates a pair of MIS sleeve post distraction elements for use with the distractor system of FIG. 1 according to one embodiment. [Figure 12A] 13A-13C illustrate an MIS sleeve adaptor for holding an MIS sleeve post distraction element, according to one embodiment. [Figure 12B] 13A-13C illustrate an MIS sleeve adaptor for holding an MIS sleeve post distraction element, according to one embodiment. [Figure 13] FIG. 1 illustrates a pedicle-based distractor system with a medial blade retractor system according to one embodiment. [Figure 14A] FIG. 13 illustrates an inner blade with drop-in connections according to one embodiment. [Figure 14B] FIG. 13 illustrates an inner blade with drop-in connections according to one embodiment. [Figure 15] FIG. 13 illustrates a pedicle-based distractor system with an inner blade retractor system according to another embodiment. [Figure 16A] 1A-1D are perspective and cross-sectional views of a click-in connector for attaching an inner blade according to one embodiment. [Figure 16B]1A-1D are perspective and cross-sectional views of a click-in connector for attaching an inner blade according to one embodiment. [Figure 17] FIG. 2 depicts one embodiment of an inner blade assembly. [Figure 18A] 13A-13C illustrate the connection interaction between the inner blade and the click-in connector according to one embodiment. [Figure 18B] 13A-13C illustrate the connection interaction between the inner blade and the click-in connector according to one embodiment. [Figure 19A] 1A-1C are perspective and cross-sectional views of a traction assembly for adjusting an inner blade according to one embodiment. [Figure 19B] 1A-1C are perspective and cross-sectional views of a traction assembly for adjusting an inner blade according to one embodiment. [Figure 20A] 13A-13C show examples of translatable blade inserts that can be attached to the inner blade. [Figure 20B] 13A-13C show examples of translatable blade inserts that can be attached to the inner blade. [Figure 21A] 13A-13C show examples of translatable blade inserts that can be attached to the inner blade. [Figure 21B] 13A-13C show examples of translatable blade inserts that can be attached to the inner blade. [Figure 21C] 13A-13C show examples of translatable blade inserts that can be attached to the inner blade. [Figure 22] 21A-21C depict components of the translatable blade insert. [Figure 23A] 21A-21C depict a dovetail feature of the translatable blade insert. [Figure 23B] 21A-21C depict a dovetail feature of the translatable blade insert. [Figure 24] FIG. 13 illustrates a pedicle-based distractor system with an inner blade retractor system according to another embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The embodiments of the present disclosure are generally directed to devices, systems, and methods for distraction and / or retraction using a modular pedicle-based system. Specifically, a modular pedicle-based distractor may include a pair of distraction elements and an optional single blade retractor. The distraction elements may include, for example, a headless post, a pre-assembled post, or an MIS sleeve configured to mate with a pedicle screw to allow spinal distraction. Medial retraction with the use of a single blade retractor allows visualization of the surgical site. A medial retractor blade may be attached to the retractor with a click-in connector, and a traction assembly may be used to pivot the blade, thereby retracting the soft tissue.

[0011] In spinal fusion, a damaged disc may be removed and replaced with an intervertebral implant (e.g., a cage, spacer, vertebral body replacement, bone graft material, or other prosthesis). The adjacent vertebrae may be stabilized, for example, with a combination of screws and rods. The procedure may be performed in an open, semi-open, percutaneous, or minimally invasive surgical (MIS) procedure. As part of the procedure, distractors and / or retractors may be used to establish, enlarge, manipulate, and / or maintain a surgical opening, thereby facilitating the passage of various implant devices and associated instruments. In some instances, different distractors / retractors may be used for different surgical approaches (e.g., anterior, posterior, transforaminal, lateral) due to the various anatomical features inherent to each approach. Retractor blades may be used to hold the soft tissue and muscle, and the exact angulation of the retractor blades may depend, at least in part, on a variety of factors, including the specific patient anatomy and surgeon preference.

[0012] Minimally invasive surgery may be used in an attempt to preserve muscle anatomy by causing disruption only where necessary. The advantage of the MIS surgical approach is that it can reduce postoperative pain and shorten the patient's recovery time. Because MIS procedures require smaller incision sizes, they result in a narrower operating window when compared to more traditional surgical techniques. The result of a narrow operating window is a lack of anatomical visualization. It is important for the surgeon to be able to establish anatomical landmarks in order to work safely and successfully.

[0013] The transforaminal lumbar interbody fusion (TLIF) technique is common in spinal fusion surgery due to the MIS nature of this approach. The procedure consists of targeting the intervertebral space from a trajectory 15°-45° off the midline and then identifying the adjacent pedicles as well as the intervertebral (facet) joints. Pedicle screws are then inserted and a facetectomy is performed. The facetectomy allows the surgeon to gain access to the intervertebral space but also removes an anatomical landmark. The MIS nature of the TLIF procedure results in the need for consistent and reliable landmarks of continuous anatomical body throughout the procedure. To ensure that the borders of the surgical site are marked, the adjacent pedicles can be used as a fiducial base.

[0014] Pedicle distraction is a surgical technique that widens a collapsed disc space. Enlarging the disc space helps to complete a full discectomy, which allows for good placement of the interbody spacer. In addition to its primary purpose, pedicle distraction also serves as a landmarking method to pinpoint the surgical safe zone, since it is pedicle-based. Pedicle distraction may also require tissue retraction to view the surgical site. Therefore, a device that can achieve pedicle-based distraction and / or medial retraction may be useful.

[0015] Overall, the distractor and / or retractor systems disclosed herein can advantageously provide screw-based distraction and optional medial retraction, resulting in more precise tissue distraction and tissue retraction of adjacent bones. In particular, a pedicle-based distraction system can include a modular pedicle-based distractor that includes a pair of distraction elements and an optional single-blade retractor. When attached to the distractor body, the distraction elements can be attached to the pedicles to distract the disc space, and the medial retractor can retract soft tissue and / or muscle to visualize the surgical site.

[0016] As used herein, the terms "proximal" and "distal" are generally utilized with respect to a user (e.g., a surgeon). The distractor may generally be oriented such that the disc space is distracted in a "cephalad" and "caudal" direction. The retractor may be oriented such that the retractor blade is in an "medial" position. These and other directional terms, such as "top" and "bottom," may be used herein for purposes of explanation and do not limit the orientation in which the device may be used.

[0017] The distractor system may include various subcomponents sized to allow for enlargement of the intervertebral disc space, for example, using screw-based components that allow for distraction of adjacent bones and retraction of soft tissue and / or muscle to establish a surgical pathway through the patient's skin to a surgical target site. By way of example, the surgical target site may be the intervertebral disc space located between two adjacent vertebrae. Although particularly suited for use in transforaminal lumbar interbody fusion (TLIF), it will be readily appreciated by those skilled in the art that the distractor and / or retractor system may be used in any number of suitable orthopedic approaches and procedures, including, but not limited to, anterior, posterior, lateral, anterior-lateral, or posterolateral approaches to the lumbar, cervical, or thoracic spine, as well as any non-spinal application, such as treatment of fractures, and the like.

[0018] Referring now to the drawings, where like reference numbers refer to like elements, FIG. 1 illustrates a modular distractor system 10 configured for pedicle-based distraction according to one embodiment. The modular nature of the system 10 allows for interchangeability of different types of distraction elements 16 (headless posts 40, 80, pre-assembled posts 170, MIS towers 190, etc.), each of which interacts with a respective pedicle screw type to enable vertebral distraction. In this embodiment, FIG. 1 illustrates the distractor system 10 with a headless post 40, however, it will be understood that any of the distraction elements 16 described herein may be used in place of the post 40.

[0019] The distractor system 10 includes a frame or base 12 that supports a distraction rack 14 that allows for connection to a distraction element 16. The rack 14 allows for cephalad / caudal movement of the distraction element 16 for vertebral distraction. The rack 14 may be utilized with the distraction element 16 in one of two primary configurations: resting on the patient or connected to a table arm or other support structure (not shown). In one embodiment, the base 12 is configured to be attached to a surgical arm, such as a universal arm, that includes sufficient joints to provide a desired number of degrees of freedom to easily adjust the rack 14 across the incision in the patient. Preferably, the rack 14 is configured to be positioned in a substantially stationary position over a surgical access site.

[0020] The distractor elements 16 may be coupled to the distractor rack 14 using one or more movable arms 18. The arms 18 may move the distractor elements 16 toward or away from one another. The arms 18 also have the ability to retract the distractor elements 16 clockwise or counterclockwise. The system 10 may include one or more knobs 20 configured to manipulate each element of the distractor 10. For example, each of the respective knobs 20 may provide independent movement of the respective distractor element 16, including cranial / caudal movement, pivoting, retraction, etc., as will be appreciated by one of ordinary skill in the art.

[0021] In one embodiment, the distractor 10 utilizes a rack and pinion system for linear motion. For example, the distraction rack 14 linearly translates the side arm 18 to move the distraction element 16, thereby distracting the bone segment and enlarging the disc space. Examples of rack and pinion systems are illustrated in U.S. Patent Nos. 10,130,348 and 10,285,680, which are incorporated by reference in their entireties for all purposes. Although a distraction rack system is illustrated, it is understood that any suitable distractor / retractor known in the art may be used to move the distractor element 16. For further details of such devices, see, for example, U.S. Patent Nos. 8,968,363, 8,992,425, 10,278,786, 10,980,528, and 11,109,753, which are incorporated by reference in their entireties for all purposes.

[0022] Each distractor element 16 is configured to interface with a fastener, such as a pedicle screw 24. The pedicle screw 24 may be inserted into the pedicle of the vertebra using, for example, an MIS approach or an open approach. The fastener or pedicle screw 24 is configured to be removably attached to the distractor element 16. In one embodiment, the pedicle screw 24 may include a head portion 26 (e.g., an enlarged head) at a proximal end configured to engage the distractor element 16 and a shank or bone engaging portion 28, e.g., tapered at a distal end, configured to engage bone. The pedicle screw 24 may have a threaded portion configured to engage a pedicle within a vertebral body. The top of the head 26 defines an instrument recess 30 configured to interface with an instrument, such as a driver 70, to provide torque to the screw 24. The head portion 26 may also be threaded or non-threaded. The pedicle screw 24 may optionally be cannulated centrally along its longitudinal length from the proximal end to the distal end of the screw 24, for example, the screw 24 may be guided over a k-wire or the like. The pedicle screw 24 may be configured to provide uniplanar, biplanar, or multiaxial orientation of the shank 28. In one embodiment, the pedicle screw 24 has a tulip head 32 configured to hold a spinal rod. In this case, the tulip head 32 may allow multiaxial movement relative to the shaft 28. An example of a pedicle screw assembly is described in U.S. Pat. No. 10,575,877, which is incorporated herein by reference in its entirety for all purposes. It will be appreciated that the fastener 24 may include other fixation members, such as nails, spikes, shims, and the like.

[0023] 2, one embodiment of a distractor element 16 for use with the distractor system 10 is shown. In this embodiment, the distractor element 16 includes a pair of headless posts 40. Each headless post 40 includes a connection assembly 42 and a post 44. The connection assembly 42 includes a connector body 46 having a first end 48 configured to mate with a side arm 18 of the distractor 10. For example, the first end 48 of the connector body 46 may include a star grind (e.g., FIG. 16A) or other suitable mechanism for mating with the arm 18 or a traction assembly at the end of the arm 18. The connector body 46 may include a spring loaded button or other suitable mechanism for locking and releasing the connection assembly 42 relative to the arm 18. The connector body 46 may be bent or offset to provide a desired positioning of the distractor post 44, and the connector body 46 may be configured to provide traction (e.g., pivoting or rotating) of the distractor post 44. The connector body 46 includes a second end 50 configured to receive and / or secure the post 44. For example, the second end 50 of the connector body 46 may define a through opening 52 configured to retain the post 44 therein. The post 44 may be secured to the connector body 46 via a set screw 162, a press fit, a pin, an adhesive, or other temporary or permanent attachment. In one embodiment, the connector body 46 functions as a MIS sleeve adapter such that any distractor element 16 may be connected to the connector body 46.

[0024] The post 44 extends along a central longitudinal axis from a proximal end 54 to a distal end 56. The post 44 may be cannulated with a channel 58 defined through its length. The proximal end 54 of the post 44 is receivable in the opening 52 of the connector body 46. The distal end 56 may define an enlarged screw head receiving portion configured to receive the screw head 26 of the pedicle screw 24.

[0025] 3A-3D, the distal end 56 of the post 44 is shown in greater detail. An inner channel 58 is in fluid communication with an enlarged inner pocket or chamber 60 that terminates at the distal end 56 of the post 44. The enlarged inner chamber 60 includes an open bottom for receiving the head 26 of the pedicle screw 24. The chamber 60 includes two screw retaining sections 62, 64. The primary chamber is the open section 62 that rests on the screw head 26 and allows free movement and positioning of the post 44. The second chamber is a contoured section 64 that captures the geometry of the screw head 26 when a force is applied by the contoured surface 64 in a direction perpendicular to the body of the screw 24. The open section 62 may be generally spherical in shape and may have a volume that is greater than the volume of the contoured section 64. In particular, the open section 62 may have a depth that is greater than the depth of the contoured section 64. The contoured section 64 may be essentially spherical, having a size and shape generally dimensioned to match the contours of the screw head 26 .

[0026] FIG. 3A shows the pedicle screw 24 in its open position 62. In the open section 62, the screw 24 is free to translate into the contoured section 64. FIG. 3B shows the screw 24 moved into contact with the contoured section 64 of the post 44. The arrows between FIG. 3A and FIG. 3B indicate the direction in which force is applied from the post 44 to the screw head 26 in order for the screw 24 to interact with the post 44. The post 44 may be easily lifted off the screw 24 unless this force is applied. In the contoured position 64, the screw 24 will not remain held by the post 44 unless a force perpendicular to the axis of the screw 24 is applied. The contoured section 64 captures the shape of the screw head 26 when force is applied by the contoured surface 64 perpendicular to the body of the screw 24. The force of this surface against the head 26 of the pedicle screw 24 forms a solid platform for distraction. If this force is not applied and the screw head 26 is positioned within the pocket 60 , the screw 24 will not remain retained by the post 44 .

[0027] FIG. 3C shows a distal view of the post 44. The contoured section 64 is coaxially aligned with the channel 58, and the open section 62 is offset to the side of the contoured section 64. The edge of the open section 66 may include a beveled edge or chamfer 66, for example, to allow for polyaxial movement of the screw 24. The edge of the contoured section 64 may include a slight undercut 68 resulting from a reduction in diameter of the distal opening of the post 44. FIG. 3C shows the reduction in diameter that allows for the undercutting of the post 44. The undercut 68 of the contour 64 may allow the screw head 26 to be cupped by the contour 64 in certain configurations.

[0028] FIG. 3D shows a driver instrument 70 positioned in the recess 30 of the head 26 of the pedicle screw 24, thereby providing torque to the screw 24 and / or holding the screw 24 in the post 40. The driver 70 can fit through the cannulated portion 58 of the post 44 to reach the screw head 26, which can be useful for screw insertion. In FIG. 3D, the screw 24 is shown in contact with the contoured location 64 of the post 44, and the driver 70 is positioned through the post 44 and into the screw head 24. With the screw 24, driver 70, and post 44 all axially aligned relative to the placement of the contoured section of the screw 24, the screw 24 is held by the post 44 without applying a vertical distraction force. In one embodiment, the entire construct may be used to implant the pedicle screw 24 into the pedicle of a vertebra.

[0029] 4A-7B, a headless post assembly 80 according to another embodiment is shown. The headless post assembly 80 may connect to the connection assembly 42 in a manner similar to the headless post 40. This embodiment of the headless post 80 features a more rigid connection such that the driver 70 does not need to be inserted through the post to retain the screw 24. The headless post assembly 80 extends along a central longitudinal axis from a proximal end 82 to a distal end 84. The headless post assembly 80 includes a drive nut 86, an outer sleeve 88, an inner sleeve 90, a screw head clamp 92, and an MIS cap 94. In this embodiment, the screw head 26 is clamped by the distal end 84 of the post 80, resulting in a rigid screw and post structure.

[0030] The outer sleeve 88 extends from a proximal end 102 to a distal end 104 along a central longitudinal axis. The outer sleeve 88 is cannulated through its length and configured to receive the inner sleeve 90. The proximal end 102 of the outer sleeve 88 may include a flange 106 configured to engage the drive nut 86. The distal end 104 of the outer sleeve 88 may be flared or enlarged to receive the screw head clamp 92. An inner surface of the outer sleeve 88 may include one or more beveled surfaces 107 configured to mate with an outer beveled surface 129 on the distal end 122 of the screw head clamp 92. The outer sleeve 88 may include one or more windows 108, for example, to enable sterilization and to visualize movement of the inner sleeve 90.

[0031] The inner sleeve 90 extends from a proximal end 110 to a distal end 112 along a central longitudinal axis. The inner sleeve 90 may be cannulated through its length to receive an instrument, such as a driver 70. The inner sleeve 90 may include a threaded portion 114 near its proximal end 110. The threaded portion 114 of the inner sleeve 90 is configured to threadably mate with the drive nut 86. For example, the threaded portion 114 may include one or more external threads configured to mate with corresponding internal threads 138 inside the drive nut 86. The inner sleeve 90 may include a first non-threaded portion 116 between the proximal end 110 and the threaded portion 114. The first non-threaded portion 116 may be receivable inside the cap 94. The inner sleeve 90 may include a second non-threaded portion 118 between the threaded portion 114 and the distal end 112 of the inner sleeve 90. The second non-threaded portion 118 may have a diameter greater than the diameter of the first non-threaded portion 116 .

[0032] The screw head clamp 92 is attached to the distal end 112 of the inner sleeve 90. The screw head clamp 92 extends from a proximal end 120 to a distal end 122 along a central longitudinal axis. The screw head clamp 92 is cannulated and defines a channel 124 therethrough. The channel 124 terminates in a chamber 126 configured to hold the head 26 of the pedicle screw 24. The proximal end 120 includes a collar 128 receivable in an opening in the distal end 112 of the inner sleeve 90. The collar 128 may have a reduced diameter relative to the remainder of the screw head clamp 92. The distal end 120 may be flared or enlarged to accommodate the screw head 26. An outer portion of the distal end 120 includes one or more outer beveled surfaces 129 configured to mate with corresponding inner beveled surfaces 107 in the outer sleeve 88. The screw head clamp 92 defines one or more slits 130 through the sidewall and in fluid communication with the central channel 124 therethrough. The slits 130 extend from the distal end 122 toward the collar 128 and may define one or more spring tabs 132. The slits 130 may be equally spaced around the screw head clamp 92 or at any suitable location. In one embodiment, the screw head clamp 92 includes four spring tabs 132 oriented about a central axis. As the outer sleeve 88 is translated downward, the screw head clamp 92 compresses around the screw head 26, thereby providing a rigid connection.

[0033] A drive nut 86 is attached to the proximal end 110 of the inner sleeve 90 and the proximal end 102 of the outer sleeve 88. The drive nut 86 extends along a central longitudinal axis from a proximal end 134 to a distal end 136. The drive nut 86 is cannulated therethrough and defines an internally threaded portion 138 near the proximal end 134. The internally threaded portion 138 of the drive nut 86 mates with the external threads 114 of the inner sleeve 90. The distal end 136 of the drive nut 86 includes a radial slot 140, such as a T-slot, cut through the face of the drive nut 86 at its proximal end 136. The radial slot 140 mates with the flange 106 at the proximal end 102 of the outer sleeve 88. The outer surface of the drive nut 86 may have ridges or grooves configured to be gripped by a user, for example. Rotation of the drive nut 86 translates the inner sleeve 90 through the outer sleeve 88, thereby allowing a screw head clamp 92 to clamp around the head 26 of the screw 24. The open position is when the drive nut 86 is threaded up and the locked position is when the drive nut 86 is threaded down. The locking mechanism functions through the interaction between the outer sleeve 88 and the screw head clamp 92.

[0034] The headless post components may be assembled together in the following order: drive nut 86, outer sleeve 88, inner sleeve 90, screw head clamp 92, and MIS cap 94. The drive nut 86 may have a radial T-slot 140 cut through one face that captures the top flange 106 of the outer sleeve 88. The drive nut 86 and outer sleeve 88 are capable of rotating independently. Once connected, the assembled drive nut 86 and outer sleeve 88 are threaded into the inner sleeve 90 such that the distal end 104 of the outer sleeve 88 is above the distal end 112 of the inner sleeve 90. The screw head clamp 92 may then be placed into the inner sleeve 90 and welded into place. The drive nut 86 is then threaded towards the distal end 112 of the inner sleeve 90 such that the proximal end 110 of the inner sleeve 90 can be placed through the MIS cap 94 and welded therein. Although welding is illustrated, any suitable attachment may be used. This assembled structure forms a rigid headless post assembly 80 for securing the pedicle screws 24 .

[0035] As shown in Figures 4A and 6A, the post 80 is in its unlocked position. The outer sleeve 88 is raised above the screw head clamp 92. In the open position, the screw head 26 is free to be inserted into or removed from the inner distal chamber 126 of the screw head clamp 92. In Figures 4B and 6B, the post 80 is in a locked position. The outer sleeve 88 is lowered onto the screw head clamp 92. As the outer sleeve 88 is forced downward by the drive nut 86, the inclined surfaces 107, 129 of the outer sleeve 88 and the screw head clamp 92 come into contact. As the outer sleeve 88 is threaded into the screw head clamp 92, the spring tabs 132 expand inward, resulting in a clamping force against the screw head 26. The inner portion 126 of the screw head clamp 92 may include a spherical contour that fits over the head 26 of the screw 24. As best seen in Figures 7A-7B, this spherical profile flares out towards the apex, allowing the screw 24 to be positioned at various angles within the construct, even when locked. The driver 70 can only be placed through the construct in an axially aligned position. A construct with the driver 70 can be used to implant the screw 24. The off-axis aligned configuration can be useful once the screw 24 is placed and an alternate orientation of the post 80 is desired for distraction purposes.

[0036] As best seen in FIG. 8A , the MIS cap 94 is configured to mate with a corresponding opening 52 in the connector body 46, thereby securing the post 80 to the distractor 10. The cap 94 may include a proximal end or upper surface 142 and an opposite distal end or lower surface 144. The cap 94 may define a central through opening 146 between the upper surface 142 and the lower surface 144 along a central longitudinal axis. The through opening 146 is configured to receive the non-threaded portion 116 of the inner sleeve 90 through the lower surface 144 of the cap 94. Although a headless post assembly 80 is illustrated, it will be understood that the cap 94 may be used with other distractor elements 16. For example, in the case of a headless post 40, the proximal end 54 of the post 44 may be replaced by or positioned within the cap 94 as a distractor post connection feature.

[0037] The outer contour of the cap 94 is configured to mimic the corresponding opening 52 of the connector body 46. In this manner, the connection assembly 42 may function as an MIS sleeve adapter. Because the MIS contour of the sleeve matches the MIS contour of the proximal end of the distractor element 16, the headless posts 40, 80, pre-assembled posts 170, MIS sleeves 190, etc. may all be used with the same connection assembly 42. In particular, the contour of the cap may mimic the MIS tower 190, which allows various types of distractor elements 16 to all be used interchangeably with the same connection assembly 42.

[0038] In one embodiment, the cap 94 has a bow-tie-like shape that mimics a similar shape of the opening 52. In particular, the cap 94 may include a pair of opposing wings 148 defined by opposing recesses 150. The wings 148 may have convexly curved sides that mate with corresponding concave curves 152 in the opening 52. The wings 148 may extend between the upper surface 142 and the lower surface 144 of the cap 94. The opposing recesses 150 may be recessed into the body while also providing convexly curved sides that mate with corresponding concave curves 154 in the opening 52. The opposing curves 154 may be oriented at 90° relative to the opposing curves 152. The recesses 150 may be provided along an upper portion of the cap 94. The lower portion of the cap 94 aligned with one of the recesses 150 may include a flat surface 156 having a hole 158. The opposite side of the cap 94 may include a ledge or shelf 160 that is receivable in a corresponding notch in the connector body 46. As best seen in FIG. 8C, the cap 94 may be retained in the opening 52 through the connector body 46 via the ledge 160 and / or set screw 162. The set screw 162 threads through a hole 164 and has one end receivable in a hole 158 in the cap 94. The placement and position of the post 80 within the sleeve 46 may be controlled by the ledge 160 and flats 156 present on both the cap 94 and the sleeve 46. The entire structure, when connected to a distraction assembly, such as the distractor rack system 10, forms a rigid connection suitable for vertebral distraction.

[0039] 9, another embodiment of the distractor element 16 for use with the distractor system 10 is shown. In this embodiment, the distractor element 16 includes a pair of preassembled posts 170. The preassembled post assemblies 170 may connect to the connection assembly 42 in a manner similar to the headless posts 40, 80. Each preassembled post assembly 170 extends along a central longitudinal axis from a proximal end 172 to a distal end 174. The preassembled post assemblies 170 may include an inner sleeve or post 176 positioned through an outer sleeve or countertorque sleeve 178. In this embodiment, the post assemblies 170 are attached to the tulips 32 of the pedicle screws 24 to provide vertebral distraction.

[0040] 10A-10C, a preassembled post 176 interacts with the screw 24 via the threads on the tulip 32. As best seen in FIG. 10A, the distal end 174 of the post 176 includes an externally threaded portion 180 that matches the internal threads of the preassembled tulip 32. Once the preassembled post 176 is screwed into place, the post 176 is free to rotate with the tulip 32. This may be useful for non-parallel distraction of the distractor element 16. If parallel distraction is desired, an instrument such as a driver 70 may be placed through the cannula of the post 176. This may also be useful for accessing the recess 30 of the screw head 26 for inserting the screw.

[0041] To aid in removal of the post 176, the post 176 may be placed through an outer counter torque sleeve 178. As best seen in FIG. 10C, the distal end of the counter torque sleeve 178 includes a pair of opposing prongs 182 sized and dimensioned to fit into the space between the arms of the tulip 32. The outer sleeve 178 is free to rotate and translate along with the inner sleeve 176. When lowered into place, the prongs 182 of the outer sleeve 178 are received within the space between the arms of the tulip 32. When the counter torque sleeve 178 is dropped into place and held on top (to prevent rotation), the post 176 is able to rotate independently of the tulip 32. When not in use, the counter torque sleeve 178 is lifted upward. 10B, a threaded portion 184 may be provided on the top of the post 176 to mate with corresponding threads on the inside of the outer sleeve 178, thereby retaining the outer sleeve 178 on the top of the post 176. The threaded interface 184 may be a dual thread or other suitable mating surface for securing the outer sleeve 178 to the inner sleeve 176.

[0042] 11, another embodiment of the distractor element 16 for use with the distractor system 10 is shown. In this embodiment, the distractor element 16 includes an MIS tower 190. The MIS tower 190 may include a pair of tulip extenders 192 attached to or integrally formed with the arms of the tulip head 32 with a gap therebetween. The MIS extenders 192 may be configured to retract tissue and provide an unobstructed channel 194 for inserting an instrument, such as a screwdriver or other suitable instrumentation. The extenders 192 are configured to be removable from the tulip 32 such that the extenders 192 can be broken and removed from the tulip 32 after use. Examples of such extenders are described in more detail, for example, in U.S. Pat. No. 10,398,454, which is incorporated herein by reference in its entirety for all purposes.

[0043] Similar to the headless posts 40, 80 and pre-assembly post 170, each MIS tower 190 may be connected to the distractor 10 using a connection assembly 42. In this embodiment, the connection assembly 42 functions as an MIS sleeve that interacts with the screw 24 through the MIS tower 190. The extender 192 is receivable through the opening 52 of the connector body 46. The extender 192 may be movable through the opening 52 such that the connector body 46 is not attached to the proximal end of the MIS tower 190. In other words, the connector body 46 may be located at any suitable location along the length of the MIS tower 190. The sleeve 42 slides over the tower 190, thereby allowing for distraction.

[0044] With emphasis on FIGS. 12A-12B, the MIS adaptor or sleeve 42 defines an opening contour 52 that matches the opening contour of the outer contour of the tower 190. Similar to the connector opening 52 shown in FIG. 8B, the opening 52 defines a wing-like recess having opposing concave curves 152 configured to receive each of the extenders 192. The opening 52 also defines a recess having opposing curves 154 to maintain access through the channel 194 between the extenders 192. In this manner, an instrument such as the driver 70 can access the top of the screw head 26. The connector 46 may optionally include a mounting region 196, defining a slot, for example, for holding an optional retractor blade. The entire structure forms a moveable connection suitable for vertebral distraction when connected to a distraction assembly, such as the distractor rack system 10. The distractor rack system 10 may allow for cephalad / caudal movement and / or retraction of the tower 190 for vertebral distraction.

[0045] 13, a distractor and retractor system 200 is shown according to one embodiment. In this embodiment, the distractor system 10 is combined with a retraction system 202. This provides a compact package of vertebral distraction with medial retraction. The modular nature of the system 200 allows for the interchangeability of different types of distraction elements 16, i.e., headless posts 40, 80, pre-assembled posts 170, MIS towers 190, etc., in combination with the retraction system 202. In this embodiment, FIG. 13 shows the distractor and retractor system 200 with a headless post 40, however, it will be understood that any of the distraction elements 16 described herein may be used in place of the post 40.

[0046] The distraction rack 22 may be connected to the retraction base 204. For example, the retraction base 204 may be releasably coupled to the distractor base 12 using a mounting shaft 206 (shown in FIG. 1 ) that projects upwardly from the base 12. In this manner, the retraction base 204 may be positioned above the distraction base 12 and the distraction rack 22 to support the retraction blades 208. Generally, the retraction base 204 provides a scaffolding for holding the various components together and one or more mechanisms for operating the retraction system 202. The ability to fasten the retraction system 202 to the distraction system 10 creates versatility at the surgeon's discretion and provides multiple effective uses for the device.

[0047] The base 204 provides a mechanism for retracting tissue and / or muscle and expanding the surgical pathway by moving the blade 208. In one embodiment, the retraction base 204 may utilize a single blade 208 to retract tissue. The blade 208 may be an inner blade configured to provide visualization of the surgical site. The base 204 may include an arm 210 configured to support and move the blade 208. The base 204 may include one or more knobs 212, similar to the knobs 20, configured to manipulate each of the elements of the retractor 202. For example, each of the respective knobs 212 may provide independent movement of the blade 208, including medial / lateral movement, pivoting, retraction, etc.

[0048] In one embodiment, medial retraction is accomplished via a self-locking rack and pinion system for linear motion. For example, the retractor 202 may utilize a retraction rack 214 to translate the arms 210 and move the blades 208, thereby retracting tissue. The rack and pinion system may be the same or similar to that used in the distraction system 10. Although a retraction rack system is illustrated, it will be understood that any suitable distractor / retractor may be used to move the retractor blades 208 to their desired position.

[0049] If present, the inner retractor blade 208 may allow visualization of the surgical site. Generally, the retractor blade 208 has a first proximal end portion 216 configured to engage the arm 210 and a second distal end portion 218 configured to retract tissue. The blade 208 also includes an inner surface, an outer surface, and a longitudinal axis that extends the length of the blade 208 from the proximal end 216 to the opposite distal end 218. Different blade geometries may be used based on the patient's anatomy and the surgeon's preferences. The type, size, and shape of the surgical retractor blade 208 may be selected and changed or updated during a surgical procedure.

[0050] The overall system 200 includes a modular pedicle-based distractor 10 that includes multiple styles of distraction elements 16 and a single blade retractor 202. The modular system 200 allows for pedicle distraction and / or medial retraction, for example, for TLIF procedures. The unique thread interface geometry of each post 40, 80, 170 and sleeve 46 allows modularity between devices. The distraction elements 16 can be fixed position devices that provide rigidity to the entire distraction assembly 10. Rigidity also provides more tactile feedback regarding the threads and distraction force. Pedicle-based distraction identifies anatomical landmarks while widening the disc space through the use of the distraction posts 40, 80, 170 or MIS tower 190. Medial retraction through the use of a single retractor blade 208 allows visualization of the surgical site. It will be understood that the resulting configuration of the system 200 is based on the surgeon's preference, and that the pedicle-based distraction system 10 and the medial retraction system 202 may be used separately, individually, or together in combination.

[0051] 14A-14B, a drop-in style connection of the stationary inner blade 208 is shown according to one embodiment. For example, the end of the arm 210 may include a mounting member 220 configured to hold the blade 208. The mounting member 220 may include one or more tracks 222 for holding corresponding rails 224 on the proximal end 216 of the blade 208. For example, the mounting member 220 may include a pair of opposing female tracks 222 for receiving corresponding male rails 224 on the edge of the blade 208. In this manner, the rails 224 slide into the tracks 222 in the mounting member 220, thereby securing the stationary blade 208 to the end of the arm 210. It will be appreciated that the track and rail system may be inverted on the component or otherwise configured to secure the blade 208 to the mounting member 220.

[0052] 15, a distractor and retractor system 300 according to another embodiment is shown. In this embodiment, the distractor system 10 is combined with a retraction system 302. The retraction system 302 is similar to the retraction system 202, except that the base 12 of the distractor 10 forms part of the retraction system 302, thereby streamlining and simplifying the overall footprint of the device. As with system 200, the modularity of the system 300 allows for the interchangeability of different types of distraction elements 16 combined with the retraction system 302. In this embodiment, FIG. 15 illustrates the distractor and retractor system 300 with the distraction elements 16 omitted for clarity, although it will be understood that any of the distraction elements 16 may be positioned within the openings 52 for pedicle-based distraction in the manner described herein.

[0053] The medial retraction system 302 includes a medial blade 304 and a medial blade connector 306. The connector 306 provides an intuitive way to connect the medial blade 304 to the retractor to prevent retracted tissue from escaping under the blade 304. The retraction system 302 may be coupled to the distraction base 12. A central arm 308 may couple the base 12 to the connector 306. The retraction system 302 may include one or more knobs 312, similar to the knobs 20, 212, configured to manipulate each of the elements of the retractor 302. For example, each respective knob 312 may provide independent movement of the blade 304, including medial / lateral movement, pivoting, retraction, etc.

[0054] If present, the inner retractor blade 304 may allow visualization of the surgical site. Generally, the retractor blade 304 has a first proximal end portion 316 configured to engage the connector 306 and a second distal end portion 318 configured to retract tissue. The blade member 304 also includes an inner surface 320, an outer surface 322, and a longitudinal axis that extends the length of the blade 304 from the proximal end 316 to the opposite distal end 318. Different blade geometries may be used based on the patient's anatomy and the surgeon's preferences. The type, size, and shape of the surgical retractor blade 308 may be selected and changed or updated during a surgical procedure.

[0055] 16A-16B, there is shown a click-in connector 330 according to one embodiment. In this embodiment, the inner blade assembly 304 is attached to the arm 308 of the retractor system 302 using a click-in connector 330 that replaces the drop-in track rail system shown in Figures 14A-14B. The click-in connector 330 includes a connecting body 332, a spring 334, a button 336, a retaining washer 338, a wave spring 340, a star grinding material 342, and a pin 344.

[0056] The connector body 332 extends along a longitudinal axis from a first end 346 configured to engage a portion of the retractor system 302 (e.g., a towing assembly 390) to a second end 348 configured to engage the inner blade 304. The connector body 332 includes a gear 350 at the first end 346 and an axial opening 352 at the second end 348. The gear 350 includes a plurality of gear teeth disposed about a gear segment at the first end 346 from a top surface to a bottom surface of the connector body 332. The gear 350 is configured to engage a corresponding worm gear 394 on the towing assembly 390. The gear 350 is capable of pivoting about a rotation axis A1 defined by the opening 354. The rotation axis A1 may be substantially perpendicular to the longitudinal axis of the connector body 332. The opening 354 is surrounded on either side by recesses 355 that are configured to receive respective Belleville washers 396 (see FIG. 19A ) that, together with screws 398 , pivotally secure the connector body 332 to the towing assembly 390 .

[0057] An axial opening 352 at the opposite end 348 of the connector body 332 is sized and configured to accommodate the internal components 338, 340, 342 and to receive at least a portion of the shaft 380 of the blade 304 (e.g., a portion of the shaft 380 that protrudes into the second end 348 of the connector body 332). The connector body 332 includes an upper bump-out 356 for retaining the button assembly 336. The upper bump-out 356 may extend the height and width of the connector 332. The upper bump-out 356 defines a cavity 358 configured to receive the button 336 and the spring 334. The cavity 358 may be aligned approximately perpendicular to the longitudinal axis of the connector 332. The connector body 332 also defines one or more pin holes 360 configured to receive the pins 344 that secure the star grinding material 342 to the distal end 348 of the connector body 332.

[0058] The button 336 includes an upper surface 362 configured to be depressed by a user and a lower surface 364 receivable within a cavity 358 in the connector 332. One surface of the button 336 may define a cutout area 366 configured to receive a portion of the washer 338. The cutout area 366 defines a through opening 368 configured to receive the shaft 380 of the blade 304. The lower surface 364 may include an overhang facing the star grinding material 342 configured to hook under the washer 338. The opposite surface of the button 336 may define an upper protrusion 370 having a pocket for receiving one end of the spring 334. The other end of the spring 334 may be secured within the cavity 358 using, for example, a dowel 359 or other suitable mechanism.

[0059] The star abrasive 342, wave spring 340, and washer 338 fit into the opening 352 of the connector 332. The washer 338 includes a ring having a through opening 372 for receiving the shaft 380 of the blade 304. The wave spring 344 includes a coiled wave spring, such as a single or multi-turn wave spring, having a through opening 374 for receiving the shaft 380 of the blade assembly 304. The star abrasive 342 includes a distal surface 376 having a plurality of protrusions (e.g., bumps, peaks, teeth, and / or ridges) and / or receptacles (e.g., valleys, channels, depressions, and / or grooves) of a star abrasive pattern extending radially around the through opening 378, for example. The star abrasive surface 376 may be configured to interdigitate and / or interdigitate with a corresponding star abrasive surface 388 on the blade 304. The star abrasive interfaces 376 , 388 allow the blade 304 to be rotationally locked with the connecting assembly 306 .

[0060] The click-in connector assembly 330 may be assembled as follows: The spring 334 is placed on the dowel 359 of the connection body 332. The button 336 is then placed in the cavity 358 of the connection body 332 so that the spring 334 is located in the pocket 370 of the button 336. While pressing the button 336 downwards, the retaining washer 338 is pressed into the connection body 332 to retain the button 336. Next, the wave spring 340 is placed in the connection body 332, followed by the star-shaped grinding material 342. Next, the pin 344 is pressed into the connection body 332 to retain the star-shaped grinding material 342. A cross section of the assembled connector 330 is shown in FIG. 16B.

[0061] 17, the blade member 304 includes a blade portion 314 and a connecting portion 324 configured to mate with the click-in connector 330. The connecting portion 324 may include a shaft 380 that projects outwardly from an outer surface 322 of the blade portion 314 near the proximal end 316 of the blade 304. The shaft 380 may be aligned generally transversely (e.g., perpendicularly) to the longitudinal axis of the blade portion 314. The shaft 380 may be generally elongated and / or at least partially cylindrical and is receivable within an axial opening 352 in the click-in connector 332. The free end of the shaft 380 may include a tapered distal tip 382 having a circumferential channel or groove 384 on its outer surface. The groove 384 may extend partially or entirely around the circumference of the shaft 380 and is configured to mate with an opening 368 in the button 336. The blade 304 includes a star abrasive 388 sized and dimensioned to correspond to and mate with the star abrasive 376 on the connector 330. The star abrasive 388 may be formed with a plurality of protrusions (e.g., bumps, peaks, teeth, and / or ridges) and / or receptacles (e.g., valleys, grooves, depressions, and / or grooves) interspersed therebetween that correspond to the opposing star abrasive 342. The star abrasive 380 may extend radially outward from the shaft 380. In addition to the automatic spring loaded button mechanism 336, the blade member 304 is held in place by interference between the star abrasive 388 on the blade member 304 and the corresponding star abrasive 342 on the connector 330.

[0062] 18A-18B show the connection interaction between the inner blade 304 and the click-in connector 330. As best seen in FIG. 18A, the shaft 380 is aligned with the axial opening 352 of the connector 332. The tip 382 of the shaft 380 is inserted through the opening 378 of the star grinder 342, through the opening 374 of the wave spring 340, through the opening 372 of the washer 338, through the opening 368 of the button 336, and into the axial opening 352 through the connector body 332. As shown in FIG. 18B, the shaft 380 is receivable through the connector body 332 and is free to rotate about its axis. When locked, the star grinders 376, 388 interlock and the button 336 is locked into the groove 384, thereby securing the shaft 380 to the connector body 332.

[0063] 19A-19B, the connector 330 is coupled to a traction assembly 390 to provide traction capability to the blade 304. This is accomplished by gear teeth 350 cut into the rear of the connector body 332, which interact with a worm gear type traction assembly 390. The traction assembly 390 includes an inner rack or traction body 392, a worm 394, a Belleville washer 396, a screw 398, a wave spring 402, and a set screw 404.

[0064] The inner rack or towing body 392 includes a proximal end 406 and a distal end 408 with a longitudinal axis therebetween. The proximal end 406 includes a threaded portion 410 for securing the towing body 392 to the inner arm 308. Alternatively, the towing body 392 may be integrally formed with the inner arm 308 or otherwise configured to couple to the retraction system 302 (e.g., the base 12). The distal end 408 includes a pair of arms 412 having a gap therebetween configured to receive the proximal end 346 of the connector body 332. The arms 412 may be vertically oriented such that the gap extends from the distal end 408 between the upper and lower surfaces of the body 392. The gap terminates in a through cavity 414 configured to receive the worm gear 394. The cavity 414 may be generally cylindrical in shape to mimic the profile of the worm 394. The arm 412 defines one or more threaded openings 416 for retaining screws 398 for pivotally securing the connector body 332 to the towing assembly 390 .

[0065] The worm 394 is receivable within a cavity 414 in the towing body 392. The worm 394 may include a lower worm gear 418 configured to interact with the gear 350 of the connecting body 332. The worm gear 418 may have a generally cylindrical body with one or more external threads. The gears 350, 418 have non-parallel, non-intersecting bodies oriented at 90° to one another. The worm 394 acts as a drive component such that the threads of the worm gear 418 advance the teeth of the gear 350, thereby causing the connector body 332 to pivot about the axis of rotation A1. An upper portion of the worm 394 includes an instrument engaging surface such as the knob 312. The knob 312 may be hexagonal, round, square, or otherwise configured to be rotated by an instrument. A flange 420 may separate the upper knob 312 from the lower worm gear 418. A flange 420 may rest on top of the towing body 392, thereby hiding the internal components. The worm 394 is attached to the towing body 392 by a wave spring 402 and a set screw 404. The set screw 404 may have a shaft 422 with an enlarged head 424. The shaft 422 is receivable in an opening through the bottom of the worm gear 418. The wave spring 402 abuts the enlarged head 424 which seats in a recess in the towing body 392, thereby securing the worm 394 to the towing body 392 while still allowing rotational movement.

[0066] To assemble the connector body 332 to the towing assembly 390, the Belleville washers 396 are placed in the respective recesses 355 around the openings 354 of the connector body 332. The Belleville washers 396 or conical spring washers may have a frusto-conical shape. The connector body 332 is then placed in the slots between the arms 412 of the towing body 392. The screw 398 is placed through both the towing body 392 and the connector body 332 and threaded into the towing body 392 to fasten the connector body 332 together. To assemble the worm gear 394 to the towing body 392, the worm 394 is placed in the towing body 392 by threading it into the gear portion 350 of the connector body 332. The wave spring 402 is placed over the set screw 404 and the set screw 404 is threaded into the worm 394 until the set screw 404 is flush with the towing body 392. A cross section of the assembled state is shown in FIG. 19B. In this manner, rotation of the worm 394 (eg, via the knob 312 ) causes pivoting movement of the connecting body 332 and attached blade 304 , thereby providing traction on the inner blade 304 .

[0067] 20A-20B, the blade 304 may be augmented with one or more blade inserts 430 configured to increase the length and / or width of the blade 304. The blade inserts 430 may connect to the blade portion 314 and function as a translating component, for example, at the distal end 318 of the blade 304. Depending on preference, the blade 304 may hold a single translating insert 430, two translating inserts 430, or three or more translating inserts 430. Any embodiment that includes two or more translating inserts 430 maintains independent translation between the components. In FIG. 17, two independently translating inserts 430 are attached to the distal end 318 of the blade 304. FIG. 20A shows a single insert 430 inserted into the blade portion 314, while FIG. 20B shows another style of blade insert 430.

[0068] The inner surface 320 of the blade portion 314 defines one or more slots 432 extending longitudinally along the length of the blade 314. As shown in FIG. 20A, the inner surface 320 may define, for example, a pair of slots 432 positioned near the sides of the blade 314. The slots 432 may be generally parallel to one another. Each slot 432 may open at the proximal end 316 of the blade 314 and extend a length toward the opposite end 318, but may stop short of the distal end 318. The slots 432 may be T-slots with a wider neck near the proximal end 316 of the blade 314. The T-slots 432 are configured to receive a straight bar 434 on the back side of the insert 430. Each T-slot 432 may define a translation opening 436 along its longitudinal length. These translating inserts 430 translate within T-slots 432 and may also have a pin 438 on the rear side that fits within a translation opening 436 in the inner blade 304 .

[0069] Each blade insert 430 includes a proximal end 440 and a distal end 442. The blade insert 430 may be curved or contoured about its longitudinal axis. The blade insert 430 may have any suitable width and length to modify the blade portion 314. In one embodiment shown in FIG. 20A, the blade insert 430 may have a width less than the width of the blade portion 314 and a length less than the length of the blade portion 314. In this manner, a pair of blade inserts 430 may be held side-by-side as shown in FIG. 17 to extend the overall length of the blade 304. In the embodiment shown in FIG. 20B, the blade insert 430 may have a width less than the width of the blade portion 314 and a length greater than the length of the blade portion 314. It will be appreciated that any suitable blade insert 430 may be used for the desired surgical outcome.

[0070] When the insert 430 is assembled to the blade portion 314, the distal end 442 of the insert 430 aligns with the proximal end 316 of the blade portion 314. As best seen in FIG. 17, once the bar 434 is aligned with the slot 432 and the insert 430 is slid downward, the distal tip 442 of the insert 430 may project downward beyond the distal end 318 of the blade portion 314 depending on its length. FIG. 20A shows how the translation insert 430 of the inner blade 304 is positioned within the blade 314 through the T-slot 432. Once the insert 430 is positioned far enough within the blade 314, the pin 438 of the insert 430 engages with the opening 436 of the blade 304. This interaction locks the insert 430 within the blade 314 within its range of motion. The range of motion depends on the length of the opening 436, thereby providing linear translation of the insert(s) 430.

[0071] 21A-21C, an alternative inner blade 502 is shown consistent with the principles of the present disclosure. The blade 502 may connect to a click-in connector 330. The blade 502 has translation components 504 and 506 at a distal end 508 of the blade 502. The blade 502 features a corresponding star grind 510 that interfaces with the star grind 376 (see, e.g., FIGS. 16A-16B) of the click-in connector 330 described above. This allows the blade 502 to be rotationally locked once the shaft 512 of the blade 502 is connected to the click-in connector 330. The star grind 510 and shaft 512 together may be considered an inner blade connector used to connect to the click-in connector 330.

[0072] As further shown in Figures 21A-21C, there are two independently translating components 504 and 506 at the distal end 508 of blade 502. For example, Figure 21A shows both translating components 504 and 506 in a first, or retracted, position, and Figure 21B shows both translating components 504 and 506 in a second, or extended, position. Because of the independent translation, each translating component may be retracted or extended separately. For example, Figure 21C shows translating component 504 retracted and translating component 506 extended.

[0073] Alternatively, other variations of blade 502 may be used where there is either a single translation component or more than two translation components. In such variations including two or more translation components, the translation components maintain independent split translation between the components.

[0074] 22 shows an exploded view of blade 502. Translation components 504 and 506 may translate in slots keyed to dovetail features. Translation components 504 and 506 may be retained by screws and nuts. Blade 502 may include a blade body 514, shaft threads 516, star grinding material 510, shaft 512, translation components 504 and 506, with screws and nuts shown to retain the translation components within blade body 514.

[0075] To assemble the blade 502, the star grinding material 510 and the shaft 512 may be attached to the proximal end of the blade 502 through a screw 516. For example, a hexagonal feature on the shaft 512 may be aligned with a hexagonal feature of the star grinding material 510. After the hexagonal features are aligned, the screw 516 is tightened through the proximal end of the blade 502 and the star grinding material 510 into the shaft 512.

[0076] The blade body 514 may have dovetail features that engage with corresponding dovetail features on the translation components 504 and 506. For example, a dovetail slot 518 of the translation component 506 may be aligned with a dovetail slot of the blade body 514. Following alignment, the translation component is slid to bottom out on the blade body 514 and then held in place by tightening a screw into a nut through the distal end of the blade. The range of motion of the translation component 506 depends on the length of the slot 520 as well as its position from the bottom based on the geometry of the blade body 514. The translation component 504 may be attached in a similar manner.

[0077] The dovetail slot 518 of the translation component 506 and the dovetail slot 522 of the blade body 514 are shown in more detail in Figures 23A and 23B. The dovetail feature allows the translation sliders to maintain a straight path of travel throughout their translation.

[0078] FIG. 24 illustrates a distractor and retractor assembly 600 that is similar to the distractor assembly 300 but has an inner blade 502 .

[0079] Components of all devices disclosed herein may be made from any suitable material, including metals (e.g., titanium), metal alloys (e.g., stainless steel, cobalt-chromium, and titanium alloys), ceramics, polymers (e.g., polyetheretherketone (PEEK), polyphenylenesulfone (PPSU), polysulfone (PSU), polycarbonate (PC), polyetherimide (PEI), polypropylene (PP), polyacetal, or mixtures or copolymers thereof), and / or combinations thereof. In some embodiments, the devices may include radiolucent and / or radiopaque materials. Components may also be machined and / or manufactured using any suitable techniques.

[0080] Advantageously, the distractor and / or retractor systems and associated devices described herein can be used with a number of different implants and devices. For example, the distractor / retractor system can be used to provide access to a surgical site so that fixation devices, such as cages or spacers, or stand-alone devices can be provided. In addition, the distractor / retractor system can be used to provide access to a variety of other devices, including, but not limited to, rods, screws (e.g., pedicle screws, cortical screws, etc.), plates, and various other implants used in spinal surgery or other orthopedic applications.

[0081] Although the present invention has been described in detail and with reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the present invention. Accordingly, it is intended that the present invention covers the modifications and variations of the present invention provided within the scope of the appended claims and their equivalents. It is intended that the elements of the various devices disclosed above can be combined and rearranged in any suitable configuration.

Claims

1. a distraction rack supporting a pair of side arms and a central arm, a connector at an end of each side arm, and a pair of distractor elements engaging the connectors, each distractor element configured to attach to a pedicle screw to provide pedicle-based distraction; a medial retractor blade coupled to the central arm, the medial retractor blade including a blade body, a blade connector, a first translation component, and a second translation component; the blade connector is coupled to a proximal end of the blade body and configured to engage the central arm; A pedicle-based distractor and retractor system, wherein the first translation component and the second translation component are configured to engage soft tissue and each are configured to move independently from a retracted position to an extended position along a longitudinal axis of the blade body.

2. The blade connector includes a mating member having a mating surface that mates with a mated surface on the blade body, and a shaft. The system of claim 1 , wherein the mated surface and the mating surface intermesh to rotationally lock the blade body with the blade connector.

3. The system of claim 2 , wherein the shaft is receivable within an axial opening in the central arm.

4. The system of claim 2 , wherein the shaft includes a tapered distal tip having a circumferential groove.

5. The system described in claim 4, wherein the central arm includes a button, the button defining an opening configured to receive the shaft, and when locked, the button locks within the circumferential groove of the shaft.

6. The system of claim 5 , wherein the central arm includes a wave spring and a washer positioned between the mating member and the button.

7. The system of claim 1 , wherein the central arm includes a click-in connector configured to engage and retain the blade connector.

8. The system of claim 1 , wherein the first translation component and the second translation component include dovetail slots that engage complementary dovetail features on a distal end of the blade body.

9. The system of claim 1 , wherein the first translation component is disposed adjacent to the second translation component.

10. a distraction rack supporting a pair of side arms and a central arm, a connector at an end of each side arm, and a pair of distractor elements engaging the connectors, each distractor element configured to attach to a pedicle screw to provide pedicle based distraction, the central arm including a click-in connector; 1. A pedicle based distractor and retractor system comprising: a medial retractor blade coupled to the central arm, the medial retractor blade including a blade body, a blade connector, a first translation component, and a second translation component; the blade connector is coupled to a proximal end of the blade body and configured to engage the central arm via the click-in connector; A pedicle-based distractor and retractor system, wherein the first translation component and the second translation component are configured to engage soft tissue and each are configured to move independently from a retracted position to an extended position along a longitudinal axis of the blade body.

11. The blade connector includes a mating member having a mating surface that mates with a mated surface on the blade body, and a shaft. The system of claim 10 , wherein the mated surface and the mating surface interlock to rotationally lock the blade body with the blade connector.

12. The system of claim 11 , wherein the shaft is receivable within an axial opening in the central arm.

13. The system of claim 11 , wherein the shaft includes a tapered distal tip having a circumferential groove.

14. 14. The system of claim 13, wherein the click-in connector includes a button defining an opening configured to receive the shaft, and when locked, the button locks within the circumferential groove of the shaft.

15. The system of claim 14 , wherein the central arm includes a wave spring and a washer positioned between the mating member and the button.

16. The system of claim 10 , wherein the click-in connector is configured to engage and retain the blade connector.

17. The system of claim 10 , wherein the first translation component and the second translation component include dovetail slots that engage complementary dovetail features on a distal end of the blade body.

18. The system of claim 10 , wherein the first translation component is disposed adjacent to the second translation component.

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