Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
  • A61B17/3421—Cannulas
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
  • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
  • A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
  • A61B17/7082—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
  • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
  • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00867—Material properties shape memory effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00946—Material properties malleable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
  • A61B17/025—Joint distractors
  • A61B2017/0256—Joint distractors for the spine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
  • A61B17/025—Joint distractors
  • A61B2017/0256—Joint distractors for the spine
  • A61B2017/0262—Joint distractors for the spine with a provision for protecting nerves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
  • A61B17/3421—Cannulas
  • A61B2017/3443—Cannulas with means for adjusting the length of a cannula

Definitions

• This disclosure relates generally to surgical instruments, systems, and methods, and more particularly to instruments, systems, and methods for stabilization of a surgical access port that can be used in various procedures, e.g., orthopedic or neurologic surgical procedures such as spinal fusion surgery.
• Surgical procedures are used to treat and cure a wide range of diseases, conditions, and injuries. Surgery often requires access to internal tissue through open or minimally invasive surgical procedures.
• minimally invasive refers to all types of minimally invasive surgical procedures, including endoscopic, laparoscopic, arthroscopic, natural orifice intraluminal, and natural orifice transluminal procedures. Minimally invasive surgery can have numerous advantages compared to traditional open surgical procedures, includedin reduced trauma, faster recovery, reduced risk of infection, and reduced scarring.
• minimally invasive or not there are a number of surgical procedures i which it can be desirable to form a working channel in a patient to provide access to a surgical site within the patient.
• orthopedic or neurologic surgical procedures including, e.g., spinal fusion procedures where it can be desirable to form a working channel through a patient's tissue to access their vertebrae and/or the intervertebral discs disposed between adjacent vertebrae.
• a variety of surgical access devices are known, including various devices that are anchored to a surgical table upon which a patient is disposed, or devices that penetrate tissue without being anchored to any other structure.
• the access device may be inadequately supported, or the access device may undesirably move relative to the patient if the patient moves relative to the operating table. Accordingly, there is a need for improved access port stabilization devices, systems, and methods that can streamline the instrumentation and methodology of various surgical procedures.
• improved ipsilateral access port stabilization may be provided via an access port configured to couple to an anchor, such as a bone screw, implanted in a patient at a location nearby the surgical site, e.g., on an ipsilateral side.
• the access port can be coupled to the anchor via a linkage and can have a variety of degrees of freedom to adjust its position relative to the anchor and patient. Further, the access port can be configured to be selectively locked in a desired position to permit stabilized access to a surgical site. While the systems, devices, and methods described herein can be utilized in a variety of surgical procedures, they can have particular utility in various orthopedic or neurologic surgical procedures, such as spinal operations.
• a surgical system can include an access port configured for percutaneous insertion into a patient to define a channel to a surgical site, and an anchor configured for insertion into the patient's bone. Further, the access port can be coupled to the anchor such that a longitudinal axis of the access port and a longitudinal axis of the anchor are non-coaxial. [0013]
• the devices and methods described herein can have a number of additional features and/or variations, all o which are within the scope of the present disclosure.
• the access port can be configured to be coupled to an anchor on an ipsilateral side of a patient's body, i.e., a same side.
• the access port can be coupled to an anchor disposed in a patient's vertebra on a same side o the spine or patient midline as the access port.
• This is in contrast to other techniques, such as those mentioned above, that couple access ports to anchors disposed on a contralateral side of the patient's body, i.e., an opposite side.
• the access port can be configured to be coupled to an anchor on a contralateral side of a patient's body.
• a position of the access port relative to the anchor can be selectively locked to maintain the access port in a desired position relative to the anchor. This can be useful, for example, to maintain the access port in alignment with a desired surgical site.
• a variety of locking mechanisms are possible, as described below.
• the access port can be coupled to the anchor by a linkage.
• the linkage can have a variety of forms.
• the l inkage can be a single shaft protruding from the access port.
• the linkage can be a multi-component structure capable of adjustment and selective locking.
• the linkage can be deformable.
• the linkage can optionally be formed from metal capable of deformation under force (i.e., manipulation by a user).
• the linkage can be selectively lockable so as to no longer be deformable.
• the linkage can be selectively locked by application of electricity thereto, or the linkage can be selectively locked by an adjustment screw or other mechanical locking mechanism.
• a length o the access port can be adjusted.
• a length of the access port can be adjusted by telescoping an inner sleeve o the access port relative to an outer sleeve of the access port. This can allow the access port to have varying heights and extend varying distances both into a patient's body and away from a patient's skin surface.
• the linkage can form a portion of an outer circumference of the access port and pivot relative to the access port.
• the access port can include a deformabie portion.
• the defonnable portion can couple with the anchor.
• the deformabie portion can optionally couple with the anchor below a poiyaxial head of the anchor.
• a number of additional components can be included and coupled to the access port in a variety of manners.
• a nerve shield or other soft tissue retractor can optionally be coupled to the deformabie portion of the access port.
• the anchor can include opposed extensions extending proximally away from a distal portion thereof and the access port can couple to the anchor by compressing a portion of the access port between the opposed extensions.
• the system can further include a clamp configured to compress the opposed extensions toward one another.
• the clamp can have a variety of forms.
• the clamp can optionally define an inner lumen configured to receive the opposed extensions such that the clamp slides along a length of the opposed extensions.
• the access port can include a shaft extending transversely to a longitudinal axis of the access port and a split ball disposed around the shaft between the opposed extensions. The clamp can cause the extensions to compress against the split ball and the shaft, thereby locking a position of the access port relative to the anchor.
• a surgical method can include inserting an anchor into a patient's bone, coupling an access port to the anchor, and positioning the access port relative to the anchor on a same side of the patient's body such that a longitudinal axis of the access port and a longitudinal axis of the anchor are non-coaxial.
• the access port can define a channel to a surgical site.
• the anchor can optionally be inserted into a patient's vertebra, such as during a spinal orthopedic procedure.
• the method can optionally further include locking a position of the access port relative to the anchor.
• positioning the access port can include deforming a linkage extending between the access port and the anchor.
• the method can include applying electricity to the linkage to lock a position of the access port relative to the anchor.
• the method can include actuating an adjustment screw to lock the position of the access port relative to the anchor.
• the method can further include adjusting a length of the access port by telescoping an inner sleeve of the access port relative to an outer sleeve of the access port.
• the method can further include deforming a portion of the access port.
• coupling the access port to the anchor can optionally include coupling the anchor with a deformable portion of the access port.
• the method can optionally further include coupling a nerve shield or other soft tissue retractor to a deformable portion of the access port.
• coupling the access port to the anchor can include compressing a portion of the access port between opposed extensions of the anchor that extend proximal ly away from a distal portion thereof.
• a surgical method can include introducing an access port and an anchor into a patient's body in a configuration wherein a longitudinal axis of the access port and a longitudinal axis of the anchor are coaxial, as well as adjusting a position of the access port relative to the anchor such that the longitudinal axis of the access port and the longitudinal axis of the anchor are non-coaxial and the access port and the anchor are on a same side of the patient's body.
• the anchor can be inserted into a patient's vertebra, or the method can include inserting the anchor into a different portion of a patient's body.
• the access port and the anchor can be coupled to a driver for introduction into the patient's body.
• the driver can optionally maintain alignment of the components and provide for rotating the anchor to implant it in a patient's bone.
• the method can optionally further include removing the driver prior to adjusting the position of the access port relative to the anchor, e.g., to free the access port to move relative to the anchor where the driver maintains alignment of the access port and anchor.
• the method ca further include inserting a second anchor into the patient's body through the access port and re-adjusting a position of the access port relative to the anchor such that the longitudinal axis of the access port and the longitudinal axis of the anchor are coaxial.
• the method can further include inserting a polyaxial receiving head through the access port and coupling the receiving head to the anchor, coupling the anchor and the second anchor with a spinal fixation element, and removing the access port.
• the method can further include locking a position of the access port relative to the anchor after adjusting a position of the access port relative to the anchor.
• FIG. 1 is a schematic illustration of one embodiment of a surgical system according to the teachings provided herein;
• FIG. 2 is a front perspective view of one embodiment of a surgical system including a deformable linkage to adjust a position of an access port;
• FIG. 3 is a side perspective view of the surgical system of FIG. 2;
• FIG. 4 is a front perspective view of one embodiment of a surgical system including opposed extensions coupled to an anchor that selectively compress to lock a position of an access port;
• FIG. 5 is a partially-transparent detail view of the system of FIG. 4;
• FIG. 6 is a top perspective view o an access port of the system of FIG. 4;
• FIG. 7 is a front perspective view of one embodiment of a surgical system including a ratchet clamp;
• FIG. 8 is a rear perspective view of the system of FIG. 7 after removal of a clamping instrument;
• FIG. 9 is a front perspective view of one embodiment of a surgical system including a pivoting lever clamp;
• FIG. 10 is a detail view of the system of FIG. 9;
• FIG. 1 1 Is a side view of one embodiment of a surgical system inc luding a sliding ring clamp;
• FIG. 12A is a front perspective view of the sliding ring clamp of FIG. 1 1 ;
• FIG. 12B is a front vie of the sliding ring clamp of FIG. 11 ;
• FIG. 12C is a side view of the sliding ring clamp of FIG. 1 1 ;
• FIG. 13A is a side view of one embodiment of a surgical system including an adjustable linkage in a first configuration;
• FIG. 13B is a side view of the system of FIG. 13 A in a second configuration:
• FIG. 14 is a top perspective view of one embodiment of a surgical system including an adjustable linkage
• FIG. 15 is a top perspective view of one embodiment of a surgical system including an adjustable linkage;
• FIG. 16 is a top view of the system of FIG. 1 5;
• FIG. 17 is a perspective view of the anchor of FIG. 15;
• FIG. 18 is a perspective view of the access port of FIG. 15;
• FIG. 19A is a perspective view of one embodiment of a telescoping access port;
• FIG. 19B is a perspective cross-sectional view of the telescoping access port of FIG. 19 ⁇ ;
• FIG. 19C is an alternative perspective cross-sectional view of the telescoping access port of FIG. 19 A;
• FIG. 20 A is a perspective view of one embodiment of an access port coupled to an anchor
• FIG. 20B is an alternative perspective view of one embodiment of an access port coupled to an anchor;
• FIG. 21 is a perspective view of one embodiment of an access port coupled to an anchor and configured for selective locking relative thereto;
• FIG. 22 is a perspective view of the access port and anchor of FIG. 21 ;
• FIG. 23A is a front view of one embodiment of an access port, anchor, and driver
• FIG. 23B is a side view of the access port and anchor of FIG. 23 A in a first configuration
• FIG. 23 C is a side view of the access port and anchor of FIG. 23 A in a second
• FIG. 23 D is a side view of the access port and anchor of FIG. 23 A and a receiving member being introduced through the access port;
• FIG. 23 E is a side view o the receiving member of FIG. 23 D being coupled to the anchor;
• FIG. 23F is a side view of the access port, anchor, and receiving member of FIG. 23 E adjacent to a second anchor;
• FIG. 23G is a side view of a spinal fixation element being inserted through the receiving member of the anchor and adjacent anchor of FIG. 23 F;
• FIG. 23 H is an alternative view of the spinal fixation element of FIG. 23G;
• FIG. 231 is a side view of the anchors of FIG. 23 H after removal of the access port and adjacent screw extensions;
• FIG. 24A is a side perspective view of one embodiment of an access port having deform able portions
• FIG. 24B is a front perspective view of the access port of FIG. 24A;
• FIG. 25 is a front view of the access port of FIG. 24A receiving a light and/or camera
• FIG. 26 is a bottom perspective view of the access port of FIG. 24A coupled to an anchor;
• FIG. 27 is a detail view of a linkage of FIG. 26 for coupling an access port to an anchor;
• FIG. 28A is a side view of the access port and light and/or camera of FIG. 25 coupled to an anchor in a first configuration
• FIG. 28B is a side view of the access port and light and/or camera of FIG. 28A in a second configuration;
• FIG. 29 is a bottom perspective view of the access port of FIG. 24A coupled to a nerve shield;
• FIG. 30 is a detail view of a nerve shield of F IG. 29;
• FIG. 3 1 A is a front view of the access port of FIG. 24A prior to coupling to a nerve shield;
• FIG. 3 I B is a front view of the access port of FIG. 3 1 A after coupling to a nerve shield;
• FIG. 3 1 C is a front view of the access port of FIG. 3 IB after advancing a nerve shield
• FIG. 3 1 D is a front view of the access port of FIG. 3 1 C after retracting a nerve shield; and [0081 ] FIG. 32 is a schematic of a selectively deformable linkage between an anchor and an access port.
• linear or circular dimensions are used in the description of the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods.
• a person skilled in the art will recognize that an equivalent to such linear and circular dimensions can ea ily be determined for any geometric shape.
• like-numbered components of the embodiments generally have similar features.
• sizes and shapes of the devices, and the components thereof can depend at least on the anatomy of the subject in which the devices will be used, the size and shape of components with which the devices will be used, and the methods and procedures in which the devices will be used.
• Surgical devices, systems, and methods are described herein that provide access port stabilization through an access port configured to couple to an anchor, such as a bone screw, that can be implanted in a patient at a location nearby a surgical site, e.g., ipsi lateral stabilization to a point on an ipsi lateral side of a patient's body or contralateral stabilization to a point on a contralateral side of the patient's body.
• the access port can be coupled to the anchor in a manner that provides a variety of degrees of freedom to adjust its position relative to the anchor and patient. Further, the access port can be configured to be selectively locked in a desired position to permit stabilized access to a surgical site. While the devices, systems, and methods described herein can be utilized in a variety of surgical procedures, they can have particular utility in various orthopedic or neurologic surgical procedures, such as spinal operations.
• FIG. 1 illustrates an exemplary surgical system 100 according to the teachings provided herein, though it will be appreciated that components of such a system can be used in various other applications instead or in addition. Further details on systems similar to that illustrated in FIG. 1 can be found in U.S. Patent Publication No. 2017/01 56814 filed on February 2 1 , 20 17 and entitled "Multi-Shield Spinal Access System,” which is hereby incorporated by reference in its entirety.
• the system 100 can be used in various surgical procedures, including spinal surgeries such as microsurgical bone resection, spinal decompression, spinal fusion, and the like.
• the system 100 can include any one or more o a pedicle post or other anchor 102 and an access port 104.
• Other possible components not illustrated here can include a tissue retractor, a camera or visualization system, and any of a variety of other surgical
• the access port 104 can have an adjustable length, e.g., as described in U.S.
• the access port 104 can be used with a surgical visualization system, e.g., as described in U.S. Application No. 15/692,845 filed on August 31 , 2017 and entitled SURGICAL VISUALIZATION SYSTEMS AND RELATED METHODS.
• the access port 104 can be used with a nerve retractor or nerve shield, e.g., as described in U.S. Application No. 15/786,846 entitled DEVICES AND METHODS FOR
• An exemplary method of using the system of FIG. 1 can include any one or more o the following steps, performed in any of a variety f sequences: a) making an incision in a skin of a patient: b) percutaneously inserting through the incision an access device having a substantially tubular shape (such as a tube or a multi-slotted retractor), the access device having a length adapted to extend from the incision to a border between sensitive and insensitive tissue (e.g., a superior articular process (SAP), or a lamina) in the spine of the patient; c) stabilizing the access device to an anchor (e.g., a pedicle anchor); d) inserting an access device integrated optical visualization instrument; e) resecting a portion of the superior articular process, and/or performing a microsurgical decompression procedure; f) inserting or deploying a tissue retractor through or from the access device so that a distal end portion of the tissue retractor extends to the
• stabilization of the access port or device 1 04 can be accomplished by coupling it to the anchor 102. In some embodiments, this can be accomplished through a linkage 106. In still further embodiments, the system can be configured to selectively lock a position of the access port 104 relative to the anchor 102 such that a lumen, channel, or passageway 108 through the access port is aligned with a desired surgical site. In some surgical procedures, an access port can be attached to an anatomical anchor point (e.g., a pedicle screw extension tab or tower) that is disposed on an opposite side of the patient's body from the access port
• an anatomical anchor point e.g., a pedicle screw extension tab or tower
• the anchor can be disposed on an opposite side of the spine or patient midline from the access port.
• Exemplary connectors for such stabilization are described herein and disclosed in U.S. Application No. 15/786,923 entitled SURGICAL INSTRUMENT CONNECTORS AND RELATED METHODS and filed on an even date herewith, which is hereby incorporated by reference in its entirety.
• ipsilateral In the system 100 of FIG.
• FIGS. 2-32 illustrate various systems, devices, and methods for access port stabilization.
• anchoring relative to a patient's body can provide an advantage by maintaining a relative position between an access device and a patient even if a patient moves during a procedure.
• anchor all devices on an ipsilateral side of the patient's body e.g., on a single or same side of a patient's spine. In some procedures, this can reduce the complexity of instrumentation utilized in a surgical procedure and allow parallel operations to proceed on both sides of a patient's spine or midline axis in parallel.
• FIGS. 2 and 3 illustrate one embodiment of a system 200 that includes an access port 202 that is coupled to an extension tower 204 by a deformable linkage 206.
• the access port or device 202 can have a generally cylindrical shape with an inner lumen 208 through which any of a variety of surgical instruments can be passed.
• the access port 202 can have any of a variety of sizes, including inner lumen diameters, lengths, sidevvall thicknesses, etc. based on intended use (e.g., size of surgical site being accessed through the port, location relative to a patient ' s body, etc.).
• the access port 202 can be formed from any of a variety of materials, including metals such as stainless steel and titanium, as well as various polymers.
• the extension tower 204 shown in FIGS. 2 and 3 can be configured to couple to, for example, a bone screw or anchor implanted in a patient's spine 2 10 (anchor not shown).
• the extension tower 204 can be configured to couple with a proximal end of a mono- or poly-axial receiver head that is coupled to a proximal portion of a bone anchor.
• bone anchor assemblies are known in the art and described, for example, in U.S. Application No. 1 5/208,872 filed on July 13, 2016 and entitled "BONE ANCHOR ASSEMBLIES AND RELATED INSTRUMENTATION," the entire contents of which are incorporated by reference herein.
• extension tower 204 can be any of a variety of such towers known in the art, including, for example, one of the towers described in U.S. Patent No. 7, 1 79,261 entitled "PERCUTANEOUS ACCESS DEVICES AND BONE ANCHOR ASSEMBLIES,” the entire contents of which is incorporated by reference herein.
• the access port 202 can be coupled to the extension tower 204 by a deformable linkage 206 that can include a length of metal or otherwise deformable material sufficiently rigid to maintain its position in the absence of force applied by a user.
• the linkage 206 can couple to the extension tower 204 via a sleeve 212 disposed about an outer circumference of the tower.
• the sleeve 212 can include a cam lever 214 or other locking mechanism that can allow the sleeve to be selectively locked to the extension tower 204. This can allow the sleeve to be positioned at any of a variety of heights relative to the extension tower 204.
• the sleeve 212 can also be configured to selectively lock against rotation about the extension tower 204 with actuation of the cam lever 2 14.
• the linkage 206 can be coupled at each end to one of the access port 202 and the extension tower 204 via any of a variety of clamping mechanisms known in the art.
• a clamping assembly 216 including a bolt and a plurality of nuts is utilized to coupie one end of the linkage 206 to an extension post 218 extending from a sidewa!l of the access port 202.
• An opposite end of the linkage 206 can be coupled to the sleeve 212 using a similar assembly 302 including a bolt and a thumbscrew.
• Such mechanisms can provide selective locking ability similar to the cam lever 2 14, such that the positions of the various components relative to one another can be adjusted prior to securing any of the cam lever 214, clamping assembly 21 6, and thumbscrew assembly 302. After tightening of each of these mechanisms, adjusting a posit ion of the access port 202 relative to the extension tower 204 can require applying a force sufficient to deform the linkage 206.
• the access port 202 can be positioned such that a longitudinal axis Li of the access port is non-coaxial with a longitudinal axis L 2 of the extension tower 204, or a longitudinal axis of any anchor to which the extension tower is coupled.
• the axis Li can be offset from and/or obliquely angled with respect to the axis L 2 .
• the access port 202 can provide access to a surgical site, such as an intervertebral disc space or a vertebra adjacent to the vertebra to which the extension tower 204 is coupled on an ipsi lateral side (e.g., a same side relative to a patient's spinal or midline axis ML) relative thereto.
• FIGS. 4 12C illustrate embodiments of a system that utilizes extension tabs that extend proximally from a distal portion of an anchor to capture and selectively lock a position of an access port.
• a first embodiment of such a system 400 can include an access port 402 coupled to an anchor assembly 404 and a locking instrument 406 (e.g., forceps) configured to selectively lock a position of the access port relative to the anchor assembly.
• the anchor assembly 404 is a polyaxial pedicle screw that includes a shank 408 configured for insertion into a patient's bone, as well as a receiver head 410 coupled to a proximal portion of the shank.
• the receiver head 410 can include extension tabs 412a, 4 12b that extend proximal I y from opposed arms of the receiver head.
• the extension tabs 412a, 41 2b can be integrally formed with the receiver head 4 10, or in other embodiments can be coupled thereto via any o a variety of attachment mechanisms.
• the access port 402 can include a shaft 414 or other mating feature integrally formed therewith or coupled thereto and extending transversely or radially away therefrom such that a longitudinal axis L 3 of the access port and a longitudinal axis L 4 of the shaft are transverse or oblique to one another.
• the shaft 414 can be integrally formed with the access port 402 or can be coupled to the access port 402 via a clamp or other connecting mechanism, in some embodiments, the shaft 414 can be threaded or have a series of repeating surface features 41 8, such as ridges or ribs, to locate a split ball 416 or other locking element along a length thereof.
• the split ball 416 can be positioned around the shaft 4 14 and disposed between the extension tabs 4 12a, 412b, as shown in the detail view of FIGS. 5 and 6.
• a relief slot 502 formed in the ball can allow its adjustment along a length of the shaft 414 by, e.g., translational sliding movement, rotation alon threads 41 8 of the shaft 414, etc.
• the split bail 416 can move polyaxially relative to the extension tabs 412a, 412b in the absence of pressure being applied to the tabs by, e.g., the locking instrument 406, including sliding along a length of the extension tabs and rotating to adjust its orientation relative to the tabs.
• the locking instrument 406 can be actuated to urge the extension tabs toward one another, thereby clamping the split ball between the extension tabs. More particularly, in the illustrated embodiment, user actuation to bring the locking instrument handles 420a, 420b toward one another can cause distal arms 422a, 422b to move toward one another and slide along a length of the extension tabs 412a, 412b. This movement of the distal arms 422a, 422b can urge the extension tabs 412a, 412b toward one another, thereby imparting a compressive force on the split ball 416 disposed therebetween.
• This compressive force can prevent polyaxial movement of the split ball 416 relative to the extension tabs 412a, 4 12b, thereby locking a position of the ball relative to the extension tabs. Further, the compressive force can also urge opposed portions of the split ball separated by the relief slot 502 toward one another, thereby clamping the ball to the shaft 4 14 and preventing relative movement between these components. As a result, actuation of the locking instrument can selectively lock a position and orientation of the access port 402 relative to the anchor assembly 404.
• the extension of the shaft 41 4 or other mating feature laterally, radially, or transversely away from the access port 402, in combination with the split ball 4 16 positioned along a length thereof, can allow the access port 402 to be positioned and selectively locked such that a longitudinal axis L 3 of the access port and a longitudinal axis Ls o the anchor assembly 404 are non-coaxial.
• the access port 402 can be positioned to access a surgical site adjacent to the anchor assembly 404 on an ipsilateral side of a patient's body.
• the lockin instrument 406 can directly contact the extension tabs 412a. 412b via distal arms 422a, 422b.
• release o the handles 420a, 420b can release pressure on the extension tabs 412a, 4 12b, thereby releasing the lock of the split ball 4 16 and access port 402.
• another mechanism possible to accomplish the selective clamping f the extension tabs 412a, 412b to lock a position of the access port 402 relative to the anchor assembly 404.
• the lockin instrument 406 can directly contact the extension tabs 412a. 412b via distal arms 422a, 422b.
• release o the handles 420a, 420b can release pressure on the extension tabs 412a, 4 12b, thereby releasing the lock of the split ball 4 16 and access port 402.
• a locking instrument 702 can include a ratcheting clamp 704 that can maintain a position of distal arms 706a, 706b to maintain the position lock of the access port 402 relative to the anchor assembly 404 even if a user releases the instrument handles 708a, 708b.
• the instrument handles 708a, 708b can be configured to be separated from the ratchet clamp 704 after actuation, such that a more streamlined or low-profile assembly is left that includes the distal arms 706a, 706b and ratchet clamp 704, as shown in FIG. 8.
• the ratchet clamp 704 can include a ratchet track 7 10 having a plurality of teeth 802 formed thereon, as well as a pawl 712 configured to engage the teeth to allow for movement of the distal arms 706a, 706b toward one another but resist opposite movement of the arms away from one another.
• a release can be included to disengage the pawl 712 from the ratchet track 710 and allow unlocking of the access port 402 relative to the anchor assembly 404.
• a clamp 902 can replace the locking instruments 406 and 702 described above.
• the clamp 902 can include a body 904 pivotably coupled to a proximal portion 602 of the split ball 416 such that the body 904 can rotate relative to the split ball 416 about an axis Ri .
• a fork including a pair of arms 1002a, 1002b can extend from the body 904 and be configured to contact and slide along outer surfaces of the extension tabs 412a, 412b as the clamp body 904 and arms are rotated toward the extension tabs.
• the arms 1002a, 1002b can apply a compressive force to the opposed extension tabs 412a, 412b in the same manner as the distal arms 422a, 422b and 706a, 706b described above such that a position o the access port 402 can be locked relative to the anchor assembly 404.
• such locking is accomplished by urging the extension tabs 412a, 412b toward one another to impart a compressive force on the split ball 416 and prevent relative movement between the split ball and the extension tabs.
• Such compression can also cause opposed portions f the split ball 416 to compress into the shaft 414, thereby preventing relative movement between the split ball and the shaft.
• a handle 906 can extend from the body 904 to provide a user with leverage when actuating the lock by rotating the body 904 and arms 1002a, 1002b toward the extension tabs
• the handle 906 can be configured to threadingiy or otherwise removably couple to the body 904 such that the handle can be removed after actuation to allow for a more streamlined or low-profile assembly once a position of the access port 402 is locked.
• a ring lock 1 102 can be employed in place of the locking instruments described above.
• the ring lock 1 102 can be slidably disposed over the extension tabs 412a, 412b such that it can translate along a length thereof.
• the ring lock 1 1 02 can include a closed proximal portion 1202 defining an inner lumen 1208 through which the extension tabs 412a, 412b can extend.
• the ring lock 1 102 can further include opposed sets of distally extending arms 1204a, 1204b that can define a U-shaped recess 1206 that can receive the shaft 414 as the ring lock is translated into position around the extension tabs 4 12a, 412b and the split ball 4 16.
• the diameter of the inner lumen 1208 can be smaller than the resting outer diameter of the extension tabs 412a, 412b such that the ring lock 1 102 applies a compressive force to the extension tabs as it is translated along the extension tabs.
• the inner diameter of the ring lock 1 102 can be tapered such that a compressive force is applied by the distal arms 1204a, 1204b but not the proximal portion 1202.
• the ring lock 1 102 can include opposed spring arms 12 10a, 1210b that can be configured to impart a compressive force on the extension tabs 4 12a, 412b and thereby permit the above-described selective locking as the ring lock 1 102 is slid into position over the extension tabs 412a, 412b and split ball 4 16.
• Such spring arms 12 1 a, 1210b can be utilized in place of, or in addition to, different inner lumen diameters to exert varying compressive forces on the extension tabs 4 12a, 412b and split ball 416.
• FIGS. 13A 1 8 illustrate still other examples of linkages or mating features that can couple an access port to an anchor to define a channel to a surgical site, for example a surgical site located on an ipsi lateral side of a patient ' s body as the anchor. More particularly, these figures illustrate various embodiments of selectively !ockable and polyaxia!ly adjustable linkages. FIGS.
• I 3A and 13B illustrate one embodiment of a polyaxially adjustable linkage 1302 that can be selectively locked via a bolt and thumbscrew 1304 that compresses opposed body portions of the linkage together, thereby compressing a first connection at one end of the linkage to an access port 1306 and a second connection at an opposite end of the linkage to an extension tower 1308 that can be coupled to, for example, a pedicle screw or other anchor (not shown).
• a bolt and thumbscrew 1304 that compresses opposed body portions of the linkage together, thereby compressing a first connection at one end of the linkage to an access port 1306 and a second connection at an opposite end of the linkage to an extension tower 1308 that can be coupled to, for example, a pedicle screw or other anchor (not shown).
• the thumbscrew 1304 By varying the tightness of the thumbscrew 1304, movement of the access port relative to the extension tower 1308 can be selectively permitted.
• the linkage 1302 is capable of polyaxial adjustment relative
• FIGS. 13A and 13B While a thumbscrew 1304 is illustrated in FIGS. 13A and 13B, a variety of other locking mechanisms can be employed to selectively permit or prevent relative movement between the access port 1306 and tower 1308.
• FIG. 14 illustrates an embodiment in which a cam 1404 is employed to selectively compress opposed portions of the linkage 1402a, 1402b to selectively lock a position of the access port 1306 relative to the extension tower 1308.
• a linkage can include a plurality of rigid segments, as shown in FIGS. 15 and 16.
• a linkage 1 502 can include a first segment 1504 coupled to the access port 1 306 and a second segment 1506 coupled to the extension tower 1308.
• first and second segments 1504, 1506 can be pivotably coupled to one another at a pivot joint 1508. Such a configuration can allow for greater flexibility and reach in positioning the access port 1306 relative to the extension tower 1308.
• the linkage 1502 of FIG. 15 can be positioned to extend over or around other instrumentation disposed between the access port 1306 and the extension tower 1 08.
• Any number o linkage segments can be included and each segment can receive a locking mechanism, e.g., a thumbscrew, cam-lock, or other locking mechanism to selectively lock movement of components coupled thereto by compressing opposed portions 1504a, 1504b or 1506a, 1506b together.
• first and second segments 1504, 1506 include through-holes 1510, 1512 to receive a thumbscrew or cam- lock mechanism, as shown in FIGS. 13A-14.
• FIGS. 13A 16 can couple to an access port 1306 and extension tower 1308 using, e.g., a split ring clamp.
• the linkage 1402 of FIG. 14 can include a first split ring clamp 1406 disposed about the access port 1306 and a second split ring clamp 1408 disposed about the extension tower 1308.
• the split ring clamps 1406, 1408 can include spherical inner surfaces that can interface with spherical outer surfaces of bushing rings coupled to the access port 1304 and extension tower 1308.
• FIG. 17 illustrates one embodiment of a bushing ring 1702 coupled to the extension tower 1308
• FIG. 18 illustrates one embodiment of a bushing ring 1802 coupled to the access port 1306.
• the bushing rings 1702, 1802 can include outer spherical surfaces and a relief slot 1704, 1804 to allow the bushing rings to slide along and/or rotate about the extension tower 1308 and access port 1306 when no clamping force is exerted thereon.
• the ability to selectively move the bushing rings 1702, 1 802 relative to the extension tower 1308 and access pot t 1306 can allow, for example, a height of the access port relative to the extension tower to be adjusted.
• the bushing rings 1702, 1 802 can be integrally formed with the extension tower 1308 and access port 1306 such no relative movement between these components is possible.
• the relief slots 1 704, 1804 may be eliminated.
• the interfacing of the inner and outer spherical surfaces of the split ring clamps 1406, 1408 and bushing rings 1 702, 1802 can allow for polyaxial movement between the components in the absence of compressive force.
• compressive force is applied to the split ring clamps 1406, 1408 via, for example, the thumbscrew 1304 or cam-lock 1404
• the split ring clamps 1406, 1408 can compress around the bushing rings 1702, 1802, thereby causing the bushing rings to compress around the access port 1306 and extension tower 1308 and prevent relative movement between these components. This can effectively lock the entire linkage to prevent relative movement between the access port 1306 and the extension tower 1308.
• a height of an access port can be adjustable such that the access port can be extend from a variety of heights above a patient's skin surface (e.g., positions along an extension tower or screw extension tabs, etc) to various depths within a patient's body (e.g., to surgical sites located at various positions below a patient's skin surface).
• FIGS. 1 9A-19C illustrate one embodiment of an access port 1902 with an adjustable height achieved by relative movement of an inner tube or sleeve 1904 and an outer tube or sleeve 1906. More particularly, the inner tube 1 904 can translate relative to the outer tube 1906.
• Such movement can be guided, in some embodiments, by various locating features 1908, such as cooperating ridges and notches, formed on the surfaces of the inner and outer tubes 1904, 1906.
• a flat spring arm can be provided on the inner tube 1904 and the outer tube 1906 can include a plurality of teeth for engaging the spring arm.
• relative movement of the inner and outer sleeves 1904, 1906 can be selectively locked to prevent further adjustment of a height of the access port.
• a relief slot 1 9 10 formed in the outer sleeve 1906 can allow the outer sleeve to be compressed around the inner sleeve 1904 to lock their relative positions when, for example, a split ring clamp, such as the clamp 1406, compresses around the outer sleeve 1906 or a bushing 1802 disposed about the outer sleeve 3906.
• a locking mechanism such as the thumbscrew 1304 or the cam-lock 1404, can be utilized to lock both relative positions of an access port and an anchor, as well as a height of the access port.
• FIGS. 20A 3 I D illustrate still other embodiments of access ports that can be coupled to an anchor, e.g., on an ipsi lateral side of a patient's body , such that longitudinal axes of the access port and the anchor are non-coaxial.
• a linkage coupling the anchor to the access port can form a portion of an outer circumference of the access port that pivots relative thereto.
• Such embodiments can be adjustable such that, in certain configurations, a longitudinal axis of the access port aligns with a longitudinal axis f the anchor.
• FIGS. 20A and 20 B illustrate alternative views of one embodiment of a split-tube access port 2000 that can be coupled to an anchor 2002, such as a pedicle screw.
• the access port 2000 can include a generally cylindrical body 2004 defining an inner lumen 2006 extending along a longitudinal a is Le, thereof.
• a linkage portion 2008 of the body 2004 can be split from the remainder and capable of pivoting relative thereto about an axis R 2 .
• a thumbscrew 201 can be included to selectively lock the pivoting motion between the body 2004 and linkage portion 2008.
• a secondary lumen 20 12 can be provided to receive additional surgical instruments.
• the secondary lumen 2012 in the illustrated embodiment can be configured to receive a camera and/or l ight source to aid a user in performing a surgical procedure.
• the secondary lumen 2012 can extend parallel to the inner lumen 2006 or transversely thereto, and the two lumens can merge in certain embodiments.
• the secondary lumen 2012 can extend transversely to the inner lumen 2006 such that a light source and/or camera passed through the secondary lumen 2012 extends into the inner lumen 2006 distal to a proximal end of the access port 2000 in some embodiments.
• the lumens can remain separate but the secondary lumen 20 12 can be angled relative to the inner lumen 2006 such that, e.g., an endoscope camera emerging from a distal end of the secondary lumen 201 2 can be viewing a surgical site located beyond a distal end of the inner lumen 2006.
• the linkage portion 2008 can couple to the anchor 2002 in any o a variety of manners.
• a fork 2014 including a pair of opposed arms can be formed at a distal end of the l inkage portion 2008 and configured to receive the anchor 2002 in a recess between the arms.
• the arms of the fork 2014 can be configured to receive a narrowed neck or shank portion 2016 of the anchor 2002 that extends dista!ly from a wider proximal head portion 20 18.
• bone anchor portions of polyaxial pedicle screws typically include a cylindrical shank extending from a more spherically- shaped proximal head portion that interfaces with a polyaxial receiver head.
• the linkage portion 2008 can be selectively locked relative to the anchor by applying upward or proximal force to frictionally lock the arms of the fork 2014 against the proximal head 201 8 of the anchor 2002.
• Such locking force can be applied in a variety of manners.
• tissue forming incision walls surrounding the anchor 2002 can exert sufficient force against the fork 2014 to prevent relative movement between the fork 2014 and the anchor 2002.
• Such force might be an inward or compression force exerted by tissue surrounding the anchor 2002, or the fork 2014 can be pulled upward such that a skin surface of the patient is disposed below the fork and exerts an upward force on the fork.
• the anchor 2002 can be tightened to compress the fork 2014 between the head portion 201 8 of the anchor and a bone surface.
• any of a variety of locking mechanisms can be provided to selectively lock the linkage portion 2008 relative to the anchor 2002.
• a locking screw 2020 can be utilized to drive the linkage portion 2008 upward relative to the anchor 2002. More particularly, a distal end of the locking screw 2020 can be configured to contact a proximal surface of the anchor 2002 and a hook 2022 can be threaded onto the locking screw 2020. The hook 2022 can engage a through-hole 2024 formed in the linkage portion 2008 such that, as the locking screw 2020 is rotated, the hook 2022 translates upward and exerts an upward force on the linkage portion 2008, thereby forcing the fork 2014 into contact with the proximal head 201 8 of the anchor 2002.
• the locking screw 2020 can exert a sufficient force to lock a relative position of the linkage portion 2008 relative to the anchor 2002.
• a position of the access port 2000 relative to the anchor 2002 can be selectively locked, or movement can be permitted to allow polyaxial movement between these components.
• FIGS. 21 and 22 illustrate an alternative embodiment of an access port 2100 with a pivoting linkage portion 2102 and a locking mechanism 2104 to selectively lock a position of the access port relative to an anchor 2106, such as a pedicle or other bone screw.
• the access port 2100 can include a generally cylindrical body 2 108 that defines an inner lumen 21 10 that can serve as a channel to access a surgical site.
• the linkage portion 2102 can be pivotably coupled to the body 2108.
• the locking mechanism 2104 can include an actuator arm 2 1 12 threading! ⁇ ' coupled to a proximal locking screw 21 14 at a proximal end thereof.
• a distal portion of the actuator arm 21 12 can include a wedge or dovetail shape 21 16 disposed within a tapered slot 21 1 8 formed i a proximal portion of the linkage portion 2 102.
• a user can rotate the locking screw 21 14 at a proximal end of the access port 2 ! 00.
• Rotation of the screw 2 1 14 can cause proximal translation o the actuator arm 21 12 relative to the body 2 108.
• Proximal movement of the actuator arm 21 12 can cause the wedge 2 1 16 to contact sidevvalls of the tapered slot 2 1 1 8 formed in the proximal portion of the linkage portion 2 102.
• This can result in the opposed proximal arms 2120a, 2120b f the linkage portion 2 102 being urged laterally outward into contact with sidevvalls of the body 2 108.
• Friction between the sidevvalls of the body 2 108, the proximal arms 2120a, 2120b, and the actuator arm 2 1 12 can lock a position of the linkage portion 2102 relative to the body 2108 of the access port 2000.
• the linkage portion 2 102 can include a slot 2122 formed in a distal portion thereof such that a fork is formed at a distal end of the linkage portion that includes opposed distal arms 2 124a, 2 124b.
• the opposed distal arms 21 24a, 2124b can be configured to interface with the anchor 2106 in the same manner described above, e.g., around a narrowed shank or neck disposed below a wider proximal anchor head.
• proximal translation of the actuator arm 21 12 that urges the proximal arms 2120a, 2120b laterally outward into factional engagement with the sidevvalls of the body 2 108 can also cause a corresponding movement of the arms 2124a, 2 124b laterally inward, thereby increasing friction of the arms 2 124a, 2 124b against the anchor 2 106.
• a central portion 2 126 of the linkage portion 21 02 can serve as a fulcrum about which the two sides of the linkage portion can pivot relative to one another.
• actuation of the locking screw 21 14 can simultaneously lock movement of the linkage portion 2102 relative to the access port body 2 108 and the anchor 2106, thereby locking a position of the access port 2000 relative to the anchor.
• a locking mechanism can include an actuator arm driven distally to push against a fork that interfaces with an anchor. Distal advancement f the actuator arm can cause the linkage portion, including the fork, to pivot back towards a center of the access port. This pivoting motion can pinch the screw or anchor head between the fork and an exterior surface of the access tube, thereby locking the tube i place with respect to the screw.
• a hook can be utilized that extends in a plane perpendicular to a longitudinal axis of the access tube.
• the hook can be attached to a longitudinal screw extending down along a length of the access tube. As the screw is rotated, the hook can rotate about an axis parallel to the longitudinal axis of the access tube. The rotating hook can grab onto the implanted bone anchor and pull it tight to the outside of the access tube to lock the tube in place.
• the access ports 2000 and 2 100 described above can advantageously transition between a first configuration in which a linkage portion thereof forms a portion of an outer circumference of the access port and a second configuration in which the linkage portion is pivoted or split away from the remainder of the access port body.
• This can allow the access ports 2000 and 2 100 to be inserted in a configuration wherein a longitudinal axis of an inner lumen of the access port is coaxial with a longitudinal axis of an anchor and subsequently moved to a configuration in which a longitudinal axis of an inner lumen of the access port and a longitudinal axis o the anchor are non-coaxial, e.g., as shown in FIGS. 20A-22.
• FIGS. 23 ⁇ -23 ⁇ illustrate one embodiment of a surgical procedure utilizing an access port 2300 similar to that shown in FIGS. 20A and 20B. Similar procedures are also possible utilizing the access port 2100 of FIGS. 21 and 22. As shown in FIG.
• a procedure can include implanting a bone screw or other anchor 2302 that is pre-assembled to the access port 2100 in a configuration in which a longitudinal axis L 7 of the access port is aligned with a longitudinal axis Lg of the anchor.
• the components can be maintained in such a position by insertin a dilator and/or driver 2304 through a lumen or channel of the access port 2300 and engaging a proximal end of the anchor 2302.
• Application of distal force by the driver 2304 to the anchor 2302 can securely restrain a position of the anchor between a distal end of the driver 2304 and a fork 2306 of the access port 2300.
• the driver 2304 and fork 2306 can cooperatively restrain the anchor 2302 from axial movement along its longitudinal axis L 8 , but allow for rotational movement of the driver and anchor relative to the fork during insertion into a patient's bone.
• the driver can be withdrawn proximally out of the access port channel or lumen, thereby leavin the access port coupled to the anchor and positioned in line therewith.
• the access port fork 2306 can be held against a proximal head 2308 of the anchor 2302 by upward or inward force applied to the fork from tissue surrounding the anchor and access port, or by inserting a locking element, such as the lock screw 2020 and hook 2022 described above in connection with the access port 2000.
• a user can angle or otherwise move a portion of the access port 2300, such as the access port body 23 10, relative to the anchor to align its channel 23 12 with the surgical site.
• the longitudinal axis L 7 of the access port 2300 can be non-coaxial with the longitudinal axis Ls of the anchor 2302.
• the access port body 23 10 can remain coupled to and stabilized by the anchor 2302 via a linkage portion 2314 that can pivot relative to the body.
• a lock such as the thumbwheel lock 23 16, can be utilized to selectively lock a position of the linkage portion 23 14 relative to the body 2310.
• a user can perform any of a variety of surgical procedures at the surgical site by introducing one or more instruments through the access port channel 2 12.
• a user can perform a spinal fusion cage insertion procedure via the channel 23 12 of the access port 2300 while the access port remains secured in position relative to the anchor 2302.
• any locks e.g., thumbwheel lock 23 16 and/or a fork/anchor lock like the screw 2020 and hook 2022
• the access port body 23 10 can be returned to its insertion position wherein the longitudinal axes L? and Lx are aligned.
• Any locks can be reengaged in such a configuration such that the access port 2300 can serve as an anchor extension tower for further surgical procedures, such as receiver head insertion, spinal fixation element insertion, locking cap insertion and lightening, etc.
• FIG. 23 C shows the access port 2300 returned to the configuration of FIG. 23 A, but without any di lator and/or driver 2304.
• FIG. 231) illustrates a polyaxial screw receiver head 23 18 being inserted through the channel 23 12 of the access port 2300 using a tool 2320.
• the receiver head 23 1 8 can be advanced distally through the channel 23 12 of the access port and coupled to the proximal head 2308 of the anchor 2302.
• the head 23 18 can be coupled to the anchor 2302 without interference from the access port fork 2306 because the fork engages the anchor distal of, or below in the figure, the spherical proximal head 2308 of the anchor (if a locking screw 2020 and hook 2022 are employed, these
• FIG. 23 E shows the receiver head 23 1 8 disposed over the proximal head (not visible) of the anchor 2302. Following coupling of the receiver head 2318 and anchor 2302, the insertion tool 2320 utilized to introduce the head through the access port channel 23 12 can be removed.
• FIG. 23 F illustrates a further step in which an adjacent anchor 2322 i introduced into a patient's bone, e.g., into an adjacent vertebra on an ipsilateral side of the patient's body.
• the anchor 2322 can be introduced pre -assembled to a receiver head 2324 and extension tower 2326 that permits manipulation of and access to the anchor 2322 from outside the patient's body.
• a spinal fixation element such as a rod 2328
• the extension tower 2326 and access port 2300 can include opposed through-holes formed in sidewalls thereof to allow passage of the rod 2328 or other spinal fixation element.
• the linkage portion 2314 of the access port 2300 can include a through-hole 2332 that can be utilized for rod passage as well as interfacing with a locking mechanism, such as the above-described locking screw 2020 and hook 2022.
• the access port body 2310 can also include a through-hole 2334 or slot or other cut-out formed therein that is aligned with the through-hole 2332 to allow the rod 2328 to pass through during insertion.
• a user can introduce locking caps, such as locking caps or set screws 2336 and 2338 shown in FIG. 231, through the extension tower 2326 and access port channel 23 12 to secure the rod 2328 or other spinal fixation element relative to each receiver head/anchor assembly.
• a further step can include removing the extension tower 2326 and access port 2300 to leave a final in-situ fixation construct, as shown in FIG. 231.
• removal of the access port 2300 can include loosening the thumbwheel lock 23 16 to allow the linkage portion 23 14 to release from the rod 2328 and anchor 2302.
• FIGS. 24A-31D illustrate a further embodiment of an access port that includes one or more malleable or bendable tabs to facilitate use of the access port in procedures like those described above.
• FIGS. 24A and 24 B illustrate one embodiment of an access port 2400 having a generally cylindrical body 2402 defining an access channel 2403 that can be formed from a malleable material, such as any of a variety of metals and polymers.
• the body 2402 can include a plurality of slots or slits 24()4a-2404k formed therein and extending axially from any of a proximal end 2406 and a distal end 2408 thereof to form one or more bendable tabs at each end of the access port 2400.
• FIGS. 24 A and 24 B can form a plurality of tabs 2410a - 241 ()g that can be deformed or bent away from the illustrated configuration in which they form part of the outer circumference of the cylindrical body 2402.
• the positioning of the slots or slits 2404a-2404k, in combination with the material's malleability, can allow for isolated deformation at desired locations, such as the virtual hinge line 241 1 of the tab 2404a shown in FIG. 24A.
• the one or more tabs 2410 can serve a variety of purposes in different surgical procedures.
• corresponding proximal and distal tabs e.g., tabs 24 10a and 2410b
• FIG. 25 illustrates the access port 2400 with a visualization system 2502 disposed through the through-holes 24 12, 24 14 of the tabs 2410a, 2410b that have been deformed or bent away from the cylindrical body 2402.
• a tab 241 Og can be utilized as a linkage for coupling with an anchor 2602, as shown in FIG. 26. More specifically, the tab 24 i Og can be configured to be coupled to a link 2604 that couples with the anchor 2602.
• the link 2604 shown in detail in FIG. 27, can include a distal portion with a fork 2606 having opposed arms 2702a, 2702b configured to engage the anchor 2602 below a proximal head portion thereof.
• the proximal head portion of the anchor can include a spherical head in the case of an unassembled bone anchor, as described above, or a distal end of a receiver head 2608 in the case of an assembled polyaxial bone screw.
• a proximal portion of the link 2604 can include a pair o opposed arms 2704a, 2704b that can be configured to capture the tab 241 Og to couple the link and the access port body 2402, as shown in FIG. 26.
• the link 2604 of the access port 2400 can include features to facilitate securing the link to an anchor 2602, as described above.
• the link can include a through-hole 2 10 formed therein that can receive a hook 2612 that forms part of a locking mechanism, similar to the locking screw 2020 and hook 2022 of FiGS. 20A and 20B.
• a locking mechanism may not be employed and upward and/or inward force exerted by surrounding tissue can be relied upon to secure the fork 2606 relative to the anchor 2602.
• the access port 2300 can be inserted in the configuration of FIG. 28A, wherein a longitudinal axis Lg of the access port 2300 is aligned with a longitudinal axis Lio of the anchor 2602.
• a preassembled assembly as shown in FIG. 28A can be inserted using a driver, similar to the embodiment shown in FIG. 23A.
• the access port 2400 can be positioned over an implantation site and the anchor 2602 and link 2604 can be implanted by passing them through the central channel or lumen of the access port from a proximal end thereof to a distal end thereof.
• the link 2604 can then be coupled to a distal portion of the access port 2400 by, e.g., sliding the tab 241 Of between the opposed arms 2704a, 2704b of the link, as shown in FIGS. 28A and 28B.
• the anchor 2602 can be implanted independently by passing it through the access port channel or by implanting without the aid of the access port, then the link 2604 can be coupled to the anchor 2602 and the access port 2400.
• the access port 2400 can be inserted down onto the link 2604 that is already coupled to an anchor 2602 implanted in a patient's bone.
• the access port 2400 can include a bendable tab 241 Of or 24 1 Og that allows the port to be moved relative to the anchor 2602 and to then hold the port in place. It is apparent in comparing FIGS. 26- 28B that the access port 2400 can include a plurality of distal tabs, such as tabs 241 Of and 2410g that are opposed about a midline of the access port 2400, for coupling to a link 2604 in different orientations.
• the port 2400 can be placed in a desired position/orientation by bending or deforming the tab and can be maintained there after positioning by the material ' s inherent rigidity.
• the access port 2400 can be moved from the above- described axial !y-aligned configuration of FIG. 28 A to a configuration in which the longitudinal axis Li; of the access port is non-coaxial w ith the longitudinal axis Lio of the anchor, as shown in FIG. 2815.
• the access port 2400 can repeatedly be moved between the configurations of FIGS. 28 A and 28B to allow for use in a variety of procedures, such as the procedure described above in connection with FIGS. 23 A 231.
• the access port 2400 can also be configured to couple to other surgical components, such as a nerve shield or soft tissue retractor 2902.
• FIG. 29 illustrates a plurality of retractors 2902a, 2902b coupled to the tabs 24 10c, 2410d, respectively.
• FIG. 30 illustrates the retractor 2902 in greater detail.
• the retractor 2902 can include a proximal handle 3002 for manipulating the retractor and any tab it is coupled to, as well as an elongate body 3004 and a distal retracting tip 3006 configured to shield and/or retract soft tissue.
• the retractor 2902 can also include a pair of opposed arms 3008a. 3008b for capturing a tab 2410 of the access port 2400, similar to the opposed arms 2704a, 2704b of the above-described link 2604.
• FIGS. 3 1 A-3 1 D illustrate one embodiment of a method for utilizing a soft tissue retractor or nerve shield 2902 in connection with the access port 2400.
• the method can include deforming or bending a tab 29 1 Od at a proximal end 2406 of the access port 2400 away from a central longitudinal axis L9 such that the tab splits away from an initial configuration in which it forms part of the outer circumference of the cylindrical body 2402 of the access port.
• the soft tissue retractor 2902 can then be introduced into the channel or lumen 2403 of the access port 2400 in a manner that engages the tab 241 Od and the opposed arms 3008a, 3008b of the retractor 2902, as shown by FIGS.
• the distal retracting tip 3006 can cross the longitudinal axis L9 or a midline of the channel 2403 to protrude from a distal end 2408 of the access port on an opposite side of the port from the tab 241 Od.
• a user can utilize the handle 3002 to bend or deform the tab 29 1 Od back to its original position aligned with an outer circumference of the access port cylindrical body 2402, as shown in F IG. 31 D.
• the distal retractor tip 3006 can move back across the access tube longitudinal axis L9 or midline such that the tip is positioned on a same side as the tab 291 Od.
• the retractor tip can capture and move any soft tissue it encounters, such as nerves, etc.
• a retractor 2902 can be useful in moving, for example, nerves commonly encountered during surgical procedures on a patient's vertebrae.
• a plurality of retractors can be employed simultaneously.
• the proximal end 2406 of the access port 2400 can include four slits or slots 2404c-2404f that create three identical tabs 2410c 241 Oe to which a retractor 2902 can be coupled.
• a method for utilizing the access port 2400 can include deforming proximal and distal tabs 241 0a, 2410b and positioning an endoscope or surgical visualization system 2502 through holes 2412, 2414 formed in the tabs 24 10a, 24 10b.
• the access port 2400 and endoscope or other visualization system 2502 can be introduced into a patient with a pedicle screw or other anchor 2602 (the screw can be preassembled with any of a variety of receiver heads, e.g., polyaxial, monoaxial, favored angle, etc., or can be headless).
• the port 2400 can be aligned with the anchor 2602 such that a longitudinal axis of the port 2400 and a longitudinal axis of the anchor 2602 are aligned.
• Introduction and insertion can be facilitated by inserting a dilator and/or driver tool through a working channel of the access port 2400 such that it interfaces with the anchor 2602.
• any dilator or driver tool can be removed and the port 2400 can be manipulated into a desired position, e.g., over intervertebral disc space adjacent to the vertebra into which the anchor 2602 was inserted, by deforming whichever tab 241 Of, 2410g is coupled to the anchor by the link 2604.
• the desired position can be on an ipsilateral side of the patient's body (e.g., adjacent to the anchor 2602 on a same side of a patient's spine or midline axis).
• a longitudinal axis of the access port 2400 can be non-coaxial with a longitudinal axis of the anchor.
• a position o the link 2604 and port 2400 can be locked relative to the anchor 2602 using, for example, a locking screw and hook 2612 to drive the distal fork 2606 of the link 2604 upward against a proximal portion of the anchor.
• the method can further include deforming one or more of the proximal tabs 24 10c.
• a retractor 2902 can be coupled to a deformed tab 2410 and advanced distal ly beyond a distal end of the port 2400 where, for example, soft tissue creep may have occurred.
• a distal retractor tip 3006 o the retractor 2902 can be positioned on an opposite side of the soft tissue from the deformed tab 2910 that is coupled to a proximal portion of the retractor. The retractor can then be manipulated in a manner that deforms the tab coupled thereto back to an original position.
• This movement can cause the distal retractor tip 3006 to capture the soft tissue and retract it towards the side of the access port 2400 where the tab 2410 couples to the retractor 2902, thereby clearing a central portion of the access tube lumen 2403.
• the retractor 2902 and captured tissue can be maintained in this position because force exerted by the captured tissue can be less than a force required to cause the tab 2410 to deform.
• a user can complete any of a variety of surgical procedures through the lumen 2403 of the access port 2400.
• procedures on the intervertebral disc space such as disc replacement, discectomy, endplate preparation, fusion cage insertion, bone graft delivery, and the like can be performed by passing instruments or implants through the access port 2400.
• any locking relative to the anchor 2602 can be released and any tissue retractor 2902 removed, if present, and whichever tab 24 1 Of, 241 Og is coupled to the link 2604 can be deformed back to its original position, thereby returning the access port 2400 to its insertion configuration wherein a longitudinal axis of the access port is aligned with a longitudinal axis of the anchor.
• the access port 2400 can continue to act as a screw tower over the anchor 2602 to aid in anchor receiver head insertion and coupling, spinal fixation element insertion, as well as locking cap insertion and tightening, as described above in connection with FIGS. 23A-23I.
• the link 2604 can be disengaged from the anchor 2602 and the port 2400 can be removed.
• FIG. 32 illustrates still another embodiment of a linkage 3200 to couple an access port and an anchor in a selectively lock able manner.
• a distal portion 3202 of the linkage 3200 can be configured to couple to an anchor, such as a pedicle screw.
• the coupling can be achieved using a variety of known mechanisms, including a threaded engagement, interfacing with one or more notches or other mating features formed on an anchor, etc.
• a proximal portion 3204 of the linkage 3200 can be configured to couple to an access port using any of a variety of known mechanisms.
• the proximal portion 3202 and distal portion 3204 can be coupled to one another by a "smart" material 3206 having mechanical properties that can be varied by application of electrical current or other input.
• the material 3206 can be normally free to move and flex, but can be made rigid by applying an electric current 3208 or other input thereto.
• the material 3206 can be reversed such that it is normally rigid and made flexible by application of an electric current or other input.
• an access port can be positioned relative to a bone screw or other anchor as desired, then current or other input can be applied to the smart material 3206 to hold it in place.
• the configuration of FIG. 32 is one example of how such a material can be utilized, but it is possible to employ it in a variety of manners in connection with the systems and devices described herein.
• such materials could be utilized to achieve clamping of extension tabs, such as the tabs described in connection with FIGS. 4-12C above.
• Such materials could also be utilized to clamp a connector onto a screw tower or port, etc.
• One example of such a “smart" material 3206 can be electroplastic elastomer hydrogels, which can exhibit altered tensile strength (e.g., from flexible to hard) based on electric current applied thereto.
• Other exemplary materials can include electroactive polymers (EAP), nitinol or shape memory materials, hydrogels, etc.
• Exemplary materials include those which are suitable for use in surgical applications, including metals such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, and so forth.
• the various components f the instruments disclosed herein can have varying degrees of rigidity or flexibility, as appropriate for their use. Device sizes can also vary greatly, depending on the intended use and surgical site anatomy. Furthermore, particular components can be formed from a different material than other components.
• One or more components or portions o the instrument can be formed from a radiopaque material to facilitate visualization under fluoroscopy and other imaging techniques, or from a radio lucent material so as not to interfere with visualization of other structures.
• Exemplary radiolucent materials include carbon fiber and high-strength polymers.
• the devices and methods disclosed herein can be used in minimally-invasive surgery and/or open surgery. While the devices and methods disclosed herein are generally described in the context of spinal surgery on a human patient, it will be appreciated that the methods and devices disclosed herein can be used in any of a variety of surgical procedures with any human or animal subject, or in non-surgical procedures.
• the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any
• the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
• reconditioning of a device can utilize a variety of techniques for disassembly,
• the devices described herein can be processed before use in a surgical procedure.
• a new or used instrument can be obtained and, if necessary, cleaned.
• the instrument can then be sterilized.
• the instrument can be placed in a closed and sealed container, such as a plastic or TYVEK bag.
• the container and its contents can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high- energy electrons.
• the radiation can kill bacteria on the instrument and in the container.
• the sterilized instrument can then be stored in the sterile container.
• the sealed container can keep the instrument sterile until it is opened in the medical facility.
• Other forms of sterilization known in the art are also possible. This can include beta or other forms of radiation, ethylene oxide, steam, or a liquid bath (e.g., cold soak). Certain forms of sterilization may be better suited to use with different portions of the device due to the materials utilized, the presence of electrical com onents, etc.

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• Health & Medical Sciences (AREA)
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• Orthopedic Medicine & Surgery (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
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• 2018
  • 2018-03-08 WO PCT/EP2018/055776 patent/WO2018162647A1/en unknown
  • 2018-03-08 EP EP18711061.4A patent/EP3592264A1/de not_active Withdrawn

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