EP3781056A1 - Length adjustable modular screw system - Google Patents
Length adjustable modular screw systemInfo
- Publication number
- EP3781056A1 EP3781056A1 EP19826132.3A EP19826132A EP3781056A1 EP 3781056 A1 EP3781056 A1 EP 3781056A1 EP 19826132 A EP19826132 A EP 19826132A EP 3781056 A1 EP3781056 A1 EP 3781056A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- collet
- component
- length adjustable
- shank
- length
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
-
- 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
- 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
- A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
- A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8685—Pins or screws or threaded wires; nuts therefor comprising multiple separate parts
Definitions
- the present invention relates to modular and adjustable assemblies for achieving alignment and fixation of two or more bones or bone segments.
- the invention relates to modular and adjustable assemblies for achieving fixation of bones in the spine.
- the human skeleton is formed of bones, each bone performing a structural role, either individually or collectively with other bones.
- the spine which surrounds and protects the spinal cord and associated nerves, provides structure to the body, and enables fluid movement in many planes. Constructed of essentially twenty-four stacked vertebrae, the spine includes seven cervical vertebrae, twelve thoracic vertebrae and five lumbar vertebrae. A healthy spine is flexible in multiple directions to enable a broad range of physical movement. Intervertebral disks are disposed between adjacent vertebrae and provide cushioning and dampening to protect the spinal column and nerves in response to the various translational and rotational forces associated with body motion. Maintenance of the structural integrity and approximate axial alignment of the vertebrae is one key to good health.
- a clinical subject's spine may be damaged or otherwise compromised in one of many ways.
- Abnormalities of or damage to the spine include but are not limited to scoliosis (abnormal lateral curvature), kyphosis, excessive lordosis, spondylolisthesis, displaced, degenerative or ruptured discs, fractures to one or more vertebral bodies and tumors.
- scoliosis abnormal lateral curvature
- kyphosis excessive lordosis
- spondylolisthesis displaced, degenerative or ruptured discs
- fractures to one or more vertebral bodies and tumors fractures to one or more vertebral bodies and tumors.
- a stabilization system can be used without fusion treatment of the spine, or in conjunction with fusion treatment of the spine wherein one or more spacing devices is used to replace all or a portion of a vertebral disc.
- discal implants are used together with natural bone components obtained from the clinical subject or a donor source, artificial bone, other biologic components to promote bone growth and fusion between the adjacent vertebral bodies.
- the fixation system operates to create a substantially rigid construct of bone and mechanical hardware that replaces damaged or diseased vertebrae and connects them to relatively healthier adjacent vertebrae.
- spinal fixation systems involve some mode of stabilization using one or more rigid or substantially rigid surgical stabilization elements, such as a rod or a plate, and means for fastening and securing the stabilization element to bone.
- Fastening means can include one or more bone anchors, such as screws or bolts, assembled with connectors that enable engagement with one or more stabilization elements.
- the connectors may include hooks, clamps, cross connectors and other structures that engage with one or more of stabilization elements and anchors.
- the mode of surgical access may be open, that is, involving a relatively extensive resection of the soft tissue to plainly expose the vertebrae to be fixated.
- the mode of surgical access may be minimal, wherein less invasive surgical techniques are used to minimize tissue resection.
- adjacent vertebrae are typically not perfectly aligned. Indeed, along any particular portion of a spine, a series of adjacent vertebrae can deviate laterally a great deal from the central axis of the spine. Further, as a result of natural spinal curvature and any vertebral defects, corresponding portions, such as pedicles, of adjacent vertebra are not in the same plane. In the context of implanting spinal fixation systems, these variations can be accommodated to some extent by introducing bends or curves in the substantially rigid stabilization element(s) used for fixation.
- anchors are adapted to achieve a range of variability in positioning based on pivotal rotation of the anchor such that the axis of the secured anchor relative to the stabilization element can be varied.
- These are referred to as poly-axial and uni-axial anchors. They are useful in particular for facilitating attachment of a stabilization element to two or more vertebrae that are not aligned along the spinal axis.
- systems that are adapted with features that facilitate engagement of non-axially aligned vertebrae.
- fixation system that includes one or more anchors that are capable of mono-, uni-, and poly-axial positioning and allow substantial vertical travel between the distal attachment point in the bone and the proximal position of a stabilization element, and are capable of locking to avoid further vertical travel after the system implantation is completed.
- anchors would enable simplified attachment of adjacent anchors to a stabilization element by reducing the extent of height variability of adjacent anchors, thereby avoiding many of the challenges faced in the surgical setting.
- the present invention describes various exemplary systems and methods of installation of one or more anchors and stabilization elements that are adapted for height adjustability during spinal fixation surgery.
- the disclosure is directed in various embodiments, both described and contemplated, to assemblies, subassemblies and modular components and their methods of use and installation for achieving adjustable fixation and/or reduction of bones and bone fragments.
- the length adjustable modular anchor system for engagement with a bone.
- the length adjustable modular anchor system includes a length adjustable modular screw that includes a neck assembly and a shank.
- the disclosure provides a length adjustable modular screw comprising: a neck assembly that includes elongate expander and collet components that are coaxially engageable by slidable insertion of the expander component in a through channel in the collet component along a common axis, and a threaded shank that includes a socket for coaxially receiving the neck assembly, wherein the modular screw length is varied by sliding the engaged neck assembly within the shank socket along the common axis, and wherein the modular screw length is selected by compressing the components of the neck assembly together to splay a portion of the collet component within the shank socket.
- the neck assembly components are engageable from between an open arrangement and a compressed arrangement.
- the neck assembly in the open arrangement provides free movement of the expander component within the collet component along the common axis.
- the modular screw is engageable with a retaining housing that is configured for accepting a rod and a rod compression set screw.
- the disclosure provides a length adjustable modular anchor system for engagement with a bone, the length adjustable modular anchor system comprising:
- the neck assembly includes elongate expander and collet components that are coaxially engageable by slidable insertion of the expander component in a through channel in the collet component along a common axis, and a threaded shank that includes a socket for coaxially receiving the neck assembly, wherein the neck assembly components are engageable from between an open arrangement and a compressed arrangement, wherein the neck assembly in the open arrangement provides free movement of the expander component within the collet component along the common axis, and wherein the modular screw length is varied by sliding the engaged neck assembly within the shank socket along the common axis, and wherein the modular screw length is selected by compressing the components of the neck assembly together to splay a portion of the collet component within the shank socket;
- the length adjustable modular anchor system further comprises one or more additional components selected from compression set screws, washers, bone anchors, and combinations of these.
- the expander component comprises a head at a proximal end and a pin that extends from the head at a distal end
- the collet component comprises at a proximal end a seat that is matable with the head of the expander component, and comprises at a distal end a collet that extends from the seat
- the collet comprises at least one through slot oriented parallel to the common axis and along at least a portion of the collet through the distal end
- the collet component through channel originating within the seat and extending through the distal end of the collet
- a shank comprises a threaded portion between proximal and distal ends and comprises at the proximal end an aperture in communication with a socket that extends within the shank along a length from the proximal end toward the distal end for receiving at least a portion of the collet of the neck assembly.
- the disclosure provides a length adjustable modular anchor system for engagement with a bone, the length adjustable modular anchor system comprising: adjustable modular anchor system comprising: a length adjustable modular screw comprising a neck assembly and a shank
- the neck assembly comprising an expander component and a collet component, a portion of the expander component insertable within a through channel in the collet component along a common axis, each of the expander and collet components comprising cooperating features that are compressible together to splay the collet
- the expander component comprising a head at a proximal end and a pin that extends from the head at a distal end
- the collet component comprising at a proximal end a seat that is matable with the head of the expander component, and comprising at a distal end a collet that extends from the seat, the collet comprising at least one through slot oriented parallel to the common axis and along at least a portion of the collet through the distal end, the collet component through channel originating within the seat and extending through the distal end of the collet, and a shank comprising a threaded portion between proximal and distal ends and comprising at the proximal end an aperture in communication with a socket that extends within the shank along a length from the proximal end toward the distal end for receiving at least a portion of the collet of the neck assembly, wherein the neck assembly is adjustably engageable within the shank to achieve variable length of the length adjustable modular screw.
- the expander and collet components of the neck assembly are engageable and positionable between open and mated arrangements, wherein in the open arrangement, the pin of the expander component is coaxially engaged with and only partially inserted in the through channel of the collet component and the expander and collet components are freely movable along the common axis, and wherein, when the components of the neck assembly are actuated into mated arrangement, the head of the expander component and the seat of the collet component are mated and the pin of the expander component is fully inserted in the through channel of the collet component.
- At least one of the expander component and the collet component includes a locking feature that is engageable when the head of the expander component and the seat of the collet component are mated.
- the locking feature comprises a circumferential flange on the pin of the expander component that interferes with the distal end of the collet when the expander and collet components are in the mated arrangement to limit displacement of the expander component.
- the pin of the expander component comprises a detent region and the collet component including one or more compression elements within the collet through channel, the one or more compression elements of the collet engageable within the detent region of the pin of the expander component when the expander and collet components are mated.
- the compression element is a shaped foot at the distal end and extends into the collet through channel, the foot having a shape that is one of angled, radiused and squared.
- the expander component pin comprises a taper between the detent region and a proximal portion of the pin, wherein the one or more compression elements of the collet, comprises a complimentary taper, which complimentary tapers, when pressed against the detent region proximal taper, splays the collet.
- the taper is conical.
- the collet component comprises a plurality of through slots arranged circumferentially around the collet and extending along at least a portion of the length of the collet and through the distal end.
- each of the collet and the shank socket having a generally square cross-sectional shape, the collet comprising four through slots, each of the through slots arranged, respectively, on a side of the collet to form four legs, the collet comprising at least one compression element on each leg.
- each of the extender component head and the collet component seat are hemispherical.
- the hemispherical head of the extender component comprises a foot having a generally square cross-sectional shape
- the hemispherical seat of the collet component comprises a seat recess having a generally square cross-sectional shape for receiving the foot of the extender component.
- the length adjustable modular screw further comprises at least one locking feature on at least one of the collet component and the shank that engages to retain the neck assembly within the shank socket.
- the locking feature comprises a shaped recess along at least a portion of the length of the collet component and a complimentary protuberance situated at the proximal end of the shank and extending into the shank socket and engageable with the shaped recess of the collet component, the locking feature preventing pull out of the neck assembly from the shank socket.
- the expander component pin comprisis an extension at its distal end
- the shank socket comprises a floor and cannula extending from the floor towards the distal end, the cannula adapted to receive the expander component extension
- the disclosure provides a length adjustable modular anchor system for engagement with a bone
- the length adjustable modular anchor system comprising: a length adjustable modular screw comprising a neck assembly and a shank the neck assembly comprising an expander component and a collet component, a portion of the expander component insertable within a through channel in the collet component along a common axis, each of the expander and collet components comprising cooperating features that are compressible together to splay the collet the expander component comprising a head at a proximal end and a pin that extends from the head at a distal end
- the collet component comprising at a proximal end a seat that is matable with the head of the expander component, and comprising at a distal end a collet that extends from the seat, the collet comprising at least one through slot oriented parallel to the common axis and along at least a portion of the collet through the distal end, the collet component through channel originating within the seat and extending through the distal end of the collet, and
- a shank comprising a threaded portion between proximal and distal ends and comprising at the proximal end an aperture in communication with a socket that extends within the shank along a length from the proximal end toward the distal end for receiving at least a portion of the collet of the neck assembly
- neck assembly is adjustably engageable within the shank to achieve variable length of the length adjustable modular screw
- one or more compression washers for engagement between a rod and a bone anchor.
- the disclosure provides a surgical method for installing a bone anchor system for spinal fixation, comprising:
- bone anchors two or more bone anchors, at least one of which bone anchors is a length adjustable modular anchor system according to the disclosure
- At least one surgical rod defining a longitudinal axis
- two or more retaining housings for engaging and securing a bone anchor and a surgical rod; two or more locking elements for securing a rod to a bone anchor;
- one or more compression washers for engagement between a rod and a bone anchor
- the vertical height (length) of the length adjustable modular screw can be adjusted intraoperatively.
- the length adjustable modular anchor system is fully assembled prior to engagement of the threaded portion of the shank with bone.
- the vertical height (length) of the length adjustable modular screw can be adjusted continuously along the length of the shank for selecting height adjustment.
- the length adjustable modular screw comprises one or more positive stop features within the shank and the vertical height (length) of the length adjustable modular screw can be incrementally along the length of the shank the increments corresponding to the one or more positive stop features.
- the length adjustable modular anchor system is provided pre-assembled.
- at least the neck assembly of the length adjustable modular anchor system is provided pre-assembled with a retaining housing.
- FIG 1 shows a front plan view and alternate perspective views of a length adjustable modular anchor system according to the disclosure
- FIG 2 shows exploded and assembled perspective views of the neck assembly of the length adjustable modular anchor system shown in FIG 1;
- FIG 3 shows a front plan view, an exploded perspective view and a close-up perspective view of the length adjustable modular anchor system shown in FIG 1;
- FIG 4 shows on the left alternate top perspective, side plan, and partial close-up side plan views of an expander component of the neck assembly shown in FIG 2, and on the left alternate top perspective, side plan, and side cross sectional views of a collet component of the neck assembly shown in FIG 2;
- FIG 5 shows an alternate side plan, top perspective, and side cross sectional views of a shank component of the length adjustable modular anchor system 10 shown in FIG 1;
- FIG 6 shows on the top bottom and top plan views, and on the bottom side plan and cross sectional views of the length adjustable modular anchor system 10 shown in FIG 1, and side plan and cross sectional views of an alternate embodiment of a length adjustable modular anchor system 10 that includes a retaining housing 20, a compression washer 30 and a locking element 40 according to the disclosure; and
- FIG 7 shows each, individually in alternate views, the retaining housing 20, a compression washer 30, locking element 40, and protuberance 570.
- proximal refers to the portion of the object that is closest to the operator of the object (or some other stated reference point)
- distal refers to the portion of the object that is farthest from the operator of the object (or some other stated reference point).
- A“clinical subject” refers to a human or other animal who is the subject of treatment with a bone fixation or reduction device in accordance with the disclosure.
- cephalad indicates a direction toward the head of the clinical subject
- the term“caudad” indicates a direction toward the feet of the clinical subject.
- the term“posterior” indicates a direction toward the back of the clinical subject
- the term“anterior” indicates a direction toward the front of the clinical subject
- the term“lateral” indicates a direction toward a side of the clinical subject.
- the term“height” as used specifically herein pertains to references to the spine of a clinical subject and refers to the relative position of one or both of vertebrae and anchors along adjacent portions of the spine.
- the terms“vertical” and“vertical adjustment” relate to the relative height variations and adjustments thereof with respect to one or both of vertebrae and anchors along adjacent portions or the length of the spine in the context of a clinical subject in a prone position wherein a length adjustment to an anchor would be in a vertical dimension from anterior to posterior.
- anchor typically refers to the screw component of an anchor assembly or subassembly
- anchor assembly refers to the screw component together with attachment features, such as a retaining housing (a conventional tulip head) or other type of attachment device, and one or more of compression washers and set screws, and optionally additional fixation components.
- Subassemblies also refer to the modular components of the screw, such as, for example, the shank and head portions and subassemblies of these. More generically, anchor components, subassemblies and assemblies can be adapted to include features suitable for use with any bones in a clinical subject, wherein the modular and adjustable features are as described and claimed herein.
- the length adjustable modular anchor system 10 includes a length adjustable modular screw 100 which can be varied in length.
- the length adjustable modular screw 100 is assembled to provide a construct that resembles a convention screw that includes a head 310 portion including at a proximal end 410 a hemispherical screw head and a separate threaded shank 500 portion including at a distal end a threaded shank 500.
- the length adjustable modular screw 100 components are adapted for interconnection along a common elongate axis and capable of vertical displacement to achieve fixed or variable length when implanted in a bone.
- pressure from the rod locked into the retaining housing 20 (tulip head) by a threaded nut results in displacement of the compression washer 30 within the tulip head 20 and compression on the head of the screw thereby transferring compressive force onto the screw, fixing it into place within the tulip head 20 and preventing any axial rotation (for uni- and poly- axial assemblies).
- FIG 6 provides an example of such a system that includes an embodiment of a length adjustable modular screw 100 according to the disclosure.
- the compressive force employed to lock a rod to a conventional screw also serves to lock the length adjustable modular screw 100 embodiments according to this disclosure, thereby fixing the vertical position selected by the surgeon.
- the length adjustable modular anchor system 10 for engagement with a bone.
- the length adjustable modular anchor system 10 includes a length adjustable modular screw 100 that includes a neck assembly 200 and a shank 500.
- the neck assembly 200 includes an expander component 300 and a collet component 400. As assembled, a portion of the expander component 200 is insertable within a through channel 430 in the collet component 400 along a common axis, as shown in FIG 2.
- the collet component 400 through channel 430 originates within the seat 440 and extends through the distal end 530 of the collet 450.
- the expander component pin 300, 330 When engaged, the head 310 of the expander component 300 contacts the seat of the collet component 400 and the pin 330 is passed through the through channel 430.
- the expander component pin 300, 330 includes an extension that extends beyond the distal end 420 of the collet 450.
- the expander component pin 330 may lack such an extension and thus, the pin 330 may not extend beyond the distal end 420 of the collet 450.
- the expander component 300 and the collet component 400 are engageable in each of open, mated and compressed configurations.
- the expander component 300 and the collet component 400 are engaged without the head 310 contacting the seat 440 and the pin 330 of the expander component 300 is coaxially engaged with and only partially inserted in the through channel 430 of the collet component 400 and the expander and collet components 300, 400 are freely movable along the common axis.
- the expander component 300 includes a head 310 at a proximal end 410 and a pin 330 that extends from the head 310 at a distal end 420.
- the collet component 400 includes at a proximal end 530 a seat 440 that is matable with the head 310 of the expander component 300, and at a distal end 420 a collet 450 that extends from the seat 440.
- each of the head 310 of the expander component 300 and the seat 440 of the collet component 400 are generally hemispherical in shape and mated 220 to form a generally spherical head 310, the mated 220 pin 330 and collet 450 features forming a generally rod-shaped extension from the sphere.
- the head 310 and seat 440 features may be other than hemispherical.
- the expander component 300 has a head 310 that is generally hemispherical and includes a flat at its apex that includes a drive recess 360 for engaging a driver.
- any suitable shaped drive recess 360 may be employed for engagement with any of a variety of drivers.
- the head 310 of the expander component 300 includes a foot 320 having a generally square cross sectional shape
- the seat 440 of the collet component 400 includes a complimentary seat recess 441 having a generally square cross sectional shape for receiving the foot 320 of the extender component 300.
- the collet 450 includes at least one through slot 452 oriented parallel to the common axis and along at least a portion of the collet 450 through the distal end 420. And in some embodiments the collet 450 includes a plurality of through slots 452 arranged circumferentially around the collet 450 and extending along at least a portion of the length of the collet 450 and through the distal end 420. As shown in the drawings, for example FIG 4, the collet 450 includes four through slots 452.
- the collet 450 has a generally square cross-sectional shape 490, and each of the through slots 452 are arranged, respectively, on a side of the collet 450 to form four legs.
- the collet 450 has chamfered comers 482 and generally planar sides on its outer surface.
- the collet 450 includes on its outer surface at its distal end 420 an array of interference enhancers 454.
- the interference enhancers 454 include a knurled texture.
- the feature may include other textural elements, or may include one or more furrows, divots or ridges.
- the interference enhancers 454 may enhance the contact with the wall 550 of the socket 540 within the shank 500 when the collet 450 is splayed. And the interference enhancers 454 may also enhance the flexibility of the shank 500 for splaying. It will be appreciated that in some embodiments the collet 450 lacks such interference enhancers 454. And as shown in the depicted embodiment, the collet 450 includes at its distal end 420 on each leg 456 and within the through channel 430 a compression element 460 that is generally block shaped with a proximally oriented taper or angle.
- collets 450 may be selected to facilitate locking and compression and/or frictional engagement between a collet 450 and engaged anchor components.
- variations in the thickness of walls 550 of one or more components can be employed to achieve compressive engagement.
- collet 450 features may include tapers along the length of engaging components. It will be understood that the features described herein are intended to be non-limiting and other features of collets 450 known in the art may be used to achieve the inventive modular and adjustable anchors in accordance with the invention.
- At least one of the expander component 300 and the collet component 400 includes a locking feature that is engageable when the head 310 of the expander component 300 and the seat 440 of the collet component 400 are mated 220.
- the locking feature includes a circumferential flange 340 on the pin 330 of the expander component 300 that interferes with the distal end 420 of the collet 450 when the expander and collet components 300, 400 are in the mated 220 arrangement to limit displacement of the expander component 300.
- the circumferential flange 340 is located at a position that is between the proximal and distal ends 410, 420 and is oriented with a generally planar surface on a proximal edge which abuts a taper 332 that is angled toward the common axis from proximal to distal to form a generally conical taper 332.
- the pin 330 has a diameter at its proximal end 410 that is greater than the diameter at its distal end 420.
- the pin 330 of the expander component 300 also includes a detent region 350, which is shown in FIG 2.
- the detent region 350 has a diameter that is approximately the same as the diameter of the pin 330 at the distal end 420.
- the detent region 350 is abutted at its proximal end 410 by a taper 332 that is angled toward the common axis from proximal to distal to form a generally conical taper 332.
- the collet component 400 includes at least one compression elements 460 within the collet 450 through channel 430.
- the at least one compression element 460 of the collet 450 is engageable within the detent region 350 of the pin 330 of the expander component 300 when the expander and collet components 300, 400 are mated 220.
- the compression element 460 extends into the collet 450 through channel 430, and has a shape that is one of angled, radiused and squared.
- the compression element 460 may be formed continuously and interrupted only by the through slots 452, and may be dome shaped, may have planer circumferential flange 340 shape, may include one or more conical or beveled edges, and may be wedge shaped. And there may be more than one compression element 460 arranged along the length of the through channel 430.
- the pin 330 has a cross sectional shape 370 that is generally cylindrical and the through channel 430 of the collet component 400 has an inner wall 431 with an inner wall cross sectional shape 432 that is cylindrical. It will be appreciated that in other embodiments, each of the pin 330 cross sectional shape 370 and the inner wall cross sectional shape 432 may be other than cylindrical.
- the expander component 300 and the collet component 400 may include features that engage to mate and compress that are located at positions other than as shown in the drawings.
- one or more of the circumferential flange 340 and the detent region 350 and the taper 332 on the pin 330 may be positioned more proximally or more distally, and the pin 330 may not include an extension beyond one or more of the circumferential flange 340 and the detent region 350 and the taper 332.
- one or more of compression elements 460 may be positioned more proximally or more distally within the through channel 430 of the collet component 400.
- the expander component 300 pin 330 includes a conical taper 332 between the detent region 350 and a proximal portion of the pin 330, wherein the one or more compression elements 460 of the collet 450 comprises a complimentary taper 332, which complimentary tapers, when pressed against the detent region 350 proximal taper 332, splays the collet 450.
- the length adjustable modular anchor system 10 also includes a shank 500 that includes a threaded portion 510 between proximal and distal ends 520, 530.
- the shank 500 includes at its distal end 530 a distal tip 532 that may be bulleted 532’ and is suitable for penetrating bone.
- the shank 500 includes at its proximal end 520 an aperture that is in communication with a socket 540.
- the socket 540 extends within the shank 500 along a length from the proximal end 520 toward the distal end 530 and is adapted for receiving at least a portion of the collet 450 of the neck assembly 200.
- the neck assembly 200 is adjustably engageable within the shank 500 to achieve variable length of the length adjustable modular screw 100.
- the threaded portion 510 of the shank 500 may be continuous from the proximal to the distal ends 520, 530, or there may be a gap at either end that lacks threading, or a gap along the length that lacks threading.
- the shank 500 includes at least a major and a minor diameter 592, 594, the minor diameter 594 defined by the outer surface of the shank 500 wall 550 excluding the threads, and the major diameter 592 defined by the threads.
- one or both of the major and minor diameters 592, 594 may be straight or may be tapered.
- at least a portion of the length of the shank 500 may taper 332 from proximal to distal either continuously or may taper 332 in a stepped down manner.
- the threading may vary to provide a proximal thread zone 524 that is different from a distal thread zone 534.
- the depicted collet has a cross sectional shape 490 that is generally square and the socket 540 of the shank 500 has a socket cross sectional shape 542 that is square, each of the collet 450 and the socket 540 including chamfered comers 482 and chamfered sidewalls 544, respectively. It will be appreciated that in other embodiments, each of the collet cross sectional shape 490 and the socket cross sectional shape 542 may be other than square and may be cylindrical.
- the shank 500 includes at least one, and as depicted, includes two wall apertures 560, 560’ that are adapted for receiving a protuberance 570, 570’ through each for engagement with the neck assembly 200, as described further below.
- the protuberance 570, 570’ may be integrated with the shank 500.
- the drawings show the pin 330 insertable in an aperture 560, 560’ through a flange 598 on the shank 500, in some embodiments, the shank 500 may lack a flange 598.
- the length adjustable modular screw 100 further includes at least one locking feature on at least one of the neck assembly 200 and the shank 500 that engages to retain the neck assembly 200 within the shank socket 500, 540.
- the locking feature includes a shaped recess 470 along at least a portion of the length of the collet component 400 and a complimentary protuberance 570, 570’ situated at the proximal end 520 of the shank 500.
- the protuberance 570, 570’ extends into the shank socket 500, 540 and is engageable with the shaped recess 470 of the collet component 400.
- the locking feature prevents pull out of the neck assembly 200 from the shank socket 500, 540.
- the locking feature also limits rotational motion of the neck assembly 200 within the socket 540.
- the shaped recess 470 has a generally elliptical shape and is elongate from the proximal 520 and towards the distal end 530 of the collet component 400.
- the shaped recess 470 includes proximal and distal stops 472, 474. It will be appreciated that other shapes for the shaped recess 470 may be employed, and the shaped recess 470 may have a longer or shorter length along the collet 450.
- the expander component pin 300, 330 includes an extension at its distal end 420
- the shank socket 500, 540 includes a floor 580 and cannula 596 extending from the floor 580 towards the distal end 530.
- the distal end 530 of the collet 450 contacts the floor 580 to limit the distal passage of the neck assembly 200 within the socket 540
- the cannula 596 is adapted to receive the expander component 300 extension which aids in stabilizing against off axis motion of the neck assembly 200 relative to the shank 500.
- the length of each of the extension of the expander component 300 and the shaped recess 470 of the collet 450 are selected such that when the neck assembly 200 is displaced proximally to the limit of the distal stop 474, the extension is retained in the cannula 596 to maximize off axis stabilization together with restriction on axis pull out.
- the floor 580 of the shank 500 has a generally conical floor taper 582.
- the floor 580 may have another shape, and may be planar, or have a spherical contour or another shape. It will be appreciated that in alternate embodiments different or additional engagement features may be used that achieve the fixed engagement between subcomponents.
- Such engagement is useful to enable torsional engagement and actuation, such as with a driving tool, of one or more components while preventing other components from experiencing torsional force.
- engagement features that serve as stops to prevent disengagement of components by the application of shear force, such as pull out of axially aligned components.
- the length adjustable modular anchor system 10 for engagement with a bone is shown.
- the length adjustable modular anchor system 10 includes a length adjustable modular screw 100 comprising a neck assembly 200 and a shank 500, a rod (not shown) and at least one retaining housing 20 and a locking element 40 for engaging and securing the length adjustable modular screw 100 and the surgical rod.
- the length adjustable modular anchor system 10 also includes one or more compression washers 30 for engagement between the rod and a bone anchor.
- one or more than one length adjustable modular anchor system 10 may be employed together with one or more conventional bone anchors, and additional components including surgical rods 50 (or other stabilizing members), retaining housings 20, locking elements 40 and optional components such as compression washers 30.
- Arrays of anchors and rods 50 may be used for example to stabilize adjacent vertebral bodies which may include placement of up to four or more anchors, two each within pedicles of adjacent vertebral bodies and engagement of a surgical rod to each of the pair of adjacent anchors to confer stabilization along the length of the spine.
- Also provided according to the disclosure is a surgical method for installing a bone anchor system for spinal fixation.
- the steps include in some embodiments selecting each of two or more bone anchors, at least one of which bone anchors is a length adjustable modular anchor system 10 that includes a neck assembly 200 and a shank 500, as described herein above, and at least one surgical rod defining a longitudinal axis, and two or more retaining housings 20 for engaging and securing a bone anchor and a surgical rod, and two or more locking elements 40 for securing a rod to a bone anchor, and optionally, one or more compression washers 30 for engagement between a rod and a bone anchor.
- the steps include, either before or after seating the neck assembly 200 in a retaining housing 20, assembling a length adjustable modular screw 100 system.
- the steps for assembling a length adjustable modular screw 100 system include first engaging the expander and collet components 300, 400 of the neck assembly 200 into one of open and mated 220 engagement, and inserting the neck assembly 200 into the shank 500 socket 540, then contacting the distal tip 532 of the shank 500 with a bone. Thereafter, using a suitable driver, engaging the drive recess 360 of the neck assembly 200 to compress the expander and collet components 300, 400 and splay the collet 450. Thereafter, under continued compression, driving the threaded portion 510 of the shank 500 into a bone.
- the steps include releasing the drive compression on the drive recess 360 of the neck assembly 200 to thereby relieve the collet 450 from being splayed and thereby allowing translation of the neck assembly 200 within the shank 500.
- the vertical height (length) of the length adjustable modular anchor system 10 may be adjusted by sliding the neck assembly 200 along the common axis within the socket 540 of the shank 500.
- the method includes tightening the fixation element within the retaining housing 20 to compress the rod against the neck assembly 200 and to drive the expander component 300 and the collet component 400 into compressed engagement to splay the collet 450 within the socket 540 of the shank 500.
- the length adjustable modular anchor system 10 is fully assembled prior to engagement of the threaded portion 510 of the shank 500 with bone.
- the length adjustable modular anchor system 10 is provided pre-assembled. And in yet other embodiments, at least the neck assembly 200 of the length adjustable modular anchor system 10 is provided pre-assembled with a retaining housing 20.
- the length adjustable modular screw 100 can be adjusted within a displacement range between zero mm to 20 mm, and more particularly 0 mm to 10 mm, including fractional increments therein, including 0.1, 0.2, 0.3, 0.4, 0.5, 1.0, 1.5, 2.0, and 2.5 up to and through 20.0 mm. Of course, other increments and ranges of travel are possible, and implementation thereof is well within the skill in the art.
- length adjustable modular screw may be provided that are of varying lengths and therefore allow for an expanded range of length adaptability.
- length adjustable modular screw components are of fixed length or offered in ranges of lengths, such possible embodiments are particularly advantageous in that they provide options in some embodiments for providing preassembled bottom and top loading anchor assemblies, as well as anchor assemblies and subassemblies that may be assembled partially by the manufacturer or partially or completely by the surgeon, providing a range of options for achieving maximal flexibility in the surgical setting.
- the components of the length adjustable modular screw 100 assembly that achieve locking of the length adjustable modular screw 100 to a rod can also actuate the collet 450 locking mechanism for fixing the neck assembly 200 of the length adjustable modular anchor system 10 to the shank 500 and optionally fixing the vertical position of the length adjustable modular screw 100 relative to the vertebra and the fixation system elements.
- the means of achieving locking may be other than .compression by the rod, and in yet other embodiments the locking means may be the same but the specific elements, such as the locking element 40, rod and compression washer 30, may be varied.
- fixation systems that include in the depicted embodiments anchors in the form of vertebral pedicle screws, and stabilization elements in the form of one or more surgical rods.
- the spine is but one example of a bone or bone system that may be the object of surgical correction, and thus, pedicle screws and rods are mere examples of the bone anchor, and vertebral stabilization system components contemplated herein.
- anchors may be screws for engagement with a tether or other tensioning means, or with one or more plates or rods or combinations of these.
- anchors and systems described herein may be suitable for other bones and bone systems in the body.
- the mechanisms for adjustment of anchor length can be adapted for use with other anchor and fixation and stabilization elements used in orthopedic applications in the spine or in other parts of the body.
- surgical rods may be made adjustable according to the features disclosed herein to enable tuned adjustment of rod length at the time of implantation or subsequently as spinal healing and or adjustment takes place, such as for adjustment of rod length in connection with scoliosis treatment.
- adjustable anchors may be employed in the reduction or fixation of other bones, such as bones of the hand, or of the foot or in other locations where adjustment of the length of an anchor or other fixation element is desirable.
- One such example would be incorporation of adjustability features disclosed herein in dual threaded headless screws or screws, rods or pins with other head and threading configurations that are used for interconnecting and reducing fractured bone fragments or adjacent bones.
- Such anchors adapted according to the instant disclosure would enable tuned adjustment of implant length to accommodate anatomical variations in a clinical subject and achieve optimized anchor placement.
- the invention is directed in various aspects to a system including assemblies and subassemblies, components including anchors and anchor components adapted for attachment to a bony structure of a clinical subject.
- a system including assemblies and subassemblies, components including anchors and anchor components adapted for attachment to a bony structure of a clinical subject.
- one, two or more such anchors in the form of screws are affixed to bones, for example, vertebral structures such as the pedicle, and each anchor is connected to a stabilizer such as a surgical rod that is inserted between the anchors.
- the anchors are novel in many respects owing to their modular nature and thus the options to provide the anchors in modular, sub-assembled and assembled forms provide a broad array of choices for the surgeon in devising the optimal surgical fixation plan.
- installation of the inventive components of the exemplary bone anchor system for spinal fixation described above includes: selecting two or more bone anchor assemblies or subassemblies, including assemblies and subassemblies selected from pre- assembled and top and bottom loading forms, wherein at least one anchor assembly includes an length adjustable modular screw; selecting a stabilization element; using a suitable driver to drive each of two or more anchors or anchor subassemblies into fixed engagement with corresponding vertebrae, wherein at least one anchor or anchor subassembly includes or is adapted to engage with modular components that allow length adjustability, including translation along the vertical axis of the anchor, so as to enable selection of the anchor length by the surgeon; engaging a proximal portion of the modular adjustable anchor, such modular portion selected from a pre-assembled or modular screw head and engagement seat, to provide a means to introduce the stabilization element into engagement with the anchor; optionally incrementally adjusting the length of the anchor so as to achieve engagement of the stabilization element in the anchor; sliding the stabilization element
- the length adjustable modular screw described herein may be employed with components of a conventional spinal stabilization system, and may be used on a single vertebra, or traversing two or more vertebra, and may be used in conjunction with fusion or non-fusion treatment of the spine.
- the anchors may be employed in isolation or in systems that include two or more anchors, connectors and stabilization elements, and the anchors may be deployed other than along the spinal axis.
- two or more anchors may be used to secure one or more stabilization elements that extend either laterally or from an anterior to posterior aspect to traverse a vertebral body, or that wrap around one or more vertebral bodies, or combinations of these.
- assemblies and subassemblies, components, including anchors and anchor components may be used in bones of the body other than the spine, and as such may be used individually, as a plurality, or in combination with other devices, and combinations of these.
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/018,942 US10758285B2 (en) | 2016-08-24 | 2018-06-26 | Length adjustable modular screw system |
PCT/US2019/039026 WO2020005971A1 (en) | 2018-06-26 | 2019-06-25 | Length adjustable modular screw system |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3781056A1 true EP3781056A1 (en) | 2021-02-24 |
EP3781056A4 EP3781056A4 (en) | 2022-01-26 |
Family
ID=68987644
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19826132.3A Withdrawn EP3781056A4 (en) | 2018-06-26 | 2019-06-25 | Length adjustable modular screw system |
Country Status (3)
Country | Link |
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EP (1) | EP3781056A4 (en) |
JP (1) | JP2021529583A (en) |
WO (1) | WO2020005971A1 (en) |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5217462A (en) * | 1991-03-05 | 1993-06-08 | Pfizer Hospital Products Group, Inc. | Screw and driver |
SE9600208D0 (en) * | 1996-01-19 | 1996-01-19 | Astra Ab | Fixture and prosthesis including the same |
NL1017932C2 (en) * | 2001-04-24 | 2002-10-29 | Paul De Windt | Fixing device for fixing swirl parts. |
DE60330010D1 (en) * | 2002-07-19 | 2009-12-24 | Interventional Spine Inc | DEVICE FOR SPINAL FUSING |
KR101280591B1 (en) * | 2003-11-07 | 2013-07-02 | 비이더만 테크놀로지스 게엠베하 & 코. 카게 | Spring Element for a Bone Stabilizing Device, and Method for the Production of said Spring Element |
ES2334811T3 (en) * | 2006-11-17 | 2010-03-16 | Biedermann Motech Gmbh | OSEO ANCHORAGE DEVICE. |
US20130035721A1 (en) * | 2011-08-04 | 2013-02-07 | John Eric Brunelle | Surgical anchor |
EP2910210B1 (en) * | 2012-06-18 | 2018-03-07 | Biedermann Technologies GmbH & Co. KG | Bone anchor |
US20140214034A1 (en) * | 2013-01-25 | 2014-07-31 | Fady Rayes | Cannulated telescopic femoral neck screw device and related fixation method |
WO2018039485A1 (en) * | 2016-08-24 | 2018-03-01 | Integrity Implants, Inc. | Adjustable bone fixation systems |
DE102016011947A1 (en) * | 2016-10-05 | 2018-04-05 | Bluewater Medical GmbH | Screw with a head part, a threaded part and a connecting part |
-
2019
- 2019-06-25 WO PCT/US2019/039026 patent/WO2020005971A1/en unknown
- 2019-06-25 EP EP19826132.3A patent/EP3781056A4/en not_active Withdrawn
- 2019-06-25 JP JP2020571823A patent/JP2021529583A/en active Pending
Also Published As
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WO2020005971A1 (en) | 2020-01-02 |
JP2021529583A (en) | 2021-11-04 |
EP3781056A4 (en) | 2022-01-26 |
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