US Spine, Inc.

Medical Designs, LLC

U.S. Spinal Technologies, LLC

Medical Design Instruments, LLC

Medical Design, LLC

Mark H Falahee

Trace R Cawley

Doris Blake

Phil Reed

John R Pepper

Leonel Dominguez

James Hooper

Ian McDermott

K Arjun Joseph

Intervertebral spacers, such as interbody vertebral cages, that facilitate minimally-invasive corrective restoration surgeries, and related methods. In some implementations, an introducer may be used introduce an intervertebral spacer in a first, straightened shape into an intervertebral disc space. The introducer may engage a plurality of adjacent recesses of the intervertebral spacer to maintain the intervertebral spacer in the first, straightened shape during introduction. An introducer, in some cases the same introducer, may be used to articulate the intervertebral spacer by actuating at least one hinge of the intervertebral spacer such that the intervertebral spacer assumes a second, curved shape once within the intervertebral disc space.

Steerable interbody fusion cage

A specialized spinous process retractor surgical instrument comprises a pair of opposing proximal handles coupled to a pair of opposing distal jaws through a joint such that when the handles are compressed the jaws spread apart, the handles defining a plane when viewed from the side. The jaws curve downwardly from the plane distally from the joint, then curve back upwardly before terminating in end portions configured for spreading. The instrument defining a centerline when viewed from above, with the jaws distally from the joint diverging outwardly from the centerline, then curving back toward the centerline before terminating in the end portions. The end portions may include opposing, outwardly facing textured or roughened bone-contacting surfaces. The end portions of the jaws when viewed from the sides may define a plane that is substantially parallel to the plane defined by the handles.

Spinous process retractor

An interbody vertebral cage facilitates minimally invasive approaches to the intervertebral disc for corrective restoration of disc height, stabilization between vertebra, and fusion. The preferred embodiment provides a streamlined, slender straight contour with a central hinge or other articulating apparatus that allows the introduction of the cage into the operative field and disc space in a minimally invasive, bone-sparing manner. After partial insertion, the hinge component is activated, allowing the operator to steer the cage anterior-medially within the disc space to an anterior-central position within the intervertebral space. In this state the cage is shaped like a crescent, chevron or boomerang.

A system may be fixed in place to stabilize a spinal fusion, or released for dynamic motion, thereby providing stability with flexibility in conjunction with artificial mechanical or plasma discs, or normal physiologic discs. In terms of apparatus, the invention involves pedicle fixation utilizing a superior facet complex (SFC) with soft tissue attachment points. The SFC receives one or more inferior facet gliding arms (IFGAs) and associated joints which permit flexion, extension, lateral bending and/or other movements.

Posterior spinal reconstruction system

In one embodiment, a bone-fastening system includes a handle, a barrel assembly connected to the handle, and a bridge assembly connected to the barrel assembly. The bridge assembly may be configured to receive a first connector element and a second connector element in axial alignment with the first connector element so as to receive a fastening element between the first and second connector elements. The system may also include a control configured to, upon actuation, approximate the first connector element and the second connector element so as to apply compressive pressure to bone portions positioned between the first connector element and the second connector element. A drive mechanism configured to advance the fastening element through the bone portions and connect the first connector element with the second connector element to fasten the bone portions under compression may also be provided with the system.

Bone fixation implant system and method

A minimally invasive bone stabilization and locking system and method are applicable to joint fusion and fracture repair, including human facet joint stabilization. A bone-boring bit on an elongated shaft is used to drill a hole through the bone or joint such that the bit penetrates through the distal surface. An implant is provided having hollow body terminating in a spreadable distal end. The implant is placed over the elongated shaft and into the drilled hole such that the spreadable end protrudes through the distal surface. The elongated shaft is then pulled, such that the bit interacts with the distal end of the implant, thereby causing the spreadable end of the implant sleeve to spread so as to prevent backout of the implant body through the hole. A proximal cap may be tightened against the proximal surface, thereby fixing the bone or joint in compression.

Percutaneous locking bone fixation system

A percutaneous facet fixation system minimally invasive, reproducible, efficient, and effective. Capable of immediate stabilization of a facet joint complex, the instrumentation and methods may be used with C-arm and/or endoscopic visualization.

Percutaneous facet fixation system

In a spinal stabilization system a facet fixation device is interconnected to an anchor or fixation device driven into a portion of the spine. The facet fixation device has a proximal head and a distal fastener providing compression across a facet joint. A rigid or elastic member interconnects the proximal head of the facet fixation device to the anchor or fixation device, facilitating static or dynamic stabilization. The facet fixation device may extend directly across the facet joint, or a translaminar or laminar transverse process facet (LTPF) fixation device may be used. In the preferred embodiment the facet fixation device includes a distal tip which is self-cutting and tapping. The anchor may be a pedicle screw. The fixation device itself be a facet fixation device, and the facet fixation device may be connected to the anchor or fixation through two members joined with a coupling unit.

Multilevel facet/laminar fixation system

Percutaneous translaminar facet fixation system

A low-profile bone anchoring system particularly suited to pelvis fixation in conjunction with spinal correction. The preferred embodiment utilizes screw fixation, followed by deployment of penetrating anchoring arms, expansion of outer sleeve, or both. The proximal ends of the screw anchors are preferably flush or deep to the bone surface. An internal screw mechanism is utilized to deploy side anchoring arms, or expansion of outer sleeve, or both. Serrated top edge interfaces with low profile variable axis/angled elbow (VAE), which has varying lengths/dimensions to accommodate anatomy and differing rod sizes. The VAEs preferably feature a serrated bottom edge to interface with anchor screw. Locking screw at elbow secures into inner threads of pelvis anchor screw. Each VAE captures a rod, end to end, or by passing rod through the side of elbow.

Low profile screw anchor with variable axis/angle fixation

A facet fixation system facilitates dynamic or static stabilization with few exposed components. A first anchor component is adapted for implantation through a facet joint and into intra-pedicle bone, and a second anchor component is adapted for fixation to the outer surface of the facet joint. A connector component connects the first and second anchor components. The connector component may be at least partially elastic, facilitating a dynamic stabilization of a facet joint, or rigid, facilitating a static stabilization of a facet joint.

Dynamic/static facet fixation device and method

Implants, tools and techniques facilitate a percutaneous posterior lateral approach to the placement of an in-situ cage, and an inventive cage design to meet this objective. In terms of apparatus, the invention includes a laterally expandable cage, including a locking gate, enabling the system to be introduced into an intradiscal space through a minimally invasive percutaneous posteo-lateral approach. In addition to the cage designs, adapted to hold bone graft and/or other biologic materials, the invention includes other novel instruments, including an introducer associated with cage placement, deployment and closure.

Percutaneous posterior lateral in-situ cage

A bone-fastening system includes an implant with a threaded screw, a distal nut with a threaded bore, and a proximal washer which may also be threaded. An instrument for implanting the implant includes a handle and a barrel terminating in a holder for the washer. A c-shaped bridge assembly has a first end connected to the barrel and a second end including a holder for the nut in axial alignment with the washer. A manually operated control on the instrument, coupled to an elongated element in the barrel, causes the washer to move toward the nut, thereby applying compressive pressure to bone portions to be fastened together. A drive mechanism disposed within the barrel has a distal end with a holder for the screw and a proximal end that is turned by a user, thereby advancing the screw through the washer to the nut to fasten the bone portions under compression. The manually operated control is preferably a trigger that is squeezed toward the handle by a user. A separate control, also preferably in the form of a trigger, is used to release pressure on the elongated element in the barrel, enabling the implant to be easily removed from the implant once in position.

A skin closure instrument and method of use are disclosed. Broadly a tool grasps skin edges and applies glue evenly in rapid and reproducible fashion, thereby enabling a single healthcare provider to perform the procedure. In the preferred embodiment, the instrument is packaged in a sterile container for a single use. The glue may be packaged along with the instrument, or may be added to a reservoir. The system is applicable to both small and large wounds, and is easy to manipulate by a single operator, resulting in a rapid consistent closure of wound edges.

Wound and skin closure instrument and method of use

An inserter and associated method improve the placement of a fastener into a bone. Although ideally suited to the placement of a pedicle screw into a vertebral body (VB), the apparatus and method are applicable to other bones and fasteners, pins, and the like. The apparatus includes cannulated body having a proximal end, a distal end, and a threaded section therebetween. The proximal end is shaped for rotational tightening by a wrench or other tool, and the distal end including a perforated nozzle so that cement and/or biologics may be injected into the bone through the cannulated body. The proximal end includes a Lur-loc or other appropriate fitting to receive a cement-filled syringe. The device is also preferably disposable using, for example, clear plastic construction. The inserter may further including a member for sealing the nozzle relative to a bone. Such a member may be composed of a silatstic or other compressible material, or may be inflatable. At least the distal end of the device is preferably provided with varying diameters for different insertion sizes.

Growing community of inventors

Ann Arbor, MI, United States of America

Mark H Falahee