# US 10,945,861 B2 · Devices and methods for minimally invasive spinal stabilization and instrumentation

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- Number: US 10,945,861 B2
- Document ID: US10945861B2
- Status: Granted
- Kind: B2
- Application number: 16/657,848
- Filed: 2019-10-18
- Published: 2020-06-18
- Granted: 2021-03-16
- Earliest claimed: 2009-12-07
- Applicants: Samy Abdou
- Inventors: Samy Abdou
- Web page: https://patentgrep.com/patent/US10945861B2

## CPC

- A61F 2/4611: {of spinal prostheses}
- A61B 17/0206: {with antagonistic arms as supports for retractor elements}
- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/025: {Joint distractors}
- A61B 17/1611: {the two jaw elements being integral with respective elongate shaft elements}
- A61B 17/1757: {for the spine}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7037: {wherein pivoting is blocked when the rod is clamped}
- A61B 17/7077: {for moving bone anchors attached to vertebrae, thereby displacing the vertebrae}
- A61B 17/7079: {Tools requiring anchors to be already mounted on an implanted longitudinal or transverse element, e.g. where said element guides the anchor motion}
- A61B 17/708: {with tubular extensions coaxially mounted on the bone anchors}
- A61B 17/7082: {for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws}
- A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)}
- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61B 17/7083: {Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements}
- A61B 2017/00473: {Distal part, e.g. tip or head (A61B2017/00464 takes precedence)}
- A61B 2017/0256: {for the spine}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped}
- A61F 2002/30772: {Apertures or holes, e.g. of circular cross section}
- A61F 2002/4435: {Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes}
- A61F 2002/4485: {comprising three or more adjacent spinal implants}
- A61F 2002/4635: {using minimally invasive surgery}
- A61F 2310/00359: Bone or bony tissue
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Described herein are devices and methods for fusion of adjacent vertebral bones of a subject using distractor platforms for the exposure and resection of at least a portion of the facet joint, such as in performance of a TLIF procedure. In one embodiment, the distractor platform contains at least a first receptacle and/or extension that are adapted to couple to the implanted screw/bone marker and the method includes advancing a first threaded segment of a first bone fastener assembly into the identified first pedicle of the first vertebral bone, wherein the first bone fastener assembly further comprises a second segment that is adapted to couple with a distraction platform adapted to concurrently attach onto at least one tissue retention blade and is adapted to retain the tissue retention blade in the displaced position.

## Claims

### Claim 1

A surgical system configured to position an implantable device at a target location within a subject, the surgical system comprising:
an implantable device, the implantable device comprising at least a top surface, an opposing bottom surface, and an interconnecting side surface, the implantable device configured and sized to be at least partially seated within an intervertebral disc space of the subject; and
a tissue retraction device comprising:
(i) a body member comprising a front side, a back side opposing the front side, a top side, a bottom side opposing the top side, a first side, a second side opposing the first side, and an internal cavity;
(ii) a first arm movably coupled to the body member, the first arm comprising a proximal first segment at least partially extending into the first side of the body member and a distal second segment extending along a longitudinal axis of the distal second segment of the first arm and away from the proximal first segment of the first arm, wherein the distal second segment comprises a top surface, an opposing bottom surface, and a first aperture extending along a central axis from the top surface to the opposing bottom surface of the distal second segment;
(iii) a second arm movably coupled to the body member, the second arm comprising a proximal first segment at least partially extending into the second side of the body member and a distal second segment extending along a longitudinal axis of the distal second segment of the second arm and away from the proximal first segment of the second arm;
(iv) a third arm configured to at least partially retract into the internal cavity of the body member, the third arm extending along a longitudinal axis of the third arm from a proximal end segment to a distal end segment of the third arm, the proximal end segment at least partially positioned within the internal cavity of the body member; and
(v) a first tissue retention member comprising an extension configured to be received within the first aperture of the distal second segment of the first arm;
wherein (a) the first arm is configured to rotate about a first axis relative to the body member, the first axis extending from the top side to the bottom side of the body member; (b) the second arm is configured to rotate about a second axis relative to the body member, the second axis being non-collinear with the first axis; (c) the central axis of the first aperture of the first arm is non-collinear with the longitudinal axis of the distal second segment of the first arm; and (d) the first tissue retention member is capable of rotation about at least the central axis of the first aperture.

### Claim 2 (depends on 1)

The surgical system of claim 1, wherein the implantable device is further configured and sized to be at least partially seated within an intervertebral disc space of the subject.

### Claim 3 (depends on 2)

The surgical system of claim 2, wherein at least one of the top surface or the opposing bottom surface of the implantable device comprises a surface feature configured to enable at least some level of fixation of the implantable device onto bone.

### Claim 4 (depends on 2)

The surgical system of claim 2, wherein the tissue retraction device further comprises a first mechanism configured to immobilizes the first tissue retention member relative to the first arm.

### Claim 5 (depends on 2)

The surgical system of claim 2, wherein the tissue retraction device further comprises a handle extending from a proximal segment to a distal segment along a longitudinal axis of the handle, wherein the longitudinal axis of the handle is positioned to be at least substantially collinear with the longitudinal axis of the third arm.

### Claim 6 (depends on 5)

The surgical system of claim 5, wherein the distal second segment of the second arm comprises a top surface, an opposing bottom surface, and a second aperture extending along a central axis from the top surface to the opposing bottom surface, the central axis of the second aperture being non-collinear with the longitudinal axis of the distal second segment of the second arm.

### Claim 7 (depends on 6)

The surgical system of claim 6, wherein the tissue retraction device further comprises a second tissue retention member comprising an extension configured to be received within the second aperture of the distal second segment of the second arm, and capable of at least rotation about the central axis of the second aperture.

### Claim 8 (depends on 7)

The surgical system of claim 7, further comprising a second mechanism configured to immobilize the second tissue retention member relative to the second arm.

### Claim 9 (depends on 5)

The surgical system of claim 5, wherein the third arm is configured to translate within the internal cavity of the body member between a fully retracted position and a fully extended position, the proximal end segment of the third arm located outside of the handle when the third arm is in the fully retracted position.

### Claim 10 (depends on 9)

The surgical system of claim 9, wherein:
the distal end segment of the third arm comprises a top surface and an opposing bottom surface; the third arm further comprises a third aperture extending along a central axis of the third aperture, the central axis of the third aperture configured to be non-collinear with the longitudinal axis of the third arm; and
the third aperture is configured to at least partially open onto a distal end surface of the distal end segment of the third arm.

### Claim 11 (depends on 10)

The surgical system of claim 10, further comprising an elongated member that extends along a longitudinal axis from a first end surface to a second end surface, the elongated member comprising at least a first segment configured to be at least partially received within the third aperture, the first segment configured to translate along the direction of the central axis of the third aperture.

### Claim 12 (depends on 11)

The surgical system of claim 11, further comprising a locking feature configured to immobilize the elongated member relative to the distal end segment of the third arm.

### Claim 13 (depends on 9)

The surgical system of claim 9, wherein the distal end segment of the third arm is at least partially positioned between the first arm and the second arm.

### Claim 14 (depends on 9)

The surgical system of tissue of claim 9, wherein the internal cavity of the body member extends along a longitudinal axis that is collinear with the longitudinal axis of the third arm.

### Claim 15 (depends on 9)

The surgical system of claim 9, wherein the tissue retraction device further comprises a first actuator configured to produce, upon actuation, a reversible rotational movement of the first arm relative to the body member.

### Claim 16 (depends on 9)

The surgical system of claim 9, wherein the tissue retraction device further comprises a second actuator configured to produce, upon actuation, a reversible rotational movement of the second arm relative to the body member.

### Claim 17 (depends on 9)

The surgical system of claim 9, wherein the tissue retraction device further comprises a third actuator configured to produce, upon actuation, a reversible movement of the third arm within the internal cavity of the body member.

### Claim 18 (depends on 5)

The surgical system of claim 5, wherein the first arm further comprises a first coupler configured to couple the first arm with a bone screw.

### Claim 19 (depends on 5)

The surgical system of claim 5, wherein the second arm further comprises a second coupler configured to couple the second arm with a bone screw.

### Claim 20 (depends on 5)

The surgical system of claim 5, further comprising a tissue retraction device coupler configured to reversibly couple with an anchoring device, the anchoring device configured to affix the tissue retraction device to an operating room table onto which the subject is positioned.

### Claim 21 (depends on 20)

The surgical system of claim 20, wherein the anchoring device comprises at least a first segment configured to couple with the tissue retraction device coupler and a second segment configured to couple with the operating room table.

### Claim 22 (depends on 21)

The surgical system of claim 21, wherein the anchoring device comprises an articulating frame configured to transition from a first configuration to a second configuration, wherein:
(i) in the first configuration of the articulating frame, the body member of the tissue retraction device is mobile relative to the operating room table, and
(ii) in the second configuration of the articulating frame, the body member of tissue retraction device is immobilized relative to the operating room table.

### Claim 23 (depends on 22)

The surgical system of claim 22, wherein the third arm is movable relative to the body member in each of the first configuration and the second configuration of the articulating frame.

### Claim 24 (depends on 5)

The surgical system of claim 5, wherein the first arm, the second arm, and the third arm of the tissue retraction device are configured to form a corridor therebetween, the corridor configured and sized to permit advancement of the implantable device therethrough.

### Claim 25

A surgical apparatus configured to advance an implantable device through a tissue corridor and to a target location within a subject, the implantable device configured to be retained at the target location and comprising a top surface, an opposing bottom surface and at least one interconnecting side surface, the apparatus comprising:
a tissue retraction device configured to at least partially create the tissue corridor to the target location, the tissue retraction device comprising:
(i) a body member comprising a front side, a back side opposing the front side, a top side, a bottom side opposing the top side, a first side, a second side opposing the first side and separated from the first side by a fixed distance, and an internal cavity;
(ii) a first arm movably coupled to the body member and configured to rotate about a first axis relative to the body member, the first axis extending from the top side to the bottom side of the body member;
(iii) a second arm movably coupled to the body member and configured to rotate about a second axis relative to the body member, the second axis being non-collinear with the first axis;
(iv) a third arm extending along a longitudinal axis from a proximal end surface to a distal end surface of the third arm, the third arm comprising a top surface extending along the longitudinal axis, a bottom surface opposing the top surface, a first side surface, a second side surface opposing the first side surface, and a third aperture extending along a central axis from the top surface to the bottom surface and at least partially open onto the distal end surface of the third arm;
(v) a handle extending along a longitudinal axis from a proximal segment to a distal segment of the handle, wherein the longitudinal axis of the handle is collinear with the longitudinal axis of the third arm; and
(vi) an elongated member extending along a longitudinal axis from a first end surface to a second end surface, the elongated member comprising at least a segment configured to be at least partially received within the third aperture of the third arm;
wherein (1) the proximal end surface of the third arm is configured to at least translate within the internal cavity of the body member between a fully extended configuration and a fully retracted configuration, the proximal end surface of the third arm being positioned outside of the handle when the third arm is in any configuration; (2) a length of the elongated member along the longitudinal axis of the elongated member is greater than a distance between the top side surface and the bottom side surface of the third arm; and (3) the segment of the elongated member is configured to translate along the direction of the central axis within the third aperture; and
wherein the implantable device is further configured and sized to be at least partially advanced through the tissue corridor created by a tissue retraction device.

### Claim 26 (depends on 25)

The surgical apparatus of tissue of claim 25, wherein the internal cavity of the body member extends along the longitudinal axis of the third arm.

### Claim 27 (depends on 26)

The surgical apparatus of claim 26, further comprising a third arm actuator configured to produce, upon actuation, a reversible movement of the third arm within the internal cavity of the body member.

### Claim 28 (depends on 25)

The surgical apparatus of claim 25, wherein the tissue retraction device further comprises a coupler configured to reversibly couple with an anchoring device, the anchoring device configured to affix the tissue retraction device to an operating room table onto which the subject is positioned.

### Claim 29 (depends on 28)

The surgical apparatus of claim 28, wherein the anchoring device comprises at least a first segment configured to couple with the coupler of the tissue retraction device, and a second segment configured to couple with the operating room table.

### Claim 30 (depends on 29)

The surgical apparatus of claim 29, wherein:
the anchoring device comprises an articulating frame configured to transition from a first configuration to a second configuration, wherein:
(i) in the first configuration of the articulating frame, the body member of the tissue retraction device is mobile relative to the operating room table, and
(ii) in the second configuration of the articulating frame, the body member of tissue retraction device is immobilized relative to the operating room table.

### Claim 31 (depends on 30)

The surgical apparatus of claim 30, wherein the third arm is configured to be mobile relative to the body member in each of the first configuration and the second configuration of the articulating frame.

### Claim 32 (depends on 25)

The surgical apparatus of claim 25, wherein the first arm comprises a proximal first segment and a distal second segment extending along a longitudinal axis of the distal second segment away from the proximal first segment, the proximal first segment of the first arm at least partially extending into the first side of the body member.

### Claim 33 (depends on 32)

The surgical apparatus of claim 32, wherein the distal second segment of the first arm comprises a top surface, an opposing bottom surface, and a first aperture extending along a central axis from the top surface to the opposing bottom surface, the central axis of the first aperture being non-collinear with the longitudinal axis of the distal second segment of the first arm.

### Claim 34 (depends on 33)

The surgical apparatus of claim 33, further comprising a first tissue retention member, the first tissue retention member comprising a first extension configured to be received within the first aperture, the first extension capable of rotation relative to the first arm and about the central axis of the first aperture.

### Claim 35 (depends on 34)

The surgical apparatus of claim 34, wherein the tissue retraction device further comprises a first mechanism configured to immobilize the first tissue retention member relative to the first arm.

### Claim 36 (depends on 25)

The surgical apparatus of claim 25, wherein the first arm comprises a first coupler configured to couple the first arm with a bone screw.

### Claim 37 (depends on 25)

The surgical apparatus of claim 25, wherein the tissue retraction device further comprises a first actuator configured to produce, upon actuation, a reversible rotational movement of the first arm relative to the body member.

### Claim 38 (depends on 25)

The surgical apparatus of claim 25, wherein the second arm comprises a proximal first segment and a distal second segment extending along a longitudinal axis of the distal second segment away from the proximal first segment, the proximal first segment of the second arm at least partially extending into the second side of the body member.

### Claim 39 (depends on 38)

The surgical apparatus of claim 38, wherein the distal second segment of the second arm comprises a top surface, an opposing bottom surface, and a second aperture extending along a central axis from the top surface to the opposing bottom surface, the central axis of the second aperture being non-collinear with the longitudinal axis of the distal second segment of the second arm.

### Claim 40 (depends on 39)

The surgical apparatus of claim 39, further comprising a second tissue retention member, the second tissue retention member comprising a second extension configured to be received within the second aperture, the second extension capable of rotation relative to the second arm and about the central axis of the second aperture.

### Claim 41 (depends on 40)

The surgical apparatus of claim 40, wherein the tissue retraction device further comprises a second mechanism configured to immobilize the second tissue retention member relative to the second arm.

### Claim 42 (depends on 25)

The surgical apparatus of claim 25, wherein the second arm comprises a second coupler configured to couple the second arm with a bone screw.

### Claim 43 (depends on 25)

The surgical apparatus of claim 25, wherein the tissue retraction device further comprises a second actuator configured to produce, upon actuation, a reversible rotational movement of the second arm relative to the body member.

### Claim 44 (depends on 25)

The surgical apparatus of claim 25, further comprising a locking feature configured to immobilize the elongated member relative to the distal end surface of the third arm.

### Claim 45 (depends on 25)

The surgical apparatus of claim 25, wherein the distal end surface of the third arm is at least partially positioned between the first arm and the second arm.

### Claim 46 (depends on 25)

The surgical apparatus of claim 25, wherein the first arm, the second arm, and the third arm of the tissue retraction device are configured to form a corridor therebetween, the corridor configured and sized to permit advancement of the implantable device therethrough.

### Claim 47 (depends on 46)

The surgical apparatus of claim 46, wherein the implantable device is configured and sized to be at least partially advanced to the target location through the corridor formed between the first arm, the second arm, and the third arm of the tissue retraction device.

### Claim 48 (depends on 46)

The surgical apparatus of claim 46, wherein the implantable device is configured and sized to be at least partially received within an intervertebral disc space of the subject.

### Claim 49 (depends on 46)

The surgical apparatus of claim 46, wherein at least one of the top surface or the bottom surface of the implantable device further comprises a surface feature configured to support fixation onto bone.

### Claim 50 (depends on 46)

The surgical apparatus of claim 46, wherein the implantable device further comprises a cavity configured to house a bone forming substance.

### Claim 51

A method for delivering an implantable device to a target site within a functional spinal unit of a subject using a tissue retraction device, the method comprising:
obtaining a tissue retraction device, the tissue retraction device comprising at least (i) a body member comprising an internal cavity, a front surface having an opening to the internal cavity, a back surface opposing the front surface, a first side surface, and a second side surface opposing the first side surface, the first side surface and the second side surface separated by a fixed distance, (ii) a first arm comprising a first segment at least partially extending into the first side surface of the body member and a second segment extending from the first segment, wherein the first arm is configured to rotate about a first axis relative to the body member; (iii) a second arm comprising a first segment at least partially extending into the second side of the body member and a second segment extending from the first segment, wherein the second arm is configured to rotate about a second axis relative to the body member, the second axis being non-collinear with the first axis, (iv) a third arm extending along a longitudinal axis from a proximal segment to a distal segment, the proximal segment configured to at least translate within the internal cavity of the body member from a fully extended position to a fully retracted position; (v) a handle extending along the longitudinal axis of the third arm; and (vi) a first coupler configured to reversibly couple with an articulating retention frame;
using a radiographic imaging modality to identify the target site within the functional spinal unit, the functional spinal unit comprising a superior vertebral bone, an inferior vertebral bone, and an intervertebral disc disposed therebetween,
creating a tissue corridor that extends from a skin incision on the subject to the target site;
advancing at least a portion of the second segment of the first arm of the tissue retraction device, at least a portion of the second segment of the second arm, and at least a portion of the distal segment of the third arm into the tissue corridor, wherein a first distance between a distal end of the second segment of the first arm and a distal end of the second segment of the second arm is maintained during the advancing;
attaching a first portion of the articulating retention frame to an operating room table onto which the subject is positioned;
coupling a second portion of the articulating retention frame with the first coupler of the tissue retraction device;
transitioning a locking feature of the articulating retention frame from a first configuration to a second configuration, the transitioning of the locking feature immobilizing the tissue retraction device relative to the operating room table;
rotating the first arm and the second arm about the first axis and the second axis, respectively, wherein the act of rotating increases the first distance;
actuating an actuator of the tissue retraction device, the actuating producing translation of the proximal segment of the third arm within the internal cavity of the body member;
accessing the target site through a tissue corridor at least partially formed between the distal end of the second segment of the first arm, the distal end of the second segment of the second arm and a distal end surface of the distal segment of the third arm;
advancing the implantable device to the target site through the tissue corridor, the implantable device comprising at least a top surface, an opposing bottom surface, and an interconnecting side surface; and
implanting the implantable device at the target site.

### Claim 52 (depends on 51)

The method of claim 51, further comprising using a radiographic imaging modality to identify the target site within the body of the subject, the target site comprising a superior vertebral bone, an immediately inferior vertebral bone, and an intervertebral disc disposed therebetween.

### Claim 53 (depends on 52)

The method of claim 52, further comprising removing at least a portion of the intervertebral disc.

### Claim 54 (depends on 52)

The method of claim 52, further comprising removing a cartilage material from one of the superior vertebral bone or the immediately inferior vertebral bone, the cartilage material being adherent to a bony endplate of at least one of the vertebral bones.

### Claim 55 (depends on 51)

The method of claim 51, wherein the advancing the implantable device to the target site comprises advancing the implantable device at least partially into an intervertebral disc space of the subject.

### Claim 56 (depends on 55)

The method of claim 55, further comprising implanting a bone forming material into the intervertebral disc space.

### Claim 57 (depends on 55)

The method of claim 55, further comprising positioning a top surface of the implantable device to abut an inferior bony surface of a vertebral bone immediately superior to the intervertebral disc space, wherein the top surface of the implantable device comprises a surface feature configured to support fixation onto bone.

### Claim 58 (depends on 55)

The method of claim 55, further comprising positioning a bottom surface of the implantable device to abut a superior bony surface of a vertebral bone immediately inferior to the intervertebral disc space, wherein the bottom surface of the implantable device comprises a surface feature configured to support fixation onto bone.
