Surgical Technique

Surgical Technique – ALL-IN-ONE G2-INSERTER

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5 KEY FUNCTIONS OF THE ALL-IN-ONE G2-INSERTER

  1. Attach and lock the Minuteman G3 to the G2-Inserter
  2. Thread the Minuteman G3 into the interspinous process space
  3. Deploy the Extension Plate of the Minuteman G3
  4. Fixate the Plates to the spinous processes
  5. Unlock and detach the Minuteman G3 from the G2-Inserter

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Remove the Guide Wire while leaving the Sleeve in place against the lateral surface of the spinous processes. After determining the appropriate Minuteman G3 size, attach the corresponding size Insertion Adaptor to the distal end of the G2-Inserter. The color of the Insertion Adaptor will match the color of the appropriate size Minuteman G3 Hex Nut

Verify the G2-Inserter is in the unlocked position in order to attach the Minuteman G3. The Position Indicator will be aligned with the arrowhead as shown above.

PercLIF – MINUTEMAN G3 ATTACHMENT TO THE G2-INSERTER

img23The spring loaded Adaptor Shaft is (1) compressed towards the Fixed Plate Knob until the Adaptor Shaft bottoms out and then (2) rotated counterclockwise approximately 1/8 turn.

Align the Extension Plate of the Minuteman G3 in the same orientation as the Plunger Slots and snap the implant into place. Proper placement allows the Extension Plate to be aligned with the Plate Reference Lines.

img26 img27To lock the Minuteman G3 to the G2-Inserter, rotate the Plunger Knob clockwise until the Position Indicator is in the locked position. The Plunger Stop automatically clicks to the right, locking the Minuteman G3 to the G2-Inserter

Hold the Fixed Plate Knob and (1) rotate the Adaptor Shaft clockwise, approximately 1/8 turn and (2) allow the Adaptor Shaft to gently spring forward. The Insertion Adaptor will engage the Minuteman G3 Hex Nut. If the Insertion Adaptor does not properly engage the Minuteman G3 Hex Nut, slowly rotate the Adaptor Shaft until the Insertion Adaptor slides into place.

Surgical Technique – INSERTING THE MINUTEMAN G3

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The bone graft material must be viscous in nature to allow the inner mechanism to properly function.

Bone graft material is placed within the threaded body of the Minuteman G3.

The G2-Inserter with the attached Minuteman G3 is inserted into the Sleeve and advanced to the interspinous process space aiming as far anterior as possible. Rotate the G2-Inserter clockwise to engage the threads of the Minuteman G3. Under fluoroscopy, the Minuteman G3 is advanced into the interspinous space, until the Fixed Plate is adjacent to the spinous processes.

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img30To deploy the Extension Plate, (1) slide and hold the Plunger Stop to the left and (2) rotate the Plunger Knob clockwise until the Plunger Knob stops. The Position Indicator will be aligned close to the Plate Deployment Symbol.

Verify under fluoroscopy that the Extension Plate has been deployed and will engage the spinous processes as far anterior as possible during fixation. The Minuteman G3 is now ready for fixation to the spinous processes.

PercLIF – MINUTEMAN G3 FIXATION TO THE SPINOUS PROCESSES

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To fixate the implant to the spinous processes, hold the G2-Inserter to stabilize the implant’s position and rotate the Fixed Plate Knob clockwise to advance the Fixed Plate. As the Fixed Plate is tightened, the Extension Plate will be brought to engage the distal lateral surface of the spinous processes.

A ratcheting sensation will be felt which represents the locking mechanism of the implant. The degree of applied torque should correspond to the bone quality and age of the patient.

img33(24) The G2-Inserter is detached from the implant by rotating the Plunger Knob counterclockwise until the Position Indicator reaches the lock position. The Plunger Stop automatically clicks to the right. (25) Slide and hold the Plunger Stop back to the left and continue to rotate the Plunger Knob counterclockwise until it stops. The G2 -Inserter is now detached from the implant.

The G2-Inserter and Sleeve are removed. Sutures or steristrips are then applied.

Surgical Technique – IMPLANT REMOVAL & EXTENSION PLATE RESET

Implant Removal

The implant can be removed through a conventional posterior open surgical approach using the Minuteman G3 Open Instrument Set. A percutaneous attempt to remove the Minuteman G3 is not recommended.

  1. Insert the Insertion Hex into the back of the implant for stabilization.
  2. Attach appropriate size Wrench to the Hex Nut and loosen the Hex Nut completely.
  3. Insert the Plate Reset Instrument into the caudal end of the Minuteman G3 and thread clockwise to engage the inner mechanism.
  4. Gentle lateral retraction of the inner mechanism unlocks the Extension Plate allowing the Extension Plate to fully collapse.
  5. With the Extension Plate collapsed, gently guide the implant out of the interspinous process space and remove from the incision.

EXTENSION PLATE RESET

If the Extension Plate is accidently deployed during attachment of the Minuteman G3 to the G2-Inserter, the Plate Reset Instrument is utilized. First detach the Minuteman G3 from the G2-Inserter. The Plate Reset Instrument is inserted into the caudal end of the Minuteman G3 and threaded clockwise (only 2-3 rotations) to engage the inner mechanism of the Minuteman G3. Gentle retraction of the inner mechanism of the Minuteman G3 is performed with the Plate Reset Instrument to unlock the Extension Plate of the Minuteman G3. The Plate Reset Instrument is then rotated counterclockwise to disengage it from the Minuteman G3, and it is then removed.

When threading the Plate Reset Instrument into the inner mechanism, only 2-3 rotations is necessary. It is important to not fully remove the inner mechanism from the Minuteman G3. As the inner mechanism is retracted, a détente from the inner mechanism will be felt. This is the limit of retraction for the inner mechanism

Minuteman G3® 5 ANATOMICAL SIZES & COLOR CODED

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Minuteman G3 PERCUTANEOUS INSTRUMENT SET

Spinal Simplicity is in constant pursuit of innovative, simple solutions. The Minuteman G3 Instrument Set is the result of this pursuit. Precision manufactured to the highest quality standards and thoughtfully designed, the set enables a surgeon to implant and fixate the Minuteman G3 away from the neural elements through a percutaneous lateral approach.

The patent-pending G2-Inserter is the first and only all-in-one inserter that provides delivery, deployment and fixation of the Minuteman G3, streamlining spinal fusion procedures.

TOP TRAY

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1 Dilators (3mm, 8mm, 14mm)
2 Bone Chip Plunger
3 Guide Wire Extension
4 Guide Wire
5 Modular Handle
6 Aiming Device

 

 

 

 

 

 

 

 

 

 

 

 

 

 BASE TRAY

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1 G2-Inserter x 2
2 Bone Rasp
3 Soft Tissue Rasp
4 Graduated Tap
5 Direct Drive T-Handle
6 Dilator/Sleeve Handle
7 Plate Reset Instrument
8 Sleeves (20mm, 23mm, 26mm)
9 Insertion Adaptors (8mm, 10mm, 12mm, 14mm, 16mm)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordering Information

Minuteman G3 Implants and disposables:

8 mm Minuteman G3 10-0004-008
10 mm Minuteman G3 10-0004-010
12 mm Minuteman G3 10-0004-012
14 mm Minuteman G3 10-0004-014
16 mm Minuteman 10-0004-016
G3 Guide Wire – Long 20-0001-001

Minuteman G3 Percutaneous Instruments:

Guide Wire 20-0001-000
Guide Wire Extension 20-0002-000
Dilator, 3 mm 20-0003-003
Dilator, 8 mm 20-0003-008
Dilator, 14 mm 20-0003-014
Sleeve, 20 mm 20-0004-020
Sleeve, 23 mm 20-0004-023
Sleeve, 26 mm 20-0004-026
Bone Rasp 20-0005-000
Soft Tissue Rasp 20-0006-000
Aiming Device 20-0007-000
Graduated Tap 20-0009-000
Insertion Adaptor, 8 mm 20-0010-008
Insertion Adaptor, 10 mm 20-0010-010
Insertion Adaptor, 12 mm 20-0010-012
Insertion Adaptor, 14 mm 20-0010-014
Insertion Adaptor, 16 mm 20-0010-016
Plate Reset Instrument 20-0012-000
Direct Drive T-Handle 20-0013-000
Dilator/Sleeve Handle 20-0014-000
Modular Handle 20-0024-000
Bone Chip Plunger 20-0025-000
G2-Inserter 20-0026-000
Aiming Device Holder 20-0049-000
Percutaneous Case/Tray 30-0001-000

G2-INSERTER DISASSEMBLY GUIDE

Disassembly Guide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 G2-INSERTER ASSEMBLY GUIDE

Assembly Guide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Minuteman G3 CONTRAINDICATIONS & POSSIBLE ADVERSE EFFECTS

CONTRAINDICATIONS

The Minuteman G3 is contraindicated in patients with

  • An allergy to titanium or titanium alloy
  • Spinal anatomy or disease that would prevent implantation of the device, or cause the device to be unstable in situations such as
    • Significant instability of the lumbar spine;
    • An ankylosed segment at the affected level(s);
    • Acute fracture of the spinous process or pars interarticularis;
    • Significant scoliosis (Cobb angle greater than 25 degrees);
  • Diagnosis of severe osteoporosis
  • Active systemic infection or infection localized to the site of implantation
  • Insufficient quality or quantity of bone, which would inhibit rigid device fixation
  • Incompetent or missing posterior arch
  • Pregnancy

POSSIBLE ADVERSE EFFECTS

Device related:

  • Implant dislodgement/migration
  • Implant not positioned correctly
  • Fracture of the spinous process
  • Additional surgery, including removal of the Minuteman G3 device
  • Foreign body reaction
  • Mechanical failure of the device
  • Failure of the device/procedure to improve symptoms and/or function

Surgery related:

  • Myocardial infarction
  • Infection
  • Blood vessel damage/bleeding
  • Deep vein thrombosis
  • Hematoma
  • Pneumonia
  • Neurological system compromise
  • Stroke
  • Nerve injury or spinal cord damage
  • Paralysis
  • Thrombus formation
  • Graft donor site complications, including pain, fracture or wound healing complications
  • Dural tear
  • Wound dehiscence or delayed healing
  • Pain/discomfort at the operative site
  • Death

Minuteman G3 PRECAUTIONS PRECAUTIONS

Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of implants, are important considerations in the successful utilization of the Minuteman G3 by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of the consequences. Obese, malnourished, and/or alcoholic patients are poor candidates for spinal fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.

The surgeon must be fully conversant with all aspects of the surgical technique and know the indicators and contraindicators of this type of implant. Before beginning the surgical procedure, the surgeon must be acquainted with the specific technique for insertion of the implant, which is available from the manufacturer. Never re-use any implant even if it appears unmarked or undamaged. Any implant implanted and then removed must be discarded.

Use only new implants for each case. Implants are not to be re-sterilized.

Minuteman G3 CLEANING & STERILZATION OF INSTRUMENTS, CASES & TRAYS

CLEANING INSTRUCTIONS

Both physical and chemical (detergent) processes are necessary to minimize the bioburden on all soiled items. Chemical (detergent) cleaners alone cannot remove all soil and debris, therefore a careful manual cleaning of each item is essential for maximum decontamination. Spinal Simplicity recommends the use of a mild enzymatic detergent with a near-neutral pH prepared following the manufacturer’s instructions for preparation and use. Saline solution should NOT be used, as saline has a corrosive effect on stainless steel. Remove heavy or large debris using single-use, non-shedding wipes soaked in cleaning solution. Immerse instruments in prepared bath. Using a soft bristle brush (do not use steel brushes) brush all surfaces of the instruments while they are submerged in bath, ensuring that all visible soil is removed. Whenever applicable: use a pipe cleaner and syringe to clean all cannulae, lumens, crevices, grooves and hard to reach areas. Repeatedly operate/bend/articulate all moveable components while cleaning. Allow instruments to soak in detergent prepared bath for manufacturer’s recommended soaking time. Final cleaning and disinfecting should be performed via sonication or an automated washer/disinfector cycle. See below recommenda- tions for each:

Sonication:

      1. Remove the instruments from bath and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressive- ly flush lumen, holes, and difficult-to-reach areas.
      2. Place prepared cleaning agents in a sonication unit. Completely submerge instruments in cleaning solution and sonicate for 10 minutes at 45-50 kHz.
      3. Rinse instruments in purified water for at least 3 minutes.
      4. Visually inspect to determine if all visible soil has been removed from the surfaces, lumen, cannulae, crevices, serrations, threading, etc. If visible soil remains, repeat the cleaning/disinfecting procedure.
      5. Dry the instruments with single-use, non-shedding absorbent wipes and/or medical compressed air (e.g. interiors and cannulae). Be sure to completely dry the instruments immediately after rinse to inhibit corrosion.

Automated Washer:

      1. Remove instruments from bath and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressive- ly flush lumen, holes, and difficult-to-reach areas.
      2. Place instruments in a suitable washer/disinfector basket and process through a standard washer/disinfector cleaning cycle. The following minimum parameters are essential for thorough cleaning and disinfecting.
        1. 2 minute prewash with cold tap water
        2. 20 second enzyme spray with hot tap water
        3. 1 minute enzyme soak
        4. 15 second cold tap water rinse
        5. 2 minute detergent wash with hot tap water (64-66°C/146-150°F)
        6. 15 second hot tap water rinse
        7. 2 minute thermal rinse (80-93°C/176-200°F)
        8. 10 second purified water rinse (64-66°C/146-150°F)
        9. 7 to 30 minute hot air dry (116°C/240°F)
          NOTE: The washer/disinfector manufacturer’s instructions should be strictly adhered to.
      3. Visually inspect to determine if all visible soil has been removed from the surfaces, lumen, cannulae, crevices, serrations, threading, etc. If visible soil remains, repeat the cleaning/disinfecting procedure.

Caution: certain cleaning solutions such as those containing formalin, glutaraldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine, iodide, and/or alkaline cleaners may damage some instruments. Such cleaning solutions should not be used.

Inspection:
Check all instruments for corrosion, damage to surfaces, chipping, pitting, discoloration, and contaminants. Remove and adequately dispose of any instruments that show signs of damage.

STERILIZATION INSTRUCTIONS

For typical steam autoclave cycles, the following are recommended times and temperatures:

1. Prevacuum Sterilizer:

Wrapped cases, trays and instruments, or cases, trays and instruments should be exposed to 135° C (275° F) for at least 3 minutes. Dry for 30 minutes. A legally marketed, FDA-cleared sterilization barrier (e.g., wrap, pouch, or container) should be used to maintain sterility after processing.

Caution: Do not stack trays during sterilization.