H-GRAFT® Surgical Technique - X

X-spine Surgical Technique
SM
H-GRAFT Interspinous Allograft
™
X-spine Surgical Technique
SM
H-GRAFT Interspinous Allograft
™
This publication recommends procedures for using X-spine products and instruments. The guidance it offers is for surgeon consideration, but,
as with any technical guide, the surgeon must evaluate the specific requirements of the patient, making appropriate adjustments as needed.
GENERAL INFORMATION
The H-GRAFT™ Interspinous Allograft spacer is to be used in conjunction with the Axle®
Interspinous Fusion System. Various implant sizes are available to adapt to different patient pathologies. All implants are intended for single use only and should not be reused
under any circumstances.
This document is intended exclusively for experts in the field, particularly physicians, and is not intended for laypersons.
Information on the products and procedures contained in this document is general in nature and does not represent medical advice
or recommendations. As with any technical guide, this information does not constitute any diagnostic or therapeutic statement with
regard to a given medical case. An evaluation, examination, and advising of the patient are absolutely necessary for the physician
to determine the specific requirements of the patient, and any appropriate adjustments needed, and the foregoing are not to be
replaced by this document in whole or in part.
Information contained in this document was gathered and compiled by experts in the field and X-spine employees to the best of their
knowledge. Care was taken to ensure the information contained herein is accurate and understandable. X-spine does not assume
any liability, however, for the accuracy and/or completeness of the quality of the information, and X-spine is not liable for any losses
whatsoever of any kind or any nature that may be caused by the use of said information.
H-GRAFT™ Interspinous Cortical Allograft System
Instrument Cleaning and Sterilization Instructions
IMPORTANT NOTE:
2.
Rinse
The user acknowledges that he/she has read and agreed to the conditions in this insert, which are to be considered as contractual.
GENERAL INFORMATION
3.
Inspection
CLEANING OF INSTRUMENTS
CAUTION: Use of sodium hydroxide (NaOH) is prohibited. Use of
corrosive products and/or instruments including abrasive sponges and
metal brushes should be avoided. Cleaning must be performed by personnel trained in the general procedures involving contaminant removal.
1. Thoroughly clean all instruments prior to use and as soon as possible after use (within a maximum of 2 hours post-operation) with intensive
rinsing under cool tap water (<40°C) to remove gross soil. Do not
allow blood and debris to dry on the instruments. If cleaning must
be delayed, place instruments in a covered container with
appropriate detergent (Enzol® Enzymatic Detergent or equivalent)
to delay drying.
2. Loosen and/or disassemble instruments with removable parts in
accordance with Table 1.
4.
Ultrasonic
Clean
(if required)
5.
Ultrasonic
RInse
Table 1 – Instruments Requiring Disassembly for Cleaning
Instrument
Name
X078-0030
Dorsal
Inserter
X078-0050
Lateral
Inserter
Disassembly
Instructions
Reassembly
Instructions
Unthread the inserter shaft from the
inserter handle assembly by rotating
the knob counterclockwise. Inspect
both components
for visible evidence
of wear and tear.
Thread the inserter
shaft into the inserter
handle assembly by
rotating the knob
clockwise until fully
seated. Verify that
the inserter shaft
smoothly travels
in both directions
within the assembly.
3. The following table (Table 2) describes the required steps for
thoroughly cleaning the system instruments:
Table 2 – Cleaning Parameters
Step
Minimum Time
(mm:ss)
Agent
Instructions
Enzol Enzymatic
Detergent Solution (or
equivalent)
1.
Initial Clean
10:00
Add one (1) ounce of Enzol to one (1) gallon of tap
water. Soak instruments immediately after use and
flush detergent through all channels until evidence of
organic material is removed. Soak for a minimum of
ten (10) minutes. Use a soft bristle brush (Spectrum™
M-16 or equivalent) to gently remove visible debris.
Pay close attention to threads, crevices, lumens and
hard to reach areas. If organic material is dried-on,
extend soak time and use two (2) ounces of Enzol per
one (1) gallon of warm tap water.
6.
Inspection
4
3:00
Thoroughly rinse each instrument with deionized
water including all channels to remove detergent for
a minimum of three (3) minutes.
Unaided eye
The H-GRAFT Interspinous Cortical Allograft System of X-spine Systems,
Inc., consists of various sizes of structural cortical allograft blocks and
associated instrumentation.
Part
Number
Deionized water
1:00
Inspect each instrument for evidence of organic material. Particular attention should be taken to remove all
debris from instruments with cannulations, holes, and
features that may be shielded from brushing action.
Subject instruments to ultrasonic cleaning if organic
matter is present after the initial cleaning step.
Enzol Enzymatic
Detergent Solution
(or equivalent)
10:00
Prepare a fresh solution by adding one (1) ounce of
Enzol and one (1) gallon of warm tap water to a sonication unit (Branson Bransonic® Ultrasonic Cleaner or
equivalent). Fully immerse the instruments in the solution and sonicate for a minimum of ten (10) minutes.
Deionized water
3:00
Thoroughly rinse each instrument with deionized
water including all holes and cannulations to remove
detergent for a minimum of three (3) minutes.
Unaided eye
1:00
Inspect each instrument for evidence of organic
material. Repeat the ultrasonic clean and rinse steps
if needed.
Upon completion, visually inspect each instrument for contamination such
as remaining soil and moisture or wetness. If soil remains, repeat the
cleaning process. If wetness remains, use filtered pressurized air or
lint-free wipes to dry.
INSPECTION OF INSTRUMENTS
1. Carefully inspect each instrument to ensure all visible blood and soil
has been removed.
2. Inspect instruments and instrument cases for damage. Check action of
moving parts to ensure proper operation.
3. If damage or wear is noted that may compromise the proper function
of the instrument or instrument case, do not use and contact customer
service or your X-spine Systems representative for a replacement.
4. If corrosion is noted, do not use and contact customer service or your
X-spine Systems representative for a replacement.
STERILIZATION OF INSTRUMENTS
All instruments are provided non-sterile and must be sterilized before use. All
instruments must be free of packaging material and bio-contaminants prior to
sterilization. To achieve a sterility assurance level of not less than 10-6, all
non-sterile instruments should be autoclave sterilized using the following
validated cycle parameter:
Steam method, pre-vacuum air removal, four pulses, 270o F (132o C), 20
minute minimum exposure time, 30 minute dry time, in a double–wrapped
case configuration.
The sterilization cycle listed above is not considered by the U.S. Food and
Drug Administration to be a standard sterilization cycle. It is the end user’s
responsibility to use only sterilizers and accessories (such as sterilization
wraps, sterilization pouches, chemical indicators, biological indicators, and
sterilization cassettes) that have been cleared by the U.S. Food and Drug
Administration for the selected sterilization cycle specifications (time and
temperature).
CAUTION: Federal Law (USA) restricts this
device to sale by or on the order of a physician.
X078-1000 rev A
Step 1
Position the patient in the prone position
on the operating table.
Identify the spinous processes at the level to
be instrumented, using manual palpation and
intraoperative imaging.
Make a midline incision from 3 to 5cm in length
to expose the spinous processes at the correct level.
Elevate the paraspinal musculature and other soft
tissue to expose the spinous processes and laminae
to the medial border of the facet joints. Use a
rongeur to fully remove the supraspinous/
interspinous ligaments between the appropriate
levels and any connective or soft tissue.
Step 2
Load the Caspar pin screwdriver with the
appropriately sized distraction pin by inserting
the distraction pin into the screwdriver shaft.
3
Step 3
Target the dorsal midpoint of the identified spinous
process then press firmly and rotate clockwise to advance the distraction pin until the base of the
distraction pin is firmly against the dorsal portion
of the spinous process.
Repeat for the adjacent spinous process.
CAUTION: Placement of excessive force on the
distraction pin may result in spinous process
fracture and/or neurological injury.
4
Step 4
With both Caspar pins secured to the dorsal
portion of the spinous process, slip the distraction
screw sleeves over the distraction pins. Then
place the spinous process distractor over the
distractor sleeves and rotate the ratcheting
key clockwise.
Use caution not to over-distract
the interspinous space.
Step 5
Decompression and decortication
is performed using standard
surgical techniques.
5
Step 6
After the interspinous space has been
prepared, select the Axle sizer/spreader
and insert to determine the size of
the space.
Step 7
Once the interspinous space is sized, select the appropriate
trial and place into the interspinous space and release the
distractor assembly to confirm proper fit on both the inferior
and superior spinious processes as well as a level position
with both the inferior and superior lamina.
Note: When placing the
H-GRAFT™ trial into place make
sure the larger recessed notch
of the trial is on the inferior
spinous process and the smaller
recessed notch is placed on the
superior spinous process.
SUPERIOR
INFERIOR
6
Step 8
After the trial size has been confirmed, turn
the ratcheting key drive clockwise to distract
and remove the trial from the interspinous space.
Step 9
Load the corresponding H-GRAFT™ onto the desired
H-GRAFT™ inserter, dorsal or lateral.
SUPERIOR
Note: When placing the H-GRAFT™
implant into place make sure the
larger recessed notch of the implant
is on the inferior spinous process
and the smaller recessed notch
is placed on the superior
spinous process.
INFERIOR
After placing the H-GRAFT™ onto
either inserter rotate the screwcap
clockwise until the screwcap stops
advancing and is secure.
CAUTION: Overtightening of the
inserter screwcap may result in
damage to the H-GRAFT™ or
instrumentation.
7
Step 10
Position the loaded H-GRAFT™
inserter as anterior as possible
with the allograft resting on
the superior and inferior spinous
processes as well as both superior
and inferior Laminae. When the
H-GRAFT™ has reached its desired position
in the interspinous space rotate the ratcheting
key drive counterclockwise on the spinous
process distractor assembly to release the
distraction. To remove the H-GRAFT™ from the
inserter, rotate the screwcap counterclockwise
until the instrument releases from the H-GRAFT™.
CAUTION: Over-impaction of the inserter
may result in damage to the H-GRAFT™ or
instrumentation.
8
During insertion, the mallet instrument
may be used to aid in the anterior
positioning of the allograft.
Step 11 – Recommended
Reference the Axle® surgical
technique for implantation of the
Axle® interspinous fusion system.
9
Instruments
X078-0030 Dorsal Inserter
X078-0050 Lateral Inserter
X078-0108 – X078-0120 Trial Block
X078-0100 Trial Inserter
X078-0075 Screwdriver, Distraction
X078-0025 Mallet Assembly
X078-0080 Sleeve, Distraction Screw
X078-0070 Distractor Assembly
X078-0082 – X078-0088 Distraction Screw
10
WARNING: In the USA, this product has labeling limitations.
See package insert for complete information.
CAUTION: Federal Law (USA) restricts this device to sale
by or on the order of a physician.
X-spineSM the X-spine logoSM and H-GRAFT™ are trademarks of
X-spine Systems, Inc.
Products Patented and Patents Pending
All products are not currently available in all markets.
© 2012 X-spine Systems, Inc., All rights reserved.
F-1000.19 Rev. A 10/12 HGRAFT TECHNIQUE GUIDE CI I2M
EC 60-1254
X-spine Systems, Inc.
452 Alexandersville Rd., Miamisburg, OH 45342
Phone: 800-903-0640 • Direct: 937-847-8400 • Fax: 937-847-8410
www.x-spine.com