2: Ds1

Front 1

Otorrhea

Back 1

leakage from the external auditory canal and may be seen as a fluid

Front 2

Rhinorrhea

Back 2

Leakage through the nose

Front 3

Incisional Leakage

Back 3

Drainage through the surgical wound

Front 4

Pseudomeningocele

Back 4

Fluid that collects outside the dura

Front 5

Watertight Seal

Back 5

– No frank leakage, seepage, or weeping of CSF from Dural Closure and no CSF leakage when testing for water tightness of a dural repair by doing a ValSalva maneuver up to 20cm H20 over 5 to 10 seconds

Front 6

Why is a watertight seal so elusive

Back 6

CSF is under pressure, holes produced by needles preclude a completely watertight repair since the needle is larger than the thread, pin holes can be problematic due to a on-way or ball valve effect, dura can shrink during long procedures causing gaps in closure, dura is often in poor condition following radiation in older patients, duraplasty does not provide a watertight seal.

Front 7

Autologous Duraplasty

Back 7

source is the patient. Materials include fat, temporalis fascia, muscle and facia lata (deep fascia of the thigh)

Front 8

Non-autologous Duraplasty

Back 8

sources other than the patient (Allografts and Xenografts)

Front 9

Allograft

Back 9

a graft of tissue or bone from the same species - usually a cadaver

Front 10

Xenograft

Back 10

A graft of bone or tissue taken from one species and grafted into another species

Front 11

Augmented Closure Techniques

Back 11

Adhesives, Hemostats, Sealants

Front 12

Diethylhexyl Phthalate (DEHP)

Back 12

used to soften vinyl plastic found in medical devices such as IV bags and Tubing. Associated with toxicity issues related to DEHP leaching out of plastic bags and tubing from the human body.

Front 13

Ethylene and Diethylene Glycol (DEG) Glycol

Back 13

Used in Antifreeze as an industrial solvent

Front 14

Why do DEG and DEHP have toxicity issues?

Back 14

Low molecular weight

Front 15

Why is PEG non-toxic

Back 15

high molecular weight polymer and is viewed as inert by the body

Front 16

Explain Crosslinking?

Back 16

Duraseal rapidly diffuses into tissue crevices and crosslinks. This microscopic interlocking results in excellent duraseal tissue adherence. The blue colorant in Duraseal allows for visualization of gel coverage and thickness.

Front 17

DuraSeal Indication

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the first and only FDA approved cranial dural sealant for watertight dural closure, designed to prevent CSF leaks. It is an effective, convenient, and safe closure option.

Front 18

CSF Complications

Back 18

Headache, Impaired Healing, infections which could be as serious as meningitis

Front 19

Consequences of CSF Complications

Back 19

Increased morbidity, prolonged hospital stays, increased costs

Front 20

Manifestations of a CSF leak

Back 20

Otorrhea, Rhinorrhea, Incisional Leakage, Pseudomeningocele

Front 21

Approximate extra costs to treat CSF Patient

Back 21

$27000

Front 22

The DuraSeal Sealant is:

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A unique, synthetic polyethelene Glycol (PEG) Polymer Technology.

Front 23

DuraSeal Provides:

Back 23

A watertight seal, quickly and effectively, intraoperatively, and through the critical healing period

Front 24

How long does it take to prepare?

Back 24

Less than 2 minutes

Front 25

Sealant forms an inert barrier that absorbs over how long?

Back 25

4 - 8 weeks

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100% Synthetic benefit?

Back 26

Risk of disease transmitted from human or animal product is eliminated

Front 27

3 layers of meninges covering the brain

Back 27

Dura Mater, Arachnoid, Pia Mater

Front 28

Duraplasty

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The use of Dural Replacement materials

Front 29

Examples of Allograft

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Amniotic or placental membranes, Pericardium, fascia from various sources, lyophilized dura, Collagen substitutes, (example alloderm)

Front 30

Examples of Xenograft

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Bovine or pericardium, peritonium dermis, flexor tendon

Front 31

3 disadvantages of adhesives (Bioglue)

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Not generally absorbable, not indicated for contact with neural tissue, associated with a higher rate of infection than other closure techniques

Front 32

Function of adhesives

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Attach organs, structures, or tissues and can be used to reduce or replace sutures (example bioglue)

Front 33

Function of Hemostats

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Used to halt bleeding. They can be applied directly to the bleeding site and work in the presence of actively flowing blood. They accelerate the clotting cascade or clot formation. Examples:Tisseel Fibran Sealant & EVICEL fibrin Sealant)

Front 34

Function of Sealants

Back 34

When applied to a dry surface, adhere to the surface creating a barrier to prevent the leakage of air, liquids, gases or solids. (example DuraSeal)

Front 35

What was mainly used before DuraSeal?

Back 35

Fibrin Glues (Hemostats)

Front 36

Disadvantages of Fibrin Glues?

Back 36

Polymerize slowly, provide a weaker seal, are absorbed in 7 days or less (before the dura has time to heal), are made from bovine and/or human blood products

Front 37

4 qualities of an ideal sealnt?

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Effective, convenient, safe, cost-effective

Front 38

Benefits of DuraSeal

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Watertight, fills in gaps, adherent, flexible, Easy to prepare, fast polymerization, Easy visibility, Safe, cost effective

Front 39

Safety Features of DuraSeal

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Not toxic to the brain, doesn't increase risk of infection, allergic reaction, or viral transmission, Absorbable so easily processed and eliminated through normal body functions, does not contain human or animal products, is biocompatible so doesn't interfere with healing process, allows for suction and irrigation after application

Front 40

Clear Precursor contains

Back 40

Trylisine Amine Solution

Front 41

PEG Powder Vial Contains

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a multi-arm reactive PEG with hydrolyzable linkages. The PEG is reconstituted with the contents of diluent syringe which contains a phosphate buffer

Front 42

Blue Precursor

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Polyethylene Glycol (PEG) ester solution

Front 43

ONce the PEG is reconstituted and they system is assembled, how long before it must be used?

Back 43

1 hour

Front 44

Reversible Hydrogel Technology

Back 44

When mixed together, the precursors crosslink and rapidly polymerize in situ to forman adsorbable hydrogel surgical sealant in 1 to 2 seconds. The mixing of the precursors is accomplished as thematerials exit the tip of the applicator.

Front 45

Components of DuraSeal Hydrogel

Back 45

90% Water, 8% Polyethylene Glycol (PEG) and 2% FD & C Blue #1 Dye.

Front 46

Why does Hydrogel have physical properties similar to tissue?

Back 46

Due to it's high water content

Front 47

What is PEG

Back 47

It is a long molecular chain of ethylene glycol groups. It is non-toxic polymer that is highly biocompatible and is safely reabsorbed by the body and elimated through the kidneys. It is made from ethylene oxide. It is not metabolized or broken down into lower molecular weight components by the body; it is water soluble, passing into the blood and excred intact in the urine.

Front 48

DuraSeal Storage

Back 48

At Room temperature for up to 18 months

Front 49

DuraSeal Contraindications

Back 49

Do not apply to confined bony structures where nerves are present since neural compression my result due to hydrogel swelling, the hydrogel may swell up to 50% of size in thickness in any dimension. It may have an increase in volue up to 200% meaning that the periphery, oredges, and mot the main body of the hydrogel, may spread during weeks 2 and 4. However, it quickly resorbs resulting in the reduction of this margin/peripheral "spread" to it's original dimensions.

Front 50

4 benefits of duraseal

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Strength - excellent tissue adherence and cohesive strength for a true, watertight closure every time. Ease of use - easily prepared under 2 minutes and forms a seal in seconds. Visibility - blue colorant for easy visualization of gel coverage and thickness. Synthetic and Absorbale - 100% synthetic polyethylene glycol (PEG) safely absorbs after the body has naturally healed.