Adherus and Duraseal are two prominent adhesive technologies that have revolutionized various industries, particularly in the medical and automotive sectors. These cutting-edge solutions have garnered significant attention for their distinct properties and applications. Adherus, known for its exceptional bonding capabilities, has found its niche in surgical procedures, offering a secure and reliable method for tissue sealing.
On the other hand, Dura-seal, renowned for its versatility and resilience, has emerged as a pivotal player in automotive engineering, providing an effective means of joining diverse materials in vehicular construction. While both Adherus and Dura-seal excel in their respective domains, their unique attributes and targeted applications set them apart, prompting a thorough examination of their strengths and limitations. This comparative analysis aims to shed light on the key features and optimal use cases of these adhesive technologies, ultimately assisting industries in making informed choices for their specific requirements.
Adherus and DuraSeal
Adherus
Adherus is an Auto-Spray battery powered Dural Sealant is a specialized medical tool utilized in neurosurgical procedures. Its primary purpose is to effectively close Dural incisions, safeguarding the delicate covering of the brain and spinal cord, thereby minimizing the risk of cerebrospinal fluid (CSF) leaks.
This device is package sterile and is a disposable design, and can be open on a sterile surgical field. It has an internal system components that provide air flow to aid in the delivery of a synthetic , absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
Adherus on sterile table
The device is supplied as a pre-assembled applicator and two separate glass vials, one of which is package within a foil pouch. The two glass vials contain either an active polyethylene glycol (PEG) ester powder or a polyethyleneimine (PEI) dissolve sterile water. How it works the solution immediately crosslinks to form a hydrogel sealant which is absorbed over approximately 90days , sufficient time to allow for healing.
Indication for use Of Adherus
Adherus Auto-Spray Dural Sealant is indicated for use in patients who are 13yrs old and older .Instead of standard methods of Dural repair, such as sutures, to provide watertight closure during cranial procedures.
Contraindications Of Adherus
Adherus Auto-Spray Dural Sealant should not be use in Confined anatomical spaces where nerve compression is of concern. The hydrogel may swell up to 13% of it size in any dimension or 46% by volume after application.
Here is a list of conditions and situations where Adherus AutoSpray Dural Sealant has not been studied or is not recommended for use:
- Paients who require a procedure involving a Translabyrinthine, Transsphenoidal, or transoral approach, or any procedure that penetrates the air sinus or mastoid air cells.
- Patients whose dural edge gaps are larger than 2 mm.
- Patients with severely altered renal or hepatic function.
- Patients with an active infection present at the surgical site.
- Patients who have treated or untreated hydrocephalus (e.g., those with devices designed to evacuate cerebrospinal fluid (CSF) or altered CSF dynamics).
- Patients who have an underlying medical co-morbidity or are on a medication known to interfere with wound healing (e.g., those with previous intracranial neurosurgical procedure in the same anatomical location, radiation and chemotherapy treatment, known malignancy, diabetes, steroid toxicity and chronic corticosteroid use, compromised immune system, or on an anticoagulant agent, aspirin or non-steroid anti-inflammatory agent).
- Patients with a known allergy to FD&C Blue #1 Dye or FD&C Yellow #5 Dye.
- Patients who are pregnant or lactating.
9 basic Precaution to follow when using Adherus Autospray
- The Adherus AutoSpray Dural Sealant pouch is provided in a sterile condition. If the pouch appears damaged or has been opened, do not use it. Avoid re-sterilization.
- The Adherus AutoSpray Dural Sealant package is designed for single-patient use exclusively. Properly dispose of any unused or opened product. Reusing the device may lead to potential cross-contamination, posing risks to patient safety.
- Store the product away from direct sunlight. Refrain from using if the PEG ester powder does not flow freely.
- Apply the Adherus AutoSpray Dural Sealant within two hours after reconstituting the crosslinking components. Extensive testing has shown that samples reconstituted for longer periods, such as 8 hours, exhibited a small but statistically significant increase in swelling compared to those reconstituted for 1, 2, or 4 hours.
- The applicator system has an operational battery life of approximately two hours when used continuously.
- Before applying the Adherus hydrogel, ensure that there is no active fluid outflow (such as cerebrospinal fluid or blood).
- Avoid using the Adherus AutoSpray Dural Sealant in conjunction with flammable anesthetics or anesthetics that contain oxidants.
- Keep the Adherus AutoSpray Dural Sealant device away from powerful magnetic fields to prevent potential interference with RF communication. Magnetic resonance equipment may generate disruptions in pump operations.
- Only open the system covers as needed for battery replacement; do not remove any other covers.
DuraSeal Sealant System
The DuraSeal Dural Sealant System is a medical device used in neurosurgery. It is designed to help prevent cerebrospinal fluid (CSF) leakage following certain surgical procedures on the brain and spinal cord.
CSF leakage can be a complication of neurosurgery, and it’s important to prevent it to avoid potential complications and infections. The DuraSeal system provides a sealant that is applied to the dura mater, which is the outermost layer covering the brain and spinal cord. This sealant helps create a watertight barrier, reducing the risk of CSF leakage.
the sealant is composed of two solutions, a polyethylene glycol(PEG) ester solution a trilysineamine solution(referred to as the blue and clear precursors, respectively).precursor crosslink when mixed together to form hydrogel sealant.
The hydrogel implant is absorbed in approximately 4 to 8 weeks, sufficient time to allow for healing.DuraSeal dural sealant was approved by the FDA in 2005 for use during brain surgery. DuraSeal spinal sealant was originally approved by FDA in September 2009.
DuraSeal
Indication for use of DuraSeal
The DuraSeal Dural Sealant System is intended for use as an adjunct to sutured Dural repair during cranial surgery to provide watertight closure.
- Closure of dural defects during neurosurgery, including:
- Craniotomy procedures
- Spinal cord surgeries
- Decompressive surgeries for conditions like tumors or hematomas
- Prevention of cerebrospinal fluid (CSF) leaks:
- Especially important in procedures involving the skull base or spine where CSF leakage can lead to complications such as meningitis or pseudomeningocele formation
- Management of dural tears or defects caused by trauma:
- DuraSeal can be used to seal traumatic injuries to the dura mater, providing a protective barrier and facilitating healing
- Reduction of postoperative complications:
- By promoting a watertight seal and supporting tissue healing, DuraSeal may help reduce the risk of complications such as infections or recurrent CSF leaks after surgery
- Adjunct to sutures or staples:
- DuraSeal can be used in conjunction with traditional closure techniques to enhance the integrity of the dural closure and minimize the risk of leaks or herniation
- Facilitation of tissue healing:
- DuraSeal’s biocompatible formulation supports tissue regeneration and healing at the surgical site, aiding in the recovery process following neurosurgical procedures
Contraindication of DuraSeal.
Do not apply to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling
The hydrogel may swell up to 50% of its size in any direction.
Shelf Life (per FDA)
A 12-month shelf life was established based on results from real-time (53 weeks) test.https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040034b.pdf
evaluations for 3 DuraSeal product lots. The devices were tested for the following
attributes following real-time and accelerated aging:
- Visual assessment
- Hydrogel performance
- Packaging assessment
DEVICE DESCRIPTION
The DuraSeal Dural Sealant System consists of components for preparation of an
absorbable polyethylene glycol (PEG) hydrogel sealant and a delivery system (i.e.,
applicator, spray tips and plunger cap) packaged in a sterile single use kit. The sealant is
composed of two solutions, a PEG ester solution and a trilysine amine solution which are
referred to as the “blue” and “clear” precursors, respectively. When mixed together, the
precursors rapidly polymerize in-situ to form the hydrogel sealant.
DuraSeal compare to Adherus
| DURASEAL | ADHERUS |
| 1.Not powered ,so thus has no on and off button. | 1. Auto-Spray battery powered, has ON/OFF button |
| 2.System has 2 syringes one with blue label one with the diluent | 2.has 2 Glass vials with active polyethylene glycol(PEG)ester powder |
| 3. A product of Integra ,for Dural repair | 3.A product Stryker, for Dural repair. |
| 4. Use within 1 hour of preparation. | 4.Use within 2 hours of preparation |
| 5. Hydrogel implant is absorbed in approximately 4-8 weeks | 5.Hydrogel sealant absorbed in approximately 90 days |
| 6.Hydrogel swell up 50% in all directions | 6.Hydrogel swells up 13% of it size in any direction |
| 7.Package sterile and consist of polyethylene glycol(PEG) | 7.Package sterile and consist of polyethylene glycol(PEG) |
| 8.Consist of Trilysineamine solution a product of l-lysine synthesis | 8.Consist of Polyethyleneimine dissolve sterile water synthetic water . |
| 9. Dose not need batteries . | 9.Has batteries and the doors to battery compartment are glued shut to prevent falling onto sterile field during a procedure or use. |
Resources
work experience and training and education from product company vendors.
https://cmf.stryker.com/assets/files/74/cmf-fl-93_rev.-2_19251-adherus-et-flyer.pdf
