A surgical sealant film is an implantable medical device used during surgery. It is a preformed flexible patch that is applied to supplement sutures and surgical staples to seal tissues and prevent leaks of fluid (including blood and cerebrospinal fluid) and air.
The sealant film is synthetic and incorporates absorbable polymers, including poly(lactide-co-glycolide). The polymeric components impart structural and adhesive properties with the sealing effect achieved by incorporation of a bioadhesive polymer. This forms a covalent bond to primary amines present on the tissue surfaces. In turn this results in the film rapidly becoming effective in providing a form of secondary wound closure. [1] [2]
The film can be used for sealing the dura mater, [3] [4] [5] preventing blood loss in general surgery and eliminating air leaks following lung resection.
Neurosurgery or neurological surgery, known in common parlance as brain surgery, is the medical specialty concerned with the prevention, diagnosis, surgical treatment, and rehabilitation of disorders which affect any portion of the nervous system including the brain, spinal cord, central and peripheral nervous system, and cerebrovascular system.
Pia mater, often referred to as simply the pia, is the delicate innermost layer of the meninges, the membranes surrounding the brain and spinal cord. Pia mater is medieval Latin meaning "tender mother". The other two meningeal membranes are the dura mater and the arachnoid mater. Both the pia and arachnoid mater are derivatives of the neural crest while the dura is derived from embryonic mesoderm. The pia mater is a thin fibrous tissue that is permeable to water and small solutes. The pia mater allows blood vessels to pass through and nourish the brain. The perivascular space between blood vessels and pia mater is proposed to be part of a pseudolymphatic system for the brain. When the pia mater becomes irritated and inflamed the result is meningitis.
Dura mater is a thick membrane made of dense irregular connective tissue that surrounds the brain and spinal cord. It is the outermost of the three layers of membrane called the meninges that protect the central nervous system. The other two meningeal layers are the arachnoid mater and the pia mater. The dura surrounds the brain and the spinal cord. It envelops the arachnoid mater, which is responsible for keeping in the cerebrospinal fluid. It is derived primarily from the neural crest cell population, with postnatal contributions of the paraxial mesoderm.
A subdural hematoma (SDH) is a type of bleeding in which a collection of blood—usually associated with a traumatic brain injury—gathers between the inner layer of the dura mater and the arachnoid mater of the meninges surrounding the brain. It usually results from tears in bridging veins that cross the subdural space.
The crown is the top portion of the head behind the vertex. The anatomy of the crown varies between different organisms. The human crown is made of three layers of the scalp above the skull. The crown also covers a range of bone sutures, and contains blood vessels and branches of the trigeminal nerve.
Encephalocele is a neural tube defect characterized by sac-like protrusions of the brain and the membranes that cover it through openings in the skull. These defects are caused by failure of the neural tube to close completely during fetal development. Encephaloceles cause a groove down the middle of the skull, or between the forehead and nose, or on the back side of the skull. The severity of encephalocele varies, depending on its location.
Polydioxanone or poly-p-dioxanone is a colorless, crystalline, biodegradable synthetic polymer.
Cranioplasty is a surgical operation on the repairing of cranial defects caused by previous injuries or operations, such as decompressive craniectomy. It is performed by filling the defective area with a range of materials, usually a bone piece from the patient or a synthetic material. Cranioplasty is carried out by incision and reflection of the scalp after applying anaesthetics and antibiotics to the patient. The temporalis muscle is reflected, and all surrounding soft tissues are removed, thus completely exposing the cranial defect. The cranioplasty flap is placed and secured on the cranial defect. The wound is then sealed.
Sealant is a substance used to block the passage of fluids through the surface or joints or openings in materials, a type of mechanical seal. In building construction sealant is sometimes synonymous with caulking and also serve the purposes of blocking dust, sound and heat transmission. Sealants may be weak or strong, flexible or rigid, permanent or temporary. Sealants are not adhesives but some have adhesive qualities and are called adhesive-sealants or structural sealants.
Surgical suture is a medical device used to hold body tissues together after an injury or surgery. Application generally involves using a needle with an attached length of thread. A number of different shapes, sizes, and thread materials have been developed over its millennia of history. Surgeons, physicians, dentists, podiatrists, eye doctors, registered nurses and other trained nursing personnel, medics, clinical pharmacists and veterinarians typically engage in suturing. Surgical knots are used to secure the sutures.
An epidural blood patch is a surgical procedure that uses autologous blood in order to close one or many holes in the dura mater of the spinal cord, usually as a result of a previous lumbar puncture. The procedure can be used to relieve post dural puncture headaches caused by lumbar puncture. A small amount of the patient's blood is injected into the epidural space near the site of the original puncture; the resulting blood clot then "patches" the meningeal leak. The procedure carries the typical risks of any epidural puncture. However, even though it is often effective, further intervention is sometimes necessary.
Patient registration is used to correlate the reference position of a virtual 3D dataset gathered by computer medical imaging with the reference position of the patient. This procedure is crucial in computer assisted surgery, in order to insure the reproducitibility of the preoperative registration and the clinical situation during surgery. The use of the term "patient registration" out of this context can lead to a confusion with the procedure of registering a patient into the files of a medical institution.
The surgical planning is the preoperative method of pre-visualising a surgical intervention, in order to predefine the surgical steps and furthermore the bone segment navigation in the context of computer-assisted surgery. The surgical planning is most important in neurosurgery and oral and maxillofacial surgery. The transfer of the surgical planning to the patient is generally made using a medical navigation system.
Orthostatic headache is a medical condition in which a person develops a headache while vertical and the headache is relieved when horizontal. Previously it was often misdiagnosed as different primary headache disorders such as migraine or tension headaches. Increasing awareness of the symptom and its causes has prevented delayed or missed diagnosis.
A cerebrospinal fluid leak is a medical condition where the cerebrospinal fluid (CSF) surrounding the brain or spinal cord leaks out of one or more holes or tears in the dura mater. A cerebrospinal fluid leak can be either cranial or spinal, and these are two different disorders. A spinal CSF leak can be caused by one or more meningeal diverticula or CSF-venous fistulas not associated with an epidural leak.
A fibrin scaffold is a network of protein that holds together and supports a variety of living tissues. It is produced naturally by the body after injury, but also can be engineered as a tissue substitute to speed healing. The scaffold consists of naturally occurring biomaterials composed of a cross-linked fibrin network and has a broad use in biomedical applications.
Endoscopic endonasal surgery is a minimally invasive technique used mainly in neurosurgery and otolaryngology. A neurosurgeon or an otolaryngologist, using an endoscope that is entered through the nose, fixes or removes brain defects or tumors in the anterior skull base. Normally an otolaryngologist performs the initial stage of surgery through the nasal cavity and sphenoid bone; a neurosurgeon performs the rest of the surgery involving drilling into any cavities containing a neural organ such as the pituitary gland. The use of endoscope was first introduced in Transsphenoidal Pituitary Surgery by Gamea, El-Guindy and Fathi in 1994.
Tissuemed is a medical device developer and manufacturer based in Leeds, UK.
William D. Spotnitz is a cardiothoracic surgeon and medical researcher who has made significant contributions to the development and testing of surgical techniques. He is a notable researcher in the United States in use of fibrin glue. Spotnitz serves as a heart surgeon in the University of Virginia Health System. He also previously served as the director of the hospital's Tissue Adhesive Center, which promoted and advanced the use of adhesives in surgery. He currently serves as the director of the Surgical Therapeutic Advancement Center, a successor program conducting more generalized research in surgical procedures.
Neuroplastic or neuroplastic and reconstructive surgery is the surgical specialty involved in reconstruction or restoration of patients who undergo surgery of the central or peripheral nervous system. The field includes a wide variety of surgical procedures that seek to restore or replace a patient’s skull, face, scalp, dura, the spine and/or its overlying tissues.