Dural repair device and method of use
Inventors
SANSUR, Charles • Ludwig, Steven C.
Assignees
University of Maryland Baltimore
Publication Number
US-12274811-B2
Publication Date
2025-04-15
Expiration Date
2038-09-12
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Abstract
Dural repair devices that are configured to effectively and reliably repair the damage of a dural tear due to incidental durotomies are provided, along with methods of use. The devices and methods enhance the ability of a surgeon to repair a patent's dura mater, or dura, during surgery of the central nervous system. The dural repair device has a multi-layer structure configured to exert a pressure or tamponade effect to compress a patient's dura to its state prior to the spinal surgery. Thus, the dural repair devices and methods of use may reduce the patient's risk morbidity, further surgery, spinal headaches, or other injuries and discomforts.
Core Innovation
The invention provides dural repair devices and methods of use that are designed to effectively and reliably repair dural tears caused by incidental durotomies during central nervous system surgeries. The devices feature a multi-layer structure capable of exerting pressure or a tamponade effect to compress a patient's dura back to its pre-surgery state, thereby creating a water-tight seal to prevent cerebrospinal fluid leakage.
The problem addressed is the difficulty of achieving a fluid-tight repair of dural defects with current methods, particularly in limited surgical spaces. Traditional suturing is time consuming and requires open surgery, while existing adhesives and patches may fail over time or lead to further complications. There is a need for improved devices that provide effective, reliable, and long-term solutions with reduced risk of complications.
The core innovation includes a tissue sealing device comprising a dual layer, multi-composite plate: a rigid and formable resorbable thermoplastic top layer, and a softer, compressible bottom layer. The plate can be heat-molded to conform to the anatomical defect, optionally cut or shaped as needed, and secured via suturing or bone fasteners. The device may also include a valvular pore to enable needle insertion for fluid management, and is suitable for use in various anatomical sites requiring fluid-tight repair.
Claims Coverage
There is one independent claim in this patent, which sets out three main inventive features.
Dual layer, multi-composite plate with thermoplastic and compressible materials
The inventive feature includes a dual layer, multi-composite plate having: - A top layer consisting of a rigid and formable resorbable thermoplastic material. - A bottom layer comprising a compressible material softer than the thermoplastic material of the top layer. The plate is moldable under heat treatment and is configured to provide a water-tight seal over the treatment site.
Valvular pore for one-way fluid flow and needle insertion
The plate incorporates a valvular pore that allows for insertion of a needle therethrough. This valvular pore is configured to provide one-way fluid flow, enabling procedures such as fluid injection or withdrawal while maintaining the water-tight nature of the closure.
Method steps forming and securing the sealing device over the treatment site
The method includes: 1. Providing the described multi-composite plate. 2. Forming a sealing device from the plate over the treatment site (including by heat-molding or cutting to shape as required). 3. Securing the formed device to the treatment site, which could include suturing or using bone fasteners.
The independent claim covers a method involving a dual-layer, moldable, resorbable plate featuring a valvular pore, with specific materials and a process for forming and securing a water-tight seal at dural or related treatment sites.
Stated Advantages
Effectively and reliably repairs the damage of a dural tear due to incidental durotomies.
Enhances the ability of surgeons to repair a patient's dura mater during surgery of the central nervous system.
Reduces patient risk morbidity, need for further surgery, spinal headaches, and other injuries or discomforts associated with cerebrospinal fluid leakage.
Provides a water-tight seal and improves sealing of the laminar defect for a fluid-tight closure.
Improves healing of the dura by enabling enhanced tamponade effect and increased adherence of the device.
Can be formed to fit various defects and cut to desired size or shape for specific applications.
Documented Applications
Repairing dural tears resulting from incidental durotomies during spinal or cranial surgeries.
Providing protection for neural elements (brain, spinal cord, nerve roots) during and after central nervous system surgeries.
Creating a water-tight seal over laminar defects of the spine.
Application to cranial defects of the skull to seal and protect vulnerable portions of the brain after craniectomy.
Serving as an additional barrier or reinforcement over fascia after wound closure in the back or abdomen.
Use in skull base surgery to seal dural leaks, such as during pituitary surgery.
Providing neural protection from postoperative hematoma or seroma, even when the dura is intact.
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