Skull base closure systems and methods
AssigneeStryker European Holdings I, LLC
InventorsPatrick Eoin Cushen, Johannes Jacobus Jacobs
Life of this patent
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Abstract
The present disclosure provides a bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull. The closure device comprises a phase-separated polymer having a porosity of greater than 80%. The device includes a stem portion having a proximal end and a distal end, and a head portion at the distal end of the stem portion. The closure device is deformed from a free shape to a constricted shape, inserted through a nasal cavity and into the opening, and released to at least partially revert back to the free shape such that the stem portion fills the opening and the head portion abuts cranium and dura to secure the closure device in position and seal the opening.
Claims20
A system for trans-nasally closing an opening in a base of a skull, the system including:
- a bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull, the device comprising a stem portion having a proximal end and a distal end, and a head portion at the distal end having at least one dimension being larger than the stem portion, the stem portion comprising a first phase-separated polymer having amorphous segments and crystalline segments, and the head portion comprising a second phase-separated polymer having amorphous segments and crystalline segments, the first phase-separated polymer and the second phase-separated polymer being the same or different, wherein the stem portion is formed from a phase-separated polymer and has a porosity of greater than 80%;
- and
- a surgical tool comprising:
- a body defining an inner channel, the body having a handle, a dispensing tip, and a central section therebetween, the dispensing tip having a tapered profile between a first region and a second region, the first region having a greater diameter than the second region;
- and
- a shaft moveably disposed in the inner channel of the body, the shaft having a control surface at a proximal region and a deformable head at a distal region, the shaft and the deformable head cooperate to define a lumen to accommodate a portion of the closure device.
A method of trans-nasally closing an opening in a base of a cranium having an inner surface and defining a cranial cavity with a surgical tool and a bioresorbable foam closure device, said method comprising the steps of:
- providing the closure device having a stem portion having a proximal end and a distal end, and a head portion at the distal end having at least one dimension being larger than the stem portion, the stem portion comprising a first phase-separated polymer having amorphous segments and crystalline segments, and the head portion comprising a second phase-separated polymer having amorphous segments and crystalline segments, the first phase-separated polymer and the second phase-separated polymer being the same or different, wherein the stem portion is formed from a phase-separated polymer and has a porosity of greater than 80%;
- deforming at least the head portion of the closure device from a free shape to a deformed shape;
- inserting the deformed head portion of the closure device through a nasal cavity and through the opening such that the head portion is in the cranial cavity and the stem portion extends through the opening and into the nasal cavity;
- and
- releasing the closure device such that the closure device at least partially reverts to the free shape such that the stem portion fills the opening and the head portion abuts an inner surface of the cranium as well as dura, thereby securing the closure device in position and sealing the opening.
Dependencies are inferred from the claim text.