US-12616511-B2 - Skull base closure systems and methods

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. 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.

Inventors

• Patrick Eoin Cushen
• Johannes Jacobus Jacobs

Assignees

• STRYKER EUROPEAN OPERATIONS LIMITED

Dates

Publication Date

20260505

Application Date

20240730

Claims (19)

1. 1 . A surgical tool for trans-nasally placing a bioresorbable foam closure device in an opening in a base of a skull, the closure device having a stem portion and a head portion, the 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; wherein upon actuation of the control surface, the deformable head moves between a first state in which the deformable head is outside of the second region of the dispensing tip and a second state where the deformable head is at least partially within the second region of the dispensing tip, wherein a diameter of the deformable head in the first state is greater than a diameter of the deformable head in the second state; and wherein the control surface comprises a thumb stirrup.
2. 2 . The surgical tool as set forth in claim 1 , wherein the dispensing tip includes sidewalls that define the tapered profile, and wherein upon actuation of the control surface the shaft moves proximally within the inner channel and the deformable head moves proximally such that the sidewalls of the dispensing tip engage and deform the deformable head to load the closure device into the surgical tool.
3. 3 . The surgical tool as set forth in claim 1 , wherein the control surface further comprises a pair of finger saddles such that a user may insert their thumb into the thumb stirrup and loop their index and middle fingers over the finger saddles and actuate the surgical tool with one hand.
4. 4 . The surgical tool as set forth in claim 1 , wherein the dispensing tip is formed separately from the central section and is coupled thereto.
5. 5 . The surgical tool as set forth in claim 1 , wherein the dispensing tip comprises an alignment flange, wherein the alignment flange is configured to rest on an outer surface of the skull when the deformable head is inserted into the opening such that the closure device is positioned in the opening and does not penetrate too far into a cranial cavity.
6. 6 . The surgical tool as set forth in claim 1 , wherein the central section of the body comprises a malleable material, and the shaft comprises a flexible material such that a shape of the surgical tool may be changed to facilitate use of the surgical tool in a nasal cavity.
7. 7 . The surgical tool as set forth in claim 1 , wherein the body has an inner surface which defines the inner channel and also a stop surface, wherein the shaft includes a stop shelf extending radially thereabout that cooperates with the stop surface to stop movement of the shaft along a longitudinal axis in a distal direction.
8. 8 . The surgical tool as set forth in claim 1 , wherein the dispensing tip is conical.
9. 9 . The surgical tool as set forth in claim 1 , wherein the deformable head is conical when not deformed.
10. 10 . A system for trans-nasally closing an opening in a base of a skull, the system comprising: 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; 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; wherein upon actuation of the control surface, the deformable head moves between a first state in which the deformable head is outside of the second region of the dispensing tip and a second state where the deformable head is at least partially within the second region of the dispensing tip, wherein a diameter of the deformable head in the first state is greater than a diameter of the deformable head in the second state.
11. 11 . The system as set forth in claim 10 , wherein the stem portion comprises a first phase-separated polymer having amorphous segments and crystalline segments, and the head portion comprises 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.
12. 12 . The system as set forth in claim 10 , wherein the dispensing tip includes sidewalls that define the tapered profile, and wherein upon actuation of the control surface the shaft moves proximally within the inner channel and the deformable head moves proximally such that the sidewalls of the dispensing tip engage and deform the deformable head to load the closure device into the surgical tool.
13. 13 . The system as set forth in claim 10 , wherein the control surface comprises a thumb stirrup.
14. 14 . The system as set forth in claim 13 , wherein the control surface comprises a pair of finger saddles such that a user may insert their thumb into the thumb stirrup and loop their index and middle fingers over the finger saddles and actuate the surgical tool with one hand.
15. 15 . The system as set forth in claim 10 , wherein the dispensing tip is formed separately from the central section and is coupled thereto.
16. 16 . The system as set forth in claim 10 , wherein the dispensing tip comprises an alignment flange, wherein the alignment flange is configured to rest on an outer surface of the skull when the deformable head is inserted into the opening such that the closure device is positioned in the opening and does not penetrate too far into a cranial cavity.
17. 17 . The system as set forth in claim 10 , wherein the central section of the body comprises a malleable material, and the shaft comprises a flexible material such that a shape of the surgical tool may be changed to facilitate use of the surgical tool in a nasal cavity.
18. 18 . The system as set forth in claim 10 , wherein the body has an inner surface which defines the inner channel and also a stop surface, wherein the shaft includes a stop shelf extending radially thereabout that cooperates with the stop surface to stop movement of the shaft along a longitudinal axis in a distal direction.
19. 19 . The system as set forth in claim 10 , wherein the dispensing tip is conical and the deformable head is conical when not deformed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The subject application is a Continuation of U.S. patent application Ser. No. 18/351,138, filed Jul. 12, 2023, which is a Continuation of U.S. patent application Ser. No. 17/416,081 filed Jun. 18, 2021, which is the National Stage of International Application No. PCT/US2019/067835, filed on Dec. 20, 2019, which claims priority to and all of the benefits of U.S. Provisional Patent Application No. 62/782,718, filed on Dec. 20, 2018, the disclosures of which are hereby incorporated by reference. BACKGROUND Trans-nasal skull based surgical techniques have advanced significantly over the years. Repairing large skull base openings and cerebrovascular structures resulting from trans-nasal skull based surgical techniques, e.g. endoscopic trans-nasal craniotomies, remains a difficult challenge. Problems with closure of the skull defect which typically includes a compromised dura mater and prevention of cerebrospinal fluid leaks are a persistent source of complications in both endoscopic and open skull based surgeries. As such, there remains a need for improved materials and methods, which may be used to prevent post-surgical cerebrospinal fluid leaks and promote the repair of large skull base openings and cerebrovascular structures resulting from skull based surgeries. SUMMARY The present disclosure provides a bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull. The closure device includes a phase-separated polymer having a porosity of greater than 50%. 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 present disclosure also provides a surgical tool for placing the closure device in an opening in a base of a skull. The surgical tool includes a body defining an inner channel. The body has a handle, a dispensing tip, and a central section therebetween. The dispensing tip has a tapered profile between a first region and a second region, with the first region having a greater diameter than the second region. A shaft is moveably disposed in the inner channel of the body, the shaft has 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. Upon actuation of the control surface, the deformable head moves between a first state in which the deformable head is outside of the second region of the dispensing tip and a second state where the deformable head is at least partially within the second region of the dispensing tip. A diameter of the deformable head in the first state is greater than a diameter of the deformable head in the second state. A method of trans-nasally closing an opening in a base of a cranium with the closure device and the surgical tool is further disclosed. The method includes the steps of providing the closure device. At least the head portion of the closure device is deformed from a free shape to a deformed shape. Once deformed, the head portion is inserted 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. Once released, 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 scaling the opening. As such, the subject disclosure provides improved materials and methods, which may be used to prevent post-surgical cerebrospinal fluid leaks and promote the repair of large skull base openings, and cerebrovascular structures resulting from skull based surgeries. BRIEF DESCRIPTION OF THE DRAWINGS Advantages of the present disclosure will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein: FIG. 1 is a perspective view of an exemplary bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull; FIG. 2 is a cross-sectional view along 2-2 of the closure device of FIG. 1; FIG. 3 is a perspective view of another exemplary bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull; FIG. 4 is a cross-sectional view along 4-4 of the closure device of FIG. 3; FIG. 5 is a perspective view of an exemplary surgical tool for placing the closure device in an opening in a base of a skull; FIG. 6 is a cross-sectional view along 6-6 of the surgical tool of FIG. 5; FIG. 7A is a perspective view of the closure device and the surgical tool prior to loading the closure device in the surgical tool; FIG. 7B is cross-sectional view along 7B-7B of the closure device and a distal end of the surgical tool prior to loading; FIG. 8A is a perspective v