Abstract: The present disclosure is directed to a degradable medical implant (10) for regeneration of soft tissue, comprising a plurality of scaffolds (1), and a plurality of connecting elements (2), wherein each scaffold (1) has a surface projected in the x-y plane, of maximum 500 mm2, and wherein the connecting elements (2) bind the scaffolds (1) together in the x-y plane.

Abstract: An adjustable cranioplasty plate assembly is provided for use following a craniectomy. The assembly includes a ring which is attached to the skull around the skull opening and a plate adjustably mounted to the ring. The plate is moveable between a raised position spaced above the ring and a lower position substantially flush with the ring. The plurality of extendable and retractable struts extends between the ring and the plate to provide the plate adjustability. The plurality of stay cables extending between the ring and the plate provide lateral stability in the raised position. The assembly replaces the native bone and eliminates the need for subsequent cranioplasty surgery. In one embodiment, the plate includes a rigid central portion, three rigid mounting tabs, and a plurality of malleable tapered perimeter petals which provide a smooth interface between the plate and the skull of the patient.

Abstract: A method for single-stage cranioplasty reconstruction includes prefabricating a clear craniofacial implant, creating a cranial, craniofacial, and/or facial defect, positioning the clear craniofacial implant over the cranial, craniofacial, and/or facial defect, tracing cut lines on the clear craniofacial implant as it lies over the cranial, craniofacial, and/or facial defect, cutting the prefabricated clear custom craniofacial implant along the hand-marked lines for optimal fit of the clear implant within the cranial, craniofacial, and/or facial defect, and attaching the final clear craniofacial implant to the cranial, craniofacial, and/or facial defect with standard fixation methods of today.

Abstract: Various embodiments of craniofacial implants, surgical instruments, and techniques are described to provide improved surgical results.

Abstract: The present invention generally relates to a device for repairing an encephalocele. Specifically, this invention relates to a patching component that can be implanted or grafted on to the skull to repair an encephalocele from the inner or outer surface of the skull.

Abstract: Various examples are provided for securing deep brain stimulation (DBS) leads. In one example, among others, a DBS cap for securing a DBS lead includes a base ring adapted to be mounted within a counterbore opening formed in the skull, a lead securing element that mounts to the base ring, and. a top cover that mounts to the base ring. In another example, a method for securing a DBS lead includes forming a counterbore opening in the skull, securing a DBS cap within the counterbore opening, passing a DBS lead through the DBS cap and the counterbore opening and positioning a tip of the lead in brain tissue, and securing the DBS lead to the DBS cap using an adhesive. The skull opening includes a lower bore, a concentric upper bore, and a step positioned at the interface of the upper and lower bores.

Abstract: The subject invention provides devices and methods for alleviating discomfort associated with neuroma formation. The devices and methods of the invention effectively use the body's natural response of reconstructing implanted biomaterials to minimize the size of, isolate, and protect a neuroma. In preferred embodiments, the subject device is a cylindrical cap, wherein the internal chamber of the cylindrical cap physically partitions the nerve to enable an arrangement of nerve fibers (as opposed to haphazardly arranged nerve fibers often produced in neuromas). In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.

Abstract: A method and apparatus for preventing brain compression subsequent to removal of a portion of a patient's cranium comprises custom forming a protective external cranial plate. The protective external cranial plate is shaped to approximate the removed portion of the patient's cranium, and to extend peripherally beyond the removed portion. The protective external cranial plate is affixed in airtight and fluid tight engagement to the scalp of the patient.

Abstract: A percutaneous gateway is provided for permanently transmission between inside of a body and outside of the body, comprising an implant (10) adapted to be at least partly anchored in a bone (1). The implant (10) has a transmission means (30) that allows a long-term stable communication through a transmitting device (20) adapted to extend from an implantable component (90) through the bone (80) to a device (91) at the outer end (3) of the percutaneous gateway.

Abstract: A method of performing a medical procedure comprises introducing a medical device through a cranial burr hole into the brain tissue, mounting a plug base around a cranial burr hole, securing the medical device within the aperture of the plug base, seating a proximal end of the medical device within a first groove of the plug base, such that the proximal end exits the aperture of the plug base through the first groove, looping the proximal end from the first groove to a second groove in the plug base, seating the proximal end within the second groove, such that the proximal end extends across the aperture of the plug base from the second groove, and seating the proximal end within a third groove of the plug base, such that the proximal end exits the plug base aperture through the third groove.

Abstract: A percutaneous gateway is provided for permanently transmission between inside of a body and outside of the body, comprising an implant (10) adapted to be at least partly anchored in a bone (1). The implant (10) has a transmission means (30) that allows a long-term stable communication through a transmitting device (20) adapted to extend from an implantable component (90) through the bone (80) to a device (91) at the outer end (3) of the percutaneous gateway.

Abstract: A burr hole plug includes a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further includes a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: A device for covering and/or reconstructing a bone defect site and a method for producing a cap of a covering device for a bone defect site, wherein the device for covering and/or reconstructing a bone defect site consists of a cap (moulded shell, rigid shell, shaped body) and of at least one fixing means for fixing the cap on a bone. The cap is distinguished by having a dimensionally stable (rigid) nature, and a wall of the cap directed towards the bone defect or a wall of the cap directed away from the bone defect corresponds to the shape of the regenerated bone.

Abstract: A burr hole plug comprises a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: A bioabsorbable plug implant, suitable for bone tissue regeneration, comprising a first portion, and a second portion extending outwardly from the first portion, the first and second portions formed from expandable material. A method for bone tissue regeneration comprising the steps of: providing a bioabsorbable plug implant, wherein the implant comprises a first portion and a second portion extending outwardly from the first portion, the first and second portions formed from expandable material; inserting the second portion into a defect or gap of a bone, the first surface engaging the outside contour of the defect or gap; allowing the plug implant to contact body fluids, thereby expanding the size of the plug implant so that the plug fits into the defect or gap.

Abstract: A surgical implant, which in use, provides a barrier between layers of tissue such that tissue on one side of the implant does not adhere to tissue on the other side, the improvement comprising that the implant is made of suitably anatomically shaped surgically acceptable sheet material.

Abstract: Embodiments relate to systems and methods for a cranial implant assembly adapted for insertion during a craniectomy procedure. In aspects, the inventive cranial implant assembly can contain a peripheral attachment member for attachment to the edge of a skull opening, as well as an articulated spanning member that over-arches and holds a cover in place over the opening. The articulated spanning member contains a central implant fastened or connected to a swollen dura in the skull opening. As swelling of the dura subsides, tension is exerted on guidewires in both the spanning member and cover to draw those constructs into a rigid state. The tips of the spanning member can gradually approach the peripheral attachment member, and register into place using a locking mechanism, such as a pair of opposing magnets. As a result, only one surgical operation or procedure Is required to both perform a craniectomy and implant a supporting assembly for eventual skull regeneration.

Abstract: A skull endosseous module for ultrasound penetration is provided and includes a fixation sleeve permanently inserted and positioned in a drilled hole of a skull, a movable sleeve movably inserted in the fixation sleeve for providing a hollow ultrasound guiding channel; and an outer cover mounted on an outer opening of the fixation sleeve and covered by a scalp tissue. Thus, an ultrasound device outside the scalp tissue can generate ultrasounds to pass through the outer cover and the ultrasound guiding channel for affecting a target region of a brain tissue in the skull.

Abstract: A burr hole plug comprises a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: The present invention relates to mosaic implant (15) comprising a plurality of mosaic plates (17) connected by a wire or mesh anchoring arrangement (9). Methods for forming such implants and methods for using said implants for correction of bone and soft tissue defects are described.

Abstract: Pre-surgical planning for cranial, facial, limb and digit muscular and bone reconstruction includes preparing a computer generated anatomical model for determining a locational position for a dental implant, a surgical bone implant to repair missing bone in the cranium, limbs and digits and to install ear, eye or nose prostheses. The computer generated anatomical model is made from medical imagery and computer aided design. A surgical guide is prepared with oversize holes in registration with analogs for the dental or surgical bone implants to be inserted in the anatomical model. The surgical guide is fitted atop each analog, and bonded to the anatomical model at a predetermined angle of the analog in the anatomy. The surgical guide is removed and attached to the anatomy of a patient for accurate drilling for insertion of the implants or prostheses into the body of the patient.

Abstract: The invention provides a method and apparatus for cranial fixation following a craniotomy and treatment for increased intracranial pressure. The cranial fixation device comprises two heads connected by a telescopic extension with one head attached to the skull and the other to the bone flap. The telescopic extension provides constrained movement of the bone flap relative to the skull to accommodate an increase in the intracranial pressure.

Abstract: A method of cranial repair and the cranial implant molding device used therein, the device having a frame or base that receives a bottom or convex molding plate and a top or concave molding plate in a manner whereby the two plates are separated a distance to receive a settable or curable implant forming material therebetween. The plates are separated by a compressible member such that by the use of threaded mechanical fasteners or similar members the distance between the two plates can be adjusted by tightening or loosening the mechanical members. The thickness of the implant is varied by varying the separation distance on different sides of the frame.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: Strip fasteners and cranial plugs for use in reattaching a skull flap removed during brain surgery and methods of using the same. The strip fasteners are flexible and can be shaped to follow the perimeter contour of the skull flap. The cranial plugs can be used to reattach the skull flap or they can be installed after the skull flap is reattached using the strip fasteners. In some embodiments, the cranial plug(s) and strip fasteners can be installed at the same time. The strip fasteners and cranial plugs are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement compositions to the surgical site.

Abstract: A burr hole cover includes a cap or cap assembly and a retainer and is configured to be partially positioned within a burr hole formed in a patient. The retainer has a cap-receiving aperture; a plurality of grooves provided in the retainer and a plurality of cut-outs wherein each cut-out is provided at an end of each groove towards the outer perimeter of the retainer. A channel may be provided at an opposite end of each groove vertically-extending from the top to the bottom of the retainer to encourage a medical device segment to remain in a groove during installation of the burr hole cover. The burr hole cover may be used to secure segments of medical devices relative to a burr hole and to allow a range of lateral motion for the portion(s) of the medical device(s) extending proximally out of the corresponding groove.

Abstract: A first tool is configured to cut a polymer implant, and includes a handle, a cutting portion, and a bending portion. A second tool is configured to cut a polymer implant, and includes a handle, a first cutting portion, and a second cutting portion. The cutting portions contain a cutter that is preferably a blade. In the second tool, the blades are preferably angled with respect to each other between about 45°. The tools can be used to reshape an implant that is to be used to replace a portion of a skull.

Abstract: Disclosed herein are implants and methods for filling voids in a cranium of a patient. A craniofacial implant that may be used for filling such voids may include at least first and second components each having outer and inner surfaces, the outer and inner surfaces being curved in an inferior to posterior direction and a medial to lateral direction. The first component includes a flange extending outwardly from a medial side surface thereof and the second component includes a recessed portion extending inwardly from a medial side surface thereof. The first and second components are preferably engageable to one another such that the medial side surfaces of the first and second components are adjacent one another and the flange of the first component is housed within the recessed portion of the second component.

Abstract: The present invention is directed to methods for collecting and processing autografts, processed autografts, kits for collecting and transporting autografts, and tools for preparing autografts. It is also directed to autologous bone grafts, and methods of preparing them.

Abstract: A burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base. The retainer includes a retainer support, a slot formed in the retainer support for receiving the medical device, and a clamping mechanism having a movable clamping element and a cam configured for being rotated relative to the retainer support to linearly translate the movable clamping element into the slot, thereby securing the medical device. The retainer further comprises another clamping mechanism having another movable clamping element and another cam configured for being rotated relative to the retainer support to linearly translate the other movable clamping element, thereby laterally securing the retainer within the plug base.

Abstract: Embodiments relate to systems and methods for a cranial implant assembly adapted for insertion during a craniectomy procedure. In aspects, the inventive cranial implant assembly can contain a peripheral attachment member for attachment to the edge of a skull opening, as well as an articulated spanning member that over-arches and holds a cover in place over the opening. The articulated spanning member contains a central implant fastened or connected to a swollen dura in the skull opening. As swelling of the dura subsides, tension is exerted on guidewires in both the spanning member and cover to draw those constructs into a rigid state. The tips of the spanning member can gradually approach the peripheral attachment member, and register into place using a locking mechanism, such as a pair of opposing magnets. As a result, only one surgical operation or procedure Is required to both perform a craniectomy and implant a supporting assembly for eventual skull regeneration.

Abstract: Craniotomy closures comprising surgical fasteners are described for use in reattaching a skull flap removed from the skull of a patient during brain surgery. Methods of using the same are also described. Surgical strips used in combination with the fasteners are shaped to follow the perimeter contour of the skull flap. The craniotomy closures are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement materials to the surgical site.

Abstract: A surgical method for positioning an extraoral bone-anchored implant device in a receiving bone site of a patient, the patient being a human being or an animal, including the following successive steps: a step of preparing the receiving bone site, a step of impacting the implant in the opening formed in the receiving bone site; a step of leveling the implant and the surrounding bone structure and making them continuous, during which the external table of the bone structure is rubbed at its part surrounding the implant, then bone fragments are positioned on the rubbed parts of the external table of the bone structure, then the bone fragments are covered with a membrane to hold the bone fragments in position, the membrane being attached to the bone structure on one side and to the implant on the other side, so as to prevent bone proliferation on the implant.

Abstract: A composite surgical implant that is made of a planar sheet of a thermoplastic resin that includes a top surface (400), a bottom surface (410), and a surgical grade metal mesh (405) contained therein. The implant may be bent by hand, wherein upon the displacement of the implant, the implant will generally maintain the shape to which it has been displaced.

Abstract: A burr hole plug comprises a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: A burr hole plug comprises a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: Methods are provided for preserving and restoring cranial bone flaps. In one aspect, the method to preserve a cranial bone flap includes cleaning a cranial bone flap, washing the cranial bone flap with a sterile saline solution including gentamycin, and washing the bone with a sterile saline solution including vancomycin. The cranial bone flap may be dried, wrapped, and packaged before being stored in a freezer. The fixing method may include removing the preserved cranial bone flap from a freezer and unwrapping the preserved cranial bone flap from any wrappings. A previous wound may be opened for insertion of the preserved cranial bone flap. The preserved cranial bone flap may be washed with a sterile saline solution including gentamycin and a sterile saline solution including vancomycin. The edges of the previous wound may be refreshed by nipping free margins to expose diploic spaces, and the preserved cranial bone flap may be fixed in place within the previous wound.

Abstract: A patch for covering an aperture associated with a skull including a plastic composite body having either a planar or arcuate shape exhibits an extending edge profile which matches a profile associated with a reconditioned edge of the skull. A fastener extends through the edge profile for securing the body to the skull. The extending edge profile further includes a first portion and a second reduced portion separated by a shoulder, the skull exhibiting a corresponding outer skull edge portion, inner stepped skull portion and intermediate shoulder being configured to mate with the configuration of the extending edge profile and in order to achieve a generally flush appearance when seating the patch over the skull aperture. One or more screws fasten the edge profile of the body to the skull. This can further include a bone screw with undercut engaging portion extending through the extending edge profile and associated skull location.

Abstract: Provided are biocompatible and implantable scaffolds for treating a tissue defect, such as a bone gap. The scaffolds can have a modular design comprising a tissue scaffold rack designed to accommodate one or more modules. Also provided are methods for fabrication and use of such scaffolds.

Abstract: A custom cranial repair implant is prepared by conforming a malleable sheet material, such as for example a thin metal foil, a polymer sheet material or a laminate of various materials, a formable cement or putty-like material, or a spray or liquid settable material, to the edges and depth of a cranial defect in a manner that creates a mold matching the cranial defect. The mold is removed from the cranial defect and a settable putty or cement material that is biocompatible is then poured into the mold and allowed to harden. Once sufficiently cured, the implant is then removed from the mold and further shaped if necessary by cutting, abrading or the like. The implant is then affixed within the cranial defect in known manner, such as by bonding, gluing, mechanical fasteners, etc.

Abstract: A method of cranial repair and the cranial implant molding device used therein, the device having a frame or base that receives a bottom or convex molding plate and a top or concave molding plate in a manner whereby the two plates are separated a distance to receive a settable or curable implant forming material therebetween. The plates are separated by a compressible member such that by the use of threaded mechanical fasteners or similar members the distance between the two plates can be adjusted by tightening or loosening the mechanical members. The thickness of the implant is varied by varying the separation distance on different sides of the frame.

Abstract: A cranial burr hole plug with an insertion tool and method of implantation is provided. The burr hole plug includes a shell; a collet interlocked within the shell; a clamp compressing the collet around an elongated medical device exiting the skull of a patient, such as a catheter or lead; and a cover over the clamp, collet, and shell. The insertion tool inserts the collet within the shell and locks the collet around the clamp. The method of implantation includes inserting the burr hole plug components in a cranial burr hole using the insertion tool and securing the exiting medical device without disturbing the position of the medical device.

Abstract: Craniotomy closure systems comprising surgical fasteners and a protective covering over the dura are described for use in reattaching a skull flap removed from the skull of a patient during brain surgery. Methods of using the same are also described. Surgical strips optionally used in combination with the craniotomy closure systems are shaped to follow the perimeter contour of the skull flap. The craniotomy closure systems are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement materials to the surgical site.

Abstract: The present invention provides composite implants for the replacement or augmentation of non-load bearing or load bearing soft tissues, and methods of making and using these implant compositions. In one embodiment, a composite implant of the present invention comprises a soft polymeric component coupled to a porous polymeric substrate.

Abstract: A method for effecting reduction, stabilization and enhancement of fusion of the human cranio-cervical junction, which may be performed in order to relieve mechanical stresses imparted to the spinal cord and brainstem as a result of an abnormal clivo-axial angle, includes steps of achieving the correct craniocervical relationship, of effecting a fusion of a first portion of a bone forming material based structural member to a human cranium, and effecting fusion of a second portion of the bone forming material based structural member to a least one portion of a human cervical spine. Fusion of the bone forming material based structural member to the human cranium may be promoted through the use an osteointegration apparatus that includes a porous ossomeric mesh and a frame member.

Abstract: Disclosed is a skull endosseous implant adapted to be implanted in the subject's skull to provide an access channel. A variety of sensor means may be installed in the access channel for monitoring the intracranial status of the subject. The present invention further provides a kit containing the skull endosseous implant.

Abstract: A spinal stabilization system that may be used to fix craniocervical junction. The system includes a cranial spinal attachment system that anchors one or more surgical instruments to a cranial surface using at least one cranial clamp and cranial fastener. The cranial spinal attachment system may be positioned along a perimeter of a cranial defect.

Abstract: Strip fasteners and cranial plugs for use in reattaching a skull flap removed during brain surgery and methods of using the same. The strip fasteners are flexible and can be shaped to follow the perimeter contour of the skull flap. The cranial plugs can be used to reattach the skull flap or they can be installed after the skull flap is reattached using the strip fasteners. In some embodiments, the cranial plug(s) and strip fasteners can be installed at the same time. The strip fasteners and cranial plugs are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement compositions to the surgical site.

Abstract: Strip fasteners and cranial plugs for use in reattaching a skull flap removed during brain surgery and methods of using the same. The strip fasteners are flexible and can be shaped to follow the perimeter contour of the skull flap. The cranial plugs can be used to reattach the skull flap or they can be installed after the skull flap is reattached using the strip fasteners. In some embodiments, the cranial plug(s) and strip fasteners can be installed at the same time. The strip fasteners and cranial plugs are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement compositions to the surgical site.