A method and apparatuses are disclosed for registration of the patient's head and oral cavity for radiation therapy treatment of head and neck cancer. The method and apparatuses comprise an intraoral positioning device (IPD) positioned in a patients mouth. The IPD incorporates fiducials embedded in or on an IPD. The fiducials function as markers for tracking and radiation beam direction. These fiducials may be incorporated manually, using 3D printers, or a combination of both. The fiducials allow better registration of the radiation therapy during treatment and from treatment to treatment, and also allows adaptive adjustment during radiation therapy to minimize the effects of patient movement.

An airway assist device (AAD) is provided. The device includes an upper AAD component and a lower AAD component. The upper AAD component includes and upper tooth guide connected to an upper plate having a pair of depending legs. The upper AAD component further includes an upper force receiving plate. The AAD also includes a lower AAD component. The lower AAD component includes a lower tooth guide connected to a lower plate. The lower AAD component further includes a lower force receiving plate. The upper and lower AAD components are connected in a way that allows relative longitudinal movement between the two components between a neutral position and a plurality of extended positions. A ratchet mechanism inhibits movement of the lower plate from any extended position toward the neutral position. The ratchet mechanism may be manually disengaged to allow the lower AAD component to return to the neutral position. An oxygen delivery housing may be connected to the upper plate to distribute oxygen.

An immobilization system, especially for use on the human head and neck area, is described in various embodiments. The system may include a bite block immobilization system having a bite block with a dental interface releasably engageable with a plurality of teeth of a patient, and a retention mask. The dental interface releasably engages the teeth of a patient and allows very highly accurate repositioning during multiple procedures. In some embodiments, the bite block may have an integral bite block airway passage, allowing a patient to have unobstructed breathing both during molding of the retention mask and during subsequent use of the system, and may include a tongue diverter, that may, by way of example only and not limitation, be used to divert the tongue away from a therapeutic radiation beam. Steps for utilizing the system are further described.

An immobilization system, especially for use on the human head and neck area, is described in various embodiments. The system may include a bite block immobilization system having a bite block with a dental interface releasably engageable with a plurality of teeth of a patient, and a retention mask. The dental interface releasably engages the teeth of a patient and allows very highly accurate repositioning during multiple procedures. In some embodiments, the bite block may have an integral bite block airway passage, allowing a patient to have unobstructed breathing both during molding of the retention mask and during subsequent use of the system, and may include a tongue diverter, that may, by way of example only and not limitation, be used to divert the tongue away from a therapeutic radiation beam. Steps for utilizing the system are further described.

Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.) to a desired location within the nose, throat, ear or cranium of the subject.

Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.) to a desired location within the nose, throat, ear or cranium of the subject.

Methods of immobilizing the head of a patient include heating a thermoplastic mask preform to a formable temperature, forming the thermoplastic mask over at least a mouth of the patient, and pushing a mouth receiving end of a bite piece into a portion of the thermoplastic mask preform that is positioned over the mouth of the patient, which moves the portion of the thermoplastic mask preform into the mouth of the patient. The methods also include allowing the thermoplastic mask preform to cool from the formable temperature, causing the portion of the thermoplastic mask moved into the mouth of the patient to harden.

Methods of immobilizing the head of a patient include heating a thermoplastic mask preform to a formable temperature, forming the thermoplastic mask over at least a mouth of the patient, and pushing a mouth receiving end of a bite piece into a portion of the thermoplastic mask preform that is positioned over the mouth of the patient, which moves the portion of the thermoplastic mask preform into the mouth of the patient. The methods also include allowing the thermoplastic mask preform to cool from the formable temperature, causing the portion of the thermoplastic mask moved into the mouth of the patient to harden.

Dental instrument assemblies (e.g., mouth pieces, bite blocks, vacuum dental mirrors, illuminated dental mirrors, illuminated dental wedges, trans-illumination dental instrument, illuminated dental bite blocks, etc.) are provided. The dental instrument assemblies may be adapted to be periodically sterilized. The dental instrument assemblies may include a magnetically energetic fiber optic coupler. The magnetically energetic fiber optic coupler may be configured to allow dental instrument adapter to rotate with respect to an associated fiber optic cable that is removably connected to the magnetically energetic fiber optic coupler. The dental instrument assemblies may include a fiber optic material that is encapsulated.

Apparatus and methods for providing three-dimensional printed oral stents are provided for head and neck radiotherapy. Movement of the jaw of the patient is simulated via a computer processor. Simulating movement of the jaw of the patient comprises rotating and translating a mandible of the jaw. A digital negative impression is transformed into a digital oral stent by adding support structures to the digital negative impression. The support structures facilitate three-dimensional (3D) printing of the patient-specific oral stent.