Sensory Head Stabilization System

Abstract

A head stabilization system that can be used to stabilize a patient's head during a medical procedure includes a sensor assembly and a connection assembly connected to a head fixation device. The sensor assembly includes one or more sensors disposed on the head fixation device to detect one or more characteristics of the head fixation device. The connection assembly receives and processes the detected characteristics and provides feedback of the detected characteristics. The head fixation device can be adjusted or modified based on the provided feedback.

Description

[Background technology]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 208,240, entitled "Head Stabilization System with Sensing Features," filed June 8, 2021, and U.S. Provisional Patent Application No. 63 / 208,255, entitled "Head Stabilization System with Sensing Features," filed June 8, 2021, the disclosures of which are incorporated herein by reference.

[0002] During certain medical procedures, it may be necessary or desirable to stabilize all or a portion of a patient to immobilize the patient or a portion of the patient. In certain neurological procedures, the portion to be stabilized includes the head and / or neck of the patient. Specific devices and methods may be used to stabilize certain parts of the patient. For example, a skull clamp is one type of head stabilization device used to stabilize the head and / or neck of a patient. Additionally, it may be necessary or desirable to use various imaging modalities to obtain images of the patient before, during, and / or after the procedure.

[0003] The skull clamp is manually adjusted against the patient's skull to apply sufficient force against the skull to stabilize the patient. If the skull clamp is not positioned sufficiently against the skull, slippage may occur and cause problems during the medical procedure. Furthermore, if the skull clamp is over-tightened against the skull, unintended fractures or other injuries may occur to the patient. Therefore, it is desirable to have a skull clamp system for supporting and stabilizing the head and / or neck of a patient during certain medical procedures that can detect and / or provide feedback on the completeness of stabilization to avoid possible problems during the medical procedure.

[0004] While various head stabilization devices and methods of use have been made and used, it is believed that no one prior to the inventors has made or used the invention as described herein. [Brief description of the drawings]

[0005] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [Figure 1] FIG. 1 is a schematic diagram of an exemplary head stabilization system. [Diagram 2] 2 is a partial front view of a first pin holder assembly of the skull clamp of the head stabilization system of FIG. 1. FIG. [Diagram 3] 3 is a partial cross-sectional view of the first pin holder assembly of FIG. 2. FIG. [Figure 4] 4 is a partial front view of a second pin holder assembly of the skull clamp of the head stabilization system of FIG. 1. FIG. [Diagram 5] 5 is a partial cross-sectional view of the second pin holder assembly of FIG. [Figure 6] FIG. 6 is a flow chart of an exemplary method of operating the exemplary head stabilization system as shown in FIG. [Figure 7] FIG. 7 is a schematic diagram of another exemplary head stabilization system. [Figure 8] FIG. 8 is a flow chart of an exemplary method of operating the exemplary head stabilization system as shown in FIG.

[0006] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in other various ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the specification, serve to explain the principles of the invention, with the understanding that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description of an illustrative example of one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention is capable of other different and obvious aspects without departing from the present invention. Thus, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0008] 1. Exemplary Head Stabilization System An exemplary head stabilization system includes a sensor assembly and a connection assembly connected to a head fixation device. The sensor assembly includes one or more sensors disposed on one or more components of the head fixation device and configured to detect one or more characteristics of the head fixation device. The connection assembly includes a data processing unit configured to receive and process data detected by the sensor assembly. For example, the data processing unit can determine whether data received from the sensor assembly reaches and / or exceeds a predetermined value or threshold, which can indicate an imminent risk of stabilization using the head fixation device. The connection system can then be configured to communicate feedback to a user and / or manufacturer based on the detected characteristics. The head fixation device can be adjusted based on the feedback to avoid possible problems during a medical procedure.

[0009] A. Exemplary Head Immobilization Device FIG. 1 illustrates an exemplary head stabilization system (10) with sensor capabilities that includes an exemplary head stabilization or fixation device (20). Throughout this specification, the term "HFD" is used interchangeably with the terms "head stabilization device," "head fixation device," or "skull clamp." In the illustrated version, the HFD (20) has the shape or form of a skull clamp. In this example, the HFD is illustrated as a U-shaped skull clamp, but the teachings herein may be applied to other forms of HFDs as would be understood by one of ordinary skill in the art in light of the teachings herein. The skull clamp (20) may be fabricated from a composite material, a polymeric material (e.g., polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), etc.), and / or a metallic material (e.g., aluminum, stainless steel, titanium, etc.). The skull clamp (20) consists of a first arm (22) and a second arm (24). The first arm (22) is connectable with the second arm (24) to form a skull clamp (20) having a U-shape. The first arm (22) has an upright portion (26) and a lateral portion (28). Similarly, the second arm (24) has an upright portion (20) and a lateral portion (22). The skull clamp (20) is adjustable to accommodate various head sizes by translating the first arm (22) relative to the second arm (24) or vice versa. The skull clamp (20) is further connectable to other structures, such as a positioning adapter or a base unit that can be further connected to a surgical table or the like, via a mounting interface (34). As shown in this embodiment in FIG. 1, the upright portion (26) of the first arm (22) connects to a first pin holder assembly (40) and the upright portion (30) of the second arm (24) connects to a second pin holder assembly (50).

[0010] 2-3, the first pin holder assembly (40) has a torque screw (42) configured to adjust the amount of clamping force that the skull clamp (20) applies to the patient's head. The torque screw (42) extends through a bore in the upright portion (26) of the arm (22) along the longitudinal axis (A). The torque screw (42) is comprised of a wheel (44), a sleeve (46), an internal spring (not shown), and an actuator in the form of an elongated member (48). The sleeve (46) engages with the bore (27) in the upright portion (26) of the arm (22). As the wheel (44) rotates, the clamping force applied by the torque screw (42) increases or decreases depending on the direction of rotation of the wheel (44). Given the teachings herein, other methods of modifying or using the torque screw (42), or another similar structure, to control the amount of clamping force applied will be apparent to one of ordinary skill in the art.

[0011] At its distal end, elongate member (48) selectively retains pin (60) including housing (62) and pin tip (64). In use, at least distal tip (66) of pin (60) contacts the patient's head. As wheel (44) is rotated in a first direction, a spring within torque screw (42) is compressed, thereby exerting an increased force on pin (60) in a direction toward the patient's head. The force exerted by pin (60) on said patient's head can be reduced by rotating wheel (44) in the opposite direction. Thus, as wheel (44) rotates, the clamping force exerted by torque screw (42) and / or pin (60) increases or decreases depending on the direction of rotation of wheel (44).

[0012] 4-5, a second pin holder assembly (50) couples to the upright portion (30) of the arm (24) as shown. The pin holder assembly (50) has a rocker arm (54) that selectively retains a pair of pins (60), each of which includes a housing (62) and a pin tip (64). The pin holder assembly (50) is rotatably adjustable about an axis B that extends through a bore in the upright portion (30). This rotation can be selectively controlled in some versions such that the rotatable position of the pin holder assembly (50) is locked in position and unlocked for adjustment. In other versions, the pin holder assembly (50) is rotatably adjustable about axis B and fixed in a rotated position based on the force applied to the patient's head when clamped. In view of the teachings herein, various methods of configuring the pin holder assembly (50) to provide locked and unlocked states for rotational adjustment will be apparent to those skilled in the art. The pin holder assembly (50) is also configured such that the rocker arm (54) is pivotally adjustable about an axis C defined longitudinally by the pin (58). Regardless of the pivotal or pivotal adjustment, a force applied to the patient's head via the torque screw (42) of the pin holder assembly (50) as described above will also result in a force being applied to the patient's head from the pin holder assembly (50) and its pin (60) configured to contact the patient's head. The configuration described above for the skull clamp (20) allows for stabilization of the patient's head.

[0013] B. Exemplary Sensor Assembly 1, the head stabilization system (10) has a sensor assembly including one or more sensors (102, 104) disposed on one or more components of the skull clamp (20), such as one or more first pin holder assembly sensors (102) disposed on the first pin holder assembly (40) and / or one or more second pin holder assembly sensors (104) disposed on the second pin holder assembly (50). The sensors (102, 104) can be configured to detect one or more characteristics (e.g., position, displacement, orientation, load, force, etc.) of one or more components of the skull clamp (20). For example, the sensors (102, 104) can include position sensors (e.g., Linear Variable Differential Transducers (LVDTs), piezoelectric transducers, linear encoders, rotary encoders, optical sensors, etc.) for detecting the absolute position or location of one or more components of the skull clamp (20) and / or the relative position or displacement of one or more components of the skull clamp (20) relative to one another and / or the patient in terms of linear movement, rotational angle, and / or three-dimensional space. The sensors (102, 104) can include force sensors (e.g., strain gauges, piezoresistive strain gauges, capacitive sensors, optical sensors, etc.) for detecting forces and / or loads on one or more components of the skull clamp (20). Further suitable configurations for the sensors (102, 104) are described in further detail below.

[0014] 2-3, the first pin holder assembly sensor (102) includes a first sensor (102a) disposed on the wheel (44), a second sensor (102b) disposed on the elongated member (48), and / or a third sensor (102c) disposed on the pin tip (64). The sensors (102a, 102b, 102c) may thereby be configured to detect the linear position and / or rotational orientation of the wheel (44), the elongated member (48), and / or the pin tip (64), respectively. For example, the sensors (102a, 102b, 102c) may determine the displacement of the wheel (44), the elongated member (48), and / or the pin tip (64) relative to one another, relative to an adjustment path traveled by the components, such as along the axis (A), and / or relative to the patient.

[0015] In some versions, the sensors (102a, 102b, 102c) detect the force or load exerted on the respective components of the first pin holder assembly (40). For example, the sensor (102c) can detect the linear force of the pin (60) along the longitudinal axis (A), such that a low pin force indicates slippage or potential slippage of the pin (60) and / or a high pin force indicates overtightening of the pin holder assembly (40). In some versions, the pin force can indicate the bone penetration depth of the pin (60) within the patient's skull.

[0016] The first pin holder assembly sensor (102) may also include a fourth sensor (102d) disposed between the torque screw (42) and the bore of the upright portion (26), and / or a fifth sensor (102e) disposed between the pin (60) and the elongated member (48). The sensors (102d, 102e) are configured to detect a shear force of the torque screw (42) and / or the pin (60) transverse to the longitudinal axis (A), which shear force also indicates slippage or potential slippage of the pin (60). In some other versions, the pin force may provide an indication of the contact angle of the pin (60) with respect to the patient's skull, such that low and / or high contact angles may indicate slippage or potential slippage of the pin (60). In this example, the optimal contact angle would be with the longitudinal axis of the pin (60) perpendicular to the tangent to the patient's skull. Sub-optimal low and / or high contact angles are those that deviate from the 90 degree or perpendicular orientation by, for example, an amount that exceeds a threshold value.

[0017] The first pin holder assembly sensor (102) may also include a sixth sensor (102f) disposed between the elongated member (48) and the housing (62) of the pin (60). The sensor (102f) is configured as a ring sensor that detects a linear or axial clamping force applied to the patient along the longitudinal axis (A). Based on data correlating bone penetration with clamping force, the data provided by the sensor (102f) provides an indication of pin penetration within the patient's skull. Based on the information collected by the first pin holder assembly sensor (102), the operator and / or manufacturer gains insight into what is happening at the interface between the pin (60) and the patient's bone. Various methods of collecting, analyzing, displaying, and using this information are described in more detail below.

[0018] 4-5, the second pin holder assembly sensor (104) includes a first sensor (104a) disposed on each pin tip (64). The sensors (104a) can thereby be configured to detect the linear position and / or angular orientation of the pin tips (64). For example, the sensors (104a) can determine the relative displacement of the pin tips (64) relative to one another, relative to an adjustment path along which the parts move, such as along or about axes (B, C), and / or relative to the patient. For example, the sensors (104a) can provide information and data for determining the relative position of the first pin holder assembly (40) with respect to the pin tips (64).

[0019] In some versions, the sensor (104a) can detect a force or load exerted on each component of the second pin holder assembly (50). For example, the sensor (104a) can detect a linear force on the pin (60) of the second pin holder assembly (50) along the longitudinal axis (B), or a longitudinal axis defined by the pin (60) itself, where a low pin force can indicate slippage or potential slippage of the pin (60) based on insufficient bone penetration, and / or a high pin force can indicate potential over-penetration of the pin (60) that may cause tissue or bone trauma. The second pin holder assembly sensor (104) may also include a third sensor (104b) disposed between the housing (62) of the pin (60) and the bore or receptacle of the rocker arm (54) that receives the pin (60) and detects a shear force on the pin (60) transverse to the longitudinal axis (B) or the longitudinal axis defined by the pin (60) itself, which may also indicate slippage or potential slippage of the pin (60). In some other versions, the pin force may be indicative of a contact angle of the pin (60) with respect to the patient's skull, where low and / or high contact angles may indicate slippage or potential slippage of one or both pins (60).

[0020] The second pin holder assembly sensor (104) may also include a third sensor (104c) disposed between the bore of the rocker arm (54) receiving the pin (60) and the housing (62) of the pin (60) such that the sensor (104c) is contactingly adjacent to the housing (62). The sensor (104c) is configured as a ring-shaped sensor that detects a linear or axial clamping force applied to the patient along the longitudinal axis defined by each pin (60) of the second pin holder assembly (50). Based on the correlation data between bone penetration and clamping force, the data provided by the sensor (104c) provides an indication of the penetration of the pin within the patient's skull. Based on the information collected by the second pin holder assembly sensor (104), the operator and / or manufacturer gains insight into what is happening at the interface between the pin (60) and the patient's bone. Various methods of collecting, analyzing, displaying and using this information are described in more detail below. Other suitable configurations for the sensors (102, 104) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0021] C. Exemplary Connection Assembly Returning to FIG. 1 , the head stabilization system (10) has a connection assembly having a data processing unit (112) connected with the sensors (102, 104) such that data collected by the sensors (102, 104) can be transmitted to the data processing unit (112) for processing. The data processing unit (112) is further configured to connect with a power source (110) to provide power to the data processing unit (112) and / or the sensors (102, 104). The power source (110) can be hardwired to a wall outlet or power source and / or the power source (110) can include a battery (e.g., disposable, rechargeable, etc.). In some versions, the data processing unit (112) is configured to provide power to the sensors (102, 104) such that a separate power source (110) can be omitted. In some other versions, the sensors (102, 104) may be powered separately from the data processing unit (112) and / or the power source (110) and may instead be powered by separate batteries associated with the sensors (102, 104). Other methods of powering the sensors (102, 104) and data processing unit (112) will be apparent to those of skill in the art given the teachings herein.

[0022] The data processing unit (112) may be configured as a computing device including a processor, a memory or storage including an operating system and other computer-readable instructions, and one or more communication facilities. For example, the processor may be operable to read and execute computer-readable instructions that may be stored locally on the data processing unit (112) or may be remote from the data processing unit (112) but accessible via one or more communication facilities. Exemplary computer-readable instructions executable by the processor are described further below with respect to the description of the use of the system (10) and may include one or more commands related to how the system (10) is operated and how the resulting data from the sensors (102, 104) is captured and processed.

[0023] In at least some embodiments, the memory is configured to store one or more applications, particularly those representing relevant computer-readable instructions for execution by the processor. One or more of the communication capabilities of the data processing unit (112) are configured to transmit and receive data or other computer-readable and executable information. The communication capabilities may include wired network capabilities or wireless network capabilities. The wireless network capabilities may include a Wi-Fi adapter, Near Field Communication (NFC) capabilities, and Bluetooth capabilities. The components described above for the data processing unit (112) are not exhaustive, and other features that may be incorporated into the data processing unit (112) will be apparent to those of skill in the art in view of the teachings herein.

[0024] Thus, the data processing unit (112) is configured to process the data received by the sensors (102, 104). For example, the data processing unit (112) can determine whether the data received by the sensors (102, 104) is less than, equal to, and / or greater than a predetermined value (e.g., position, displacement, orientation, load, force, etc.). If the data received by the sensors (102, 104) is less than, equal to, and / or less than the predetermined value, the data processing unit (112) can be configured to determine whether this indicates that the stabilization of the patient in the skull clamp (20) is not stable, that the skull clamp (20) has been overtightened, and / or that a failure of a component or setup of the skull clamp (20) has occurred. Such information can be provided to a user and / or to a manufacturer of the system (10).

[0025] In the illustrated version, the data processing unit (112) is connected to the data-contacting surface (114) such that data analyzed by the data processing unit (112) can be transmitted to the data interface (114) for display and / or further processing. The data-contacting surface (114) can be connected to the data processing unit (112) by wired and / or wireless network capabilities. The data-contacting surface (114) can include a display configured to visually present information to a user. The data-contacting surface (114) can be further configured to provide a visual and / or audio alarm when the data processing unit (112) determines that the data received by the sensors (102, 104) is less than, equal to, and / or greater than a predetermined value. The data-contacting surface (114) can be operative to provide feedback based on the sensors (102, 104) in real time and / or from data stored in the data processing unit (112). In some versions, the data processing unit (112) includes a display configured to present information such that a separate data contact surface (114) can be omitted.

[0026] In some other versions, the head fixation device (20) includes one or more displays or indicators configured and operable to indicate to an operator the status of one or more detected characteristics of the head fixation device (20). By way of example and not limitation, the head fixation device (20) in some versions includes an indicator (70) that may have one or more forms, such as optical, audible, etc., to communicate the status of one or more characteristics of the head fixation device (20) detected by the sensors (102, 104). For example, the indicator (70) may be illuminated as a green LED when one or more characteristics, such as the clamping force, are within an acceptable deviation from a predetermined target. However, the indicator (70) may be presented as a flashing red LED when the same one or more characteristics are outside the acceptable deviation from the predetermined target. Other methods of communicating the status of one or more detected characteristics of the head fixation device (20) will be apparent to those skilled in the art in light of the teachings herein.

[0027] In the illustrated version, the data-contact surface (114) is further configured to connect the data processing unit (112) with other devices, such as a navigation system (116) and / or an augmented reality system (118). The data-contact surface (114) is thereby configured to transmit data received from the data processing unit (112) to the navigation system (116) and / or the augmented reality system (118). Similarly, data from the navigation system (116) and / or the augmented reality system (118) can be transmitted to the data-contact surface (114) and / or the data processing unit (112) such that data from the sensors (102, 104) can be combined with data from the navigation system (116) and / or the augmented reality system (118).

[0028] The data-contact surface (114) can be connected to a navigation system (116) and / or an augmented reality system (118) by wired and / or wireless network capabilities. The navigation system (116) can be configured to display a visual map or diagram of a patient's head for a medical procedure. Thus, the navigation system (116) can include data received by the navigation system (116) from the data-contact surface (114) to display one or more components of the skull clamp (20) relative to the map or diagram of the patient's head for a medical procedure. The augmented reality system (118) can be configured to display a visual image of the patient's skull. Thus, the augmented reality system (118) can include data received by the augmented reality system (118) from the data-contact surface (114) to display one or more components of the skull clamp (20) relative to the image. The navigation system (116) and / or the augmented reality system (118) can thereby show the relative relationship of the pins (60) of the skull clamp (20) to the patient's skull. In some versions, the navigation system (116) and / or the augmented reality system (118) can be omitted or combined.

[0029] D. Exemplary Uses 6 illustrates an exemplary method (200) for operating a head stabilization system (10). The method (200) includes detecting one or more characteristics of one or more components of a skull clamp (20) (step (202)), analyzing the one or more detected characteristics (step (204)), displaying the one or more detected characteristics (step (206)), and / or providing an alarm based on the one or more detected characteristics (step (208)). For example, the sensors (102, 104) can detect one or more characteristics (e.g., position, displacement, orientation, load, force, etc.) of a pin holder assembly (40, 50) of the skull clamp (20). The data processing unit (112) can then receive data measured or detected by the sensors (102, 104) such that the data processing unit (112) can analyze the one or more characteristics detected by the sensors (102, 104). For example, the data processing unit (112) can process the data received by the sensors (102, 104) and compare the detected characteristic to a predetermined value to determine whether the detected characteristic is above, equal to, and / or below the predetermined value. Based on the comparison of the detected characteristic to the predetermined value, the data processing unit (112) can provide a visual and / or audio alarm to indicate whether the detected characteristic deviates from and / or exceeds the predetermined value. The data processing unit (112) can further display the detected characteristic via the data processing unit, the data interface (114), the navigation system (116), and / or the augmented reality system (118). A user can then adjust the pin holder assembly (40, 50) of the skull clamp (20) based on the feedback provided by the head stabilization system (10).

[0030] By way of example only, the sensors (102, 104) can measure the force or load exerted on the pin (60) during a medical procedure. The data processing unit (112) can then receive and process the data measured by the sensors (102, 104) to determine how the force detected by the sensors (102, 104) compares to a predetermined value. For example, a force above the predetermined value can indicate that the pin (60) has been overtightened. In some versions, a force below the predetermined value can indicate that the pin (60) has slipped or has reduced penetration with the bone. Thus, the data processing unit (112) can provide an alarm indicating that the force on the pin (60) is outside of a desired range based on a comparison of the detected force to the predetermined value. Based on the feedback of the head stabilization system (10), the user can adjust the position of the pin holder assembly (40, 50) of the skull clamp (20) to increase or decrease the force on the pins (60) depending on a comparison of the detected value to the predetermined value, threshold, and / or target value. The data processing unit (112) can further display the detected force via the data processing unit, the data interface (114), the navigation system (116), and / or the augmented reality system (118). Thus, the user can also adjust the pin holder assembly (40, 50) of the skull clamp (20) based on the display of the head stabilization system (10) in these other components or systems. Still other suitable methods for operating the head stabilization system (10) will be apparent to those of skill in the art in light of the teachings herein.

[0031] 2. Alternative Embodiments of Head Stabilization System An exemplary head stabilization system includes a sensor assembly and a connection assembly connected to a head fixation device. The sensor assembly includes one or more sensors disposed on one or more components of the head fixation device and is configured to detect one or more characteristics of the head fixation device. The connection assembly includes a data processing unit configured to receive and process data detected by the sensor assembly. For example, the data processing unit can determine whether data received from the sensor assembly reaches and / or exceeds a predetermined value or threshold, which can indicate a situation or condition that may require corrective action or intervention. The connection system can then be configured to communicate feedback to a user and / or manufacturer based on the detected characteristics. The head fixation device can be adjusted based on the feedback to avoid potential problems during a medical procedure.

[0032] A. Alternative Embodiments of Head Immobilization Device FIG. 7 shows an exemplary head stabilization system (10') for an exemplary head stabilization or fixation device (20'). Throughout this specification, the term "HFD" is used interchangeably with the terms "head stabilization device", "head fixation device", or "skull clamp". In the illustrated version, the HFD (20') has the shape or form of a skull clamp. In this example, the HFD is illustrated as a U-shaped skull clamp, but the teachings herein can be applied to other forms of HFDs as will be understood by those of skill in the art in light of the teachings herein. The skull clamp (20') can be made from a composite material, a polymeric material (e.g., polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), etc.), and / or a metallic material (e.g., aluminum, stainless steel, titanium, etc.). The skull clamp (20') has a first arm (22') and a second arm (24'). The first arm (22') is connectable with the second arm (24') to form a skull clamp (20') having a U-shape. The first arm (22') has an upright portion (26') and a lateral portion (28'). Similarly, the second arm (24') has an upright portion (20') and a lateral portion (22'). The skull clamp (20') is adjustable to accommodate various head sizes by translating the first arm (22') relative to the second arm (24') or vice versa. The skull clamp (20') is further connectable with other structures, such as a base unit, which can be further connected with a positioning adapter, a surgical table, etc., via a mounting interface (34'). As shown in this embodiment in FIG. 7, the upright portion (26') of the first arm (22') connects to a first pin holder assembly (40') and the upright portion (30') of the second arm (24') connects to a second pin holder assembly (50').

[0033] The first pin holder assembly (40') has a torque screw (42') configured to adjust the amount of clamping force that the skull clamp (20') applies to the patient's head. The torque screw (42') extends through a bore in the upright portion (26') of the arm (22'). The torque screw (42') has an actuator in the form of a wheel (44'). As the wheel (44') rotates, the clamping force applied by the torque screw (42') increases or decreases depending on the direction of rotation of the wheel (44'). In light of the teachings herein, other methods of modifying or using the torque screw (44'), or another similar structure, to control the amount of clamping force applied will be apparent to one of ordinary skill in the art.

[0034] At its distal end, torque screw (42') selectively retains pin (60') including housing (62') and pin tip (64'). In use, at least the distal tip of pin (60') contacts the patient's head. As wheel (44') is rotated in a first direction, a spring within torque screw (42') is compressed, thereby exerting an increased force on pin (60') in a direction toward the patient's head. The force exerted by pin (60') on the patient's head can be reduced by rotating wheel (44') in the opposite direction. Thus, as wheel (44') rotates, the clamping force exerted by torque screw (42') and / or pin (60') increases or decreases depending on the direction of rotation of wheel (44').

[0035] The second pin holder assembly (50') connects with the upright portion (30') of the arm (24') as shown. The second pin holder assembly (50') has a rocker arm (54') that selectively holds a pair of pins (60'), each including a housing (62') and a pin tip (64'). The pin holder assembly (50') is rotatably adjustable about its longitudinal axis that extends through a bore in the upright portion (30'). This rotation can be selectively controlled in some versions such that the rotatable position of the pin holder assembly (50') is locked in place or unlocked for adjustment. In other versions, the pin holder assembly (50') is rotatably adjustable about its longitudinal axis and fixed in its rotated position based on the force applied to the patient's head when clamped. In view of the teachings herein, various methods of configuring the pin holder assembly (50') to provide locked and unlocked states for rotational adjustment will be apparent to those skilled in the art.

[0036] The second pin holder assembly (50') is also configured such that the rocker arm (54') is pivotally adjustable. Regardless of the pivotal or pivotal adjustment, a force applied to the patient's head via the torque screw (42') of the first pin holder assembly (40') as described above will also cause a force to be applied to the patient's head from the second pin holder assembly (50') and its pins (60') configured to contact the patient's head. The configuration described above for the skull clamp (20') allows for stabilization of the patient's head.

[0037] B. Alternative Embodiments of the Sensor Assembly 7, the head stabilization system (10') has a sensor assembly including one or more sensors disposed on one or more components of the skull clamp (20'), such as one or more frame sensors (100') disposed on one or more of the arms (22', 24') and / or one or more second pin holder assembly sensors (104') disposed on the second pin holder assembly (50'). In some versions, one or more sensors may be provided on the first pin holder assembly (40') instead of or in addition to the sensors discussed above.

[0038] The sensors (100', 104') can be configured to detect one or more characteristics (e.g., position, displacement, orientation, vibration, exposure, temperature, etc.) of one or more components of the skull clamp (20'). For example, the sensors (100', 104') can include position sensors (e.g., Linear Variable Differential Transducers (LVDTs), piezoelectric transducers, linear encoders, rotary encoders, optical sensors, etc.) for detecting the absolute position or location of one or more components of the skull clamp (20') and / or the relative position or translation of one or more components of the skull clamp (20') to each other and / or to the patient in terms of linear movement, rotational angle, and / or three-dimensional space. The sensors (100', 104') can include vibration sensors or shock sensors for detecting impacts to one or more components of the skull clamp (20'). The sensors (100', 104') may include temperature sensors (e.g., thermocouples, resistance temperature detectors (RTDs), thermistors, etc.) for detecting temperature at one or more components of the skull clamp (20'). The sensors (100', 104') may include exposure sensors for detecting the presence of one or more substances proximate one or more components of the skull clamp (20'). Further suitable configurations for the sensors (100', 104') are described in further detail below.

[0039] In the illustrated version, the frame sensor (100') includes a first sensor (100a') disposed on a lateral portion (28') of the first arm (22'), a second sensor (100b') disposed on an upright portion (26') of the first arm (22'), a third sensor (100c') disposed on a lateral portion (32') of the second arm (24'), and / or a fourth sensor (100d') disposed on an upright portion (30') of the second arm (24'). The frame sensor (100') may thereby be configured to detect a position or adjustment of the first arm (22') with respect to the second arm (24') when the first arm (22') is translated relative to the second arm (24') or vice versa. The frame sensor (100') may be further configured to detect a rotational orientation of the first arm (22') and / or the second arm (24'), such as relative to an adapter or a surgical table. In some other versions, the frame sensor (100') is configured to detect a position of the first arm (22') and / or the second arm (24') relative to a patient's head that is stabilized within the skull clamp (20').

[0040] The second pin holder assembly sensor (104') includes a sensor (104a') disposed on the rocker arm (54') as shown. The sensor (104a') may be configured to thereby detect the linear position and / or rotational orientation of the rocker arm (54'). For example, the sensor (104a') may determine the translation of the rocker arm (54') relative to the adjustment path along which the components travel and / or relative to the patient. Still other suitable configurations for the sensors (100', 104') will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0041] C. Alternative Embodiments of Connection Assembly Still referring to FIG. 7 , the head stabilization system (10′) has a connection assembly having a data processing unit (112′) connected with the sensors (100′, 104′) such that data collected by the sensors (100′, 104′) can be transmitted to the data processing unit (112′) for processing. The data processing unit (112′) is further configured to connect with a power source (110′) to provide power to the data processing unit (112′) and / or the sensors (100′, 104′). The power source (110′) can be hardwired to a wall outlet or power source and / or the power source (110′) can include a battery (e.g., disposable, rechargeable, etc.). In some versions, the data processing unit (112′) is configured to provide power to the sensors (100′, 104′) such that a separate power source (110′) can be omitted. In some other versions, the sensors (100', 104') may be powered separately from the data processing unit (112') and / or the power source (110') and may instead be powered by a separate battery associated with the sensors (100', 104'). Other methods of powering the sensors (100', 104') and data processing unit (112') will be apparent to those of skill in the art given the teachings herein.

[0042] The data processing unit (112') may be configured as a computing device having a processor, a memory or storage including an operating system and other computer-readable instructions, and one or more communication capabilities. For example, the processor may be operable to read and execute computer-readable instructions stored locally on the data processing unit (112') or accessible remotely from the data processing unit (112') via one or more communication capabilities. Exemplary computer-readable instructions executable by the processor are described further below with respect to the description of the use of the system (10') and may include one or more commands related to how the system (10') is operated and how resultant data from the sensors (100', 104') is captured and processed.

[0043] In at least some embodiments, the memory is configured to store one or more applications, particularly those representing relevant computer-readable instructions for execution by the processor. One or more of the communication functions of the data processing unit (112') are configured to transmit and receive data or other computer-readable and executable information. The communication functions may include wired network functions or wireless network functions. The wireless network functions may include a Wi-Fi adapter, a Near Field Communication (NFC) function, and a Bluetooth (Bluetooth) function. The components described above for the data processing unit (112') are not exhaustive, and other functions that may be incorporated into the data processing unit (112') will be apparent to those of skill in the art in view of the teachings herein.

[0044] Thus, the data processing unit (112') is configured to process the data received by the sensors (100', 104'). For example, the data processing unit (112') can determine whether the data received by the sensors (100', 104') is less than, equal to, and / or greater than a predetermined value (e.g., position, displacement, orientation, vibration, exposure, temperature, etc.). If the data received by the sensors (100', 104') is greater than, equal to, and / or less than a predetermined value, the data processing unit (112') can be configured to determine whether this indicates an undesirable condition or status of one or more components of the skull clamp (20') that requires corrective action or intervention. Such information can be provided to a user and / or a manufacturer of the system (10').

[0045] In the illustrated version, the data processing unit (112') is connected to the data-contacting surface (114') such that data analyzed by the data processing unit (112') can be transmitted to the data interface (114') for display and / or further processing. The data-contacting surface (114') can be connected to the data processing unit (112') by wired and / or wireless network capabilities. The data-contacting surface (114') can include a display configured to visually present information to a user. The data interface (114') can be further configured to provide a visual and / or audio alarm when the data processing unit (112') determines that the data received by the sensor (100', 104') is less than, equal to, and / or greater than a predetermined value. The data interface (114') can operate to provide feedback based on the sensor (100', 104') in real time and / or from data stored in the data processing unit (112'). In some versions, the data processing unit (112') includes a display configured to present information, such that a separate data interface (114') can be omitted.

[0046] In some other versions, the head fixation device (20') includes one or more displays or indicators configured and operable to indicate to an operator the status of the one or more detected characteristics of the head fixation device (20'). By way of example only and not limitation, the head fixation device (20') in some versions includes an indicator (70') that may have one or more forms, such as optical, audible, etc., to communicate the status of the one or more characteristics of the head fixation device (20') detected by the sensors (100', 104'). For example, the indicator (70') may be illuminated as a green LED when the one or more characteristics, e.g., vibration, are within an acceptable deviation from a predetermined target. However, the indicator (70') may be presented as a flashing red LED when the same one or more characteristics are outside the acceptable deviation from the predetermined target. Other methods of communicating the status of the one or more detected characteristics of the head fixation device (20') will be apparent to one of ordinary skill in the art in light of the teachings herein.

[0047] In the illustrated version, the data interface (114') is further configured to connect the data processing unit (112') to other devices, such as a navigation system (116') and an augmented reality system (118'). Thereby, the data interface (114') is configured to transmit data received from the data processing unit (112') to the navigation system (116') and / or the augmented reality system (118'). The data interface (114') can be connected to the navigation system (116') and / or the augmented reality system (118') by wired and / or wireless network capabilities. The navigation system (116') can be configured to display a visual map or diagram of the patient's brain for the medical procedure. Thus, the navigation system (116') can include data received by the navigation system (116') from the data interface (114') to display one or more components of the skull clamp (20') relative to a map or diagram of the patient's brain for the medical procedure. The augmented reality system (118') can be configured to display a visual image of the patient's skull. The augmented reality system (118') can then display one or more components of the skull clamp (20') against the image, including data received by the augmented reality system (118') from the data interface (114'). The navigation system (116') and / or the augmented reality system (118') can thereby indicate the relative relationship of the pins (60') or other components of the skull clamp (20') to the patient's skull and / or the surrounding environment. In some versions, the navigation system (116') and / or the augmented reality system (118') can be omitted.

[0048] D. Alternative Examples of Methods of Use 8 illustrates an exemplary method (200') for operating the head stabilization system (10'). The method (200') includes detecting one or more characteristics of one or more components of the skull clamp (20') (step (201')), analyzing the one or more detected characteristics (step (204')), displaying the one or more detected characteristics (step (206')), and / or providing an alarm based on the one or more detected characteristics (step (208')). For example, the sensors (100', 104') can detect one or more characteristics of the arms (22', 24') and / or the pin holder assembly (50') of the skull clamp (20'), as described above. The data processing unit (112') can then receive the data measured or detected by the sensors (100', 104') such that the data processing unit (112') can analyze the one or more characteristics detected by the sensors (100', 104'). For example, the data processing unit (112') can process the data received by the sensors (100', 104') and compare the detected characteristics to a predefined value to determine whether the detected characteristics are above, equal to, and / or below a predefined value. Based on the comparison of the detected characteristics to the predefined value, the data processing unit (112') can provide a visual and / or audio alarm indicating whether the detected characteristics deviate from and / or exceed the predefined value. The data processing unit (112') can further display the detected characteristics via the data processing unit, the data interface (114'), the navigation system (116') and / or the augmented reality system (118'). A user may then take corrective or intervening action based on the feedback provided by head stabilization system 10'. Certain exemplary detection features and methods are described in the following sections. Additionally, additional exemplary detection features and methods will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0049] E. Exemplary Reprocessing and / or Sterilization Detection In some versions, one or more components of the skull clamp (20') are exposed to higher temperatures to sterilize and / or reprocess the one or more components so that the one or more components can be reused in another medical procedure. For example, in some versions, reprocessing can expose the components to a temperature of about 90 degrees Celsius or greater for a predetermined period of time, and in some versions, sterilization can expose the components to a temperature of about 120 degrees Celsius or greater for a predetermined period of time. In some embodiments, it may be desirable to determine whether one or more components of the skull clamp (20') have been reprocessed and / or sterilized and / or how many times one or more components have been reprocessed and / or sterilized. Accordingly, the sensors (100', 104') may include temperature sensors for detecting temperatures at or near the sensors (100', 104'). Such temperature data detected by the sensors (100', 104') may be transmitted to the data processing unit (112'). The data processing unit (112') can process and analyze the sensor data by comparing the detected data to a predetermined temperature value to determine whether the one or more components of the skull clamp (20') have been exposed to a reprocessing and / or sterilization temperature. For example, if the detected data exceeds the predetermined temperature value, the data processing unit (112') can determine that the one or more components have been subjected to reprocessing and / or sterilization. The data processing unit (112') can also determine the number of times the detected data exceeds the predetermined temperature value to determine the number of times the one or more components have been reprocessed and / or sterilized. In some versions, the data processing unit (112') can provide an alarm indicating when one or more components of the skull clamp (20') have exceeded a desired amount of reprocessing and / or sterilization.Still other suitable configurations and / or methods for providing reprocessing and / or sterilization detection with head stabilization system (10') will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0050] F. Exemplary Steam Sterilization Detectors In some versions, one or more components of the skull clamp (20') can be exposed to steam to sterilize the one or more components so that the one or more components can be reused in another medical procedure. In some cases, it may be desirable to determine whether one or more components of the skull clamp (20') have been exposed to steam. Thus, the sensors (100', 104') can include sensors for detecting the presence of steam at or near the sensors (100', 104'). Such data detected by the sensors (100', 104') can be transmitted to a data processing unit (112'). The data processing unit (112') can process and analyze the sensor data to determine whether the one or more components of the skull clamp (20') have been exposed to steam. The data processing unit (112') can also determine the number of times the one or more components have been exposed to steam. In some versions, the data processing unit (112') can provide an alarm indicating when or how many times the one or more components of the skull clamp (20') have been exposed to steam. Still other suitable configurations and / or methods for providing steam sterilization detection by the head stabilization system (10') will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0051] G. Exemplary Reuse Detection In some versions, one or more components of the skull clamp (20') can be reused in another medical procedure. In some embodiments, it may be desirable to determine whether one or more components of the skull clamp (20') have been used previously, the duration of said previous use, and / or whether said one or more components need to be replaced. Accordingly, one or more components of the arms (22', 24'), the pin holder assemblies (40', 50') and / or the sensors (100', 104') can include a unique identifier (e.g., a radio frequency identification (RFID) chip). The data processing unit (112') can be configured to connect to and / or detect said identifier, such as by wireless network functionality (e.g., a Wi-Fi adapter, a near field communication (NFC) functionality, a Bluetooth functionality, etc.). The data processing unit (112') can thereby be configured to determine whether one or more components have been used previously, the duration of said previous use, and / or whether said one or more components need to be replaced based on detection of said identifier. For example, the data processing unit (112') can determine whether the time that the data processing unit (112') has been connected to the identifier exceeds a predetermined duration value for the one or more components. If the predetermined duration value has been exceeded, the data processing unit (112') can instruct the one or more components to be replaced or provide an alarm. In some versions, the data processing unit (112') can determine whether the one or more components have been replaced with a previously used component when the data processing unit (112') reconnects with an identifier to which it has previously been connected. If the data processing unit (112') reconnects with a previously used identifier, the data processing unit can indicate that the one or more components have not been replaced or provide an alarm.Still other suitable configurations and / or methods for providing reuse detection by head stabilization system (10') will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0052] H. Example of Impact Detection In some cases, it may be desirable to determine whether one or more components of the skull clamp (20') have been subjected to an impact or physical shock that may damage the one or more components, such as during shipping and / or handling of the one or more components. Accordingly, the sensors (100', 104') may include one or more shock sensors for detecting vibrations and / or physical shock of the one or more components. For example, the sensors (100', 104') may include an accelerometer that detects acceleration of a component, such as when the component is dropped, a harmonic oscillator that may be displaced from an equilibrium position during an impact, a fragile component with a known fragility that may break during an impact, and / or other suitable shock sensors configured to detect an impact or physical shock. The data processing unit (112') may be configured to connect to and / or detect such impact sensors to determine whether the one or more components have previously been subjected to an impact or physical shock. If the data processing unit (112') determines that an impact has occurred, the data processing unit may indicate that the one or more components have experienced an impact or provide an alarm. Still other suitable configurations and / or methods for providing impact detection by head stabilization system (10') will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0053] I. Example of sensor communication to external devices In some versions, the sensors (100', 102') are configured to communicate their location to an external device (120'), as shown in FIG. 7. Additionally, these sensors (100', 102') can also be configured to communicate the exact location of the head fixation device (20') as well as its location in space. In this way, the external device (120') is provided with the spatial location of the head fixation device (20') and can use this information as needed during the procedure to avoid complications and achieve the desired results.

[0054] By way of example only and not limitation, external device (120') represents a robotic surgical device that may or may not be assisted by a surgeon. In such an example, the sensors (100', 104') communicate their position information and data regarding the head fixation device (20') to the robotic surgical device. In some versions, this communication occurs via the data processing unit (112') and the data interface (114'). In other versions, this communication occurs directly between the sensors (100', 104') and the external device (120'), for example using a wireless communication modality. In still other versions, the sensors (100', 104') may instead or additionally be detectable by the external device (120') via a wireless communication modality such as Bluetooth, RFID, NFC, etc. By having the robotic surgical device in this embodiment have information and data regarding the location of head fixation device (20'), the robotic surgical device can effectively "see" head fixation device (20') and navigate around head fixation device (20') during the procedure being performed.

[0055] In yet another example, the external device (120') represents a scanner that collects pre-treatment, intra-treatment, or post-treatment image scans. In a similar manner as described above, the sensors (100', 104') communicate their spatial location and the spatial location of the head fixation device (20') to the scanner. Thus, when the scan is performed, the scanner has the necessary information to navigate around the head fixation device (20') to achieve the desired outcome of the scan obtained. In some examples where the sensors (100', 104') are detected by the external device (120'), the sensors (100', 104') may include optical features, RFID capabilities, NFC capabilities, etc., although other suitable sensor formats may be used as well and will be apparent to those of skill in the art in light of the teachings herein.

[0056] 3. Typical combination The following examples relate to various non-exhaustive methods in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of the claims that may be presented at any time in this application or any subsequent application of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. Also, variations that omit certain features mentioned in the following examples are contemplated. Thus, none of the aspects or features mentioned below should be considered critical unless later expressly indicated as such by the inventors or their successors in interest. If a claim is presented in this application or any subsequent application related to this application that includes additional features other than those mentioned below, those additional features shall not be presumed to have been added for any reason regarding patentability.

[0057] Example 1 An apparatus for stabilizing a patient having a head fixation device having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly, and one or more sensors disposed on the head fixation device, the one or more sensors configured to detect one or more characteristics of the head fixation device.

[0058] Example 2 The device of Example 1 further comprises a data processing unit connected to the one or more sensors such that the data processing unit is configured to receive data from the one or more sensors, and the data processing unit is configured to analyze the characteristics detected by the one or more sensors and provide feedback based on the detected characteristics.

[0059] Example 3 In one or more of the devices of any of Examples 1 or 2, the one or more characteristics of the head fixation device include one or more of a position, a displacement, an orientation, a load, and a force of the head fixation device.

[0060] Example 4 In any one or more of the devices of Examples 1 to 3, the first pin holder assembly has a torque screw assembly including an actuator and a pin configured to contact a head, and the actuator is configured to adjust the pin relative to the head.

[0061] Example 5 In the apparatus of Example 4, at least one sensor is disposed on the actuator and configured to detect one or more of a position, a displacement, and an angle of the actuator.

[0062] Example 6 The device of any one or more of Examples 4 to 5, wherein at least one of the sensors is disposed adjacent to the pin in a contact configuration.

[0063] Example 7 The device of any one or more of Examples 4 to 6 is configured to detect one or more of a position, a displacement, an angle, and a force of the pin.

[0064] Example 8 The apparatus of any one or more of Examples 1-7, wherein the second pin assembly comprises a rocker arm and a pin coupled to the rocker arm.

[0065] Example 9 The apparatus of Example 8 includes at least one sensor disposed on the pin of the second pin assembly, the sensor configured to detect one or more of a position, a displacement, an angular orientation, and a force of the pin.

[0066] Example 10 Any one or more of the devices of Examples 2 to 9 further comprises a power source connected to the one or more sensors and the data processing unit, the power source being configured to supply power to the one or more sensors and the data processing unit.

[0067] Example 11 The device of any one or more of Examples 2 to 10, wherein the data processing unit is configured to determine whether the fixation by the head fixation device is stable.

[0068] Example 12 The device of any one or more of Examples 2 to 11 is configured such that the data processing unit compares the characteristic detected by the one or more sensors with a predetermined value to determine whether the fixation provided by the head fixation device is stable.

[0069] Example 13 The device of any one or more of Examples 2 to 12, wherein the data processing unit is configured to provide an alarm when the fixation by the head fixation device is not stable.

[0070] Example 14 The device of any one or more of Examples 2 to 13 further comprises a data interface connected to the data processing unit such that the characteristics analyzed by the data processing unit can be transmitted to the data interface.

[0071] Example 15 In the apparatus of Example 14, the data interface comprises a display for displaying the characteristics analyzed by the data processing unit.

[0072] Example 16 The apparatus of any one or more of Examples 14 to 15, wherein the data interface is configured to connect the data processing unit with a remote device.

[0073] Example 17 The device of any one or more of Examples 14 to 16, wherein the data interface is configured to connect the data processing unit to a navigation system configured to display a schematic diagram of the analyzed characteristics on the patient's head.

[0074] Example 18 The device of any one or more of Examples 14 to 17, wherein the data interface is configured to connect the data processing unit to an augmented reality system configured to display an image of the analyzed characteristics on the patient's head.

[0075] Example 19 The device of Example 1 further includes a connection assembly connected to the sensor assembly, the connection assembly having a data processing unit configured to receive data from the one or more sensors, and the connection assembly configured to analyze the characteristic detected by the one or more sensors and provide feedback of the detected characteristic.

[0076] Example 20 A method of operating a head stabilization system having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly, one or more sensors disposed on the head fixation device, and a data processing unit connected to the one or more sensors such that the data processing unit receives data from the one or more sensors, comprises the steps of detecting one or more characteristics of the head fixation device and analyzing the one or more detected characteristics.

[0077] Example 21 The method of Example 20 further comprises displaying the one or more detected characteristics.

[0078] Example 22 The method of any one or more of Examples 20 to 21 further comprises providing an alarm based on the one or more detected characteristics.

[0079] Example 23 The method of any one or more of Examples 20 to 22, wherein the one or more characteristics include one or more of a position, a displacement, an orientation, a load, and a force of the head fixation device.

[0080] Example 24 The method of any one or more of Examples 20 to 23 may further comprise adjusting the head immobilization device based on the one or more detected characteristics.

[0081] Example 25 An apparatus for stabilizing a patient includes a head fixation device having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly, and one or more sensors disposed on the head fixation device, the one or more sensors configured to detect one or more characteristics of the head fixation device.

[0082] Example 26 The device of Example 25 further comprises a data processing unit connected to the one or more sensors and configured to receive data from the one or more sensors, the data processing unit configured to analyze the characteristics detected by the one or more sensors and provide feedback based on the detected characteristics.

[0083] Example 27 Any one or more of the devices of Examples 25 to 26 may include a first sensor of the one or more sensors disposed in a selected one of the first arm and the second arm of the head fixation device, and the first sensor configured to detect a position of the selected one of the first arm and the second arm.

[0084] Example 28 In the device of Example 27, a second sensor of the one or more sensors is positioned on the other of a selected one of the first arm and the second arm of the head fixation device such that the second sensor detects the position of the other of the selected one of the first arm and the second arm, the first arm is translatable relative to the second arm, and the first sensor and the second sensor are configured to detect the relative position of the first arm with respect to the second arm.

[0085] Example 29 In any one or more of the devices of Examples 25 to 28, the one or more characteristics of the head fixation device include one or more of the position, displacement, orientation, vibration, exposure, and temperature of the head fixation device.

[0086] Example 30 The device of any one or more of Examples 25-29, wherein the second pin assembly comprises a rocker arm and a pin coupled to the rocker arm.

[0087] Example 31 In Example 30, the apparatus includes at least one sensor disposed on the rocker arm and configured to detect one or more of a position, a displacement, and an angular orientation of the rocker arm.

[0088] Example 32 Any one or more of the devices of Examples 26 to 31 further comprises a power source connected to the one or more sensors and the data processing unit, the power source configured to supply power to the one or more sensors and the data processing unit.

[0089] Example 33 The device of any one or more of Examples 26 to 32 further comprises a data interface connected to the data processing unit such that the characteristics analyzed by the data processing unit can be transmitted to the data interface.

[0090] Example 34 In an embodiment, the data interface has a display for displaying the characteristics analyzed by the data processing unit.

[0091] Example 35 Any one or more of the devices of Examples 33 to 34 are configured such that the data interface is configured to connect the data processing unit to selected one or more of a navigation system, an augmented reality system, and / or an external device.

[0092] Example 36 In any one or more of Examples 25 to 35, the one or more sensors include a temperature sensor configured to detect when the head fixation device is exposed to a reprocessing temperature.

[0093] Example 37 The device of any one or more of Examples 25 to 36, wherein the data processing unit is configured to determine a number of times the head fixation device has been reprocessed.

[0094] Example 38 In a thirty-seventh embodiment, the apparatus is configured such that the data processing unit provides an alarm if the number of times the head fixation device has been reprocessed exceeds a predetermined value.

[0095] Example 39 The device of any one or more of Examples 25 to 38, wherein the one or more sensors are configured to detect when the head fixation device has been exposed to a sterilization temperature.

[0096] Example 40 In Example 39, the apparatus is configured such that the data processing unit determines the number of times the head fixation device has been exposed to a sterilization temperature.

[0097] Example 41 In Example 40, the apparatus is configured such that the data processing unit provides an alarm if the number of times the head fixation device has been exposed to a sterilization temperature exceeds a predetermined value.

[0098] Example 42 The device of any one or more of Examples 26 to 41, wherein the head fixation device includes a unique identifier and the data processing device is configured to detect the unique identifier.

[0099] Example 43 In Example 42, the device is configured such that the data processing unit determines, based on the unique identifier, when one or more components of the head fixation device need to be replaced.

[0100] Example 44 Any one or more of the devices of Examples 42 to 43 are configured such that the data processing unit determines whether the one or more components of the head fixation device have been replaced based on the unique identifier.

[0101] Example 45 The device of any one or more of Examples 26 to 44 is configured to provide an alarm when the data processing unit needs to replace one or more components of the head fixation device.

[0102] Example 46 In any one or more of Examples 25 to 45, the one or more sensors include an impact sensor configured to detect when the head fixation device is subjected to a physical impact.

[0103] Example 47 In Example 46, the device is configured such that the data processing unit determines whether the head immobilization device has been subjected to a physical impact based on the data received by the impact sensor.

[0104] Example 48 The device of any one or more of Examples 46 to 47, wherein the data processing unit is configured to provide an alarm if the head fixation device is subjected to a physical impact.

[0105] Example 49 An apparatus for stabilizing a patient includes a head fixation device having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly, and a sensor assembly including one or more sensors disposed on the head fixation device, the one or more sensors configured to communicate position information to an external device, the position information including position information related to a spatial position of the head fixation device relative to the external device.

[0106] Example 50 1. A method of using a head stabilization system having a head fixation device having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly, one or more sensors disposed on the head fixation device, and a data processing unit connected to the one or more sensors such that the data processing unit is configured to receive data from the one or more sensors, the method comprising: detecting one or more characteristics of the head fixation device; and analyzing the one or more detected characteristics.

[0107] Example 51 The method of Example 50 includes displaying the one or more detected characteristics.

[0108] Example 52 The method of any one or more of Examples 50 to 51 further comprises providing an alarm based on the one or more detected characteristics.

[0109] Example 53 The method of any one or more of Examples 50 to 52, wherein the one or more characteristics include one or more of the position, displacement, orientation, vibration, exposure, and temperature of the head fixation device.

[0110] Example 54 The method of any one or more of Examples 50 to 53 may further comprise modifying the head fixation device based on the one or more detected characteristics.

[0111] others It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the teachings, expressions, embodiments, examples, etc. described above should not be viewed in isolation and relative to one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those of skill in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0112] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some of such potential modifications have been mentioned, but others will be apparent to those skilled in the art. For example, the above-mentioned examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. are illustrative and not required. Thus, the scope of the present invention should be considered in terms of the following claims and is not limited to the details of structure and operation shown and described in the specification and drawings.

Claims

1. An apparatus for stabilizing a patient, comprising: (a) a head fixation device having a first arm coupled to a first pin holder assembly and a second arm coupled to a second pin holder assembly; (b) one or more sensors disposed on the head fixation device, the one or more sensors being configured to detect one or more characteristics of the head fixation device; An apparatus having the above components.

2. The apparatus according to claim 1, further comprising: A data processing unit connected to the one or more sensors and configured to receive data from the one or more sensors, the data processing unit being configured to analyze the characteristics detected by the one or more sensors and provide feedback based on the detected characteristics.

3. The apparatus according to claim 1, wherein the one or more characteristics of the head fixation device include one or more of position, displacement, orientation, load, and force of the head fixation device.

4. The apparatus according to claim 1, wherein the first pin holder assembly has a torque screw assembly including an actuator and a pin configured to contact the head, the actuator being configured to adjust the pin with respect to the head.

5. The apparatus according to claim 4, wherein at least one sensor is disposed on the actuator and configured to detect one or more of position, displacement, and angle of the actuator.

6. The apparatus according to claim 4, wherein at least the one sensor is disposed adjacent to the pin in a contact configuration.

7. The apparatus according to claim 6, wherein the at least one sensor is configured to detect at least one of position, variation, angular direction, and force of the pin.

8. The apparatus according to claim 1, wherein the second pin assembly is composed of a rocker arm and a pin coupled to the rocker arm.

9. In the apparatus according to claim 8, at least one sensor is arranged on the pin and is configured to detect one or more of the position, displacement, angular direction, and force of the pin.

10. In the apparatus according to claim 2, further, it has a power supply connected to the one or more sensors and the data processing unit, and the power supply is configured to supply power to the one or more sensors and the data processing unit.

11. In the apparatus according to claim 2, the data processing unit is configured to determine whether the fixation by the head fixing device is stable.

12. In the apparatus according to claim 2, the data processing unit is configured to compare the characteristics detected by the one or more sensors with a predetermined value to determine whether the fixation provided by the head fixing device is stable.

13. In the apparatus according to claim 12, the data processing unit is configured to provide an alarm when the fixation by the head fixing device is not stable.

14. In the apparatus according to claim 2, further, it has a data interface connected to the data processing unit such that the characteristics analyzed by the data processing unit can be transmitted to the data interface.

15. In the apparatus according to claim 14, the data interface has a display for displaying the characteristics analyzed by the data processing unit.

16. In the apparatus according to claim 14, the data interface is configured to connect the data processing unit to a remote device.

17. In the apparatus according to claim 14, the data interface is configured to connect the data processing unit to a navigation system configured to display a schematic diagram of the analyzed characteristics on the patient's head.

18. In the apparatus according to claim 14, the data interface is configured to connect the data processing unit to an augmented reality system configured to display an image of the analyzed characteristics on the patient's head.

19. The apparatus according to claim 1, further comprising a connection assembly connected to the sensor assembly, the connection assembly having a data processing unit configured to receive data from the one or more sensors, the connection assembly being configured to analyze the characteristics detected by the one or more sensors and provide feedback on the detected characteristics.

20. A method of operating a head stabilization system having a first arm coupled to a first pin holder assembly, a second arm coupled to a second pin holder assembly, one or more sensors disposed on the head fixing device, and a data processing unit connected to the one or more sensors so that the data processing unit receives data from the one or more sensors, the method comprising: (a) detecting one or more characteristics of the head fixing device; and (b) analyzing the one or more detected characteristics.

21. The method according to claim 20, further comprising displaying the one or more detected characteristics.

22. The method according to any one or more of claims 20 to 21, further comprising providing an alarm based on the one or more detected characteristics.

23. The method according to claim 20, wherein the one or more characteristics include one or more of position, displacement, orientation, load, and force of the head fixing device.

24. The method according to claim 20, further comprising adjusting the head fixing device based on the one or more detected characteristics.