Head stabilization device with a removable torque applicator

Abstract

The head stabilizer includes a stabilization assembly and an applicator for controlling the amount of force a stabilization mechanism applies to a patient's head. The applicator includes a torque control mechanism that prevents a required torque setting from being exceeded during use. The applicator can be detached from the rest of the system, allowing the head stabilizer to be used without a torque control mechanism or structure. One version of the applicator controls torque by adjusting the bend length of a pair of arms extending within the applicator.

Description

Background Art

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 939,053, filed November 22, 2019, entitled "Head Stabilization Device with Removable Torque Applicator", the disclosure of which is incorporated herein by reference.

[0002] The disclosed devices and methods relate to patient stabilization, particularly head and neck stabilization using stabilization devices, also known as head fixation devices (hereinafter referred to as "HFDs" or the singular "HFD"). HFDs may be used during various surgical and other medical procedures, such as head and neck surgeries or examinations where it is desirable to hold the patient's head firmly in a particular position. When stabilizing a patient's head, techniques include invasive and non-invasive settings. In an invasive setting, the stabilization function can be used in the form of pins that contact the patient's head, particularly the skull. In a non-invasive setting, the stabilization function can be used in the form of pads and other structures configured to contact the patient's head without penetrating the skin. HFDs used in invasive and non-invasive settings include structures or assemblies configured to hold and position one or more stabilization functions.

[0003] HFDs also have the function of adjusting their size to accommodate patients with various head sizes. When stabilizing a patient with an HFD, one or more stabilization functions can be tightened in a controlled manner to apply the necessary amount of force to the patient's head to achieve acceptable stabilization. The devices and methods herein also relate to adjusting this force applied by one or more stabilization functions. Although various head stabilization devices have been manufactured and used, it is believed that none of the inventor's predecessors have made or used the invention described herein. The prior art document information related to the invention of this application includes the following (including documents cited in the international phase after the international filing date and documents cited when entering the national phase in other countries). (Prior Art Document) (Patent Document) (Patent Document 1) U.S. Patent No. 5,537,704 (Patent Document 2) European Patent Application Publication No. 2903554 (Patent Document 3) U.S. Patent No. 4,758,754 (Patent Document 4) U.S. Patent Application Publication No. 2019 / 053967

Brief Description of the Drawings

[0004] This specification concludes with the claims that particularly point out and distinctly claim the invention, but the invention is believed to be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0005] 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, which is one of the best modes contemplated for carrying out the present invention. As implemented, the present invention is capable of other different and distinct aspects without departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0006] 1. Exemplary Patient Head Support System FIGS. 1 and 2 show an exemplary patient head support system (10) having an HFD in the form of a skull clamp (100) and a torque applicator (200). The skull clamp (100) includes arms (102) that define upright portions (104) and lateral portions (106). The skull clamp (100) further includes arms (108) that define upright portions (110) and side portions (112). As shown, the side portions (106, 112) are configured to be connected together in a selectively adjustable manner. This configuration allows for changing the spacing between the upright portions (104, 110) to accommodate patients with various head sizes.

[0007] Each upright portion (104, 110) of the skull clamp (100) includes a bore at one end, and the bore is configured to receive a stabilization assembly. In this example, the upright portion (104) is shown with a stabilization assembly (114), and the upright portion (110) is shown with a stabilization assembly (116). The stabilization assembly (114) is composed of a rocker assembly (118) that can hold two stabilization mechanisms (250). The stabilization assembly (116) is composed of a bore that can hold a single stabilization mechanism (250). In one version, the stabilization mechanism (250) held by the stabilization assemblies (114, 116) is a skull pin. However, in other versions, the stabilization mechanism (250) held by the stabilization assemblies (114, 116) is a pad or a combination of a pin and a pad. In this way, the system (10) can be in either an invasive or non-invasive configuration depending on the type or style of the stabilization mechanism used.

[0008] The skull clamp (100) also includes a torque applicator (200) configured to selectively connect to the skull clamp (100) via a joint sleeve (230) of the stabilization assembly (116) and the torque applicator (200). This selective connection can be seen by comparing FIGS. 1 and 2, where the torque applicator (200) is connected to the skull clamp (100) in FIG. 1 and removable from the skull clamp (100) as shown in FIG. 2. As shown and described below, the torque applicator (200) includes a joint sleeve (230) (see also FIG. 12) that allows the torque applicator (200) to connect safely and selectively to the stabilization assembly (116) and remain connected without being held in place by the user. The joint sleeve (230) can be actuated to remove or detach the torque applicator (200) from the stabilization assembly (116) of the skull clamp (100). Again, for details of the joint sleeve, see below with reference to FIG. 12.

[0009] In use, the patient's head is placed within the space of the head support system (10) between the upright portions (104, 110) of the skull clamp (100). Next, the skull clamp (100) is adjusted by bringing the upright portions (104, 110) of the arms (102, 108) closer together until the stabilization mechanism (250) of the stabilization assembly (114, 116) almost contacts or just touches the patient's head. Next, a torque applicator (200) is used to adjust the amount of force that the stabilization mechanism (250) applies to the patient's head. This is accomplished by using the torque applicator (200) to apply a predetermined amount of force to the patient's head to obtain stabilization without applying excessive force that could cause trauma to the patient's head. Thus, the torque applicator (200) has a function of preventing the torque applicator (200) from applying more torque than the predetermined amount set using the torque applicator (200).

[0010] When applying torque, the torque applicator (200) applies the predetermined force to the stabilization mechanism (250) connected to the stabilization assembly (116). The stabilization assembly (114) is generally opposite to the stabilization assembly (116), and the stabilization assembly (114) is fixed when its stabilization mechanism (250) contacts the patient's head. In this way, equal and opposite forces are applied by the diametrically opposed stabilization assemblies (114, 116). However, the number of stabilization mechanisms (250), the position of each stabilization mechanism (250), and the angle that each stabilization mechanism (250) makes with the patient's head affect the direction and magnitude of the applied stabilization force. Thus, not all individual stabilization mechanisms (250) necessarily apply the same magnitude or direction of force to the patient's head. In the next section, further details regarding the torque applicator (200) and its use will be described.

[0011] 2. Exemplary Removable Torque Applicator with a Rotatable Actuator Figures 3 - 11 illustrate an exemplary torque applicator (200), which may be referred to herein simply as the applicator (200). In Figures 3 - 5, and 7, the applicator (200) includes a housing (120). The housing (120) extends longitudinally from the proximal end of the applicator (200) to the distal end of the applicator (200). The housing (120) further generally defines the outer perimeter of the applicator (200). At the distal end, the housing (120) includes an opening (122) through which the elongate bit (130) extends. The applicator (200) defines a longitudinal axis (LA). The longitudinal axis (LA) defines an axis of rotation about which the elongate bit (130) and other components of the applicator (200) can rotate. In this example, the distal end of the elongate bit (130) is six-pointed star-shaped; however, in other versions, the distal end of the elongate bit (130) can have other shapes, such as, among others, grooved, cross-shaped, square-shaped, etc., which would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0012] As shown in FIG. 4, at the proximal end of the housing (120) there is another opening (124) and a cover (140) that fits within the opening (124). In some versions, the cover (140) has a snap fit with the housing (120), while in other versions, the cover (140) can be secured to the housing (120) by a pin that passes through the housing (120) and the cover (140). In some versions, the cover (140) includes a plurality of slots that provide visual access within the housing (120). At the center of the cover (140) there is an opening (142) configured to receive a calibration sleeve (180) that is part of a calibration assembly or function. As shown in FIG. 4, the proximal end of the elongate bit (130) is received within the calibration sleeve (180). In some versions, the calibration sleeve (180) includes a pair of openings configured to receive a tool for rotating the calibration sleeve (180), as will be described in more detail below when explaining the calibration process.

[0013] Continuing to refer to FIGS. 3 and 4, housing (120) also includes lateral openings (121, 123). The openings (121, 123) are on opposite sides of housing (120). In this example, openings (122, 123) are also generally disposed toward the distal end of housing (120). Openings (121, 123) provide access to actuator (150), which can be used to adjust the torque setting of applicator (200), as will be described in more detail below. Along the outer surface of housing (120), there is an elongate detent (125) extending longitudinally. In this example, detents (125) are spaced around housing (120). Thus, detents (125) are configured as a gripping feature to improve the gripping ability when gripping torque applicator (200). In some versions, actuator (150) can include detents spaced around the perimeter of actuator (150) and extending longitudinally. Thus, such detents can be configured as a gripping feature to improve the gripping ability when gripping actuator (150) and rotating actuator (150) to adjust the torque setting of applicator (200).

[0014] The two pivots (125) of the housing (120) include elongated slots (126). In this example, the elongated slots (126) are on opposite sides of the housing (120). Within each elongated slot (126), there is a pin (161) configured to translate within its respective slot (126). As will be discussed in more detail below, these pins (161) translate when the actuator (150) is rotated to adjust the torque setting. In some versions, adjacent to the elongated slots (126), there are torque setting graduations marked on the outer surface of the housing (120). In such versions, the pins (161) are force indicators by pointing to or being associated with the graduations. In some versions, the graduations can be numerical, while in other versions, the graduations can provide a relative indication. By way of non-limiting example only, a relative indication can include color-coded graphics where one color indicates an acceptable torque setting and another color indicates a torque setting that is too low or too high. Given the teachings herein, other ways to provide feedback or indication of the torque setting will be apparent to those of ordinary skill in the art.

[0015] In some versions, there may be a plurality of bores that extend laterally within the housing (120) and are equally spaced around the perimeter of the housing (120) along the perimeter near the proximal end. Such bores can be configured to receive positioning screws (162) (see FIGS. 8A and 8B). As will be explained in more detail below, the positioning screws (162) are configured to secure the calibration setting of the torque applicator (200). In some versions, as described above, there are also additional bores that can be configured to receive pins for securing the cover (140) to the housing (120).

[0016] In some versions, there may be a lateral bore configured to receive a pin configured to secure a bifurcated member (170) (see FIGS. 6A and 6B) to or near the distal end of the housing (120). The bifurcated member (170) is a control feature for altering the torque applied by a torque applicator (200), as will be described in more detail below. This exemplary pin connection with the housing (120) causes the bifurcated member (170) to rotate in unison with the housing (120), as will be further described below. In some other versions, such a pin connection can be replaced with another fastener, such as a grub screw.

[0017] With reference to FIGS. 5-11, the details of the internal components of the torque applicator (200) will be described along with the operational features of the torque applicator (200). Beginning with FIGS. 5-6B, the actuator (150) is shown as a tubular structure having an internal space (153) and a distal opening (154) and a proximal opening (155). Disposed within the internal space (153) and extending from the proximal end (155) of the actuator (150) is a sleeve (190). The sleeve (190) is also shown as a tubular structure having an internal space (192) and a distal opening (193) and a proximal opening (194).

[0018] The actuator (150) includes a threaded portion (152) that threadably engages with the threaded portion (191) of the sleeve (190). Thus, rotation of the actuator (150) causes translation of the sleeve (190) due to the threaded engagement between these components. The direction of translation of the sleeve (190) depends on the direction of rotation of the actuator (150). In this version, when the actuator (150) is rotated clockwise when viewing the applicator (200) from the proximal end, the sleeve (190) translates in the proximal direction as seen in FIG. 6B compared to FIG. 6A. In the opposite manner, when the actuator (150) is rotated counterclockwise when viewing the applicator (200) from the proximal end, the sleeve (190) translates distally. In this example, the sleeve (190) is configured to translate over a distance extending from the cover (140) at one end of the applicator (200) to the edge portion (173) of the bifurcated member (170) at the other end of the applicator (200). In other versions, as will be apparent to those skilled in the art in light of the teachings herein, the actuator (150) and the sleeve (190) can be configured to cause translation of the sleeve (190) in a manner opposite to that described immediately above or to a lesser extent with respect to the translation distance. Further, the actuator (150) can have various structures and forms in addition to the rotating tubular structure shown in FIGS. 5 - 11. For example, the actuator (150) can be structured as a thumbwheel, a rotating sleeve or tubular body, or a slider configured to translate, among other alternative structural forms that will be apparent to those skilled in the art in light of the teachings herein.

[0019] The sleeve (190) includes a pin (161) at its proximal end as described above. When the sleeve (190) translates based on the rotation of the actuator (150), the pin (161) moves with the sleeve (190) along the groove portion (126) of the housing (120). As described above, the pin (161) is configured to act as a force indicator by indicating a set torque, as will be more clearly understood from the following description. Since the pin (161) extends into the groove portion (126) of the housing (120), rotation of the housing (120) causes corresponding rotation of the pin (161), and thus the sleeve (190) and the connected actuator (150). This rotation of the actuator (150) and the housing (120) of the sleeve (190) is performed without changing the relative position of the sleeve (190) with respect to the actuator (150).

[0020] The sleeve (190) is also configured to have a lateral opening (196) in its side wall. The opening (196) is configured to reduce mass and also provides access to the internal space (192) for cleaning, observation, etc. In some versions, the number of lateral openings (196) may be more or less than that illustrated in this embodiment. The sleeve (190) includes an inner surface (198) that defines the internal space (192). The inner surface (198) generally tapers from the proximal end to the distal end of the sleeve (190), although a portion (197) of the sleeve (190) is straight or non-tapering.

[0021] The bifurcated member (170) extends through the internal space (153) of the actuator (150) and extends from the distal opening (154). The bifurcated member (170) includes a distal body portion (171) and a pair of arms (172) extending proximally from the body portion (171). The body portion (171) includes a flange portion (173). When assembled with the actuator (150), the flange portion (173) has a diameter larger than the distal opening (154) of the actuator (150) so that the bifurcated member (170) cannot pass through the distal opening (154) of the actuator (150). In some other versions, the bifurcated member (170) may also be pinned to the housing (120). In this way, the actuator (150) cannot move proximally beyond the flange portion (173) of the bifurcated member (170) and is thus maintained in its longitudinal position relative to the housing (120). Similarly, the distal end of the actuator (150) contacts or is immediately adjacent to the inner distal flange (129) of the housing (120), which prevents the actuator (150) from moving distally relative to the housing (120).

[0022] As shown in FIGS. 8A and 8B, the elongate bit (130) extends through the body portion (171) of the bifurcated member (170) and ultimately emerges from the distal end of the housing (120). The body portion (171) of the elongate bit (130) and the bifurcated member (170) are configured such that the bifurcated member (170) and the elongate bit (130) can rotate independently of each other. As will be further described below, such independent rotation occurs when a torque setting or limit is reached and the bifurcated member (170) rotates but the elongate bit (130) does not rotate with further rotation of the housing (120). Nevertheless, under certain conditions, the elongate bit (130) and the bifurcated member (170) can rotate integrally. As will also be described below, this may be the case when the torque setting or limit has not yet been reached and the elongate bit (130) rotates integrally with the bifurcated member (170). In the present embodiment, the applicator (200) includes a pin (164) disposed between the body portion (171) of the bifurcated member (170) and the elongate bit (130). The pin (164) is configured to allow rotation between the elongate bit (130) and the fork member (170) based on the conditions during use of the applicator (200). In some versions, multiple pins (164) may be used between the bit (130) and the bifurcated member (170).

[0023] Referring to FIGS. 7, 8A and 8B, the interaction between the sleeve (190) and the bifurcated member (170) is described and setting a predetermined or regulated amount of torque is described. As described above, the bifurcated member (170) includes a pair of arms (172) extending proximally from the body portion (171). At the proximal end, the arms (172) are configured to selectively contact the knob (210). When the proximal end of the arm (172) contacts the knob (210) under certain conditions, the arm (172) bends or deflects away from the longitudinal axis (LA) in response to such contact. Based on the contact between the arm (172) and the knob (210) under such conditions, bending stress is applied to the arm (172). In at least some embodiments, this bending stress occurs when the force is generally exerted on the arm (172) and the direction of the force is not parallel to the longitudinal axis or length of the arm (172). Although not in all examples, in some examples, the direction of the force may be orthogonal to the longitudinal axis or length of the arm (172). The result of such a force is to bend or deflect the arm (172) from its neutral position or state. However, the proximal end of the arm (172) can contact the knob (210) under other conditions where the arm (172) does not bend or deflect away from the longitudinal axis (LA).

[0024] Referring to FIGS. 8 and 9, the knob (210) is positioned relative to the elongate bit (130) such that the bit (130) extends through the knob (210). Further, the knob (210) includes a distal opening (211) having a flat side (212). The elongate bit (130) includes an outer profile having a flat side (131) along its length at the position where the elongate bit (130) passes through the opening (211). The corresponding flat sides (131, 212) of the bit (130) and the opening (211) of the knob (210) create an interference fit between the elongate bit (130) and the knob (210). Due to this interference fit, the knob (210) and the elongate bit (130) rotate integrally. Thus, when the knob (210) rotates, the elongate bit (130) rotates correspondingly.

[0025] Referring to FIGS. 10A - 10C, the knob (210) includes a pair of curved hook mechanisms (213). As shown, the proximal ends of the arms (172) are configured to contact the respective hook mechanisms (213) when the bifurcated member (170) is rotated counterclockwise as viewed from the proximal end of the applicator (200). This is shown in FIG. 10A by the arrow (A1) indicating the direction of rotation. In this manner, the counterclockwise rotation of the bifurcated member (170) causes a corresponding counterclockwise rotation of the knob (210) and the elongate bit (130). Further, the contact between the arm (172) and the hook mechanism (213) of the knob (210) in this method occurs without causing bending or deflection away from the longitudinal axis (LA) of the arm (172). Also, the proximal ends of the arms (172) are received within respective slots (143) of the cover (140). The groove portions (143) maintain the position of the arms (172) so that the arms (172) do not bend, i.e., when the proximal ends of the arms (172) contact the hook mechanisms (213) of the knob (210). As previously described, the bifurcated member (170) can be fixed to the housing (120) by a pin or other structure such that the bifurcated member (170) rotates integrally with the housing (120). As a result, a counterclockwise rotation of the housing (120) as viewed from the proximal end of the applicator (200) causes a corresponding rotation of the elongate bit (130) in the same direction. This counterclockwise rotation can be considered one condition for the use of the torque applicator (200). In at least some embodiments, the rotation in this method loosens or reduces the contact or engagement of the stabilization mechanism (250) of the stabilization assembly (116) with the patient's head.

[0026] Here, considering the clockwise rotation of the housing (120) as viewed from the proximal end, the bifurcated member (170) will rotate integrally with the housing (120) for the reasons described above. Referring to FIGS. 10A - 10C, this clockwise rotation moves the arms (172) in the same way, which is indicated by the direction of arrow (A2). The distance between the arms (172) is smaller than the diameter of the knob (210) across the hook mechanism (213) at its maximum point. As a result, when the arms (172) rotate in the direction of arrow (A2), the proximal ends of the arms (172) will contact or engage with the outer curved surface (214) of the hook mechanism (213). Further, since the distance between the proximal ends of the arms (172) is smaller than the maximum diameter point of the hook mechanism (213), when the proximal ends of the arms (172) contact the outer curved surface (214) of the hook mechanism (213), it causes the arms (172) to adopt a bent or deflected position as shown in FIGS. 10B and 10C. As shown in FIGS. 9 - 10C, the groove portion (143) of the cover (140) is elongated to allow for the deflection of the proximal ends of the arms (172) away from the longitudinal axis (LA) when the applicator (200) is being used in this way.

[0027] In this bent or deflected configuration for the arms (172), the arms (172) exert an inwardly directed force on the hook mechanism (213) of the knob (210). This results in the arms (172) holding or pressing on the knob (210). If the force applied by the arms (172) is higher than the resistance force applied to the elongate bit (130), based on the engagement with the stabilization assembly (116) and the contact of the stabilization mechanism (250) with the patient's head, the rotation of the housing (120) and the arms (172) of the bifurcated member (170) can hold the knob (210) with sufficient force to rotate the elongate bit (130) connected to the knob (210) integrally with the arms (172). In this manner, when viewed from the proximal end of the applicator (200), by rotating the housing (120) clockwise, the stabilization mechanism (250) of the stabilization assembly (116) can be tightened.

[0028] When the resistance force applied to the elongate bit (130) is higher than the force applied by the arm (172) to the knob (210) based on the engagement with the stabilization assembly (116) and the contact of the stabilization mechanism (250) with the patient's head, the arm (172) will slide or slip over the hook mechanism (213) of the knob (210). When the arm (172) slides or slips sufficiently, the arm (172) reaches a position as shown in FIG. 10A by elastically rebounding or returning to its relaxed state. In this neutral or relaxed state, the arm (172) no longer bends or deflects outward from the longitudinal axis (LA). Thus, the arm (172) and the connected housing (120) rotate, but there will be no corresponding rotation of the knob (210) and the elongate bit (130). Therefore, although additional tightening or rotational forces may be applied to the housing (120) and the bifurcated member (170), such additional tightening or rotational forces are not transmitted to the knob (210) and the elongate bit (130), and thus the stabilization assembly (116) to which the elongate bit (130) is connected also does not receive additional tightening or rotational forces, and therefore the elongate bit (130) does not rotate relative to the knob (210) and the elongate bit (130). This clockwise rotation of the knob (210) can be considered as another operating condition of the torque applicator (200), and similarly, the non-clockwise rotation of the knob (210) can be considered as another operating condition of the torque applicator (200).

[0029] In this embodiment of the torque applicator (200), the amount of force exerted or applied by the arm (172) on the knob (210) is a function of the bending length of the arm (172). For example, referring to FIGS. 8A and 8B, the arm (172) is shown to have different bending lengths. Further, the applicator (200) is configured such that the bending length of the arm (172) is adjustable. This adjustment is achieved by the interaction between the sleeve (190) of the bifurcated member (170) and the arm (172).

[0030] The sleeve (190) includes a portion (197) positioned alongside the arm (172). As shown when comparing FIGS. 8A and 8B, the portion (197) is located further distally in FIG. 8A compared to FIG. 8B. The bending length is defined as the length from the portion (197) of the sleeve (190) to the point where the arm (172) extending proximally is aligned with the distal portion of the knob (210). Thus, FIG. 8A shows a state having a first bending length that is greater than a second bending length in another state shown in FIG. 8B. As described above, the rotation of the actuator (150) causes the translation of the sleeve (190), and as a result, provides the different bending lengths for the arm (172). In this way, the bending length of the arm (172) of the bifurcated member (170) is controlled by the rotation of the actuator (150). As will be further described below, the bending length of the arm (172) is also affected by a calibration process in which the distal portion of the knob (210) is moved relative to the arm (172). However, calibration in this way is configured as a separate calibration process and is not configured to replace adjusting the bending length to control the torque in use.

[0031] Regarding torque setting, the smaller the bending length, the greater the bending force is related. That is, when the bending length of the arm (172) becomes shorter, a greater force is required to bend the arm (172). Similarly, a greater force will be applied to the hook mechanism (213) by the arm (172). Thus, in this version, the shortest bending length of the arm (172), and thus the maximum torque setting, will be when the sleeve (190) is translated to its most proximal position. Similarly, the longest bending length of the arm (172), and thus the smallest torque setting, will be when the sleeve (190) is translated to its most distal position.

[0032] In this version, the bending force is applied based on the interaction between the knob (210) and the arm (172). More specifically, the interaction here is between the hook mechanism (213) of the knob (210) and the arm (172). For example, based on the position of the sleeve (190), when the housing (120) is rotated clockwise, if the bending length of the arm (172) is short or small, a greater force is required to bend the arm (172) to the point where it slides or slips over the hook mechanism (213) of the knob (210). In other words, the applicator (200) can apply a greater torque to the stabilization assembly (116) when tightening. In the reverse aspect, the greater the bending length of the arm (172), again based on the position of the sleeve (190), when the housing (120) is rotated clockwise, less force is required to bend the arm (172) to the point where it slides or slips over the hook mechanism (213) of the knob (210). In other words, the applicator (200) applies less torque to the stabilization assembly (116) when tightening.

[0033] By way of example only and not limitation, in one exemplary use, the applicator (200) is adjusted by rotation of the actuator (150) such that the torque indicator reads 60 Newton meters. The head support system (10) is configured such that the patient's head is disposed within the skull clamp (100) and the skull clamp (100) has a stabilization assembly (114, 116) constituted by skull pins as a stabilization mechanism (250). The skull clamp (100) is adjusted to move the arms (102, 108) such that the skull pins contact the patient's head. The applicator (200) is connected to the stabilization assembly (116), and the elongate bit (130) engages the star-shaped recess (221) of the stabilization assembly (116). The housing (120) of the applicator is then rotated in a clockwise manner when viewed from its proximal end. The rotation of the housing (120) causes corresponding rotation of the bifurcated member (170) and the cover (140) as described above. The arm (172) of the bifurcated member (170) rotates around the knob (210) and ultimately contacts the outer curved surface (214) of the hook mechanism (213) as shown, for example, in FIG. 10B.

[0034] Since the stabilization mechanisms (250) of the stabilization assembly (116) are not yet tightened, a force of less than 60 Newton meters is required to tighten them. As a result, when the housing (120) of the applicator is rotated, the skull pin stabilization mechanism (250) connected to the stabilization assembly (116) is tightened. This occurs in order to apply sufficient force to the knob (210) such that the proximal end of the arm (172) engages or contacts the hook mechanism (213) of the knob and holds and rotates the knob (210) and the elongate bit (130) extending therethrough. FIG. 10C shows a view in which the knob (210) and the elongate bit (130) are rotated based on the force applied by the arm (172) to the hook mechanism (213) of the knob as described above.

[0035] After a certain amount of tightening, the stabilization mechanism (250) of the stabilization assembly (116) requires a force greater than 60 Newton - meters for further tightening. At this point, further clockwise rotation of the housing (120) rotates the arm (172) of the bifurcated member (170) again. However, the force required to bend the arm (172) away from the longitudinal axis (LA) until the arm (172) slides or slips along the outer curved surface (214) of the hook mechanism (213) is set at 60 Newton - meters. As mentioned, the torque setting on the applicator (200) needs to be greater than 60 Newton - meters to further tighten the stabilization mechanism (250). In this example, since the torque setting is 60 Newton - meters, when the housing (120) is rotated, the arm (172) will then slide or slip over the hook mechanism (213). As an example, this is shown in sequential figures when the arm (172) slides over the hook mechanism (213), as shown, for example, in FIG. 10C, and assumes the position shown, for example, in FIG. 10A. When this occurs, the arm (172) snaps or clicks back to the position shown in FIG. 10A when the arm (172) clears the hook mechanism (213) so that the bending or deflecting force on the arm (172) is removed. This snap or click provides a feedback function of the applicator (200) to inform the user that the torque limit has been reached when tightening the stabilization mechanism (250). By this operation, the knob (210) and the elongate bit (130) do not rotate with the rotation of the housing (120) and the bifurcated member (170) under these conditions.

[0036] If the user of the patient head support system (10) determines that a greater clamping pressure is desired, the torque setting is increased, for example, up to 100 Newton meters by rotation of the actuator (150). Thereafter, further rotation of the housing (120) of the applicator (200) causes the proximal end of the arm (172) to contact the outer surface (214) of the hook mechanism (213) and rotates the arm (172) with sufficient force to engage the hook mechanism (213) of the knob (210) to cause rotation of the knob (210) and the elongate bit (130) extending therethrough. When the stabilizing mechanism (250) of the stabilization assembly (116) is tightened to the point where it requires a force greater than 100 Newton meters to further tighten the stabilizing mechanism (250), rotation of the housing (120) of the applicator (200) again rotates the arm (172), but the elongate bit (130) and the knob (210) slide or slip over the hook mechanism (213) of the knob (210) such that sufficient bending force is applied to the arm (172) instead of the arm (172) bending and gripping and rotating the knob (210).

[0037] When it comes time to loosen the stabilizing mechanism and, in some cases, remove the patient's head from the skull clamp (100), the applicator (200) engages the recess (221) and the applicator (200) is rotated counterclockwise as viewed from the proximal end of the applicator (200). Due to the configuration of the arm (172) and the knob (210), torque setting adjustment by the actuator (150) and the sleeve (190) is not required prior to loosening the stabilizing mechanism. As described above, with the counterclockwise rotation, the proximal end of the arm (172) contacts the tip region (215) of the hook mechanism (213), thereby enabling rotation of the knob (210) and the elongate bit (130) regardless of the bending length configuration of the arm (172) with the sleeve (190). The examples described above are merely illustrative. In view of the teachings herein, one of ordinary skill in the art will understand other ways of using the devices and systems shown and described herein to securely stabilize the patient's head with a known clamping force without exceeding the desired clamping force.

[0038] In addition to the bending force on the arm (172) described above, and the influence on the torque setting and application of the applicator (200) due to the arm (172) rotating the knob (210) or gripping or applying force to the knob (210) to slide past the mechanism of the knob (210), frictional forces also affect the torque setting and application of the applicator (200). For example, the frictional force is present where the proximal end of the arm (172) contacts the hook mechanism (213) of the knob (210). Thus, the threshold at the torque limit at which the arm (172) slides or slips along and past the hook mechanism (213) is a function of the bending force applied to the arm (172) and the frictional force between the arm (172) and the hook mechanism (213) of the knob (210). In some embodiments, the structure of the arm (172) and / or the knob (210) can be configured or modified to provide greater or lesser friction between these components. Considering the teachings herein, other ways to control and modify the interaction of the forces between the arm (172) and the hook mechanism (213) of the knob (210) will be apparent to those skilled in the art.

[0039] Figures 6A, 6B, 8A, 8B, and 11 illustrate the mechanism of an applicator (200) configured to calibrate the applicator (200) with respect to its torque setting ability. As shown, the applicator (200) includes a calibration sleeve (180). As described above, the calibration sleeve (180) is disposed at the proximal end of the applicator (200). The calibration sleeve (180) is located within the opening of the cover (140) and extends distally within the housing (120) of the applicator (200). In some versions, the proximal portion of the calibration sleeve (180) can include a pair of openings configured to receive a tool for rotating and thereby adjusting the calibration sleeve (180). In other versions, the calibration sleeve (180) is rotatable by hand or other tool when the cover (140) and / or housing (120) is disassembled from the applicator (200), thereby providing access to the calibration sleeve (180) for adjustment. The distal portion of the calibration sleeve (180) includes a threaded portion (182).

[0040] The threaded portion (182) of the calibration sleeve (180) engages the threaded portion (216) of the knob (210). As shown in Figures 6A, 6B, 8A, and 8B, the knob (210) includes an opening (217) that extends through the knob (210) from its proximal end to its distal end. The threaded portion (216) is disposed along the inner surface of the opening (217). Further, the distal portion of the calibration sleeve (180) is configured to be threadably engaged within the opening (217) of the knob (210) such that the threads (182, 216) are threadable. In this way, when the calibration sleeve (180) is rotated, the knob (210) translates distally or proximally depending on the direction of rotation of the calibration sleeve (180).

[0041] As best seen in FIGS. 8A and 8B, the distal portion of the knob (210) is positioned along the inner surface of the arm (172) of the bifurcated member (170). Movement of the knob (210) based on rotation of the calibration sleeve (180) moves the distal portion of the knob (210) along the inner surface of the arm (172). Based on the amount by which the distal portion of the knob (210) overlaps the inner surface of the arm (172), the bending length of the arm (172) is adjustable. In this regard, controlling the bending length provides a method of calibrating the torque setting.

[0042] In an exemplary calibration sequence, the first step is to remove the cover (140) and then the positioning screw (162) from the proximal end of the applicator (200). As shown in FIG. 11, the positioning screw (162) is configured to connect the calibration sleeve (180) to the elongate bit (130). The elongate bit (130) includes a spoke-like outer profile along this location as shown. When the positioning screw (162) is attached, the tip of the positioning screw is received within the space between two spokes (132) of the spoke-like outer profile of the elongate bit (130). By removing the positioning screw (162), the calibration sleeve (180) can then be rotated. As described above, this rotation of the calibration sleeve (180) causes a corresponding translation of the knob (210) based on its screw engagement with the calibration sleeve (180). In this regard, the positioning screw (162) is removed from contact with the elongate bit (130) so that the knob (210) can translate in response to rotation of the calibration sleeve (180). As described above, the arrangement of the flat sides (131, 212) of the elongate bit (130) and the knob (210) shown in FIG. 9 provides that rotation of the calibration sleeve (180) causes rotation of the elongate bit (130) when the positioning screw (162) is engaged with the elongate bit (130), which causes a corresponding rotation of the knob (210). Thus, when rotating the calibration sleeve (180) to translate the knob (210) for calibration, the positioning screw (162) is removed from the elongate bit (130) so that the elongate bit (130) remains stationary.

[0043] During the calibration process, the applicator (200) can be checked against a reference device having a known torque or can be used with a torque measuring device. For example, when connected to a torque measuring device or used with a reference device having a known torque of 80 Newton - meters, the applicator (200) can be adjusted by rotation of the actuator (150) such that the pin (161) indicates a torque setting of 80 Newton - meters. The applicator (200) can then be used with the torque measuring device or the reference device at the known torque of 80 Newton - meters to see whether the applicator is providing the torque set point of 80 Newton - meters. If the actual torque provided by the applicator (200) is low or high compared to the 80 Newton - meter setting, the knob (210) can adjust the calibration sleeve (180) to provide an adjustment of the torque output of the applicator (200) to achieve 80 Newton - meters in this example.

[0044] When the calibration is completed such that the applicator (200) provides a torque output that matches the set value of the torque, next, the positioning screw (162) is fully inserted and the relative positions of the knob (210), calibration sleeve (180), and elongate bit (130) are corrected or fixed. In some other versions, the applicator (200) includes a plurality of bores that extend laterally from the housing (120) toward the longitudinal axis (LA). In one such version, there may be six such bores equally spaced around the applicator (200). In such a version, when inserting the positioning screw (162) after calibration, the threaded bore (183) of the calibration sleeve (180) aligns with one of the bores and the positioning screw (162) can then be inserted and fixed within the bore and the threaded bore (183). In one such example having these bores in the housing (120), there may be six such bores and the applicator (200) provides calibration in at least six increments or every 60 degrees about the circumference of the applicator (200). In other versions, the applicator (200) may have more or fewer such bores for receiving the positioning screw (162) for calibration and thus have different increments of calibration. In the illustrated example without such bores, the calibration increment is defined by the number of spaces between the spokes (132) of the elongate bit (130). For example, in a three-spoke configuration, calibration can be performed in three increments or every 120 degrees about the circumference of the applicator. The torque calibration structures and processes described above are exemplary. Other structures and techniques for calibrating the torque setting of the applicator (200) will be apparent to those skilled in the art in view of the teachings herein.

[0045] Figures 12 and 13 depict a close-up view of a joint sleeve (230) that can be used with an applicator (200). The joint sleeve (230) is configured to connect to the applicator (200) and further selectively connect to a stabilization assembly (116). In this embodiment, the joint sleeve (230) is an extension of a bifurcated member (170) that extends distally from the housing (120) of the applicator (200). In other versions, the joint sleeve (230) may be separated from the bifurcated member (170) and can be connected to the applicator (200) in other ways that will be apparent to those skilled in the art considering the teachings of this specification. With these connections, the applicator (200) is selectively connectable and detachable from the stabilization assembly (116) of the skull clamp (100).

[0046] The joint sleeve (230) includes a collar (232) and a pair of attachment mechanisms (233) that connect to the collar (232) and extend distally therefrom. The attachment mechanism (233) is configured as an elongated angled body having a latch member (234) directed inwardly with respect to the longitudinal axis (LA). The attachment mechanism (233) is further configured as an elastic member such that the attachment mechanism (233) is deflectable toward or away from the longitudinal axis (LA) depending on the direction in which a force is applied to the attachment mechanism (233).

[0047] Figure 13 shows a stabilization assembly (116) configured to selectively receive the joint sleeve (230). The stabilization assembly (116) includes a bushing (222) configured to fit within the bore in the upright portion (110) of the skull clamp (100). In some versions, an O-ring is positioned between the bore of the upright portion (110) and the bushing (222) around the outer periphery of the bushing (222). The distal cap (224) is connected to the bushing (222) by a pinned connection. The cap (224) includes a bore, and extending within the bore is a holder (225) configured to receive a stabilization mechanism such as a skull pin.

[0048] Proximally of the stabilization assembly (116) there is a body (226) having a star-shaped recess (221). The body (226) has a threaded portion (227) that threadably engages with a threaded portion (228) within the bushing (222). In some versions, an O-ring can be disposed between the outer periphery of the bushing (222) and the body (226). The elongate bit (130) of the applicator (200) engages the recess (221) of the body (226) and is capable of rotating the body (226) such that the body (226) translates longitudinally based on its threaded connection with the bushing (222). The body (226) is further configured to receive a holder (225). In the illustrated version, the holder (225) has an open proximal end configured to receive an extension mechanism (240) of the body (226). A fastener (229) connects the holder (225) to the body (226) via the extension mechanism (240). In some versions, a spacer may be used between the holder (225) and the body (226). As described above, the holder (225) is configured to receive a stabilization mechanism such as a skull pin. Further, the holder (225) is configured to translate relative to the cap (224) such that when driven distally by rotation of the body (226), the attached stabilization mechanism advances distally towards the patient's head supported within the skull clamp (100).

[0049] The body (226) has a helical portion (242) at its proximal end. The helical portion (242) is configured to selectively engage with a latch member (234) of the attachment mechanism (233) of the joint sleeve (230). For example, the latch member (234) is configured with an inclined surface such that when the joint sleeve (230) is advanced distally while the latch member (234) is in contact with the proximal most surface of the body (226), the attachment mechanism (233) deflects. This deflection allows the latch member (234) to move beyond the helical portion (242) and then return to a non - deflected state after passing the helical portion (242), enabling a selective yet secure connection between the joint sleeve (230) and the body (226). Since the joint sleeve (230) is attachable to the applicator (200), the applicator (200) is attachable to the body (226) via the joint sleeve (230).

[0050] The applicator (200) having the connected joint sleeve (230) is further removable or detachable from the stabilization assembly (116) as described above. For example, due to the elasticity of the attachment mechanism (233), when the applicator (200) having the attached joint sleeve (230) is moved proximally, the angled surface of the helical portion (242) contacts the latch member (234) and the attachment mechanism (233), causing it to deflect outwardly from the longitudinal axis (LA). With further proximal movement, the latch member (234) moves over the helical portion (242) until the attachment mechanism (233) is no longer connected to the body (226). As shown in FIG. 13, the helical portion (242) of the body (226) is configured to function as a stop to prevent the body (226) from translating distally beyond a certain distance. This is because the helical portion (242) ultimately contacts the proximal surface of the bushing (222). In some other versions, the bushing (222) includes a recess at its proximal end, where this recess has a property that matches the helical portion (242). In this aspect, the body (226) cannot advance distally beyond the point where the helical portion (242) fits into this recess of the bushing (222).

[0051] In this exemplary selectively removable configuration for the applicator (200) and the skull clamp (100), there is less equipment remaining on the skull clamp (100), which is beneficial in terms of weight, obstacles, and imaging capabilities. Further, having an applicator (200) with components and mechanisms for setting the desired torque, in contrast to those components and mechanisms being integrated with the stabilization assembly or the skull clamp, when the applicator (200) is removable from the stabilization assembly (116) of the skull clamp (100), there is less equipment remaining on the skull clamp (100) after the patient's head is fixed, thereby again providing advantages at least in terms of weight, obstacles, and imaging capabilities. Considering the teachings herein, other ways of modifying or configuring the applicator (200) such that the applicator (200) is selectively removable from the stabilization assembly (116) of the skull clamp (100) will be apparent to those skilled in the art.

[0052] FIG. 14 shows a front view of the stabilization assembly (116) shown with the stabilization mechanism (250) omitted. As shown and understood from other figures, the stabilization mechanism (250) is received by a holder (225). In this embodiment, the stabilization mechanism (250) is slidably received by the holder (225). In this way, the stabilization mechanism (250) can slide freely into and out of the holder (225) when other objects do not obstruct access to the stabilization mechanism (250). In other versions, the stabilization mechanism (250) is received within the holder (225) by screw engagement, interference fit, or other engagement types as will be apparent to those skilled in the art in light of the teachings herein.

[0053] As described above, the clockwise rotation of the applicator (200) is used to rotate the body (226) of the stabilization assembly (116) clockwise and ultimately to limit or increase the torque applied to the patient's head by the stabilization mechanism (250). The screw engagement of the body (226) with the bushing (222) is configured such that the body (226) translates longitudinally as it rotates. The holder (225) is disposed adjacent to the body (226), and the fastener (229) creates a contact or interference fit between portions of the body (226) and the holder (225). This connection or contact between the holder (225) and the body (226) is configured such that the body (226) can rotate and translate distally relative to the bushing (222) while pushing the holder (225) distally without the holder (225) rotating. In this way, when the body (226) rotates, the expansion mechanism (240) of the body (226) slides along the holder (225) with the rotation of the body (226), while the proximal end of the holder (225) does not rotate.

[0054] Referring to FIG. 14, the stabilization assembly (116) components in this embodiment are configured using the shape conformity between the cap (224) and the holder (225) such that longitudinal translation is the only degree of freedom of movement of the holder (225). In one such embodiment, the stabilization assembly (116) components are configured with flat sides in contact in several regions to facilitate the action of the holder (225) and associated stabilization mechanism (250) translating longitudinally without rotating. In use, this is beneficial as it can reduce tissue and structural trauma that a patient may experience at the stabilization contact site during stabilization. As shown in FIG. 14, the holder (225) has at least one flat side (235), and in this embodiment, a pair of flat sides (235). Further, the cap (224) has at least one flat side (236), and in this embodiment, a pair of flat sides (236). The flat sides (235, 236) of the holder (225) and the cap (224) are adjacent and in contact. Further, as described above, the cap (224) is pin - coupled to the stationary bushing (222) such that the cap (224) remains stationary. By the arrangement of the flat sides (235, 236), the holder (225) is prevented from rotating despite contact with the rotating body (226). In this way, the contact between the flat sides (235, 236) ensures that when the body (226) rotates, its expansion mechanism (240) slides along the proximal portion of the holder (225) without causing rotation of the holder (225).

[0055] As can also be seen in FIG. 14, the cap (224) and the bushing (222) also have flat sides that contact similarly. In view of the teachings herein, other ways of configuring the stabilization assembly (116) to translate without rotating when the stabilization mechanism (250) is tightened will be apparent to those skilled in the art in view of the teachings herein. Further, in other versions, the stabilization assembly (116) is configured to allow rotation of the stabilization mechanism (250) during tightening. Again, such modifications to the stabilization assembly (116) will be apparent to those skilled in the art in view of the teachings herein.

[0056] In one version, the skull clamp (100) and the stabilization assemblies (114, 116) are made from a radiolucent device. In such versions, the applicator (200) is also made from a radiolucent device, although in some other versions, the applicator (200) is made from at least some devices that are not radiolucent. Due to the removability of the applicator (200), the imagination is not impaired by the device of the structure for the applicator (200). It is further contemplated herein that the applicator (200) can be used with devices other than the skull clamp (100) and the stabilization assembly (116). For example, the applicator (200) is adapted to be used with other fasteners that require applying torque to the fastener within the range of torque configured to be provided by the applicator (200).

[0057] When using the applicator (200), regardless of whether it is the skull clamp (100) or another structure, the resistance experienced by the user when setting the predetermined torque amount using the applicator (200) is constant regardless of the value of the predetermined torque amount. For example, when setting a desired torque using the applicator (200), the resistance experienced by the user is the same whether the user sets the torque to 50 Newton - meters or 100 Newton - meters. This is different from torque devices that use springs to establish torque settings and ranges. Similarly, when setting the predetermined amount of torque using the applicator (200), the resistance experienced by the user only includes overcoming the frictional force between the movable parts of the device. For example, there is frictional force when rotating the actuator (150) to translate the sleeve (190) along the arm (172). Different torques can be set, and by doing so, the user can experience the same level of frictional force regardless of the value of the set torque.

[0058] As described above, the torque is controlled by changing the bending length of the arm (172). Further, the bending length does not affect the resistance experienced by the user when setting the predetermined amount of torque using the applicator (200). Further, when the applicator (200) is configured with a positive torque setting, at the same time the applicator (200) is configured such that the arm (172) does not receive a bending force. This means that the applicator (200) can maintain a state stored at a positive predetermined torque setting value without causing distortion to the internal components of the applicator (200). Again, this is different from a torque device that uses one or more springs to control torque. In those devices using a spring control mechanism, the device must be stored at a zero torque setting in order to avoid the strain of the spring over time that would then affect the torque. In the version described herein, the applicator (200) is set at a positive torque without tensing the internal components. More specifically, this is achieved by rotating the housing (120) while keeping the elongate bit (130) stationary, such that the arm (172) slides over the hook portion (213) as described above. In this orientation, any bending force on the arm (172) is removed.

[0059] III. Example of a detachable torque applicator with a sliding actuator Figures 15 - 17 are diagrams showing another exemplary torque applicator (1200) and stabilization assembly (1116) that can be used with a head support system (10) instead of torque applicator (200) and stabilization assembly (116). Torque applicator (1200) may sometimes be simply referred to herein as applicator (1200). Applicator (1200) includes a housing (1120). Housing (1120) extends longitudinally from the proximal end of applicator (1200) to the distal end of applicator (1200). Housing (1120) further generally defines the outer perimeter of applicator (1200). At the distal end, housing (1120) includes an opening through which an elongate bit (1130) extends. Applicator (1200) defines a longitudinal axis (LA1). Longitudinal axis (LA1) defines a rotational axis about which elongate bit (1130) and the other components of applicator (1200) can rotate. In this embodiment, the distal end of elongate bit (1130) has a six-point star, although in other versions, the distal end of elongate bit (1130) can have other shapes, such as, for example, a slotted, cross-shaped, square-shaped, etc., which will be apparent to those skilled in the art in light of the teachings herein.

[0060] At the proximal end of housing (1120), there is a cover (1140) that fits within the proximal opening of housing (1120). In some versions, cover (1140) has a snap fit with housing (1120), while in some other versions, cover (1140) is secured to housing (1120) by a pin that extends through housing (1120) and cover (1140). In some versions, cover (1140) includes a plurality of slots that provide visual access within housing (1120). The proximal end of elongate bit (1130) is received within cover (1140).

[0061] The housing (1120) also includes lateral openings (1121, 1123). The openings (1121, 1123) are disposed on opposite sides of the housing (1120). The openings (1121, 1123) provide access to an actuator (1150) that is used to adjust the torque setting of the applicator (1200), as will be described in more detail below. Along the outer surface of the housing (1120), there may be other openings or elongated recesses that function as a grip mechanism to improve the gripping ability when gripping the torque applicator (1200).

[0062] The actuator (1150) in this embodiment consists of a pair of sliding members (1151) located on opposite sides of the housing (1120), with one sliding member (1151) disposed within the opening (1121) and the other sliding member (1151) disposed within the opening (1123). The sliding members (1151) are configured as a recess mechanism that is slidable when in a recessed state and stationary when not recessed. On each sliding member (1151), there is an indicator (1161) that moves with the sliding member (1151) when the sliding member (1151) is moved to adjust the torque setting. In some versions, there are torque setting scales marked on the outer surface of the housing (1120) adjacent to one or both of the openings (1121, 1123). In such versions, the indicator (1161) serves as a force indicator by pointing to or being associated with the scale. In some versions, the scale can be numerical, and in other versions, the scale can provide a relative indication. By way of non-limiting example, a relative indication can include a color-coded graphic where one color indicates an acceptable torque setting while another color or multiple colors indicate either a too-low or too-high torque setting. Considering the teachings of this specification, other ways to provide torque setting feedback or indication will be apparent to those skilled in the art.

[0063] In some versions, at or near the distal end of the housing (1120), there is one or more lateral bores configured to receive pins (1122) respectively configured to fix the bifurcated member (1170) to the housing (1120). The bifurcated member (1170) is a control mechanism for changing the torque applied by the applicator (1200), as will be described in more detail below. With this exemplary pin connection to the housing (1120), the fork member (1170) rotates integrally with the housing (1120), as will be further described below.

[0064] The actuator (1150) includes the pair of sliding members (1151) as described above. Further, the actuator (1150) is composed of an elastic mechanism such as a spring (1152) that is connected to the sliding member (1151) and can push down the sliding member (1151) to enable the sliding movement of the sliding member (1151). Arranged within the housing (1120) is a sleeve (1190). The sleeve (1190) is shown as a tubular structure and is connected to the sliding member (1151) via one or more pins (1153). In this way, the sleeve (1190) moves integrally with the sliding member (1151).

[0065] With the above-described configuration in which the sliding members (1151) of the actuator (1150) are respectively disposed within the respective openings (1121, 1123) and the sleeve (1190) is connected to the sliding member (1151), when the housing (1120) is rotated, the actuator (1150) and the sleeve (1190) undergo corresponding rotations. Further, with the bifurcated member (1170) connected to the housing (1120), when the housing (1120) is rotated, a corresponding rotation of the bifurcated member occurs.

[0066] The bifurcated member (1170) extends within the housing (1120) and includes a distal body portion (1171) and a pair of arms (1172) that extend proximally from the body portion (1171). The elongate bit (1130) extends through the body portion (1171) of the bifurcated member (1170) and ultimately emerges from the distal end of the housing (1120). The elongate bit (1130) and the body portion (1171) of the bifurcated member (1170) are configured such that the bifurcated member (1170) and the elongate bit (1130) rotate independently of each other. As will be further described below, such independent rotation occurs when the torque setting or limit is reached and the bifurcated member (1170) rotates but the elongate bit (1130) does not rotate with further rotation of the housing (1120). Nevertheless, under certain conditions, the elongate bit (1130) and the bifurcated member (1170) can rotate integrally. As will also be described below, this can be the case when the torque setting or limit has not yet been reached and the elongate bit (1130) rotates integrally with the bifurcated member (1170). In the present embodiment, the applicator (1200) includes one or more pins (1164) disposed between the body portion (1171) of the bifurcated member (1170) and the elongate bit (1130). The pins (1164) are configured to allow rotation between the elongate bit (1130) and the bifurcated member (1170) based on the conditions during use of the applicator (1200).

[0067] As described above, the bifurcated member (1170) includes a pair of arms (1172) that extend proximally from the body portion (1171). At the proximal end, the arms (1172) are configured to selectively contact the knob (1210). When the proximal end of the arm (1172) contacts the knob (1210) under certain conditions, the arm (1172) bends or deflects away from the longitudinal axis (LA1) in response to such contact. However, the proximal end of the arm (1172) can contact the knob (1210) under other conditions where the arm (1172) does not bend or deflect away from the longitudinal axis (LA1).

[0068] The knob (1210) is positioned relative to the elongate bit (1130) such that the bit (1130) extends through the knob (1210). Further, the knob (1210) and the elongate bit (1130) are connected by a pin (1131). This connection provides for the knob (1210) and the elongate bit (1130) to rotate integrally. Thus, when the knob (1210) rotates, a corresponding rotation of the elongate bit (1130) occurs.

[0069] The knob (1210) also includes a pair of curved hook mechanisms (1213). The proximal end of the arm (1172) is configured to contact respective hook mechanisms (1213) when the bifurcated member (1170) is rotated counterclockwise as viewed from the proximal end of the applicator (1200). This is similar to the illustration of FIG. 10A with respect to the applicator (200). In this aspect, a counterclockwise rotation of the bifurcated member (1170) will cause a corresponding counterclockwise rotation of the knob (1210) and the elongate bit (1130). Further, the contact between the arm (1172) and the hook mechanisms (1213) of the knob (1210) in this manner occurs without causing bending or deflection of the arm (1172) away from the longitudinal axis (LA1). Also, the proximal end of the arm (1172) is received within respective slots (1143) of the cover (1140). The slots (1143) maintain the position of the arm (1172) such that the arm (1172) does not deflect, i.e., when the proximal end of the arm (1172) contacts the hook mechanisms (1213) of the knob (1210). Based on the above description, a counterclockwise rotation of the housing (1120) as viewed from the proximal end of the applicator (1200) results in a corresponding rotation of the elongate bit (1130) in the same direction. This counterclockwise rotation can be considered one of the operating conditions of the torque applicator (1200). In at least some examples, rotation in this manner loosens or reduces the contact or engagement of the stabilization mechanism (250) of the stabilization assembly (1116) with the patient's head.

[0070] Here, considering the clockwise rotation of the housing (1120) when viewed from the proximal end, the bifurcated member (1170) will rotate integrally with the housing (1120) for the reasons described above. Due to this clockwise rotation, the arm (1172) will move in the same manner. The distance between the arms (1172) is smaller than the diameter of the knob (1210) across the hook mechanism (1213) at its maximum point. As a result, when the arms (1172) rotate in this way, the proximal ends of the arms (1172) will contact or engage with the outer curved surface (1214) of the hook mechanism (1213). Further, since the distance between the proximal ends of the arms (1172) is smaller than the maximum diameter point of the hook mechanism (1213), when the proximal ends of the arms (1172) contact the outer curved surface (1214) of the hook mechanism (1213), the arms (1172) are caused to adopt a bent position or a deflected state similar to that shown in FIGS. 10B and 10C with respect to the applicator (200). The groove portion (1143) of the cover (1140) is elongated to allow deflection of the proximal ends of the arms (1172) away from the longitudinal axis (LA1) when the applicator (1200) is used in this manner.

[0071] With this bent or deflected configuration for the arm (1172), the arm (1172) exerts an inwardly directed force on the hook mechanism (1213) of the knob (1210). This creates an effect where the arm (1172) holds or compresses the knob (1210). If the force applied by the arm (1172) is higher than the resistance force applied to the elongated bit (1130), based on the engagement with the stabilization assembly (1116) and the contact of the stabilization mechanism (250) with the patient's head, the rotation of the housing (1120) and the arm (1172) of the bifurcated member (1170) can hold the arm (1172) with sufficient force to rotate the knob (1210) and the connected elongated bit (1130) integrally with the arm (1172). In this manner, the stabilization mechanism (250) of the stabilization assembly (1116) can be tightened by rotating the housing (1120) clockwise when viewed from the proximal end of the applicator (1200).

[0072] If the resistance applied to the elongate bit (1130) is higher than the force applied by the arm (1172) to the knob (1210) based on engagement with the stabilization assembly (1116) and contact with the stabilization mechanism (250) of the patient's head, the arm (1172) slides or slips over the hook mechanism (1213) of the knob (1210). When the arms (1172) have slid or slipped sufficiently, they bounce back elastically or return to their relaxed or non - deflected state. In this neutral or relaxed state, the arm (1172) is no longer bent or deflected outward from the longitudinal axis (LA1). The arm (1172) and the connected housing (1120) rotate, but it is as if the corresponding rotation of the knob (1210) and the elongate bit (1130) did not occur. Thus, additional tightening or rotational force may be applied to the housing (1120) and the bifurcated member (1170), but such additional tightening or rotational force is not transmitted to the knob (1210) and the elongate bit (1130), and thus the stabilization assembly (1116) to which the elongate bit (1130) is connected also does not receive additional tightening or rotational force, and this is how it becomes. This clockwise rotation of the knob (1210) can be considered as another use condition of the torque applicator (1200), and similarly, the counter - clockwise rotation of the knob (1210) when it does not rotate can be considered as another use condition of the torque applicator (1200).

[0073] In this embodiment of the torque applicator (1200), the amount of the force exerted or applied by the arm (1172) to the knob (1210) is a function of the bending length of the arm (1172). For example, the arm (1172) has been shown to have a bending length. Further, the applicator (1200) is configured such that the bending length of the arm (1172) is adjustable. This adjustment is achieved by the interaction between the sleeve (1190) of the bifurcated member (1170) and the arm (1172).

[0074] The sleeve (1190) includes a portion (1197) positioned alongside the arm (1172). The bending length can be defined as the length of the arm (1172) extending proximally from the portion (1197) of the sleeve (1190) to the point where the arm (1172) is alongside the distal portion of the knob (1210). As described above, the translation or sliding of the sliding member (1151) of the actuator (1150) causes the translation of the sleeve (1190), which in turn provides different bending lengths for the arm (1172). Thus, the bending length of the arm (1172) of the fork member (1170) is controlled by the sliding movement of the actuator (1150).

[0075] In relation to torque setting, the smaller the bending length, the greater the bending force required. In other words, as the bending length of the arm (1172) decreases, a greater force is required to bend the arm (1172). Similarly, the force applied to the hook mechanism (1213) by the arm (1172) becomes greater. Accordingly, in this version, the shortest bending length of the arm (1172), and thus the maximum torque setting, will be when the sleeve (1190) is translated to its most proximal position. Similarly, the longest bending length of the arm (1172), and thus the smallest torque setting, will be when the sleeve (1190) is translated to its most distal position.

[0076] In this version, a bending force is applied based on the interaction between the knob (1210) and the arm (1172). More specifically, the interaction here is between the hook mechanism (1213) of the knob (1210) and the arm (1172). For example, based on the position of the sleeve (1190), if the bending length of the arm (1172) is short or small, a greater force will be required to bend the arm (1172) to the point where it slides or slips over the hook mechanism (1213) of the knob (1210) when the housing (1120) rotates clockwise. In other words, the applicator (1200) can apply a greater torque to the stabilization assembly (1116) when tightening. In the reverse aspect, the longer or greater the bending length of the arm (1172), again based on the position of the sleeve (1190), less force will be required to bend the arm (1172) to the point where it slides or slips over the hook mechanism (1213) of the knob (1210) when the housing (1120) is rotated clockwise. In other words, the applicator (1200) applies less torque to the stabilization assembly (1116) when tightening.

[0077] By way of example and not limitation, in one exemplary use, the applicator (1200) can be adjusted by sliding the actuator (1150) such that the torque indicator reads 60 Newton - meters. The head support system (10) is configured such that the patient's head is disposed within the skull clamp (100), and the skull clamp (100) has a stabilization assembly (114, 1116) constituted by skull pins as a stabilization mechanism (250). The skull clamp (100) is adjusted to move the arms (102, 108) such that the skull pins contact the patient's head. The applicator (1200) is connected to the stabilization assembly (1116), and the elongate bit (1130) engages a star - shaped recess (1221) of the stabilization assembly (1116). The housing (1120) of the applicator is then rotated in a clockwise manner when viewed from its proximal end. The rotation of the housing (1120) causes corresponding rotation of the bifurcated member (1170) and the cover (1140) as described above. The arm (1172) of the bifurcated member (1170) rotates about the knob (1210) and ultimately contacts the outer curved surface (1214) of the hook mechanism (1213).

[0078] Since the stabilization mechanisms (250) of the stabilization assembly (1116) are not yet tightened, a force of less than 60 Newton - meters is required to tighten them. As a result, rotating the housing (1120) of the applicator will tighten the skull pin stabilization mechanism (250) connected to the stabilization assembly (1116). This occurs because the proximal end of the arm (1172) engages or contacts the hook mechanism (1213) of the knob, applying sufficient force to the knob to hold and rotate the knob and the elongate bit (1130) extending therethrough.

[0079] After a certain amount of tightening, the stabilization mechanism (250) of the stabilization assembly (1116) requires a force greater than 60 Newton-meters for further tightening. At this point, further clockwise rotation of the housing (1120) rotates the arm (1172) of the bifurcated member (1170) again. However, the force required to bend the arm (1172) away from the longitudinal axis (LA1) until the arm (1172) slides or slips along the outer curved surface (1214) of the hook mechanism (1213) is set at 60 Newton-meters. As mentioned, the torque setting on the applicator (1200) needs to be greater than 60 Newton-meters to further tighten the stabilization mechanism (250). In this example, since the torque setting is 60 Newton-meters, when the housing (1120) is rotated, the arm (1172) will now slide or slip over the hook mechanism (1213). When this occurs, the arm (1172) will snap or click back to its neutral, non-deflected position as the arm (1172) clears the hook mechanism (1213) so that the bending or deflecting force on the arm (1172) is removed. This snap or click provides a feedback mechanism for the applicator (1200) to inform the user that the torque limit has been reached when tightening the stabilization mechanism (250). By this operation, the knob (1210) and the elongate bit (1130) do not rotate with the rotation of the housing (1120) and the fork member (1170) under these conditions.

[0080] If the user of the patient head support system (10) determines that a greater clamping pressure is desired, the sliding member (1151) of the actuator (1150) can be further moved to increase the torque setting, for example, up to 100 Newton - meters. Thereafter, further rotation of the housing (1120) of the applicator (1200) causes the proximal end of the arm (1172) to contact the outer surface (1214) of the hook mechanism (1213) and rotates the arm (1172) such that it engages the hook mechanism (1213) of the knob (1210) with sufficient force to cause rotation of the knob (1210) and the elongate bit (1130) extending therethrough. When the stabilizing mechanism (250) of the stabilization assembly (1116) is tightened to a point where it requires a force greater than 1100 Newton - meters to further tighten the stabilizing mechanism (250), rotation of the housing (1120) of the applicator (1200) will again cause rotation of the arm (1172). However, the elongate bit (1130) and the knob (1210) will either slide over or tend to slide over the hook mechanism (1213) of the knob (1210) instead of the arm (1172) bending and grasping and rotating the knob (1210), as sufficient bending force is applied to the arm (1172).

[0081] When it comes time to loosen the stabilization mechanism and, in some cases, remove the patient's head from the skull clamp (100), the applicator (1200) engages the recess (1221) and the applicator (1200) is rotated counterclockwise as viewed from the proximal end of the applicator (1200). In the configuration of the arm (1172) and the knob (1210), no torque setting adjustment by the actuator (1150) and the sleeve (1190) is necessary before loosening the stabilization mechanism. As described above, with this counterclockwise rotation, the proximal end of the arm (1172) contacts the tip region of the hook mechanism (1213), thereby enabling rotation of the knob (1210) and the elongate bit (1130) regardless of the bending length configuration of the arm (1172) together with the sleeve (1190). The examples described above are merely illustrative. In view of the teachings herein, one of ordinary skill in the art will understand other ways of using the devices and systems shown and described herein to securely stabilize the patient's head with a known clamping force without exceeding the desired clamping force.

[0082] In addition to the bending force on the arm (1172) described above and the influence on the force applied to grip or not grip the knob (1210) due to whether the arm (1172) rotates the knob (1210) or slides past the mechanism of the knob (1210), friction also affects the torque setting and application of the applicator (1200). For example, there is friction where the proximal end of the arm (1172) contacts the hook mechanism (1213) of the knob (1210). Thus, the threshold at the torque limit for the arm (1172) to slide or slip along and past the hook mechanism (1213) is a function of the bending force applied to the arm (1172) and the friction between the arm (1172) and the hook mechanism (1213) of the knob (1210). In some embodiments, the devices of the structures of the arm (1172) and / or the knob (1210) are configured or modified to provide greater or lesser friction between these components. Considering the teachings herein, other ways to control and modify the interaction of the forces between the arm (1172) and the hook mechanism (1213) of the knob (1210) will be apparent to those skilled in the art.

[0083] The applicator (1200) further includes a joint sleeve (1230) configured to connect the applicator (1200) to the stabilization assembly (1116). In this embodiment, the joint sleeve (1230) connects to the housing (1120) of the applicator (1200) and extends distally therefrom. The joint sleeve (1230) includes a pair of attachment mechanisms (1233) configured as an elongated body having a latch member (1234) directed outwardly away from the longitudinal axis (LA1). The attachment mechanism (1233) is further configured as an elastic member such that the attachment mechanism (1233) is deflectable toward or away from the longitudinal axis (LA1) depending on the direction in which a force is applied to the attachment mechanism (1233).

[0084] As described above, the stabilization assembly (1116) is configured to selectively receive the joint sleeve (1230). The stabilization assembly (1116) includes a bushing (1222) configured to fit within the bore of the upright portion (110) of the skull clamp (100). The bushing (1222) includes a distal bore, and extending within said bore is a holder (1225) configured to receive a stabilization mechanism such as a skull pin.

[0085] Proximal to the stabilization assembly (1116) are bodies (1226, 1229). The body (1226) includes a star-shaped recess (1221). The body (1226) extends within the bushing (1222), and the body (1226) includes a threaded portion (1227) that is threadably engageable with the threaded portion (1228) of the holder (1225). The body (1226) is configured to rotate, and when the body (1226) rotates, the holder (1225) translates longitudinally without rotating based on the threaded engagement with the body (1226).

[0086] The body (1229) includes an opening such that the star-shaped recess (1221) of the body (1226) is accessible through the body (1229). The body (1229) further engages threadably with the bushing (1222). The body (1229) includes an internal recess (1231) configured to selectively receive the attachment mechanism (1233) of the joint sleeve (1230) in order to connect the applicator (1200) to the stabilization assembly (1116) thereby. For example, the attachment mechanism (1233) includes an angled surface that contacts the body (1229) when moving the applicator (1200) towards the body (1229) of the stabilization assembly (1116). This contact deflects the attachment mechanism (1233) so that they can be positioned within the internal recess (1231) of the body (1229) to selectively fix the applicator (1200) to the stabilization assembly (1116). The applicator (1200) is further removable or detachable from the stabilization assembly (1116) as described above. For example, due to its elastic nature, the attachment mechanism (1233) can be pushed inwards towards the longitudinal axis (LA1). This positions the attachment mechanism (1233) within the recess (1231) so that it can move freely proximally with respect to the body (1229) and thus separate from the body.

[0087] In this exemplary selectively removable configuration for the applicator (1200) and the skull clamp (100), there is less equipment remaining on the skull clamp (100), which is beneficial in terms of weight, obstructions, and imaging capabilities. Further, having the applicator (1200) with the components and mechanisms for setting the desired torque, in contrast to those components and mechanisms being integrated with the stabilization assembly or the skull clamp, and the applicator (1200) being removable from the stabilization assembly (1116) of the skull clamp (100), results in less equipment remaining on the skull clamp (100) after the patient's head is fixed, thereby again providing advantages at least in terms of weight, obstructions, and imaging capabilities. Other ways of modifying or configuring the applicator (1200) such that the applicator (1200) is selectively removable from the stabilization assembly (1116) of the skull clamp (100) will be apparent to those skilled in the art in view of the teachings herein.

[0088] As described above, the holder (1225) is threadably engagable with the body (1226) and is configured to receive the stabilization mechanism (250). In this embodiment, the stabilization mechanism (250) is slidably received by the holder (225). In this way, the stabilization mechanism (250) can freely slide in and out of the holder (225) if other objects do not obstruct access to the stabilization mechanism (250). In other versions, the stabilization mechanism (250) is received within the holder (225) by a threaded engagement, an interference fit, or other engagement type as will be apparent to those skilled in the art in view of the teachings herein.

[0089] In this embodiment, the stabilization assembly (1116) components are configured such that, using the shape conformity between the bushing (1222) and the holder (1225), longitudinal translation is the only degree of freedom of movement of the holder (1225). As an example of such, the stabilization assembly (1116) components are configured to have flat sides in contact in several regions to facilitate this action where the holder (1225) and the associated stabilization mechanism (250) translate longitudinally without rotating. In use, this is beneficial as it can reduce tissue and structural trauma that a patient may experience at the stabilization contact site during stabilization. As an example, the holder (1225) has at least one flat side (1235), in this embodiment a pair of flat sides (1235). Further, the distal opening of the bushing (1222) has at least one flat side (1236), in this embodiment a pair of flat sides (1236). The flat sides (1235, 1236) of the holder (1225) and the bushing (1222) are adjacent and in contact. By the arrangement of the flat sides (1235, 1236), the holder (1225) is prevented from rotating despite being in contact with the rotator (1226). In this way, the contact between the flat sides (1235, 1236) ensures that when the body (1226) rotates, the holder (1225) translates without rotating based on the screw engagement of the holder with the body (1226).

[0090] In view of the teachings of this specification, other ways of configuring the stabilization assembly (1116) such that it translates without rotating when the stabilization mechanism (250) is tightened will be apparent to those skilled in the art in view of the teachings of this specification. Further, in other versions, the stabilization assembly (1116) is configured to allow rotation of the stabilization mechanism (250) during tightening. Again, such modifications to the stabilization assembly (1116) will be apparent to those skilled in the art in light of the teachings of this specification. Further, other modifications to the applicator (1200) will be apparent to those skilled in the art in light of the teachings of this specification. By way of example and not limitation, in some versions, the applicator (1200) may further incorporate a calibration function as described above with respect to the applicator (200).

[0091] In one version, the skull clamp (100) and the stabilization assemblies (114, 1116) are made of a radiolucent material. In such versions, the applicator (1200) is also made of a radiolucent material, but in some other versions, the applicator (1200) is made of at least some materials that are not radiolucent. Due to the detachable nature of the applicator (1200), the imagination is not impaired by the material of the structure for the applicator (1200). It is further contemplated herein that the applicator (1200) can be used with devices other than the skull clamp (100) and the stabilization assembly (1116). For example, the applicator (1200) is adapted to be used with other fasteners that require applying torque to the fastener within the range of torque provided by the applicator (1200).

[0092] When using the applicator (1200), whether it is the skull clamp (100) or another structure, the resistance experienced by the user when setting the predetermined torque amount using the applicator (1200) is constant regardless of the value of the predetermined torque amount. For example, the resistance experienced by the user when setting the desired torque using the applicator (1200) is the same whether the user sets the torque to 50 Newton - meters or 100 Newton - meters. This is different from torque devices that use springs to establish torque settings and ranges. Similarly, the resistance experienced by the user when using the applicator (1200) to set the predetermined torque amount only includes overcoming the frictional force between the movable parts of the device. For example, there is a frictional force when moving the actuator (1150) to translate the sleeve (1190) along the arm (1172). Different torques can be set, and by doing so, the user can experience the same level of frictional force regardless of the value of the set torque.

[0093] As described above, the torque is controlled by varying the bending length of the arm (1172). Further, the bending length does not affect the resistance experienced by the user when setting the predetermined amount of torque using the applicator (1200). Further, when the applicator (1200) is configured with a positive torque setting, at the same time the applicator (1200) is configured such that the arm (1172) does not receive a bending force. This means that the applicator (1200) can remain stored at a positive predetermined torque setting without causing distortion to the internal components of the applicator (1200). Again, this is different from a torque device that uses one or more springs to control torque. In those devices that use a spring control mechanism, the device must be stored at a zero torque setting in order to avoid the aging spring strain that would then affect the torque. In the version described herein, the applicator (1200) can be set at a positive torque without straining the internal components. More specifically, this is achieved by rotating the housing (1120) while maintaining the elongate bit (1130) in a stationary state, such that the arm (1172) slides over the hook portion (1213) as described above. In this orientation, any bending force on the arm (1172) is removed.

[0094] IV. EXEMPLARY COMBINATION The following examples relate to various non-exhaustive ways in which the teachings of this specification can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or in a subsequent application of this application. There are no disclaimers. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein can be arranged and applied in numerous other ways. It is also contemplated that some variations can omit certain features mentioned in the following examples. Accordingly, none of the aspects or features mentioned below should be considered important unless so explicitly indicated by the inventor or the successor in interest of the inventor at a later date. If, in this application or a subsequent application related to this application, claims are presented that include additional features beyond those mentioned below, those additional features shall be presumed not to have been added for any reason related to patentability.

[0095] Example 1 An apparatus for stabilizing a patient's head during a medical procedure, the apparatus comprising: (a) a head fixation device configured to receive the patient's head; (b) a stabilization assembly connected to the head fixation device and configured to receive a stabilization mechanism configured to contact the patient's head; and (c) an applicator connectable to the stabilization assembly and configured to transmit torque to the stabilization assembly without exceeding a predetermined amount of torque. The applicator has: (i) a first member; and (ii) a second member, wherein, under a first condition, bending stress is applied to the first member by an interaction between the first member and the second member.

[0096] Example 2 In the apparatus according to Example 1, under a second condition, the first member is in a relaxed state in which the bending stress is not applied to the first member.

[0097] Example 3 In the apparatus described in Example 1, under a second condition, due to the interaction between the first member and the second member, a bending stress is applied to the first member, and the bending stress under the second condition is different in degree from the bending stress under the first condition.

[0098] Example 4 In the apparatus according to any one or more of Examples 1 to 3, the applicator further has a third member configured to be adjustable to set the predetermined amount of torque.

[0099] Example 5 In the apparatus described in Example 4, the third member contacts the first member at different positions along the longitudinal direction of the first member based on the set predetermined amount of torque.

[0100] Example 6 In the apparatus according to any one or more of Examples 4 to 5, the bending length of the first member is determined by the contact between the third member and the first member, and the bending length corresponds to the predetermined amount of torque.

[0101] Example 7 In the apparatus according to any one or more of Examples 1 to 6, the first member has at least one arm extending longitudinally with respect to the applicator.

[0102] Example 8 In the apparatus described in Example 7, the first member has a pair of arms extending longitudinally with respect to the applicator.

[0103] Example 9 In the apparatus described in Example 8, the second member is disposed between the pair of arms, and the pair of arms is configured to selectively contact the outer surface of the second member.

[0104] Example 10 In the apparatus according to any one or more of Examples 1 to 9, the second member has a pair of hook mechanisms, and the first member is configured to selectively contact the hook mechanisms.

[0105] Example 11 In the apparatus according to any one or more of Examples 1 to 10, when the torque applied to the stabilization assembly is less than the predetermined torque, the first member is operable to couple to the outer surface of the second member, and thus rotation of the applicator causes corresponding rotation of the second member.

[0106] Example 12 In the apparatus according to any one or more of Examples 1 to 11, when the torque applied to the stabilization assembly is greater than or equal to the predetermined torque, the first member is operable to slide over the second member, thus keeping the second member stationary during rotation of the applicator and further strengthening the stabilization assembly.

[0107] Example 13 In the apparatus according to any one or more of Claims 16 to 27, the applicator further has a bit configured to engage the stabilization assembly, the second member is connected to the bit, and the second member and the bit are configured to rotate integrally.

[0108] Example 14 In the apparatus according to any one or more of Examples 1 to 13, the stabilization assembly is configured to translate the stabilization mechanism without rotation of the stabilization mechanism.

[0109] Example 15 In the device according to any one or more of Examples 1 to 14, the applicator defines a rotation axis, and the stabilization assembly is configured to receive the stabilization mechanism such that the stabilization mechanism is oriented coaxially with the rotation axis.

[0110] Example 16 In the device according to any one or more of Examples 1 to 15, the applicator has an indicator mechanism that displays the predetermined amount of torque.

[0111] Example 17 In the device according to any one or more of Examples 1 to 16, the stabilization mechanism has skull pins.

[0112] Example 18 In the device according to any one or more of Examples 1 to 17, the applicator has a housing, and the first member is configured to rotate integrally with the housing.

[0113] Example 19 In the device according to any one or more of Examples 1 to 18, the applicator is detachably connectable to the stabilization assembly.

[0114] Example 20 In the device according to any one or more of Examples 1 to 19, the stabilization assembly has the stabilization assembly according to any one or more of Examples 22 to 27.

[0115] Example 21 In the device according to any one or more of Examples 1 to 20, the applicator has the device according to any one or more of Examples 28 to 41.

[0116] Example 22 An apparatus for stabilizing a patient's head during a medical procedure, comprising: (a) a head fixation device configured to receive the patient's head; and (b) a stabilization assembly connected to the head fixation device and configured to receive a stabilization mechanism configured to contact the patient's head. The stabilization assembly has: (i) a rotating member; and (ii) a translating member. The stabilization assembly further has: (c) an applicator configured to rotate the rotating member of the stabilization assembly, wherein the translating member is configured to translate in response to rotation of the rotating member.

[0117] Example 23 In the apparatus according to Example 22, there is a shape conformity between the rotating member and the translating member such that longitudinal translation is the only degree of freedom of movement of the translating member.

[0118] Example 24 In the apparatus according to any one or more of Examples 22 or 23, the translating member is threadably engaged with the rotating member.

[0119] Example 25 In the apparatus according to any one or more of Examples 22 to 24, the applicator is removable from the stabilization assembly, and the rotating member and the translating member remain with the stabilization assembly when the applicator is removed from the stabilization assembly.

[0120] Example 26 In the apparatus according to any one or more of Examples 22 to 25, the translating member is configured to receive the stabilization mechanism, and translation of the translating member causes corresponding translation of the stabilization mechanism without rotation of the stabilization mechanism.

[0121] Example 27 In the apparatus according to any one or more of Examples 22 to 26, the applicator is composed of the equipment according to any one or more of Claims 28 to 41.

[0122] Example 28 An apparatus for setting a torque amount and applying torque to an object, comprising: (a) a housing configured to rotate during use for applying torque to the object; (b) a bit extending from the housing, the bit being configured to be received by the object; (c) an actuator configured to set the torque amount; and (d) one or more arms extending longitudinally within the housing. Further, the bending length of the one or more arms changes by the operation of the actuator, and the torque amount applied by the apparatus correlates with the bending length of the one or more arms.

[0123] Example 29 In the apparatus according to Example 28, the actuator is accessible from the housing.

[0124] Example 30 In the apparatus according to any one or more of Examples 28 and 29, further comprising a main body, wherein the actuator is configured to adjust the position of the main body with respect to the one or more arms, and by adjusting the position of the main body with respect to the one or more arms, the bending length of the one or more arms is changed, and the torque applied by the apparatus correlates with the bending length of the one or more arms.

[0125] Example 31 In the apparatus according to any one or more of Examples 28 to 30, the actuator is rotatable for adjusting and setting the torque amount.

[0126] Example 32 In the device described in Example 31, the rotation of the actuator causes translation in the longitudinal direction of the main body.

[0127] Example 33 In the device according to any one or more of Examples 28 to 30, the actuator is slidable to adjust and set the torque amount.

[0128] Example 34 Regarding the device described in Example 33, sliding the actuator causes translation in the longitudinal direction of the main body.

[0129] Example 35 In the device according to any one or more of Examples 28 to 34, it further has a calibration mechanism configured to adjust the torque amount applied by the applicator.

[0130] Example 36 In the device according to any one or more of Examples 28 to 35, the bit defines a rotation axis and is configured to be received by at least a part of the object.

[0131] Example 37 In the device according to any one or more of Examples 28 to 36, when the device is used to set the torque amount, the resistance received by the user is constant regardless of the set value of the torque amount.

[0132] Example 38 In the device according to any one or more of Examples 28 to 37, when the device is used to set the torque amount, the resistance received by the user is configured to overcome only the frictional force between the movable parts of the device.

[0133] Example 39 In the device according to any one or more of Examples 28 to 38, when the device is used to set the torque amount, the bending length does not affect the resistance acceptable to the user.

[0134] Example 40 In the device according to any one or more of Examples 28 to 39, the device is configured to set a positive torque, and at the same time, the one or more arms are configured not to receive bending stress.

[0135] Example 41 In the device according to any one or more of Examples 28 to 40, the device further has a knob configured to rotate integrally with the bit, and the one or more arms are configured to contact the knob when rotating the housing. The contact of the knob applies bending stress to the one or more arms, and the knob and the bit are stationary under a first condition, and the knob and the bit rotate under a second condition.

[0136] Others It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be viewed relatively separately from each other. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0137] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some such potential modifications have been mentioned and others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are illustrative and not essential. Accordingly, the scope of the present invention should be considered from the perspective of the following claims and is understood not to be limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus for stabilizing a patient's head during a medical procedure, the apparatus comprising: (a) a head fixation device configured to receive the patient's head; (b) a stabilization assembly connected to the head fixation device and configured to receive a stabilization mechanism configured to contact the patient's head, the stabilization assembly; (c) an applicator connectable to the stabilization assembly, the applicator being configured to transmit torque to the stabilization assembly without exceeding a predetermined torque amount in order to adjust the magnitude of the force applied to the patient's head by the stabilization mechanism; (i) a first member; (ii) a second member, wherein under a first condition, bending stress is applied to the first member by an interaction between the first member and the second member; (iii) a third member configured to adjustably set the predetermined torque amount, the third member contacting the first member at different positions along the longitudinal direction of the first member based on the set predetermined torque amount, and the bending length of the first member being determined by the contact between the third member and the first member, the bending length corresponding to the predetermined torque amount, the third member; having, the applicator; having, an apparatus.

2. The apparatus according to claim 1, wherein under a second condition, the first member is in a relaxed state in which no bending stress is applied to the first member.

3. The apparatus according to claim 1, wherein under a second condition, bending stress is applied to the first member by the interaction between the first member and the second member, and the bending stress under the second condition is different in degree from the bending stress under the first condition.

4. The apparatus according to claim 1, wherein the first member has at least one arm extending longitudinally with respect to the applicator.

5. The apparatus according to claim 4, wherein the first member has a pair of arms extending longitudinally with respect to the applicator.

6. The apparatus according to claim 5, wherein the second member is disposed between the pair of arms, and the pair of arms are configured to selectively contact an outer surface of the second member. **Claim 7**: The apparatus according to claim 1, wherein the second member has a pair of hook mechanisms, and the first member is configured to selectively contact the hook mechanisms. **Claim 8**: The apparatus according to claim 1, wherein when the torque applied to the stabilization assembly is less than the predetermined torque amount, the first member is operable to couple to the outer surface of the second member, and thus rotation of the applicator causes corresponding rotation of the second member. **Claim 9**: The apparatus according to claim 1, wherein when the torque applied to the stabilization assembly is greater than or equal to the predetermined torque amount, the first member is operable to slide over the second member, and thus the second member remains stationary during rotation of the applicator and further tightens the stabilization assembly. **Claim 10**: The apparatus according to claim 1, wherein the applicator further has a bit configured to engage the stabilization assembly, the second member is connected to the bit, and the second member and the bit are configured to rotate integrally. **Claim 11**: The apparatus according to claim 1, wherein the stabilization assembly is configured to translate the stabilization mechanism without rotation of the stabilization mechanism. **Claim 12**: The apparatus according to claim 1, wherein the applicator defines a rotation axis, and the stabilization assembly is configured to receive the stabilization mechanism such that the stabilization mechanism is oriented coaxially with the rotation axis. **Claim 13**: The apparatus according to claim 1, wherein the applicator has an indicator mechanism for displaying the predetermined torque amount. **Claim 14** In the apparatus according to any one or more of claims 1 to 13, the stabilization mechanism has a skull pin. **Claim 15**: The apparatus according to claim 1, wherein the applicator has a housing, and the first member is configured to rotate integrally with the housing. **Claim 16**: The apparatus according to claim 1, wherein the applicator is detachably connectable to the stabilization assembly.

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