Head stabilization device with detachable torque applicator

Abstract

A head stabilization device includes a stabilizing component and an applicator to control the amount of force applied to a patient's head by the stabilizing feature. The applicator includes a torque control feature that ensures that a desired torque setting is not exceeded during use. The applicator can be detached from the rest of the system, allowing the head stabilization device to be used without the attached torque control feature or structure. In one variation, the applicator controls the torque by adjusting the bending length of a pair of arms extending within the applicator.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 939,053, filed November 22, 2019, entitled “Head Stabilization Device with Detachable Torque Applicator,” the disclosure of which is incorporated herein by reference.

[0003] background

[0004] The disclosed devices and methods relate to the field of patient stabilization, and particularly to stabilizing the head and neck using stabilization devices known as head stabilization devices, also referred to as head fixation devices (hereinafter “HFDs” or “HFD” in the singular). HFDs are sometimes used during various surgical and other medical procedures, such as during surgery or examinations of the head or neck where it may be desirable to hold the patient’s head firmly in a specific position. When stabilizing a patient’s head, techniques include invasive and non-invasive setups. Invasive setups may use stabilizing features in the form of pins to contact the patient’s head, and particularly the skull. Non-invasive setups may use stabilizing features in the form of pads or other structures configured to contact the patient’s head but not penetrate the skin. HFDs used with both invasive and non-invasive setups include structures or components configured to hold and position one or more stabilizing features.

[0005] HFDs are also configured to adjust their size to accommodate patients with different head sizes. When stabilizing a patient with an HFD, one or more stabilizing features can be tightened in a controlled manner to apply a desired amount of force to the patient's head to achieve acceptable stability. The apparatus and method described herein also relate to adjusting this force applied by one or more stabilizing features. While various head stabilization devices have been manufactured and used, it is believed that no one had manufactured or used an invention as described herein before the inventors. Brief description of the attached diagram

[0007] Although the specification concludes by explicitly pointing out and clearly claiming the claims of the invention, it is believed that the invention will be better understood through the following description of certain examples taken in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements and wherein:

[0008] Figure 1 A perspective view of an exemplary patient head support system is depicted, showing a skull clamp with a stabilizing component having a detachable torque applicator.

[0009] Figure 2 Depicting Figure 1 A perspective view of the patient's head support system, showing the torque applicator detached from the stabilizing component.

[0010] Figure 3 Depicting Figure 1 A perspective view of the torque applicator.

[0011] Figure 4 Depicting Figure 1 Another perspective view of the torque applicator.

[0012] Figure 5 Depicting Figure 1 Side view of the torque applicator.

[0013] Figure 6A Depicting along Figure 5 The line 6-6 was cut Figure 1 A cross-sectional view of the torque applicator, showing the applicator in the first torque setting.

[0014] Figure 6B Depicting along Figure 5 The line 6-6 was cut Figure 1 A cross-sectional view of the torque applicator, showing the applicator in the second torque setting.

[0015] Figure 7 Depicting Figure 1 Another side view of the torque applicator, which is from... Figure 5 The side view is rotated 90 degrees around its longitudinal axis.

[0016] Figure 8A Depicting along Figure 7 The line 8-8 cut Figure 1 A cross-sectional view of the torque applicator, showing the applicator in the first torque setting.

[0017] Figure 8B Depicting along Figure 7 The line 8-8 cut Figure 1 A cross-sectional view of the torque applicator, showing the applicator in the second torque setting.

[0018] Figure 9 Depicting along Figure 5 The line 9-9 was cut off Figure 1 A cross-sectional view of the torque applicator.

[0019] Figures 10A-10C Depicting along Figure 5 The line cut from 10-10 Figure 1 A series of cross-sectional views of the torque applicator, showing the location of the components of the torque applicator in use.

[0020] Figure 11Depicting along Figure 5 The line 11-11 cut Figure 1 A cross-sectional view of the torque applicator.

[0021] Figure 12 Depicting Figure 1 A partial perspective view of an exemplary coupling sleeve for a torque applicator.

[0022] Figure 13 Depicting Figure 1 A cross-sectional view of a portion of the stabilizing component of the skull clamp, showing the connecting sleeve connected to the stabilizing component.

[0023] Figure 14 A front view of the stabilizing assembly within the arm of the skull clamp is depicted, showing the stabilizing features removed.

[0024] Figure 15 A perspective view of another exemplary patient head support system is depicted, showing... Figure 1 The skull clamp and another stabilizing component with another detachable torque applicator.

[0025] Figure 16 Depicting along Figure 15 The line 16-16 was cut Figure 15 Cross-sectional view of the stabilizing components and the detachable torque applicator.

[0026] Figure 17 Depicting along Figure 15 The line 17-17 was cut off Figure 15 Cross-sectional view of the stabilizing components and the detachable torque applicator.

[0027] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the invention can be conceived to be implemented in various other ways, including those not necessarily depicted in the drawings. The drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with this description, serve to explain the principles of the invention; however, it is to be understood that the invention is not limited to the explicit arrangement shown.

[0028] Detailed description

[0029] The following description of certain examples of the invention should not be construed as limiting the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is illustrative and represents one of the best modes contemplated for carrying out the invention. As will be appreciated, the invention can have other different and obvious aspects, all of which do not depart from the invention. Therefore, the drawings and description should be considered illustrative in nature and not restrictive.

[0030] I. Exemplary Patient Head Support System

[0031] Figure 1 and Figure 2 An exemplary patient head support system (10) is illustrated, which has an HFD in the form of a skull clamp (100) and a torque applicator (200). The skull clamp (100) includes an arm (102) defining an upright portion (104) and a lateral portion (106). The skull clamp (100) also includes an arm (108) defining an upright portion (110) and a lateral portion (112). As shown, the lateral portions (106, 112) are configured to be connected together in a selectively adjustable manner. This configuration allows for variation in the spacing between the upright portions (104, 110) to accommodate patients with different head sizes.

[0032] Each upright portion (104, 110) of the skull clamp (100) includes a hole at one end configured to receive a stabilizing component. In this example, the upright portion (104) is shown with a stabilizing component (114), while the upright portion (110) is shown with a stabilizing component (116). The stabilizing component (114) is configured with a rocker assembly (118) capable of holding two stabilizing features (250). The stabilizing component (116) is configured with a hole capable of holding a single stabilizing feature (250). In one variation, the stabilizing feature (250) held by the stabilizing components (114, 116) is a skull pin. However, in other variations, the stabilizing feature (250) held by the stabilizing components (114, 116) is a pad or a combination of a pin and a pad. In this way, depending on the type or style of stabilizing feature used, the system (10) can be either invasive or non-invasive.

[0033] The skull clamp (100) also includes a torque applicator (200) configured to selectively connect with the skull clamp (100) via a stabilizing assembly (116) and a connecting sleeve (230) of the torque applicator (200). When compared... Figure 1 and Figure 2 This selective connection can be seen when the torque applicator (200) is in Figure 1 It is connected to the skull clamp (100) and can be detached from the skull clamp (100), such as Figure 2 As seen below, the torque applicator (200) includes a coupling sleeve (230) (see also...). Figure 12The coupling sleeve (230) allows the torque applicator (200) to be securely and selectively connected to the stabilizing assembly (116) and to maintain the connection without requiring the user to hold it in place. The coupling sleeve (230) can be actuated to remove or detach the torque applicator (200) from the stabilizing assembly (116) of the skull clamp (100). Again, further details of the coupling sleeve will be referenced below. Figure 12 supply.

[0034] In use, the patient's head is positioned within the space of the head support system (10) between the upright portions (104, 110) of the skull clamp (100). The skull clamp (100) is then adjusted so that the upright portions (104, 110) of the arms (102, 108) are brought closer together until the stabilizing features (250) of the stabilizing components (114, 116) are almost or just in contact with the patient's head. Next, a torque applicator (200) is used to adjust the amount of force applied to the patient's head by the stabilizing features (250). This is achieved by applying a predetermined amount of force to the patient's head using the torque applicator (200) to achieve stability without applying excessive force that could cause trauma to the patient's head. In this way, the torque applicator (200) includes features to prevent the torque applicator (200) from applying a torque exceeding a predetermined amount set using the torque applicator (200).

[0035] When torque is applied, the torque applicator (200) applies a predetermined force to a stabilizing feature (250) connected to a stabilizing component (116). A stabilizing component (114) is typically opposite to the stabilizing component (116), and once the stabilizing feature (250) of the stabilizing component (114) contacts the patient's head, the stabilizing component (114) is secured. In this way, equal and opposite forces are applied by the opposing stabilizing components (114, 116). However, the number of stabilizing features (250), the position of each stabilizing feature (250), and the angle of each stabilizing feature (250) relative to the patient's head affect the direction and magnitude of the applied stabilizing force. Therefore, not all individual stabilizing features (250) must apply a force of the same magnitude or direction to the patient's head. Further details regarding the torque applicator (200) and its use will be described in the following sections.

[0036] II. An exemplary detachable torque applicator with a rotatable actuator

[0037] Figures 3-11 An exemplary torque applicator (200) is illustrated. The torque applicator (200) is sometimes simply referred to herein as applicator (200). Reference Figures 3-5 and Figure 7The 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) also generally defines the outer periphery of the applicator (200). At the distal end, the housing (120) includes an opening (122) through which an elongated drill bit (130) extends. The applicator (200) defines a longitudinal axis (LA). The longitudinal axis (LA) defines an axis of rotation about which the elongated drill bit (130) and other components of the applicator (200) can rotate. In this example, the distal end of the elongated drill bit (130) has a six-point star shape; however, in other variations, the distal end of the elongated drill bit (130) may have other shapes, such as slotted, cross-shaped, square, etc., and other shapes that will be apparent to those skilled in the art given the teachings herein.

[0038] At the proximal end of the housing (120), such as Figure 4 As shown is another opening (124) and a cover (140) fitting within the opening (124). In some variations, the cover (140) has a snap-fit ​​engagement with the housing (120), while in other variations, the cover (140) can be secured to the housing (120) by a pin that extends through both the housing (120) and the cover (140). In some variations, the cover (140) includes a plurality of slots that provide visual access to the interior of the housing (120). At the center of the cover (140) is an opening (142) configured to receive a calibration sleeve (180), which is part of a calibration assembly or feature. Figure 4 As shown, the proximal end of the elongated drill bit (130) is received within the calibration sleeve (180). In some variations, 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 further detail below when the calibration process is described.

[0039] Still referencing Figure 3 and Figure 4The housing (120) also includes lateral openings (121, 123). The openings (121, 123) are located on opposite sides of the housing (120). In this example, the openings (121, 123) are also generally positioned towards the distal end of the housing (120). The openings (121, 123) provide access to an actuator (150) which can be used to adjust the torque setting of the applicator (200), as will be described in more detail below. Longitudinally extending elongated divots (125) are present along the outer surface of the housing (120). In this example, the divots (125) are spaced around the perimeter of the housing (120). In this way, the divots (125) are configured as gripping features to enhance gripping capability when gripping the torque applicator (200). In some variations, the actuator (150) may include longitudinally extending recesses spaced around the periphery of the actuator (150). In this way, such recesses may be configured as gripping features to enhance gripping capability when gripping the actuator (150), thereby adjusting the torque setting of the applicator (200) by rotating the actuator (150).

[0040] The housing (120) has two recesses (125) comprising elongated slots (126). In this example, the elongated slots (126) are located on opposite sides of the housing (120). Within each elongated slot (126) is a pin (161) configured to translate within its corresponding slot (126). These pins (161) translate when the actuator (150) is rotated to adjust the torque setting. In some variations, adjacent to the elongated slots (126) are torque setting graduations marked on the outer surface of the housing (120). In this variation, the pins (161) act as force indicators by pointing to or being associated with the graduations. In some variations, the graduations may be numerical, while in others, they may provide a relative indication. By way of example only and not limitation, relative indications may include color-coded graphics, where one color may indicate an acceptable torque setting, while another or more colors may indicate a torque setting that is too low or too high. Given the teachings of this document, other ways of providing feedback or indication of torque settings will be apparent to those skilled in the art.

[0041] In some variations, a plurality of holes may be present near the proximal end along the periphery of the housing (120), extending laterally into the housing (120) and evenly spaced around the periphery of the housing (120). These holes may be configured to receive set screws (162) (see...). Figure 8A and Figure 8BAs will be described in more detail below, the set screw (162) is configured to fix the calibration setting of the torque applicator (200). In some variations, there may also be an additional hole that can be configured to receive a pin to secure the cover (140) to the housing (120) as described above.

[0042] In some variations, a transverse aperture may be present at or near the distal end of the housing (120), the transverse aperture being configured to receive a pin, which is configured to receive the fork member (170) (see...). Figure 6A and Figure 6B The fork member (170) is fixed to the housing (120). The fork member (170) is a control feature for changing the torque applied by the applicator (200), as will be described in more detail below. Through this exemplary pin-connection with the housing (120), the fork member (170) rotates uniformly with the housing (120), as will be further described below. In some other variations, this pin-connection can be replaced by another type of fastener, such as a flathead screw.

[0043] refer to Figures 5-11 Further details of the internal components of the torque applicator (200) and its operating characteristics will be described. From Figures 5-6B Initially, the actuator (150) is shown as a tubular structure having an internal space (153) and a distal opening (154) and a proximal opening (155). A sleeve (190) is positioned within the internal space (153) and extends from the proximal end (155) of the actuator (150). 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).

[0044] The actuator (150) includes a threaded portion (152) that threadedly engages with a threaded portion (191) of the sleeve (190). In this way, rotation of the actuator (150) results in 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 variant, when the applicator (200) is viewed from the proximal end, clockwise rotation of the actuator (150) results in proximal translation of the sleeve (190), as with... Figure 6A Compared to the time Figure 6BAs seen in the document. In the opposite manner, when the applicator (200) is viewed from the proximal end, the actuator (150) rotates counterclockwise, causing the sleeve (190) to translate distally. In this example, the sleeve (190) is configured to translate a distance that spans from the cap (140) at one end of the applicator (200) to the lip (173) of the fork member (170) at the other end of the applicator (200). In other variations, the actuator (150) and the sleeve (190) may be configured to cause the sleeve (190) to translate in a manner opposite to that just described above, or to translate to a smaller extent in terms of the translation distance, as will be apparent to those skilled in the art given the teachings herein. Furthermore, the actuator (150) may have, in addition to Figures 5-11 Various structures and forms other than the rotating tubular structure shown herein. For example, the actuator (150) may be designed as a thumbwheel, a rotating sleeve or tubular body, a slider configured for translation, and other structural forms that will be apparent to those skilled in the art given the teachings herein.

[0045] As described above, the sleeve (190) includes a pin (161) at its proximal end. When the sleeve (190) translates based on the rotation of the actuator (150), the pin (161) moves along the sleeve (190) along a slot (126) in the housing (120). As described above, the pin (161) is configured in this way to act as a force indicator by indicating torque setting, which will be more clearly understood from the following description. Because the pin (161) extends within the slot (126) of the housing (120), rotation of the housing (120) will cause a corresponding rotation of the pin (161), and thus the sleeve (190) and the connected actuator (150). This rotation of the actuator (150) and the sleeve (190) with the housing (120) occurs without changing the relative position of the sleeve (190) with respect to the actuator (150).

[0046] The sleeve (190) is also configured with transverse openings (196) within its sidewalls. The openings (196) are configured to reduce mass and provide access to the interior space (192) for cleaning, observation, etc. In some variations, the number of transverse openings (196) may be greater or less than that shown in this example. The sleeve (190) includes an inner surface (198) defining the interior space (192). The inner surface (198) is generally tapered from the proximal to the distal end of the sleeve (190); however, a portion (197) of the sleeve (190) may be straight or non-tapered.

[0047] A fork-shaped member (170) extends through the internal space (153) of the actuator (150) and extends from a distal opening (154). The fork-shaped 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 lip (173). When assembled with the actuator (150), the diameter of the lip (173) is larger than the distal opening (154) of the actuator (150) such that the fork-shaped member (170) cannot extend beyond the distal opening (154) of the actuator (150). In some other variations, the fork-shaped member (170) may also be pinned to the housing (120). In this way, the actuator (150) is maintained in its longitudinal position relative to the housing (120) because the actuator (150) cannot move proximally across the lip (173) of the fork member (170). Similarly, the distal end of the actuator (150) is adjacent to or immediately abutted against the inner distal flange (129) of the housing (120), which prevents the actuator (150) from moving distally relative to the housing (120).

[0048] like Figure 8A and Figure 8B As shown, the elongated drill bit (130) extends through the body portion (171) of the fork member (170) and eventually protrudes from the distal end of the housing (120). The elongated drill bit (130) and the body portion (171) of the fork member (170) are configured such that the fork member (170) and the elongated drill bit (130) can rotate independently of each other. This independent rotation occurs when the torque setting or limit is reached and the elongated drill bit (130) does not rotate with further rotation of the housing (120) (although the fork member (170) rotates with the housing (120)). However, under certain conditions, the elongated drill bit (130) and the fork member (170) can rotate synchronously. This can also be the case when the torque setting or limit has not been reached and the elongated drill bit (130) rotates synchronously with the fork member (170), as described below. In this example, the applicator (200) includes a pin (164) located between the body portion (171) of the fork member (170) and the elongated drill bit (130). The pin (164) is configured to allow rotation between the elongated drill bit (130) and the fork member (170) under certain conditions during use of the applicator (200). In some variations, more than one pin (164) may be used between the drill bit (130) and the fork member (170).

[0049] refer to Figure 7 , Figure 8A and Figure 8BThe interaction between the sleeve (190) and the fork member (170) will be described to explain the setting of a predetermined or preset torque amount. As described above, the fork 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 from the longitudinal axis (LA) in response to such contact. Based on this contact between the arm (172) and the knob (210) under these conditions, bending stress is imposed on the arm (172). In at least some instances, this bending stress occurs when a force is normally applied to the arm (172), wherein the direction of the force is not parallel to the longitudinal axis or length of the arm (172). In some, but not all, cases, the direction of the force may be orthogonal to the longitudinal axis or length of the arm (172). The result of this force is that the arms (172) bend or deflect from their neutral position or state. However, under other conditions, the proximal end of the arm (172) may contact the knob (210), in which case the arm (172) does not bend or deflect away from the longitudinal axis (LA).

[0050] Refer to Figure 8 and Figure 9 A knob (210) is positioned around an elongated drill bit (130) such that the drill bit (130) extends through the knob (210). Furthermore, the knob (210) includes a distal opening (211) having a flat side (212). The elongated drill bit (130) includes a profile having a flat side (131) along its length at the location where the elongated drill bit (130) passes through the opening (211). The corresponding flat sides (131, 212) of the openings (211) of the drill bit (130) and the knob (210) form an interference fit between the elongated drill bit (130) and the knob (210). This interference fit causes the knob (210) and the elongated drill bit (130) to rotate synchronously. Therefore, when the knob (210) rotates, the corresponding rotation of the elongated drill bit (130) occurs.

[0051] refer to Figures 10A-10C The knob (210) includes a pair of curved hook-like features (213). As shown, the proximal end of the arm (172) is configured to contact the corresponding hook-like feature (213) when the fork-shaped member (170) is rotated counterclockwise (when the applicator (200) is viewed from its proximal end). This in Figure 10AThe direction of rotation is indicated by the arrow (A1). In this way, counterclockwise rotation of the fork member (170) will result in a corresponding counterclockwise rotation of the knob (210) and the elongated drill bit (130). Furthermore, the arm (172) contacts the hook feature (213) of the knob (210) in such a way that the arm (172) does not bend or deflect away from the longitudinal axis (LA). In addition, the proximal end of the arm (172) is received in a corresponding slot (143) of the cover (140). The slot (143) maintains the position of the arm (172) so that the arm (172) does not deflect, that is, the arm (172) does not deflect when the proximal end of the arm (172) contacts the hook feature (213) of the knob (210). As previously described, the fork-shaped member (170) can be secured to the housing (120) by a pin or other structure, such that the fork-shaped member (170) rotates uniformly with the housing (120). Therefore, a counter-clockwise rotation of the housing (120) (when the applicator (200) is viewed from its proximal end) produces a corresponding rotation of the elongated drill bit (130) in the same direction. This counter-clockwise rotation can be considered a use case for the torque applicator (200). In at least some cases, rotation in this manner loosens or reduces the contact or engagement of the stabilizing feature (250) of the stabilizing component (116) with the patient's head.

[0052] Now consider the housing (120) rotating clockwise (when viewed from the proximal end). For the reasons described above, the fork-shaped member (170) will rotate in unison with the housing (120). Reference Figures 10A-10C This clockwise rotation causes the arms (172) to move in the same manner, as indicated by the direction of arrow (A2). The distance between the arms (172) is less than the diameter of the hook-shaped feature (213) at the point of maximum diameter of the knob (210). Therefore, 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-shaped feature (213). Furthermore, since the distance between the proximal ends of the arms (172) is less than the distance between the points of maximum diameter of the hook-shaped feature (213), the contact between the proximal ends of the arms (172) and the outer curved surface (214) of the hook-shaped feature (213) causes the arms (172) to adopt a position as shown by arrow (A2). Figure 10B and Figure 10C The location or state of the bend or deflection shown. For example... Figures 9-10C As shown, the slot (143) of the cover (140) is elongated to allow the proximal end of the arm (172) to deflect away from the longitudinal axis (LA) when the applicator (200) is used in this manner.

[0053] With this bending or deflecting configuration of the arm (172), the arm (172) applies an inward force to the hook-shaped feature (213) of the knob (210). This produces a holding or squeezing effect where the arm (172) holds or squeezes the knob (210). Based on the engagement of the elongated drill bit (130) with the stabilizing component (116) and the contact between the stabilizing feature (250) and the patient's head, when the force applied by the arm (172) is higher than the resistance applied to the elongated drill bit (130), the rotation of the arm (172) of the housing (120) and the fork member (170) allows the arm (172) to hold the knob (210) with sufficient force so that the knob (210) and the connected elongated drill bit (130) rotate in unison with the arm (172). In this way, the stabilizing feature (250) of the stabilizing component (116) can be tightened by rotating the housing (120) clockwise (when viewed from the proximal end of the applicator (200).

[0054] Based on the engagement of the elongated drill bit (130) with the stabilizing component (116) and the contact between the stabilizing feature (250) and the patient's head, when the resistance applied to the elongated drill bit (130) is higher than the force applied by the arm (172) to the knob (210), the arm (172) will slide or glide over the hook-shaped feature (213) of the knob (210). When the arm (172) slides or glides a sufficient distance, it returns to its relaxed state by elastically snapping back on the arm (172). Figure 10A The position shown. In this neutral or relaxed state, the arm (172) no longer bends or deflects outward from the longitudinal axis (LA). Therefore, the arm (172) and the connected housing (120) will rotate, but the knob (210) and the elongated drill bit (130) do not rotate accordingly. Therefore, although further tightening or rotational force may have been applied to the housing (120) and the fork member (170), this further tightening or rotational force will not be transmitted to the knob (210) and the elongated drill bit (130), and therefore the stabilizing component (116) connected to the elongated drill bit (130) will not be subjected to further tightening or rotational force. Clockwise rotation with the knob (210) rotating can be considered another use case of the torque applicator (200), and similarly, clockwise rotation with the knob (210) not rotating can be considered another use case of the torque applicator (200).

[0055] In the torque applicator (200) of this example, the amount of force applied or applied by the arm (172) to the knob (210) is a function of the bending length of the arm (172). For example, refer to Figure 8A and Figure 8BThe arm (172) is shown to have different bending lengths. Furthermore, the applicator (200) is configured such that the bending length of the arm (172) is adjustable. This adjustment is achieved through the interaction between the sleeve (190) and the arm (172) of the fork member (170).

[0056] The sleeve (190) includes a portion (197) positioned next to the arm (172). (See comparison...) Figure 8A and Figure 8B As shown in the time, with Figure 8B In comparison, Figure 8A In the middle, part (197) is located further to the side. The bending length can be defined as the length of the arm (172) extending proximally from part (197) of the sleeve (190) to the point next to the distal part of the knob (210) at the arm (172). Therefore, Figure 8A The illustration shows a case with a first bending length, which is greater than... Figure 8B The second bending length is shown in another case. As described above, rotation of the actuator (150) causes translation of the sleeve (190), thereby providing a different bending length for the arm (172). Thus, the bending length of the arm (172) of the fork member (170) is controlled by rotation of the actuator (150). As will be further described below, the bending length of the arm (172) is also affected by a calibration step in which the distal portion of the knob (210) moves relative to the arm (172). However, calibration performed in this way is configured as a separate calibration process and is not configured to replace or supersede adjustment of the bending length to control the torque in use.

[0057] Since the bending length is related to the torque setting, a smaller bending length is associated with a larger bending force. In other words, as the bending length of the arm (172) decreases, more force is required to bend the arm (172). Similarly, the greater the force exerted by the arm (172) on the hook feature (213), the shorter the bending length of the arm (172) will be, and therefore the maximum torque setting will be. Likewise, when the sleeve (190) is translated to its furthest position, the bending length of the arm (172) will be the longest, and therefore the minimum torque setting will be.

[0058] In this variant, a 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-shaped feature (213) of the knob (210) and the arm (172). For example, depending on the position of the sleeve (190), for a shorter or smaller bending length of the arm (172), a larger force will be required to cause the arm (172) to bend to the point where the arm (172) slides or glides past the hook-shaped feature (213) of the knob (210) when the housing (120) is rotated clockwise. In other words, when tightened, the applicator (200) can apply a larger torque to the stabilizing assembly (116). Conversely, the longer or greater the bending length of the arm (172), also based on the position of the sleeve (190), the less force is required to cause the arm (172) to bend to the point where the arm (172) slides or glides past the hook feature (213) of the knob (210) when the housing (120) is rotated clockwise. In other words, when tightened, the applicator (200) applies a smaller torque to the stabilizing assembly (116).

[0059] By way of example only and not limitation, in one exemplary use, the applicator (200) can be adjusted by rotation of the actuator (150) such that the torque indicator reading is 60 Nm. The head support system (10) is configured to position the patient's head within a skull clamp (100), and the skull clamp (100) has stabilizing components (114, 116) configured with skull pins as stabilizing features (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 stabilizing component (116), and the elongated drill bit (130) engages with the star-shaped groove (221) of the stabilizing component (116). The applicator housing (120) is then rotated clockwise (when viewed from the proximal end of the applicator housing (120)). As described above, rotation of the housing (120) causes corresponding rotation of the fork-shaped member (170) and the cover (140). The arm (172) of the fork-shaped member (170) rotates about the knob (210) and eventually contacts the outer curved surface (214) of the hook-shaped feature (213), for example, as Figure 10B As shown.

[0060] Since the stabilizing features (250) of the stabilizing assembly (116) are not yet tightened, tightening them requires a force of less than 60 Nm. Therefore, rotating the applicator housing (120) will tighten the skull pin stabilizing feature (250) connected to the stabilizing assembly (116). This is because the proximal end of the arm (172) engages or contacts the hook-shaped feature (213) of the knob and applies sufficient force to the knob (210) to hold and rotate the knob (210) and the elongated drill bit (130) extending through the knob. Figure 10CThe diagram shows a view in which the knob (210) and the elongated drill bit (130) have been rotated based on the force applied by the arm (172) to the hook-shaped feature (213) of the knob (210) as described above.

[0061] After some tightening, the stabilizing feature (250) of the stabilizing assembly (116) requires a force greater than 60 Nm to further tighten. At this point, a further clockwise rotation of the housing (120) again causes the arm (172) of the fork member (170) to rotate. However, the force required to bend the arm (172) away from the longitudinal axis (LA) to the point where the arm (172) will slide or glide along the outer curved surface (214) of the hook feature (213) is set to 60 Nm. As previously stated, further tightening of the stabilizing feature (250) requires a torque setting greater than 60 Nm on the applicator (200). Since the torque is set at 60 Nm in this example, rotating the housing (120) will cause the arm (172) to now slide or glide over the hook feature (213). For example, when, for example Figure 10C The arm (172) shown slides over the hook-shaped feature (213) and employs, for example... Figure 10A This is illustrated in a series of views when the position is shown. When this occurs, as the arm (172) passes the hook-shaped feature (213), the arm (172) will snap back or click back to its original position. Figure 10A The position shown eliminates bending or deflection forces on the arm (172). This snap or click provides feedback to the applicator (200), signaling to the user that the torque limit has been reached when the stabilizing feature (250) is tightened. In this case, the knob (210) and the elongated drill bit (130) do not rotate with the rotation of the housing (120) and the fork member (170).

[0062] If the user of the patient head support system (10) decides that a greater clamping pressure is required, the torque setting can be increased, for example, to 100 Nm, by rotating the actuator (150). Subsequently, further rotation of the housing (120) of the applicator (200) will cause the arm (172) to rotate such that the proximal end of the arm (172) contacts the outer curved surface (214) of the hook feature (213) and presses it against the hook feature (213) of the knob (210) with sufficient force to cause rotation of the knob (210) and the elongated drill bit (130) extending through the knob. Once the stabilizing feature (250) of the stabilizing component (116) is tightened to the point where a force greater than 100 Nm is required to further tighten the stabilizing feature (250), the rotation of the housing (120) of the applicator (200) will again rotate the arm (172), but the elongated drill bit (130) and the knob (210) will apply sufficient bending force to the arm (172) so that the arm (172) will bend and slide or glide over the hook feature (213) of the knob (210) instead of gripping the knob (210) and causing the knob (210) to rotate.

[0063] When it is necessary to release the stabilizing component and possibly remove the patient's head from the skull clamp (100), the applicator (200) engages with the groove (221) and rotates counterclockwise (when viewed from the proximal end of the applicator (200)). Due to the configuration of the arm (172) and knob (210), torque setting adjustments with the actuator (150) and sleeve (190) are not required before releasing the stabilizing feature. As described above, by rotating counterclockwise, the proximal end of the arm (172) contacts the tip region (215) of the hook feature (213), thereby rotating the knob (210) and the elongated drill bit (130), regardless of the bending length configuration of the arm (172) and the sleeve (190). The above example is merely exemplary. In light of the teachings herein, those skilled in the art will understand other methods for securely stabilizing a patient's head with known clamping forces without exceeding the desired clamping force using the devices and systems shown and described herein.

[0064] In addition to the effects of the bending force on the arm (172) and the characteristics of the arm (172) in gripping the knob (210), applying force to the knob (210) to rotate the knob (210), or sliding over the knob (210), friction also affects the torque setting and application of the applicator (200). For example, friction exists where the proximal end of the arm (172) contacts the hook-shaped feature (213) of the knob (210). Therefore, the threshold at which the arm (172) slides or slides along the hook-shaped feature (213) and over the hook-shaped feature (213) is a function of the bending force applied to the arm (172) and the friction between the arm (172) and the hook-shaped feature (213) of the knob (210). In some cases, the materials of the arm (172) and / or the knob (210) can be configured or modified to provide greater or less friction between these components. In light of the teachings herein, other methods of controlling and modifying the force interaction between the arm (172) and the hook-shaped feature (213) of the knob (210) will be apparent to those skilled in the art.

[0065] Figure 6A , Figure 6B , Figure 8A , Figure 8B and Figure 11 The illustration shows features of an applicator (200) configured to calibrate the applicator (200) for torque setting capability. As shown, the applicator (200) includes a calibration sleeve (180). As described above, the calibration sleeve (180) is located at the proximal end of the applicator (200). The calibration sleeve (180) is positioned within an opening of a cap (140) and extends distally within a housing (120) of the applicator (200). In some variations, the proximal portion of the calibration sleeve (180) may include a pair of openings configured to receive a tool for rotating and thereby adjusting the calibration sleeve (180). In other variations, the calibration sleeve (180) may be rotated by hand or other tools when the cap (140) and / or housing (120) are removed from the applicator (200), thereby providing access to the calibration sleeve (180) for adjustment. The distal portion of the calibration sleeve (180) includes the threaded portion (182).

[0066] The threaded portion (182) of the calibration sleeve (180) engages with the threaded portion (216) of the knob (210). For example... Figure 6A , Figure 6B , Figure 8A and Figure 8BAs shown, the knob (210) includes an opening (217) extending from its proximal end through the knob (210) to its distal end. A threaded portion (216) is positioned along the inner surface of the opening (217). Furthermore, the distal portion of the calibration sleeve (180) is configured to engage within the opening (217) of the knob (210), wherein the threaded portions (182, 216) are threadedly engaged. 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).

[0067] like Figure 8A and Figure 8B As best shown, the distal portion of the knob (210) is positioned along the inner surface of the arm (172) of the fork member (170). Translation of the knob (210) based on rotation of the calibration sleeve (180) causes the distal portion of the knob (210) to move along the inner surface of the arm (172). The bending length of the arm (172) is adjustable depending on the amount of overlap between the distal portion of the knob (210) and the inner surface of the arm (172). Controlling the bending length in this respect provides a method for setting the calibration torque.

[0068] In the exemplary calibration sequence, the first step is to remove the cap (140) and then remove the set screw (162) from the proximal end of the applicator (200). Figure 11 As shown, a set screw (162) is configured to connect a calibration sleeve (180) to a long drill bit (130). As shown, the long drill bit (130) includes a spoke-shaped profile along this location. When the set screw (162) is installed, the tip of the set screw is received in the space between the two spoke portions (132) of the spoke-shaped profile of the long drill bit (130). By removing the set screw (162), the calibration sleeve (180) can be rotated. As described above, this rotation of the calibration sleeve (180) is based on the threaded engagement of the knob (210) with the calibration sleeve (180), resulting in a corresponding translation of the knob (210). In this respect, the set screw (162) is removed from contact with the long drill bit (130) so that the knob (210) can translate in response to the rotation of the calibration sleeve (180). As described above, Figure 9 The arrangement of the flat sides (131, 212) of the elongated drill bit (130) and the knob (210) shown ensures that, with the set screw (162) engaged with the elongated drill bit (130), rotation of the calibration sleeve (180) will cause rotation of the elongated drill bit (130), which in turn will cause a corresponding rotation of the knob (210). Therefore, removing the set screw (162) from the elongated drill bit (130) allows the elongated drill bit (130) to remain stationary while the calibration sleeve (180) is rotated to calibrate using the translation knob (210).

[0069] During the calibration step, the applicator (200) can be checked with a reference device having a known torque or used with a torque measuring device. For example, if connected to a torque measuring device or used with a reference device having a known torque of 80 Nm, the applicator (200) can be adjusted by rotating the actuator (150) so that the pin (161) indicates a torque setting of 80 Nm. The applicator (200) can then be used with a torque measuring device or a reference device having a known torque of 80 Nm to see if the applicator provides a torque setpoint of 80 Nm. If the actual torque provided by the applicator (200) is lower or higher than the 80 Nm setting, the calibration sleeve (180) can be adjusted so that the knob (210) is translated to provide adjustment of the torque output of the applicator (200) to 80 Nm in this example.

[0070] Once calibration is complete, ensuring the applicator (200) provides a torque output matching the setpoint, the set screw (162) is fully inserted to tighten or secure the relative positions of the knob (210), calibration sleeve (180), and elongated drill bit (130). In some other variations, the applicator (200) includes a plurality of holes extending laterally from the housing (120) toward the longitudinal axis (LA). In one such variation, six such holes may be evenly spaced around the perimeter of the applicator (200). In this variation, when the set screw (162) is inserted after calibration, the threaded hole (183) of the calibration sleeve (180) aligns with one of these holes, and the set screw (162) can then be inserted and secured within the hole and to the threaded hole (183). In one example where these holes are present in the housing (120), there may be six such holes, and the applicator (200) provides at least six incremental calibrations, or one increment every 60 degrees around the circumference of the applicator (200). In other variations, the applicator (200) may have more or fewer such holes for receiving set screws (162) for calibration, thus providing different calibration increments. In this example where there are no such holes, the calibration increment is determined by the number of intervals between the spoke portions (132) of the elongated drill bit (130). For example, in the case of a three-spoke configuration, calibration may be performed in three increments, or one increment every 120 degrees around the circumference of the applicator. The torque calibration structure and steps 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 light of the teachings herein.

[0071] Figure 12 and Figure 13A close-up view of a connecting sleeve (230) for use with the applicator (200) is depicted. The connecting sleeve (230) is configured to connect with the applicator (200) and further selectively connect with the stabilizing assembly (116). In this example, the connecting sleeve (230) is an extension of the fork member (170) extending distally from the housing (120) of the applicator (200). In other variations, the connecting sleeve (230) may be detachable from the fork member (170) and may otherwise connect with the applicator (200), as will be apparent to those skilled in the art in light of the teachings herein. Through these connections, the applicator (200) can be selectively connected to and detached from the stabilizing assembly (116) of the skull clamp (100).

[0072] The connecting sleeve (230) includes a collar (232) and a pair of attachment features (233) connected to and extending distally from the collar (232). The attachment features (233) are configured as elongated, angled bodies having latching members (234) oriented inward toward the longitudinal axis (LA). The attachment features (233) are also configured as resilient members, such that the attachment features (233) can deflect toward or away from the longitudinal axis (LA) depending on the direction of the force applied to the attachment features (233).

[0073] Figure 13 A stabilizing assembly (116) is depicted, configured to selectively receive a connecting sleeve (230). The stabilizing assembly (116) includes a bushing (222) configured to engage within a bore in the upright portion (110) of a skull clamp (100). In some variations, an O-ring may be positioned around the outer periphery of the bushing (222) and between the bore in the upright portion (110) and the bushing (222). A distal cap (224) is connected to the bushing (222) by means of a pin connection. The cap (224) includes a bore, and a retainer (225) extends within the bore, configured to receive a stabilizing feature, such as a skull pin.

[0074] A body (226) with a star-shaped groove (221) is located proximal to the stabilizing assembly (116). The body (226) has a threaded portion (227) that threadedly engages with a threaded portion (228) within the bushing (222). In some variations, an O-ring may be positioned between the outer periphery of the bushing (222) and the body (226). An elongated drill bit (130) of the applicator (200) engages with the groove (221) of the body (226) and can rotate 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 retainer (225). In the variation shown, the retainer (225) has an open proximal end configured to receive an extension feature (240) of the body (226). Fasteners (229) connect the retainer (225) to the body (226) via extension features (240). In some variations, spacers may be used between the retainer (225) and the body (226). As described above, the retainer (225) is configured to receive stabilizing features, such as skull pins. Furthermore, the retainer (225) is configured to translate relative to the cap (224) when driven distally by rotation of the body (226), such that the attached stabilizing feature advances distally toward the head of the patient supported within the skull clamp (100).

[0075] The body (226) has a lip (242) at its proximal end. The lip (242) is configured to selectively engage with a latching member (234) of the attachment feature (233) of the connecting sleeve (230). For example, the latching member (234) is configured with an inclined surface such that when the latching member (234) contacts the nearest side surface of the body (226), it causes the connecting sleeve (230) to advance distally, resulting in deflection of the attachment feature (233). This deflection allows the latching member (234) to cross the lip (242) and then return to an undeflected state once it has crossed the lip (242), so as to make a selective but fixed connection between the connecting sleeve (230) and the body (226). Since the connecting sleeve (230) is attachable to the applicator (200), the applicator (200) can be attached to the body (226) by means of the connecting sleeve (230).

[0076] As described above, the applicator (200) with the connecting sleeve (230) can also be removed or detached from the stabilizing assembly (116). For example, due to the elastic nature of the attachment feature (233), proximal movement of the applicator (200) with the connecting sleeve (230) will cause the angled surface of the lip (242) to contact the latching member (234) and the attachment feature (233), and deflect the latching member (234) and the attachment feature (233) outward from the longitudinal axis (LA). With further proximal movement, the latching member (234) crosses the lip (242) until the attachment feature (233) is no longer connected to the body (226). Figure 13 As shown, the lip (242) of the body (226) is configured such that the lip (242) acts as a stop to prevent the body (226) from translating distally beyond a certain distance. This is because the lip (242) will eventually contact the proximal surface of the bushing (222). In some other variations, the bushing (222) may include a groove at its proximal end, wherein the groove has a profile that matches the lip (242). In this way, the body (226) cannot advance distally beyond the point where the lip (242) engages within the groove of the bushing (222).

[0077] Utilizing this exemplary selectively detachable configuration for the applicator (200) and the skull clamp (100), the skull clamp (100) retains less material, which is advantageous in terms of weight, occlusion, and imaging capability. Furthermore, by configuring the applicator (200) with components and features for setting the desired torque (these components and features differ from those integrated with the stabilizing component or the skull clamp), and by making the applicator (200) removable from the stabilizing component (116) of the skull clamp (100), the skull clamp (100) retains less material after the patient's head has been secured, again providing advantages in at least weight, occlusion, and imaging capability. In light of the teachings herein, other methods of modifying or configuring the applicator (200) to make it selectively detachable from the stabilizing component (116) of the skull clamp (100) will be apparent to those skilled in the art.

[0078] Figure 14A front view of the stabilizing component (116) is depicted, showing the stabilizing feature (250) omitted. As shown and understood from the other figures, the stabilizing feature (250) is received by the retainer (225). In this example, the stabilizing feature (250) is slidably received by the retainer (225). Thus, the stabilizing feature (250) can freely slide in and out of the retainer (225) when no other object obstructs access to the stabilizing feature (250). In other variations, the stabilizing feature (250) may be received within the retainer (225) by a threaded engagement, interference fit, or other engagement type, which will be apparent to those skilled in the art in light of the teachings herein.

[0079] As described above, clockwise rotation of the applicator (200) is used to clockwise rotate the body (226) of the stabilizing assembly (116) to ultimately tighten or increase the torque applied to the patient's head by the stabilizing feature (250). The threaded engagement of the body (226) with the bushing (222) causes the body (226) to translate longitudinally during rotation. The retainer (225) is positioned adjacent to the body (226), and the fastener (229) creates contact or interference fit between portions of the body (226) and the retainer (225). The connection or contact between the retainer (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 retainer (225) distally without rotating the retainer (225). Thus, when the body (226) rotates, the proximal end of the retainer (225) does not rotate, while the extension feature (240) of the body (226) slides along the retainer (225) as the body (226) rotates.

[0080] refer to Figure 14 In this example, the stabilizing component (116) is configured to form a shape fit between the cap (224) and the retainer (225) such that longitudinal translation is the only degree of freedom of movement for the retainer (225). In one such example, the stabilizing component (116) is configured to have contact flat sides in certain areas to facilitate longitudinal translation of the retainer (225) and the associated stabilizing feature (250) without rotation. In use, this can be advantageous as it can reduce tissue and structural trauma that the patient may experience at the stabilizing contact site during stabilization. Figure 14As shown, the retainer (225) includes at least one flat side (235), and in this example, a pair of flat side surfaces (235). Furthermore, the cap (224) includes at least one flat side (236), and in this example, a pair of flat side surfaces (236). The flat side surfaces (235, 236) of the retainer (225) and the cap (224) are adjacent and in contact. Additionally, as described above, the cap (224) is pinned to the stationary bushing (222), making the cap (224) stationary. The arrangement of the flat side surfaces (235, 236) prevents the retainer (225) from rotating, even though it is in contact with the rotating body (226). In this way, the contact between the flat side surfaces (235, 236) ensures that when the body (226) rotates, its extended feature (240) slides along the proximal portion of the retainer (225) without causing rotation of the retainer (225).

[0081] like Figure 14 As shown, the cap (224) and bushing (222) also have similar contact flat sides. In light of the teachings herein, it will be apparent to those skilled in the art that other ways of configuring the stabilizing assembly (116) to allow the stabilizing feature (250) to translate without rotation during tightening will be apparent. Additionally, in other variations, the stabilizing assembly (116) may be configured to allow rotation of the stabilizing feature (250) during tightening. Again, in light of the teachings herein, such modifications to the stabilizing assembly (116) will be apparent to those skilled in the art.

[0082] In one variant, the skull clamp (100) and stabilizing components (114, 116) are made of a radiopaque material. In this variant, the applicator (200) may also be made of a radiopaque material; however, in some other variants, the applicator (200) is made of at least some radiopaque material. Utilizing the removability of the applicator (200), imaging is not hindered by the construction material of the applicator (200). This document also envisions that the applicator (200) can be used with devices other than the skull clamp (100) and stabilizing components (116). For example, the applicator (200) may be adapted for use with other fasteners that require torque to be applied to the fastener within the torque range provided by the applicator (200).

[0083] When the applicator (200) is used with the skull clamp (100) or other structures, the resistance experienced by the user when setting a predetermined amount of torque using the applicator (200) remains constant, regardless of the value of the predetermined amount of torque. For example, whether the user sets the torque to 50 Nm or 100 Nm, the resistance experienced by the user when using the applicator (200) to set the desired torque is the same. This is different from torque instruments that use springs to establish torque settings and ranges. Similarly, when using the applicator (200) to set a predetermined amount of torque, the resistance experienced by the user involves only overcoming friction between the moving parts of the device. For example, friction exists when rotating the actuator (150) to translate the sleeve (190) along the arm (172). Different torques can be set, and in doing so, the user experiences the same level of friction, regardless of the torque setting value.

[0084] As described above, the torque is controlled by changing the bending length of the arm (172). Furthermore, the bending length has no effect on the resistance experienced by the user when setting a predetermined amount of torque using the applicator (200). Additionally, when the applicator (200) is configured for a positive torque setting, it is also configured such that the arm (172) is not subjected to bending forces. This means that the applicator (200) can be stored at a positive predetermined torque setting without straining the internal components of the applicator (200). Again, this differs from torque devices that use one or more springs to control torque. For instruments using spring control features, the device must be stored at a zero torque setting to avoid straining the springs over time, thus affecting the torque. In this variant described herein, the applicator (200) can be set to a positive torque without straining the internal components. More specifically, this can be achieved by rotating the housing (120) while keeping the elongated drill bit (130) stationary, allowing the arm (172) to slide past the hook-shaped portion (213) as described above. In this orientation, any bending force on the arm (172) is eliminated.

[0085] III. An exemplary detachable torque applicator with a sliding actuator

[0086] Figures 15-17Another exemplary torque applicator (1200) and stabilizing assembly (1116) are illustrated, which can be used with a head support system (10) in place of the torque applicator (200) and stabilizing assembly (116). The torque applicator (1200) is sometimes simply referred to herein as the applicator (1200). The applicator (1200) includes a housing (1120). The housing (1120) extends longitudinally from the proximal end of the applicator (1200) to the distal end of the applicator (1200). The housing (1120) also generally defines the outer periphery of the applicator (1200). At the distal end, the housing (1120) includes an opening through which an elongated drill bit (1130) extends. The applicator (1200) defines a longitudinal axis (LA1). The longitudinal axis (LA1) defines an axis of rotation about which the elongated drill bit (1130) and other components of the applicator (1200) can rotate. In this example, the distal end of the elongated drill bit (1130) has a six-point star shape; however, in other variations, the distal end of the elongated drill bit (1130) may have other shapes, such as slotted, cross-shaped, square, etc., and other shapes that will be obvious to those skilled in the art given the teachings herein.

[0087] A cover (1140) is located at the proximal end of the housing (1120), and the cover (1140) fits within a proximal opening of the housing (1120). In some variations, the cover (1140) has a snap-fit ​​engagement with the housing (1120), while in other variations, the cover (1140) can be secured to the housing (1120) by a pin extending through both the housing (1120) and the cover (1140). In some variations, the cover (1140) includes a plurality of slots that provide visual access within the housing (1120). The proximal end of an elongated drill bit (1130) is received within the cover (1140).

[0088] The housing (1120) also includes lateral openings (1121, 1123). The openings (1121, 1123) are located on opposite sides of the housing (1120). The openings (1121, 1123) provide access to the actuator (1150), which can be used to adjust the torque setting of the applicator (1200), as will be described in more detail below. Other openings or elongated recesses may be present along the outer surface of the housing (1120) to act as gripping features, enhancing gripping capability when gripping the torque applicator (1200).

[0089] The actuator (1150) in this example includes a pair of sliding members (1151) located on opposite sides of a housing (1120), one sliding member (1151) being located within an opening (1121) and the other sliding member (1151) being located within an opening (1123). The sliding members (1151) are configured as pressable features, which are slidable when pressed and stationary when not pressed. Each sliding member (1151) has an indicator (1161) that moves with the sliding member (1151) when the sliding member (1151) is moved to adjust the torque setting. In some variations, adjacent to one or both openings (1121, 1123) is a torque setting scale marked on the outer surface of the housing (1120). In this variation, the indicator (1161) is a force indicator implemented by pointing to or associated with the scale. In some variations, the scale may be numerical, while in others it may provide a relative indication. By way of example only and not limitation, a relative indication may include color-coded graphics, where one color may indicate an acceptable torque setting, while another or more colors may indicate a torque setting that is too low or too high. Given the teachings herein, other ways of providing feedback or indication of torque settings will be apparent to those skilled in the art.

[0090] In some variations, one or more lateral holes are present at or near the distal end of the housing (1120), each configured to receive a pin (1122) that is configured to secure the fork member (1170) to the housing (1120). The fork member (1170) is a control feature for changing the torque applied by the applicator (1200), as will be described in more detail below. Through this exemplary pin-connection with the housing (1120), the fork member (1170) rotates uniformly with the housing (1120), as will be further described below.

[0091] The actuator (1150) includes a pair of sliding members (1151) as described above. Additionally, the actuator (1150) includes an elastic feature, such as a spring (1152), which is connected to the sliding members (1151) and allows the sliding members (1151) to be pressed down to allow sliding movement of the sliding members (1151). A sleeve (1190) is positioned within the housing (1120). The sleeve (1190) is shown as a tubular structure and is connected to the sliding members (1151) via one or more pins (1153). In this way, the sleeve (1190) moves in unison with the sliding members (1151).

[0092] In the above configuration, the sliding member (1151) of the actuator (1150) is positioned within the corresponding openings (1121, 1123), and the sleeve (1190) is connected to the sliding member (1151). Rotating the housing (1120) causes corresponding rotation of the actuator (1150) and the sleeve (1190). Furthermore, when the fork-shaped member (1170) is connected to the housing (1120), rotating the housing (1120) causes corresponding rotation of the fork-shaped member (1170).

[0093] A fork-shaped member (1170) extends within a housing (1120) and includes a distal body portion (1171) and a pair of arms (1172) extending proximally from the body portion (1171). An elongated drill bit (1130) extends through the body portion (1171) of the fork-shaped member (1170) and ultimately protrudes from the distal end of the housing (1120). The elongated drill bit (1130) and the body portion (1171) of the fork-shaped member (1170) are configured such that the fork-shaped member (1170) and the elongated drill bit (1130) can rotate independently of each other. As further described below, this independent rotation occurs when a torque setting or limit is reached and the elongated drill bit (1130) does not rotate with further rotation of the housing (1120) (although the fork-shaped member (1170) rotates with the housing (120)). However, under certain conditions, the elongated drill bit (1130) and the fork member (1170) can rotate in unison. This can also be the case, as described below, when the torque setting or limit has not been reached and the elongated drill bit (1130) rotates in unison with the fork member (1170). In this example, the applicator (1200) includes one or more pins (1164) located between the body portion (1171) of the fork member (1170) and the elongated drill bit (1130). The pins (1164) are configured to allow rotation between the elongated drill bit (1130) and the fork member (1170) under certain conditions during use of the applicator (1200).

[0094] As described above, the fork-shaped member (1170) includes a pair of arms (1172) extending proximally from the main 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, under other conditions, the proximal end of the arm (1172) may contact the knob (1210) without bending or deflecting away from the longitudinal axis (LA1).

[0095] A knob (1210) is positioned around an elongated drill bit (1130) such that the drill bit (1130) extends through the knob (1210). Furthermore, the knob (1210) and the elongated drill bit (1130) are connected by a pin (1131). This connection allows the knob (1210) and the elongated drill bit (1130) to rotate in unison. Therefore, when the knob (1210) rotates, the corresponding elongated drill bit (1130) rotates.

[0096] The knob (1210) also includes a pair of curved hook-like features (1213). The proximal end of the arm (1172) is configured to contact the corresponding hook-like feature (1213) when the fork-shaped member (1170) is rotated counterclockwise (when the applicator (1200) is viewed from the proximal end). This is similar to Figure 10A The diagram shows the applicator (200). In this way, counterclockwise rotation of the fork member (1170) will cause a corresponding counterclockwise rotation of the knob (1210) and the elongated drill bit (1130). Furthermore, the arm (1172) contacts the hook feature (1213) of the knob (1210) in such a way that the arm (1172) does not bend or deflect away from the longitudinal axis (LA1). In addition, the proximal end of the arm (1172) is received in a corresponding slot (1143) of the cover (1140). The slot (1143) maintains the position of the arm (1172) such that the arm (1172) does not deflect, that is, the arm (1172) does not deflect when the proximal end of the arm (1172) contacts the hook feature (1213) of the knob (1210). Based on the above description, when the applicator (1200) is viewed from its proximal end, the housing (1120) rotates counterclockwise to produce a corresponding rotation of the elongated drill bit (1130) in the same direction. This counterclockwise rotation can be considered a use case for the torque applicator (1200). In at least some cases, rotating in this manner loosens or reduces the contact or engagement of the stabilizing feature (250) of the stabilizing component (1116) with the patient's head.

[0097] Now consider rotating the housing (1120) clockwise (when viewed from the proximal end). For the reasons described above, the fork-shaped member (1170) will rotate uniformly with the housing (1120). This clockwise rotation causes the arms (1172) to move in the same manner. The distance between the arms (1172) is less than the diameter of the knob (1210) spanning the hook-shaped feature (1213) at its point of maximum diameter. Therefore, when the arms (1172) rotate in this manner, the proximal ends of the arms (1172) will contact or engage with the outer curved surface (1214) of the hook-shaped feature (1213). Furthermore, since the distance between the proximal ends of the arms (1172) is less than the distance between the points of maximum diameter of the hook-shaped feature (1213), the contact between the proximal ends of the arms (1172) and the outer curved surface (1214) of the hook-shaped feature (1213) causes the arms (1172) to adopt a similar Figure 10B and Figure 10C The position or state of the bend or deflection shown with respect to the applicator (200). The slot (1143) of the cover (1140) is elongated to allow the proximal end of the arm (1172) to deflect away from the longitudinal axis (LA1) when the applicator (1200) is used in this manner.

[0098] With this bending or deflecting configuration of the arm (1172), the arm (1172) applies an inward force to the hook-shaped feature (1213) of the knob (1210). This produces a holding or squeezing effect where the arm (1172) holds or squeezes the knob (1210). Based on the engagement of the elongated drill bit (1130) with the stabilizing component (1116) and the contact between the stabilizing feature (250) and the patient's head, when the force applied by the arm (1172) is greater than the resistance applied to the elongated drill bit (1130), the rotation of the arm (1172) of the housing (1120) and the fork member (1170) allows the arm (1172) to hold the knob (1210) with sufficient force so that the knob (1210) and the connected elongated drill bit (1130) rotate in unison with the arm (1172). In this way, the stabilizing feature (250) of the stabilizing component (1116) can be tightened by rotating the housing (1120) clockwise (when viewed from the proximal end of the applicator (1200)).

[0099] Based on the engagement of the elongated drill bit (1130) with the stabilizing component (1116) and the contact between the stabilizing feature (250) and the patient's head, when the resistance applied to the elongated drill bit (1130) is higher than the force applied by the arm (1172) to the knob (1210), the arm (1172) will slide or glide over the hook-shaped feature (1213) of the knob (1210). When the arms (1172) have slid or glided a sufficient distance, they elastically snap back or return to their relaxed or undeflected state. In this neutral or relaxed state, the arms (1172) no longer bend or deflect outward from the longitudinal axis (LA1). Therefore, the arms (1172) and the connected housing (1120) will rotate, but the knob (1210) and the elongated drill bit (1130) will not rotate accordingly. Therefore, although further tightening or rotational force may have been applied to the housing (1120) and the fork member (1170), this further tightening or rotational force will not be transmitted to the knob (1210) and the elongated drill bit (1130), and therefore the stabilizing component (1116) to which the elongated drill bit (1130) is connected will not be subjected to further tightening or rotational force. Clockwise rotation of the knob (1210) when it is rotated can be considered another use case of the torque applicator (1200), and similarly, clockwise rotation of the knob (1210) when it is not rotated can be considered another use case of the torque applicator (1200).

[0100] In the torque applicator (1200) of this example, the amount of force applied 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) is shown to have a bending length. Furthermore, the applicator (1200) is configured such that the bending length of the arm (1172) is adjustable. This adjustment is achieved through the interaction between the sleeve (1190) and the arm (1172) of the fork member (1170).

[0101] The sleeve (1190) includes a portion (1197) positioned next to 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 located next to the distal portion of the knob (1210). As described above, translation or sliding of the sliding member (1151) of the actuator (1150) causes translation of the sleeve (1190), which in turn provides different bending lengths for the arm (1172). Therefore, the bending length of the arm (1172) of the fork member (1170) is controlled by the sliding motion of the actuator (1150).

[0102] Since the bending length is related to the torque setting, a smaller bending length is associated with a larger bending force. In other words, as the bending length of the arm (1172) decreases, more force is required to bend the arm (1172). Similarly, the greater the force exerted by the arm (1172) on the hook feature (1213), the shorter the bending length of the arm (1172) will be in this variant, and therefore the maximum torque setting will be. Likewise, when the sleeve (1190) is translated to its furthest position, the longest bending length of the arm (1172) will be in this variant, and therefore the minimum torque setting will be.

[0103] In this variant, a bending force is applied based on the interaction between the knob (1210) and the arm (1172). More specifically, the interaction here is the interaction between the hook-shaped feature (1213) of the knob (1210) and the arm (1172). For example, depending on the position of the sleeve (1190), for a shorter or smaller bending length of the arm (1172), a larger force will be required to cause the arm (1172) to bend to the point where the arm (1172) slides or glides past the point where the hook-shaped feature (1213) of the knob (1210) is located when the knob (1210) is turned clockwise. In other words, when tightened, the applicator (1200) can apply a larger torque to the stabilizing assembly (1116). Conversely, the longer or greater the bending length of the arm (1172), also based on the position of the sleeve (1190), the less force is required to cause the arm (1172) to bend to the point where the arm (1172) slides or glides past the hook feature (1213) of the knob (1210) when the housing (1120) is rotated clockwise. In other words, when tightening, the applicator (1200) applies a smaller torque to the stabilizing assembly (1116).

[0104] By way of example only and not limitation, in one exemplary use, the applicator (1200) can be adjusted by sliding the actuator (1150) such that the torque indicator reading is 60 Nm. The head support system (10) is configured to position the patient's head within a skull clamp (100), and the skull clamp (100) has stabilizing components (114, 1116) configured with a skull pin as a stabilizing feature (250). The skull clamp (100) is adjusted to move the arms (102, 108) such that the skull pin contacts the patient's head. The applicator (1200) is connected to the stabilizing component (1116), and an elongated drill bit (1130) engages with the star-shaped groove (1221) of the stabilizing component (1116). The housing (1120) of the applicator is then rotated clockwise (when viewed from its proximal end). As described above, rotation of the housing (1120) causes corresponding rotation of the fork-shaped member (1170) and the cover (1140). The arm (1172) of the fork-shaped member (1170) rotates about the knob (1210) and eventually contacts the outer curved surface (1214) of the hook-shaped feature (1213).

[0105] Since the stabilizing features (250) of the stabilizing assembly (1116) are not yet tightened, tightening them requires a force of less than 60 Nm. Therefore, the housing (1120) of the rotary applicator will tighten the skull pin stabilizing feature (250) connected to the stabilizing assembly (1116). This is because the proximal end of the arm (1172) engages or contacts the hook-shaped feature (1213) of the knob and applies sufficient force to the knob (1210) to hold and rotate the knob (1210) and the elongated drill bit (1130) extending through the knob.

[0106] After some tightening, the stabilizing feature (250) of the stabilizing assembly (1116) requires a force greater than 60 Nm to tighten further. At this point, further clockwise rotation of the housing (1120) again causes the arm (1172) of the fork member (1170) to rotate. However, the force required to bend the arm (1172) away from the longitudinal axis (LA1) to the point where the arm (1172) will slide or glide along the outer curved surface (1214) of the hook feature (1213) is set to 60 Nm. As previously stated, further tightening of the stabilizing feature (250) requires a torque setting greater than 60 Nm on the applicator (1200). Since the torque is set at 60 Nm in this example, rotating the housing (1120) will cause the arm (1172) to now slide or glide over the hook feature (1213). When this occurs, as the arm (1172) passes the hook-shaped feature (1213), the arm (1172) will snap back or click back to a neutral, undeflected position, thus eliminating the bending or deflecting force on the arm (1172). This snapping or clicking provides feedback to the applicator (1200), which signals to the user that the torque limit has been reached when the stabilizing feature (250) is tightened. In this situation, the knob (1210) and the elongated drill bit (1130) do not rotate with the rotation of the housing (1120) and the fork member (1170).

[0107] If the user of the patient head support system (10) decides that greater clamping pressure is required, the torque setting can be increased, for example, by moving the sliding member (1151) of the actuator (1150) further. Subsequently, further rotation of the housing (1120) of the applicator (1200) will cause the arm (1172) to rotate such that the proximal end of the arm (1172) contacts the outer curved surface (1214) of the hook feature (1213) and presses it firmly against the hook feature (1213) of the knob (1210) with sufficient force, resulting in rotation of the knob (1210) and the elongated drill bit (1130) extending through the knob. Once the stabilizing feature (250) of the stabilizing component (1116) is tightened to the point where a force greater than 100 Nm is required to further tighten the stabilizing feature (250), the rotation of the housing (1120) of the applicator (1200) will again rotate the arm (1172), but the elongated drill bit (1130) and the knob (1210) will apply sufficient bending force to the arm (1172) so that the arm (1172) will bend and slide or slip over the hook feature (1213) of the knob (1210) instead of gripping the knob (1210) and causing the knob (1210) to rotate.

[0108] When it is necessary to release the stabilizing component and possibly remove the patient's head from the skull clamp (100), the applicator (1200) engages with the groove (1221), and the applicator (1200) rotates counterclockwise (when viewed from the proximal end of the applicator (1200)). Due to the configuration of the arm (1172) and knob (1210), torque setting adjustments with the actuator (1150) and sleeve (1190) are not required before releasing the stabilizing feature. As described above, in the case of counterclockwise rotation, the proximal end of the arm (1172) contacts the tip region of the hook feature (1213), thereby rotating the knob (1210) and the elongated drill bit (1130), regardless of the bending length configuration of the arm (1172) and the sleeve (1190). The above example is merely exemplary. In light of the teachings herein, those skilled in the art will understand other ways of using the devices and systems shown and described herein to securely stabilize a patient’s head with known clamping forces without exceeding the desired clamping force.

[0109] In addition to the effects of the bending force on the arm (1172) and the characteristics of the arm (1172) in gripping the knob (1210), applying force to the knob (1210) to rotate the knob (1210), or sliding over the knob (1210), friction also affects the torque setting and application of the applicator (1200). For example, friction exists where the proximal end of the arm (1172) contacts the hook-shaped feature (1213) of the knob (1210). Therefore, the threshold at which the arm (1172) slides or slides along the hook-shaped feature (1213) and over the hook-shaped feature (1213) is a function of the bending force applied to the arm (1172) and the friction between the arm (1172) and the hook-shaped feature (1213) of the knob (1210). In some cases, the materials used in the construction of the arm (1172) and / or the knob (1210) can be configured or modified to provide greater or less friction between these components. In light of the teachings herein, other methods of controlling and modifying the force interaction between the arm (1172) and the hook-like feature (1213) of the knob (1210) will be apparent to those skilled in the art.

[0110] The applicator (1200) also includes a connecting sleeve (1230) configured to connect the applicator (1200) to the stabilizing assembly (1116). In this example, the connecting sleeve (1230) is connected to and extends distally from the housing (1120) of the applicator (1200). The connecting sleeve (1230) includes a pair of attachment features (1233) configured as an elongated body having latching members (1234) oriented outward away from the longitudinal axis (LA1). The attachment features (1233) are also configured as resilient members such that the attachment features (1233) can deflect toward or away from the longitudinal axis (LA1) depending on the direction of the force applied to the attachment features (1233).

[0111] As described above, the stabilizing assembly (1116) is configured to selectively receive the connecting sleeve (1230). The stabilizing assembly (1116) includes a bushing (1222) configured to engage within a hole in the upright portion (110) of the skull clamp (100). The bushing (1222) includes a distal hole, and a retainer (1225) extends within this hole, the retainer (1225) being configured to receive a stabilizing feature such as a skull pin.

[0112] The bodies (1226, 1229) are located proximal to the stabilizing assembly (1116). 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 can threadedly engage with a threaded portion (1228) of the retainer (1225). The body (1226) is configured to rotate, and when the body (1226) rotates, the retainer (1225) translates longitudinally based on its threaded engagement with the body (1226), but does not rotate.

[0113] The body (1229) includes an opening that allows the star-shaped recess (1221) of the body (1226) to be accessed through the body (1229). The body (1229) may also be threadedly engaged with a bushing (1222). The body (1229) includes an internal recess (1231) configured to selectively receive an attachment feature (1233) of a coupling sleeve (1230) for connecting the applicator (1200) to the stabilizing assembly (1116). For example, the attachment feature (1233) includes an angled surface that contacts the body (1229) as the applicator (1200) is moved toward the body (1229) of the stabilizing assembly (1116). This contact deflects the attachment features (1233) so that they can be positioned within an internal recess (1231) of the body (1229) to selectively secure the stabilizing assembly (1116) and the applicator (1200) together. As described above, the applicator (1200) can also be removed or detached from the stabilizing assembly (1116). For example, due to the elastic nature of the attachment features (1233), the attachment features (1233) can be pressed inward toward the longitudinal axis (LA1). This positions the attachment features (1233) within the recess (1231) so that they can move freely proximally relative to the body (1229) and thus separate from the body.

[0114] By utilizing this exemplary selectively detachable configuration for the applicator (1200) and the skull clamp (100), less material is retained in the skull clamp (100), which offers advantages in terms of weight, occlusion, and imaging capability. Furthermore, configuring the applicator (1200) with components and features for setting the desired torque (these components and features differ from those integrated with the stabilizing component or the skull clamp), and making the applicator (1200) removable from the stabilizing component (1116) of the skull clamp (100), results in less material remaining in the skull clamp (100) after immobilization of the patient's head, again providing advantages in at least weight, occlusion, and imaging capability. In light of the teachings herein, other methods of modifying or configuring the applicator (1200) to allow selective detachment from the stabilizing component (1116) of the skull clamp (100) will be apparent to those skilled in the art.

[0115] As described above, the retainer (1225) is threadedly engaged with the body (1226), and the retainer (1225) is also configured to receive the stabilizing feature (250). In this example, the stabilizing feature (250) is slidably received by the retainer (225). Thus, the stabilizing feature (250) can freely slide in and out of the retainer (225) when no other object obstructs access to the stabilizing feature (250). In other variations, the stabilizing feature (250) may be received within the retainer (225) by threaded engagement, interference fit, or other engagement types, as will be apparent to those skilled in the art in light of the teachings herein.

[0116] In this example, the stabilizing component (1116) is configured to form a shape fit between the bushing (1222) and the retainer (1225) such that longitudinal translation is the only degree of freedom of movement for the retainer (1225). In one such example, the stabilizing component (1116) is configured to have contacting flat sides in some areas to facilitate this longitudinal translation of the retainer (1225) and the associated stabilizing feature (250) without rotation. This can be advantageous in use as it can reduce tissue and structural trauma that the patient may experience at the stabilizing contact site during stabilization. For example, the retainer (1225) includes at least one flat side (1235), and in this example, a pair of flat sides (1235). Additionally, the distal opening of the bushing (1222) includes at least one flat side (1236), and in this example, a pair of flat sides (1236). The flat sides (1235, 1236) of the retainer (1225) and the bushing (1222) are adjacent and in contact. By arranging the flat sides (1235, 1236), the retainer (1225) is prevented from rotating even though it is in contact with the rotating body (1226). In this way, the contact between the flat sides (1235, 1236) ensures that when the body (1226) rotates, the retainer (1225) translates without rotating based on the threaded engagement between the retainer (1225) and the body (1226).

[0117] In light of the teachings herein, it will be apparent to those skilled in the art that other ways of configuring the stabilizing component (1116) to allow the stabilizing feature (250) to translate without rotation during tightening will be readily apparent. Additionally, in other variations, the stabilizing component (1116) may be configured to allow rotation of the stabilizing feature (250) during tightening. Again, in light of the teachings herein, such modifications to the stabilizing component (1116) will be readily apparent to those skilled in the art. Furthermore, in light of the teachings herein, other modifications to the applicator (1200) will be readily apparent to those skilled in the art. By way of example only and not limitation, in some variations, the applicator (1200) may also incorporate a calibration feature as described above with respect to the applicator (200).

[0118] In one variant, the skull clamp (100) and stabilizing components (114, 1116) are made of a radiopaque material. In this variant, the applicator (1200) may also be made of a radiopaque material; however, in some other variants, the applicator (1200) is made of at least some radiopaque material. Utilizing the removability of the applicator (1200), imaging is not hindered by the construction material of the applicator (1200). This document also envisions that the applicator (1200) can be used with devices other than the skull clamp (100) and stabilizing components (1116). For example, the applicator (1200) may be adapted for use with other fasteners that require the application of torque within the range of torque provided by the applicator (1200).

[0119] When the applicator (1200) is used with the skull clamp (100) or other structures, the resistance experienced by the user when setting a predetermined amount of torque using the applicator (1200) remains constant, regardless of the value of the predetermined amount of torque. For example, whether the user sets the torque to 50 Nm or 100 Nm, the resistance experienced by the user when using the applicator (1200) to set the desired torque is the same. This is different from torque instruments that use springs to establish torque settings and ranges. Similarly, when using the applicator (1200) to set a predetermined amount of torque, the resistance experienced by the user involves only overcoming friction between the moving parts of the device. For example, friction exists when moving the actuator (1150) to translate the sleeve (1190) along the arm (1172). Different torques can be set, and in doing so, the user experiences the same level of friction, regardless of the torque setting value.

[0120] As described above, the torque is controlled by changing the bending length of the arm (1172). Furthermore, the bending length has no effect on the resistance experienced by the user when setting a predetermined torque using the applicator (1200). Additionally, when the applicator (1200) is configured for a positive torque setting, it is also configured such that the arm (1172) is not subjected to bending forces. This means that the applicator (1200) can remain stored at a positive predetermined torque setting without causing tension on the internal components of the applicator (1200). Again, this differs from torque devices that use one or more springs to control torque. For instruments using spring control features, the device must be stored at a zero torque setting to avoid the springs tightening over time, thus affecting the torque. In this variant described herein, the applicator (1200) can be set to a positive torque without tightening the internal components. More specifically, this can be achieved by rotating the housing (1120) while keeping the elongated drill bit (1130) stationary, allowing the arm (1172) to slide over the hook-shaped portion (1213) as described above. In this orientation, any bending forces on the arm (1172) are eliminated.

[0121] IV. Exemplary Combinations

[0122] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claim that may appear at any time in this application or in subsequent documents thereof. No waiver of claims is intended. The examples provided below are provided merely for illustrative purposes. It is conceivable that the various teachings herein may be arranged and applied in a variety of other ways. It is also conceivable that some variations may omit certain features mentioned in the following examples. Therefore, no aspect or feature mentioned below should be considered critical unless explicitly stated later by the inventor or a successor with an interest in the inventor. If any claim set forth in this application or in subsequent documents related to this application includes additional features other than those described below, such additional features shall not be presumed to have been added for any reason relating to patentability.

[0123] Example 1

[0124] An apparatus for stabilizing a patient's head during a medical procedure includes: (a) a head fixation device configured to receive a patient's head; (b) a stabilization assembly connected to the head fixation device, wherein the stabilization assembly is configured to receive a stabilization feature configured to contact the patient's head; and (c) an applicator connectable to the stabilization assembly, wherein the applicator is configured to transmit torque to the stabilization assembly without exceeding a predetermined torque amount. The applicator includes (i) a first member and (ii) a second member, wherein under a first condition, the interaction between the first member and the second member imparts bending stress to the first member.

[0125] Example 2

[0126] According to the device of Example 1, under the second condition, the first component is in a relaxed state and there is no bending stress on the first component.

[0127] Example 3

[0128] According to the device of Example 1, under a second condition, the interaction between the first member and the second member imparts bending stress to the first member, wherein the bending stress under the second condition is different in degree from the bending stress under the first condition.

[0129] Example 4

[0130] The device according to any one or more of Examples 1 to 3, wherein the applicator further includes a third component configured to adjustably set a predetermined torque amount.

[0131] Example 5

[0132] According to the device of Example 4, the third member contacts the first member longitudinally at different positions along the first member based on a predetermined torque amount.

[0133] Example 6

[0134] According to any one or more of Examples 4 to 5, the contact between the third member and the first member determines the bending length of the first member, wherein the bending length corresponds to a predetermined torque amount.

[0135] Example 7

[0136] The device according to any one or more of Examples 1 to 6, wherein the first component includes at least one arm extending longitudinally relative to the applicator.

[0137] Example 8

[0138] According to the device of Example 7, the first component includes a pair of arms extending longitudinally relative to the applicator.

[0139] Example 9

[0140] According to the device of Example 8, the second member is positioned between the pair of arms, and the pair of arms are configured to selectively contact the outer surface of the second member.

[0141] Example 10

[0142] The device according to any one or more of Examples 1 to 9, wherein the second member includes a pair of hook-like features, wherein the first member is configured to selectively contact the hook-like features.

[0143] Example 11

[0144] According to any one or more of Examples 1 to 10, the device wherein, when the torque applied to the stabilizing component is less than a predetermined torque, the first component is operable to abut against the outer surface of the second component, such that rotation of the applicator causes a corresponding rotation of the second component.

[0145] Example 12

[0146] According to any one or more of Examples 1 to 11, the device wherein, when the torque applied to the stabilizing component is equal to or greater than a predetermined torque, the first component is operable to slide over the second component, such that the second component remains stationary as the applicator rotates to further tighten the stabilizing component.

[0147] Example 13

[0148] The apparatus according to any one or more of Examples 1 to 12, wherein the applicator further includes a drill bit configured to engage with a stabilizing component, wherein a second component is connected to the drill bit, and wherein the second component and the drill bit are configured to rotate in unison.

[0149] Example 14

[0150] The device according to any one or more of Examples 1 to 13, wherein the stabilizing component is configured as a translational stabilizing feature without a rotational stabilizing feature.

[0151] Example 15

[0152] The apparatus according to any one or more of Examples 1 to 14, wherein the applicator defines a rotation axis, and wherein the stabilizing component is configured to receive a stabilizing feature such that the stabilizing feature is coaxially oriented with the rotation axis.

[0153] Example 16

[0154] The device according to any one or more of Examples 1 to 15, wherein the applicator includes an indicator feature indicating a predetermined amount of torque.

[0155] Example 17

[0156] The device according to any one or more of Examples 1 to 16, wherein the stabilizing feature includes a skull pin.

[0157] Example 18

[0158] The apparatus according to any one or more of Examples 1 to 17, wherein the applicator includes a housing, and wherein the first member is configured to rotate in unison with the housing.

[0159] Example 19

[0160] The device according to any one or more of Examples 1 to 18, wherein the applicator can be detachably connected to the stabilizing component.

[0161] Example 20

[0162] The device according to any one or more of Examples 1 to 19, wherein the stabilizing component includes the stabilizing component of any one or more of Examples 22 to 27.

[0163] Example 21

[0164] The apparatus according to any one or more of Examples 1 to 20, wherein the applicator includes means according to any one or more of Examples 28 to 41.

[0165] Example 22

[0166] An apparatus for stabilizing a patient's head during a medical procedure includes: (a) a head fixation device configured to receive the patient's head; and (b) a stabilization component connected to the head fixation device, wherein the stabilization component is configured to receive a stabilization feature configured to contact the patient's head. The stabilization component includes (i) a rotation member and (ii) a translation member. The apparatus further includes (c) an applicator configured to rotate the rotation member of the stabilization component, wherein the translation member is configured to translate in response to rotation of the rotation member.

[0167] Example 23

[0168] According to the device of Example 22, there is a form fit between the rotating member and the translating member, such that longitudinal translation is the only degree of freedom of movement of the translating member.

[0169] Example 24

[0170] The device according to any one or more of Examples 22 to 23, wherein the translational member and the rotational member are threadedly engaged.

[0171] Example 25

[0172] The apparatus according to any one or more of Examples 22 to 24, wherein the applicator is detachable from the stabilizing component, wherein when the applicator is detached from the stabilizing component, the rotating component and the translating component remain together with the stabilizing component.

[0173] Example 26

[0174] The device according to any one or more of Examples 22 to 25, wherein the translation member is configured to receive a stabilizing feature, wherein translation of the translation member results in a corresponding translation of the stabilizing feature without resulting in rotation of the stabilizing feature.

[0175] Example 27

[0176] The apparatus according to any one or more of Examples 22 to 26, wherein the applicator includes means according to any one or more of Examples 28 to 41.

[0177] Example 28

[0178] An apparatus for setting a torque amount and applying torque to an object includes: (a) a housing configured to rotate during use to apply torque to the object; (b) a drill bit extending from the housing, wherein the drill bit is 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. Furthermore, the actuator is manipulated to change the bending length of one or more arms, wherein the torque amount applied by the apparatus is related to the bending length of one or more arms.

[0179] Example 29

[0180] According to the device of Example 28, the actuator is accessible from the housing.

[0181] Example 30

[0182] The apparatus according to any one or more of Examples 28 to 29 further includes a body, wherein the actuator is configured to adjust the position of the body relative to one or more arms. Adjusting the position of the body relative to one or more arms changes the bending length of one or more arms, wherein the torque applied by the apparatus is related to the bending length of one or more arms.

[0183] Example 31

[0184] The apparatus according to any one or more of Examples 28 to 30, wherein the actuator is rotatable to adjust and set the amount of torque.

[0185] Example 32

[0186] According to the apparatus of Example 31, rotation of the actuator causes longitudinal translation of the body.

[0187] Example 33

[0188] The apparatus according to any one or more of Examples 28 to 30, wherein the actuator is slidable to adjust and set the amount of torque.

[0189] Example 34

[0190] According to the apparatus of Example 33, sliding the actuator causes longitudinal translation of the body.

[0191] Example 35

[0192] The apparatus according to any one or more of Examples 28 to 34 further includes a calibration feature configured to adjust the amount of torque applied by the applicator.

[0193] Example 36

[0194] The apparatus according to any one or more of Examples 28 to 35, wherein the drill bit defines a rotation axis and is configured to be received by at least a portion of an object.

[0195] Example 37

[0196] According to any one or more of Examples 28 to 36, the resistance experienced by the user when using the device to set the torque amount remains constant, regardless of the value of the set torque amount.

[0197] Example 38

[0198] According to any one or more of Examples 28 to 37, the resistance experienced by the user when using the device to set the amount of torque consists only of overcoming the friction between the moving parts of the device.

[0199] Example 39

[0200] According to any one or more of Examples 28 to 38, the bending length has no effect on the resistance experienced by the user when using the device to set the amount of torque.

[0201] Example 40

[0202] The device according to any one or more of Examples 28 to 39, wherein the device is configured to have a positive torque setting, and at the same time the device is also configured such that one or more arms are not subjected to bending forces.

[0203] Example 41

[0204] According to any one or more of Examples 28 to 40, the device further includes a knob configured to rotate in unison with the drill bit, one or more arms configured to contact the knob when the housing is rotated, wherein contact with the knob applies a bending force to one or more arms, wherein the knob and the drill bit will remain stationary under a first condition, and wherein the knob and the drill bit will rotate under a second condition.

[0205] V. Other

[0206] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0207] Various embodiments of the invention have been shown and described. Those skilled in the art can make further adjustments to the methods and systems described herein with appropriate modifications without departing from the scope of the invention. Several 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., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A device for stabilizing a patient's head during a medical procedure, wherein, The device includes: (a) Head restraint device; (b) A stabilizing component connected to the head immobilization device, wherein the stabilizing component is configured to receive a stabilizing feature configured to contact the patient's head, wherein the stabilizing component includes: (i) Rotating components, and (ii) Translational components; and (c) An applicator configured to rotate the rotating member of the stabilizing assembly, wherein the translational member is configured to translate in response to rotation of the rotating member, wherein the applicator is configured to transmit torque to the stabilizing assembly without exceeding a predetermined torque amount, wherein the applicator comprises: (i) First component, (ii) a second member, wherein, under the first condition, the interaction between the first member and the second member imparts bending stress to the first member, and (iii) A third component configured to adjustably set the predetermined torque amount, wherein, based on the set predetermined torque amount, the third component contacts the first component longitudinally at different positions along the first component, wherein the contact between the third component and the first component determines the bending length of the first component, wherein the bending length corresponds to the predetermined torque amount.

2. The device according to claim 1, wherein there is a form fit between the rotating member and the translating member, such that longitudinal translation is the only degree of freedom of movement of the translating member.

3. The device according to claim 1, wherein the translational member is threadedly engaged with the rotating member.

4. The device of claim 1, wherein the applicator is detachable from the stabilizing assembly, wherein when the applicator is detached from the stabilizing assembly, the rotating member and the translating member remain together with the stabilizing assembly.

5. The device of claim 1, wherein the translation member is configured to receive the stabilizing feature, wherein translation of the translation member results in a corresponding translation of the stabilizing feature without causing rotation of the stabilizing feature.

6. The device according to claim 1, wherein, Under the second condition, the first component is in a relaxed state and there is no bending stress on the first component.

7. The device of claim 1, wherein, under a second condition, the interaction between the first member and the second member imparts a bending stress to the first member, wherein the bending stress under the second condition is different in degree from the bending stress under the first condition.

8. The device of claim 1, wherein the first component includes at least one arm extending longitudinally relative to the applicator.

9. The device of claim 8, wherein the first member includes a pair of arms extending longitudinally relative to the applicator, wherein the second member is positioned between the pair of arms, and wherein the pair of arms are configured to selectively contact the outer surface of the second member.

10. The device of claim 1, wherein the second member comprises a pair of hook-like features, wherein the first member is configured to selectively contact the hook-like features.

11. The device according to claim 1, wherein, When the torque applied to the stabilizing component is less than the predetermined torque, the first member is operably pressed against the outer surface of the second member, such that rotation of the applicator causes a corresponding rotation of the second member. When the torque applied to the stabilizing component is equal to or greater than the predetermined torque, the first member is operably slid past the second member, such that the second member remains stationary as the applicator rotates to further tighten the stabilizing component.

12. The device of claim 1, wherein the applicator further comprises a drill bit configured to engage with the stabilizing component, wherein the second member is connected to the drill bit, and wherein the second member and the drill bit are configured to rotate in unison.

13. A device for stabilizing a patient's head during a medical procedure, wherein, The device includes: (a) Head restraint device; (b) A stabilizing component connected to the head immobilization device, wherein the stabilizing component is configured to receive a stabilizing feature configured to contact the patient's head; and (c) An applicator capable of being connected to the stabilizing component, wherein the applicator is configured to transmit torque to the stabilizing component without exceeding a predetermined torque amount, wherein the applicator includes: (i) First component, (ii) a second member, wherein, under the first condition, the interaction between the first member and the second member imparts bending stress to the first member, and (iii) A third component configured to adjustably set the predetermined torque amount, wherein, based on the set predetermined torque amount, the third component contacts the first component longitudinally at different positions along the first component, wherein the contact between the third component and the first component determines the bending length of the first component, wherein the bending length corresponds to the predetermined torque amount.

14. The device according to claim 13, wherein, Under the second condition, the first component is in a relaxed state, and there is no bending stress on the first component.

15. The device of claim 13, wherein, under a second condition, the interaction between the first member and the second member imparts a bending stress to the first member, wherein the bending stress under the second condition is different in degree from the bending stress under the first condition.

16. The device of claim 13, wherein the first member includes at least one arm extending longitudinally relative to the applicator.

17. The device of claim 16, wherein the first member comprises a pair of arms extending longitudinally relative to the applicator.

18. The device of claim 17, wherein the second member is positioned between the pair of arms, and wherein the pair of arms are configured to selectively contact the outer surface of the second member.

19. The device according to any one of claims 13 to 18, wherein the second member comprises a pair of hook-like features, wherein the first member is configured to selectively contact the hook-like features.

20. The device according to any one of claims 13 to 18, wherein, When the torque applied to the stabilizing component is less than the predetermined torque, the first component is operably pressed against the outer surface of the second component, such that rotation of the applicator causes a corresponding rotation of the second component.

21. The device according to any one of claims 13 to 18, wherein, When the torque applied to the stabilizing component is equal to or greater than the predetermined torque, the first component operably slides past the second component, such that the second component remains stationary as the applicator rotates to further tighten the stabilizing component.

22. The device according to any one of claims 13 to 18, wherein the applicator further comprises a drill bit configured to engage with the stabilizing component, wherein the second member is connected to the drill bit, and wherein the second member and the drill bit are configured to rotate in unison.

23. The device according to any one of claims 13 to 18, wherein, The stabilizing component is configured to translate the stabilizing feature without rotating it.

24. The device according to any one of claims 13 to 18, wherein the applicator defines a rotation axis, and wherein the stabilizing component is configured to receive the stabilizing feature such that the stabilizing feature is coaxially oriented with the rotation axis.

25. The device according to any one of claims 13 to 18, wherein the applicator includes an indicator feature indicating the predetermined amount of torque.

26. The device according to any one of claims 13 to 18, wherein the stabilizing feature comprises a skull pin.

27. The device according to any one of claims 13 to 18, wherein the applicator comprises a housing, and wherein the first member is configured to rotate in unison with the housing.

28. The device according to any one of claims 13 to 18, wherein the applicator is detachably connected to the stabilizing component.

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