Tension adding mechanism and usage method in a head stabilization device

Abstract

[Solution] A head stabilization device usable to stabilize a patient's head during a medical procedure includes a modular design in which stabilization assemblies of various configurations are interchangeable at receptacles along a frame. The device includes a tensioning mechanism that is positioned away from the stabilization assembly and is operable to increase or decrease the amount of force the stabilization assembly applies to the patient's head. The device includes a locking mechanism for a stabilization assembly having a rotatable member with one or more stabilization mechanisms connected thereto. The device includes an adjustment mechanism for adjusting the spacing between frame members, which provides a continuous range of adjustment instead of limited adjustment increments.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 967,712, filed January 30, 2020, entitled "Radiolucent Head Stabilization Device and Method of Use", the disclosure of which is incorporated herein by reference. The U.S. Provisional Patent Application further claims priority to U.S. Provisional Patent Application No. 63 / 091,572, filed October 14, 2020, entitled "Head Stabilization Device Tensioning Feature and Method of Use", the disclosure of which is incorporated herein by reference.

Background Art

[0002] During certain medical procedures, it may be necessary or desirable to stabilize and immobilize all or a part of a patient's body. Certain neurological procedures involve stabilizing the head and / or neck. Specific devices and methods are utilized to stabilize a specific part of a patient. For example, a skull clamp is a type of head stabilization device that stabilizes a patient's head and / or neck. Further, it may be necessary or desirable to obtain images before, during, and / or after a procedure using various imaging modalities.

[0003] Although various head stabilization devices and methods of using such devices have been devised and used, it is believed that no one prior to the inventors has devised and used the inventions described herein. The prior art document information related to the invention of this application is as follows (including documents cited at the international stage after the international filing date and documents cited when entering the national phase in other countries). (Prior art document) (Patent document) (Patent document 1) European Patent Application Publication No. 2614790 (Patent document 2) European Patent Application Publication No. 2819607 (Patent document 3) European Patent Application Publication No. 3132767 (Patent document 4) US Patent Application Publication No. 2006 / 190010 (Patent document 5) US Patent Application Publication No. 2014 / 276823 (Patent document 6) US Patent Application Publication No. 2009 / 306662 (Patent document 7) European Patent Application Publication No. 1152727

Brief Description of the Drawings

[0004] This specification concludes with the claims that identify and particularly prescribe the present invention, but it is considered that understanding will be further enhanced by the description of the following specific embodiments in conjunction with the accompanying drawings. In the drawings, the same reference numerals identify the same elements.

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6A

Figure 6B

Figure 6C

Figure 7A

Figure 7B

Figure 7C

Figure 7D

Figure 8A

Figure 8B

Figure 8C

Figure 8D

Figure 8E

Figure 9

Figure 10

Figure 11A

Figure 11B

Figure 11C

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16A

Figure 16B

Figure 16C

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

[0005] This drawing is not intended to be limiting, and it is contemplated that various embodiments of the present invention can be implemented in other ways that include aspects not necessarily depicted in this drawing. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some aspects of the present invention and, together with the related description, explain the principles of the present invention. However, the present invention is not limited to the precise arrangements shown in the drawings.

DETAILED DESCRIPTION OF THE INVENTION

[0006] The following description of specific embodiments of the present invention is not intended to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will be apparent to those skilled in the art from the following exemplary description, which is one of the best modes for carrying out the present invention. It is understood that the present invention can have other different aspects and obvious aspects without departing from the invention. Therefore, the drawings and description are substantially exemplary and should not be construed as limiting.

[0007] Figures 1A and 1B illustrate an exemplary head stabilization device or head fixation device (10). Throughout this specification, the term "HFD" is used synonymously with the terms "head stabilization device", "head fixation device", or "skull clamp". In the illustrated embodiment, the HFD (10) has the shape or form of a skull clamp. In this regard, the HFD (10) has a frame (100). The frame (100) includes a first frame portion (102) and a second frame portion (104). The frame portions (102, 104) can be adjustably connected, whereby the spacing between the frame portions is adjusted. The frame portions (102, 104) each include a receiving portion (106, 108) configured to receive a stabilization assembly. In the illustrated embodiment, the stabilization assembly (200) is received by the receiving portion (106) of the frame portion (102). Further, the stabilization assembly (300) is received by the receiving portion (108) of the frame portion (104).

[0008] As shown more clearly in FIG. 1B, the HFD (10) includes a frame adjustment mechanism (400) operable to adjust the relative spacing between the frame portions (102, 104). The frame adjustment mechanism (400) includes an actuator (402), as shown in FIG. 1B. Additional components and operability of the frame adjustment mechanism (400) will be described in detail below with reference to FIGS. 2A-3.

[0009] The HFD (10) has a modular design, and the receiving portions (106, 108) are not configured to receive only a single type or single design of stabilization assembly, but are configured to receive various stabilization assemblies. For example, in the embodiments illustrated in FIGS. 1A and 1B, the stabilization assembly (200) and the stabilization assembly (300) are interchangeable, such that the stabilization assembly (200) is connected to the receiving portion (108), and similarly the stabilization assembly (300) is connected to the receiving portion (106). Additional components and operability of the modular HFD (10) related to various stabilization assemblies will be described in detail below with reference to FIGS. 4A-7D.

[0010] Further, referring to FIGS. 1A and 1B, the HFD (10) includes a tension adding mechanism (500) operable to adjust the amount of force applied to the patient by the stabilization assembly. The tension adding mechanism (500) includes an actuator (502) as shown in FIGS. 1A and 1B. Additional components and operation of the tension adding mechanism (500) will be described in detail below with reference to FIGS. 8A-8D.

[0011] I. Exemplary Frame Adjustment Mechanism Referring to FIGS. 2A-2C, a frame adjustment mechanism (400) is illustrated and will be described in detail below. As shown in FIG. 2A, the frame portion (102) includes an elongated shaft (110) received within an elongated shaft (112) of the frame portion (104). A lock mechanism (404) of the frame adjustment mechanism (400) extends within the elongated shaft (110). In this embodiment, the lock mechanism (404) is connectable to the actuator (402) via a pin joint. As shown in FIGS. 1B and 2B, the actuator (402) is rotatable about this pin joint. As shown in FIG. 2B, when the actuator (402) is rotated upward or in the vertical direction, the lock mechanism (404) is pulled or drawn toward the pin joint associated with the actuator (402). Conversely, when the actuator (402) is rotated in the opposite direction, the actuator (402) pushes the lock mechanism (404) away from the pin joint associated with the actuator (402).

[0012] In the illustrated embodiment, the locking mechanism (404) includes a distal portion (406) having an outer surface (408) that is inclined or angled. In this embodiment, the outer surface (408) has a curved surface in addition to being inclined or angled. Thus, in this embodiment, the distal portion (406) has a tapered or conical shape such that the diameter is maximum at the leading end of the distal portion (406). The distal portion (406) further has a proximal shoulder (410). The elongated shaft (110) includes a hollow interior (114) through which the locking mechanism (404) extends. A stop (116) is defined near the distal end of the hollow interior (114), and by the interaction of this stop (116) with the shoulder (410), the locking mechanism (404) is prevented from being pulled into the actuator side from the elongated shaft (110).

[0013] The elongated shaft (110) includes an opening (118) near the distal end. The opening (118) is configured to receive a locking mechanism (412) that is contactable by the surface (408) of the distal portion (406) of the locking mechanism (404). The locking mechanism (412) includes an outer surface (414) that is inclined or angled and contacts the surface (408) of the distal portion (406) of the locking mechanism (404). Thus, when the locking mechanism (404) is moved toward the actuator (402) arrangement side, due to the interaction of the inclined or angled outer surfaces (408, 414), the locking mechanism (412) acts on the elongated shaft (112) of the frame portion (104). This contact is sufficient to create a friction fit between these components, thereby preventing the frame portions (102, 104) from moving away from each other. In this embodiment, when the engagement or contact of the locking mechanism (412) with the shaft (112) is sufficient, the movement of the frame portions (102, 104) away from each other is prevented, but it should be further noted that the frame portions (102, 104) can be moved toward each other, whereby the frame (100) is arranged in a closer position.

[0014] If it is desirable to release the frame (100), basically, the steps reverse to those described above are performed. In particular, the actuator (402) is rotated downward away from the orientation perpendicular to the locking mechanism (404). As a result, the locking mechanism (404) is moved toward the frame portion (104), the distal portion (406) is disengaged from the locking mechanism (412), the locking mechanism (412) is disengaged from the shaft (112) to an extent that any frictional force can be overcome, and the frame portions (102, 104) are adjusted to a more open position (separated position) as required.

[0015] As described above, the frame adjustment mechanism (400) is configured such that the frame portions (102, 104) are adjustable relative to each other, and then, when a desired position or arrangement is achieved, the frame portions (102, 104) are fixed to prevent the frame portions from being released. Further, unlike mechanical engagement by complementary structures such as meshing teeth, where an increase in the adjustment range is limited by a mechanical engagement structure, in the adjustment of the relative positions of the frame portions (102, 104) by this locking configuration having a friction fit between components, the increase amount can be infinitely varied. In other words, in the illustrated embodiment, a stepless fit can be achieved by the configurations of the locking mechanism (412), the distal portion (406), and the shaft (112). Thus, in contrast to an apparatus that controls or regulates an increase in the adjustment range of the frame portions (102, 104) using a meshing engagement mechanism or a stepped mechanism, the adjustment range of the frame portions (102, 104) can be changed without limitation. Of course, in some other embodiments, if an interference fit is desirable, one or more stepped or engagement mechanisms can be included in the locking mechanisms (404, 412). Such a change is considered obvious to those skilled in the art in view of the teachings of this specification.

[0016] As best seen in FIGS. 2B and 2C, the elongated shaft (110) includes a groove portion (120) along the bottom region. The alignment mechanism (416) extends through the elongated shaft (112) and is configured to be received inside the groove portion (120), thereby maintaining the alignment of the elongated shafts (110, 112) and preventing a change in the relative rotational position of the elongated shafts (110, 112) when the spacing between the frame portions (102, 104) is adjusted.

[0017] FIG. 3 shows an alternative frame portion (102') that can be used with the HFD (10) instead of the frame portion (102). The frame portion (102') is similar to the frame portion (102), except that the actuator configuration is different. The frame portion (102') has an actuator (402') that connects to the locking mechanism. The actuator (402') includes a pushable portion provided in proximity to or in the vicinity of the stabilization assembly and along the upright portion of the frame portion (102'). In this embodiment, the actuator (402') is biased by a spring, whereby the locking mechanism (404) is biased away from the frame portion (104), so that the distal portion (406) contacts the locking mechanism (412) to produce a friction fit or friction lock between the frame portions (102, 104). By the push-type actuator (402') overcoming the biasing force of the spring and pushing the locking mechanism (404) towards the frame portion (104), the friction fit or friction lock is reduced or removed, enabling the opening of the frame portions (102, 104) or an increase in the spacing between the frame portions.

[0018] II. Exemplary Modular Stabilization Assembly Figures 4A and 4B show a stabilization assembly (200). The stabilization assembly (200) has a housing (202). The housing (202) includes a hole (204) configured to receive a pin holder (12) with a pin (14) configured to contact a patient. The housing (202) includes a proximal notch (206) configured to receive a pin (122) that extends through receiving portions (106, 108) according to the frame portions (102, 104) on which the stabilization assembly (200) is mounted. The housing (202) has a spherical member (208) that contacts an elastic member (210) therein. A pin (212), or a combination of the pin (212) and a body portion, is disposed below the elastic member (210).

[0019] When attaching the stabilization assembly (200), the housing (202) is slid or translated in its proximity so as to fit within the receiving portions (106, 108). The housing (202) and the receiving portions (106, 108) include a complementary engagement mechanism, such as a complementary dovetail mechanism, that guides the stabilization assembly (200) to an appropriate position and maintains the housing (202) in a particular orientation, for example. The pin (122) aligns with the notch (206) and contacts the spherical member (208), which is then pressed against the elastic member (210). This enables the spherical member (208) to be moved to fully seat the pin (122) within the notch (206). When fully seated, the pin (122) passes through the spherical member (208), and the spherical member (208) returns behind the pin (122) due to the biasing force of the elastic member (210). In such a manner, a locking effect is achieved to maintain the stabilization assembly (200) in an appropriate position relative to the receiving portions (106, 108).

[0020] Figures 5A-6C illustrate a stabilization assembly (600). The stabilization assembly (600) is similar to the stabilization assembly (200), except that it includes a housing (602) having a hole (604) configured to receive an adapter (614). In one embodiment shown in Figure 5B, the adapter (614) is configured to receive a pin (14) configured to contact a patient. In another embodiment shown in Figures 6A and 6B, the adapter (614) is configured to receive a rocker arm assembly (616).

[0021] The stabilization assembly (600) includes a spherical member (618) and an elastic member (620) to maintain the adapter (614) in a proper position within the hole (604). The adapter (614) includes an annular groove (622) configured to connect with the spherical member (618) when the adapter (614) is fully seated within the hole (604). When the adapter (614) is inserted, the spherical member (618) is pressed against the elastic member (620). However, when the adapter (614) is fully seated, the annular groove (622) is aligned above the spherical member (618), so that the biasing force of the elastic member (620) causes the spherical member (618) to return to its original position and engage with the annular groove (622). In such a configuration, the adapter (614) is fixed by translational movement but is rotatable by the spherical member (618) that maintains engagement with the annular groove (622).

[0022] In another aspect of the stabilization assembly (600), a plurality of adapters (614) can be used with the housing (602). For example, the adapter (614) is configured to be used with a single pin (14), and another adapter is configured to be used with a rocker arm assembly (616). In such a modular design, it is possible to change the type of the stabilization mechanism by replacing the adapter associated with a specific type of stabilization mechanism. Also, in another aspect as described above, the same adapter (614) can be used with multiple types of stabilization mechanisms. In such a modular design, it is possible to change the type of the stabilization mechanism by replacing the stabilization mechanism itself while maintaining the same adapter (614).

[0023] Figures 7A - 7D show a stabilization assembly (300) configured with a locking rocker arm assembly (316). The stabilization assembly (300) includes a housing (302), actuators (324, 326), spherical members (208, 618), elastic members (210, 620), a pin (212), and a hole (304) configured to receive a portion of the locking rocker arm assembly (316). The stabilization assembly (300) is connected to the receiving portions (106, 108) in a manner similar to the stabilization assembly (200) described above. As shown in Figure 7A, the housing (302) includes a dovetail mechanism in a manner similar to the stabilization assemblies (200, 600).

[0024] As shown in FIGS. 7C and 7D, the fixing rocker arm assembly (316) includes a body portion (328) having a pair of extensions (330) configured to receive a rocker arm (332) via a pin joint. The body portion (328) further includes an adapter (314) similar to the adapter (614), but this adapter (314) further incorporates a locking mechanism for fixing the rotational position of the fixing rocker arm assembly (316). For example, the adapter (314) includes an annular flange (622) that engages a spherical member (618). However, the adapter (314) further includes a toothed member (334), and this toothed member (334) is configured to selectively engage a shaft (336) having a toothed end configured to engage the teeth of the toothed member. The engagement between the shaft (336) and the toothed member (334) fixes the rotational position of the rocker arm (332) relative to the housing (302) and the frame (100).

[0025] When the actuators (324, 326) are not pressed, or when the rocker arm (332) is in a fixed neutral state, the surface (327) of the notch of the actuator (326) is in contact with the surface (337) of the notch of the shaft (336). Therefore, the shaft (336) maintains an engaged and fixed state with the toothed member (334). To adjust the rotational position of the rocker arm (332), the pressing actuator (326) overcomes the biasing force of the spring (340) to disengage the surface (327) from the surface (337). As a result, the notch of the actuator (326) is aligned with the notch of the shaft (336) without interference. By being aligned without such interference, the release actuator (324) and the shaft (336) connected to the actuator are driven upward and away from the toothed member (334) by the spring (338) and the biasing force provided by the spring, disengaging the toothed mechanism and enabling rotational adjustment. When the desired rotational adjustment is achieved, the release actuator (324) is pressed downward to overcome the biasing force of the spring (338) and align the notch of the shaft (336) with the notch of the release actuator (326). Further, the biasing spring (340) on the actuator (326) causes the actuator (326) to translate, so that the surface (327) contacts the surface (337) of the shaft (336) again. In such a manner, the toothed portion of the shaft (336) engages with the toothed member (334), and the rotational position of the rocker arm (332) is fixed.

[0026] III. Exemplary Torsion Rod Tensioning Mechanism Figures 8A - 8D show a tensioning feature (500) used to adjust the amount of force applied to a patient by an attached stabilization assembly during use of the HFD (10). The tensioning feature (500) has an actuator (502) with one end extending through a hole in the frame portion (104) and threaded to the body portion (504). The body portion (504) has a hole for receiving a rod (506), and this rod (506) connects an elongate member (508) to the body portion (504). The rod (506) is fastened to the body portion (504) and includes a polygonal outer shape at at least one location on the body portion (504) through which the rod (506) passes. In this manner, the rod (506) is fixed to the body portion (504) and does not rotate relative to the body portion (504). As shown in Figure 8C, the elongate member (508) is connected to the rod (506). At another location on the elongate member (508) through which the rod (506) passes, the rod (506) includes a polygonal outer shape, so the elongate member (508) is fixed to the rod (506) and does not rotate relative to the rod (506).

[0027] At the other end, the elongate member (508) has a pair of spaced - apart extensions (510). The receiving portion (108) is disposed within this space and is pinned to the pair of extensions (510). As shown in Figures 8C and 8D, the holes in the receiving portion (108) that are pinned to the pair of extensions are elongated, and this elongated configuration allows for a predetermined lateral movement of the receiving portion (108).

[0028] To adjust the tension applying mechanism (500), the actuator (502) is rotated, thereby causing the main body portion (504) to translate. The direction of translation depends on the rotation direction of the actuator (502). When the main body portion (504) is moved towards the frame portion (102), the tension increases, i.e., the force applied to the patient increases. Due to this movement, the rod (506) moves in the same direction. Since the elongated member (508) is connected to the rod (506), it also moves in the same direction. As described above, the elongated member (508) is pivotally connected to the receiving portion (108) at its upper end. This pivotal connection fixes, or limits, the range within which the elongated member (508) can move when the HFD (10) is in a mounted state where the patient's head is positioned in its middle portion and the stabilization assembly and each stabilization mechanism are in contact. Thus, under such conditions, there is a torsional force or torque acting on the rod (506). In this way, the rod (506) functions similar to a torsion rod. That is, as the main body portion (504) and the rod (506) move towards the frame portion (102), the tension within the rod (506) and the elongated member (508) increases, and as a result, a greater force is applied to the receiving portion (108) by the elongated member (508). In such a manner, the elongated member (508) functions as a tension applying member, and this tension is adjustable. When the patient's head is positioned within the HFD (10), the receiving portion (108) remains stationary in the lateral direction, so when the tension increases, a greater force is applied to the patient's head. By rotating the actuator (502) in the opposite direction and translating the main body portion (504) and the rod (506) towards the frame portion (104), the force applied to the patient can be decreased.

[0029] The elongated member (508) also includes an actuator (512). The actuator (512) is configured as a pre-tensioning feature. In such an aspect, before fixing the patient within the HFD (10), the actuator (512) can be pressed to simultaneously move both of the frame portions (102, 104) until the stabilization mechanism connected to the frame portions (102, 104) contacts the patient's head. When contact with the patient's head is achieved, the actuator (512) is released and the tension can be adjusted using the tensioning mechanism as described above. By way of non-limiting example only, in some embodiments, the pre-tensioning mechanism using the actuator (512) can apply a force of about 50 to 150 Newtons to the patient's head.

[0030] Referring to FIG. 8B, in some aspects, a force indicator or scale (514) is included in the tensioning mechanism. This scale may be configured to correlate the tension within the rod (506) and the elongated member (508) based on the movement of the body portion (504) with the force applied to the stabilization assembly (300) resulting from this tension. In one embodiment, the scale (514) can be included on the outer surface of the rod (506). Those skilled in the art will appreciate that other ways of displaying tension and / or force are apparent in view of the teachings herein.

[0031] IV. Exemplary Alternative Skull Clamp with a Tensioning Mechanism Comprising a Bending Beam FIG. 9 shows an alternative HFD (1010) that is substantially similar to the HFD (10) described above. For example, as described above with the HFD (10), the HFD (1010) of the present embodiment has the shape or form of a skull clamp. Thus, the HFD (1010) of the present embodiment has a frame (1100) similar to the frame (100) described above. The frame (1100) includes a first frame portion (1102) and a second frame portion (1104). The frame portions (1102, 1104) can be adjustably connected, whereby the spacing between the frame portions is adjusted. The frame portions (1102, 1104) each include a receiving portion (1106, 1108) configured to receive a stabilization assembly. In the illustrated aspect, the stabilization assembly (1200) is received by the receiving portion (1106) of the frame portion (1102). Further, the stabilization assembly (1300) is received by the receiving portion (1108) of the frame portion (1104).

[0032] As described above with the HFD(10), the HFD(1010) of the present embodiment further includes a frame adjustment mechanism operable to adjust the relative spacing between the frame portions (1102, 1104). In some aspects, the frame adjustment mechanism may be the same as or similar to the frame adjustment mechanism (400) described above. In the present embodiment, the HFD(1010) includes a frame adjustment mechanism (1400) including a pair of engagement members (not shown), each of the engagement members having one or more teeth (not shown). In such an aspect, the teeth of one engagement member are configured to selectively engage the teeth of the other engagement member. The actuating mechanism (1103), when actuated, moves or displaces at least one of the engagement members to disengage the teeth of each engagement member. When the engagement members are disengaged, the spacing of the frame assembly can be adjusted to be larger or smaller. In some aspects, the spacing of the frame assembly is fixed when the engagement members are engaged. On the other hand, in another aspect, the spacing of the frame assembly can be adjusted to be smaller but not to be larger. Such a frame adjustment mechanism may incorporate one or more safety mechanisms (not shown), in which case the operation of the actuating mechanism (1103) is blocked unless one or more safety mechanisms are actuated first. In another embodiment, those skilled in the art will appreciate that various alternative frame adjustment mechanisms can be readily incorporated into the HFD(1010) or the HFD(10) in view of the teachings herein.

[0033] Similar to the HFD(10), the HFD(1010) of the present embodiment has a modular design, and the receiving parts (1106, 1108) are not configured to receive only a single type or a stabilized assembly of a design, but are configured to receive various stabilized assemblies. Similar to what has been described above, since the stabilization assemblies (1200) and the stabilization assembly (1300) are interchangeable with each other, the stabilization assembly (1200) can be connected to the receiving part (1108), and similarly, the stabilization assembly (1300) can be connected to the receiving part (1106). In this way, the modular system and compatibility related to the stabilization assemblies (1200, 1300) and the HFD(1010) are provided in the same or similar manner as described above in relation to the stabilization assemblies (200, 300) and the HFD(10).

[0034] Figure 10 shows the second frame portion (1104) in more detail. The second frame portion (1104) of the present embodiment includes a tension adding mechanism (1500). The tension adding mechanism (1500) of the present embodiment is used to adjust the amount of force applied to the patient during the use of the HFD (1010). As shown in FIG. 11A, the tension adding mechanism (1500) of the present embodiment has an actuator (1502) and an elongated member (1508). The actuator (1502) is configured to adjust the position of the elongated member (1508) to adjust the amount of force applied to the patient by the connected stabilization assembly (1300) during the use of the HFD (1010). As shown, in some embodiments, the tension adding mechanism (1500) is disposed at a predetermined distance from the actuator (1502) disposed at a predetermined distance from the stabilization assembly (1300). In other words, the actuator (1502) of the tension adding mechanism (1500) can be disposed along the bottom or side of the frame (1100) rather than the upright portion thereof. At the same time, the other part of the tension adding mechanism (1500) that contacts the stabilization assembly (1300) to adjust the fixing force by the pin is disposed at a predetermined distance from the actuator (1502). In some embodiments, this distance may be substantially the same as the distance represented by the size of a standard patient's head, so that when the patient's head is positioned within the HFD (1010), the actuator (1502) does not overlap the patient's temple.

[0035] FIG. 11A shows the configuration of the actuator (1502) in more detail. The actuator (1502) of the present embodiment is generally configured to interact with the main body portion (1504) to perform selective rotation and release of the main body portion (1504). As will be described in more detail below, the main body portion (1504) is configured to engage a part of the elongated member (1508) or other components associated with the elongated member, whereby the parallel movement of the elongated member (1508) is driven through the rotation of the main body portion (1504) by the actuator (1502).

[0036] A suitable and selective rotational engagement between the actuator (1502) and the body portion (1504) can be achieved in various ways. Shown only as an example, the actuator (1502) of the present embodiment includes a handle (1510) having an elongated rod (1512), and this elongated rod (1512) extends from the handle (1510) into the interior of the second frame portion (1104). The end of the elongated rod (1512) opposite the handle (1510) includes a keyed end (1516). As will be described in more detail below, typically, after the actuator (1502) is translated to a predetermined position, the keyed end (1516) engages with a part of the body portion (1504) and is configured to provide rotation of the body portion (1504).

[0037] The body portion (1504) includes a hollow interior (1520) configured to receive the elongated rod (1512) of the actuator (1502) for engagement with the actuator (1502). The hollow interior (1520) defines a cylindrical portion (1522) and an engaging portion (1524) that extends toward the opposite end of the body portion (1504). The cylindrical portion (1522) typically defines a generally cylindrical shape within which the keyed end (1516) can rotate freely. On the other hand, the engaging portion (1524) typically defines a shape corresponding to the shape of the keyed end (1516). Thus, the engaging portion (1524) receives the keyed end (1516) to form a keyed relationship, thereby enabling the transmission of rotational motion from the elongated rod (1512) to the body portion (1504).

[0038] As described above, when the actuator (1502) is at a predetermined longitudinal position relative to the main body portion (1504), it is configured to rotate the main body portion (1504). Therefore, as will be described in more detail below, the actuator (1502) is movable between one or more positions to selectively engage or disengage from the main body portion (1504) to rotate the main body portion. To maintain the actuator (1502) at a predetermined position relative to the main body portion (1504), the elongated rod (1512) of the actuator includes one or more retaining shaped portions (1514) extending from its surface inwardly. In the present embodiment, the elongated rod (1512) includes three semi-circular notches positioned at three positions along the longitudinal axis of the rod. Each retaining shaped portion (1514) is configured to engage with a spring-biased bearing, a ball, or other elastic mechanism to releasably hold the elongated rod (1512) at a predetermined position along the longitudinal axis of the rod. As will be described in more detail below, with this configuration, the actuator (1502) is selectively fixed to one of a plurality of predetermined positions corresponding to the operation of the actuator.

[0039] The main body portion (1504) defines a substantially cylindrical shape. The outside of the main body portion (1504) includes an external thread. As will be described in more detail below, such an external thread can be configured to drive an elongated member (1508) or other components associated with the elongated member (1508). The main body portion (1504) is fixed at an appropriate position inside the second frame portion (1104). In particular, the internal shape of the second frame portion (1104) is such that the main body portion (1504) is fixed at a single lateral and longitudinal position. However, even when the main body portion (1504) is fixed in this way, it is configured to rotate within the second frame portion (1104).

[0040] The elongated member (1508) is shown in more detail in FIG. 11A. The elongated member (1508) of the present embodiment is typically configured to move during use of the HFD (1010) to adjust the amount of force applied to the patient by the connected stabilization assembly (1300). As can be seen from this figure, the elongated member (1508) extends upward from the main body portion (1504) toward the stabilization assembly (1300). As will be described in more detail below, at least a portion of the elongated member (1508) is in contact with the connected stabilization assembly (1300), thereby transmitting the force from the main body portion (1504) to the stabilization assembly (1300).

[0041] The elongated member (1508) is associated with an indicator member (1542). In particular, since the lower part of the indicator member (1542) is fastened to the lower part of the elongated member (1508), the lower part of the indicator member (1542) and the lower part of the elongated member (1508) are firmly fixed to each other. Such fixation can be achieved by any suitable means. For example, in the present embodiment, such fixation is achieved using one or more pins.

[0042] The indicator member (1542) extends upward within a second frame portion (1104) independently of the elongated member (1508). That is, the indicator member (1542) is connected to the elongated member (1508) only at its lower part. Since the other parts of the indicator member (1542) are not connected to the elongated member (1508), the upper part of the indicator member (1542) and the upper part of the elongated member (1508) are movable relative to each other. As will be described in more detail below, this configuration enables the indicator member (1542) to function as a scale or force indicator regarding the amount of force applied to the patient's head by the stabilization assembly (1300).

[0043] The elongated member (1508) includes a threaded opening (1530) at an end opposite the stabilization assembly (1300). The threaded opening (1530) is generally configured to receive the body portion (1504) therein and engage with the male thread of the body portion (1504). As described above, the body portion (1504) is in a fixed position inside the second frame portion (1104). Thus, when the threaded opening (1530) receives the body portion (1504), the bottom of the elongated member (1508) is similarly fixed in position by the body portion (1504). Further, as will be described in more detail below, the elongated member (1508) is configured to translate in the second frame portion (1104) by rotation of the body portion (1504) and engagement of the thread of the threaded opening (1530) with the thread of the body portion (1504). That is, the body portion (1504) has a similar configuration to a lead screw that mechanically fixes a part of the elongated member (1508) while translating the elongated member (1508) by a rotational input from the actuator (1502).

[0044] As shown in FIG. 11B, for adjustment of the tensioning mechanism (1500), the actuator (1502) is first pulled away from the second frame portion (1104). By this pulling movement, the actuator (1502) transitions from an initial received form to an operating form. Although not shown, it should be understood that in some embodiments, the actuator (1502) may be configured to have an intermediate form. In this intermediate form, the actuator (1502) is rotatable without affecting the tensioning mechanism (1500) at all. Shown as an example only, such a form is desirable for adjusting the operating position of the actuator (1502) before the operator uses the actuator (1502) for adjustment of the tensioning mechanism (1500).

[0045] As shown in FIG. 11B, when in the actuated form, the actuator (1502) is aligned for adjustment of the tensioning mechanism (1500). As shown in FIG. 11C, the actuator (1502) is rotated when the actuator (1502) is in the actuated form, and in response to this rotation, the body portion (1504) rotates. As the body portion (1504) rotates, the screw on the outside of the body portion (1504) engages with the screw on the inside of the threaded opening (1530), whereby the elongated member (1508) translates along the longitudinal axis of the body portion (1504).

[0046] In some embodiments, the translation of the elongated member (1508) can be visualized by one or more openings or windows in the second frame portion (1104). For example, referring again to FIGS. 9 and 10, the second frame portion (1104) includes an opening (1105) configured such that an operator can visualize the movement of the elongated member (1508). The opening (1105) of the present embodiment is configured as an elongated slot that receives a pin protruding from the elongated member (1508). Accordingly, the forward movement of the elongated member (1508) along the entire movement path can be indicated by the pin of the elongated member (1508) advancing along the length defined by the opening (1105). Although the opening (1105) of the present embodiment is configured as an elongated slot, it should be understood that in other embodiments, various alternative forms can be used, such as an oval or square window, a transparent section, etc.

[0047] The direction of translation of the elongated member (1508) depends on the direction of rotation of the actuator (1502). When the body portion (1504) is rotated so that the elongated member (1508) moves towards the frame portion (1102), the tension, i.e., the force applied to the patient, increases. On the other hand, when the body portion (1504) is rotated in the opposite direction by the actuator (1502) and the elongated member (1508) is moved away from the frame portion (1102), the tension decreases.

[0048] As shown in FIG. 12, the ends of the elongated member (1508) on the side opposite to the main body part (1504) have a pair of extensions (1509) arranged at intervals. The stabilization assembly (1300) is arranged within this interval and is pin - coupled to the pair of extensions (1509). Thus, when the elongated member (1508) is moved towards the first frame part (1102), pressure is applied to the stabilization assembly (1300) in the direction towards the frame part (1102). On the other hand, when the elongated member (1508) moves away from the first frame part (1102), the pressure applied to the stabilization assembly (1300) decreases. FIG. 12 also shows one of a pair of slots (1302) incorporated in the stabilization assembly (1300). The slots (1302) are provided on each side of the stabilization assembly (1300), and by receiving the protruding upper part of the second frame part (1104) in the slots, the stabilization assembly (1300) can translate or slide horizontally with respect to the frame part (1104) in response to the force applied by the elongated member (1508).

[0049] FIG. 12 also shows an interface (1304) located at the top of the stabilization assembly (1300) in this figure and oriented upward or away from the frame part (1104). In this embodiment, the interface (1304) is configured as a star - shaped part, but in another aspect, it can be configured in another way. Furthermore, various accessories used in medical procedures such as neurosurgery can be selectively attached to the interface (1304).

[0050] Turning to the tension - applying mechanism again, the elongated member (1508) of the present embodiment is configured to curve or bend with respect to the main body portion (1504). In particular, the patient's head can be positioned between the frame portions (1102, 1104) by bringing the pins of the stabilization assemblies (1200, 1300) into contact with the head. When the patient is in the position fixed by the pins in this way, as described above, the elongated member (1508) is moved toward the first frame portion (1102) in order to apply a force to the stabilization assembly (1300), and since the patient's head is in the position fixed by the pins, a force in the opposite direction is applied to the elongated member (1508). As a result, the portion extending in a direction away from the main body portion (1504) of the elongated member (1508) curves or bends. Therefore, this curvature or bending of the elongated member (1508) provides a spring force or bending force applied to the stabilization assembly (1300) and ultimately to the pins that contact the patient. In this way, the elongated member (1508) provides a method for adjusting the fixing force of the pins used for the patient.

[0051] Referring to FIG. 13, the tension - applying mechanism (1500) of the present embodiment further includes a force indicator or scale (1540) associated with the elongated member (1508) and an indicator member (1542). The scale (1540) is generally configured to correlate with the tension inside the elongated member (1508) based on the force applied to the stabilization assembly (1300). Generally, the scale (1540) utilizes the relative movement between the elongated member (1508) and the indicator member (1542) to display the tension inside the elongated member (1508), and this tension correlates with the pin - fixing force applied to the patient. As shown in this figure, the scale (1540) is formed by a plurality of horizontally - extending, color - coded bar - like portions (1544) disposed on the upper surface of the indicator member (1542).

[0052] Additionally, the elongated member (1508) includes an inclined protrusion (1546) adjacent to the bar line portion (1544) of the indicator member (1542). The inclined protrusion (1546) is typically angled to protrude away from the first frame portion (1102). Therefore, when the elongated member (1508) curves or bends, a corresponding plurality of bar line portions (1544) are covered or exposed depending on a specific amount of curvature or bending of the elongated member (1508), which results from relative movement between the upper portion of the elongated member (1508) and the upper portion of the indicator member (1542). As understood from the teachings herein, when the elongated member (1508) curves or bends more, greater tension is generated in the elongated member (1508), thereby applying a greater pin fixation force to the patient. Thus, for example, when a relatively large tension is applied to the elongated member (1508), the upper portion of the elongated member (1508) moves a longer distance relative to the indicator member (1542), so that more bar line portions (1544) are covered by the inclined protrusion (1546).

[0053] As described above, the bar line portions (1544) are color-coded to indicate the amount of tension within the elongated member (1508). The specific color-coding used in this embodiment is a gradation between orange or yellow (low tension) and red (high tension). In another embodiment, one of ordinary skill in the art can use other suitable color-codings as will be apparent in view of the teachings herein. In this embodiment, individual bar line portions of various colors are used for illustration, but in another embodiment, a continuous gradation can be used without using individual bar line portions. Additionally or alternatively, symbols that do not depend on color-coding, such as numbers or symbols, can be used. Also, in some aspects, instead of using color-coding, the number of visible bar line portions can be used to indicate tension.

[0054] V. Exemplary Alternative Skull Clamp with a Tensioning Mechanism Comprising a Bending Beam and a Movable Frame FIG. 14 shows an alternative HFD (2010) that is substantially similar to the HFD (10, 1010) described above, unless otherwise specified in this specification. For example, as described above with the HFD (10), the HFD (2010) of this embodiment has the shape or form of a skull clamp. Thus, the HFD (2010) of this embodiment has a frame (2100) similar to the frame (100) described above. The frame (2100) includes a first frame portion (2102) and a second frame portion (2104). The frame portions (2102, 2104) can be adjustably connected, whereby the spacing between the frame portions is adjusted. The frame portions (2102, 2104) each include a receiving portion (2106, 2108) configured to receive a stabilization assembly. In the illustrated aspect, the stabilization assembly (2200) is received by the receiving portion (2106) of the frame portion (2102). Further, the stabilization assembly (2300) is received by the receiving portion (2108) of the frame portion (2104).

[0055] As described above with the HFD (10, 1010), the HFD (2010) of this embodiment further includes a frame adjustment mechanism operable to adjust the relative spacing between the frame portions (2102, 2104). In some aspects, the frame adjustment mechanism may be the same as or similar to the frame adjustment mechanism (400) or the frame adjustment mechanism (1400) described above. In another embodiment, various alternative frame adjustment mechanisms can be readily incorporated into the HFD (2010) or the HFD (10, 1010), which is believed to be understood by those skilled in the art in view of the teachings of this specification.

[0056] Similar to the HFD(10), the HFD(2010) of this embodiment has a modular design, and the receiving parts (2106, 2108) are not configured to receive only a single type or a stabilized assembly of the design, but are configured to receive various stabilized assemblies. Similar to what has been described above, since the stabilization assemblies (2200) and the stabilization assembly (2300) are interchangeable with each other, the stabilization assembly (2200) can be connected to the receiving part (2108), and similarly, the stabilization assembly (2300) can be connected to the receiving part (2106). In this way, the modular method and compatibility related to the stabilization assemblies (2200, 2300) and the HFD(2010) are provided in the same or a similar manner as the aspects described above in relation to the stabilization assemblies (200, 300) and the HFD(10).

[0057] FIG. 15 shows the second frame part (2104) in more detail. As described above together with the second frame parts (104, 1104), the second frame part (2104) of this embodiment includes a tension adding mechanism (2500). The tension adding mechanism (2500) of this embodiment is used to adjust the amount of force applied to the patient by the stabilization assembly (2200) during the use of the HFD(2010). The tension adding mechanism (2500) of this embodiment has an actuator (2502) and an elongated member (2508). The actuator (2502) is configured to adjust the amount of force applied to the patient by the connected stabilization assembly (2300) during the use of the HFD(2010) by adjusting the position of the elongated member (2508). However, different from the actuator (1502) described above, the actuator (2502) of this embodiment not only adjusts the position of the elongated member (2508), but also adjusts the position of the elongated member (2508) by adjusting the positions of the second frame part (2104) and the elongated member (2508).

[0058] FIG. 16A shows the configuration of the actuator (2502) in more detail. The actuator (2502) of the present embodiment is normally configured to interact with the main body portion (2504) to perform selective rotation and rotation release of the main body portion (2504). As will be described in more detail below, the main body portion (2504) is configured to engage with a part of the second frame portion (2104) or other components associated with the second frame portion, whereby the second frame portion (2104) together with the main body portion (2504) is driven to translate the elongated member (2508) through the rotation of the main body portion (2504) by the actuator (2502).

[0059] The suitable and selective rotational engagement between the actuator (2502) and the main body portion (2504) can be realized in various ways. Shown only as an example, the actuator (2502) of the present embodiment includes a handle (2510) having an elongated rod (2512), and this elongated rod (2512) extends from the handle (2510) into the second frame portion (2104). The end of the elongated rod (2512) opposite to the handle (2510) includes a keyed end (2516). As will be described in more detail below, normally, after the actuator (2502) is translated to a predetermined position, the keyed end (2516) is configured to engage with a part of the main body portion (2504) to provide rotation of the main body portion (2504).

[0060] The body part (2504) includes a hollow interior (2520) configured to receive the elongated rod (2512) of the actuator (2502) for engagement therewith. The hollow interior (2520) defines a cylindrical portion (2522) and an engagement portion (2524) that extends toward the opposite end of the body part (2504). The cylindrical portion (2522) generally defines a substantially cylindrical shape within which the keyed end (2516) can rotate freely. On the other hand, the engagement portion (2524) generally defines a shape corresponding to the shape of the keyed end (2516). Thus, the engagement portion (2524) receives the keyed end (2516) to form a keyed relationship, thereby enabling the transmission of rotational movement from the elongated rod (2512) to the body part (2504).

[0061] As described above, the actuator (2502) is configured to rotate the body part (2504) when in a predetermined longitudinal position relative to the body part (2504). Thus, as will be described in more detail below, the actuator (2502) is movable between one or more positions to selectively engage or disengage from the body part (2504) to rotate the body part. To maintain the actuator (2502) in a predetermined position relative to the body part (2504), the elongated rod (2512) of the actuator includes one or more detent-shaped portions (2514) that extend inwardly from its surface. In this embodiment, the elongated rod (2512) includes three semi-circular notches positioned at three locations along the longitudinal axis of the rod. Each detent-shaped portion (2514) is configured to engage with a spring-biased bearing, a ball, or other elastic mechanism to releasably hold the elongated rod (2512) in a predetermined position along the longitudinal axis of the rod. As will be described in more detail below, this configuration causes the actuator (2502) to be selectively fixed to one of a plurality of predetermined positions corresponding to the operation of the actuator.

[0062] The body part (2504) defines a generally cylindrical shape, and the outside of the body part (2504) includes external threads. As will be described in more detail below, such external threads can be configured to drive the second frame part (2104) and / or other components associated with the second frame part (2104). The body part (2504) is fixed at an appropriate position within a portion of the frame (2100). In particular, the internal shape of the lower part of the frame (2100) is formed such that the body part (2504) is fixed in a single lateral and longitudinal position. However, even when the body part (2504) is fixed in this way, it is configured to rotate within the second frame part (2106).

[0063] The elongated member (2508) is shown in more detail in FIG. 16A. The elongated member (2508) of the present embodiment is typically configured to move to adjust the amount of force applied to the patient by the connected stabilization assembly (2300) during use of the HFD (2010). As can be seen from this figure, the elongated member (2508) extends upward from the body part (2504) toward the stabilization assembly (2300). As will be described in more detail below, at least a portion of the elongated member (2508) is in contact with the connected stabilization assembly (2300), thereby transmitting the force from the body part (2504) to the stabilization assembly (2300).

[0064] The elongated member (2508) is pinned to a part of the second frame part (2104). In particular, the lower part of the elongated member (2508) is fixed to the lower part of the second frame part (2104) by one or more pins. Therefore, it should be understood that when the second frame part (2104) moves, at least the lower part of the elongated member (2508) moves in response to such movement, as will be described in more detail below.

[0065] The second frame portion (2104) includes a threaded hole portion (2530) near its lower part. The threaded hole portion (2530) is generally configured to receive the main body portion (2504) therein and engage with the male thread of the main body portion (2504). As described above, generally, the main body portion (2504) is in a fixed position relative to the lower part of the frame (2100). Therefore, when the threaded hole portion (2530) receives the main body portion (2504), the second frame portion (2104) is similarly fixed in position by the main body portion (2504). Since the lower part of the elongated member (2508) is fixed to the second frame portion (2104), the lower part of the elongated member (2508) is similarly fixed in position by the main body portion (2504). Further, as will be described in more detail below, the elongated member (2508) is configured to translate by the rotation of the main body portion (2504) and the engagement of the thread of the threaded hole portion (2530) with the thread of the main body portion (2504). That is, the main body portion (2504) mechanically fixes a part of the second frame portion (2104) and a part of the elongated member (2508), while having a configuration similar to a lead screw that translates the second frame portion (2104) and the elongated member (2508) by a rotational input from the actuator (2502).

[0066] As shown in FIG. 16B, for the adjustment of the tension applying mechanism (2500), the actuator (2502) is first pulled in a direction away from the second frame portion (2104). By this pulling movement, the actuator (2502) transitions from the initial accommodation form to the operating form. It should be understood that in some embodiments, the actuator (2502) may be configured to have an intermediate form. In this intermediate form, the actuator (2502) is rotatable without affecting the tension applying mechanism (2500) at all. Although shown as an example only, such a form is desirable for adjusting the operating position of the actuator (2502) before the operator uses the actuator (2502) for the adjustment of the tension applying mechanism (1500).

[0067] As shown in FIG. 16B, when in the operating mode, the actuator (2502) is aligned for adjustment of the tension adding mechanism (2500). As shown in FIG. 16C, the actuator (2502) is rotated when the actuator (1502) is in the operating mode, and accordingly, the main body portion (2504) rotates. As the main body portion (2504) rotates, the screw on the outside of the main body portion (2504) engages with the screw inside the threaded hole portion (2530) of the second frame portion (2104), whereby the second frame portion (2104) translates parallel to the longitudinal axis of the main body portion (2504). At the same time, due to the translation of the second frame portion (2104), at least the bottom portion of the elongated member (2508) translates parallel to the longitudinal axis of the main body portion (2504) according to this translation.

[0068] In some embodiments, one or more openings or windows within the second frame portion (2104) allow visualization of the translation of the second frame portion (2104) and the elongated member (1508). For example, referring again to FIGS. 14 and 15, the second frame portion (2104) includes an opening (2105) configured to allow an operator to visualize the movement of the second frame portion (2104) and the elongated member (2508). The opening (2105) of the present embodiment is configured as an elongated slot for receiving a pin protruding from the lower portion of the frame (2100). Accordingly, the forward movement of the second frame portion (2104) and the elongated member (2508) along the entire movement path can be indicated by the forward movement of the pin at the lower portion of the frame (2100) along the length defined by the opening (2105). Although the opening (2105) of the present embodiment is configured as an elongated slot, it should be understood that various alternative forms such as an elliptical or square window, a transparent section, etc. can be used in other embodiments.

[0069] The direction of translation of the second frame part (2104) and the elongated member (2508) depends on the direction of rotation of the actuator (2502). When the main body part (2504) is rotated so as to move the second frame part (2104) and the elongated member (2508) toward the first frame part (2102), the tension, that is, the force applied to the patient, increases. On the other hand, when the main body part (2504) is rotated in the opposite direction by the actuator (2502) and the second frame part (2104) and the elongated member (2508) are moved away from the first frame part (2102), the tension decreases.

[0070] As shown in FIG. 17, the end of the elongated member (2508) on the side opposite to the main body part (2504) has a pair of extensions (2509) arranged at intervals. The stabilization assembly (2300) is disposed within this interval and is pin-connected to the pair of extensions (2509). Therefore, when the elongated member (2508) is moved toward the first frame part (2102), pressure is applied to the stabilization assembly (2300) in the direction toward the frame part (2102). On the other hand, the pressure applied to the stabilization assembly (2300) decreases due to the movement of the elongated member (2508) in the direction away from the first frame part (2102). FIG. 17 also shows one of a pair of slots (2302) incorporated in the stabilization assembly (2300). The slot (2302) is provided on each side of the stabilization assembly (2300), and by receiving the protruding upper part of the second frame part (2104) in the slot, the second frame part (2104) can be translated or slid laterally with respect to the stabilization assembly (2300) in response to the force applied by the elongated member (1508).

[0071] The elongated member (2508) of the present embodiment is configured to bend or flex with respect to the main body portion (2504). In particular, the patient's head can be positioned between the frame portions (2102, 2104) by bringing the pins of the stabilization assemblies (2200, 2300) into contact with the head. When the patient is in the position fixed by the pins in this way, as described above, the elongated member (2508) is moved toward the first frame portion (2102) in order to apply a force to the stabilization assembly (2300), and since the patient's head is in the position fixed by the pins, a force in the opposite direction is applied to the elongated member (2508). As a result, the portion extending in a direction away from the main body portion (2504) of the elongated member (2508) bends or flexes. Therefore, this bending or flexing of the elongated member (2508) provides a spring force or bending force applied to the stabilization assembly (2300) and ultimately to the pins that contact the patient. In this way, the elongated member (2508) provides a method for adjusting the fixing force of the pins used for the patient.

[0072] Referring to FIG. 18, the tension adding mechanism (2500) of the present embodiment further includes a force indicator or scale (2540) associated with the elongated member (2508). The scale (2540) is generally configured to correlate with the tension inside the elongated member (2508) based on the force applied to the stabilization assembly (2300). Generally, the scale (2540) displays the tension inside the elongated member (2508) by utilizing the relative movement between the elongated member (2508) and the second frame portion (2104), and this tension correlates with the pin fixing force applied to the patient. As shown in this figure, the scale (2540) is formed by a plurality of horizontally extending, color-coded bar lines (2544) disposed on the upper surface of the second frame portion (2104).

[0073] Additionally, the elongated member (2508) includes an inclined protrusion (2546) adjacent to the bar portion (2544) of the second frame portion (2104). The inclined protrusion (1546) is generally angled to protrude in a direction away from the first frame portion (2102). Therefore, when the elongated member (2508) bends or flexes, depending on a particular amount of bending or flexing of the elongated member (2508) resulting from relative movement between the upper portion of the elongated member (2508) and the upper portion of the second frame portion (2104), the inclined protrusion (2546) is moved to intersect, indicate, or align with a predetermined bar portion (2544) among the plurality of bar portions (2544). As understood from the teachings herein, as the elongated member (2508) bends or flexes more, greater tension is created in the elongated member (2508), thereby applying a greater pinning force to the patient. Thus, for example, when a relatively large tension is applied to the elongated member (2508), the upper portion of the elongated member (2508) moves a greater distance relative to the first frame portion (2102), so the inclined protrusion (2546) is moved to a position that aligns with a bar portion (2544) higher up on the scale.

[0074] As described above, the bar portions (2544) are color - coded to indicate the amount of tension within the elongated member (2508). The particular color - coding used in this embodiment is a gradation between orange or yellow (low tension) and red (high tension). In another embodiment, one of ordinary skill in the art can use other suitable color - codings, as would be apparent in view of the teachings herein. In this embodiment, individual bar portions of various colors are used for illustration, but in another embodiment, a continuous gradation can be used without using individual bar portions. Additionally or alternatively, non - color - dependent markings such as numbers or symbols can be used. Also, in some aspects, instead of using color - coding, the number of visible bar portions can be used to display the tension.

[0075] VI. Exemplary Locker Arm Lock Mechanism Another feature of the HFDs (1010, 2010) relates to the locking mechanism of the stabilization assemblies (1300, 2300). FIGS. 19 and 20 show cross-sectional perspective views of the stabilization assembly (2300). The locking mechanism and the operability are the same in the stabilization assembly (1300) and the stabilization assembly (2300). For the sake of brevity, the locking mechanism will be described with reference to FIGS. 19 and 20 showing the stabilization assembly (2300), but it is understood that the description is equally applicable to the stabilization assembly (1300).

[0076] Referring now to FIGS. 19 and 20, the locking mechanism enables selective rotational adjustment of the rocker arm assembly (2316) relative to the housing (2301) of the stabilization assembly (2300). The stabilization assembly (2300) has an actuator (2303) including a key or pressing member (2305), a pin (2307), a spring (2309), a spring seat portion (2311), and a lever (2315). The rocker arm assembly (2316) has a holding portion (2317) that is pin-coupled to the rocker arm (2332). The stabilization assembly (2300) further has a locking member (2319).

[0077] In the state shown in FIG. 19, the rocker arm assembly (2316) is in a locked state or a locked position. For example, in the present embodiment, the holding portion (2317) has a gear or toothed annular portion (2321) formed inside the holding portion. The toothed annular portion (2321) has a plurality of teeth provided radially about a longitudinal axis passing through the inner hole of the holding portion (2317). That is, in the present embodiment, the plurality of teeth forming the toothed annular portion (2321) extend along the circumferential surface of the holding portion (2317). To achieve the locked state, the toothed annular portion (2321) engages with the gear or toothed annular portion (2323) of the locking member (2319). In the state where the toothed annular portions (2321, 2323) are engaged, the rocker arm assembly (2316) is fixed against rotation relative to the housing (2301).

[0078] FIG. 20 shows the rocker arm assembly (2316) in an adjustable or unlocked state. In this state, the toothed annular portions (2321, 2323) are separated from each other, and the corresponding teeth of the toothed annular portions (2321, 2323) are not engaged. Specifically, as shown in FIG. 20, the holding portion (2317) defines a longitudinal axis (LA), and the toothed annular portion (2323) of the locking member (2319) is offset from the toothed annular portion (2321) of the holding portion (2317) towards the rocker arm (2332). Similarly, this offset can also mean that the toothed annular portions (2321, 2323) are in different translational positions along the longitudinal axis (LA). As shown in FIG. 20, when the toothed annular portions (2321, 2323) are not engaged, the rocker arm assembly (2316) is rotatably adjustable relative to the housing (2301).

[0079] When the user presses the key (2305) to move the stabilization assembly (2300) to a locked or unlocked state, or a fixed or adjustable state, and the opposite state thereof, the spring (2309) is thereby pressed against the seat portion (2311). The key (2305) is translatable relative to the fixed insertion member (2313) when it is in a pressed state. As shown in FIG. 22, when the key (2305) is not pressed, the key (2305) is fixed in the translational direction relative to the insertion member (2313) because it includes a protruding shape portion (2306) that engages with the slot (2314) of the insertion member (2313). For example, as shown in FIGS. 19 and 20, when the key (2305) is in the raised state or not pressed, the key (2305) is fixed in the translational direction relative to the insertion member (2313). The insertion member (2313) has two or more slots (2314) to correspond the key (2305) to any of the positions shown in FIGS. 19 and 20. As shown in FIG. 22, the key (2305) can also include a plurality of protruding shape portions (2306).

[0080] Continuing with the embodiment regarding the movement between the fixed state shown in FIG. 19 and the adjustable state shown in FIG. 20, after being pressed, the key (2305) moves forward or translates parallel towards the rocker arm (2332). Together with the key (2305), the pin (2307), the spring (2309), the seat part (2311), the lock member (2319), and the lever (2315) move. As shown in the comparison between FIGS. 19 and 20, the lever (2315) rotates about the pin joint with the housing (2301), while the key (2305), the pin (2307), the spring (2309), the seat part (2311), and the lock member (2319) translate. In the state where the toothed annular parts (2323) of the key (2305) and the lock member (2319) shown in FIG. 20 have advanced, the pressing key (2305) stops and returns to the neutral position by the biasing force of the spring (2309). Next, as described above, the protruding member on the key (2305) engages with the corresponding slot of the insertion member (2313) to fix the translational position of the key (2305) and the related components of the key.

[0081] As described above, the stabilization assembly (2300) is configured such that the actuator (2303) can move between a first position and a second position. In the first position, the rocker arm assembly (2316) is fixed in the rotational direction, and in the second position, it is adjustable in the rotational direction. Further, in this aspect, due to the engagement between the key (2305) and the insertion member (2313), it is not necessary for the user to hold the key (2305) at the pressing position or the translational position to adjust or fix the rocker arm assembly (2316). With such a configuration, after the user sets the stabilization assembly (2300) at a desired position, it becomes possible to fix the rotational position of the rocker arm assembly (2316). Additionally, as described above, the operation of moving the stabilization assembly between a state where the rocker arm assembly is adjustable and a fixed state is achieved by the translation of the radially arranged toothed annular parts (2321, 2323).

[0082] One skilled in the art would consider it obvious, in view of the teachings herein, to configure the stabilization assembly (2300) in other ways or to use other stabilization assemblies to adjust the rotational position of the rocker arm assembly. Shown by way of example only, FIG. 21 shows a stabilization assembly (3300) that can be used with both HFDs (1010, 2010) instead of the stabilization assemblies (1300, 2300). The stabilization assembly (3300) has an actuator (3303) with a key (3305), a pin (3307), a spring (3309), a seat portion (3311), an insertion member (3313), and a lever (2315). The stabilization assembly also has a locking member (3319) with a toothed annular portion (3323), while the rocker arm assembly (3316) has a holding portion (3317) with a toothed annular portion (3321). These components can operate in a manner similar to the manner described above for corresponding components similar to the stabilization assembly (2300) shown in FIGS. 19 and 20.

[0083] However, the stabilization assembly (3300) and the stabilization assembly (2300) differ in that, in the case of the stabilization assembly (3300), the toothed annular portion (3323) of the locking member (3319) is engaged with the toothed annular portion (3321) of the holding portion (3317) by advancing the key (3305) towards the rocker arm (3332), thereby fixing the rocker arm assembly (3316) relative to the housing (3301). This is a movement opposite to, or in the opposite direction of, the movement described above in connection with the stabilization assembly (2300). Similarly, as shown in FIG. 21, in the case of the stabilization assembly (3300), to adjust the rocker arm assembly (3316), the locking member (3319) moves backward from the rocker arm (3332) or translates in a direction away from the rocker arm (3332) to disengage the toothed regions (3321, 3323).

[0084] Moreover, those skilled in the art would consider it obvious that, in view of the teachings of this specification, there are other ways to modify the stabilization assemblies (1300, 2300, 3300) to implement a locking mechanism that selectively adjusts the rotational position of the associated locker arm assembly.

[0085] VII. Exemplary Combinations The following examples relate to non - inclusive ways of combining or applying the teachings of this specification. It should be understood that the following examples are not intended to limit any of the claims presented at any time in this application or any subsequent application of this application. Nor are they intended as a disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this specification can be configured and applied in many other different ways. Also, the specific configurations mentioned in the following examples may be omitted in some of the alternative embodiments. Therefore, none of the aspects or features mentioned below should be considered essential unless expressly stated otherwise by the inventors or their successors in interest at a later date. If any claim containing additional features beyond those recited in the following claims is presented in this application or a subsequent application related to this application, such additional features should not be considered as added for any reason related to patentability.

Example

[0086] An apparatus for stabilizing a patient, comprising: (a) a stabilization assembly configured to receive a stabilization mechanism configured to contact the patient; and (b) a tensioning mechanism configured to receive the stabilization assembly at a first position, the tensioning mechanism further including a second position spaced a predetermined distance from the first position, the second position being spaced a predetermined distance from the stabilization assembly, the tensioning mechanism including an actuator disposed at the second position and spaced from the stabilization assembly, and an elongate member extending from the actuator to the stabilization assembly, the actuator being configured to move the elongate member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, thereby adjusting the amount of force applied to the patient by the stabilization assembly.

Example

[0087] The apparatus according to Example 1, wherein at least a portion of the elongate member is configured to curve in response to an increase in the force applied to the stabilization assembly.

Example

[0088] The apparatus according to one or more of Examples 1 to 2, wherein the actuator has a body portion configured to transmit a rotational motion to the body portion, the body portion having a cylindrical portion including a thread, the thread being configured to engage with a thread of the elongate member to move the elongate member relative to the body portion.

Example

[0089] In the device according to one or more of Examples 1 to 2, further comprising a frame assembly having a first frame portion and a second frame portion, the actuator having a main body portion and being configured to transmit a rotational movement to the main body portion, the main body portion having a cylindrical portion including a thread, the thread being configured to engage with the thread of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion.

Example

[0090] In the device according to one or more of Examples 1 to 4, the actuator further having a rod and a locking mechanism configured to releasably hold the rod at a selected position among a plurality of predetermined positions relative to the main body portion.

Example

[0091] In the device according to one or more of Examples 1 to 5, further having a force display mechanism configured to indicate the amount of force applied to the patient by the stabilization assembly.

Example

[0092] In the device according to Example 6, the force display mechanism includes a plurality of indicators, and the elongated member is movable relative to the plurality of indicators to indicate the amount of force applied to the patient by the stabilization assembly.

Example

[0093] In the device according to one or more of Examples 1 to 3, further comprising a frame assembly having a first frame portion and a second frame portion, the first and second frame portions being movable relative to each other, whereby the distance between the first and second frame portions is adjusted.

Example

[0094] In the device described in Example 8, the tension applying mechanism is configured to maintain the relative positions of the first and second frame portions while adjusting the amount of force applied to the patient by the stabilization assembly, whereby the distance between the first and second frame portions does not change. Device.

Example

[0095] In the device described in Example 8, the tension applying mechanism is configured to adjust the amount of force applied to the patient by the stabilization assembly, and as the amount of force applied to the patient by the stabilization assembly is adjusted, the relative positions of the first and second frame portions change, whereby the distance between the first and second frame portions changes. Device.

Example

[0096] In the device described in one or more of Examples 1 to 2, the tension applying mechanism has a main body portion, and the actuator is configured to transmit force to the elongated member by moving the elongated member relative to the main body portion, and the elongated member is configured to transmit at least a part of the force to the stabilization assembly in order to adjust the amount of force applied to the patient by the stabilization assembly. Device.

Example

[0097] In the device described in one or more of Examples 1 to 3, further, a frame assembly having a first frame portion and a second frame portion, and an adjustment mechanism configured to adjust the relative positions of the first and second frame portions in order to overcome the force applied to the stabilization assembly by the tension applying mechanism. Device.

Example

[0098] In the device according to one or more of Examples 1 to 12, the tension applying mechanism has a torsion rod, and a force is transmitted to the elongated member by the torque applied to the torsion rod, and the elongated member transmits at least a part of the force to the stabilization assembly, whereby the amount of force applied to the patient by the stabilization assembly is increased. Device.

Example

[0099] In the device according to one or more of Examples 1 to 13, the tension applying mechanism is configured to apply the amount of force to the stabilization assembly by a torsional operation. Device.

Example

[0100] In the device according to one or more of Examples 1 to 14, the actuator is configured to provide a pre-tension to the stabilization assembly. Device.

Example

[0101] In the device according to one or more of Examples 1 to 15, the device has two or more stabilization assemblies. Device.

Example

[0102] In the device according to one or more of Examples 4 to 10 and Examples 12 to 16, the frame assembly has a U shape. Device.

Example

[0103] In the device according to one or more of Examples 1 to 17, the stabilization assembly defines a proximal end and a distal end, the distal end being configured to receive the stabilization mechanism, the stabilization assembly further defining an axis extending from the proximal end to the distal end, and the actuator disposed at the second position being disposed along an axis different from the axis defined by the stabilization assembly.

Example

[0104] A device configured to be used with a device for stabilizing a patient, the device being for adjusting the amount of force applied to the patient by the device for stabilizing the patient, the device comprising: (a) a first body portion having a first end and a second end, the first end being configured to connect to a stabilization assembly of the stabilization device; and (b) an actuator directly or indirectly connectable to the first body portion, the actuator being configured to generate a torque applied to the first body portion, an increase in the torque applied to the first body portion causing an increase in the tension inside the first body portion, and an increase in the tension inside the first body portion causing an increase in the force applied to the stabilization assembly by the first body portion.

Example

[0105] In the device according to Example 19, the first body portion is a rigid body.

Example

[0106] In the device according to one or more of Examples 19 to 20, during the torque being applied to the first body portion and the tension inside the body portion increasing, the dimensions of the first body portion are maintained constant.

Example

[0107] In the device according to one or more of Examples 19 to 21, the device has a second main body portion that is key-connected to the first main body portion at the second end portion, whereby relative rotation of the first main body portion and the second main body portion is prevented.

Example

[0108] In the device according to Example 22, the second main body portion and the first main body portion are arranged substantially perpendicular to each other.

Example

[0109] In the device according to one or more of Examples 22 to 23, the second main body portion is a rigid body.

Example

[0110] In the device according to one or more of Examples 22 to 24, the actuator can be directly or indirectly connected to the second main body portion, the actuator is configured to generate a torque applied to the second main body portion, and the torque is transmitted to the first main body portion to generate a torque applied to the first main body portion, whereby the internal tension of the first main body portion is increased.

Example

[0111] In the device according to one or more of Examples 22 to 25, the dimensions of the second main body portion are maintained constant while a torque for increasing the internal tension of the first main body portion is applied to the second main body portion.

Example

[0112] An apparatus for stabilizing a patient, comprising: (a) a frame having a receiving portion and a pin extending laterally through the receiving portion; and (b) a stabilization assembly having a stabilization mechanism configured to contact the patient, the stabilization assembly being configured to be selectively received in the receiving portion, the stabilization assembly having a housing, the housing including: (i) a slot located proximal to the housing and configured to receive the pin extending laterally through the receiving portion of the frame, the slot; and (ii) a first retaining mechanism movable relative to the housing from a first position to a second position, in the first position, the first retaining mechanism enables the pin of the frame to be fully seated within the slot of the housing, whereby the stabilization assembly is fully seated within the receiving portion of the frame, and in the second position, the first retaining mechanism secures the stabilization assembly within the receiving portion, the apparatus having the stabilization assembly.

Example

[0113] In the apparatus according to Example 27, the housing has a hole located distal to the housing, the hole being configured to selectively hold the stabilization mechanism, the apparatus.

Example

[0114] In the apparatus according to one or more of Examples 27 to 28, the housing has a first elastic mechanism connectable to the first retaining mechanism, the first elastic mechanism having a biasing force for maintaining the first retaining mechanism in the second position within the housing, and the first retaining mechanism being movable to the first position by compressing the first elastic mechanism, the apparatus.

Example

[0115] In the device according to one or more of Examples 27 to 29, the device has an adjustment mechanism for setting the width of the frame.

Example

[0116] In the device according to one or more of Examples 27 to 29, the housing has a hole located on the distal side of the housing, and the device further has an adapter selectively held in the hole of the housing, and the adapter is configured to selectively hold the stabilization mechanism.

Example

[0117] In the device according to Example 31, the adapter has an engagement mechanism.

Example

[0118] In the device according to one or more of Examples 31 to 32, the housing has a second holding mechanism movable with respect to the housing, and the second holding mechanism can be configured to align with and engage the engagement mechanism of the adapter, and by the engagement between the second holding mechanism and the engagement mechanism of the adapter, the adapter is fixed in the hole of the housing.

Example

[0119] In the device according to one or more of Examples 31 to 33, by fixing the adapter in the hole of the housing, the translational movement of the adapter in the hole of the housing is blocked, while the rotational movement of the adapter with respect to the housing is allowed.

Example

[0120] In the device according to one or more of Examples 32 to 34, the engagement mechanism of the adapter has an annular groove portion, and the second holding mechanism has a spherical member that fits into the annular groove portion.

Example

[0121] In the device according to one or more of Examples 33 to 35, the housing has a second elastic mechanism that can be connected to the second holding mechanism, and the second elastic mechanism has a biasing force that maintains the second holding mechanism in an extended position in the housing to maintain the engagement between the second holding mechanism and the engagement mechanism of the adapter. The second holding mechanism is movable to compress the second elastic mechanism to disengage from the engagement mechanism of the adapter.

Example

[0122] A device for stabilizing a patient's head, comprising: (a) a frame having a receiving portion; and (b) a stabilization assembly configured to be received within the receiving portion, the stabilization assembly being configured to hold one or more stabilization mechanisms configured to contact the patient's head, the stabilization assembly comprising: (i) a selectively rotatable member; and (ii) an actuator that translates longitudinally between a first position and a second position, wherein in the first position, the selectively rotatable member is adjustable in the rotational direction, and in the second position, the selectively rotatable member is fixed in the rotational direction, the actuator having a locking mechanism having a first engagement mechanism; the actuator; and (iii) a holding portion connectable to the selectively rotatable member, the holding portion having a second engagement mechanism configured to selectively engage with the first engagement mechanism, wherein the first and second engagement mechanisms translate longitudinally parallel to each other to selectively engage and disengage, thereby adjusting or fixing the rotational position of the selectively rotatable member.

Example

[0123] In the device according to Example 37, the actuator has a pressing member configured to move between a third position and a fourth position, the pressing member is biased to the third position, and the pressing member is moved from the third position to the fourth position in order to move the actuator between the first and second positions, whereby the biasing force is overcome. A device.

Example

[0124] In the device according to one or more of Examples 37 to 38, the locking mechanism having the first engagement mechanism moves in a direction away from the selectively rotatable member in the longitudinal direction when the actuator is moved from the first position to the second position. A device.

Example

[0125] In the device according to one or more of Examples 37 to 38, the locking mechanism having the first engagement mechanism advances toward the selectively rotatable member in the longitudinal direction when the actuator is moved from the first position to the second position. A device.

Example

[0126] In the device according to one or more of Examples 37 to 40, each of the first engagement mechanism and the second engagement mechanism has a toothed annular form. A device.

Example

[0127] In the device according to one or more of Examples 38 to 41, the selectively rotatable member is maintained in either an adjustable state or a fixed state in the rotational direction when the actuator is in the third position. A device.

Example

[0128] In the device described in Example 37, the actuator has a pressing member and an insertion member, the pressing member can be selectively engaged with the insertion member, and by the engagement between the pressing member and the insertion member, the selectively rotatable member is maintained in a selected one of a state adjustable in the rotational direction or a fixed state according to the position in the longitudinal direction of the actuator.

Example

[0129] In the device described in one or more of Examples 37 to 43, the user can set the stabilization assembly to a desired rotational position without maintaining contact with the actuator while adjusting the rotational direction of the stabilization assembly.

Example

[0130] In the device described in Example 37, the pressing member is biased to the third position and is configured to move between the third position and the fourth position, and the pressing member engages with the insertion member at the third position and disengages from the insertion member at the fourth position.

Example

[0131] A stabilization assembly for use with a device for stabilizing a patient, comprising: (a) a selectively rotatable member configured to hold one or more stabilization mechanisms configured to contact the patient; and (b) a pair of engagement mechanisms configured to move longitudinally parallel to each other from a first position to a second position, wherein at the first position, the pair of engagement mechanisms are engaged and the selectively rotatable member is fixed, and at the second position, the pair of engagement mechanisms are disengaged and the selectively rotatable member is adjustable in the rotational direction.

Example

[0132] An apparatus for stabilizing a patient, comprising: (a) a frame having a first receiving portion; and (b) a first stabilization assembly configured to receive one or more stabilization mechanisms, further configured to be connected to the first receiving portion of the frame, the first stabilization assembly including: (i) a housing connected to the first receiving portion of the frame; (ii) an arm portion connectable to the housing and configured to receive the one or more stabilization mechanisms, the arm portion being configured to be in a first state in which it is rotatable relative to the housing and further configured to be in a second state in which it is not rotatable relative to the housing; and (iii) a first actuator configured to place the arm portion in the second state. (iv) a second actuator configured to place the arm portion in the first state.

Example

[0133] In the apparatus according to Example 47, the first actuator is connectable to the housing and has a first engagement mechanism configured to contact a second engagement mechanism associated with the arm portion to fix the rotational position of the arm portion.

Example

[0134] In the apparatus according to Example 48, the second actuator is connectable to the housing and is biased to maintain contact between the first engagement mechanism of the first actuator and the second engagement mechanism. By overcoming the biasing force of the second actuator, disengagement of the first engagement mechanism from the second engagement mechanism is possible, thereby enabling adjustment of the arm portion in the rotational direction.

Example

[0135] In the apparatus according to one or more of Examples 48 to 49, the first actuator is biased to disengage a first engagement mechanism from a second engagement mechanism associated with the arm portion.

Example

[0136] In the apparatus according to Example 50, by overcoming the biasing force of the first actuator, the first engagement mechanism engages or contacts the second engagement mechanism, and further, the second engagement mechanism can be biased, and the engagement between the first and second engagement mechanisms is maintained.

Example

[0137] In the apparatus according to one or more of Examples 47 to 51, the frame further has a second receiving portion, and the apparatus has a second stabilizing assembly connectable to the second receiving portion.

Example

[0138] An apparatus for stabilizing a patient, comprising: (a) a frame having a first member and a second member, wherein the positions of the first and second members are adjustable such that the relative positions of the first and second members change relative to each other; (b) an actuator connectable to the frame; and (c) a first locking mechanism connectable to the actuator, wherein the actuator is configured to move the first locking mechanism between a first position and a second position, and in the first position, the first locking mechanism provides a friction fit that prevents the first and second members of the frame from moving away from each other, and in the second position, the first locking mechanism allows the first and second members of the frame to move away from each other.

Example

[0139] In the device described in Example 53, the device has a skull clamp for stabilizing the head of the patient.

Example

[0140] In the device described in one or more of Examples 53 to 54, the device has a second locking mechanism configured to contact the first locking mechanism.

Example

[0141] In the device described in Example 55, a part of the second locking mechanism and the first locking mechanism each have an inclined surface, and each of the inclined surfaces is configured to contact each other.

Example

[0142] In the device described in one or more of Examples 55 to 56, when the first locking mechanism moves parallel in a first direction, the first locking mechanism drives the second locking mechanism to contact a part of the frame.

Example

[0143] An apparatus for stabilizing a patient, comprising: (a) a frame having a first member and a second member, wherein the positions of the first and second members are adjustable such that the relative positions of the first and second members change relative to each other; (b) an actuator connectable to the frame; and (c) a first locking mechanism connectable to the actuator, wherein the actuator is configured to move the first locking mechanism between a first position and a second position, and in the first position, the first locking mechanism provides a stepless fit that prevents the first and second members of the frame from moving away from each other, and in the second position, the first locking mechanism allows the first and second members of the frame to move away from each other, and the stepless fit enables the adjustment range of the relative spacing between the first and second members to be changed without limitation.

Example

[0144] In the apparatus according to Example 58, the apparatus has a skull clamp for stabilizing the head of the patient.

Example

[0145] In the apparatus according to one or more of Examples 58 to 59, the apparatus has a second locking mechanism configured to contact the first locking mechanism.

Example

[0146] In the apparatus according to Example 60, a part of the second locking mechanism and the first locking mechanism each has an inclined surface, and each of the inclined surfaces is configured to contact the other.

Example

[0147] In the apparatus according to one or more of Examples 60 to 61, when the first locking mechanism moves in parallel in the first direction, the first locking mechanism drives the second locking mechanism to contact a part of the frame. Apparatus.

[0148] VIII. Miscellaneous Rules Any one or more of the teachings, expressions, embodiments, examples, etc. described in this specification can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described in this specification. Therefore, the teachings, expressions, embodiments, examples, etc. described above should not be regarded as independent of each other. It is obvious to those skilled in the art that various appropriate combinations of the teachings in this specification are possible. Such modified embodiments and variant embodiments are intended to be included within the scope of the claims of this patent.

[0149] Although various embodiments of the present invention have been illustrated and described, further improvements to the methods and systems described herein are possible by those skilled in the art making appropriate changes without departing from the scope of the present invention. Some of such possible modified embodiments have been described, but other modified embodiments will be obvious to those skilled in the art. For example, the examples, embodiments, geometric properties, materials, dimensions, ratios, processes, etc. described above are illustrative and not essential. Therefore, it should be understood that the scope of the present invention should be considered based on the following claims and is not limited to the details of the structures and operations illustrated and described in this specification and the drawings.

Claims

Claim 1. An apparatus for stabilizing a patient, comprising: (a) a stabilization assembly configured to receive a stabilization mechanism configured to contact the patient; (b) a tension - adding mechanism configured to receive the stabilization assembly at a first position, the tension - adding mechanism further including a second position spaced a predetermined distance from the first position, the second position being spaced a predetermined distance from the stabilization assembly, the tension - adding mechanism comprising: an actuator disposed at the second position and spaced from the stabilization assembly; and an elongate member extending from the actuator to the stabilization assembly; wherein: the actuator is configured to move the elongate member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, whereby the amount of force applied to the patient by the stabilization assembly is adjusted; the tension - adding mechanism; and at least a portion of the elongate member is configured to bend in response to an increase in the force applied to the stabilization assembly. Claim 2. An apparatus for stabilizing a patient, comprising: (a) a stabilization assembly configured to receive a stabilization mechanism configured to contact the patient; (b) a tension - adding mechanism configured to receive the stabilization assembly at a first position, the tension - adding mechanism further including a second position spaced a predetermined distance from the first position, the second position being spaced a predetermined distance from the stabilization assembly, the tension - adding mechanism comprising: an actuator disposed at the second position and spaced from the stabilization assembly; and an elongate member extending from the actuator to the stabilization assembly; wherein: the actuator is configured to move the elongate member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, whereby the amount of force applied to the patient by the stabilization assembly is adjusted; the tension - adding mechanism; and the actuator has a body portion, and the actuator is configured to transmit a rotational motion to the body portion. The main body portion has a cylindrical portion including a thread, and the thread is configured to engage with the thread of the elongated member to move the elongated member relative to the main body portion. Device. **Claim 3**: A device for stabilizing a patient, (a) A stabilization assembly configured to receive a stabilization mechanism configured to contact the patient; (b) A tension adding mechanism configured to receive the stabilization assembly at a first position, the tension adding mechanism further including a second position spaced a predetermined distance from the first position, the second position being spaced a predetermined distance from the stabilization assembly, and the tension adding mechanism includes: An actuator disposed at the second position and spaced from the stabilization assembly; An elongated member extending from the actuator to the stabilization assembly; Including; The actuator is configured to move the elongated member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, thereby adjusting the amount of force applied to the patient by the stabilization assembly. The tension adding mechanism; (c) A frame assembly having a first frame portion and a second frame portion; Having; The actuator has a main body portion, and the actuator is configured to transmit a rotational motion to the main body portion. The main body portion has a cylindrical portion including a thread, and the thread is configured to engage with the thread of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion. Device. **Claim 4**: A device for stabilizing a patient, (a) A stabilization assembly configured to receive a stabilization mechanism configured to contact the patient; (b) A tension adding mechanism configured to receive the stabilization assembly at a first position, the tension adding mechanism further including a second position spaced a predetermined distance from the first position, the second position being spaced a predetermined distance from the stabilization assembly, and the tension adding mechanism includes: An actuator disposed at the second position and spaced from the stabilization assembly; An elongated member extending from the actuator to the stabilization assembly; Including; The actuator is configured to move the elongated member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, whereby the amount of force applied to the patient by the stabilization assembly is adjusted. The tension applying mechanism, (c) a frame assembly having a first frame portion and a second frame portion and having, the first and second frame portions are movable relative to each other, whereby the distance between the first and second frame portions is adjusted, the tension applying mechanism is configured to maintain the relative positions of the first and second frame portions while adjusting the amount of force applied to the patient by the stabilization assembly, whereby the distance between the first and second frame portions does not change, a device.

5. The device according to any one of claims 2 to 4, wherein at least a part of the elongated member is configured to bend in response to an increase in the force applied to the stabilization assembly.

6. The device according to claim 1 or 4, wherein the actuator has a main body portion, and the actuator is configured to transmit a rotational motion to the main body portion, the main body portion has a cylindrical portion including a thread, and the thread is configured to engage with the thread of the elongated member to move the elongated member relative to the main body portion.

7. The device according to claim 3, wherein the thread of the cylindrical portion is configured to engage with the thread of the elongated member to move the elongated member relative to the main body portion.

8. The device according to claim 1 or 2, further comprising a frame assembly having a first frame portion and a second frame portion, the actuator has a main body portion, and the actuator is configured to transmit a rotational motion to the main body portion, the main body portion has a cylindrical portion including a thread, and the thread is configured to engage with the thread of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion.

9. The device according to claim 4, The actuator has a main body, and the actuator is configured to transmit a rotational motion to the main body. The main body has a cylindrical portion including a thread, and the thread is configured to engage with the thread of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion. Device.

10. In the device according to claim 1 or 4, The actuator has a main body, and the actuator is configured to transmit a rotational motion to the main body. The actuator further has a rod and a locking mechanism configured to releasably hold the rod at a selected position among a plurality of predetermined positions with respect to the main body. Device.

11. In the device according to claim 2 or 3, the actuator further has a rod and a locking mechanism configured to releasably hold the rod at a selected position among a plurality of predetermined positions with respect to the main body. Device.

12. In the device according to any one of claims 1 to 4, further, The device has a force display mechanism configured to indicate the amount of force applied to the patient by the stabilization assembly.

13. In the device according to claim 12, the force display mechanism includes a plurality of indicators, and the elongated member is movable relative to the plurality of indicators to indicate the amount of force applied to the patient by the stabilization assembly. Device.

14. In the device according to claim 1, further, The device has a frame assembly having a first frame portion and a second frame portion, The first and second frame portions are movable relative to each other, whereby the distance between the first and second frame portions is adjusted. Device.

15. In the device according to claim 2, further, The device has a frame assembly having a first frame portion and a second frame portion, The first and second frame portions are movable relative to each other, whereby the distance between the first and second frame portions is adjusted. Device.

16. The apparatus according to claim 3, wherein the first and second frame portions are movable relative to each other, whereby the distance between the first and second frame portions is adjusted.

17. The apparatus according to any one of claims 14 to 16, wherein the tension applying mechanism is configured to adjust the amount of force applied to the patient by the stabilization assembly while maintaining the relative positions of the first and second frame portions, whereby the distance between the first and second frame portions does not change.

18. The apparatus according to any one of claims 14 to 16, wherein the tension applying mechanism is configured to adjust the amount of force applied to the patient by the stabilization assembly, and the relative positions of the first and second frame portions change as the amount of force applied to the patient by the stabilization assembly is adjusted, whereby the distance between the first and second frame portions changes.

19. The apparatus according to any one of claims 1 to 4, wherein the tension applying mechanism has a main body portion, the actuator is configured to transmit force to the elongated member by moving the elongated member relative to the main body portion, the elongated member is configured to transmit at least a part of the force to the stabilization assembly in order to adjust the amount of force applied to the patient by the stabilization assembly.

20. The apparatus according to claim 1 or 2, further comprising a frame assembly having a first frame portion and a second frame portion, an adjustment mechanism configured to adjust the relative positions of the first and second frame portions in order to overcome the force applied to the stabilization assembly by the tension applying mechanism.

21. The apparatus according to claim 3 or 4, further comprising an adjustment mechanism configured to adjust the relative positions of the first and second frame portions in order to overcome the force applied to the stabilization assembly by the tension applying mechanism.

22. The apparatus according to any one of claims 1 to 4, wherein the tension applying mechanism has a torsion rod. A force is transmitted to the elongated member by the torque applied to the torsion rod, and the elongated member transmits at least a part of the force to the stabilization assembly, so that the amount of force applied to the patient by the stabilization assembly is increased. An apparatus. **Claim 23** The apparatus according to any one of claims 1 to 4, wherein the tension applying mechanism is configured to apply the amount of the force to the stabilization assembly by a torsional operation. **Claim 24** The apparatus according to any one of claims 1 to 4, wherein the actuator is configured to provide a pre-tension to the stabilization assembly. **Claim 25** The apparatus according to any one of claims 1 to 4, wherein the stabilization assembly defines a proximal end portion and a distal end portion, and the distal end portion is configured to receive the stabilization mechanism, the stabilization assembly further defines an axis extending from the proximal end portion to the distal end portion, and the actuator disposed at the second position is disposed along an axis different from the axis defined by the stabilization assembly. An apparatus.

Images