Head stabilization device tensioning feature and method of use

Abstract

To provide a head stabilization device for stabilizing a specific part of a patient during a specific medical measure.SOLUTION: A head stabilization device 10 useable for stabilizing a head of a patient during a medical procedure includes a modular design where stabilization assemblies 200 of various configurations are interchangeable at receiving portions 106 along a frame 100. The device includes a tensioning feature 500 positioned away from the stabilization assembly but still operable to increase or decrease an amount of force the stabilization assembly applies to the patient's head. The device includes a locking feature for the stabilization assembly having a rotatable member having one or more stabilization features connected thereto. The device includes an adjustment feature to adjust a spacing between frame members with the adjustment feature providing a continuous range of adjustment rather than finite adjustment increments.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

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

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

[0003] While 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 invention described herein. [Brief explanation of the drawings]

[0004] While this specification concludes with claims that particularly and distinctly define the invention, it is believed that the invention will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and in which: [Figure 1A] FIG. 1A shows a perspective view of an exemplary skull clamp. [Figure 1B] FIG. 1B shows another perspective view of the skull clamp of FIG. 1A. [Figure 2A] FIG. 2A is a partial perspective view of the skull clamp release mechanism of FIG. 1A, with some parts shown in dashed lines to reveal internal components. [Figure 2B] FIG. 2B is a partial cross-sectional view of the skull clamp of FIG. 1A showing an exemplary release mechanism. [Figure 2C] FIG. 2C is an enlarged, partial cross-sectional view of the skull clamp of FIG. 2B, showing the relative positions of the arms of the skull clamp in an unwrapped state. [Figure 3] FIG. 3 shows a cross-sectional view of another exemplary arm that can be used with the skull clamp of FIG. 1A and has another exemplary release mechanism. [Figure 4A] FIG. 4A shows a front view of an exemplary modular pin assembly. [Figure 4B] FIG. 4B shows a cross-sectional view of FIG. 4A. [Figure 5A] FIG. 5A shows a front view of another exemplary modular pin assembly including an adapter. [Figure 5B] FIG. 5B shows a cross-sectional view of FIG. 5A. [Figure 6A] FIG. 6A is a front view of the exemplary modular pin assembly of FIG. 5A shown with a rocker arm assembly having two pins. [Figure 6B] FIG. 6B shows a cross-sectional view of FIG. 6A. [Figure 6C] FIG. 6C is a perspective view of the assembly of FIG. 6A shown with skull pins and removable caps that prevent accidental contact with the skull pins. [Figure 7A]FIG. 7A shows a perspective view of an exemplary rocker arm assembly having two pins for modular fixation. [Figure 7B] FIG. 7B shows another perspective view of the assembly of FIG. 7A. [Figure 7C] FIG. 7C is another perspective view of the assembly of FIG. 7A, showing the housing in dashed lines to reveal the internal components. [Figure 7D] FIG. 7D shows a cross-sectional view of the assembly of FIG. 7A. [Figure 8A] FIG. 8A is an arm of the skull clamp of FIG. 1A showing the pin assembly tension adjustment mechanism. [Figure 8B] FIG. 8B shows an exemplary scale that can be incorporated into or used with the arm of FIG. 8A. [Figure 8C] FIG. 8C shows a cross-sectional view of the arm portion of FIG. 8A. [Figure 8D] FIG. 8D shows a perspective view of the upper part of the arm portion of FIG. 8A. [Figure 8E] FIG. 8E is another cross-sectional view of the arm portion of FIG. 8A, illustrating the pinned connections between certain components in the tensioning mechanism. [Figure 9] FIG. 9 shows a perspective view of another exemplary skull clamp. [Figure 10] FIG. 10 is a side view of the arm of the skull clamp of FIG. 9, showing an alternative tension adjustment mechanism. [Figure 11A] FIG. 11A shows a cross-sectional view of the arm portion of FIG. [Figure 11B] FIG. 11B is another cross-sectional view of the arm portion of FIG. 10, showing the actuator operating configuration. [Figure 11C] FIG. 11C is another cross-sectional view of the arm portion of FIG. 10, illustrating adjustment of the tension adjustment mechanism using the actuator of FIG. 11B. [Figure 12] FIG. 12 shows a side view of the upper part of the arm portion of FIG. [Figure 13] FIG. 13 shows a perspective view of an exemplary force indicator of the arm portion of FIG. [Figure 14]FIG. 14 shows a perspective view of another exemplary skull clamp. [Figure 15] FIG. 15 is a side view of the arm of the skull clamp of FIG. 14, showing another alternative tension adjustment mechanism. [Figure 16A] FIG. 16A shows a cross-sectional view of the arm portion of FIG. [Figure 16B] FIG. 16B is another cross-sectional view of the arm portion of FIG. 15, showing the actuator operating configuration. [Figure 16C] FIG. 16C is another cross-sectional view of the arm portion of FIG. 15, illustrating adjustment of the tension adjustment mechanism using the actuator of FIG. 16B. [Figure 17] FIG. 17 shows a side view of the upper part of the arm portion of FIG. [Figure 18] FIG. 18 shows a perspective view of an exemplary force indicator of the arm portion of FIG. [Figure 19] 19 is a perspective view in cross section of an exemplary stabilization assembly of the skull clamp of FIG. 14 shown with a rotationally fixed rocker arm assembly. [Figure 20] 20 is a cross-sectional perspective view of the exemplary stabilization assembly of FIG. 19 shown with a rotationally adjustable rocker arm assembly. [Figure 21] FIG. 21 is a perspective view in cross section of another exemplary stabilization assembly usable with the skull clamp of FIGS. 9 and 14 shown with a rotationally adjustable rocker arm assembly. [Figure 22] 22 is a cross-sectional perspective view of the exemplary stabilization assembly of FIG. 14. FIG.

[0005] The drawings are not intended to be limiting, and it is understood that various embodiments of the invention may be practiced in other ways, including aspects not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate some aspects of the invention and, together with the associated description, explain the principles of the invention. However, the 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 does not 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 illustrative description of one of the best modes for carrying out the invention. It is understood that the present invention has other different and obvious aspects without departing from the invention. Accordingly, the drawings and description are illustrative in nature and should not be interpreted as limiting.

[0007] 1A and 1B illustrate an exemplary head stabilization or head fixation device (10). Throughout this specification, the term "HFD" is used interchangeably 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) are adjustably connectable, thereby adjusting the spacing between the frame portions. The frame portions (102, 104) each include a receiver (106, 108) configured to receive a stabilization assembly. In the illustrated embodiment, the stabilization assembly (200) is received by the receiver (106) of the frame portion (102). Additionally, the stabilization assembly (300) is received by the receiving portion (108) of the frame portion (104).

[0008] As shown more clearly in Figure 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 Figure 1B. Additional components and operability of the frame adjustment mechanism 400 are described in more detail below with reference to Figures 2A-3.

[0009] The HFD (10) has a modular design, such that the receptacles (106, 108) are configured to accept a variety of stabilization assemblies, rather than a single type or design of stabilization assembly. For example, in the embodiment depicted in Figures 1A and 1B, the stabilization assembly (200) and the stabilization assembly (300) are interchangeable, such that the stabilization assembly (200) is connected to the receptacle (108), and the stabilization assembly (300) is connected to the receptacle (106). Additional components and operability of the modular HFD (10) associated with the various stabilization assemblies are described in more detail below with reference to Figures 4A-7D.

[0010] 1A and 1B, the HFD (10) includes a tensioning mechanism (500) operable to adjust the amount of force that the stabilization assembly applies to the patient. The tensioning mechanism (500), as shown in FIGS. 1A and 1B, includes an actuator (502). Additional components and operability of the tensioning mechanism (500) are described in more detail below with reference to FIGS. 8A-8D.

[0011] I. Exemplary Frame Adjustment Mechanism Referring to Figures 2A-2C, a frame adjustment mechanism 400 is illustrated, which will be described in detail below. As shown in Figure 2A, the frame portion 102 includes an elongated shaft 110 that is received within the elongated shaft 112 of the frame portion 104. A locking mechanism 404 of the frame adjustment mechanism 400 extends within the elongated shaft 110. In this embodiment, the locking mechanism 404 is connectable to an actuator 402 via a pinned connection. As shown in Figures 1B and 2B, the actuator 402 is rotatable about the pinned connection. As shown in Figure 2B, when the actuator 402 is rotated upward or vertically, it pulls or retracts the locking mechanism 404 toward the pinned connection associated with the actuator 402. Conversely, when actuator (402) is rotated in the opposite direction, actuator (402) urges locking mechanism (404) away from the pin connection associated with actuator (402).

[0012] In the illustrated embodiment, the locking mechanism 404 includes a distal portion 406 having a sloped or angled outer surface 408. In this embodiment, the outer surface 408 is curved in addition to being sloped or angled. Thus, in this embodiment, the distal portion 406 has a tapered or conical shape with a maximum diameter at the most distal end of the distal portion 406. The distal portion 406 also includes a proximal shoulder 410. The elongate shaft 110 includes a hollow interior 114 from which the locking mechanism 404 extends. The hollow interior 114 defines a stop 116 near its distal end that interacts with the shoulder 410 to prevent the locking mechanism 404 from being retracted from the elongate shaft 110 toward the actuator.

[0013] The elongate shaft 110 includes an opening 118 near its distal end. The opening 118 is configured to receive a locking mechanism 412 that is contactable by a surface 408 of the distal portion 406 of the locking mechanism 404. The locking mechanism 412 includes a sloped or angled outer surface 414 that contacts the surface 408 of the distal portion 406 of the locking mechanism 404. As such, when the locking mechanism 404 is moved toward the deployment side of the actuator 402, the interaction of the sloped or angled outer surfaces 408, 414 causes the locking mechanism 412 to act on the elongate shaft 112 of the frame portion 104. This contact is sufficient to create a friction fit between these components, thereby preventing movement of the frame portions 102, 104 away from each other. It is further noted that in this embodiment, when locking mechanism (412) is sufficiently engaged or contacted with shaft (112), movement of frame portions (102, 104) away from one another is prevented, but frame portions (102, 104) can be moved toward one another, thereby positioning frame (100) in a closer position.

[0014] When it is desired to release the frame 100, the steps described above are essentially reversed. Specifically, the actuator 402 is rotated downward, away from a perpendicular orientation relative to the locking mechanism 404. This moves the locking mechanism 404 toward the frame portion 104, disengaging the distal portion 406 from the locking mechanism 412, which disengages the locking mechanism 412 from the shaft 112 to the extent that any frictional forces can be overcome, and the frame portions 102, 104 are adjusted to a more open (separate) position, if desired.

[0015] As described above, the frame adjustment mechanism (400) is configured to allow the frame portions (102, 104) to be adjusted relative to one another, and then, once a desired position or configuration is achieved, to lock the frame portions (102, 104) together and prevent them from being released. Furthermore, unlike mechanical engagement using complementary structures, such as interlocking teeth, where the incremental adjustment is limited by the mechanical engagement structure, the present locking arrangement, which includes a friction fit between components, allows for infinitely variable increments of adjustment of the relative position of the frame portions (102, 104). In other words, in the illustrated embodiment, the configuration of the locking mechanism (412), distal portion (406), and shaft (112) allows for a stepless fit. In this manner, the incremental adjustment of the frame portions (102, 104) can be varied without limit, as opposed to devices that use interlocking or stepped mechanisms to control or restrict the incremental adjustment of the frame portions (102, 104). Of course, in other embodiments, where an interference fit is desired, one or more shoulder or engagement features may be included in the locking mechanism (404, 412), particularly as such modifications are believed to be obvious to those skilled in the art in light of the teachings herein.

[0016] 2B and 2C, the elongate shaft (110) includes a groove (120) along a bottom region thereof. The alignment feature (416) extends through the elongate shaft (112) and is configured to be received within the groove (120), thereby maintaining the alignment of the elongate shafts (110, 112) and preventing change in the relative rotational position of the elongate shafts (110, 112) when the spacing of the frame portions (102, 104) is adjusted.

[0017] FIG. 3 illustrates an alternative frame portion 102′ that can be used with the HFD 10 in place of the frame portion 102. The frame portion 102′ is similar to the frame portion 102, except for the actuator configuration. The frame portion 102′ includes an actuator 402′ that interfaces with the locking mechanism. The actuator 402′ includes a depressible portion located adjacent or near the stabilization assembly and along an upright portion of the frame portion 102′. In this embodiment, the actuator 402′ is spring-biased, which biases the locking mechanism 404 away from the frame portion 104, causing the distal portion 406 to contact the locking mechanism 412 and create a friction fit or lock between the frame portions 102, 104. The pressure actuator (402') overcomes the spring force and pushes the locking mechanism (404) toward the frame portion (104), thereby reducing or eliminating the frictional fit or lock and allowing the frame portions (102, 104) to open or increase the spacing between them.

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

[0019] To install the stabilized assembly 200, the housing 202 is slid or translated to its approximate position so that it fits within the receivers 106, 108. The housing 202 and receivers 106, 108 include complementary engagement features, such as complementary dovetail features, that guide the stabilized assembly 200 into the appropriate position and maintain the housing 202 in a specific orientation. The pin 122 aligns with the notch 206 and contacts the spherical member 208, which is then pressed against the resilient member 210. This allows the spherical member 208 to move and fully seat the pin 122 within the notch 206. Once fully seated, pin 122 passes through spherical member 208, which returns behind pin 122 due to the biasing force of resilient member 210. In this manner, a locking effect is achieved that maintains stabilization assembly 200 in the proper position relative to receivers 106, 108.

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

[0021] The stabilizer assembly 600 includes a spherical member 618 and a resilient member 620 for maintaining the adapter 614 in the proper position within the bore 604. The adapter 614 includes an annular groove 622 configured to interlock with the spherical member 618 when the adapter 614 is fully seated within the bore 604. When the adapter 614 is inserted, the spherical member 618 is pressed against the resilient member 620; however, once the adapter 614 is fully seated, the annular groove 622 is aligned above the spherical member 618, causing the biasing force of the resilient member 620 to return the spherical member 618 to its original position and engage the annular groove 622. In such a configuration, adapter (614) is fixed in translation but is rotatable by means of spherical member (618) which remains engaged with annular groove (622).

[0022] In another embodiment of the stabilizer assembly 600, multiple adapters 614 can be used with the housing 602; for example, one adapter 614 is configured for use with a single pin 14, while another adapter is configured for use with a rocker arm assembly 616. This modular design allows for interchangeable stabilizer types by swapping in the adapter associated with a particular type of stabilizer. Also, as noted above, in another embodiment, the same adapter 614 can be used with multiple stabilizer types; this modular design allows for interchangeable stabilizer types by swapping out the stabilizers themselves and maintaining the same adapter 614.

[0023] 7A-7D show a stabilizer assembly (300) configured with a locking rocker arm assembly (316). The stabilizer assembly (300) includes a housing (302), actuators (324, 326), spherical members (208, 618), resilient members (210, 620), a pin (212), and a bore (304) configured to receive a portion of the locking rocker arm assembly (316). The stabilizer assembly (300) interfaces with the receivers (106, 108) in a manner similar to the stabilizer assembly (200) described above. As shown in FIG. 7A, the housing (302) includes a dovetail mechanism in a manner similar to the stabilizer assemblies (200, 600).

[0024] As shown in Figures 7C and 7D, the locking 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 connection. The body portion (328) further includes an adapter (314) similar to the adapter (614), but the adapter (314) further incorporates a locking mechanism to secure the rotational position of the locking rocker arm assembly (316). For example, the adapter (314) includes an annular flange (622) that engages with the spherical member (618). However, the adapter (314) also includes a toothed member (334) configured to selectively engage a shaft (336) having a toothed end configured to engage the teeth of the toothed member. This engagement between shaft (336) and toothed member (334) fixes the rotational position of rocker arm (332) relative to housing (302) and frame (100).

[0025] When actuators 324, 326 are not pressed, or when rocker arm 332 is in a fixed, neutral position, notch surface 327 of actuator 326 contacts notch surface 337 of shaft 336, thereby maintaining shaft 336 engaged and locked with toothed member 334. To adjust the rotational position of rocker arm 332, push-type actuator 326 overcomes the biasing force of spring 340 to disengage surface 327 from surface 337, thereby aligning the notch of actuator 326 with the notch of shaft 336 without interference. With this interference-free alignment, spring 338 and its associated biasing force drive release actuator 324 and its associated shaft 336 upward and away from toothed member 334, disengaging the toothed mechanism and thereby permitting rotational adjustment. Once the desired rotational adjustment is achieved, release actuator 324 is forced downward to overcome the biasing force of spring 338 and align the notch in shaft 336 with the notch in release actuator 326. Additionally, biasing spring 340 on actuator 326 translates actuator 326 so that surface 327 again contacts surface 337 on shaft 336. In this manner, the toothed portion of shaft 336 engages toothed member 334, locking the rotational position of rocker arm 332.

[0026] III. Exemplary Torsion Rod Tensioning Mechanism 8A-8D illustrate a tensioning feature 500 used to adjust the amount of force applied to the patient by the connected stabilization assembly during use of the HFD 10. The tensioning mechanism 500 includes an actuator 502 having one end that extends through a hole in the frame portion 104 and threadably attaches to a body portion 504. The body portion 504 includes a hole that receives a rod 506, which connects an elongated member 508 to the body portion 504. The rod 506 is fastened to the body portion 504 and includes a polygonal profile at least at 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, elongated member (508) is connected to rod (506). At another location on elongated member (508) through which rod (506) passes, elongated member (508) is fixed to rod (506) and cannot rotate relative to rod (506) because rod (506) includes a polygonal profile.

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

[0028] To adjust the tensioning mechanism 500, the actuator 502 is rotated, which translates the body 504. The direction of translation depends on the direction of rotation of the actuator 502. When the body 504 is moved toward the frame 102, the tension increases, i.e., the force applied to the patient increases. This movement causes the rod 506 to move in the same direction. The elongated member 508, connected to the rod 506, also moves in the same direction. As mentioned above, the elongated member 508 is pin-coupled to the receiver 108 at its upper end. This pin connection fixes or limits the range of movement of the elongated member 508 when the HFD 10 is in a mounted state with the patient's head positioned at its midsection and the stabilization assembly and stabilization mechanisms in contact. Therefore, under these conditions, a torsional force or torque is applied to the rod 506. In this manner, the rod 506 functions similarly to a torsion rod. That is, as the body portion 504 and rod 506 move toward the frame portion 102, tension in the rod 506 and elongated member 508 increases, resulting in the elongated member 508 exerting a greater force against the receiver 108. In this manner, the elongated member 508 functions as a tensioning member, and this tension is adjustable. Because the receiver 108 remains laterally stationary when the patient's head is positioned within the HFD 10, increased tension results in a greater force being exerted on the patient's head. By rotating the actuator 502 in the opposite direction, translating the body portion 504 and rod 506 toward the frame portion 104, the force exerted on the patient can be reduced.

[0029] The elongate member 508 also includes an actuator 512. The actuator 512 is configured as a pre-tensioning feature. In this manner, prior to securing a patient within the HFD 10, the actuator 512 can be depressed to simultaneously move both frame portions 102, 104 until the stabilizing mechanism connected to the frame portions 102, 104 contacts the patient's head. Once contact with the patient's head is achieved, the actuator 512 is released, and tension can be adjusted using the tensioning mechanism, as described above. By way of example only and not limitation, in some embodiments, the pre-tensioning mechanism using the actuator 512 can apply a force of approximately 50-150 Newtons against the patient's head.

[0030] Referring to Figure 8B, in some embodiments, a force indicator or scale (514) is included in the tensioning mechanism. The scale may be configured to correlate the tension within the rod (506) and elongate member (508) based on movement of the body portion (504) to the resulting force applied to the stabilization assembly (300). In one embodiment, the scale (514) may be included on the outer surface of the rod (506). Other methods of indicating tension and / or force will be apparent to those skilled in the art in light of the teachings herein.

[0031] IV. Exemplary Alternative Skull Clamp Having a Tensioning Mechanism with Bending Beams FIG. 9 illustrates an alternative HFD (1010) substantially similar to the HFD (10) described above. For example, as described above with the HFD (10), the HFD (1010) of this embodiment has the shape or configuration of a skull clamp. Accordingly, the HFD (1010) of this embodiment includes 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) are adjustably connectable, thereby adjusting the spacing between the frame portions. The frame portions (1102, 1104) each include a receiver (1106, 1108) configured to receive a stabilization assembly. In the illustrated embodiment, the stabilization assembly (1200) is received by the receiver (1106) of the frame portion (1102). Additionally, the stabilization assembly (1300) is received by the receiving portion (1108) of the frame portion (1104).

[0032] As described above with respect to the HFD (10), the HFD (1010) of this 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 this embodiment, the HFD (1010) includes a frame adjustment mechanism (1400) including a pair of engagement members (not shown), each of which has one or more teeth (not shown). In such aspects, the teeth of one engagement member are configured to selectively engage with the teeth of the other engagement member. When actuated, the actuation mechanism (1103) 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 frame assembly spacing can be adjusted to be larger or smaller. In some aspects, when the engagement members are engaged, the frame assembly spacing is fixed, while in other aspects, the frame assembly spacing can be adjusted to be smaller, but not larger. One or more safety mechanisms (not shown) may be incorporated with such frame adjustment mechanisms, which will prevent operation of the actuation mechanism (1103) unless the one or more safety mechanisms are first activated. In alternative embodiments, those skilled in the art will recognize, in light of the teachings herein, that a variety of alternative frame adjustment mechanisms may be readily incorporated into the HFD (1010) or HFD (10).

[0033] Like the HFD 10, the HFD 1010 of this embodiment has a modular design, such that the receptacles 1106, 1108 are configured to accept a variety of stabilization assemblies, rather than being configured to accept only a single type or design of stabilization assembly. As described above, the stabilization assembly 1200 and the stabilization assembly 1300 are interchangeable with one another, such that the stabilization assembly 1200 can be connected to the receptacle 1108, and similarly, the stabilization assembly 1300 can be connected to the receptacle 1106. In this manner, the modularity and interchangeability associated with the stabilization assemblies 1200, 1300 and the HFD 1010 are provided in the same or similar manner as described above in connection with the stabilization assemblies 200, 300 and the HFD 10.

[0034] FIG. 10 shows the second frame portion (1104) in more detail. In this embodiment, the second frame portion (1104) includes a tensioning mechanism (1500). The tensioning mechanism (1500) in this embodiment is used to adjust the amount of force applied to the patient during use of the HFD (1010). As shown in FIG. 11A, the tensioning mechanism (1500) in this embodiment includes 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 use of the HFD (1010). As shown, in some embodiments, the tensioning mechanism (1500) is positioned at a distance from the actuator (1502), which is positioned a predetermined distance from the stabilization assembly (1300). In other words, the actuator (1502) of the tensioning mechanism (1500) can be located along the bottom or side of the frame (1100) rather than on the upright portion thereof. At the same time, other portions of the tensioning mechanism (1500) that contact the stabilization assembly (1300) to adjust the pin fixation force are located a predetermined distance away from the actuator (1502). In some embodiments, this distance can be approximately the same as the distance represented by the size of a standard patient's head, so that the actuator (1502) does not overlap the side of the patient's head when the patient's head is positioned within the HFD (1010).

[0035] 11A illustrates the configuration of actuator 1502 in more detail. In this embodiment, actuator 1502 is generally configured to interact with body 1504 to selectively rotate and de-rotate body 1504. As will be described in more detail below, body 1504 is configured to engage a portion of elongate member 1508 or other component associated with the elongate member, thereby driving translation of elongate member 1508 via rotation of body 1504 by actuator 1502.

[0036] Suitable and selective rotational engagement between the actuator 1502 and the body portion 1504 can be achieved in a variety of ways. By way of example only, the actuator 1502 of this embodiment includes a handle 1510 having an elongated rod 1512 extending 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, the keyed end 1516 is typically configured to engage a portion of the body portion 1504 to provide rotation of the body portion 1504 after the actuator 1502 is translated into position.

[0037] Body portion 1504 includes a hollow interior 1520 configured to receive elongated rod 1512 of actuator 1502 for engagement with actuator 1502. Hollow interior 1520 defines a cylindrical portion 1522 and an engagement portion 1524 toward the opposite end of body portion 1504. Cylindrical portion 1522 typically defines a generally cylindrical shape within which keyed end 1516 can freely rotate, while engagement portion 1524 typically defines a shape corresponding to the shape of keyed end 1516. Thus, engagement portion 1524 receives keyed end 1516 in a keyed relationship, thereby enabling the transmission of rotational motion from elongated rod 1512 to body portion 1504.

[0038] As described above, the actuator 1502 is configured to rotate the body portion 1504 when in a predetermined longitudinal position relative to the body portion 1504. Accordingly, as described in more detail below, the actuator 1502 is movable between one or more positions to selectively engage or disengage the body portion 1504 and rotate the body portion. To maintain the actuator 1502 in a predetermined position relative to the body portion 1504, the actuator's elongated rod 1512 includes one or more detent features 1514 extending inwardly from its surface. In this embodiment, the elongated rod 1512 includes three semicircular notches positioned at three locations along the rod's longitudinal axis. Each detent feature 1514 is configured to engage a spring-loaded bearing, ball, or other resilient mechanism to releasably hold the elongated rod 1512 in a predetermined position along the rod's longitudinal axis. As will be explained in more detail below, this configuration allows actuator (1502) to be selectively fixed in a selected one of a plurality of predetermined positions corresponding to the movement of the actuator.

[0039] The body portion (1504) defines a generally cylindrical shape. The exterior of the body portion (1504) includes external threads. As described in more detail below, such external threads can be configured to drive the elongated member (1508) or other components associated with the elongated member (1508). The body portion (1504) is fixed in a suitable position within the second frame portion (1104). In particular, the interior shape of the second frame portion (1104) is such that the body portion (1504) is fixed in a single lateral and longitudinal position. However, even when so fixed, the body portion (1504) is configured to rotate within the second frame portion (1104).

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

[0041] Elongated member 1508 is associated with indicator member 1542. In particular, the lower portion of indicator member 1542 is fastened to the lower portion of elongated member 1508, thereby securely fastening the lower portion of indicator member 1542 and the lower portion of elongated member 1508 to one another. Such fastening may be achieved by any suitable means. For example, in this embodiment, such fastening is achieved using one or more pins.

[0042] Indicator member 1542 extends upward within second frame portion 1104 independently of elongated member 1508. That is, indicator member 1542 is connected to elongated member 1508 only at its lower portion. Because the remainder of indicator member 1542 is not connected to elongated member 1508, the upper portion of indicator member 1542 and the upper portion of elongated member 1508 are free to move relative to each other. As will be described in more detail below, this configuration allows indicator member 1542 to function as a scale or force indicator for the amount of force being applied to the patient's head by stabilization assembly 1300.

[0043] The elongated member 1508 includes a threaded opening 1530 at the end opposite the stabilized assembly 1300. The threaded opening 1530 is generally configured to receive the body portion 1504 therein and engage with the external threads of the body portion 1504. As described above, the body portion 1504 is fixedly positioned within the second frame portion 1104. Thus, the threaded opening 1530 receives the body portion 1504, and the bottom of the elongated member 1508 is similarly secured in place by the body portion 1504. Furthermore, as will be described in more detail below, the elongated member 1508 is configured to translate within the second frame portion 1104 by rotation of the body portion 1504 and engagement of the threads of the threaded opening 1530 with the threads of the body portion 1504. That is, the main body portion (1504) has a configuration similar to a lead screw that mechanically fixes a portion of the elongated member (1508) while allowing the elongated member (1508) to translate in response to rotational input from the actuator (1502).

[0044] As shown in FIG. 11B, to adjust the tensioning mechanism 1500, the actuator 1502 is first pulled away from the second frame portion 1104. This pulling motion transitions the actuator 1502 from an initial stowed configuration to an actuated configuration. While not shown, it should be understood that in some embodiments, the actuator 1502 may be configured to have an intermediate configuration. In this intermediate configuration, the actuator 1502 is free to rotate without affecting the tensioning mechanism 1500. By way of example only, such a configuration may be desirable to allow an operator to adjust the operative position of the actuator 1502 before using the actuator 1502 to adjust the tensioning mechanism 1500.

[0045] As shown in Figure 11B, when the actuator (1502) is in the actuated configuration, it is aligned for adjustment of the tensioning mechanism (1500). As shown in Figure 11C, the actuator (1502) is rotated when the actuator (1502) is in the actuated configuration, which rotates the body portion (1504) in response. As the body portion (1504) rotates, the exterior threads of the body portion (1504) engage the interior threads of the threaded opening (1530), causing the elongated member (1508) to translate along the longitudinal axis of the body portion (1504).

[0046] In some embodiments, the translational movement of the elongated member (1508) can be visualized through 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 to allow an operator to visualize the movement of the elongated member (1508). The opening (1105) in this embodiment is configured as an elongated slot that receives a pin protruding from the elongated member (1508). Thus, the advancement of the pin of the elongated member (1508) along the length defined by the opening (1105) can indicate the advancement of the elongated member (1508) along its entire path of movement. While the opening (1105) in this embodiment is configured as an elongated slot, it should be understood that various alternative configurations, such as an oval or square window, a transparent partition, etc., can be used in other embodiments.

[0047] The direction of translation of elongate member 1508 depends on the direction of rotation of actuator 1502. When body portion 1504 is rotated to move elongate member 1508 toward frame portion 1102, the tension, i.e., the force applied to the patient, increases. Conversely, when actuator 1502 rotates body portion 1504 in the opposite direction, moving elongate member 1508 away from frame portion 1102, the tension decreases.

[0048] As shown in FIG. 12, the end of the elongated member 1508 opposite the body portion 1504 has a pair of spaced apart extensions 1509. The stabilization assembly 1300 is positioned within this space and is pin-connected to the pair of extensions 1509. Thus, moving the elongated member 1508 toward the first frame portion 1102 applies pressure to the stabilization assembly 1300 in a direction toward the frame portion 1102. Conversely, moving the elongated member 1508 away from the first frame portion 1102 reduces the pressure applied to the stabilization assembly 1300. FIG. 12 also shows one of a pair of slots 1302 incorporated into the stabilization assembly 1300. A slot (1302) is provided on each side of the stabilization assembly (1300) that receives a protruding upper portion of the second frame portion (1104), allowing the stabilization assembly (1300) to translate or slide laterally relative to the frame portion (1104) in response to a force applied by the elongated member (1508).

[0049] 12 also shows interface 1304, which in this view is located at the top of stabilization assembly 1300 and oriented upward, or away from frame portion 1104. In this embodiment, interface 1304 is configured as a star-shaped portion, but in other aspects, it may be configured otherwise. Additionally, various accessories, such as those used in neurosurgical procedures, may be selectively attached to interface 1304.

[0050] Referring again to the tensioning mechanism, the elongate member 1508 in this embodiment is configured to bend or curve relative to the body portion 1504. In particular, the patient's head can be positioned between the frame portions 1102, 1104 by contacting the pins of the stabilization assemblies 1200, 1300 with the patient's head. With the patient in this pinned position, the elongate member 1508 is moved toward the first frame portion 1102 to apply a force to the stabilization assembly 1300, as described above, and the patient's head in the pinned position applies an opposing force to the elongate member 1508. As a result, the portion of the elongate member 1508 extending away from the body portion 1504 curves or curves. This curvature or bending of the elongated member (1508) therefore provides a spring or bending force that is applied to the stabilization assembly (1300) and ultimately to the pins that contact the patient, and thus the elongated member (1508) provides a way to adjust the fixation force of the pins used on the patient.

[0051] Referring to FIG. 13 , the tensioning mechanism 1500 of this embodiment further includes a force indicator or scale 1540 associated with the elongate member 1508 and an indicator member 1542. The scale 1540 is generally configured to correlate to tension within the elongate member 1508 based on the force applied to the stabilization assembly 1300. Typically, the scale 1540 utilizes relative motion between the elongate member 1508 and the indicator member 1542 to indicate tension within the elongate member 1508, which in turn correlates to the pinning force applied to the patient. As shown in this figure, the scale 1540 is formed by a plurality of horizontally extending, color-coded bars 1544 disposed on the upper surface of the indicator member 1542.

[0052] Additionally, the elongate member 1508 includes angled protrusions 1546 adjacent the rods 1544 of the indicator member 1542. The angled protrusions 1546 are generally angled to protrude away from the first frame portion 1102. Therefore, as the elongate member 1508 bends or flexes, the corresponding rods 1544 are covered or exposed depending on the particular amount of bending or flexing of the elongate member 1508 caused by the relative movement between the top of the elongate member 1508 and the top of the indicator member 1542. As will be appreciated from the teachings herein, the greater the bending or flexing of the elongate member 1508, the greater the tension exerted on the elongate member 1508, which in turn exerts a greater pinning force on the patient. Thus, for example, if a relatively large tension is applied to elongated member (1508), the upper portion of elongated member (1508) will move a greater distance relative to indicator member (1542), resulting in more of rod portion (1544) being covered by angled protrusion (1546).

[0053] As noted above, bars 1544 are color-coded to indicate the amount of tension within elongate member 1508. The particular color coding used in this embodiment is a gradient between orange or yellow (low tension) and red (high tension). In alternative embodiments, other suitable color coding can be used, as would be apparent to one of ordinary skill in the art in light of the teachings herein. While this embodiment uses individual bars of various colors for illustration, in alternative embodiments, a continuous gradient can be used without the use of individual bars. Additionally or alternatively, a symbol that does not rely on color coding, such as a number or symbol, can be used. Also, in some aspects, the number of visible bars can be used to indicate tension instead of using a color coding.

[0054] V. Exemplary Alternative Skull Clamp with Tensioning Mechanism Comprising Bending Beams and a Movable Frame FIG. 14 illustrates an alternative HFD (2010) that is substantially similar to the HFDs (10, 1010) described above, unless otherwise specified herein. For example, as described above with the HFD (10), the HFD (2010) of this embodiment has the shape or configuration of a skull clamp. Accordingly, 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) are adjustably connectable, thereby adjusting the spacing between them. The frame portions (2102, 2104) each include a receiving portion (2106, 2108) configured to receive a stabilization assembly. In the illustrated embodiment, stabilization assembly 2200 is received by receiver 2106 of frame portion 2102. Additionally, stabilization assembly 2300 is received by receiver 2108 of frame portion 2104.

[0055] As discussed 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 frame adjustment mechanism (1400) described above. In alternative embodiments, various alternative frame adjustment mechanisms may be readily incorporated into the HFD (2010) or HFD (10, 1010), as would be understood by one of ordinary skill in the art in view of the teachings herein.

[0056] Like the HFD 10, the HFD 2010 of this embodiment has a modular design, such that the receptacles 2106, 2108 are configured to accept a variety of stabilization assemblies, rather than being configured to accept only a single type or design of stabilization assembly. As described above, the stabilization assembly 2200 and the stabilization assembly 2300 are interchangeable with one another, such that the stabilization assembly 2200 can be connected to the receptacle 2108, and similarly, the stabilization assembly 2300 can be connected to the receptacle 2106. In this manner, the modularity and interchangeability associated with the stabilization assemblies 2200, 2300 and the HFD 2010 are provided in the same or similar manner as described above in connection with the stabilization assemblies 200, 300 and the HFD 10.

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

[0058] 16A illustrates the configuration of the actuator 2502 in more detail. The actuator 2502 in this embodiment is generally configured to interact with the body portion 2504 to selectively rotate and de-rotate the body portion 2504. As will be described in more detail below, the body portion 2504 is configured to engage a portion of the second frame portion 2104 or other component associated with the second frame portion, such that rotation of the body portion 2504 by the actuator 2502 drives translation of the elongated member 2508 along with the second frame portion 2104.

[0059] Suitable and selective rotational engagement between the actuator 2502 and the body portion 2504 can be achieved in a variety of ways. By way of example only, the actuator 2502 of this embodiment includes a handle 2510 having an elongated rod 2512 extending from the handle 2510 into the interior of the second frame portion 2104. The end of the elongated rod 2512 opposite the handle 2510 includes a keyed end 2516. As will be described in more detail below, the keyed end 2516 is typically configured to engage a portion of the body portion 2504 to provide rotation of the body portion 2504 after the actuator 2502 is translated into position.

[0060] The body portion 2504 includes a hollow interior 2520 configured to receive the elongated rod 2512 of the actuator 2502 for engagement with the actuator 2502. The hollow interior 2520 defines a cylindrical portion 2522 and an engagement portion 2524 toward the opposite end of the body portion 2504. The cylindrical portion 2522 typically defines a generally cylindrical shape within which the keyed end 2516 can freely rotate, while the engagement portion 2524 typically 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 motion from the elongated rod 2512 to the body portion 2504.

[0061] As described above, the actuator 2502 is configured to rotate the body portion 2504 when in a predetermined longitudinal position relative to the body portion 2504. Accordingly, as described in more detail below, the actuator 2502 is movable between one or more positions to selectively engage or disengage the body portion 2504 and rotate the body portion. To maintain the actuator 2502 in a predetermined position relative to the body portion 2504, the actuator's elongated rod 2512 includes one or more detent features 2514 extending inwardly from its surface. In this embodiment, the elongated rod 2512 includes three semicircular notches positioned at three positions along the rod's longitudinal axis. Each detent feature 2514 is configured to engage a spring-loaded bearing, ball, or other resilient mechanism to releasably hold the elongated rod 2512 in a predetermined position along the rod's longitudinal axis. As will be explained in more detail below, this configuration allows actuator (2502) to be selectively fixed in a selected one of a plurality of predetermined positions corresponding to the movement of the actuator.

[0062] The body portion (2504) defines a generally cylindrical shape, and the exterior of the body portion (2504) includes external threads. As described in more detail below, such external threads can be configured to drive the second frame portion (2104) and / or other components associated with the second frame portion (2104). The body portion (2504) is fixed in a suitable position within the frame (2100). In particular, the interior shape of the lower portion of the frame (2100) is configured to fix the body portion (2504) in a single lateral and longitudinal position. However, even when fixed in this manner, the body portion (2504) is configured to rotate within the second frame portion (2106).

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

[0064] Elongated member 2508 is secured to a portion of second frame portion 2104 by pins. In particular, a lower portion of elongated member 2508 is secured to a lower portion of second frame portion 2104 by one or more pins. Therefore, it should be understood that as second frame portion 2104 moves, at least a lower portion of elongated member 2508 moves in response, as described in more detail below.

[0065] The second frame portion 2104 includes a threaded hole 2530 adjacent its lower portion. The threaded hole 2530 is generally configured to receive the body portion 2504 therein and engage with the external threads of the body portion 2504. As described above, the body portion 2504 is generally in a fixed position relative to the lower portion of the frame 2100. Thus, the second frame portion 2104 is similarly secured in position by the body portion 2504 as the threaded hole 2530 receives the body portion 2504. Because the lower portion of the elongated member 2508 is secured to the second frame portion 2104, the lower portion of the elongated member 2508 is similarly secured in position by the body portion 2504. Furthermore, as will be described in more detail below, elongated member 2508 is configured to translate by rotation of body portion 2504 and engagement of threads in threaded bore 2530 with threads on body portion 2504. That is, body portion 2504 has a lead screw-like configuration that mechanically fixes a portion of second frame portion 2104 and a portion of elongated member 2508, while translating second frame portion 2104 and elongated member 2508 in response to rotational input from actuator 2502.

[0066] As shown in FIG. 16B, to adjust the tensioning mechanism 2500, the actuator 2502 is first pulled away from the second frame portion 2104. This pulling motion transitions the actuator 2502 from an initial stowed configuration to an actuated configuration. It should be appreciated that in some embodiments, the actuator 2502 may be configured to have an intermediate configuration. In this intermediate configuration, the actuator 2502 is free to rotate without affecting the tensioning mechanism 2500. By way of example only, such a configuration may be desirable to allow an operator to adjust the operative position of the actuator 2502 before using the actuator 2502 to adjust the tensioning mechanism 1500.

[0067] As shown in FIG. 16B, when the actuator (2502) is in the actuated configuration, it is aligned for adjustment of the tensioning mechanism (2500). As shown in FIG. 16C, the actuator (2502) is rotated when the actuator (1502) is in the actuated configuration, causing the body portion (2504) to rotate in response. As the body portion (2504) rotates, the exterior threads of the body portion (2504) engage the interior threads of the threaded hole (2530) in the second frame portion (2104), causing the second frame portion (2104) to translate along the longitudinal axis of the body portion (2504). Simultaneously, the translation of the second frame portion (2104) causes corresponding translation of at least the bottom of the elongated member (2508) along the longitudinal axis of the body portion (2504).

[0068] In some embodiments, one or more openings or windows in the second frame portion (2104) allow visualization of the translational movement of the second frame portion (2104) and the elongated member (2508). 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). In this embodiment, the opening (2105) is configured as an elongated slot that receives a pin protruding from the bottom of the frame (2100). Thus, the advancement of the pin on the bottom of the frame (2100) along the length defined by the opening (2105) can indicate the advancement of the second frame portion (2104) and the elongated member (2508) along the entire path of movement. While the opening (2105) in this embodiment is configured as an elongated slot, it should be understood that in other embodiments various alternative shapes may be used, such as an oval or square window, a transparent partition, etc.

[0069] The direction of translation of the second frame portion (2104) and the elongated member (2508) depends on the direction of rotation of the actuator (2502). When the body portion (2504) is rotated to move the second frame portion (2104) and the elongated member (2508) toward the first frame portion (2102), the tension, i.e., the force applied to the patient, increases. On the other hand, when the actuator (2502) rotates the body portion (2504) in the opposite direction, moving the second frame portion (2104) and the elongated member (2508) away from the first frame portion (2102), the tension decreases.

[0070] As shown in FIG. 17, the end of the elongated member 2508 opposite the body portion 2504 has a pair of spaced apart extensions 2509. The stabilization assembly 2300 is positioned within this space and is pin-connected to the pair of extensions 2509. Thus, moving the elongated member 2508 toward the first frame portion 2102 applies pressure to the stabilization assembly 2300 in a direction toward the frame portion 2102. Meanwhile, moving the elongated member 2508 away from the first frame portion 2102 reduces the pressure applied to the stabilization assembly 2300. FIG. 17 also shows one of a pair of slots 2302 incorporated into the stabilization assembly 2300. A slot (2302) is provided on each side of the stabilization assembly (2300), and the slot receives a protruding upper portion of the second frame portion (2104), allowing the second frame portion (2104) to translate or slide laterally relative to the stabilization assembly (2300) in response to a force applied by the elongated member (1508).

[0071] The elongate member 2508 in this embodiment is configured to curve or bend relative to the body portion 2504. In particular, the patient's head can be positioned between the frame portions 2102, 2104 by contacting the pins of the stabilization assemblies 2200, 2300 with the patient's head. When the patient is in this pinned position, the elongate member 2508 is moved toward the first frame portion 2102 to apply a force to the stabilization assembly 2300, as described above, and the patient's head in the pinned position applies an opposing force to the elongate member 2508. As a result, the portion of the elongate member 2508 extending away from the body portion 2504 curves or bends. This curvature or bending of the elongated member (2508) therefore provides a spring or bending force that is applied to the stabilization assembly (2300) and ultimately to the pins that contact the patient, and thus the elongated member (2508) provides a way to adjust the fixation force of the pins used on the patient.

[0072] Referring to FIG. 18 , the tensioning mechanism 2500 of this embodiment further includes a force indicator or scale 2540 associated with the elongate member 2508. The scale 2540 is generally configured to correlate to tension within the elongate member 2508 based on the force applied to the stabilization assembly 2300. Typically, the scale 2540 utilizes relative motion between the elongate member 2508 and the second frame portion 2104 to indicate tension within the elongate member 2508, which in turn correlates to the pinning force applied to the patient. As shown in this figure, the scale 2540 is formed by a plurality of horizontally extending, color-coded bars 2544 disposed on the top surface of the second frame portion 2104.

[0073] Additionally, the elongate member 2508 includes an angled protrusion 2546 adjacent to the rod 2544 of the second frame portion 2104. The angled protrusion 2546 is generally angled to protrude away from the first frame portion 2102. Therefore, as the elongate member 2508 bends or bends, depending on the particular amount of curvature or bending of the elongate member 2508 caused by the relative movement between the top of the elongate member 2508 and the top of the second frame portion 2104, the angled protrusion 2546 moves to intersect with, point to, or align with a specific rod 2544 of the plurality of rods 2544. As will be appreciated from the teachings herein, the greater the curvature or bending of the elongated member 2508, the greater the tension on the elongated member 2508, which in turn applies a greater pinning force to the patient. Thus, for example, if a relatively large tension is applied to the elongated member 2508, the upper portion of the elongated member 2508 will move a greater distance relative to the first frame portion 2102, causing the angled protrusion 2546 to move into alignment with the upper bar 2544 on the scale.

[0074] As noted above, bars 2544 are color-coded to indicate the amount of tension within elongate member 2508. The particular color coding used in this embodiment is a gradient between orange or yellow (low tension) and red (high tension). In alternative embodiments, other suitable color coding can be used, as would be apparent to one of ordinary skill in the art in light of the teachings herein. While this embodiment uses individual bars of various colors for illustration, in alternative embodiments, a continuous gradient can be used without the use of individual bars. Additionally or alternatively, symbols independent of color coding, such as numbers or symbols, can be used. Also, in some aspects, the number of visible bars can be used to indicate tension rather than using color coding.

[0075] VI. Exemplary Rocker Arm Locking Mechanism Another feature of the HFDs (1010, 2010) relates to the locking mechanism of the stabilized assemblies (1300, 2300). Figures 19 and 20 show cross-sectional perspective views of the stabilized assembly (2300). The locking mechanism and operability are identical for the stabilized assembly (1300) and the stabilized assembly (2300). For simplicity, the locking mechanism will be described with reference to Figures 19 and 20, which show the stabilized assembly (2300), but it will be understood that the description applies equally to the stabilized assembly (1300).

[0076] 19 and 20, a locking mechanism allows for selective rotational adjustment of rocker arm assembly 2316 relative to housing 2301 of stabilizer assembly 2300. Stabilizer assembly 2300 includes actuator 2303 including key or biasing member 2305, pin 2307, spring 2309, spring seat 2311, and lever 2315. Rocker arm assembly 2316 includes retaining portion 2317 that is pin-coupled to rocker arm 2332. Stabilizer assembly 2300 further includes locking member 2319.

[0077] In the state shown in FIG. 19, the rocker arm assembly 2316 is in a locked state or position. For example, the retaining portion 2317, in this embodiment, has a gear or toothed ring 2321 formed on the interior of the retaining portion. The toothed ring 2321 has a plurality of teeth arranged radially about a longitudinal axis passing through the interior bore of the retaining portion 2317. That is, in this embodiment, the teeth comprising the toothed ring 2321 extend along the circumferential surface of the retaining portion 2317. To achieve the locked state, the toothed ring 2321 engages with the gear or toothed ring 2323 of the locking member 2319. With the toothed rings 2321, 2323 engaged, the rocker arm assembly 2316 is rotationally fixed relative to the housing 2301.

[0078] FIG. 20 illustrates the rocker arm assembly 2316 in an adjustable or unlocked state. In this state, the toothed rings 2321, 2323 are separated from one another, and corresponding teeth on the toothed rings 2321, 2323 are not engaged. Specifically, as shown in FIG. 20, the retaining portion 2317 defines a longitudinal axis LA, and the toothed ring 2323 of the locking member 2319 is offset from the toothed ring 2321 of the retaining portion 2317 toward the rocker arm 2332. Similarly, this offset can be expressed as the toothed rings 2321, 2323 being at different translational positions along the longitudinal axis LA. When the toothed rings 2321, 2323 are not engaged, as shown in FIG. 20, the rocker arm assembly 2316 is rotationally adjustable relative to the housing 2301.

[0079] To move the stabilizer assembly 2300 between a locked or unlocked state, or between a fixed or adjustable state, a user presses the key 2305, thereby forcing the spring 2309 against the seat 2311. When the key 2305 is in a depressed state, it is translatable relative to the fixed insert 2313. As shown in FIG. 22 , when the key 2305 is not depressed, the key 2305 is translationally fixed relative to the insert 2313 because the key 2305 includes a protruding feature 2306 that engages with a slot 2314 in the insert 2313. For example, as shown in FIGS. 19 and 20 , when the key 2305 is in a raised state or undepressed, the key 2305 is translationally fixed relative to the insert 2313. Insert 2313 has two or more slots 2314 to allow key 2305 to correspond to either of the positions shown in Figures 19 and 20. Key 2305 can also include multiple protruding features 2306, as shown in Figure 22.

[0080] Continuing with the embodiment of movement between the fixed state shown in FIG. 19 and the adjustable state shown in FIG. 20, after being depressed, key 2305 advances or translates toward rocker arm 2332. Along with key 2305, pin 2307, spring 2309, seat 2311, locking member 2319, and lever 2315 move. As shown by comparing FIGS. 19 and 20, lever 2315 rotates about its pin connection with housing 2301, while key 2305, pin 2307, spring 2309, seat 2311, and locking member 2319 translate. With key 2305 and toothed annulus 2323 of locking member 2319 advanced, as shown in Figure 20, depression key 2305 stops and returns to a neutral position due to the biasing force of spring 2309. Then, as described above, protruding members on key 2305 engage corresponding slots in insert member 2313 to fix the translational position of key 2305 and its associated components.

[0081] As described above, the stabilizer assembly 2300 is configured such that the actuator 2303 can move between a first position and a second position, where the rocker arm assembly 2316 is rotationally fixed in the first position and rotationally adjustable in the second position. Furthermore, in this embodiment, the engagement between the key 2305 and the insert 2313 eliminates the need for a user to hold the key 2305 in a depressed or translated position to adjust or lock the rocker arm assembly 2316. This configuration allows a user to lock the rotational position of the rocker arm assembly 2316 after setting the stabilizer assembly 2300 to a desired position. Additionally, as described above, movement of the stabilizer assembly between the adjustable and locked states of the rocker arm assembly is accomplished by translation of the radially arranged toothed annular portions 2321, 2323.

[0082] Other configurations of stabilizer assembly 2300 or other stabilizer assemblies for adjusting the rotational position of rocker arm assemblies will be apparent to those skilled in the art in light of the teachings herein. By way of example only, FIG. 21 illustrates stabilizer assembly 3300 that can be used with HFDs 1010 and 2010 in place of stabilizer assemblies 1300 and 2300. Stabilizer assembly 3300 includes actuator 3303 with key 3305, pin 3307, spring 3309, seat 3311, insert 3313, and lever 2315. The stabilizer assembly also includes locking member 3319 with toothed ring 3323, while rocker arm assembly 3316 includes retainer 3317 with toothed ring 3321. These components are operable in a manner similar to that described above for corresponding components similar to the stabilization assembly (2300) shown in Figures 19 and 20.

[0083] However, stabilizer assembly 3300 differs from stabilizer assembly 2300 in that, for stabilizer assembly 3300, advancement of key 3305 toward rocker arm 3332 engages toothed annular portion 3323 of locking member 3319 with toothed annular portion 3321 of retaining portion 3317 to secure rocker arm assembly 3316 relative to housing 3301. This is the reverse or opposite movement from that described above in connection with stabilizer assembly 2300. Similarly, as shown in FIG. 21 , for stabilizer assembly 3300, to adjust rocker arm assembly 3316, locking member 3319 is retracted or translated away from rocker arm 3332 to disengage toothed regions 3321, 3323.

[0084] Additionally, other methods of modifying the stabilization assembly (1300, 2300, 3300) to provide a locking mechanism that selectively adjusts the rotational position of an associated rocker arm assembly will be apparent to those skilled in the art in light of the teachings herein.

[0085] VII. Exemplary Combinations The following examples relate to non-exhaustive aspects of combining or applying the teachings herein. It should be understood that the following examples are not intended to limit the scope of any claims that may be filed at any time in this application or in any subsequent application of this application. Furthermore, no disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be configured and applied in numerous other different ways. It is also contemplated that specific features referred to in the following examples may be omitted in some of the alternative embodiments. Therefore, none of the aspects or features referred to below should be considered essential unless expressly stated later by the inventors or the inventors' successors in interest. If any claims including additional features beyond those recited in the following claims are filed in this application or in any subsequent application related to this application, such additional features should not be considered added for any reason related to patentability. [Example]

[0086] 1. 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 comprising 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 elongated member extending from the actuator to the stabilization assembly, the actuator configured to move the elongated member relative to the stabilization assembly when the stabilization mechanism is in contact with the patient, thereby adjusting an amount of force applied to the patient by the stabilization assembly. [Example]

[0087] 2. The device of Example 1, wherein at least a portion of the elongated member is configured to bend in response to an increase in force applied to the stabilization assembly. [Example]

[0088] 10. The device of claim 1, wherein the actuator has a body portion and is configured to transmit rotational motion to the body portion, the body portion having a cylindrical portion including a screw thread, the screw thread being configured to engage with the screw thread of the elongated member to move the elongated member relative to the body portion. [Example]

[0089] The device of one or more of Examples 1-2, further comprising a frame assembly having a first frame portion and a second frame portion, wherein the actuator has a body portion and is configured to transmit rotational motion to the body portion, the body portion having a cylindrical portion including a screw thread, the screw thread being configured to engage with the screw thread of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion. [Example]

[0090] 5. The device of claim 1, wherein the actuator further comprises a rod and a locking mechanism configured to releasably hold the rod in a selected one of a plurality of predetermined positions relative to the body portion. [Example]

[0091] The device of one or more of Examples 1 to 5, further comprising: A device comprising a force indicating mechanism configured to indicate an amount of force applied to the patient by the stabilization assembly. [Example]

[0092] In the device described in Example 6, the force indication 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] The device of one or more of Examples 1-3, 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, thereby adjusting the spacing between the first and second frame portions. [Example]

[0094] In the device described in Example 8, the tensioning mechanism is configured to maintain the relative position of the first and second frame portions while adjusting the amount of force applied to the patient by the stabilization assembly, thereby preventing the spacing between the first and second frame portions from changing. [Example]

[0095] In the device described in Example 8, the tensioning mechanism is configured to adjust the amount of force applied to the patient by the stabilization assembly, and the relative position of the first and second frame portions changes as the amount of force applied to the patient by the stabilization assembly is adjusted, thereby changing the spacing between the first and second frame portions. [Example]

[0096] A device described in one or more of Examples 1-2, wherein the tensioning mechanism has a body portion, the actuator is configured to transfer a force to the elongated member by moving the elongated member relative to the body portion, and the elongated member is configured to transfer at least a portion of the force to the stabilization assembly to adjust the amount of force applied to the patient by the stabilization assembly. [Example]

[0097] The device of one or more of Examples 1-3, further comprising a frame assembly having a first frame portion and a second frame portion, and an adjustment mechanism configured to adjust the relative position of the first and second frame portions to overcome the force applied to the stabilization assembly by the tensioning mechanism. [Example]

[0098] In a device described in one or more of Examples 1 to 12, the tensioning mechanism includes a torsion rod, and torque applied to the torsion rod transmits a force to the elongated member, and the elongated member transmits at least a portion of the force to the stabilization assembly, thereby increasing the amount of force applied to the patient by the stabilization assembly. [Example]

[0099] 14. The device of claim 1, wherein the tensioning mechanism is configured to apply the amount of force to the stabilization assembly through a twisting action. [Example]

[0100] 15. The device of claim 14, wherein the actuator is configured to provide a pretensioning force to the stabilization assembly. [Example]

[0101] The device of one or more of Examples 1-15, wherein the device comprises two or more stabilization assemblies. [Example]

[0102] The apparatus of one or more of Examples 4-10 and 12-16, wherein the frame assembly has a U-shape. [Example]

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

[0104] 1. A device configured for use with a patient stabilization device that adjusts the amount of force applied to the patient by the patient stabilization device, the device comprising: (a) a first body portion having a first end and a second end, the first end configured to connect to a stabilization assembly of the stabilization device; and (b) an actuator connectable directly or indirectly to the first body portion, the actuator configured to generate a torque applied to the first body portion, wherein an increase in the torque on the first body portion increases tension within the first body portion, and wherein an increase in the tension within the first body portion increases the force applied to the stabilization assembly by the first body portion. [Example]

[0105] 20. The device of Example 19, wherein the first body portion is rigid. [Example]

[0106] 21. The device of one or more of Examples 19-20, wherein the torque is applied to the first body portion such that the dimensions of the first body portion remain constant while increasing tension within the body portion. [Example]

[0107] 22. The device of one or more of Examples 19-21, wherein the device has a second body portion that is keyed to the first body portion at the second end, thereby preventing relative rotation between the first body portion and the second body portion. [Example]

[0108] 23. The device of Example 22, wherein the second body portion and the first body portion are disposed substantially perpendicular to each other. [Example]

[0109] 24. The device according to one or more of Examples 22-23, wherein the second body portion is rigid. [Example]

[0110] 25. The device according to one or more of Examples 22 to 24, wherein the actuator is directly or indirectly connectable to the second body portion; the actuator is configured to generate a torque that is applied to the second body portion, which is transferred to the first body portion, thereby generating a torque that is applied to the first body portion, thereby increasing tension within the first body portion. [Example]

[0111] 26. The device of one or more of Examples 22-25, wherein a dimension of the second body portion is maintained constant while a torque is applied to the second body portion that increases tension within the first body portion. [Example]

[0112] 1. An apparatus for stabilizing a patient, the apparatus comprising: (a) a frame having a receiver and a pin extending laterally through the receiver; and (b) a stabilization assembly having a stabilization mechanism configured to contact the patient, the stabilization assembly being selectively received in the receiver, the stabilization assembly having a housing having: (i) a slot located proximally of the housing, the slot configured to receive the pin extending laterally through the receiver on the frame; and (ii) a first retention mechanism movable relative to the housing from a first position to a second position, wherein in the first position, the first retention mechanism allows the pin on the frame to be fully seated in the slot on the housing, thereby fully seating the stabilization assembly within the receiver on the frame, and in the second position, the first retention mechanism secures the stabilization assembly within the receiver. [Example]

[0113] The device of Example 27, wherein the housing has a hole located distally of the housing, the hole configured to selectively retain the stabilization mechanism. [Example]

[0114] In the device described in one or more of Examples 27 to 28, the housing has a first elastic mechanism that can be freely connected to the first retaining mechanism, the first elastic mechanism has a biasing force that maintains the first retaining mechanism in the second position within the housing, and the first retaining mechanism can be moved to the first position by compressing the first elastic mechanism. [Example]

[0115] 30. The device according to one or more of Examples 27-29, wherein the device has an adjustment mechanism for setting the width of the frame. [Example]

[0116] A device described in one or more of Examples 27 to 29, wherein the housing has a hole located distally of the housing, and the device further has an adapter selectively retained in the hole of the housing, the adapter configured to selectively retain the stabilization mechanism. [Example]

[0117] 32. The device of claim 31, wherein the adapter has an engagement mechanism. [Example]

[0118] In the device described in one or more of Examples 31 to 32, the housing has a second retention mechanism that is movable relative to the housing, and the second retention mechanism can be configured to align and engage with the engagement mechanism of the adapter, and the engagement of the second retention mechanism with the engagement mechanism of the adapter secures the adapter within the hole of the housing. [Example]

[0119] In the device described in one or more of Examples 31 to 33, the adapter is fixed within the hole in the housing, preventing translational movement of the adapter within the hole in the housing while allowing rotational movement of the adapter relative to the housing. [Example]

[0120] In the device described in one or more of Examples 32 to 34, the engagement mechanism of the adapter has an annular groove, and the second retention mechanism has a spherical member that fits within the annular groove. [Example]

[0121] In the device described in one or more of Examples 33 to 35, the housing has a second elastic mechanism that is freely connectable to the second retention mechanism, the second elastic mechanism has a biasing force that maintains the second retention mechanism in an extended position within the housing that maintains engagement between the second retention mechanism and the engagement mechanism of the adapter, and the second retention mechanism is movable to compress the second elastic mechanism and release the engagement with the engagement mechanism of the adapter. [Example]

[0122] 1. A device for stabilizing a patient's head, the device comprising: (a) a frame having a receiver; and (b) a stabilization assembly configured to be received within the receiver and configured to hold one or more stabilization mechanisms configured to contact the patient's head, the stabilization assembly including: (i) a selectively rotatable member; (ii) an actuator for longitudinal translation between a first position and a second position, wherein in the first position, the selectively rotatable member is rotationally adjustable and in the second position, the selectively rotatable member is rotationally fixed, the actuator having a locking mechanism having a first engagement mechanism; and (iii) a retainer connectable to the selectively rotatable member, the retainer having a second engagement mechanism configured to selectively engage with the first engagement mechanism, the first and second engagement mechanisms longitudinally translating relative to one another to selectively engage and disengage, thereby adjusting or fixing the rotational position of the selectively rotatable member. [Example]

[0123] In the device described in 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 to move the actuator between the first and second positions, thereby overcoming the biasing force. [Example]

[0124] In the device described in one or more of Examples 37-38, the locking mechanism having the first engagement mechanism moves longitudinally away from the selectively rotatable member when the actuator is moved from the first position to the second position. [Example]

[0125] 39. The device according to one or more of Examples 37-38, wherein the locking mechanism having the first engagement mechanism advances longitudinally toward the selectively rotatable member when the actuator is moved from the first position to the second position. [Example]

[0126] 41. The device of one or more of Examples 37-40, wherein the first engagement feature and the second engagement feature each have a toothed annular configuration. [Example]

[0127] 42. The device of claim 38, wherein the selectively rotatable member is maintained in either a rotationally adjustable state or a fixed state when the actuator is in the third position. [Example]

[0128] In the device described in Example 37, the actuator has a pressing member and an insert member, the pressing member being selectively engageable with the insert member, and the engagement between the pressing member and the insert member maintains the selectively rotatable member in a selected one of a rotationally adjustable state or a fixed state depending on the longitudinal position of the actuator. [Example]

[0129] The device of any one or more of Examples 37-43, wherein a user can set the stabilization assembly to a desired rotational position without maintaining contact with the actuator while adjusting the rotational orientation of the stabilization assembly. [Example]

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

[0131] 1. A stabilization assembly for use with a device for stabilizing a patient, the stabilization assembly 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 translate longitudinally relative to one another from a first position to a second position, wherein in the first position, the pair of engagement mechanisms are engaged and the selectively rotatable members are fixed, and in the second position, the pair of engagement mechanisms are disengaged and the selectively rotatable members are rotationally adjustable. [Example]

[0132] 1. An apparatus for stabilizing a patient, comprising: (a) a frame having a first receiver; (b) a first stabilization assembly configured to receive one or more stabilization mechanisms, the first stabilization assembly further configured to connect with the first receiver of the frame, the first stabilization assembly comprising: (i) a housing that connects with the first receiver of the frame; (ii) an arm connectable with the housing and configured to receive the one or more stabilization mechanisms, the arm 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 position the arm in the second state. (iv) a second actuator configured to place the arm portion in the first state. [Example]

[0133] In the device described in Example 47, the first actuator is freely 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 device described in Example 48, the second actuator is freely connectable to the housing and is biased to maintain contact between the first engagement mechanism of the first actuator and the second engagement mechanism, and by overcoming the biasing force of the second actuator, the first engagement mechanism can be disengaged from the second engagement mechanism, thereby enabling adjustment of the arm portion in the rotational direction. [Example]

[0135] 49. The device of claim 48, wherein 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 device described in Example 50, the biasing force of the first actuator is overcome, causing the first engagement mechanism to engage or contact the second engagement mechanism, and further allowing the second engagement mechanism to be biased, thereby maintaining engagement between the first and second engagement mechanisms. [Example]

[0137] A device described in one or more of Examples 47 to 51, wherein the frame further has a second receiving portion, and the device has a second stabilization assembly that is freely connectable to the second receiving portion. [Example]

[0138] 1. An apparatus for stabilizing a patient, the apparatus comprising: (a) a frame having a first member and a second member, wherein positions of the first and second members are adjustable such that relative positions of the first and second members are changed with respect to one another; (b) an actuator connectable to the frame; and (c) a first locking mechanism connectable to the actuator, the actuator configured to move the first locking mechanism between a first position and a second position, wherein in the first position, the first locking mechanism provides a friction fit that prevents the first and second members of the frame from moving apart, and wherein in the second position, the first locking mechanism allows the first and second members of the frame to move apart. [Example]

[0139] The device of Example 53, wherein the device has a skull clamp for stabilizing the patient's head. [Example]

[0140] 55. The device of one or more of Examples 53-54, wherein the device includes a second locking mechanism configured to contact the first locking mechanism. [Example]

[0141] 56. The device of claim 55, wherein a portion 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 55-56, the first locking mechanism moves parallel in a first direction, causing the first locking mechanism to drive the second locking mechanism into contact with a portion of the frame. [Example]

[0143] 1. A device for stabilizing a patient, the device comprising: (a) a frame having a first member and a second member, wherein positions of the first and second members are adjustable to change the relative positions of the first and second members with respect to one another; (b) an actuator connectable to the frame; and (c) a first locking mechanism connectable to the actuator, the actuator configured to move the first locking mechanism between a first position and a second position, wherein in the first position, the first locking mechanism provides a stepless fit that prevents the first and second members of the frame from moving apart, and in the second position, the first locking mechanism allows the first and second members of the frame to move apart, the stepless fit allowing an unlimited range of adjustment of the relative spacing of the first and second members. [Example]

[0144] The device of Example 58, wherein the device has a skull clamp for stabilizing the patient's head. [Example]

[0145] 60. The device of one or more of Examples 58-59, wherein the device includes a second locking mechanism configured to contact the first locking mechanism. [Example]

[0146] 61. The device of claim 60, wherein a portion 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]

[0147] In the device described in one or more of Examples 60 to 61, the first locking mechanism moves parallel in a first direction, causing the first locking mechanism to drive the second locking mechanism into contact with a portion of the frame.

[0148] VIII. Miscellaneous Any one or more teachings, expressions, embodiments, and examples described herein may be combined with any one or more other teachings, expressions, embodiments, and examples described herein. Thus, the teachings, expressions, embodiments, and examples described above should not be considered independent of one another. In light of the teachings herein, those skilled in the art will recognize that various suitable combinations of the teachings are possible. Such modifications and variations are intended to be within the scope of the claims.

[0149] While various embodiments of the present invention have been illustrated and described, those skilled in the art can make appropriate modifications to further improve the methods and systems described herein without departing from the scope of the present invention. While some of these possible modifications have been described, others will be apparent to those skilled in the art. For example, the examples, embodiments, geometrical characteristics, materials, dimensions, proportions, steps, and the like described above are illustrative and not required. Therefore, the scope of the present invention should be considered based on the following claims, and should not be limited to the details of structure and operation shown and described in this specification and drawings.

Claims

1. 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 tensioning mechanism configured to receive the stabilizing assembly at a first location, the tensioning mechanism further including a second location spaced a predetermined distance from the first location, the second location being spaced a predetermined distance from the stabilizing assembly, the tensioning mechanism comprising: an actuator disposed at the second location and spaced apart 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. Device.

2. The device of claim 1 , wherein at least a portion of the elongate member is configured to bend in response to an increase in force applied to the stabilization assembly.

3. 10. The device of claim 1, wherein the actuator has a body and is configured to transmit rotational motion to the body; The device, wherein the body portion has a cylindrical portion including threads configured to engage threads on the elongated member to move the elongated member relative to the body portion.

4. 10. The apparatus of claim 1 further comprising: a frame assembly having a first frame portion and a second frame portion; the actuator has a body and is configured to transmit rotational motion to the body; The device, wherein the main body portion has a cylindrical portion including threads that are configured to engage with threads on the second frame portion to move the second frame portion and the elongated member relative to the first frame portion.

5. 10. The device of claim 1, wherein the actuator further comprises a rod and a locking mechanism configured to releasably hold the rod in a selected one of a plurality of predetermined positions relative to the body.

6. 10. The apparatus of claim 1 further comprising: a force indicating mechanism configured to indicate an amount of force applied to the patient by the stabilization assembly.

7. 7. The device of claim 6, wherein the force indicating 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.

8. 10. The apparatus of claim 1 further comprising: a frame assembly having a first frame portion and a second frame portion; The first and second frame portions are movable relative to one another to adjust the spacing between the first and second frame portions.

9. 9. The device of claim 8, wherein the tensioning mechanism is configured to maintain the relative position of the first and second frame portions while adjusting the amount of force applied to the patient by the stabilization assembly, such that the spacing between the first and second frame portions does not change.

10. 9. The device of claim 8, wherein the tensioning mechanism is configured to adjust the amount of force applied to the patient by the stabilization assembly, such that as the amount of force applied to the patient by the stabilization assembly is adjusted, the relative position of the first and second frame portions changes, thereby changing the spacing between the first and second frame portions.

11. 10. The device of claim 1, wherein the tensioning mechanism comprises a body portion; the actuator is configured to transfer a force to the elongated member by moving the elongated member relative to the body; The elongated member is configured to transfer at least a portion of the force to the stabilization assembly to adjust the amount of force applied to the patient by the stabilization assembly.

12. 10. The apparatus of claim 1 further comprising: a frame assembly having a first frame portion and a second frame portion; an adjustment mechanism configured to adjust the relative position of the first and second frame portions to overcome the force applied to the stabilization assembly by the tensioning mechanism; and The device has:

13. 10. The device of claim 1, wherein the tensioning mechanism comprises a torsion rod; a torque applied to the torsion rod transmits a force to the elongated member; The elongated member transmits at least a portion of the force to the stabilization assembly, thereby increasing the amount of force applied to the patient by the stabilization assembly.

14. 10. The device of claim 1, wherein the tensioning mechanism is configured to apply the amount of force to the stabilization assembly through a twisting action.

15. The apparatus of claim 1 , wherein the actuator is configured to provide a pretensioning force to the stabilization assembly.

16. 10. The device of claim 1, wherein the stabilization assembly defines a proximal end and a distal end, the distal end configured to receive the stabilization mechanism; the stabilization assembly further defines an axis extending from the proximal end to the distal end; The actuator at the second position is disposed along an axis different from the axis defined by the stabilization assembly.

17. 1. A device configured for use with a patient stabilization device, the device adjusting an amount of force applied to the patient by the patient stabilization device; (a) a first body portion having a first end and a second end, the first end configured to connect with a stabilization assembly of the stabilization device; (b) a second body portion, the second body portion being keyed to the first body portion at the second end, thereby preventing relative rotation between the first body portion and the second body portion; and (c) an actuator directly or indirectly connectable to the second body portion, the actuator is configured to generate a torque that is applied to the second body portion; an increase in torque on the second body portion increases tension within the first body portion; the force applied to the stabilization assembly by the first body portion increases in response to an increase in tension within the first body portion. The actuator A device having:

18. 18. The device of claim 17, wherein the first body portion is rigid.

19. 18. The device of claim 17, wherein the dimension of the first body portion remains constant while the torque is applied to the first body portion to increase tension within the body portion.

20. 18. The device of claim 17, further comprising a second body portion keyed to the first body portion at the second end, thereby preventing relative rotation of the first body portion and the second body portion.

21. 21. The device of claim 20, wherein the second body portion and the first body portion are disposed substantially perpendicular to one another.

22. 21. The device of claim 20, wherein the second body portion is rigid.

23. 21. The device of claim 20, wherein the actuator is connectable directly or indirectly to the second body portion; the actuator is configured to generate a torque that is applied to the second body portion, which is transferred to the first body portion, thereby generating a torque that is applied to the first body portion, thereby increasing tension within the first body portion.

24. 24. The device of claim 23, wherein the dimension of the second body portion remains constant while a torque is applied to the second body portion that increases tension within the first body portion.

25. 1. An apparatus for stabilizing a patient, comprising: (a) a frame having a receptacle and a pin extending laterally through the receptacle; (b) a stabilization assembly having a stabilization mechanism configured to contact the patient and selectively receive in the receiver, the stabilization assembly having a housing, the housing comprising: (i) a slot located proximally in the housing, the slot configured to receive the pin extending laterally through the receptacle of the frame; (ii) a first retention mechanism movable relative to the housing from a first position to a second position, in the first position, the first retention mechanism allows the pin of the frame to be fully seated within the slot of the housing, such that the stabilization assembly is fully seated within the receptacle of the frame; In the second position, the first retention mechanism secures the stabilization assembly within the receiver. the stabilization assembly; A device having:

26. 26. The device of claim 25, wherein the housing includes a hole located distally of the housing, the hole configured to selectively retain the stabilization mechanism.

27. 26. The device of claim 25, wherein the housing includes a first resilient mechanism connectable with the first retention mechanism; the first elastic mechanism has a biasing force that maintains the first retention mechanism in the second position within the housing, and the first retention mechanism is movable to the first position by compressing the first elastic mechanism.

28. 26. The device of claim 25, wherein the device includes an adjustment mechanism for setting the width of the frame.

29. 26. The device of claim 25, wherein the housing has a hole located distally of the housing; The apparatus further includes an adapter selectively retained in the cavity of the housing, the adapter configured to selectively retain the stabilizing mechanism.

30. 30. The device of claim 29, wherein the adapter comprises an engagement mechanism.

31. 31. The device of claim 30, wherein the housing includes a second retention mechanism movable relative to the housing; the second retention feature can be configured to align and engage with the engagement feature of the adapter, wherein engagement of the second retention feature with the engagement feature of the adapter secures the adapter within the bore of the housing.

32. 32. The apparatus of claim 31, wherein securing the adapter within the bore of the housing prevents translational movement of the adapter within the bore of the housing while allowing rotational movement of the adapter relative to the housing.

33. 33. The device of claim 32, wherein the engagement feature of the adapter comprises an annular groove, and the second retention feature comprises a spherical member that fits within the annular groove.

34. 32. The device of claim 31, wherein the housing includes a second resilient mechanism connectable with the second retention mechanism; the second elastic mechanism has a biasing force that maintains the second retention mechanism in the housing at an extended position that maintains engagement between the second retention mechanism and the engagement mechanism of the adapter, The second retention mechanism is movable to compress the second resilient mechanism to disengage from the engagement mechanism of the adapter.

35. 1. An apparatus for stabilizing a patient's head, comprising: (a) a frame having a receiving portion; (b) a stabilization assembly configured to be received within the receptacle, the stabilization assembly configured to hold one or more stabilization mechanisms configured to contact the patient's head; (i) a selectively rotatable member; (ii) an actuator for longitudinal translation between a first position and a second position, wherein in the first position the selectively rotatable member is rotationally adjustable and in the second position the selectively rotatable member is rotationally fixed, the actuator having a locking mechanism with a first engagement mechanism; 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, the first and second engagement mechanisms moving parallel to each other in a longitudinal direction to selectively engage and disengage, thereby adjusting or fixing the rotational position of the selectively rotatable member; and the stabilization assembly having An apparatus having:

36. 36. The device of claim 35, wherein the actuator comprises a biasing member configured to move between a third position and a fourth position; the pressing member is biased to the third position; the biasing member is moved from the third position to the fourth position to move the actuator between the first and second positions, thereby overcoming a biasing force.

37. 36. The device of claim 35, wherein the locking mechanism having the first engagement mechanism moves longitudinally away from the selectively rotatable member when the actuator is moved from the first position to the second position.

38. 36. The device of claim 35, wherein the locking mechanism having the first engagement mechanism advances longitudinally toward the selectively rotatable member when the actuator is moved from the first position to the second position.

39. 36. The device of claim 35, wherein the first engagement mechanism and the second engagement mechanism each have a toothed annular configuration.

40. 36. The device of claim 35, wherein the selectively rotatable member remains either rotationally adjustable or fixed when the actuator is in the third position.

41. 36. The device of claim 35, wherein the actuator comprises a biasing member and a bayonet member, the biasing member selectively engageable with the bayonet member; wherein engagement of the biasing member with the insert member maintains the selectively rotatable member in a selected one of a rotationally adjustable state or a fixed state depending on the longitudinal position of the actuator.

42. 42. The device of claim 41, wherein a user can set the stabilization assembly to a desired rotational position without maintaining contact with the actuator while making rotational adjustments to the stabilization assembly.

43. 42. The device of claim 41, wherein the biasing member is biased to the third position and configured to move between the third position and a fourth position; The biasing member engages the insert in the third position and disengages the insert in the fourth position.

44. 1. A stabilization assembly for use with an apparatus for stabilizing a patient, comprising: (a) a selectively rotatable member configured to hold one or more stabilizing mechanisms configured to contact the patient; (b) a pair of engagement mechanisms configured to translate longitudinally relative to one another from a first position to a second position; In the first position, the pair of engagement mechanisms are engaged and the selectively rotatable member is fixed; In the second position, the pair of engagement mechanisms are disengaged and the selectively rotatable member is rotationally adjustable. the pair of engagement mechanisms; a stabilization assembly having

45. 1. An apparatus for stabilizing a patient, comprising: (a) a frame having a first receptacle; (b) a first stabilization assembly configured to receive one or more stabilization mechanisms, the first stabilization assembly further configured to connect with the first receiving portion of the frame; (i) a housing that connects with the first receiving portion of the frame; (ii) an arm connectable to the housing and configured to receive the one or more stabilization mechanisms, the arm configured to be in a first state in which it is rotatable relative to the housing and 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; and (iv) a second actuator configured to place the arm portion in the first state; and An apparatus having:

46. 46. The device of claim 45, wherein 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 to fix the rotational position of the arm.

47. 47. The device of claim 46, wherein the second actuator is connectable to the housing and biased to maintain contact between the first engagement mechanism and the second engagement mechanism of the first actuator; The device allows the first engagement mechanism to be disengaged from the second engagement mechanism by overcoming the biasing force of the second actuator, thereby allowing adjustment of the arm portion in a rotational direction.

48. 47. The device of claim 46, wherein the first actuator is biased to disengage a first engagement mechanism from a second engagement mechanism associated with the arm portion.

49. 49. The device of claim 48, wherein the biasing force of the first actuator is overcome to cause the first engagement mechanism to engage or contact the second engagement mechanism, and further biasing of the second engagement mechanism is permitted to maintain engagement between the first and second engagement mechanisms.

50. 46. The device of claim 45, wherein the frame further comprises a second receiver; The device includes a second stabilizing assembly connectable with the second receiver.

51. 1. An apparatus for stabilizing a patient, comprising: (a) a frame having a first member and a second member, the positions of the first and second members being adjustable such that the relative positions of the first and second members with respect to one another are changed; (b) an actuator connectable to the frame; (c) a first locking mechanism connectable to the actuator, the actuator is configured to move the first locking mechanism between a first position and a second position; in the first position, the first locking mechanism provides a friction fit that prevents the first and second members of the frame from moving apart; In the second position, the first locking mechanism allows the first and second members of the frame to move away from each other. the first locking mechanism; An apparatus having:

52. 52. The apparatus of claim 51, further comprising a skull clamp for stabilizing the patient's head.

53. 52. The device of claim 51, wherein the device includes a second locking mechanism configured to contact the first locking mechanism.

54. 54. The device of claim 53, wherein a portion of the second locking mechanism and the first locking mechanism each have an angled surface, the angled surfaces configured to contact each other.

55. 54. The apparatus of claim 53, wherein translation of the first locking mechanism in a first direction causes the first locking mechanism to drive the second locking mechanism into contact with a portion of the frame.

56. 1. An apparatus for stabilizing a patient, comprising: (a) a frame having a first member and a second member, the positions of the first and second members being adjustable such that the relative positions of the first and second members with respect to one another are changed; (b) an actuator connectable to the frame; (c) a first locking mechanism connectable to the actuator, the actuator is configured to move the first locking mechanism between a first position and a second position; in the first position, the first locking mechanism provides a stepless fit that prevents the first and second members of the frame from moving apart; In the second position, the first locking mechanism allows the first and second members of the frame to move away from each other; The non-stepwise fitting allows the adjustment range of the relative spacing between the first and second members to be changed without limit. the first locking mechanism; An apparatus having:

57. 57. The apparatus of claim 56, further comprising a skull clamp for stabilizing the patient's head.

58. 57. The device of claim 56, wherein the device includes a second locking mechanism configured to contact the first locking mechanism.

59. 60. The device of claim 58, wherein a portion of the second locking mechanism and the first locking mechanism each have an angled surface, the angled surfaces configured to contact each other.

60. 60. The apparatus of claim 58, wherein translation of the first locking mechanism in a first direction causes the first locking mechanism to drive the second locking mechanism into contact with a portion of the frame.

Images