Systems, devices and methods for patient positioning before, during, and / or after a medical procedure

Abstract

SOLUTION: A system for positioning a patient before, during, or after a medical procedure can include an arm assembly and a surgical drape for use with the arm assembly. The surgical drape may be configured to be placed around a surgical site where a surgical procedure is to be performed. The surgical drape includes a transparent viewing window, a plurality of handle covers, and an expandable opening in a top surface of the surgical drape. In addition, the surgical drape may also include an adhesive member on the bottom surface of the drape that may be independently removed to secure the drape around the surgical site.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Patent Application No. 15 / 912,530, filed March 5, 2018, and U.S. Patent Application No. 15 / 493,700, filed April 21, 2017, the disclosures of both of which are incorporated herein by reference in their entireties. U.S. Patent Application No. 15 / 912,530 is a continuation-in-part of U.S. Patent Application No. 15 / 493,700. [Background technology]

[0002] Proper positioning or repositioning of a patient before and during a medical procedure can be important. For example, in cervical surgery, accurate, convenient, and repeatable positioning of a patient's head and neck helps enable access to the surgical site. It is desirable for a surgeon or other medical personnel to be able to fix the patient's exact position and, if appropriate, to change that position to another fixed position. Conventional operating tables or devices often place patients in positions that are not physiologically or ergonomically optimal. Improper head and neck positioning can result in serious position-related complications.

[0003] During medical procedures, surgeons generally seek to avoid placing patients in stressful positions, such as positions that place undue tension or compression on the spine or that could otherwise cause complications. To limit the time under anesthesia or other complications associated with lengthy medical procedures, it can be beneficial to quickly and conveniently reposition the patient. Such quick and convenient patient repositioning can also be beneficial to the medical procedure team, thereby reducing fatigue and avoiding unnecessary distractions. It is desirable to perform all repositioning without compromising the sterility of the medical procedure. If the surgeon or other staff are forced to access areas behind the surgical drape (e.g., to reposition the patient), resterilization becomes necessary. This prolongs the medical procedure and introduces the risk of compromising the sterility of the medical procedure.

[0004] The prior art includes various mechanical mechanisms for supporting a patient's head and neck during cervical medical procedures. Some existing positioning devices have numerous adjustments or knobs that require several members of the surgical team to position or reposition the patient. In use, one person is required to hold or otherwise support the patient's head, while at least one other person is required to manually loosen and tighten the knobs. This can be a time-consuming and tedious method to achieve satisfactory positioning.

[0005] The relatively long time required for a surgeon or medical staff to support the patient's weight while positioning or repositioning the patient is not ideal. First, when attaching existing prior art devices or arms to a patient's head in a skull clamp, some devices require four separate knobs that must be rotated and fully tightened. This can take anywhere from 15 to 45 seconds, and the surgeon or medical team member is often leaning or moving in an unergonomic or awkward position during the procedure. Adjusting the patient's head orientation with prior art devices or arms typically involves releasing, repositioning, and then retightening two or three of the axes. This procedure can take approximately 30 seconds, during which the physician must hold the patient's immobilized head. Given the relatively long time required to complete the above steps, these portions of surgery or pre-operative procedures can be cumbersome for the medical treatment team.

[0006] One specific example of a prior art device is the MAYFIELD® Ultra 360™ Patient Positioning System (“Mayfield”). The Mayfield has independent, pivoting, and self-locking handles, as well as two double-cam action locking handles for easier opening and closing for secure and rapid fixation. Another specific example of a prior art system for supporting and positioning a patient's body part is the Allen Medical Systems C-Flex® model described in U.S. Pat. No. 8,413,660 (“the '660 patent”), the disclosure of which is incorporated herein by reference in its entirety. The '660 patent device includes at least two joints, each of which has a locked and unlocked state, and a release system for allowing an operator, e.g., a surgeon, to select between the locked and unlocked states. The '660 patent release system has an operator control interface separate from the joints and located in a position that allows the operator to support the weight of the body part while at least one of the joints is in the unlocked state.

[0007] The above-described conventional devices have several limitations. For example, fully mechanically operated devices often force or result in relatively abrupt movements by the patient before or during surgery. Prior art devices often require surgeons or other medical staff to "break sterile practice" by entering or accessing areas behind or under surgical drapes. Some of these devices only allow adjustment in discrete increments, rather than a continuous series of adjustability. Discrete adjustability can result in suboptimal positioning.

[0008] In the case of the '660 patent, the ball pivot 166 is located close to the device's joint connection mechanism near the attachment to the operating table, which is a relatively long distance from the patient's head, making delicate or relatively small movements of the patient's head more difficult. Other movements of the '660 patent's system require unlocking thumbscrews that are remote from the corresponding joints. Thus, positioning and repositioning the patient of the '660 patent often requires multiple people and potentially compromises the sterility of the medical procedure. Additionally, in the unlocked state, movement of the '660 patent's arms is not particularly smooth. The '660 patent's system has relatively high static friction to initiate each movement, which makes patient movements jerky. Summary of the Invention

[0009] In one embodiment, the disclosed technology relates to a system for positioning a patient before, during, or after a medical procedure. The system can include an arm assembly having a proximal end, an opposing distal end, and at least one joint therebetween. The joint can be configured to allow the distal end of the arm assembly to move relative to the proximal end of the arm assembly. The proximal end of the arm assembly can be configured to be fixed relative to a surgical table. The system can also include a ball joint mechanism attached to (i) the distal end of the arm assembly and (ii) a head support configured to support the patient's head. The ball joint mechanism can include a ball joint and a motor. Actuation of the motor can allow or prevent rotation of the ball joint.

[0010] In another embodiment, the disclosed technology relates to a system for positioning a patient before, during, or after a medical procedure. The system can include a surgical table, a base removably attached to the surgical table, and a head support configured to contact the patient's head. At least a portion of the head support may include at least one exposed electrical contact. The system may also include an arm assembly having a proximal end, an opposing distal end, at least three joints spaced therebetween, and at least two arm links. Each joint may be configured to allow the distal end of the arm assembly to move relative to the proximal end of the arm assembly. The proximal end of the arm assembly may be configured to be fixed relative to a base attached to the operating table. At least one of the two arm links may include at least one battery. The system may also include a ball joint mechanism attached to (i) the distal end of the arm assembly and (ii) the head support. The ball joint mechanism may include a ball joint and a motor. Actuation of the motor may allow or prevent rotation of the ball joint.

[0011] In yet another embodiment, the disclosed technology relates to a system for positioning a patient before, during, or after a medical procedure. The system can include a base having a first body and a second body. The first body can be attached to a surgical table and movable relative to the surgical table along a first axis. The second body can be movable relative to the first body in a direction perpendicular to the first axis. The system can also include an arm assembly having a proximal end, an opposing distal end, and at least one joint therebetween. The joint can be configured to allow the distal end of the arm assembly to move relative to the proximal end of the arm assembly. At least a portion of the proximal end of the arm assembly can be inserted into and secured to the first body of the base.

[0012] In one embodiment of the surgical drape, the surgical drape may include a top surface and an opposing bottom surface, one or more transparent windows on the top surface of the drape, one or more openings on the top surface of the drape, one or more fastening members, and one or more covers on the top surface of the drape, the one or more covers extending vertically upward from the top surface of the drape, wherein the one or more covers are configured to receive a control handle of a surgical device.

[0013] The one or more covers may include a first segment extending over the top surface of the drape and a second segment including a flange of the respective cover. The flange may be below the top surface of the drape. Further, in one embodiment, the cover may include one or more fastening members. An annular ring may include adhesive tape to form a bond between the bottom surface of the drape and the flange.

[0014] According to one surgical drape embodiment, the drape may be folded in an accordion fashion, with the proximal and distal ends of the drape folded inward toward the center of the drape. Additionally, the drape may be folded at right angles in both lateral directions, with each side bending inward toward the midline. The folding method may further include identifying a first marking on the proximal-most end of the drape before folding the proximal-most end; and identifying a second marking on the distal-most end of the drape before folding the distal-most end. Furthermore, the drape may be inserted into a package. [Brief explanation of the drawings]

[0015] The above summary of the invention, as well as the following detailed description, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the invention, there are shown in the drawings various exemplary embodiments. It is to be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown in the drawings. The drawings are illustrated as follows:

[0016] [Figure 1] 1 is a perspective view of at least a portion of a system or apparatus in accordance with one embodiment of the disclosed technology;

[0017] [Figure 2] FIG. 2 is another perspective view of the structure shown in FIG. 1.

[0018] [Figure 3] 3 is a perspective view of one embodiment of one member of the structure shown in FIGS. 1 and 2, with a segment of the member shown in cross section along line 3-3 of FIG. 2; FIG.

[0019] [Figure 4] 4 is a perspective view of at least a portion of the member shown in FIG. 3, segments of which are shown as partially transparent for clarity;

[0020] [Figure 5]2 is a perspective view of one embodiment of another member of the structure shown in FIG. 1, segments of which are shown as partially transparent for clarity; FIG.

[0021] [Figure 6] 6 is a cross-sectional perspective view of the member shown in FIG. 5 taken along line 6-6 of FIG. 5.

[0022] [Figure 7] 2 is another perspective view of the structure shown in FIG. 1, shown attached to yet another member of one embodiment of the disclosed technology.

[0023] [Figure 8] FIG. 8 is an enlarged perspective view of a segment of the structure shown in FIG. 7.

[0024] [Figure 9] FIG. 10 is a perspective view of one embodiment of yet another member of a system or apparatus in accordance with an embodiment of the disclosed technique.

[0025] [Figure 10] 10 is another perspective view of the member shown in FIG. 9.

[0026] [Figure 11] FIG. 1 is a perspective view of one embodiment of one component of a system or apparatus in accordance with one embodiment of the disclosed technique.

[0027] [Figure 12] FIG. 10 is a perspective view of one embodiment of a further component of a system or apparatus in accordance with one embodiment of the disclosed technique.

[0028] [Figure 13A] FIG. 13 is another perspective view of the member shown in FIG. 12.

[0029] [Figure 13B]FIG. 13B is a side elevation cross-sectional view of a portion of the member shown in FIG. 13A, with the two clasps shown in a fully open or upward position, and the cross-section being through the first or larger clasp.

[0030] [Figure 13C] 13B is another side elevation cross-sectional view of a portion of the member shown in FIG. 13A along the same plane as FIG. 13B, with one clasp shown in a closed position and another clasp shown in a fully open or upward position.

[0031] [Figure 13D] 13B and 13C is a side elevation cross-sectional view of a portion of the member shown in FIG. 13A along a different plane than FIGS. 13B and 13C, with both clasps shown in the same orientation as shown in FIG. 13C, and the cross-section being through a second or smaller clasp.

[0032] [Figure 13E] 13B and 13C is yet another side elevation cross-sectional view of a portion of the member shown in FIG. 13A along the same plane as FIGS. 13B and 13C, with both clasps shown in a closed position.

[0033] [Figure 13F] 13D is an enlarged side elevation cross-sectional view of a portion of the member shown in FIG. 13A along the same plane as FIG. 13D, with both clasps shown in the closed position.

[0034] [Figure 14] 12 is a perspective view of another embodiment of the member shown in FIG. 11.

[0035] [Figure 15] FIG. 15 is another perspective view of the member shown in FIG. 14.

[0036] [Figure 16] FIG. 1 is a perspective view of one arrangement of at least some components of the disclosed technology.

[0037] [Figure 17]FIG. 10 is a perspective view of a second arrangement of at least some components of the disclosed technology.

[0038] [Figure 18] FIG. 18 is a side elevation view of the arrangement shown in FIG. 17.

[0039] [Figure 19] FIG. 1 is a perspective view of one embodiment of a surgical drape for use with the present system or device.

[0040] [Figure 20] FIG. 10 is another perspective view of a surgical drape for use with the present system or device.

[0041] [Figure 21] FIG. 10 illustrates a top view of another embodiment of a surgical drape for use with the present system or device.

[0042] [Figure 22] 22 shows a bottom view of one embodiment of the surgical drape shown in FIG. 21 for use with the present system or device.

[0043] [Figure 23] FIG. 10 is another perspective view of one embodiment of the top surface of a surgical drape showing a transparent window and an expandable opening disposed on the top surface of the surgical drape.

[0044] [Figure 23A] FIG. 10 shows a top view of one embodiment of a transparent window placed on the top surface of a surgical drape and a representation of an alternative liner below the transparent window on the bottom surface of the surgical drape.

[0045] [Figure 23B] FIG. 1 is a top view of one embodiment of an expandable opening disposed on the top surface of a surgical drape.

[0046] [Figure 23C]FIG. 10 is a bottom view of one embodiment of markings along with a tape arrangement on the bottom surface of a surgical drape.

[0047] [Figure 24] FIG. 1 is a side view of one embodiment of a surgical drape.

[0048] [Figure 24A] 22 is a side exploded view of one embodiment of a cover and its relationship to the surgical drape shown in FIG. 21. FIG.

[0049] [Figure 25] FIG. 1 illustrates one embodiment of the bottom surface of a surgical drape showing accordion-style fold lines.

[0050] [Figure 26] FIG. 26 illustrates one embodiment of the side view of FIG. 25 showing a partial accordion fold of the surgical drape.

[0051] [Figure 27] 22 illustrates one embodiment of a complete accordion-folded configuration of the surgical drape of FIG. 21 along an axis parallel to the top surface of the surgical drape.

[0052] [Figure 28] FIG. 28 is a side view of FIG. 27.

[0053] [Figure 29] FIG. 10 shows one embodiment of each side of a drape folded into a full accordion fold, folded back towards the center.

[0054] [Figure 30] FIG. 10 is an end view of one embodiment of the final folded configuration.

[0055] [Figure 31]FIG. 32 illustrates one embodiment of the surgical drape shown in FIG. 31 folded in a right-angle manner placed over a protective wrap.

[0056] [Figure 32] FIG. 1 is a perspective view of one embodiment of a package for containing a surgical drape.

[0057] [Figure 33] 22A-22C show one embodiment of markings on the proximal and distal ends of the top surface of the surgical drape shown in FIG. 21.

[0058] [Figure 34] 23 shows one embodiment of markings on the bottom surface of the surgical drape shown in FIG. 22. DETAILED DESCRIPTION OF THE INVENTION

[0059] Although systems, devices, and methods have been described herein by way of examples and embodiments, those skilled in the art will recognize that the systems, devices, and methods of the disclosed technology are not limited to the described embodiments or drawings. It should be understood that the drawings and descriptions are not intended to be limited to the particular forms disclosed. Rather, the intent is to embrace all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims. Any headings used herein are for organizational purposes only and are not intended to limit the scope of the description or claims herein. As used herein, the word "may" is used in an permissive sense (i.e., having the potential to), rather than a mandatory sense (i.e., must). Similarly, the words "include," "including," and "includes" mean including, but not limited to. Unless otherwise specified herein, the terms "a," "an," and "the" should be read to mean "at least one" and not limited to one element. The term "actuator" is broadly defined herein to mean any member capable of at least initiating movement or control of a mechanism or system, and includes a trigger, button, switch, or any other enabling device. The term as used herein includes the above words, their derivatives, and synonyms.

[0060] Referring in detail to the drawings, wherein like reference numerals indicate like elements throughout, one embodiment of the disclosed technology relates to a modular, multi-component system, apparatus, and method that enables a surgeon and / or medical team to position or reposition a patient pre-, intra-, and / or post-operatively by electrical or mechanical means. Compared to the prior art, the cervical management system of one embodiment of the disclosed technology increases both the speed with which a patient can be positioned or repositioned in a desired position and the reliability with which the desired positioning is achieved. The term "patient" is defined broadly herein to include human patients of all sizes, sexes, and demographics, as well as animals (e.g., for veterinary purposes).

[0061] The disclosed technology allows a single surgeon or medical professional, as opposed to a team of two or more, to perform intraoperative (e.g., both pre- and post-operative) patient adjustments without the need to "break sterile practice." This should result in more efficient and effective surgery. The overall design 100 of the disclosed technology's system or device includes components with specific ranges of motion and adjustability that can be combined in various ways to address various clinical requirements for (i) simple or complex medical procedures (e.g., but not limited to, cervical medical procedures and neurosurgery), (ii) intraoperative adjustments, (iii) small or large adjustment ranges, and / or (iv) prone positioning for the cervical and / or thoracic / lumbar regions. Thus, the system or device can enable precise, smooth, and continuous movement without jerks or any sudden movements. The system or device 100 can support patient movement in all degrees of freedom (i.e., lateral, longitudinal, vertical, yaw, pitch, and roll). The system or device can provide optimal sagittal plane range of motion, free-floating lateral and longitudinal motion, and allow for low force compensation during head adjustments.

[0062] 1-7 and 16-18 illustrate an embodiment of an arm assembly, generally designated by the reference numeral 200, a ball joint mechanism, generally designated by the reference numeral 400, and a first operator control interface, generally designated by the reference numeral 300, of the disclosed technology. In one embodiment, the arm assembly 200, the ball joint mechanism 400, and the first operator control interface 300 can be permanently or permanently attached. In another embodiment, one or more of these components can be removably attached to one another to create a modular system of interchangeable components. As described in detail below, at least a portion of the arm assembly 200 can pivot, rotate, and / or rotate relative to at least a portion of the ball joint mechanism 400. Additionally, at least a portion of the ball joint mechanism 400 can pivot, rotate, and / or rotate relative to at least a portion of the first operator control interface 300. Such relative movement of these members provides surgeons and other medical personnel with increased control over patient positioning before, during, and / or after surgery and contributes to the overall effectiveness and functionality of the systems, devices, and methods of the disclosed technology.

[0063] As shown in FIGS. 1-4, 7, and 16-18, the arm assembly 200 can include a proximal end 202 and an opposite distal end 204. One or more spaced apart rotary joints 220a, 220b, 220c can be positioned between the ends 202 and 204. One or more of the joints 220a, 220b, 220c can be pivot joints. In one embodiment, using an analogy to a human arm, the first or most proximal joint 220c can function as a shoulder joint, the second or middle joint 220b can function as an elbow joint, and the third or most distal joint 220a can function as a wrist joint. One or more link arms 218a, 220b can be connected by one or more of the joints 220b. The disclosed technology allows for the use of arm assemblies 200 with more than three rotary joints (or any type of joint) and more than two arm links as shown herein where such additional movement or dexterity would be beneficial to the surgeon or other medical practitioner.

[0064] Each joint 220a, 220b, 220c can be configured to enable movement of the distal end 204 of the arm assembly 200 relative to the proximal end 202 of the arm assembly 200. At least a portion of the proximal end 202 of the arm assembly 200 can be coupled (directly or indirectly) and / or removably or permanently fixed (directly or indirectly) with respect to a support apparatus 150, e.g., a surgical table. At least a portion of the distal end 204 of the arm assembly 200 can be coupled (directly or indirectly) and / or removably or permanently fixed (directly or indirectly) with one or more devices, e.g., devices configured to support a patient's head. In one embodiment, one or more batteries 222 or other power sources can be enclosed within one or more of the link arms 218a, 218b and operably connected (e.g., via wires) to one or more components of the system 100 requiring power. The battery 222 can provide convenience by allowing the system to be wireless. The battery 222 can be rechargeable.

[0065] As previously mentioned, one problem with conventional head positioners is that the weight of the patient's head and neck, combined with the weight of the positioner, can make it difficult for the surgeon to safely support the patient's body at the moment the joints are released. To address this drawback, the release of rotary joints 220a, 220b, 220c and ball joint mechanism 400 can be safety-enabled to prevent accidental unlocking. Additionally, one or more of joints 220a, 220b, 220c can include a motion damping mechanism that provides appropriate inertia to counter any acceleration of joints 220a, 220b, 220c when one or more of joints 220a, 220b, 220c is in an unlocked state, thereby minimizing unwanted movement of the patient's head and / or neck.

[0066] 3 and 4, one or more of the joints 220a, 220b, 220c can include at least one brake 270 operably connected to at least one gear or gear train 272. Each brake 270 can be an electromechanical or electromagnetic fail-safe brake, and each gear 272 can be a high-ratio harmonic gear drive, a distorted wave gear, a planetary gear, or another type of gearbox. The gears 272 are not limited to the above types or configurations, as one or more can be other types of gears, such as planetary or cycloidal gears, or even direct drives (no gearing at all). Each gearbox 272 can reflect or generate brake rotor inertia multiplied by the square of the gear ratio to a user (e.g., a surgeon) to provide inertial damping. For example, this inertial damping can prevent a sudden drop of the patient's head when a joint release mechanism is engaged by a surgeon or other medical personnel or when one or more of the operator control interfaces are released. One or more of the joints 220a, 220b, 220c may include additional features or components that are incorporated into the functionality of the system. For example, encoders may be placed on or within one or more of the joints 220a, 220b, 220c to aid the medical team's ability to return the arm assembly 200 and / or the entire system to a desired or original position. One or more counter-force springs and / or motors may be used on or within one or more of the joints 220a, 220b, 220c to provide gravity assist and / or operational positioning.

[0067] In one embodiment, the higher the gear ratio of gearbox 272, the smaller brake 270 can be to perform the desired function. Additionally, the timing of the release of one or more of joints 220a, 220b, 220c and / or ball-joint mechanism 400 can be staggered so that the weight of the patient's head and neck is gradually transferred from the apparatus to the operator, giving the surgeon time to react to any sudden drop of the patient's head. One or more torsion or other spring types capable of providing gravity compensation torque can be operably connected to joints or gears 272 to further reduce the likelihood of sudden acceleration of the patient's head and neck.

[0068] The rotary joints 220a, 220b, 220c and ball joint mechanism 400 can be configured to lock at any precise desired head position and not skid while locked. The brakes 270 and / or motors (described in detail below) of the ball joint mechanism 400 can lock quickly (e.g., in milliseconds) so that a surgeon or other medical personnel does not have to hold the patient's head still for long periods of time, as is required with prior art devices.

[0069] One or more of the batteries 222 can provide power to each brake 270 and / or motor (described in detail below) of the ball joint mechanism 400. The present disclosure is not limited to batteries as the sole power source for these or other electrical components of the system, as other well-known power sources can be used. For example, the system, or any portion thereof, could be plugged directly into a powered operating table or wall plug to obtain its power. As described in detail below, one or more operator control interfaces are operatively and / or electrically coupled to each brake 270, each motor, and / or each battery 222 or other power source. In one embodiment, when one or more of the operator control interfaces is activated, power can be provided to one or more of the brakes 270 and / or motors.

[0070] In one embodiment, the brake 270 and one or more of the motors are configured to be “fail-safe.” Thus, when power is removed from the brake 270 and / or motor, one or more of the link arms 218 a, 218 b and / or the ball-joint mechanism 400 can be completely locked up, which is the normal state during surgery. When power is applied (via the enable and / or release buttons described herein), the brake 270 and / or motor can rotate freely. Additional motors and servos could be added to provide any amount of holding or driving torque. In alternative embodiments, one or more brakes, motors, or other members can apply variable friction to one or more of the link arms 218 a, 218 b and / or the ball-joint mechanism 400, thereby slowing the motion of these members.

[0071] The above arrangements and features allow one or more of the joints 220a, 220b, 220c and / or each ball joint mechanism 400 to have an unlocked state and a locked state. In the unlocked state, each of the joints 220a, 220b, 220c and each ball joint mechanism 400 can move freely with no or negligible resistance. This can allow for maximum manipulation or maneuverability of the entire system. In the unlocked state, each of the joints 220a, 220b, 220c and each ball joint mechanism 400 can be fixed, thereby providing maximum support and / or stability to the patient. Of course, it is not required that all of the joints 220a, 220b, 220c or ball joint mechanisms 400 be locked or unlocked at the same time. For example, one or more of the joints 220a, 220b, 220c and / or the ball joint mechanism 400 can be unlocked while one or more of the remaining joints 220a, 220b, 220c or the ball joint mechanism 400 can be locked. Such an arrangement allows for some or more finite movement or manipulation of the system.

[0072] As shown in FIGS. 1 and 2 , the first mount or quick connect 230 can be located at or proximal to the proximal end 202 of the arm assembly 200. The first mount 230 can include a body 260 having a longitudinal axis L (see FIG. 2 ), which can extend in a plane defined by the link arms 218 a, 218 b. At least a portion of the first mount 230 can be sized, shaped, and / or configured to fit within and / or be received by a recess or receiver of a base (embodiments of which are described in detail below) that is attached to, for example, a surgical table. In one embodiment, the first mount 230 can be fixedly or permanently attached to the proximal-most rotary joint 220 c. The proximal-most link arm 218 b can pivot about the first mount 230 as a result of the proximal-most rotary joint 220 c. The distal end 232 of the first mount 230 can include a tapered portion to facilitate easy insertion into the recess or receiver. The opposite proximal end 234 can include a spring-biased tab or button 236. Depressing the button 236 can retract an outwardly biased protrusion 238 from the first mount 230, which can facilitate removal of the first mount 230 from the recess or receiver. The opposite side of the first mount 230 can include grooves or notches 239a, 239b designed to mate with or complement portions of the recess or receiver.

[0073] 5 and 6 show detailed images of one embodiment of a ball joint mechanism 400 of the disclosed technology. The ball joint mechanism 400 can include at least one ball joint 410 operably connected to at least one motor 420, such as a DC brush motor. The motor 420 can be operably connected to one or more of the batteries 220 and can be activated by one or more of the operator control interfaces. The ball joint 410 can be a conventional three-degree-of-freedom ball joint, allowing rotation in all three axes. The ball joint 410 can include a ball seat 412 and a pivot ball 414. A rod or pin 416 can be threaded, which can extend through at least a portion of each of the ball seat 412 and the pivot ball 414 and into a biasing compression spring pack 460. The biasing compression spring pack 460 can be a stack of spring washers or a spring pack.

[0074] The opening at the bottom of the ball seat 412, through which the rod 416 passes, can be a slot that limits motion in one plane, thereby creating a ball joint with two degrees of freedom. If the plane to which the ball joint is limited coincides with the plane in which the three rotary joints are allowed to move, the redundancy of motion will be reduced. In one embodiment, because of this slot, which can limit the motion of the ball joint 410, the ball joint 410 can only adjust for yaw and roll. In this embodiment, if the surgeon wants to make sagittal (i.e., pitch) adjustments, the surgeon rotates all three joints 220a, 220b, 220c.

[0075] Through a thrust bearing / bushing interface 440, the lower end of the rod 416 contacts or engages with the upper end of a threaded shaft 462, such as a ball screw or lead screw, but can translate independently. A lower flange or shoulder of the interface 440 can act as a bushing because the threaded shaft 462 can rotate, but the rod 416 cannot. The lower flange can act as a thrust bearing to limit movement when the screw pack 460 pushes the rod 416 downward. In one embodiment, the bottom end of the threaded shaft 462 can extend into and engage with a first gear 430a. The first gear 430a can meshingly engage with a second gear 430b, which in turn meshingly engages with a clutch 430c. The clutch 430c can be a one-way bearing or a Sprag-type clutch. The clutch 430c is not limited to the exact position shown in FIGS. 5 and 6. For example, clutch 430c could be moved from proximal to second gear 430b to proximal to first gear 430a on the opposite side. Gear reducer 480 could be attached to clutch 430c on one end and to motor 420 on the opposite end (e.g., top).

[0076] The threaded shaft 462 can be or form part of a rotary to linear (or vice versa) device. In particular, a cylindrical ball screw nut or lead screw nut 444 (see FIG. 6) can be keyed to a housing 445, allowing the nut 444 to move linearly as the threaded shaft 462 rotates. Ball screw nut 444 can be positioned directly above the bearing. Rotation of threaded shaft 462 in one direction (e.g., clockwise) can drive or move ball screw nut 444 at least slightly upward, thereby at least slightly compressing spring pack 460 and thus driving rod 416 at least slightly upward. Similarly, downward movement of rod 416 (e.g., driven by the force of spring pack 460) can translate or otherwise move ball screw nut 444 at least slightly downward. This movement "backdrives" threaded shaft 462.

[0077] Thus, linear motion of ball screw nut 444 can push rod 416 upward. Pushing rod 416 upward requires a motive force sufficient to compress spring pack 460. When this motive force is released, spring pack 460 pushes ball screw nut 444 back downward, thereby rotating threaded shaft 462. The purpose of clutch 430c is to minimize the amount of friction and inertia that must be overcome. When the clutch is properly aligned, the motor and its gearbox do not need to rotate, ensuring quick and safe lockup of ball joint 410 of ball joint mechanism 400.

[0078] In one embodiment, the ball joint mechanism 400 can be biased to lock the ball joint 410, thereby preventing movement in either of the two degrees of freedom. More specifically, in one embodiment, when the motor 420 is in a relaxed or "off" state, the biasing spring pack 460 biases the rod 416 downward, thereby moving the pivot ball 414 downward into engagement with the ball seat 412. Additionally, the biasing spring pack 460 can also press the ball seat 412 into engagement with the cup housing 442 (see FIG. 6 ), which is located below the ball seat 412 and above the biasing spring pack 462. Such engagement can lock the position of the ball joint 410 and prevent its rotation. This feature helps to hold the system 100 in a desired configuration or position, thereby supporting a patient while a surgeon or other medical personnel performs a medical procedure. In one embodiment, the patient's head is (indirectly) attached to the ball seat 412, and thus the above arrangement and members provide two friction surfaces, both of which create a holding torque, thereby creating a dual (concentric) ball joint. This torque is "doubled" because the ball seat 412 is captured and clamped tightly by both its inner (e.g., upper) and opposing outer (e.g., lower) ball surfaces.

[0079] When it is desired to reposition the patient, power can be supplied to motor 420, which in one embodiment can rotate second gear 430b via engagement of clutch 430c. Rotation of second gear 430b engages first gear 430a, thereby causing rotation of threaded shaft 462. Rotation of threaded shaft 462 (e.g., clockwise when viewed from below ball joint mechanism 400) can cause a change in biasing spring pack 460, which can open ball joint 410. For example, in one embodiment, this rotation of threaded shaft 462 can move ball screw nut 444 and the lower end of spring pack 460 at least slightly upward, thereby at least slightly compressing spring pack 460, which in turn can release or at least reduce the tension or downward force previously applied to rod 416. This allows the rod 416 to move at least slightly upward, releasing the ball joint 410 from the clamp created by the rod 416 compressing the pivot ball 414 into the ball seat 412. This clamp can be a dual (concentric) surface ball joint clamp.

[0080] When motor 420 is turned "off" or power to motor 420 is removed, torque is no longer applied to threaded shaft 462. When this occurs, the force of compressed spring pack 460 pushes ball screw nut 444 down at least slightly. Because ball screw nut 444 is keyed, this linear motion causes threaded shaft 462 to rotate (i.e., backdrive). In this embodiment, without clutch 430c, the entire drive train, including motor 420, would backdrive.

[0081] Thus, in one embodiment, when the motor 420 is engaged, actuated, or powered, the rod 416 may allow the pivot ball 414 of the ball joint 410 to move in two degrees of freedom of motion, but may prevent the ball joint 410 from moving or rotating in a third degree of freedom of motion. However, when the motor 420 is not engaged, actuated, or powered, the rod 416 may prevent any movement or rotation of the ball joint 410. In alternative embodiments, as will be understood by those skilled in the art, the drive train and / or members of the ball joint mechanism 400 may be designed such that actuation of the motor 420 prevents movement of the ball joint 410, and deactivation of the motor 420 allows movement of the ball joint 410.

[0082] In one embodiment, the first and second gears 430a, 430b can be omitted from the design. For example, the same or similar function could be achieved with an "in-line" design in which the motor 420, clutch 430c, and ball screw 462 are all on the same axis. Such a design would eliminate a gear set, if desired, but could double the height of the ball joint mechanism 400 (which may be acceptable in some situations).

[0083] As shown in FIGS. 1, 2, and 16-18, the location of ball joint mechanism 400 and / or ball joint 410 can be advantageous in relation to other components of system 100. In one embodiment, ball joint 410 can be placed or positioned proximate to the patient's head, generally between the patient's head and arm assembly 200. Placing ball joint 410 proximate to the patient's head can be advantageous when attempting to slightly change the position of the patient's head, since any rotation of the patient's head affects the patient's neck. Specifically, when changing the patient's head orientation in the coronal plane (yaw), rotating the head about a point proximate to the neck minimizes translation of the head in the coronal plane, thus limiting lateral movement of the cervical spine. This proximity of the two degrees of freedom provided by ball joint 410 allows a surgeon or other medical personnel to make small or limited changes to the patient's head orientation while minimizing impact on the surgical site. In the prior art, any ball joint is spaced from the patient's head such that all or most of any articulating arm is located between the patient's head and the ball joint, which can limit the effectiveness and range of coronal adjustments.

[0084] In one embodiment, one key feature of the ball joint 410 and / or ball joint mechanism 400 is the lock / unlock function. Locking can be provided by a fail-safe spring pack 460, which can be similar to spring packs used in electromechanical brakes, such as those used in rotary joints 220a, 220b, and 220c. Once power to the motor 420 is removed, the clutch 430c allows the ball joint 410 to quickly lock and / or unlock because the inertia and friction of the motor 420 do not need to be backdriven, thus enhancing system safety. The motor 420 can provide the unlock function by rotating the ball screw 462 and compressing the brake 270. Other key features of the ball joint 410 are the concentric locking surfaces, which essentially double the holding torque, and the pin-in-slot 416, which reduces the degrees of freedom to two and eliminates sagittal adjustment conflicts.

[0085] Referring to FIGS. 1 and 2 , the first operator control interface 300 can include a body 302 having a first actuator 304 and a second actuator 306. The first and second actuators 304, 306 can be spaced apart. The first actuator 304 can be in the form of a spring-activated trigger or tab that can be depressed and / or engaged by a user when the user grips the body 302. The second actuator 306 can be in the form of a spring-activated push button that can be depressed and / or engaged with the user's finger. In operation, when a user firmly grips the body 302 and activates the actuator 304, the user is in control of the device and is likely gripping tightly enough to support the weight of the unlocked actuator. In this position, it may be most comfortable for the user to depress the second actuator 306 with their thumb. Each of the first and second actuators 304, 306 of the first operator control interface 300 can be operatively and / or electrically connected to the motor 420 of the ball joint mechanism 400 and / or one or more brakes 270 of the joints 220a, 220b, 220c such that both of the actuators 304, 306 must be activated to release the mechanism. Thus, in one embodiment, a surgeon or other medical personnel can move or reposition a patient only by taking control of the mechanism through engagement of the first actuator 304 and then or subsequently actuating the mechanism through engagement of the second actuator 306. In one embodiment, the actuators 304, 306 can be engaged simultaneously to produce or enable a desired movement.

[0086] The first operator control interface 300 is not limited to including two separate, spaced-apart actuators. For example, the first operator control interface 300 could include three or more actuators, depending on the desired functionality of the system. The additional actuator 307 (see FIG. 1 ) could be located on the opposite side of the body 302 from the second actuator 306. The position or location of the additional actuator 307 could enable actuation similar to that described above when the first operator control interface 300 is in an upside-down configuration from that shown in FIG. 1 , which may occur when rotating or flipping a patient on an operating table in certain procedures (e.g., spinal surgery).

[0087] As with all components described herein, first operator control interface 300 is not limited to the exact size, arrangement, and / or positioning shown in the figures accompanying this specification. Although body 302 is shown as being generally cylindrical and having a longitudinal axis that generally extends in a plane defined by link arms 218 a, 218 b, the disclosed technology is not so limited. For example, in an alternative embodiment, the longitudinal axis of body 302 can extend generally perpendicular to the plane defined by link arms 218 a, 218 b and can include only first actuator 304 at one end or side thereof.

[0088] The body 302 of the first operator control interface 300 can be spaced apart from the ball joint 410 and the attachment mechanism 310 of the first operator control interface 300. In particular, the body 302 can be attached to the top or output side of the ball joint 410 by a shaft 312. The attachment mechanism 310 can thus be spaced apart from the body 302 and permanently and / or fixedly attached to the body 302 by the shaft 312. Such an arrangement allows a user (e.g., a surgeon) to move or drive all axes of the system when the brake 270 and motor 420 are in a released state.

[0089] The attachment mechanism 310 can include one or more features that enable permanent or removable attachment to the ball joint mechanism 400, one or more head supports, the second operator control interface 332, and / or the third operator control interface 240 (described in more detail below). For example, a rotatable knob 314 or a tightening clamp (see FIG. 2) can be configured to move (e.g., open and close) the vise-like jaws 321 a, 321 b, which can be configured to grip a portion of the head support between them. In one embodiment, the gripped portion of the head support can be snapped into place by pressing an internal button 322. If the jaws 321 a, 321 b are not tightened sufficiently by the knob 314 to properly clamp the head support, the internal button 322 can function as a safety catch to prevent the head support from inadvertently releasing from the attachment mechanism 310. A release button 316 (see FIG. 1) allows the head support to be removed or released from the attachment mechanism 310. Thus, another action (e.g., pressing the release button 316) may be required to remove the head support from the attachment mechanism 310.

[0090] The attachment mechanism 310 may further include a first receptacle 318 and a second receptacle 320. The longitudinal axis of the first receptacle 318 may extend perpendicular to the longitudinal axis of the second receptacle 320. The first receptacle 318 may be sized, shaped, and / or configured to receive at least a portion of one or more of the head supports (described in more detail below), and the second receptacle 320 may be sized, shaped, and / or configured to receive at least a portion of the third operator control interface 240 (described in more detail below). Each of the receptacles 318, 320 may include one or more exposed electrical contacts (e.g., pogo pins). It will be understood by those skilled in the art that the receptacles 318, 320 are not limited to being located on or within the attachment mechanism 310. For example, either or both of the receivers 318, 320 may be formed on or within the ball joint mechanism 400, the body 302 of the first operator control interface 300, the distal end 204 of the arm assembly 200 or the first link arm 218a.

[0091] 1, 2 and 16-18, the location of first operator control interface 300 relative to other components of the system can be advantageous. In particular, during initial setup of system 100 and / or prior to surgery, it can be beneficial for first operator control interface 300 to be located in close proximity to the upper end of ball joint mechanism 400 and / or distal end 204 of arm assembly 200. Such proximity allows a surgeon or other medical personnel to position their hand near the free end of arm assembly 200 and change the position of the free end of arm assembly 200 by small or finite amounts, thereby facilitating attachment to various attachments, such as a head support (embodiments described in detail below).

[0092] With reference to FIGS. 7-10 and 16-18, one or more head supports are removably attachable or securable to one or more portions of a support or device generally designated 100 of the present disclosure. The system or device 100 can include or be attached to a variety of different types of head supports, depending on the medical procedure and / or patient condition. One embodiment of a head support is a head clamp 330, shown in FIGS. 7, 17, and 18. The head clamp 330 can be beneficial for lengthy and tedious medical procedures requiring more precise head control. Head clamps are generally known in the art. However, one unique feature of the head clamp 330 of the present disclosure is the manner in which it is removably attachable to the remainder of the system or device.

[0093] In one embodiment, as shown in FIG. 8 , an adapter, generally designated 500, allows the head clamp 330 to be removably attached to the attachment mechanism 310 of the first operator control interface 300. The adapter 500 can also be used to secure or fix the head clamp to the arm assembly 200 or the remainder of the system 100 so that an operator can selectively position and / or turn the patient's head about any axis. A first or distal end 504 of the adapter 500 can be sized, shaped, and / or configured to be inserted into at least a portion of the head clamp 330. An opposite second or proximal end 502 (e.g., a second mount) of the adapter 500 can be sized, shaped, and / or configured to be inserted into at least a portion of the second receiver 320 of the attachment mechanism 310. More specifically, in one embodiment, at least a portion of the second end 502 can be inserted into the second receiver 320 of the attachment mechanism 310. In operation of one embodiment of the disclosed technology, first end 504 can be placed onto head clamp 330 before head clamp 330 is attached to the patient. Once head clamp 330 is placed on the patient, the patient can be moved or rotated into position and then second end of adapter 500 can be inserted into attachment mechanism 310 or otherwise attached to arm assembly 200.

[0094] The adapter 500 can include a wheel 512 that can rotate relative to the remainder of the adapter 500 and / or the body 508. The wheel 512 can be fixedly attached to the first end 504 and can include one or more threads on its outer surface. The wheel 512 is configured to be grasped or contacted by a surgeon or other healthcare provider such that rotation of the wheel 512 causes the first end 504 to rotate, thereby moving the first end 504 into or out of engagement with mating internal threads of the head clamp 330. Thus, the wheel 512 can be rotated to tighten the adapter 500 to the head clamp 330. As a result, the second end 502 of the adapter 500 can serve as a quick connection to the attachment mechanism 310 (e.g., the second end 502 can be latched into place (by the internal button 322), and then the second end 502 can be securely clamped to the attachment mechanism 310). This quick connection can be beneficial because it can reduce the time required for a surgeon or other medical personnel to stabilize the patient's head while engaging the head clamp 330 to the first operator control interface 300.

[0095] The plate 510 or a portion of the body 508 can include a series of spaced ridges or teeth 514 that can be sized, shaped, and / or configured to complementarily engage spaced grooves or teeth on the head clamp 330. The complementary tooth combination can lock or secure the head clamp 330 to the adapter 500, which in turn can be locked to the attachment mechanism 310. In one embodiment, the plate 510 can be removably attached to the body 508. In one embodiment, the system 100 can include two or more plates 510, each plate having a unique tooth pattern or size. The plates 510 can be selectively attached to or detached from the body 508 to accommodate, for example, different brands or models of head clamps 330.

[0096] Another embodiment of a head support is a head support plate 332 shown in FIGS. 9, 10, and 16. A conventional support mask, helmet, pillow, or other device can be attached to the head support plate 332. The head support plate 332 can be useful for shorter, less cumbersome, or less invasive medical procedures requiring less head adjustment, or for lumbar or thoracic medical procedures where the cervical spine is intact. The head support plate 332 can include an upper plate 340 spaced apart from a lower plate 342. The upper plate 340 can include an opening 341 therein, and the lower plate 342 can include a mirrored surface or portion. At least a portion of the patient's face can be placed within or aligned with the opening 341. The lower plate 342 can move or pivot relative to the upper plate 340. This arrangement allows a medical professional, such as an anesthesiologist, to easily and quickly view the patient's face during a medical procedure. A protrusion 344 (e.g., a third mount) with one or more exposed electrical contacts can extend outward from the head support plate 332. At least a portion of the protrusion 344 can be sized, shaped, and / or configured to matingly engage with one or both of the first and second receptacles 318, 320 of the mounting mechanism 310 of the first operator control interface 300 such that the electrical contacts of the protrusion 344 can engage with the electrical contacts of the first receptacle 318 or the second receptacle 320.

[0097] The head support plate 332 can include or be in the form of a second operator control interface. More specifically, the head support plate 332 can include a first or left handle 334 spaced apart from a second or right handle 336. In one embodiment, each of the first and second handles 334, 336 can be disposed on a bottom surface of the top plate 340 and can be engaged when pressed upward toward the top surface of the head support plate 332. Each of the first and second handles 334, 336 of the head support plate 332 can be operatively and / or electrically connected to the motor 420 of the ball joint mechanism 400 and / or one or more brakes 270 of the joints 220a, 220b, 220c. In one embodiment, each handle 334, 336 can include an actuator or release trigger 334a, 336a on an inner surface thereof. Such a design may require a user to fully wrap their fingers around each handle 334, 336 before the actuator 334a, 336a can be activated, engaged, or depressed. In this embodiment, each of the first and second handles 334, 336 and actuators 334a, 336a of the head plate 332 may be operatively and / or electrically connected to the motor 420 of the ball joint mechanism 400 and / or one or more brakes 270 of the joints 220a, 220b, 220c. One goal of such an embodiment may be to require a user to take control of the system 100 and / or head support plate 332 before the brake 270 and ball joint 410 are released. In one embodiment, both the left and right triggers 334a, 336a must be actuated before the brake 270 is released, which may ensure the safety of the system 100 and head support plate 332. In one embodiment, the head plate 332 may include a rotatable knob, the structure and function of which is similar to that described below for the third operator control interface.

[0098] In this manner, with the patient's head supported on or by the head support plate 332, a surgeon or other medical personnel can selectively move the head support plate 332 and / or the patient's head by engaging one or both of the first and second handles 334, 336 and / or the actuators 334a, 336a. Adjusting the position of the first and second handles 334, 336 and / or the actuators 334a, 336a can be advantageous because it allows the surgeon or other medical personnel to position their hands very close to the patient's head during movement of the head support plate 332. This allows the surgeon or other medical personnel to increase the range of adjustment for patient movement. Additionally, the surgeon or other medical personnel may not need to reach behind or under surgical drapes to move or reposition the patient.

[0099] FIG. 11 shows a perspective view of the third operator control interface 240. The third operator control interface 240 can include one or more spaced apart handles 242 a, 242 b, which can be coupled to an extension or “horn” 244 attached to a housing 246 (e.g., a fourth mount). The housing 246 can include one or more exposed electrical contacts. At least a portion of the housing 246 can be sized, shaped, and / or configured to engage or be received in one or both of the first and second receptacles 318, 320 of the mounting mechanism 310 of the first operator control interface 300 such that the electrical contacts of the housing 246 can engage with the electrical contacts of the first receptacle 318 or the second receptacle 320. The rotatable knob 248 can be secured to a shaft 250, which can be insertable into and extendable through at least one passage in the housing 246. Knob 248 allows a surgeon or other medical personnel to tighten, lock or more securely attach third operator control interface 240 to first operator control interface 300 and / or to prepare to loosen or release third operator control interface 240 from first operator control interface 300.

[0100] Each handle 242a, 242b can include one or more actuators 244a, 246a, 244b, 246b. Two or more of the actuators 246a, 246b can be in the form of spring-activated triggers or tabs that can be depressed and / or engaged by the palm of a user's hand when the user grips the handle 242a, 242b, respectively. Two or more of the actuators 244a, 244b can be in the form of spring-activated push buttons that can be depressed and / or engaged by the user's fingers. In operation, it can be most comfortable for a user to depress the actuators 244a, 244b with their thumbs while gripping the handles 242a, 242b. Each of the actuators 244a, 246a, 244b, 246b of the third operator control interface 240 can be operatively and / or electrically connected to the motor 420 of the ball joint mechanism 400 and / or the brake 270 of one or more of the joints 220a, 220b, 220c. It will be understood that the actuators 244a, 244b, 246a, 246b can be coupled in any suitable manner to the joints 220a, 220b, 220c and / or the ball joint mechanism 400. As a result of the coupling or connection, a surgeon or other medical personnel can move or reposition the patient through engagement of one or both of the actuators 244a, 246a, 244b, 246b.

[0101] In operation of one embodiment, handles 242a, 242b enable precise positioning of a patient's head, for example, through movement of head clamp 330 when joints 220a, 220b, 220c and / or ball joint mechanism 400 are in an unlocked state. This can be accomplished by a surgeon or other personnel grasping one or both of handles 242a, 242b and actuating actuators 246a, 246b followed by actuators 244a, 244b to move handles 242a, 242b to a desired position with joints 220a, 220b, 220c and / or ball joint mechanism 400 in an unlocked state. Releasing actuators 244a, 244b, 246a, 246b locks joints 220a, 220b, 220c and / or ball joint mechanism 400 to hold the desired position. This arrangement does not allow for inadvertent movement of the patient's head, nor does it allow for the surgeon to have a balanced, two-handed grasp of the handles 242a, 242b.

[0102] In one embodiment, the surgeon may be required to engage (e.g., firmly grip) both handles 242 a, 242 b before being able to release the brake 270 and / or joint 220. In this embodiment, the algorithms of the system 100 may require that both enablement buttons 246 a, 246 b be engaged, depressed, or fully depressed before any movement of the system 100 is permitted or possible. Then, once a firm grip is achieved, the surgeon can easily and ergonomically release one or both of the trigger buttons 244 a, 244 b. This provides a high level of safety by ensuring that the physician is ready and able to support the weight of the patient's head.

[0103] Additionally, the algorithm allows for three release modes. For example, in one embodiment, when only one trigger button 244a, 244b is activated or depressed, the ball joint 410 can unlock, allowing coronal and yaw motion. When the other trigger button 244a, 244b is activated or depressed, one or more of the brakes 270 can be released, thereby allowing sagittal adjustment. When both trigger buttons 244a, 244b are released or engaged together or simultaneously, all joints (e.g., each brake 270 and ball joint 410) can be released. As soon as the activation or trigger buttons 244a, 244b are released, all axes immediately lock up.

[0104] 12-18, the present system or device can include a base for removably attaching arm assembly 200 to support apparatus 150. It can be beneficial if arm assembly 200 can move relative to support apparatus 150 to provide a surgeon or other medical personnel with additional options for moving or repositioning a patient. Thus, it can be beneficial for the base of the disclosed technology to be able to move in two degrees of freedom (e.g., in the X and Y directions) relative to support apparatus 150.

[0105] 12, 13, and 16, one embodiment of a base, generally designated by reference numeral 600, can include a first body 602 and a second body 604. The first body 602 can be configured to contact or directly attach to a portion of the support apparatus 150. The second body 604 can include a receiver 606, which can be sized, shaped, and / or configured to receive at least a portion of the body 260 of the first mount 230. A rotatable knob 608 can be secured to a shaft that is insertable into and extendable through at least one passageway in the second body 604. The knob 608 can allow a surgeon or other medical personnel to tighten or more securely attach the arm assembly 200 to the base 600 and / or to loosen or prepare the arm assembly 200 for release from the base 600.

[0106] The second body 604 can be configured to move relative to the first body 602. More specifically, a portion of the second body 604 can include one or more ball or roller bearings that can engage and / or ride on the rails 610 of the first body 602. In this manner, the second body 604 can move generally perpendicular to the patient's longitudinal axis and / or the plane in which the arm assembly 200 extends. A locking tab or handle 612 can be attached to the second body 604 and can be movable between a first, or locked, position and a second, or unlocked, position. In the locked position, the locking tab 612 can engage a brake mechanism that grips at least a portion of the first body 602 (e.g., the rails 610) or otherwise prevents the second body 604 from moving relative to the first body 602. In the unlocked position, the brake mechanism is released and / or the locking tab 612 does not interfere with the second body 604, allowing the second body 604 to move relative to the first body 602. In one embodiment, to move the second body 604 relative to the first body 602, the locking tab 612 can be rotated from a locked position to an unlocked position. A surgeon or other medical personnel can grasp or otherwise contact a part of the system 100, such as the arm assembly 200, the skull clamp 330, the steering horn 240, or the head support 332, and easily move or adjust the second body 604 laterally. This allows the surgeon to position the patient's head exactly where needed. The rails 610 and bearings provide low friction and stiffness to make this task easy.

[0107] The first body 602 can be configured to lock and / or move or slide relative to the support apparatus 150. Notably, in one embodiment, opposing sides of the first body 602 can each include a two-part or two-stage clamping mechanism. For purposes of brevity and convenience only, some of the following description may focus on the clamping mechanism on only one side of the first body 602, although it is understood that the opposing side can include mirrored structures and features. More specifically, one or each opposing side of the first body 602 can include a first clasp 614a, 614b, which can include or be secured to a pin 616 extending along the Y-axis (e.g., parallel to the direction in which the patient extends). As shown in Figures 13B-13F, the pin 616 can engage with and / or pass through a slot in the housing 628 of the first body 602, which can allow the pin 616 (and therefore the first clasp 614) to pivot (e.g., rotate) and / or translate vertically (e.g., move linearly).

[0108] Each first clasp 614a, 614b can include a portion extending vertically downward from the pin 616a, 616b and another portion extending generally perpendicular to that portion so as to extend below at least a portion of the support apparatus 150. A segment of the first clasp 614 that can be positionable below the support apparatus 150 (e.g., a "horizontal" segment of the first clasp 614) can include one or more spaced apart compressible friction members 630. In one embodiment, each compressible friction member 630 can be a rubber grommet. Each first clasp 614a, 614b can be moved between a first disengaged position and a second engaged position (see FIGS. 12 and 13A-F). One or each opposing side of the first body 602 can also include a second clasp 618a, 618b, which can pivot about the pin 616 and can be located longitudinally centrally of the first clasp 614a, 614b. Each second clasp 618a, 618b can move, rotate, and / or pivot relative to its respective first clasp 614a, 614b. Similar to the first clasps 614a, 614b, each second clasp 618a, 618b can move between a first, disengaged position (see, e.g., FIGS. 13B-13D) and a second, engaged position (see, e.g., FIGS. 12, 13A, 13E, and 13F). As shown in Figures 13D and 13F, each second clasp 618 can include a cam or cam surface 632 that can selectively engage a second pin 634 fixed to the housing 620 and / or a roller 636 that can surround the second pin 634.

[0109] In one embodiment, when the second catch 618 is in the second engaged position, the cam surface 632 of the second catch 618 acts against a second or fixed pin 634 and roller 636 (see FIG. 13F), thereby moving the first catch 614 upward and forcing the compressible friction member 630 into engagement with at least a portion of the support apparatus 150, preventing the base 600 from moving relative to the support apparatus 150 in the Y direction or along the longitudinal axis. During operation, the compressible friction member 630 is at least slightly compressed under the engagement force of the first catch 614 and the support apparatus 150, thereby creating a high friction surface. When second clasps 618a, 618b are in the first, disengaged position (see FIGS. 13B-13D), first clasps 614a, 614b can be in either (i) a first, disengaged position (see FIG. 13B) such that base 600 can be separated from support apparatus 150, or (ii) a second, engaged position (see FIGS. 13C and 13D) such that base 600 can contact and / or move relative to support apparatus 150 along the Y direction, or longitudinal axis. At least a slight gap G (see FIG. 13C) between housing 628 or another portion of first body 602 and grommet 630 enables or permits movement of base 600 relative to support apparatus 150 when first clasp 614 is in the downward position but second clasp 618 is in the upward position. Thus, the first catches 614a, 614b may function to (i) generally hold the base 600 in place on the support apparatus 150, (ii) generally prevent inadvertent movement of the base 600, and / or (iii) allow the base 600 to slide or otherwise move relative to the support apparatus 150 without becoming detached from the support apparatus. The second catches 618a, 618b may function generally to lock the base 600 in place on the support apparatus 150.

[0110] In one embodiment, the first catches 614a, 614b are configured to pivot into a position below the table support spar and latch into place. A spring-activated finger latch 638 can be located at the longitudinal center of each first catch 614. The latch 638 can be covered or otherwise at least partially hidden by the second catch 618 when the second catch 618 is closed or pivoted downward (see FIGS. 13C-13F), but can be at least partially exposed or visible to a user when the second latch 618 is open or pivoted upward (see FIGS. 13A and 13D). The latch 638 can be configured to retain the first catch 614 in a latched, locked, or downward position by engaging with a portion of the housing 628 or another portion of the first body 602. In one embodiment, as shown in FIG. 13D , the user or surgeon may be required to engage and / or rotate (e.g., clockwise in FIG. 13D ) the latch 638 to allow the first clasp 614 to reopen. The cam or cam surface 632 of the second clasp 618 may drive the first clasp 614 upward, thereby allowing it to grasp at least a portion of one of the spar of the support device 150. As shown in FIGS. 13C and 13E , passive or complementary locking tabs 640, 642 on the first clasp 614 and housing 628, respectively, may engage in this position, ensuring that the first clasp 614 does not open due to an unpleasant jolt. This combination allows for three independent or distinct states via the catch mechanism: (i) both a fully open and unlocked state in which the base 600 can be placed on the table 150; (ii) a state in which the first catches 614a, 614b are latched, so that the base 600 is not lifted off the table 150 but is still free to translate freely along the table 150; and (iii) a state in which the second catches 618a, 618b are latched, which drives the first catches 614a, 614b upward to firmly grip the table 150 so that the base 600 is fully restrained.

[0111] As shown in FIGS. 14, 15, 17, and 18, a second embodiment of a base, generally designated by reference numeral 600′, can include many or all of the features of the first embodiment base 600. The same or similar features of the second embodiment base 600′ are designated with the same reference numerals as the first embodiment, but with the addition of a prime (′) designation. Descriptions of identical or similar features are omitted herein for clarity and brevity only. One distinguishing feature of the second embodiment base 600′ is that the first body 602′ can include three or more components configured to move relative to one another, thereby adding an additional degree of control or motion to the system.

[0112] In particular, the first body 602' can include a first end 620a', a second end 620b', and a mount 624' therebetween. The mount 624' can move (e.g., slide) relative to the first and second ends 620a', 620b'. More specifically, opposing ends of the mount 624' contact or engage the first and second ends 620a', 620b', respectively, and can include one or more ball or roller bearings that engage and / or ride on at least a portion of the first and second ends 620a', 620b'. Thus, in addition to the horizontal or lateral movement that the second body 604' can provide, the first body 602' of the second embodiment of the base 600' can provide vertical movement. As shown in FIG. 14 , the top surface of each of the first and second ends 620a', 620b' can include distance markings or a ruler that can be used to track the relative movement of the mount 624' with the first and second ends 620a', 620b' to assist a surgeon or other medical personnel in positioning or repositioning a patient.

[0113] At least one or more locking levers or handles 626a', 626b' can be attached to the mount 624' and can be movable (e.g., pivotable) between a first or locked position and a second or unlocked position. In the locked position, each locking lever 626a', 626b' can grip at least a portion of the first and second ends 620a', 620b', respectively, or otherwise prevent the mount 624' from moving relative to the first and second ends 620a', 620b'. In the unlocked position, each locking lever 626a', 626b' does not interfere with the mount 624, or the mount 624 allows each locking lever 626a', 626b' to move relative to the first and second ends 620a', 620b'. The above-described vertical adjustment provided by the base 600' has many advantages. For example, this design provides easy adjustment during patient positioning, allowing the arm assembly 200 to connect to the skull clamp 330 rather than releasing the second clasps 618a', 618b' and sliding the entire unit. This design allows for a greater range of motion during intraoperative adjustments; i.e., low friction allows the user to guide the patient's head without having to push or move the base 600' and / or first body 602'. This design can provide static friction; i.e., the surgeon can release the levers 626a', 626b', pull the unit and / or second body 604' longitudinally, applying a certain amount of static friction to distend the patient's neck. This design can provide active traction; i.e., the surgeon can release the levers 626a', 626b' and apply a certain amount of traction by attaching a weight bag to the base 600' and / or second body 604' (for example) via a pulley.

[0114] 17 and 18 , in one embodiment, instead of directly attaching the arm assembly 200 to the base 600, 600′, a tower 700 can be interposed between the arm assembly 200 and the base 600, 600′. More specifically, the first mount 230 of the arm assembly 200 can be inserted into a receptacle on the tower 700, and a protrusion (e.g., the fifth mount) on the tower 700 can be at least partially or fully inserted into the receptacle 606, 606′ on the base 600, 600′. The tower 700 can raise or lower the proximal end 202 of the arm assembly 200 vertically (e.g., along the Z-axis) relative to the base 600, 600′. A rotatable crank 702 can be located on the top or bottom of the tower 700, which can enable a surgeon or other medical personnel to selectively raise or lower the proximal end 202 of the arm assembly via any of a variety of different mechanisms (e.g., a leadscrew or a rack-and-pinion system). The tower 700 can provide a range of vertical movement or motion for the system 100. For example, the tower 700 can provide a "stroke" of 6 to 7 inches (15.2 to 17.8 cm).

[0115] The term "operating table" is broadly defined herein to include any structure to which the present system 100 can be attached and supported during a medical procedure. Any type, style, size, and / or configuration of operating table can be used as part of or attached to the system 100 of the presently disclosed technology. For example, the operating table disclosed in U.S. Patent Application Publication No. 2016 / 0228315 can be used in combination with the presently disclosed technology. The present system 100 is not limited to use with operating tables in the form of an H-frame with rectangular supports. Additionally, various patient support accessories and other devices can be used in combination with the present invention.

[0116] During operation, at least a portion of one, two, or each of first operator control interface 300, second operator control interface 332, and third operator control interface 240 can be engaged or manipulated by a surgeon or other medical personnel to provide or generate desired intra-operative movement of the patient. In one embodiment, one or more of the actuators or buttons of one or more of first operator control interface 300, second operator control interface 332, and third operator control interface 240 can be engaged to incrementally or sequentially release, unlock, or lock ball joint 410 and / or joints 220a, 220b, 220c. In such an embodiment, one goal is to sequentially release brakes 270, thereby (i) providing additional movement of system 100 after each brake 270 release, giving the surgeon more control, and / or (ii) providing a gradual or predictable transfer of weight from system 100 to the surgeon and / or other medical personnel. To perform different operations in this same embodiment or in other embodiments, one or more of the actuators or buttons of one or more of the first operator control interface 300, the second operator control interface 332, and the third operator control interface 240 can be engaged to release, unlock, or lock in parallel or simultaneously. Of course, the actuators or buttons could be engaged in any combination, parallel or serial. For example, in one embodiment, movement (of the ball joint 410 and / or at least one of the joints 220a, 220c, 220c) may not begin until two actuators (e.g., the first actuator 304 and the second actuator 306 of the first operator control interface 300) are depressed or engaged (e.g., serially or in parallel).In another embodiment, engagement of one of the actuators allows the system 100 to move in one plane (e.g., the sagittal plane), engagement of a second one of the actuators releases the ball joint 410, thereby allowing both roll and yaw movement, and engagement of both actuators allows movement in all degrees of freedom of movement. In one embodiment, upon engagement of one or each of the actuators or buttons, the system 100 can be configured to execute (e.g., initiate) the desired movement or motion within approximately 300 milliseconds, the typical human reaction time. This is a significant improvement over the prior art, ensuring that patient positioning and repositioning can be performed quickly and reliably by medical staff.

[0117] As shown in Figures 16-18, the location and / or placement of each of the first operator control interface 300, second operator control interface 332, and third operator control interface 240 can be beneficial. In one embodiment, the location of each of the operator control interfaces 300, 332, 240 allows a surgeon or other medical personnel to (i) perform a sterile procedure, (ii) maintain visibility of the surgical site, and (iii) move and / or control the patient's head through a drape without relying on assistance from any other person. Each of the operator control interfaces 300, 332, 240 can be accessible from above the patient and / or exposed above the patient.

[0118] 19 and 20, the present system 100 can be configured to complement and / or include a surgical drape 900. The drape 900 can be designed to at least partially cover, entirely cover, and / or interface with the patient as well as at least some or all of the operator control interfaces 300, 332, 240 of the present system 100. In one embodiment, the drape 900 allows a sterile surgeon or other medical personnel to (i) perform a sterile procedure (i.e., remain completely sterile) and / or (ii) maintain visibility of the surgical site, without disturbing the drape / patient interface at the surgical site and without relying on assistance from any other person, and (iii) directly move, adjust, and / or control the third operator control interface 240, and thus adjust the position and orientation of the patient's head through the drape.

[0119] Such intraoperative adjustments cannot be made with prior art systems. In contrast, prior art systems require a member of the medical treatment team to move the patient's head in a sterile manner during surgery, access the operating table and / or under the patient's head, make the adjustment, and then perform the sterile procedure. While the surgical site remains sterile during this adjustment in prior art systems, this procedure can be awkward, cumbersome, and time-consuming.

[0120] In one embodiment, during a medical procedure, the third operator control interface 240, including the actuators 244a, 244b, 246a, 246b, can be accessible from above the patient and / or exposed above the patient and accessible through the drape 900. The drape 900 can be completely transparent. Alternatively, the surgical drape is primarily opaque and includes one or more spaced transparent windows or pockets 902 that allow the third operator control interface 240 to be viewed, grasped, and / or engaged through the drape 900 by a user or surgeon. Thus, the drape 900 can be contoured so that the third operator control interface 240 can be viewed by a user and easily grasped through the drape 900 without disturbing the drape 900 at the surgical site. Prior to application of the drape 900, a transparent sock can be applied over at least a portion of the third operator control interface 240 to provide a second transparent protective barrier. Other embodiments of the drape 900 may provide interfaces or pockets to the first and second operator control interfaces 300, 322 and / or other actuators or controls 612, 626a', 626b' of the system 100 in a similar manner.

[0121] The electrical characteristics of system 100 can also provide feedback when movement of any part of system 100 occurs. For example, when one of the actuators engages and there is movement of at least one of joints 220a, 220b, 220c, system 100 may emit a beep, display an image or word on a monitor, turn on a light or series of lights, etc. The feedback may also be in the form of data, such as the speed, angle, range, displacement, etc. Such feedback may be useful to a surgeon or other medical professional in any of a variety of ways, such as to teach others how to perform a procedure, to repeat a successful procedure, and / or for legal matters such as malpractice claims.

[0122] 21, which shows a top view of another embodiment of a surgical drape for use with the systems or devices disclosed herein. The top view of the surgical drape 2100 includes a drape 2101, a window 2102, one or more covers 2103A, 2103B, a surgical opening 2104, one or more fastening members 2105A-D, and one or more markings 2106, 2107 at a proximal end 2108 and a distal end 2109 of the drape 2101.

[0123] The drape embodiment 2101 shown in Figure 21 is generally rectangular in shape, having a length and a width. The proximal end 2108 and the distal end 2109 of the drape 2101 may be the same width. However, a central portion of the drape 2101 may include a width that is greater than the width of the proximal end 2108 and the distal end 2109 of the drape 2101.

[0124] A window 2102 is included in the top surface 2100 of the drape 2101 and may be visible therein. Window 2102 is transparent and, as such, functions as an observation window for the physician to see through and observe activity on the opposite side of drape 2101. Window 2102 need not be a hole or opening for passing an object from top surface 2100 to bottom surface 2200 of drape 2101 and may be made of a substantially transparent material. Window 2102 may be rectangular in shape and located closer to the proximal end 2108 of drape 2101. Window 2102, along with the remainder of drape 2100, functions like a sterile barrier between top surface 2100 and the opposing bottom surface 2200. Those skilled in the art will appreciate that one window 2102 is illustrated in FIG. 21 . However, multiple windows of different sizes and configurations may be incorporated into drape 2100.

[0125] In some embodiments, one or more covers 2103A, 2103B may be included on the top surface of the drape 2101. As shown in FIG. 21 , the top surface of the drape 2101 includes a right cover 2103A and a left cover 2103B. These covers are distal to the window 2102 and extend substantially vertically upward from the top surface of the drape 2101. The right cover 2103A and the left cover 2103B may be transparent and may be made of a polyethylene material or any other flexible material. As shown in FIG. 22 and discussed further below, the right cover 2103A includes a cover opening 2203, and the left cover 2103B includes another, distinct cover opening 2202. Cover opening 2202 allows passage of one handle, for example, handle 242b shown in FIG. 11, so that once positioned there, handle 242b is surrounded by cover 2103A and ready to be engaged by a physician from the top side of drape 2101. On the other hand, opening 2203 allows passage of a second, different handle, for example, handle 242a shown in FIG. 11, so that once positioned there, handle 242a is surrounded by cover 2103B and ready to be engaged by a physician from the top side of drape 2101.

[0126] A surgical opening 2104 may be included through the drape 2101. The surgical opening 2104 will be discussed with reference to FIG. 23B, designated as 2300B. The surgical opening 2104 is positioned distal to the one or more covers 2103A, 2103B, such that the one or more covers 2103A, 2103B are positioned between the window 2102 and the surgical opening 2104, as shown in FIG. 21. The surgical opening 2104 may be substantially rectangular in shape and may include two segments or sections. The first segment or section comprises a surgical opening or passageway through which a device can pass from the top surface 2100 of the drape 2101 to the bottom surface 2200 of the drape 2101. The surgical opening allows access to a surgical site, for example, an incision made in a patient. The incision can be made, for example, in the patient's neck or upper back. However, the exemplary embodiments disclosed herein are not limited to these areas. The surgical opening 2104 may also be expandable and include a second surgical opening segment or section 2104-1, which may be represented as a dotted line as shown in FIG. 23B, such that removing the second surgical opening segment or section 2104-1 may expand the surgical opening between the first section and the second surgical opening segment or section 2104-1. For example, if a physician desires an expanded surgical opening in the area of ​​the surgical opening 2104 for increased workspace flexibility, to enlarge the surgical site, or to introduce additional objects therethrough from the top side 2100 of the drape 2101 to the bottom side 2200 of the drape 2101, the physician may simply remove the second surgical opening segment or section 2104-1 of the drape 2101, thereby expanding the surgical opening 2104. Removal of the second surgical opening segment or section 2104-1 may be accomplished using scissors, as shown in Figures 21 and 23B, or other similar means recognized by one skilled in the art.

[0127] In one embodiment, the distance between the surgical opening 2104 and the window 2102 may be spaced apart by approximately 14 inches (36 cm) or more. One skilled in the art will appreciate optimizing the distance between the surgical opening 2104 and the window 2102 to allow the patient's head to rotate within a range of ±30 degrees during the surgical procedure without shifting the fabric of the drape 2101 or tearing the fabric, particularly around the area of ​​the window 2102 and one or more covers 2103A, 2103B.

[0128] Still referring to FIG. 21 , in some embodiments, fastening members 2105A-D may be disposed on the top surface of the surgical drape 2101. The fastening members 2105A-D are disposed at the distal end 2109 of the drape 2101 and at the proximal end of the surgical opening 2104. The fastening members 2105A-D hold in place an object, such as an object passing through the surgical opening 2104. The object may include a surgical instrument or tool required for the surgical procedure. These surgical instruments or tools may include, for example, but are not limited to, a suction device and / or a mechanical device such as an electric knife or an ultrasonic probe. The fastening members 2105A-D may secure a portion of the object, such as a tube or wire. In some embodiments, the fastening members 2105A-D may be selected from a group including, for example, a hook and loop strap, e.g., a Velcro™ strap, a clip, and a clamp. 21, one skilled in the art will understand that additional fasteners and types of fasteners may be incorporated as desired. For example, additional fasteners may be incorporated along window 2102 or one or more covers 2103A, 2103B, and their orientation on top surface 2100 may be adjusted as desired.

[0129] In certain embodiments, one or more markings 2106, 2107 may be included on the top surface 2100 of the drape 2101. However, these one or more markings 2106, 2107 may equally be included on the bottom surface 2200 of the drape 2101. For example, a marking 2106 may be included on the proximal end 2108 of the drape 2101, and another marking 2107 may be included on the distal end 2109 of the drape 2101. These markings are shown in more detail in FIG. 34. Thus, referring to FIG. 21 in conjunction with FIG. 34, the markings 2106, 2107 may represent a symbol of a hand holding the drape 2101 and the direction of an arrow instructing the physician or user to pull the drape 2101 in a particular direction during deployment of the drape. For example, marking 2106 may indicate an arrow direction in one direction, and marking 2107 may indicate an arrow direction in the opposite direction from the arrow shown on marking 2106. These markings 2106, 2107 may instruct the physician on how to unfold drape 2101 once drape 2101 is removed from its packaging.

[0130] 22, there is shown the bottom surface of drape 2200. In various embodiments, the bottom surface of drape 2200 may include markings 2205 along with window 2102, additional window material 2301, cover openings 2202, 2203, and adhesive members, such as tape 2204.

[0131] The above features may be illustrated and discussed in conjunction with Figures 23, 23A, 23B, and 23C. Figure 23 shows the top surface of a surgical drape showing a transparent window and an expandable opening disposed on the top surface of the surgical drape 2101. This view of the top surface 2100 of the drape 2101 shows the window 2102 along with additional window material 2301 and the surgical opening 2104 along with markings 2205 on the bottom surface 2200 of the drape 2101.

[0132] In one embodiment, the window 2102 is described in conjunction with FIG. 23A , which is shown from the perspective of the top surface 2100 of the drape 2101. The window 2102 is placed on the bottom surface of the drape 2200. In one embodiment, as shown in FIG. 23A , the width and length of the window 2102 are slightly larger than the width and length of the drape opening so that the outline of the additional window material 2301 can be displayed. Also, the diameter of the cover flange 2302 is larger than the diameter of the holes 2202, 2203. The window 2102 and cover flange 2302 may be bonded to the bottom surface of the drape 2200 using a method selected from a pressure-sensitive adhesive, a heat-seal adhesive, an ultrasonic sealant, and combinations thereof, thereby securing the window 2102 and cover flange 2302 to the bottom surface 2200 of the drape 2101. Such a securing mechanism is particularly important to prevent cracks or tears in the drape 2101, particularly around the area of ​​the window 2102 and one or more covers 2103A, 2103B, when the drape 2101 is being used in a surgical procedure. Those skilled in the art will understand that the additional window material 2301 and covers 2103A, 2103B may be attached to the drape 2101 using other methods known in the art.

[0133] As discussed under Figure 21, openings 2202, 2203 allow one or more handles to pass therethrough so that they can be engaged from the top side of the device by a physician. For example, as shown in Figure 11, handles 242a, 242b can pass from the bottom of the drape into openings 2202, 2203 so that handles 242a, 242b are securely positioned within one or more covers 2103A, 2103B for use by the physician.

[0134] In one embodiment, adhesive members such as tape 2204 and markings 2205 are described in more detail in conjunction with FIG. 23C. Tape 2204 and markings 2205 are positioned on the bottom surface of drape 2101, surrounding surgical opening 2104 and second surgical opening 2104-1, and distal to window 2102. As shown in more detail in FIG. 23C, tape 2204 may include longitudinal strips 2304, 2305, 2308, 2309 and horizontal strips 2303, 2306, and 2307. These longitudinal and horizontal strips are positioned on the bottom surface 2200 of drape 2101, surrounding surgical opening 2104 and second surgical opening 2104-1, as shown in FIG. 23B. Longitudinal strips 2304, 2305, 2308, 2309 and horizontal strips 2303, 2306, and 2307 may be made adhesive by removing the outer protective covering layer, i.e., liner. Longitudinal strips 2305 and 2308 may be comprised of two different strips such that they are not joined at their intersection with horizontal strip 2306. Similarly, longitudinal strips 2304 and 2309 may be comprised of two different strips such that they are not joined at their intersection with horizontal strip 2306.

[0135] Additionally, longitudinal strips 2304, 2305 and horizontal strips 2303, 2306 may be selectively made adhesive, while longitudinal strips 2308, 2309 and horizontal strips 2306, 2307 may not be made adhesive by removing the outer coating layer. For example, if a physician wishes to work with a smaller surgical opening 2104, the physician may not need to remove the outer coating layer of longitudinal strips 2308 and 2309 and horizontal strip 2307. Instead, the physician may limit the removal of the outer coating layer to only longitudinal strips 2304, 2305 and horizontal strips 2303 and 2306. However, if a physician wishes to increase the surgical opening 2104 by including a second surgical opening section 2104-1 to provide more working space, the physician may remove the second surgical opening section 2104-1 and may also remove the outer coating layer on the longitudinal strips 2308 and 2309 and the horizontal strip 2307, as discussed above in connection with FIGS. 21 and 23B. This makes the longitudinal strips 2308, 2309 and the horizontal strip 2307 adhesive, allowing the physician to secure them to the patient. In this embodiment, the horizontal strip 2306 may be removed upon cutting or removal of the second surgical opening section 2104-1. Thus, the longitudinal and horizontal strips may be selectively removable as desired by the physician.

[0136] Additionally, in some embodiments, the longitudinal and horizontal strips may each include a pull tab. To create the pull tab, the adhesive underlying the horizontal or longitudinal strips may not extend to the end of the strip, thereby allowing for easy grip of the pull tab. For example, as shown in FIG. 23C , strips 2304, 2305, 2308, and 2309 may each include pull tabs 2305-1, 2305-2, 2305-3, and 2305-4. Additional pull tabs (not shown) may be included at the ends of horizontal strips 2303, 2306, and 2307. These respective pull tabs are used to engage or retain the longitudinal and horizontal strips. In certain embodiments, each of the pull tabs 2305-1, 2305-2, 2305-3, and 2305-4 may or may not be adhesive such that each of the pull tabs assists a user in engaging each of the pull tabs to remove the outer cover layer from each of the longitudinal and horizontal strips to reveal or expose the underlying adhesive surface.

[0137] Finally, with regard to the markings 2205, as also shown in FIGS. 22, 23C, and 34, in one embodiment, the markings 2205 may represent the patient's orientation that must be observed when placing the drape 2201 on the patient. For example, as shown in the markings 2205, the patient may be oriented with their head oriented toward the proximal end 2108 and their feet oriented toward the distal end 2109. Such markings 2205 may allow the physician to properly orient the drape 2201 relative to the patient during a surgical procedure so that the physician can view the surgical procedure through the window 2102, engage the handles 242 a, 242 b as they pass through one or more covers 2103A, 2103B, and access the patient's surgical site through the surgical opening 2104. Those skilled in the art will understand that the markings 2205 disclosed herein are not limited to such indications and similar indications may be provided.

[0138] 24, a side view of one embodiment of drape 2101 is shown, showing one cover 2103B along with two adhesive members 2105C, 2105D.

[0139] One embodiment of cover 2103B is shown in more detail in the exploded view shown in FIG. 24A. Cover 2103B includes a first segment that extends over top surface 2100 of drape 2101, as shown in FIG. 24A. A second segment includes flange 2403 of cover 2103B. Flange 2403 of cover 2103B is below the top surface of drape 2101. Additionally, this embodiment may include one or more adhesive members 2402. These adhesive members 2402 are single-sided tapes spaced apart from flange 2403. Cover 2103B shown in FIG. 24A is not drawn to scale; the length of drape 2101 may be longer than flange 2403, and the length of one or more adhesive members 2402 may be longer than the length of flange 2403 but shorter than the length of drape 2101. The structural components described herein with respect to cover 2103B apply to the other cover 2103A as well. In this embodiment, flange 2403 may be joined to bottom surface 2200 of drape 2101 by a pressure-sensitive adhesive, a heat-sensitive adhesive, an ultrasonic sealant, and any combination thereof. Flange 2403 may be joined between bottom surface 2200 of drape 2101 and, optionally, tape 2402 on the opposite side of flange 2403. Tape 2402 may overlap flange 2403 onto bottom surface 2200 of drape 2101.

[0140] 25 and 26, an embodiment of folding of drape 2101 is shown. FIG. 25 shows drape 2101 laid flat on a surface extending from proximal end 2108 to distal end 2109, with the bottom surface 2200 of drape 2101 facing the physician. The dotted lines depicted in FIG. 25 represent accordion-style folds made to wrap or fold drape 2101. FIG. 26 is a side view of drape 2101 shown in FIG. 25 as it is folded inward from both ends toward the center, or as it is unfolded.

[0141] A disclosure regarding folding and packaging of certain embodiments of drape 2101 will now be discussed with reference to Figures 24-32. Figure 27 depicts a side view 2700 of drape 2101 when folded inward. With regard to folding drape 2101, a physician, user, or technician may start with the proximal end 2108 and distal end 2109 of drape 2101 so that the bottom surface 2200 of drape 2101 faces the user as shown in Figure 25. A user may fold the drape 2101 inward by placing the proximal-most end over the proximal end and the distal-most end over the distal end, with such ends facing inward. The user may fold the proximal-most and distal-most ends simultaneously or independently of each other. When folding the proximal-most and distal-most ends, the user may perform an accordion-style fold so that such ends are parallel along the surface of the drape 2101, as shown in FIG. 26. The proximal-most end is folded inward in an accordion-style manner until the proximal end 2108 reaches the center of the drape, as shown in FIG. 27. Then, the distal-most end is folded inward in an accordion-style manner until the distal end 2109 reaches the center of the drape, as shown in FIG. 27.

[0142] By folding the proximal end 2108 and distal end 2109 in an accordion fashion until they reach the center of the drape 2101, a stack of drapes 2101 is obtained having a head stack and a foot stack, as shown in FIG. 28. The illustration shown in FIG. 28 is a partially folded configuration 2800, where a gap is maintained along an orthogonal axis on the bottom surface of the drape 2101 between the head stack and the foot stack. FIG. 29 shows another cross-sectional view 2900 of the partially folded configuration 2800 shown in FIG. 28. In particular, FIG. 29 shows an orthogonal view illustrating the partially folded configuration 2800 with an additional fold with the seam facing the midline. Each side stack is folded inward several times until the configuration 2900 shown in FIG. 29 is achieved.

[0143] After achieving such a partial folded configuration 2900, each side drape stack is folded once more along the midline axis of the bottom of the drape 2101. As shown in Figure 30, one embodiment of the complete and final folded configuration 3000 is shown, in which each side stack is folded along the midline axis of the bottom of the drape 2101, thereby providing a compact configuration of the drape 2101 for ease of packaging, shipping, and handling.

[0144] With reference to Figure 31, there is shown a top view of a surgical drape 2101 folded in the orthogonal manner shown in Figure 30. After the surgical drape 2101 achieves the final folded configuration 3000, it is placed in a package 3101 such that from the top view 3100 of the package 3101, the user can see the markings 2205, which assist the user in orienting the drape 2101.

[0145] 32, a side view of package 3101 is shown with a product label or instructions for use 3202 on the side of package 3101. As such, a manufacturer or manufacturer of a drape may package drape 2101 in a package 3101 that fits drape 2101 in its final folded configuration 3000.

[0146] The use of one embodiment of drape 2101, for example, for a surgical procedure, will now be described. A physician, user, or technician may remove drape 2101 from package 3101 after reading instructions 3202 provided with package 3101. Drape 2101 may include an additional protective wrap, which will need to be removed before using drape 2101. After removal from package 3101, drape 2101 is in final folded configuration 3000 as shown in FIG. 30 , and the physician can view markings 2205 from the top view shown in FIG. 31 , which assists the physician in orienting drape 2101 relative to the patient. The book-like format allows the user to easily handle and manipulate drape 2101 out of package 3101. 21 and 23B over the surgical site and place the drape 2101 around the surgical site. The user may then remove the outer protective covering layers from the longitudinal strips 2304, 2305 and horizontal strips 2303, 2306, exposing the underlying adhesive layer and preparing it for use. The user may also remove the release paper covering the top or bottom of the window 2102.

[0147] After orienting the drape 2101 relative to the markings 2205, the user may position the longitudinal strips 2304, 2305 and horizontal strips 2303, 2306 around the incision site or area of ​​interest so that the surgical opening 2104 in the top surface 2100 of the drape 2101 is around the incision site, allowing the physician or user to visualize and access the incision site.

[0148] The user then unfolds the drape 2101 along the orthogonal and parallel axes of the drape 2101. In other words, the drape 2101 is unfolded, thereby revealing the configuration of the drape 2101 shown in FIGS. 27, 28, and 29. After the drape 2101 is in this partially unfolded configuration, the user identifies the markings 2106, 2107 on the top surface 2100 of the drape 2101. Identifying these markings 2106, 2107 instructs the user to pull the proximal end 2108 and distal end 2109 to the patient's foot and head ends of the operating table on which the patient is resting. This allows the drape 2101 to be fully unfolded, so that the drape 2101 lies flat on the surface as shown in FIG.

[0149] If the user or physician determines that the surgical opening 2104 needs to be widened or made larger to increase working space or to allow additional objects to pass therethrough, the user or physician may remove the second surgical opening section 2401-1 shown in FIG. 23B. By removing the surgical opening section 2401-1, the surgical opening 2104 can be made larger to increase the physician's working space. This allows the user to enlarge the incision site or introduce additional objects through the opening.

[0150] After the bottom surface 2200 of the drape 2101 is in place and the surgical opening 2104 is correctly positioned, the user may introduce the handles 241 a, 241 b from the bottom surface 2200 of the drape 2101 and thread the handles 241 a, 241 b through the openings 2202, 2203 so that the handles 241 a, 241 b are positioned within their respective covers 2103A, 2103B. Once the handles 241 a, 241 b are positioned within their respective covers 2103A, 2103B, the surgeon may engage the handles 241 a, 241 b and perform the desired surgical procedure while appropriately manipulating the patient's head or viewing through the window 2102. Finally, the user may position an object, such as a surgical instrument or tool, to engage the fastener members 2105A-D and secure such object in place for use during the procedure.

[0151] Those skilled in the art will appreciate that modifications can be made to the above-described embodiments without departing from the broad inventive concept thereof. For example, various mechanical and electrical connection elements and actuators can be used to achieve the disclosed functionality. It is to be understood, therefore, that this invention is not limited to the particular embodiments disclosed, but that it is intended to cover modifications within the spirit and scope of the invention as defined by the appended claims.

Claims

1. 1. A system for patient positioning, comprising: an arm assembly extending between a proximal end and a distal end, the proximal end configured to be fixed relative to a surgical table, the arm assembly comprising a plurality of arm links extending between the proximal end and the distal end of the arm assembly, the plurality of arm links comprising a plurality of joints, each of the plurality of joints configured to pivot, and each of the plurality of joints configured to transition between a locked state and an unlocked state; a ball joint mechanism attached to a distal end of the arm assembly, the ball joint mechanism configured to be fixed relative to a head support that supports a patient's head, the ball joint mechanism comprising a ball joint having at least two degrees of freedom, the ball joint configured to transition between a locked state and an unlocked state; and Equipped with the plurality of joints are configured to transition from the locked state to the unlocked state in a staggered manner such that the weight of the patient's head is gradually transferred to an operator.

2. The system of claim 1 , wherein the plurality of joints are configured for gradual unlocking.

3. 10. The system of claim 1, wherein the ball joint mechanism includes a body, a first actuator, and a second operator control interface having a spaced apart second actuator, wherein engagement of the first actuator and subsequent engagement of the second actuator unlocks the plurality of joints.

4. 10. The system of claim 1, wherein the plurality of joints are configured to transition from the locked state to the unlocked state in a staggered manner such that the weight of the patient's head is gradually transferred to the operator.

5. 1. A system for patient positioning, comprising: a head support configured to support the patient's head; an arm assembly having a proximal end, an opposing distal end, and at least one joint therebetween, the at least one joint configured to allow the distal end of the arm assembly to move relative to the proximal end of the arm assembly, the proximal end of the arm assembly configured to be fixed relative to a surgical table; a ball joint mechanism attached to the distal end of the arm assembly and to the head support, the ball joint mechanism comprising a ball joint; a first operator control interface disposed proximate to the ball joint mechanism, the first operator control interface including an actuator configured to rotate the ball joint; and A system comprising:

6. 6. The system of claim 5, wherein the first operator control interface is positioned proximate to the ball joint mechanism such that the first operator control interface is intermediate the ball joint mechanism and the proximal end of the arm assembly.

7. 6. The system of claim 5, wherein the first operator control interface is located adjacent an upper end of the ball joint mechanism and adjacent a distal end of the arm assembly.

8. 6. The system of claim 5, wherein the first operator control interface is located at a distal end of the arm assembly and spaced from the at least one joint.

9. the head support is a board; the head support includes a second operator control interface; 6. The system of claim 5, wherein the second operator control interface comprises a handle adjacent to the plate, the handle configured to rotate the ball joint.

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