Improved positioner for orthopaedic surgery and methods of use

Abstract

An improved positioners used during orthopaedic surgery is provided. Specifically, an improved beach chair positioner for use in arthroscopic shoulder surgeries is provided.

Description

IMPROVED POSITIONER FOR ORTHOPAEDIC SURGERY AND METHODS OF USEFIELD

[0001] Embodiments herein are generally related to positioners used during orthopaedic surgery, and specifically to beach chair positioners used in arthroscopic shoulder surgeries.BACKGROUND

[0002] Orthopaedic surgery often requires precise positioning of patients to ensure optimal access to surgical sites, improved visibility for surgeons, and enhanced patient safety. Among the various positioning techniques, the ‘beach chair’ position has gained widespread acceptance, particularly for shoulder and upper extremity surgeries. This position, which involves seating the patient in a semi-reclined posture resembling a beach chair, provides numerous clinical advantages.

[0003] Many beach chair positioners are known in the industry. Such positioners are specialized devices designed to facilitate the specific patient orientation, often consisting of an adjustable framework that supports the patient's back, head, and neck, allowing fine-tuned angulation and elevation. Positioners can be crucial for accommodating different body types, optimizing the surgical field, and minimizing the risk of neurovascular complications.

[0004] The development of beach chair positioners has been driven by the need to address challenges encountered with traditional supine or lateral decubitus positions. These conventional positions can pose difficulties in accessing the shoulder joint, limit the range of motion for arthroscopic instruments, and increase the likelihood of softtissue interference. The semi-reclined posture offered by the beach chair positioner not only mitigates these issues, but also enhances the gravitational drainage of fluids away from the surgical site, reducing the risk of edema and hematoma formation. The primary benefit of the beach chair position is that it can facilitate both open and arthroscopic procedures.

[0005] Moreover, the ergonomic benefits of beach chair positioners extend to both the patient and the surgical team. For the patient, the semi-upright position can alleviate pressure on the respiratory system, promoting better ventilation and reducing the risk of perioperative complications. For surgeons and other operating room staff, the enhanced visibility and access to the shoulder joint afforded by the beach chair position can lead to more precise and efficient procedures, potentially improving surgical outcomes and reducing operative times. In some regards, the beach chair position is regarded as the “anatomic” position.

[0006] Proper installation and secure attachment of beach chair positioners is paramount to ensuring patient safety. To date, however, known beach chair positioners, such as those described in U.S. Patent Nos 6,564,406, 6,804,846, 8,020,228, and the like, have limited applicability, failing to provide improved functionality and intraoperative safety. For instance, many known positioners, such as the positioner described in U.S. Patent No. 6,564,406, cannot be used with any surgical table without being coupled with dimensional specific clamp, increasing the risk of incorrect attachment. Failure to ensure proper connection (i.e., using approximately sized rail clamps) can result in the positioner detaching from the table, dropping the patient. Rail clamps are often misplaced or lost, causing surgical delaysor even cancellations. Clamps can also be improperly locked or latched after installation. Moreover, known positioners often comprise asymmetrical designs, where attachment of fixed and / or movable components occurs out of sequence.

[0007] Many known positioners are also not adjustable to accommodate all patients, regardless of patient size (weight), height, and / or physical proportions (e.g., having a longer torso, shorter legs, etc.). Despite attempts to provide positioners that can be adapted to varying patients, known positioners often suffer from uneven pressure distribution, or circumstances where a patient’s position may be adjusted horizontally but not vertically or vice versa.

[0008] Moreover, securing the patient’s head during surgery is essential, specifically when a general anesthetic is used. Some known positioners use a disposable foam pad that is tensioned around the patient’s head using nylon webbing or hook and loop, e.g. as described in U.S. Patent No. 6,564,406, while others use a rigid restraint, e.g., as described in U.S. Patent No. 8,020,228. Such tensioning methods are known to cause concentrated pressure points along the line of compression against the patient’s head, posing additional risk.

[0009] The use of fluoroscopy in some surgical procedures can require the use of x- ray imaging. However, known beach positioners have structural members that are often not radiolucent and / or further impede physical access of the x-ray machine to move about the shoulder joint, significantly impairing clinical assessment.

[0010] One functional benefit of positioning the patient in the alternative lateral decubitus position is the option to use a secondary traction accessory to lift the humeral head away from the glenoid, increasing the repair site access. To achievesimilar access using the beach chair position requires an additional surgical team member to hold and pull on the arm during the procedure. The extra team member is then physically in the way of the surgeon and functionally their hands are tied preventing them from assisting in other surgical tasks.

[0011] Current beach chair positioners do not support intubation tubing. The tubing either hangs loose down the patient’s front and is routed around their non-operative arm or it is placed over their shoulder and in some cases, taped to the beach chair to prevent it from slipping during the surgery.

[0012] In addition to the functional limitations of existing beach chair positioners, an underlying and contradicting user requirement is reducing the device complexity in terms of device attachment to the operating room table, patient setup, and intraoperative adjustments.

[0013] There remains a need for an improved beach chair positioner for orthopaedic surgeries. Specifically, there is a need for an improved beach chair that overcomes the functional limitations, while simplifying the device complexity to improve both patient and surgical team experiences.SUMMARY

[0014] According to embodiments, an improved beach chair positioner, for releasable connection to a surgical table. In some embodiments, the positioner may have at least one chair attachment, the chair attachment having a base configured to releasably mount and to vertically and laterally adjust the at least one chair attachment to the surgical table.

[0015] In some embodiments, the positioner may comprise at least one vertical support assembly having at least one adjustment means for controllably adjusting the positioning of the at least one vertical support assembly relative to the surgical table. In some embodiments, the positioner may comprise at least one lateral support assembly having at least one torso support arm pivotally and telescopically connected to the at least one chair attachment. In some embodiments, the positioner may comprise at least one securing means for releasably securing the at least one chair attachment to the surgical table, regardless of whether the table has articulated sections (e.g., articulated leg sections).

[0016] In some embodiments, the at least one chair attachment of the present positioner may comprise at least one releasable connection means for mounting to the surgical table. In some embodiments, the at least one releasable connection means may comprise at least two opposed arms telescopically extending from the base, the at least two opposed arms each having at least one adjustable clamping mechanism.

[0017] In some embodiments, the at least one chair attachment of the present positioner may be adjusted laterally along the at least one releasable connection means.

[0018] In some embodiments, the at least one vertical support means of the present positioner may further comprise a plurality of patient support pads, wherein at least one of the plurality of patient support pads may be adjusted laterally, i.e., independently from at least one of the other plurality of support pads.

[0019] In some embodiments, the at least one adjustment means may comprise at least one adjustable gas spring.

[0020] In some embodiments, the at least one vertical support means of the present positioner may further comprise at least one locking mechanism for locking the at least one vertical support assembly in place.

[0021] In some embodiments, the lateral support assembly of the present positioner may comprise at least two opposed torso support arms, each support arm being independently pivotally and telescopically connected to the at least one chair attachment. In some embodiments, each of the at least two torso support arms may be independently pivotable about an x-axis, a y-axis, and telescopable about a z-axis, relative to the surgical table. In some embodiments, the torso support arms may be telescoped inwardly and outwardly from the surgical table.

[0022] In some embodiments, the positioner may further comprise at least one headrest releasably secured to the at least one vertical support assembly, the at least one headrest configured for releasably receiving at least one face mask. In some embodiments, at least one headrest may be mounted to the at least one vertical support assembly via a ball-and-socket joint.

[0023] In some embodiments, the positioner may further comprise at least one face mask for securing the head of the patient. In some embodiments, the face mask may comprise at least one flexible attachment means for securing the mask to the headrest. In some embodiments, the face mask may comprise at least one adjustment mechanism for securing the mask to the headrest. In some embodiments, the adjustment mechanism comprises a ratchet mechanism.

[0024] In some embodiments, the positioner may comprise at least one intubation tubing support assembly. The positioner of claim 17, the at least one intubation tubing support assembly may be releasably secured to the positioner.

[0025] In some embodiments, the present positioner may further comprise at least one bump arm assembly.

[0026] According to embodiments, methods of using an improved beach chair positioner releasably connected to a surgical table are provided. In some embodiments, the methods comprise releasably mounting the positioner to a surgical table, whether or not the table comprises articulated sections, adjusting at least one vertical support assembly of the positioner, such adjustment being vertically, laterally, or both (relative to the surgical table), and pivotally and telescopically adjusting at least one lateral support assembly, the lateral support assembly having at least one torso support arm, to support a patient placed on the surgical table.

[0027] In some embodiments, the methods may comprise releasably mounting the positioner is to the surgical table using at least one quick-release connection means.

[0028] In some embodiments, the methods comprise adjusting the vertically support means using at least one adjustable gas spring. In some embodiments, the methods comprise locking the at least one vertical support means in place.

[0029] In some embodiments, the methods may comprise providing a lateral support assembly having at least two opposed torso support arms, and each at least two arms being pivotable and telescopable independently.

[0030] In some embodiments, the methods further comprise providing at least one headrest adjustably mounted to the positioner for receiving and supporting thepatient’s head. In some embodiments, the methods further comprise providing at least one adjustable face mask for securing the patient’s head to the at least one headrest.

[0031] In some embodiments, the methods further comprise providing at least one intubation support assembly. In some embodiments, the methods further comprise providing at least one bump arm assembly.

[0032] According to embodiments, an improved face mask for use with a headrest element of an improved beach chair positioner is provided. In some embodiments, the face mask may comprise at least one support band for receiving and supporting the face of the patient, the at least one band being releasably connected to the headrest, at least one releasable connection means for connecting the at least one supports back to the headrest, and at least one adjustment means for adjusting the tension of the at least one band supporting the face of the patient.

[0033] In some embodiments, the mask may be manufactured from flexible biocompatible material. In some embodiments, the mask may be reusable or disposable.

[0034] In some embodiments, the releasable connections may comprise snap fit connections. In some embodiments, wherein the snap fit connections may form a male end releasably inserted into a corresponding female end. In some embodiments, the at least one of the male and female ends form an interior cavity having a plurality of teeth for receiving and gripping the at least one band.

[0035] According to embodiments, methods of using an improved face mask to support the head of a patient in a headrest during surgery are provided. In some embodiments, the methods comprise positioning at least one support band on the faceof the patient, connecting the at least one support band to the headrest, adjusting the tension of the at least one support band on the face of the patient, wherein the tension of each at least one support band may be adjusted independently.BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Embodiments of the present disclosure will now be described, by way of example only, with reference to the attached Figures.

[0037] Figure 1 is a perspective view of the presently improved positioner, the positioner shown attached to a conventional surgery table, according to embodiments;

[0038] Figure 2A is a perspective front view of the positioner shown in FIG. 1 , the positioner shown in isolation, according to embodiments;

[0039] Figure 2B is an exploded perspective rear view of the positioner shown in FIG. 2A, according to embodiments;

[0040] Figure 3 is a perspective side view of a vertical support assembly portion of the positioner shown in FIG. 1 , the vertical support assembly shown in isolation, according to embodiments;

[0041] Figure 4A is a perspective rear view of the vertical support assembly shown in FIG. 3, according to embodiments;

[0042] Figure 4B is an exploded perspective rear view of the vertical support assembly shown in FIG. 4A, the positioner shown in an extended arrangement, according to embodiments;

[0043] Figure 5A is a perspective front view of a lateral support assembly portion of the positioner shown in FIG. 1 , the support assembly having side torso support elements shown in isolation, according to embodiments;

[0044] Figure 5B is an exploded perspective front view of the side torso support elements shown in FIG. 5A, according to embodiments;

[0045] Figure 6A is a rear perspective view of a base for mounting the positioner shown in FIG. 1 to a surgical table, according to embodiments;

[0046] Figure 6B is a bottom perspective view of the base shown in FIG. 6A, according to embodiments;

[0047] Figure 7 shows a first embodiment headrest for mounting to the positioner shown in FIG. 1 , according to embodiments;

[0048] Figure 8 shows a second embodiment headrest for mounting to the positioner shown in FIG. 1 , according to embodiments;

[0049] Figure 9 shows a face mask connected to the headrest shown in FIG. 8, according to embodiments;

[0050] Figure 10A shows a zoomed in view of a snap fit connection between the face mask and headrest shown in FIG. 9, according to embodiments;

[0051] Figure 10B shows a zoomed in view of the snap fit connection shown in FIG. 10A, a male end of the connection being inserted into a female end, according to embodiments;

[0052] Figure 10C shows a zoomed in side perspective view of a female end of the snap fit connection shown in FIG. 10B, according to embodiments;

[0053] Figure 10D shows a perspective exploded view of the interior wall of the female end of the snap fit connection shown in FIG. 10C, according to embodiments;

[0054] Figure 11 shows an example ratchet mechanism for adjustably securing the face mask to the headrest shown in FIGS. 10A and 10B, according to embodiments;

[0055] Figure 12 shows an example intubation support assembly, according to embodiments;

[0056] Figure 13A shows an example bump arm support assembly, according to embodiments; and

[0057] Figure 13B shows a zoomed in view of a base element of the bump arm support assembly showing in FIG. 13A (circle A); according to embodiments.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] The presently improved apparatus and methods of use will now be described having regard to FIGS. 1 - 13.

[0059] According to embodiment, having regard to FIG. 1 , an improved beach chair positioner 100 is provided. The presently improved positioner 100 may be configured for attachment to a conventional surgery table 2 having standard attachment rails 3, e.g., such as attachment guide rails 3 positioned along either side of table 2.

[0060] According to embodiments, the presently improved beach chair positioner 100 may comprise, in combination, at least one chair attachment 10, having at least one vertical and lateral support assembly 20,30, respectively, and at least one headrest attachment 50 for connecting with a face mask 60 and, optionally, at least one intubation support attachment 70, at least one bump arm assembly 80, and at least one arm support (e.g., non-operative arm support, not shown).

[0061] In some embodiments, positioner 100 may be configured for releasable connection to a surgery table 2, regardless of the size and configuration of table 2 and / or attachment rails 3 (e.g., eliminating the need to specifically couple the rail clamps with the surgical table being used). Without limitation, advantageously,positioner 100 may be configured for attachment to any surgery table 2, regardless of the dimensions of rails 3, which are known to vary in width and thickness, as well as nominal units (e.g., inches and mm) based on international differences. Positioner 100, or components thereof, may be configured for releasable attachment to rails 3 of table 2, allowing easy retrofitting of positioner 100 to any table 2.

[0062] According to embodiments, as above, the presently improved positioner 100 may comprise at least one chair attachment 10. In some embodiments, chair attachment 10 may be configured for releasable connection to a surgical table 2 and to support a patient positioned thereon during surgery. In some embodiments, chair attachment 10 may be configured to effectively secure the position of a patient’s head, torso, and arms on table 2, ensuring the patient’s safety during surgery.

[0063] For example, having regard to FIGS. 2A - 2B, and 6A - 6B, the at least one chair attachment 10 may comprise a base 12 for releasably and adjustably mounting chair attachment to surgical table 2. In some embodiments, base 12 may be configured to provide at least one releasable connection means 40 (FIG. 2), enabling adjustable, secure connection of base 12 to rails 3 of surgical table 2 (i.e., providing easy, quick-release, mounting and dismounting of chair attachment 10 to any surgical table 2 being used).

[0064] In some embodiments, releasable connection means 40 may comprise at least two opposed arms 42, arms 42 extending from base 12 and each providing at least one adjustable clamping mechanism 44 for securely connecting attachment 10 to rails 3 of table 2. For example, in some embodiments, adjustable clamps 44 may be configured to be compatible with the standardized dimensions of side rails 3 and maybe configured to readily tighten and lock attachment 10 in place. In some embodiments, clamps 44 may comprise a ‘dual-jaw’ C-clamp configuration (akin to an interlocking ski-boot connection), with one jaw fixed in place while the other jaw can be adjusted to accommodate any width of rail 3. The fixed jaw may provide stability, while the adjustable jaw can be tightened to create a firm grip. Advantageously, the releasable connection means 40 may serve to ensure appropriate tension between attachment 10 and table 2 is achieved, eliminating the possibility uneven connection or of attachment 10 coming loose (i.e., mitigating the risk of the patient falling).

[0065] In some embodiments, in operation, the sandwich design of the clamps 44 enable arms 42 of attachment 10 to slide smoothly along rail 3 of table 2, ensuring precise positioning of attachment 10. The C-shaped frame encircles rails 3 and, once the desired position is achieved, each clamp 44 may be tightened (e.g., turn knob 43; FIG. 2A), locking attachment 10 securely in place. Moreover, arms 42 may be adjusted laterally (i.e., away from connection means 40), allowing chair attachment 10 to be positioned on any width of surgical table 2. Further, where desired, clamps 44 may extend laterally away from arms 42, allowing for chair attachment 10 to be placed directly over rails 3 and / or from behind rails 3, reducing the complexity and improving usability of positioner 100. Advantageously, the presently configured releasable connection means 40 enable quick adjustments and easy installation / removal, enhancing the versatility and efficiency of the surgical setup.

[0066] In some embodiments, having regard to FIG. 2B, base 12 may be further configured to enable lateral adjustment of chair attachment 10, i.e., from side to side along releasable connection means 40. In this manner, where desired, chairattachment 10 may be readily maneuvered laterally along means 40, e.g., where arms 42 may slide through internal bore extending through base 12, enabling positioning of attachment 10 as close as possible to the operative side of table 2 for improved patient positioning. Advantageously, the adjustability of chair attachment 10 from side to side along connection means 40 enhances the surgeon’s access to the shoulder joint and further improves access for x-ray machines.

[0067] According to embodiments, having regard to FIGS. 3, and 4A - 4B, chair attachment 10 may be configured such that, when releasably mounted to surgical table 2, at least one vertical support assembly 20 may extend upwardly (vertically) from table 2 to support the torso of the patient positioned on table 2.

[0068] In some embodiments, vertical supports assembly 20 may be specifically designed to be centered about the patient’s center of mass, while being sufficiently narrow to enable the radiolucent window about the shoulder, providing optimal patient support while maximizing imaging capacity. In some embodiments, assembly 20 may be configured to provide a plurality of patient support pads 26,27, with at least one pad being adjustable 26 while at least one other pad remains fixed 27. Advantageously, the at least one fixed pad 27 may support the patient’s torso and distribute the patient’s’ weight (body mass) evenly, while the at least one adjustable pad 26 may be slidably mounted on guide rails for lateral adjustment (from left to right) to expose the operative shoulder joint and maximize the radiolucent window. For example, in some embodiments, adjustable pad 26 may be laterally maneuvered using handles 28, or the like.

[0069] In some embodiments, vertical support assembly 20 may be adjustable, ensuring patient comfort and safety during surgery. For example, vertical support assembly 20 may comprise at least one ‘lift-assist’ adjustment means configured for controlling the position of a patient resting on assembly 20, e.g., for controlling the angle at which assembly 20 extends from table 2 to adjust the patient’s positioning. Advantageously, the at least one adjustment means may be assisted, i.e., gas- or hydraulically-controlled, without using power from table 2, eliminating any risk of vertical support assembly 20 falling should table 2 be impacted by a power outage or reduced power supply. Moreover, the at least one assisted adjustment means may significantly reduce the load required by the operator to raise or lower vertical support assembly 20 (i.e., offering precise control and ensuring smooth and steady adjustment, regardless of the weight / size of the patient).

[0070] In some embodiments, having regard to FIGS. 4A - 4B, vertical support assembly 20 may be configured to provide at least one locking gas assisted adjustment means 22. In some embodiments, adjustment means may comprise at least one gas-operated spring, or the like, having a locking mechanism allowing the spring(s) to controllably extend or compress for height adjustment, tilt, and positioning of vertical support assembly 20 during surgical procedures.

[0071] For example, having regard to FIG. 4B, vertical support assembly 20 may comprise at least one spring-controlled adjustment means 22. In some embodiments, adjustment means 22 may comprise compressed fluids, gases, or both (e.g., nitrogen gas, or the like), contained within a sealed cylinder 23 having a piston rod 24. When piston rod 24 is compressed (by operator using handle 25), fluids within cylinder 23are forced into a smaller volume, increasing pressures therein. This pressure then acts to extend piston rod 24 when the external force is removed.

[0072] In some embodiments, adjustment means 22 may comprise at least one locking mechanism, holding adjustment means (i.e., gas springs) 22 at a desired position. For example, adjustment means 22 may comprise at least one handle or lever 25 operable to control the extension or compression of adjustment means 22, as desired. In this manner, vertical support assembly 20 is configured for easy adjustment of chair attachment 10, providing smooth and controllable force that can be readily locked into position. Moreover, advantageously, handle 25 may be configured to comprise at least one hinge 29, enabling handle 25 to be pivotally rotated, accommodating optimal hand placement and lifting direction regardless of position (angle) of vertical support assembly 20. In some embodiments, one or more additional handles may be provided on headrest 50, enhancing lifting force using a fulcrum and facilitating control of headrest 50 while raising and lowering vertical support assembly 20.

[0073] Advantageously, adjustment means 22 may be configured to require minimal effort to operate, providing resistance to ensure the speed of movement can be precisely controlled (e.g., preventing sudden jerks or drops). Moreover, adjustment means 22 may be light-weight, easy to install, and configured for frequent adjustments that can be required during surgery. As will be described, vertical support assembly 20 may be releasably mounted to base 12 of chair attachment 10, and operative to controllably rotate thereabout (e.g., wherein vertical support assembly 20 may be pivotable about base 12).

[0074] In some embodiments, having further regard to FIGS. 2 - 5, chair attachment 10 may also be configured such that, when releasably mounted to table 2, the at least one lateral support assembly 30 extends laterally (horizontally) from table 2 so as to support the torso (sides) and arms of the patient positioned on table 2. For example, having regard to FIGS. 2A and 3, the at least one lateral support assembly 30 may be configured to comprise at least one side torso support 32, each at least one support 32 being both pivotally and telescopically mounted to chair attachment 10. As will be described, lateral support assembly 30 may be pivoted about and telescopically extend from base 12 of chair attachment 10.

[0075] For example, in some embodiments, the at least one side support arm 32 may be pivotally mounted to chair attachment 10. Each at least one side support 32 may be independently pivotable (e.g., about pivot points 33; FIG. 2A) to maneuver torso supports 32 upwards and / or downwards relative to table 2). In this manner, each at least one side support 32 may be independently pivoted about pivot points 33 when the patient is being positioned on table 2 (i.e. , one or both torso support arms 32 may conveniently be pivoted downwardly and out of the way while patient is transferred to / from table 2).

[0076] In some embodiments, having regard to FIGS. 5A and 5B, torso support arms 32 may be further pivotable about one or more additional pivot points 35, providing enhanced placement of supports 32 relative to table 2. In other embodiments, torso supports 32 may be further pivotal about one or more additional pivot points (e.g. akin to opening a door away from table 2), advantageously providing adjustment about two degrees of freedom. For explanatory purposes only, for example, first pivot points 33may be used to maneuver supports 32 about a first y axis, pivot points 35 may be used to maneuver supports 32 about a second x axis (FIG. 5A). The foregoing pivot points serve to accommodate the transfer and support of patients of varying heights without the need to remove or detach torso support arms in either the upright or reclined orientations, enhancing functionality of the presently improved positioner 100.

[0077] In some embodiments, the at least one torso support arm 32 may further be telescopically mounted to chair attachment 10. Having regard to FIG. 5B, each at least one torso support arm 32 may independently telescope from chair attachment 10 to maneuver supports 32 towards (inwardly; a, FIG. 5B) and away (outwardly; b, FIG. 5B) from table 2, increasing or decreasing the distance between supports 32 and table 2, e.g., as desired depending upon the size of the patient.

[0078] For example, each at least one torso support arm 32 may comprise an adjustable telescoping means for slidably extending or retracting supports 32. Without limitation, in some embodiments, telescoping means may comprise a guide slot (37; FIG. 5B) correspondingly extending along support arms 32. In other embodiments, telescoping means may comprise a solid element (i.e., without guide slot 37). Arm supports 32 may further comprise means for releasably locking arms 32 in place, for example, by means of a two-piece rotating gear 33 and threaded knob 38 (FIG. 5B). In some embodiments, knob 38 may be threadably released to telescope support arm 32 and then tightened to secure support arm 32 in place. In some embodiments, without limitation, knob 38 may advantageously be used to both pivot support arms 32 about pivot points 33 and to telescope support arms 32 along guide slot 37 (e.g.,FIGS. 5A and 5B). Moreover, advantageously, the presently configured at least onetorso support arms 32 may be configured to be adjusted without reliance upon power from table 2 or other such lift assist devices, ensuring patient comfort and safety during surgery.

[0079] According to embodiments, the presently improved positioner 100 may comprise at least one headrest attachment 50, the headrest serving to position a patient’s head during surgery. As would be understood, head support during shoulder and upper body surgeries can be critical, requiring precise positioning and minimizing pressure points.

[0080] According to embodiments, at least one headrest attachment may be provided, each attachment advantageously providing a safe, stable means for securing a patient’s head during surgery. As shown in FIG. 1 , headrest 50 may be readily mounted to vertical support assembly 20.

[0081] In some embodiments, having regard to FIGS. 7 and 8, an improved headrest 50 is provided. In such embodiments, headrest 50 may be releasably secured to positioner 100. For example, headrest 50 may be operably connected to vertical support assembly 20 via at least one ball-and-socket joint mechanism 52.

[0082] In some embodiments, joint 52 may be operably connected to headrest 50 via at least one joint support arm 54 configured to receive and lock at least one positioner bar 56 of headrest 50 in place. For example, a first end of support arm 54 may be configured to releasably receive and adjust (horizontally) support bar 56 of headrest 50. Once in place, at least one locking mechanism 53 (e.g., toggle handle or threaded knob) may serve to secure bar 56 in arm 54. When desired, locking mechanism 53 may be disengaged for easy release and removal of bar 56.

[0083] In some embodiments, joint 52 may comprise a conventional ball-and-socket configuration, wherein joint 52 contains a spherical ball 55 attached to a second end of support arm 54. Ball 55 fits snugly into the socket of joint 52, enabling headrest 50 supported thereon to pivot and rotate the position of the patient’s head in any direction. Such smooth, multi-directional movement is crucial for fine-tuning the position of the patient, ensuring adjustments in tilt, rotation, and height can be tailored to each individual and to the specific requirements of the surgical procedure. Although a ball- and-socket joint 52 is described, it should be understood that any versatile and secure method for adjustably and stably mounting headrest 50 to vertical support assembly 20 is contemplated.

[0084] In some embodiments, once headrest 50 is in the desired position, joint 52 may be locked in place using a locking mechanism located at the side of joint 52. In some embodiments, having regard to FIG. 7, a first embodiment locking mechanism 58 may comprise a quick-release toggle handle. In other embodiments, having regard to FIG. 8, a second embodiment locking mechanism 58 may comprise a tightening knob. In either embodiment, when locking mechanism 58 is engaged, the mechanism exerts pressure on ball 55, securing it firmly within socket joint 52, preventing any further movement. Advantageously, either embodiment provided herein ensures that headrest 50 remains stable through surgery, even when subjected to external forces.

[0085] In all embodiments, the presently improved headrest 50 may be padded with a slip-resistant padding material 57 to provide comfort and to distribute pressure evenly across the patient’s head and neck, reducing the risk of pressure sores and other complications during prolonged surgeries. Pad 57 may be manufactured to be anysuitable shape for cradling the crown of the head, e.g., oval shape. In some embodiments, an oval shape, or the like, may ensure improved pressure distribution (versus known devices having a single point of contact with the back of the patient’s head). In some embodiments, pad 57 may be further manufactured to have a low- profile bottom edge to safely accommodate the patient’s neck.

[0086] According to embodiments, having regard to FIG. 9, headrest 50 may be mounted to vertical support assembly 20 by a lockable telescoping support 51. The height of the telescoping support can be adjusted and locked by means of a clamping mechanism 59, by means of a threaded knob of a cam handle, or the like. During intubation all joints of headrest 50 can be unlocked to allow unrestricted control of the patient’s head, including flexion and extension about the sagittal plane, lateral inclination about the frontal plane, rotation about the transverse plane, and height of the headrest. Unrestricted control of the patient’s head is essential for anatomic alignment of their neurovascular regions about the head, neck and spine and to facilitate an open airway for intubation. Once the patient is intubated and raised for surgery the joints of the headrest 50 can be locked in place for the surgical procedure.

[0087] According to embodiments, having regard to FIG. 9, headrest 50 may further comprise at least one face mask 60 for adjustably securing the head of the patient firmly, yet comfortably and safely to headrest 50. In some embodiments, face mask 60 may be reusable or disposable. Face mask 60 may comprise at least one support band 61 (FIG. 10B), each band 61 manufactured from any soft, biocompatible material operative to contour to the patient’s face, providing secure immobilization and even pressure distribution. Face mask 60 may be designed such that bands 61 cover keyareas of the face, such as the forehead, cheeks, and chin, leaving the mouth, nose, and eyes exposed to facilitate breathing and monitoring. In some embodiments, where a patient may be awake during the surgical procedure, face mask 60 may be configured to allow for a lower portion to be cut away and removed, whereby the patient’s forehead remains secure while their face and lower jaw are unrestrained. In some embodiments, mask 60 may be manufactured from a uniform material having moderate elasticity, allowing bands 61 of mask 60 to stretch around the patient’s head, preventing over tensioning and mitigating patient injury.

[0088] In some embodiments, mask 60 may comprise a plurality of adjustable attachment points 64 for connecting mask 60 to headrest 50. For example, having regard to FIG. 9, mask 60 may form a plurality of quick-release snap connections 64.

[0089] In some embodiments, having regard to FIG. 10A, connections 64 may comprise a three-prong buckle (FIG. 10D), or the like, buckle forming a male end 63 secured to mask 60 for releasable insertion into a corresponding female end 65 secured to headrest 50. Advantageously, connections 64 may be angled such that they impose an upward and backward pulling force on bands 61 supporting the patient’s jaw, while correspondingly imposing a downward and backward pulling force on bands 61 supporting the patient’s forehead. The opposing angles (and resulting pulling forces) of the applied tension prevents mask 60 from slipping on the patient’s face. Although quick-release snap connections 64 are described, any means for adjustably attaching face mask 60 to headrest 50 is contemplated such as keys, hocks, magnets, latches and buttons, or the like.

[0090] According to embodiments, having regard to FIGS. 10C and 10D, connections 64 may be configured to securely receive and grip at least one band 61 , without the use of adhesives or glue. For example, having regard to FIG. 10D, connections 64 may be configured to comprise a plurality of gripping elements or ‘teeth’ 69 to effectively secure material of band 61 therein. In some embodiments, at least one of the male and / or female ends 63,65 may form a cavity having an internal surface, the surface forming the plurality of teeth 69. Connections 64 may further comprise at least two opposed flexible barbs (77; FIG. 10C) for further securing and containing band 61 therein. Barbs 77 may further serve to securely receive at least one retaining ring 66, whereby ring 66 can be inserted into the folded-over snap connection 64 and locked in place. In some embodiments, a plurality of corresponding interlocking blocks 78 fit together and connect (like a puzzle), ensuring connection 64 is folded and secured to form a unitary component.

[0091] According to embodiments, during manufacture and assembly of mask 60, bands 61 may be securely positioned within connections 64 such that male and / or female ends 63,65 of bands 61 closes or loops over and grip bands 61. Teeth 69 of male ends 63 serve to ‘bite’ into bands 61 , securely receiving bands 61 therein. In this manner, where pulling forces are imposed bands 61 , band material may tear or shear prior to bands 61 dislodging from connections 64. Advantageously, it is contemplated that connections 64 may be utilized as effective mechanical fasteners for any other suitable uses in the operating room such as, without limitation, to secure sterile equipment drapes or other positioning pads (avoiding the use of elastic bands or tape, which are known to be non-sterile dirt traps).

[0092] According to embodiments, headrest 50 may further comprise means for adjusting the tension of mask 60 about the patient’s face. For example, having regard to FIG. 11 , headrest 50 may provide at least one adjustment mechanism 66, such as a ratchet mechanism. In this manner, once mask 50 is fitted to the patient’s face, means 66 may be tightened to secure mask 60 to headrest 50. Ratchet mechanism66 may be integrated into headrest 50, providing both security and fin-tuned control over tightening. For example, once snap connections 64 are in place, a tension knob67 may be turned in small increments clockwise or counterclockwise, to tighten or loosen ratchet straps 68 (having a series of teeth enabling incremental tightening), securing mask 60 in place with fine, controlled adjustments. In operation, as strap 68 is pulled through the ratchet mechanism 66, each ‘click’ of mechanism 66 tightens straps 68 further, increasing the pressure on face mask 60 and thereby stabilizing the patient’s head. This step-by-step adjustment is crucial in scenarios where precision is key, such as aligning the head with imaging equipment or ensuring that the surgical site remains perfectly exposed throughout the procedure. Advantageously, the ratchet mechanism 66 ensures uniform, equal, and symmetrical tensioning on both the left and right sides of the mask 60.

[0093] Advantageously, the tension of straps 68 of the presently improved mask 60 can be adjusted to achieve the desired level of restraint, ensuring the head remains stable throughout the surgery, even during complex or lengthy procedures. In addition to securing the head, mask 60 also aids in maintaining proper alignment of the neck and spine, which is particularly important in surgeries involving the shoulder and upper body (e.g., ensures access to the glenoid). Herein, the presently improved mask 60ensures that the head is held in a neutral or slightly flexed position, depending on the surgical requirements, reducing the risk of strain or injury.

[0094] According to embodiments, having regard to FIG. 12, the presently improved beach chair positioner 100 further comprises at least one optional intubation support assembly 70. The presently improved intubation support assembly 70 may comprise a flexible arm for securely supporting intubation tubing during surgery, aiding anesthesiologist and surgeons maintain an open and stable airway, particularly during complex or length surgeries. As shown in FIG. 1 , intubation support assembly 70 may be readily mounted to vertical support assembly 20, for supporting any number of tubes, wires, and / or surgical equipment to facilitate and organize the surgical procedure.

[0095] In some embodiments, the presently improved intubation support assembly 70 may be releasably anchored to table 2, providing a stable support for intubation tubing during the surgery. Having regard to FIG. 12, at a first end, intubation assembly 70 may comprise a base 72. In some embodiments, base 72 may comprise a C-clamp 71 and threaded knob 73, or the like, although any appropriate means for releasably securing assembly 70 for use with positioner 100 is contemplated. Advantageously, the presently improved means for securing intubation support assembly 70 may be configured such that assembly 70 can be positioned on table 2 or base 12, so as to be out of the way of the surgical team.

[0096] In some embodiments, intubation support assembly 70 may comprise at least one flexible arm 74. Arm 74 may be manufactured from bendable material such as coiled wire or may form multiple joints such that it may be readily adjusted to variouspositions and angles and then, once in position, remain in place to hold the airway device. In some embodiments, arm 74 may flex when under excessive load, such that it bends or moves rather than pulling or crushing the intubation tubing.

[0097] In some embodiments, the presently improved intubation support assembly 70 may be configured to provide a specialized holder or clamp to grip the airway device without damaging it. In some embodiments, at a second end, intubation support assembly 70 may comprise at least one tubing holder 76. Tubing holder 76 may comprise an intubation support element 75 configured for receiving and supporting the airway device. Tubing holder 76 may further comprise a restraining element 87 (e.g., strap, or the like) that, when in position, securely holds the tubing within holder 76. In some embodiments, restraining element 87 may be secured via at least one screw and magnetic connector 79, or the like, although any means for securing tubing within holder 76 is contemplated. In some embodiments, tubing support element 75 may be maneuverable about swivel 88, enabling free rotation of support element 75 (i.e. , about the center axis of arm 74).

[0098] In operation, once the patient is intubated, a user may readily position arm 74 of intubation support assembly 70 in such a way that it holds the airway device tubing in place, ensuring that it remains securely in place throughout surgery. In this manner, the presently improved intubation support assembly 70 serves to maintain assembly’s 70 position even if the patient is moved slightly or can be readily repositioned and secured if the surgical team needs to move assembly 70 to work around the shoulder area.

[0099] According to embodiments, having regard to FIG. 1 , the presently improved beach chair positioner 100 further comprises at least one optional bump arm assembly 80. The presently improved bump arm assembly 80 may comprise a specialized device for elevating the patient’s humerus during surgery, particularly when the surgeon needs additional access to the shoulder joint. Bump arm assembly 80 may be used to maintain the arm in a consistent and comfortable position, allowing enhanced access to the surgical site, while minimizing risk of injury or strain to the patient. As shown in FIG. 1 , bump arm assembly 80 may be readily mounted to vertical support assembly 20, the table rail 2 or the base 12.

[0100] Having regard to FIGS. 13A and 13B, at a first end, bump arm assembly 80 may comprise a base 82. In some embodiments, base 82 may comprise a bracket fixture 81 and a corresponding threaded handle 83, although any appropriate means for releasably securing assembly for use with positioner 100 is contemplated. Advantageously, the presently improved means for securing bump arm assembly 80 may be configured such that assembly 80 can be positioned on table 2, the table rail 2 or the base 12 so as to be out of the way of the surgical team.

[0101] In some embodiments, having regard to FIG. 13A, bump support assembly 80 may comprise at least one flexible arm 84. Arm 84 may be manufactured from bendable, non-slip material such that it may be readily adjusted to various positions and angles and then, once in position, remain in place to the patient’s arm.

[0102] In some embodiments, at a second end, bump arm assembly 80 may comprise a contoured ‘bump’ or cushion 86 for raising and supporting the patient’s arm. Bump 86 may be manufactured from a contoured material operative to raise the patient’sarm laterally, while ensuring patient comfort regardless of patient size or anatomy. In some embodiments, bump arm 84 may be manufactured from any suitable flexible material, ensuring arm is sufficiently strong to support the patient’s arm while also being sufficiently flexible to contour to the patient’s anatomy.

[0103] In operation, bump arm assembly 80 may be positioned under a sterile curtain or draping. When desired, bump arm assembly 80 may easily and quickly be attached to table 2 and maneuvered into position by the surgeon within the sterile field. Assembly 80 provides stable and consistent support of the patient’s arm, reducing the risk of movement during surgery. Assembly 80 further ensures that the patient’s arm is elevated effectively, improving the surgeon's access to the target area. Herein, the padded design ensures the patient's arm is supported comfortably, reducing the risk of pressure injuries. When no longer needed, arm 80 may be quickly released and moved away from the patient. By placing bump arm 80 under a sterile drape, the surgeon maintains complete control over when arm 84 is used or removed from use.

[0104] According to embodiments, methods of using an improved beach chair positioner for releasably mounting the positioner to a surgical table, adjusting at least one vertical support assembly of the positioner, and pivotally and telescopically adjusting at least one lateral support assembly, the lateral support assembly having at least one torso support arm, to support a patient placed on the surgical table.

[0105] In some embodiments, the positioner may be releasably mounted to the surgical table using at least one quick-release connection means.

[0106] In some embodiments, the at least one vertical support means may be adjusted laterally relative to the surgical table. For example, the vertical support means may beadjusted using at least one adjustable gas spring and easily locked in place using at least one locking mechanism.

[0107] In some embodiments, the lateral support assembly may comprise at least two opposed torso support arms, and each at least two arms may be pivoted and telescoped independently.

[0108] In some embodiments, the method may further comprise providing at least one headrest adjustably mounted to the positioner for receiving and supporting the patient’s head.

[0109] In some embodiments, the method may further comprise providing at least one adjustable face mask for securing the patient’s head to the at least one headrest.

[0110] In some embodiments, the method may further optionally comprise providing at least one intubation support assembly.

[0111] In some embodiments, the method may further optionally comprise providing at least one bump arm assembly.

[0112] Although a few embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications can be made to these embodiments without changing or departing from their scope, intent or functionality. The terms and expressions used in the preceding specification have been used herein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and the described portions thereof.

Claims

WE CLAIM:1 ) An improved beach chair positioner, for releasable connection to a surgical table, the positioner comprising: at least one chair attachment, the chair attachment having a base configured to releasably mount and to vertically and laterally adjust the at least one chair attachment to the surgical table, and having at least one vertical support assembly having at least one adjustment means for controllably adjusting the positioning of the at least one vertical support assembly relative to the surgical table, at least one lateral support assembly having at least one torso support arm pivotally and telescopically connected to the at least one chair attachment, and at least one securing means for releasably securing the at least one chair attachment to the surgical table.2) The positioner of claim 1 , wherein the at least one chair attachment comprises at least one releasable connection means for mounting to the surgical table.3) The positioner of claim 2, wherein the at least one releasable connection means comprises at least two opposed arms telescopically extending from the base, the at least two opposed arms each having at least one adjustable clamping mechanism.4) The positioner of claim 2, wherein the at least one chair attachment may be adjusted laterally along the at least one releasable connection means.5) The positioner of claim 1 , the at least one vertical support means further comprising a plurality of patient support pads, wherein at least one of the plurality of patient support pads may be adjusted laterally.6) The positioner of claim 1 , wherein the at least one adjustment means comprise at least one adjustable gas spring.7) The positioner of claim 1 , the at least one vertical support means further comprising at least one locking mechanism for locking the at least one vertical support assembly in place.8) The positioner of claim 1 , wherein the lateral support assembly may comprise at least two opposed torso support arms, each support arm being independently pivotally and telescopically connected to the at least one chair attachment.9) The positioner of claim 8, wherein each of the at least two torso support arms are independently pivotable about an x-axis, a y-axis, and telescopable about a z- axis, relative to the surgical table.10)The positioner of claim 1 , wherein the at least one side arm supports are telescoped inwardly and outwardly from the surgical table.11 )The positioner of claim 1 , the positioner further comprising at least one headrest releasably secured to the at least one vertical support assembly, the at least one headrest configured for releasably receiving at least one face mask.12)The positioner of claim 11 , wherein the at least one headrest may be mounted to the at least one vertical support assembly via a ball-and-socket joint.13)The positioner of claim 1 , wherein the positioner further comprises at least one face mask for securing the head of the patient.)The positioner of claim 13, wherein the face mask may comprise at least one flexible attachment means for securing the mask to the headrest. )The positioner of claim 13, wherein the face mask may comprise at least one adjustment mechanism for securing the mask to the headrest. )The positioner of claim 15, wherein the adjustment mechanism comprises a ratchet mechanism. )The positioner of claim 1 , wherein the positioner further comprises at least one intubation tubing support assembly. )The positioner of claim 17, wherein the at least one intubation tubing support assembly may be releasably secured to the positioner. )The positioner of claim 1 , wherein the positioner further comprises at least one bump arm assembly. )A method of using an improved beach chair positioner releasably connected to a surgical table, the method comprising: releasably mounting the positioner to a surgical table, adjusting at least one vertical support assembly of the positioner, and pivotally and telescopically adjusting at least one lateral support assembly, the lateral support assembly having at least one torso support arm, to support a patient placed on the surgical table. )The method of claim 20, wherein the positioner is releasably mounted to the surgical table using at least one quick-release connection means. )The method of claim 20, wherein the at least one vertical support means may be adjusted vertically and laterally relative to the surgical table.)The method of claim 20, wherein the vertical support means may be adjusted using at least one adjustable gas spring. )The method of claim 20, wherein the method further comprises locking the at least one vertical support means in place. )The method of claim 20, wherein the lateral support assembly may comprise at least two opposed torso support arms, and each at least two arms may be pivoted and telescoped independently. )The method of claim 20, wherein the method further comprises providing at least one headrest adjustably mounted to the positioner for receiving and supporting the patient’s head. )The method of claim 26, wherein the method further comprises providing at least one adjustable face mask for securing the patient’s head to the at least one headrest. )The method of claim 20, wherein the method further comprises providing at least one intubation support assembly. )The method of claim 20, wherein the method further comprises providing at least one bump arm assembly. )An improved face mask for use with a headrest element of a beach chair positioner, the face mask comprising: at least one support band for receiving and supporting the face of the patient, the at least one band releasably connected to the headrest, at least one releasable connection means for connecting the at least one supports back to the headrest, andat least one adjustment means for adjusting the tension of the at least one band supporting the face of the patient.31 )The mask of claim 30, wherein the mask is manufactured from flexible biocompatible material.32)The mask of claim 30, wherein the mask may be reusable or disposable.33) The mask of claim 30, wherein the releasable connections comprise snap fit connections.34)The mask of claim 33, wherein the snap fit connections form a male end releasably inserted into a corresponding female end.35)The mask of claim 34, wherein at least one of the male and female ends form an interior cavity having a plurality of teeth for receiving and gripping the at least one band.36)A method of using an improved face mask to support the head of a patient in a headrest during surgery, the method comprising: positioning at least one support band on the face of the patient, connecting the at least one support band to the headrest, adjusting the tension of the at least one support band on the face of the patient, wherein the tension of each at least one support band may be adjusted independently.

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