WO2014193739A1 - A system, apparatus and method for shoulder migration - Google Patents

A system, apparatus and method for shoulder migration Download PDF

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Publication number
WO2014193739A1
WO2014193739A1 PCT/US2014/039255 US2014039255W WO2014193739A1 WO 2014193739 A1 WO2014193739 A1 WO 2014193739A1 US 2014039255 W US2014039255 W US 2014039255W WO 2014193739 A1 WO2014193739 A1 WO 2014193739A1
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WO
WIPO (PCT)
Prior art keywords
shoulder
patient
recited
patient care
platform
Prior art date
Application number
PCT/US2014/039255
Other languages
French (fr)
Inventor
Michael Campagna
Original Assignee
Michael Campagna
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Michael Campagna filed Critical Michael Campagna
Publication of WO2014193739A1 publication Critical patent/WO2014193739A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G13/00Operating tables; Auxiliary appliances therefor
    • A61G13/10Parts, details or accessories
    • A61G13/12Rests specially adapted therefor; Arrangements of patient-supporting surfaces
    • A61G13/1205Rests specially adapted therefor; Arrangements of patient-supporting surfaces for specific parts of the body
    • A61G13/1255Shoulders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G13/00Operating tables; Auxiliary appliances therefor
    • A61G13/0036Orthopaedic operating tables
    • A61G13/0072Orthopaedic operating tables specially adapted for shoulder surgeries
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G13/00Operating tables; Auxiliary appliances therefor
    • A61G13/009Physiotherapeutic tables, beds or platforms; Chiropractic or osteopathic tables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G13/00Operating tables; Auxiliary appliances therefor
    • A61G13/10Parts, details or accessories
    • A61G13/12Rests specially adapted therefor; Arrangements of patient-supporting surfaces
    • A61G13/1205Rests specially adapted therefor; Arrangements of patient-supporting surfaces for specific parts of the body
    • A61G13/121Head or neck
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G2200/00Information related to the kind of patient or his position
    • A61G2200/30Specific positions of the patient
    • A61G2200/32Specific positions of the patient lying
    • A61G2200/325Specific positions of the patient lying prone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G2200/00Information related to the kind of patient or his position
    • A61G2200/30Specific positions of the patient
    • A61G2200/32Specific positions of the patient lying
    • A61G2200/327Specific positions of the patient lying supine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61GTRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G2210/00Devices for specific treatment or diagnosis
    • A61G2210/50Devices for specific treatment or diagnosis for radiography

Definitions

  • One or more embodiments of the invention generally relate to medical equipment.
  • the invention relates to a table mount for use with an anatomical positioner.
  • an aspect of the prior art generally useful to be aware of is that, traditionally, said migration of a subject's shoulders is effected via the following means.
  • One traditional method of migrating the subject's shoulders involves Kurlix Bandages that are wrapped around the forearms or wrists of the subject and pulled upon forcefully during live radiography for the purpose of temporary distal migration of the shoulder structures. This method may result in injury for example, without limitation, Brachial Plexus injury or insult to the subject's shoulder capsule due to over-application of distal migratory force.
  • shoulder separation Such an injury is referred to as shoulder separation, wherein the injury is typically characterized by the Rockwood Classification as Ligament Sprain to the Acromioclavicular Joint (AC Joint), possible Ligament Disruption and tearing , and vertical disruption of the Ac Joint as the acromion is separated from the acromial head of the clavicle .
  • Another traditional method of moving the subject's shoulders involves taping down the subject's shoulder's and trapezius muscles for the entirety of the procedure.
  • the shoulders are typically immobilized for the entirety of the procedure, which may result in some unintended results including, without limitation, Brachial Palsy Injury , sore trapezius, nerve damage, tingling hands, reduced digital sensation, and numbness as a consequence of extended unnatural positioning.
  • Figure 1 illustrates an exemplary universal table mount for a shoulder press in use on a surgical table, in accordance with an embodiment of the present invention
  • Figure 2 illustrates an exemplary mount for a shoulder press for use on patient surfaces without side rails, in accordance with an embodiment of the present invention
  • Figures 3 A and 3B illustrate an exemplary shoulder pusher, in accordance with the prior art.
  • Figure 3A is a diagrammatic top view
  • Figure 3B is a diagrammatic side view;
  • Figure 4 is a diagrammatic side view of an exemplary shoulder pusher, in accordance with an embodiment of the present invention.
  • Figures 5 A, 5B and 5C illustrate an exemplary one-piece shoulder pusher, in accordance with an embodiment of the present invention.
  • Figure 5 A is a diagrammatic side view.
  • Figure 5B is a diagrammatic top view, and
  • Figure 5C is a diagrammatic front view;
  • Figures 6A through 6C illustrate an exemplary shoulder pusher in accordance with an embodiment of the preset invention.
  • Figure 6A is a side perspective view.
  • Figure 6B is a diagrammatic top view, and
  • Figure 6C is a diagrammatic side view;
  • Figure 7 is a side perspective view of an exemplary anatomical positioning system comprising a shoulder pusher and universal table mounts, in accordance with an embodiment of the present invention
  • Figure 8 is a diagrammatic side view of an exemplary mounting clamp, in accordance with an embodiment of the present invention.
  • Figure 9 is an exemplary diagrammatic side view of the Visualization of the Lower
  • Figures 10 A-C show an exemplary diagrammatic front view of the anatomic structures of the shoulders , to include the Acromioclavicular joint , the Sternoclavicular Joint as well as the Brachial Plexus Nerve Bundle and Sub Clavial Arterial and veinous formations, in accordance with an embodiment of the present invention
  • Figures 11 A - E further depicts the anatomy of the Acromioclavicular joint by way of presenting a diagrammatic view of the bony structures of this joint, namely , the Acromion and the Clavicle both with and without the accompanying capsule and ligaments ;
  • Figure 12 illustrates a superior view of the entirety of the " Shoulder Girdle " , comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention
  • Figure 13 identifies the specific exemplary points of caudal migratory contact which are often directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub C la vial Arterial and Veinous formations;
  • Figure 14 further identifies exemplary points of compromise to the Brachial Plexus
  • Figure 15 illustrates an exemplary mechanism of possible damage expected to the Shoulder capsule via the application of force LATERAL to the Acromioclavicular Joint
  • Figure 16 illustrates various exemplary views depicting the normal anatomic function of the Shoulder Girdle as it migrates caudally;
  • Figures 17-20 illustrate various procedural aspects of an exemplary method of using a means of migration apparatus such as, without limitation, that of Figure 7, to more safely perform a shoulder migration procedure, in accordance with an embodiment of the present invention
  • Figure 17 illustrates an exemplary angle of approach and exemplary contact points of the present shoulder migration procedure method, in accordance with the foregoing embodiment of the present invention
  • Figure 18 further illustrates the exemplary Method of anatomic contact with the means of migration, e.g., without limitation, the Radiolucent and/or imaging compatible Arch, at the natural prominence of the Acromionclavicular Joint or Very proximately medial to the Joint at the Acromial Head of the Clavicle for the Radiolucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention;
  • the means of migration e.g., without limitation, the Radiolucent and/or imaging compatible Arch
  • Figures 19A and 19B illustrate a diagramatic side view of the method of usage shown in Figure 18;
  • Figure 20 illustrates the Thoracic Outlet 2001 , thru which the subclavial artery and subclavial vein , as well as the brachial plexus are enabled to pass without impingement as the natural mechanism of the shoulder girdle articulates caudally;
  • Figures 21 A to 21 F illustrate a plan, anterior view of the Supine Patient undergoing the exemplary naturalistic replication of the caudal migration of the shoulder girdle via the exemplary method of usage shown in Figures 17-20;
  • Figures 22 A-F illustrates an exemplary posterior overhead view of the Prone Patient from Figures 21 A-F, in accordance with an embodiment of the present invention
  • Figures 23 A and B illustrate an exemplary Superior View of the method of Usage shown in Figures 21 A-F, in accordance with an embodiment of the present invention
  • Figures 24 A and B depict a same or similar Method of Usage of the foregoing embodiment with all of the same or similar benefits as is depicted in Figures 23 A and B, except in the instance shown, usage is illustrated with a PRONE Patient;
  • Figures 25 A to D illustrate a Lateral View of the Supine Patient undergoing Caudal
  • Figure 26 A to D depicts the same results as Figures 25 A to D, except in the PRONE
  • Figures 27 thru 29 depict the Autcorrection of Angulation of the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention
  • Figure 28 illustrates the forgoing Method for Auto correction of Angulation and positioning for Prone Patient, in accordance with an embodiment of the present invention
  • Figure 29 illustrates the forgoing Method for Auto correction of Angulation and positioning for Supine Patient, in accordance with an embodiment of the present invention
  • Figures 30 A-C and 31 A and B illustrate an exemplary version of the foregoing embodiment that is fully compatible with and able to fit inside of the fixed or rotating;
  • Figures 30 A-C illustrate an example C-Arm Compatibility, in accordance with an embodiment of the present invention.
  • Figures 31 A and B illustrate the C-Arm Compatibility with an exemplary patient in prone position, in accordance with an embodiment of the present invention.
  • Figure 32 illustrates an exemplary O-arm / Body Tom Compatible version, in accordance with an embodiment of the present invention.
  • a reference to “a step” or “a means” is a reference to one or more steps or means and may include sub-steps and subservient means. All conjunctions used are to be understood in the most inclusive sense possible. Thus, the word “or” should be understood as having the definition of a logical “or” rather than that of a logical “exclusive or” unless the context clearly necessitates otherwise. Structures described herein are to be understood also to refer to functional equivalents of such structures. Language that may be construed to express approximation should be so understood unless the context clearly dictates otherwise.
  • references to "one embodiment,” “an embodiment,” “example embodiment,” “various embodiments,” etc., may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase "in one
  • a commercial implementation in accordance with the spirit and teachings of the present invention may configured according to the needs of the particular application, whereby any aspect(s), feature(s), function(s), result(s), component(s), approach(es), or step(s) of the teachings related to any described embodiment of the present invention may be suitably omitted, included, adapted, mixed and matched, or improved and/or optimized by those skilled in the art, using their average skills and known techniques, to achieve the desired implementation that addresses the needs of the particular application.
  • An aspect of the present invention is to recognize the problems caused by conventional shoulder migration methods, and to identify a more optimal approach, as will be explained in some detailed in the form of exemplary embodiments.
  • various prior art methods of shoulder migration may result in injury for example, without limitation, Brachial Plexus injury or insult to the subject's shoulder capsule due to over-application of distal migratory force.
  • shoulder separation Such an injury is referred to as shoulder separation, wherein the injury characterized by the Rockwood Classification as Ligament Sprain to the Acromioclavicular Joint , possible Ligament Disruption and tearing , and vertical disruption of the Ac Joint as the acromion is separated from the acromial head of the clavicle .
  • Another traditional method of moving the subject's shoulders involves taping down the subject's shoulder's and trapezius muscles for the entirety of the procedure.
  • the shoulders are typically immobilized for the entirety of the procedure, which may result in some unintended results including, without limitation, Brachial Palsy Injury , sore trapezius, nerve damage, tingling hands, reduced digital sensation, and numbness as a consequence of extended unnatural positioning, as well as the prolonged restriction of blood flow to the extremities of the arm and hand, due to prolonged compression of blood flow thru the sub -clavial artery and sub -clavial vein.
  • Another related method involves the usage of cloth or fabric harnesses , which replicate the effects of compressing the the trapezius thru taping , and actually aggravate these complications as the harness based solution applies significantly more compressive force not only across the trapezius but to the Acromioclavicular joint as well , migrating the AC Joint not caudally, but medialy as well , thereby not only compressing the brachial plexus and sub clavial arterial and veinous formations, but impinging the thoracic outlet thru which this neurovascular bundle would normally travel unimpeded.
  • Some embodiments of the present invention may provide a table attached device, or universal table mount, for a shoulder press that provides a firm and stable, horizontal cradled platform upon which the shoulder press can travel and lock in such a way as to effectively and consistently replicate the action and application of sustained force for the duration of an X-Ray, which would otherwise be delivered by a live operator.
  • the table mount allows for the reliable and correct positioning and quick release of the shoulder press without the necessity or presence of a live operator during the actual patient X- Ray, thereby generally eliminating the possibility of exposure to radiation for all personnel.
  • the handheld nature of the shoulder press device offers no such protection and precludes the use of the shoulder press device in environments where a C-ARM (i.e., Intraoperative Flouroscope) is utilized due to harmful exposure levels.
  • a C-ARM i.e., Intraoperative Flouroscope
  • the table mount allows for one time set-up and continuous positioning of the shoulder press in immediate proximity to the usage site, thereby generally eliminating the complicated procedure of maneuvering and positioning the shoulder press in the ubiquitous environment of leads, lines, anesthesia and monitoring equipment, as well as greatly simplifying the usage of the shoulder press without disturbing these sensitive arrays.
  • some preferred embodiments of the present invention enable the application of continuous and consistent traction/ migration of the shoulders for the entirety of the approximate 10 minute duration of either an actual screw placement during a cervical vertebral plating procedure, or for the approximate 10 minute duration of trial placement and implantation of an artificial cervical disc during a cervical arthroplasty disc placement procedure, thereby allowing fully optimized live , real time fluoroscopy of the entirety of these crucial phases of the surgical procedure.
  • some embodiments of the present invention may offer significant clinical benefit to correct placement of implants with commensurate significant benefit to surgical outcome for the patient.
  • alternate usages for some embodiments of the present invention may be conceived such as, but not limited to, usage in an X-Ray room, usage by paramedics, usage in the trauma specialty for diagnosis, usage by orthopedic surgeons as a surgical positioner for patient extremities during revision hip arthroplasty, etc.
  • Further alternate usages for preferred embodiments of the present invention may also be conceived such as, but not limited to, usage in various surgical, diagnostic and imaging procedures as an anatomical positioner for applications throughout the entire human anatomy relating to all aspects of patient care and specialties.
  • FIG. 1 illustrates an exemplary universal table mount 101 for a shoulder press 103 in use on a surgical table 105, in accordance with an embodiment of the present invention.
  • table mount 101 is comprised of two distinct yet mirror imaged sections, a dedicated right section 107 and a dedicated left section 109. Alternate embodiments may be implemented in which the left and right sections of the mount are connected.
  • right section 107 and left section 109 clamp onto surgical table 105, which is equipped with industry standard accessory side rails 111 provided by table manufacturers for the use of the surgical staff in mounting various necessary equipment to surgical table 105 for use during surgery.
  • Accessory side rails 111 may use American standard or metric measurements, and universal table mounts according to preferred embodiments of the present invention may be available in distinct clamping sizes to accommodate these industry standards.
  • Right section 107 and left section 109 of table mount 101 slide easily onto accessory side rails 111, and an attachment mechanism 113 fully seats and is secured with a simple twist dial 115.
  • Guide rails 117 extend from attachment mechanisms 113 onto which upward supports 118 are slidably attached with slides 119.
  • Attachment mechanisms 113 are preferably made of aluminum; however, the attachment mechanisms in alternate embodiments may be made of different materials such as, but not limited to, different metals or plastic.
  • Guide rails 117 and upward supports 118 are preferably one-inch square aluminum bars.
  • mount rails and upward supports in alternate embodiments may be made in different shapes and sizes and be made of various different materials such as, but not limited to, different metals or plastic.
  • slides 119 are preferably made of plastic; however, alternate materials such as, but not limited to, various metals may also be used.
  • slides 119 comprise handbrakes 121 that enable upward supports 118 to be locked into place on guide rails 117.
  • shoulder press 103 In typical use of the present embodiment, after mounting table mount 101 to accessory side rails 111, placement of shoulder press 103 within a shoulder press cradle is quick and easy, and shoulder press 103 is secured within the shoulder press cradle with adjustable/pivoting L-Shaped restraints 123 provided to accommodate this function.
  • an operator may apply the 24 to 37 pounds of motive force upon the acromioclavicular joint and/or the Acromial head of the clavicle very proximately medial to the AC Joint with shoulder press 103 by squeezing handbrakes 121 and pushing upward supports 118 or shoulder press 103 toward the patient on surgical table 105.
  • the application of motive force by the operator along with the hand actuation of handbrakes 121 advances the position of shoulder press 103.
  • shoulder press 103 is correctly positioned, the operator releases handbrakes 121 to lock sliders 119 and therefore shoulder press 103 in place.
  • the operator may swiftly and easily unlock and move shoulder press 103 away from the patient by squeezing handbrakes 121 and pulling back.
  • Some embodiments may also comprise a quick release mechanism for the handbrakes so that the shoulder press may be immediately moved away from the patient in case of an emergency.
  • the travel of the upward supports and the shoulder press within the shoulder press cradle along the guide rails is unidirectional toward the patient.
  • the upward supports are able to move freely toward the patient and are prevented from moving away from the patient through the incorporation of an internal friction braking system.
  • the actuation of a brake release allows for a reversal of travel away from the patient by releasing the internal friction braking system.
  • the friction brake resists all backward motion due to tilting and comprises a hand control that reorients the tilt by finger tapping in order to enable backward movement.
  • the friction brake preferably uses a large trigger somewhat akin to a bicycle handbrake lever.
  • a bicycle brake uses a caliper style set of rubber pads whereas this friction brake uses no calipers, discs or pads and instead utilizes the slight offset of a channel and the guide rail of the table mount to halt backward motion unless the internal offset is lessened through application of the trigger/brake release.
  • Other alternative embodiments may employ differing means for halting the backward motion. These other alternative means will also have at least one hand control means for enabling backward movement.
  • guide rails 107 and 117 are equipped with a toothed rack assembly situated within an internal channel, such that the toothed rack assembly provides an additional means of braking to the internal friction braking system when actuated via the release of the trigger mechanism 121, such braking system to enable a spring loaded caliper to mesh with the toothed rack assembly for purposes of halting travel across guide rails 107 and 117 upon release of trigger actuator 121, and said spring loaded caliper to be released from communication with the toothed rack assembly for purposes of restoration of free travel across guide rails 107 and 117 upon application of pressure to trigger actuator 121.
  • FIG. 2 illustrates an exemplary mount 201 for a shoulder press 203 for use on patient surfaces without side rails, in accordance with an embodiment of the present invention.
  • mount 201 comprises variable clamps 207 rather than attachment mechanisms for sliding onto an accessory side rail.
  • Variable clamps 207 slide over the edges of a patient surface and are held in place by actuating plates 209 that squeeze the edges of the patient surface when clamp locks 211 are employed.
  • clamps may be locked into position by any number of devices such as, but not limited to, levers, dials, knobs, etc. that are deemed appropriate to the patient anatomy the alternate embodiments address.
  • mount 201 to be attached to surfaces other than operating room surgical tables with side rails for example, without limitation, other types of patient beds and tables, paramedic long boards, imaging tables, exam tables, etc., any other patient care surfaces unrestricted to unrestricted to horizontal positions, and whatever variable geometry offered by the patient care surface, whether fixed or movable during usage
  • shoulder press 203 may be attached to a long board with mount 201 to quickly assist in correct visualization of the cervical spine of the patient to determine if there is an injury.
  • One aspect of the present invention is the of identifying and solving problems attendant to prior art approaches is to discover approaches that more optimally achieve a very difficult balance between the competing properties of sufficient strength and sufficient radio lucent and/or imaging compatible properties.
  • Some embodiments of the present invention provide means for shoulder migration during radiography that alleviate line of sight overlayment of the vertebral structures while maintaining sufficient strength to exert the motive force necessary to migrate the shoulders.
  • Preferred embodiments are implemented without a carbon/glue interface, which directly overlays the lower cervical vertebral bodies in the prior art. Preferred embodiments also provide density reduction to all structures of the shoulder pusher as compared to the prior art.
  • the Shoulder Pusher is a rigid radiolucent and/or imaging compatible positioning device utilized for migrating the shoulders.
  • the Shoulder Pusher is a radiolucent and/or imaging compatible U shaped member that is positioned on the shoulders to transmit motive force.
  • the structure of this device does not have a method of construction that can accomplish this feat effectively.
  • the difficulty of construction of such a device stems from the occurrence of an artifact, which refers to the obscuration of radiography via structural density. Dense objects cause an opaque shadow during X-ray which obscure a clear view of pertinent structures necessary for diagnostic and intra-operative radiography.
  • none of the prior arts which have been cited in reference to the Shoulder Pusher involved any radio lucent and/or imaging compatible function as a pertinent part of their designs. They are all merely simple uniform density arches which shared a simple external appearance to the arch as illustrated in the shoulder pusher.
  • FIGs 3A and 3B illustrate an exemplary shoulder pusher 300, in accordance with the prior art.
  • Figure 3A is a diagrammatic top view
  • Figure 3B is a diagrammatic side view.
  • Shoulder pusher 300 comprises a pair of simple arches 303 of uniform density that are bisected by a pair of simple pusher tubes 305.
  • Pusher tubes 305 are connected by an adjustable connection tube 306.
  • Shoulder pusher 300 provides a means of temporary migration of the shoulders via the handheld application of bilateral motive force during cervical vertebral radiography for the purpose of obtaining optimized lateral imaging of a subject's cervical vertebral column unimpeded by the unintended imaging of the structures of the subjects shoulders.
  • Arch 303 is permanently attached to pusher tube 305 via a carbon/glue interface 307 at the point of bisection.
  • carbon fiber is an essentially brittle material
  • the thickness and density of arch design are essential for purposes of strength as is the placement of pusher tubes 305 in such a manner as to bisect the circumference of arches 303.
  • arches 303 of shoulder pusher 300 are positioned on the subject's shoulders and, when pusher tubes 305 are pushed by an operator, transmit a motive force upon the shoulders, facilitating the transient movement of these structures to visualize an additional two to three vertebrae.
  • shoulder pusher 300 actually alleviates some artifact due to a clear view of the cervical vertebral structures via a temporary migration of the shoulders, shoulder pusher 300 concurrently contributes artifact.
  • surgeons have reported that shoulder pusher 300 actually contributes as much artifact as it alleviates, rendering shoulder pusher 300 a partial, as opposed to complete, improvement over the traditional means of optimization of radiography via migration of the subject's shoulders.
  • FIG 4 is a diagrammatic side view of an exemplary shoulder pusher 400, in accordance with an embodiment of the present invention.
  • shoulder pusher 400 comprises an arch 403 and a pusher tube 405 similar to shoulder pusher 300 shown by way of example in Figure 3.
  • pusher tube 405 in shoulder pusher 400 is asymmetrically positioned at the lower portion of arch 403 as opposed to bisecting the arch from a straight position, as in the prior art. This generally eliminates the direct line of sight occlusion of the vertebral column by pusher tube 405 as viewed laterally.
  • shoulder pusher 400 incorporates a method to reduce the density in the construction of arch 403 in portions where arch 403 directly overlays the radiographic line of sight of the vertebral column when viewed laterally. In many practical applications, this is achieved via elimination and replacement of the tube component and accompanying carbon/glue interface to the arch portion with a single unified composition planar sheet of radiolucent and/or imaging compatible material including, without limitation, Carbon Fiber, PEEK, Beryllium, Glass Fiber Reinforced Acrylic (which may also be referred to as fiberglass) , Thermoplastics,
  • arch 403 comprises an advanced curvilinear design employing eccentric geometry in order to further reduce density as much as possible.
  • This eccentric geometry uses segments of circles with different centers to create arch 403, rather than an arch that is a composed of a single circle segment with a single center point. Incorporating what may be thought of by analogy to a "Stealth Technology".
  • This variable density curvilinear architecture is constructed so as to present the thinnest portions of the planar segment to the lateral radiographic view of the cervical vertebral structures, while concurrently widening in the portions outside of the critical beam path, thus distributing the acceptable force load evenly across the shoulders as they are migrated temporarily via the application of distal motive force by the handheld operator. Additionally, the present embodiment eliminates the carbon/ glue plug as a means of fixating the various portions, and instead fashions the entirety of the portions into a one-piece composition as referenced above. It is important that strength be preserved in this more gracile design, while simultaneously preserving sufficient thickness so as to not cause overt of pressure to the subject's shoulders during the application of motive force.
  • shoulder pusher 400 comprises a thin, invisible buttress 407 (being constructed of a radiolucent and/or imaging compatible material) attached to the top of the thin, eccentric, curvilinear arch 403 for purposes of strength and stability.
  • the present embodiment may also comprise an ergonomic handgrip at the end of pusher tube 405 away from arch 403 for the operator to hold during use.
  • Shoulder pusher 400 is preferably made of carbon fiber; however, other radiolucent and/or imaging compatible materials may be used such as, but not limited to Carbon Fiber, PEEK, Beryllium a non-Magnetic Metal, Glass Fiber Reinforced Acrylic, Thermoplastics, Polycarbonates, Polyketones, and any other such compositions as prove amenable to usage in Rigid Radiolucent and/or imaging compatible Positioning. Clinical trials of shoulder pushers according to the present embodiment have resulted in vast improvements in radiographic results as artifact is significantly reduced.
  • Figure 4 relies upon glue to join the disparate parts of complex arch 403.
  • Some embodiments of the present invention seek to generally eliminate any inherent weaknesses while concurrently seeking to reduce any and all artifact to virtually non-existent levels with the ultimate goal of producing a virtually invisible and virtually indestructible radiolucent and/or imaging compatible arch.
  • Buttress 407 is focused on for optimization to improve the entire design via an increase of strength and radiolucent and/or imaging compatible properties since buttress 407 is the main load bearing component of shoulder pusher 400 and the most radiolucent and/or imaging compatible component.
  • Preferred embodiments extend the buttress to create the main body of the shoulder pusher as a one- piece structure to provide strength and to eliminate glue interfaces which may produce artifact.
  • Figures 5 A, 5B and 5C illustrate an exemplary one-piece shoulder pusher 500, in accordance with an embodiment of the present invention.
  • Figure 5 A is a diagrammatic side view.
  • Figure 5B is a diagrammatic top view
  • Figure 5C is a diagrammatic front view.
  • shoulder pusher 500 is a one-piece anatomic radiolucent and/or imaging compatible positioning device of variable density comprising a variable width radiolucent and/or imaging compatible arch 503 formed at the terminus of an asymmetrically offset tapered arm 505 of radiolucent and/or imaging compatible sheeting.
  • shoulder pusher 500 is preferably made of carbon; however, alternate embodiments may be made of various different radiolucent and/or imaging compatible materials such as, but not limited to, Carbon Fiber, PEEK, Beryllium, Glass Fiber Reinforced Acrylic/Fiberglass, Thermoplastics, Polycarbonates,
  • tapered arm 505 is asymmetrically positioned at the lower portion of arch 503 and is slightly angled. This positioning of tapered arm 505 generally eliminates artifact caused by the shoulder pusher directly overlaying the vertebral column when in use, as in the prior art, while still enabling an operator to transmit the necessary motive force to migrate the shoulders. Alternate embodiments may be implemented where the tapered arm is positioned at the top of the arch. In the present embodiment, the reduced density of the thin yet strong combination of all of the radiolucent and/or imaging compatible structures into one low density sheet renders shoulder pusher 500 virtually free of artifact.
  • the thickness of shoulder pusher 500 varies throughout its structure. This enables the density of shoulder pusher 500 to be lower over key anatomical features to be visualized while still preserving the mechanical integrity necessary to efficiently and comfortably migrate the shoulders. For example, without limitation, a middle portion 511 of arch 503 is thinner than outer portions 513. This enables arch 503 to be thick enough where needed to comfortably migrate a subject's shoulders without the excessive pressure that would be caused by a uniformly thin arch while providing low density in the area over the cervical vertebrae. Those skilled in the art, in light of the present teachings, will readily recognize that the variance in density of the structure of the shoulder pusher may be different in alternate embodiments.
  • one alternate embodiment may have a uniform thin density except for a thickened edge, similar to a lip, along the arch where the shoulder pusher comes into contact with the subject.
  • Some embodiments may be implemented to view specific portions of the subject's anatomy; for example, without limitation, one such embodiment may have a thicker density near the arch and a lower density away from the arch in order to obtain radiographic images of the higher cervical vertebrae.
  • Some embodiments may include padding along the edge of the arch for the comfort of the subject.
  • arch 503 has an eccentric curvilinear design that also contributes to the low density of shoulder pusher 500.
  • Alternate embodiments of the present invention may have eccentric arches of various different shapes and sizes to accommodate a variety of subjects, such that the density reduction methodologies described herein may be applied to various anatomical structures outside of the cervical vertebral bodies, while still utilizing the single piece planar composition of radio lucent and/or imaging compatible material combined with the eccentric geometry of the variable density arch.
  • One practical embodiment of the variable density arch employs variation in the structural geometry of the arch itself in order to minimize radiographic artifact while still preserving crucial structural strength and integrity.
  • shoulder pusher 500 comprises attachment means 509 for a connection tube, a handle, a table mount, or other such equipment that aids in the use of shoulder pusher 500.
  • two shoulder pushers 500 are used to migrate the shoulders of a subject during a radiographic procedure. Some procedures may only require the use of one shoulder pusher 500 to migrate one shoulder.
  • shoulder pushers 500 may be coupled together, for example, without limitation, with an adjustable connecting tube, as shown by way of example in Figure 3.
  • Shoulder pusher 500 is typically used to migrate the shoulders of a subject toward the subject's feet in a pushing mode. In the pushing mode, arch 503 of shoulder pusher 500 is placed on the subject's shoulder and an operator pushes shoulder pusher 500 into the subject's shoulder in order to cause the shoulder to migrate toward the subject's feet.
  • shoulder pusher 500 not only has utility in the pushing mode but also in a pulling mode and an encircling mode for various usages where radiographic anatomical positioning may be necessary for example, without limitation, MRI compatible anatomic limb positioning, Scoliosis positioning, diagnostic positioning, etc.
  • the pulling mode whereas the present arch would be fashioned so as to transmit proximal migratory pressure for purposes of rigid radio lucent and/or imaging compatible positioning, the unified composition could be altered slightly while simultaneously making full usage of the density reduction methodology herein described.
  • the present arch would be constructed so as to reverse the direction of the arch such that in the hand held or table mounted functions, the method of the variable density / variable geometry arch could pull as opposed to push the shoulders with attachment points to a Patient Positioning Platform, which, in many practical applications, could be of significant clinical and diagnostic value as regards Radiography for Emergent Trauma in the E.R.
  • the present arch In the encircling mode, whereas the present arch would be fashioned to work in tandem so as to encircle limbs, etc.
  • the unified composition could be altered slightly while simultaneously making full usage of the density reduction methodology herein described, it should be noted that in the encircling modality it is contemplated that the present arch would have practical value and implementations as a limb / anatomical positioner in the clinical / surgical / diagnostic settings of the, without limitation, MRI / CT and other emerging imaging environments , where the method and discipline of rigid radio lucent and/or imaging compatible positioning is being pioneered and made possible by the present embodiment of the arch method of mechanically usable / viable density reduction of radio lucent and/or imaging compatible structures.
  • a multiplicity of alternative usages of the present arch embodiment as a lateral anatomic rigid radio lucent and/or imaging compatible positioner for clinical / diagnostic / surgical settings will be readily apparent to those skilled in the art in light of the teaching of the present invention. Examples of which include, without limitation, spinal and hip positioners for usage during surgery to correct for scoliosis , possible usage for pinpoint mammography , head positioners ( halos) which would capture and gently fixate the patients head in encircling radio lucent and/or imaging compatible arches without resort to percutaneous pin fixation thru the patients skin. Testing with shoulder pusher 500 has shown near total elimination of all density artifact such that the usage of shoulder pusher 500 appears to occur almost invisibly.
  • Shoulder pusher 500 also exhibits tremendous strength of design, such that a pair of shoulder pushers according to the present embodiment can withstand load bearing of weight up to and beyond 1200 pounds.
  • a multiplicity of alternative applications of the present arch as a lateral anatomic rigid radio lucent and/or imaging compatible positioner for clinical / diagnostic / surgical settings will be obvious to those skilled in the art. Examples of which include, without limitation, spinal and hip positioners for usage during surgery to correct for scoliosis, possible usage for pinpoint mammography, head positioners (halos) which would capture and gently fixate the patients head in encircling radio lucent and/or imaging compatible arches without resort to percutaneous pin fixation thru the patients skin.
  • a multiplicity of alternative usages as rigid radio lucent and/or imaging compatible positioners is possible for use throughout the anatomy.
  • Some shoulder pushers are hand held radiolucent and/or imaging compatible shoulder positioning devices designed to effect the transient distal migration of a subject's shoulders during lateral radiography, thereby allowing optimized visualization of the cervical vertebrae under X-Ray or other radiography.
  • the utilization of such shoulder pushers in this modality is effected by a live operator positioned at the head of a surgical table delivering this motive force thru handheld positioning and manipulation.
  • the live operator is exposed to radiation from the radiography, which is an undesirable consequence of using hand held shoulder pushers.
  • these shoulder pushers are often used in a complex surgical environment comprising a multitude of leads, lines and monitoring equipment around which the operator must maneuver, which may be a difficult task.
  • shoulder presses are typically utilized below sterile draping, which is
  • said device routinely delivers an average of 12 to 16 lbs. of pressure directly to area of the acromioclavicular joint and to points very proximately medial, namely , the acromial head of the clavicle, all the while coming into simultaneous contact with the subject's epidermis.
  • some embodiments may comprise sufficient padding so as to alleviate said distal migratory pressure for the comfort of the subject, while concurrently providing an impermeable layer between the shoulder press and the subject's epidermis for purposes of generally preventing pathogen transfer from subject to subject.
  • a practical embodiment of the present invention provides means for rigid radiolucent and/or imaging compatible shoulder positioning for purposes of improved intraoperative and diagnostic lateral radiographic visualization of the cervical vertebral column during lateral views. Many practical embodiments alleviate density artifacts while maintaining strength in a rigid radiolucent and/or imaging compatible shoulder positioning apparatus. Additionally many practical embodiments comprise means for attaching said improved rigid radiolucent and/or imaging compatible shoulder positioning devices to a patient positioning table in an operating room setting such that direct manual operation of the device is typically rendered unnecessary during live radiography of the subject. Furthermore, some practical embodiments comprise a padded, substantially impermeable sheath for purposes of subject comfort, safety, and the general prevention of pathogen transfer from subject to subject.
  • One practical embodiment of the present invention provides a hands free, variably positioning, variably position-able, table mounted system comprising a pair of fully radio lucent and/or imaging compatible , asymmetrically offset, high strength, parallel laminar sheets yoked in tandem via an adjustable width crossbar.
  • These laminar sheets are equipped with a pair of radio lucent and/or imaging compatible , ergonomically padded, disposable sheaths provided for the dual purpose of creating a substantially impermeable barrier against subject to subject pathogen transfer, while concurrently providing a cushioned layer to dissipate and ameliorate the distal migratory motive force transferred via the yoked tandem arches to the shoulders of the subject.
  • the shoulder pusher may be variably and universally mounted to an operating room table to be brought into contact with a subject's shoulders and made to temporarily migrate and hold said shoulders under conditions of live lateral radiography, without radiation exposure to an operator holding the shoulder pusher in place.
  • Figures 6A through 6C illustrate an exemplary shoulder pusher 600 in accordance with an embodiment of the preset invention.
  • Figure 6A is a side perspective view.
  • Figure 6B is a diagrammatic top view
  • Figure 6C is a diagrammatic side view.
  • shoulder pusher 600 comprises two parallel laminar sheets 603, which are yoked in tandem by an adjustable width cross member 605.
  • Laminar sheets 603 are made of a radio lucent and/or imaging compatible material and are asymmetrically offset terminating in complex geometric, variable density arches 607.
  • Laminar sheets 603 generally do not overlay the vertebral column during radiography, and the unified construction of laminar sheets 603 offers strength and low density due to the lack of glue joints.
  • Laminar sheets 603 also comprise an optimized geometry that is thinner over a target point for radiology and thicker in other areas to provide strength.
  • Variable density arches 607 provide the typical point of contact between shoulder pusher 600 and the anatomy of the subject at or very proximately medial to the acromioclavicular joint.
  • cross member 605 comprises an adjustment dial 611, which enables a user to extend or retract cross member 605 to make the space between laminar sheets 603 wider or narrower.
  • this cross member may not be adjustable, and other alternate embodiments may be implemented without a cross member.
  • the laminar sheets may be used independently from each other or may be connected by various different means such as, but not limited to, a curved handlebar-type mechanism, a flexible connector, a cable, etc.
  • cross member 605 comprises ergonomic handles 613.
  • handles in alternate embodiments may have a multiplicity of suitable shapes, and some alternate embodiments may be implemented without handles on the cross member.
  • the pusher member(s) may comprise a variety of different shapes and sizes including, without limitation, tubes, bars, lattice-like networks, sheets with or without openings, etc. all of which may be solid or hollow.
  • some alternate embodiments may comprise more or fewer pusher members.
  • Embodiments comprising a plurality of pusher members may be fashioned so as to make contact of the pusher member with the arch member along the full continuum of the arch
  • Some alternate embodiments may comprise solid pusher members which are contiguous in all ways with the arch members.
  • Other alternate embodiments may comprise pusher members that are laminar sheets of varying shapes and sizes such as, but not limited to, L-shapes, triangular shapes, rectangular shapes, etc.
  • the point of contact between arch 607 and the subject is typically at the anatomic feature identified as the acromioclavicular joint and/or very proximately medial to this structure at the acromial head of the clavicle , said acromial head involving itself with the ligaments of the capsule of the Acromioclavicular Joint, as this narrow point of contact typically yields an excellent result for distal migration of the shoulders, replicating the functionality of the articulating shoulder girdle as it migrates caudally.
  • contact may be established between the arch and areas adjacent to the acromioclavicular joint very proximately medial, such as, without limitation, the acromial head of the clavicle , as the application of distal migratory motive force to these anatomical points of interface with a rigid radio lucent and/or imaging compatible member will replicate the function of the shoulder girdle without either compression or elongation to the brachial plexus and sub-clavial bloodflow as is commonplace with the Traditional means , thereby delivering significantly safer and more efficient clinical results.
  • some embodiments of the present invention provide temporary distal migration and temporary traction of the acromioclavicular joint and the area of the Acromial head of the Clavicle , situated very proximately medial to the acromioclavicular joint, in order to facilitate optimized intraoperative and diagnostic lateral radiographic views of the cervical vertebral column.
  • FIG. 7 is a side perspective view of an exemplary anatomical positioning system comprising a shoulder pusher 700 and universal table mounts 701, in accordance with an embodiment of the present invention.
  • shoulder pusher 700 comprising two high strength, radio lucent and/or imaging compatible, parallel laminar sheets 703 terminating in complex variable density arches 705 connected by an adjustable cross member 707, is seated in a pair of cradles 709, one on each table mount 701, equipped with swivel locks 711 for purposes of supporting and affixing shoulder pusher 700 variably to a patient platform 719.
  • Swivel locks 711 allow for full width adjustment of cross member 707 while concurrently allowing for automatic correct angulation of laminar sheets 703 to provide a proper interface between arches 705 and the anatomy of a subject's shoulders. Swivel locks 711 swivel around in both clockwise and counterclockwise fashion thus allowing the T-intersections of cross member 707 and laminar sheets 703 to pass through swivel locks 711 during length adjustment of cross member 707.
  • Cradles 709 connect to a pair of movable slides 713 offering full travel along the length of twin rail assemblies 715, which are mountable anywhere along the full continuum of a typical accessory side rail 717, which runs along the full length of both sides of patient platform 719.
  • Rail assemblies 715 attach to side rails 717 via a set of lockable clamps 721, which are variably position-able and lockable anywhere along the full continuum and length of side rails 717, making universal table mounts 701 compatible with virtually all, tables, surgical set-ups, and techniques common and uncommon to cervical vertebral surgery.
  • Movable slides 713 offer full travel along the length of rail assemblies 715 and are equipped with trigger mechanisms 723 for releasing and actuating a braking mechanism within each slide 713. Slides 713 allow for back and forth directional movement along rail assemblies 715 when triggers 723 are depressed by a user. Braking mechanisms within slides 713 automatically halt travel along rail assemblies 715 when triggers 723 are released.
  • the braking mechanisms within slides 713 interlock with a toothed rack within rail assemblies 715 to provide a unidirectional automatic braking system.
  • Engaging triggers 723 actuates the braking mechanisms away from the toothed racks to enable free movement of slides 713, and letting go of triggers 723 releases the braking mechanisms back into the toothed racks thereby resulting in automatic hands free braking of travel of slides 713 cradling shoulder pusher 700 against the shoulders of the patient.
  • a multiplicity of suitable braking systems may be implemented in some alternate embodiments including, but not limited to, a friction braking system, a ratcheting brake system, a pneumatic brake system, an electromechanical braking system, a spring loaded braking system, an air cylinder braking system, a bladder/inflation actuated braking system, etc.
  • any of these braking systems may be fitted with remotely or non- remotely operated electromechanical means of single or multiple operator actuation.
  • the braking systems in some alternate embodiments may be configured to provide bidirectional braking.
  • the braking system is operator actuated via passive means, whereby the release of triggers 723 (i.e., the absence of the operator) renders automatic braking and the actuation of triggers 723 retards the braking system, restoring travel.
  • triggers 723 i.e., the absence of the operator
  • various different direct means of operating, actuating and/or releasing the braking system may be apparent to those skilled in the art.
  • direct means include, without limitation, dials, twist knobs, handles, buttons, levers, rods, etc.
  • the actuation of the direct means of operation variously apply and set the braking system, thereby retarding travel, while the opposite actuation of which releases the braking system and restores full functionality of travel.
  • Yet other alternate embodiments may comprise various different indirect means of operation of the braking system, including, but not limited to, any and all mechanical and electromechanical remote means which would affect simultaneous hands free locking and release of the brake by a single operator or multiple operators.
  • the anatomical positioning system also comprises a pathogen guard 725, which is a padded, impermeable, disposable sheath that covers portions of laminar sheets 703 that come into contact with or are near the subject.
  • a pathogen guard 725 which is a padded, impermeable, disposable sheath that covers portions of laminar sheets 703 that come into contact with or are near the subject.
  • pathogen guard 725 comprises a Polyolefm material. In other embodiments transparent materials such as, but not limited to, PVC or polycarbonate may be used. Pathogen guard 725 comprises a radio lucent and/or imaging compatible pad 727 at the point of contact with the subject (i.e., without limitation, the acromioclavicular joint and/or slightly medial at the acromial end of the clavicle /shoulder). Radio lucent and/or imaging compatible pad 727 may comprise a medical grade foam such as, but not limited to, polyether, polyester, polyethylene, cross-link polypropylene, & flexible urethane.
  • Pathogen guard 725 acts as a padded prophylaxis generally preventing subject to subject transfer of pathogens such as, but not limited to, MRSA, as well as providing padding for patient comfort and to generally prevent abrasions to the subject thru which pathogens may enter the body.
  • the pathogen guard may be a pad which is permanently affixed to the arch portion of the laminar sheet where it makes patient contact or a variably affixed pad or may be non-disposable pads that slip over the ends of the laminar sheets.
  • pathogen guard 725 may be form fitting or loosely configured.
  • the pathogen guard may be fixated via various different means such as, but not limited to, a press seal, hook and loop material, tape, elastic, adhesive, etc.
  • Other alternate embodiments may provide separate padding and protection from pathogens. These embodiments enable the padding to be reused, and the pathogen guard alone to be discarded after use.
  • embodiments may be implemented without a padding feature, without a pathogen guard or with neither of these features.
  • the anatomical positioning system is mounted to patient platform 719.
  • the shoulder pusher 700 may be positioned with the arches 705 in a vertical position such that the patient may be positioned on the table and/or other equipment is placed on or about the table.
  • the position of shoulder pusher 700 is rotated and adjusted so that arches 705 are brought into contact with the shoulders of the subject.
  • a user may temporarily migrate the shoulders by depressing triggers 723 and pushing on shoulder press 700. Once the shoulders are properly migrated, the user releases triggers 723 to activate the braking mechanisms and hold shoulder press 700 in place. This enables the shoulders to remain in the migrated position under conditions of live lateral radiography, typically without the need of a hand held operator.
  • the system may or may not be used with pathogen guards 725 on one or both laminar sheets 703.
  • the positioning system according to the present embodiment is compatible with the three most common surgical set-ups in addition to other types of set-ups. Furthermore, the positioning system is compatible with virtually all tables and virtually all surgeon stances and techniques. The operation of the positioning system does not require a user to exert much strength and can be easily operated by a single user in accordance with some safety considerations.
  • the positioning system also provides automatic hands free locking and means for immediate withdrawal by a single user. In a non-limiting example, a user may tap the release triggers 723 to withdraw the shoulder press 700 from the patient. Complete withdrawal of shoulder press 700 from a surigal field is accomplished by simply disengaging swivel locks 711.
  • the positioning systems allows for variable intra-operative migration, as opposed to static migration provided by some traditional techniques such as, but not limited to, sand bags on straps, harnesses, or tape.
  • the positioning system provides high strength braking under continuous load.
  • the positioning system fits within the already crowded area of a typical cervical surgical environment, generally without interference to other commonplace and necessary equipment.
  • a user can push as hard as he likes on shoulder pusher 700.
  • the acromioclavicular joint typically migrates until it reaches the best caudal (i.e., towards the feet) migration, and then it stops. This migrating motion is similar to a subject placing a 15 to 20 pound bag on his shoulder.
  • arches 705 By placing arches 705 on the
  • Some alternate embodiments may comprise mechanical force gauges to provide feedback to the medical personnel as to the force being applied to the subject's
  • electronic sensors and displays may be incorporated to monitor the forces applied.
  • automatic safety releases may activate to release the braking mechanisms if an amount of force exceeds a preset limit.
  • Some alternate embodiments may comprise an emergency brake in the form of a clamshell-like rail clamp that can open and drop down. A rail clamp, shuch as shown in Figure 8, may be quickly removed without removing other equipment from the rail.
  • mounting clamps 721 of the universal table mounts are shown to slide onto accessory side rails 717, as provided ubiquitously and to standard measurements by many manufacturers of operating room tables.
  • Mounting clamps 721 may also be attached to drop down side rail attachments configured as temporary rails which can be added to radio lucent and/or imaging compatible tops available in newer tables being offered with compatibility to the evolving CT, MRI and O-Arm imaging environments as these tables typically do not include permanently affixed accessory side rails.
  • the mounting clamps may be configured to fit the standard rail dimensions as applicable to all international usage including, without limitation, metric standards as well as Japanese standards.
  • the mounting clamps may be attached to the end or side of the operating table itself and not to the accessory side rails.
  • the laminar sheets may be lengthened to accommodate this alternative clamp.
  • the rail assemblies may be made to attach to a central cantilevered column (i.e., pylon) of a Jackson Table, offering a Jackson Table specific solution.
  • Yet other alternate embodiments may be configured to fit various different types of tables at specific locations such as, but not limited to, mounting clamps which fit universally at the peripheries of the head of the bed , specifically at the upper corners of the bead , to which the rail assembly is attached, such that the system can be universally attached without resort to the use of any side rails.
  • some alternate embodiments may be configured to function with a particular type of surgical set-up, as opposed to a universal solution as disclosed in the present embodiment.
  • Non-limiting examples of such embodiments include, without limitation, a clamp which fits onto the same portion of the operating table that a typical Mayfield head holder attaches or a clamp which may work with a head on a typical bed set-up, yet would not be compatible with the Jackson Table or the various surgical head holders commonplace in cervical vertebral surgery.
  • Yet another alternative embodiment comprises a clamp which mounts under the patient platform.
  • Such an embodiment may also comprise a U-shaped member to enable the universal table mount to reach the correct position to affect distal migration of a subject's shoulders.
  • Yet other alternate embodiments may be implemented with attachment means other than clamps such as, but not limited to, screwed or bolted connections, hooks, clips, magnets, adhesives, etc.
  • FIG 8 is a diagrammatic side view of an exemplary mounting clamp 800, in accordance with an embodiment of the present invention.
  • mounting clamp 800 comprises an offset open channel 801 at the bottom of clamp 800, allowing clamp 800 to mount by being dropped down onto an accessory side rail while preserving the equivalent slide function and locking ability.
  • a setscrew 803 enables a user to tighten or loosen clamp 800 upon the side rail at a desired location.
  • a rail assembly of a table mount may be connected to clamp 800 through a hole 805.
  • table mounts may be attached to the patient platform in various different locations using various different means or may be separate from the patient platform.
  • Some alternate embodiments may be implemented as pole-mounted systems; for example, without limitation, the rail assemblies and clamps may be mounted to their own independent poles, or the system may be configured to attach to a typical two pole stand routinely provided at the head of operation tables for purposes of supporting sterile drapes.
  • Another alternative embodiment provides a floor-mounted system comprising a rail assembly and clamp mounted to a variably position-able, wheeled carriage, such that the rail guides can be brought in immediately behind the shoulders, generally without interfering with any table mounted accessories such as, but not limited to, a Mayfield Head Holder while still being workable with a Jackson Table.
  • Yet another alternative embodiment provides a ceiling-mounted system, similar to the fashion of surgical operating microscopes, lighting arrays, and various other components commonly used in surgical settings.
  • Yet another alternative embodiment comprises a swivel mechanism to attach the system to a patient platform. This embodiment enables the system to be mounted to the patient platform before the subject is on the table and rotated out of the way while the subject is transferred to the patient platform. Then, the system can be rotated into a functional position before draping the subject under sterile field conditions.
  • the anatomical positioning system of the present embodiment is shown using height and angle parameters of universal table mounts 701 and size parameters of laminar sheets 703 that generally eliminate difficulty in set-up.
  • these measurements preferably are configured to form an acute angle of 63 degrees to 65 degrees (from the horizontal) for support members 731 of cradles 709 with a 1 inch gap between rail assemblies 715 and accessory side rails 717.
  • an angle of 62 degrees or less may cause table mounts 701 or shoulder pusher 700 to rub padding that may be present on patient platform 719 yet may be suitable in some alternate embodiments.
  • the range of the angle may be broader.
  • an alternative embodiment of the present invention includes configurations adapted to enable the user to adjust height and angulation of the apparatus thru support members which can lengthen and shorten via the operation of a set-screw, a clamp, or via any number of means of varying the height and angulation of these members., depending upon many practical consideration, including, without limitation, the configuration of the gap and padding.
  • laminar sheets 703 are 17 1 ⁇ 2 inches long from where shoulder pusher 700 fits into cradles 709 to the location on arches 705 that make contact with the subject.
  • one alternative embodiment of the present invention comprises a fully adjustable platform that is adaptable to any platform or set-up.
  • the universal table mounts may include, without limitation, a multiplicity of height, width, and angle adjustments for purposes of maintaining universal compatibility. It is contemplated that other alternate embodiments may be implemented with a multiplicity of suitable parameters for use in various different set-ups and with various different patient platforms.
  • Figure 9 is an exemplary diagrammatic side view of the Visualization of the Lower
  • Figure 10 is a exemplary diagrammatic front view of the anatomic structures of the shoulders , to include the Acromioclavicular joint , the Sternoclavicular Joint as well as the Brachial Plexus Nerve Bundle and Sub Clavial Arterial and veinous formations, in accordance with an embodiment of the present invention.
  • Figure 10 illustrates the anatomy of the Shoulder Girdle with which the present invention makes contact.
  • Figure 10 A depicts the Acromioclavicular Joint comprised of the Acromion 104 connected to the Clavicle 1003 at the Acromion Head of the Clavicle 1002 via the Ligaments and capsule of the ACROMIOCLAVICULAR JOINT 1001.
  • Figure 10B Illustrates the Brachial Plexus Nerve Bundle which communicates to the Upper Extremity of the Arm and Hand, as well as the sub clavial Artery 1007 and Subclavial Vein 1006, which communicate thru to the arm unde the Clavicle 1003.
  • Figure 10c depicts the same structures with the addition of 1008 the sternoclavicular joint which articulates distally and proximally with the clavicle.
  • Figures 11 A to E further depict the anatomy of the Acromioclavicular joint by way of presenting a diagrammatic view of the bony structures of this joint, namely, the Acromion and the Clavicle both with and without the accompanying capsule and ligaments, as well as illustrating the various shapes of the acromion within the population in accordance with the Bigliani Classification of these structures.
  • the Method of Usage of the Present Invention avoids contact at the Acromion which in addition to being a point of contact which inherently communicates stress to the shoulder capsule ( as occurs during the Traditional Means of "Pulling on the Arms", which can result in Shoulder Separation) , ALSO is connected to the Scapula by only a thin portion of the Acromion Process , which is subject to fracture.
  • the Present method of Usage of the Present Invention avoids contact with the Acromion as a point of Caudal Migration.
  • Figure 11 A depicts the bony structures of the Acromioclacicular Joint and the
  • the Glenoid Fossa connects to 1102 the Humerus.
  • 1004 is the Acromion, which butts against 1002 the Acromial Head of the Clavicle 1003.
  • 1101 is the Coracoid Process, an attachment point for ligaments and muscle of the shoulder and chest.
  • Figure 1 lb illustrates the Shoulder and the Acromioclavicular Joint with associated ligaments.
  • 1001 represents the shoulder capsule of the Acromioclavicular Join, which involves the Acromion Head of the Clavicle 1002 with the Acromion 1004.
  • 1003 depicts the clavicle itself, connected to Coracoid Process 1101 via the Trapezoid Ligament 1105 and the Conoid Ligament 1106.
  • Figures l lC, 1 ID, and 1 IE represent the variations within the population of the Acromion, with Said variations rendering caudal migration at the Acromion itself problematic, as the Curved and the Hooked Acromion Processes as depicted in Figure 1 ID and Figure H E, focus all of the distal migratory force at ONE Point on the Acromion, which is then translated as stress to the Acromial Ligament of the Shoulder Capsule, rendering the capsule susceptible to separation of the Acromion from the Clavicle (As id Illustrated fully in Figure 15). According to Bigliani, the noted authority on the Acromion, these two problematic shapes account for 83 % of the Global Population.
  • the Method of Usage of the Present Invention avoids contact at the Acromion which in addition to being a point of contact which inherently communicates stress to the shoulder capsule (as occurs during the Traditional Means of "Pulling on the Arms", which can result in Shoulder Separation), ALSO is connected to the Scapula by only a thin portion of the Acromion Process, which is subject to fracture.
  • the Present method of Usage of the Present Invention avoids contact with the Acromion as a point of Caudal Migration.
  • Figure 12 illustrates a superior view of the entirety of the "Shoulder Girdle", comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention
  • Figure 12 illustrates a superior view of the entirety of the "Shoulder Girdle", comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention.
  • 1005 depicts the Acromion Process and 1004 depicts the Acromion itself, the application of caudal migration to which can be problematic in that it can result in "Shoulder Separation", which is an associated risk entailed with the Traditional Method of "Pullling on the Arms" for purposes of Shoulder Migration.
  • 1001 represents the ACROMIONCLAVICULAR Joint itself, which along with the Acromion Head of the Clavicle 1002 located very proximately medial to the AC Joint, represent the METHOD of Application of Caudal Migratory Force via the present Invention.
  • 1003 represents the Clavicle itself, which articulates superiorly and inferiorly via the 1008 the
  • sternoclavicular joint as it connects to the Sternum 1009. 1202 illustrates a thick portion of bone referred to as the Spine of the Scapula, the Scapula itself depicted as 1201. 1203 represents the Spinal Column.
  • Figure 13 identifies the specific exemplary points of caudal migratory contact which are often directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub Clavial Arterial and Veinous formations, all of which commonly associated with usage of the so -called "traditional means" of shoulder migration, namely, these points of contact being the Trapezius and the Acromion Process which is LATERAL to the ACROMIOCLAVICULAR Joint. Stress to the Acromion Process resulting in Shoulder Separation, and compression to the trapezius resulting in deleterious consequence to the Brachial Plexus and Sub Clavial Arterial and Veinous formations.
  • FIG. 13A depicts 1502, a Grade 1 Shoulder Separation according to the Rockwood Classification, which is a Separation of the Ligaments of the Acromialclavicular Joint 1001 from the Acromion 1004, from the Clavicle 1003.
  • Figure 13B represents insult or Injury to the Brachial Plexus nerve bundle either thru compression of the trapezius of thru aggressive pulling on the wrists and Arms for purposes of caudal migration of the shoulders.
  • Figure 13C identifies two points of contact associated with the Traditional Means of Shoulder Migration, these two points of contact associated with the traditional means.
  • Figure 13 Illustrates typical complications associated with Traditional Means of Shoulder Migration.
  • Figure 13 identifies the specific points of caudal migratory contact which are directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub Clavial Arterial and Veinous formations, all of which commonly associated with usage of the so -called "traditional means" of shoulder migration. These points of contact being the Trapezius and the Acromion Process which is LATERAL to the
  • Figure 14 further identifies exemplary points of compromise to the Brachial Plexus and Sub-Clavial Arterial and Veinous formations, often associated both with compression of the Trapezius as well as associated with "Pulling on the Arms", Taping the Trapezius , and with the usage of Compression Harnesses during radiography.
  • Figure 15 illustrates an exemplary mechanism of possible damage expected to the Shoulder capsule via the application of force LATERAL to the Acromioclavicular Joint, said diagrammatic view depicted in accordance with the " Rockwood Scale ", said damage commonly referred to as " Shoulder Separation”, with said insult and/or injury to the shoulder capsule associated with the traditional means of Shoulder migration via Pulling the Arms. Said anatomic contact to be avoided.
  • Figure 16 illustrates various exemplary views depicting the normal anatomic function of the Shoulder Girdle as it migrates caudally, as well as illustrating the normal interaction of the brachial plexus and sub clavial arterial and veinous structures within the structures of the articulating shoulder Girdle without exposure to impingement and/or stretching or compression, all of which as are generally associated with the so-called "Traditional Means" of Shoulder Migration.
  • Figure 16 illustrates exemplary Normal Function of AC Joint and Superior Scapula During Caudal Migration
  • Figures 17-20 illustrate various procedural aspects of an exemplary method of using a means of migration apparatus such as, without limitation, that of Figure 7, to more safely perform a shoulder migration procedure, in accordance with an embodiment of the present invention.
  • the exemplary method shown seeks to significantly replicate the normal function of the articulating shoulder girdle as presented in Figure 16, said replication of proper caudal migration effected via the application of caudal migration directly at the Acromionclavicular Joint and/or very proximately medial to the joint at the Acromion Head of the Clavicle , usage of said method in the operation of the apparatus of the present invention REPLICATING the Function of the natural motion of the shoulder girdle without exposure to the risks of "Shoulder Separation", Brachial Plexus Insult and Injury, Impingement Syndrome, and suppression of blood flow thru the sub clavial arterial and veinous formations, all of which complications are typically associated with the "Traditional Means" of Shoulder Migration.
  • Figure 17 also designates the anatomic portions to be avoided for the application of caudal migratory force, these areas associated with the "Traditional Means" of Shoulder migration, namely, the Acromion Process and the Trapezius, as the application of cauda migratory force to these areas replicates the complications of the so-called “traditional means” of shoulder migration, risking shoulder separation, loss of adequate blood flow to the upper extremities, and brachial plexus insult and injury.
  • Figure 17 illustrates an exemplary angle of approach and exemplary contact points of the present shoulder migration procedure method, in accordance with the foregoing embodiment of the present invention.
  • the present method of caudal migration is substantially at the ac joint and slightly medial at the acromial head of the clavicle.
  • Figure 18 further illustrates the exemplary Method of anatomic contact with the means of migration, e.g., without limitation, the Radio lucent and/or imaging compatible Arch, at the natural prominence of the Acromionclavicular Joint or Very proximately medial to the Joint at the Acromial Head of the Clavicle for the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention.
  • the means of migration delivers a Caudal Migratory Force in such a method so as to substantially approximate the Normal function of the Articulating Shoulder Girdle without risk of slipping laterally as the geometry of the shoulder is altered thru distal motion, and without risk of application of force Lateral to the
  • Figures 19A and 19B illustrate a diagramatic side view of the method of usage shown in Figure 18.
  • the natural function of the Shoulder Girdle is substantially replicates as it articulates caudally , said method offering no compression to the brachial plexus or sub clavial blood flow, said method spreading the caudal migratory force across the two major migratory points of the shoulder girdle, namely at both the Acromioclavicular Joint and at the Spine of the Scapula, as opposed to focusing all of the motive force upon the ligaments of the ACROMION, or via COMPRESSION of the trapezius, said Method of usage of the present invention exposing the patient to little, if no, possibility of Shoulder Separation and to little, if no, compression of the Neurovascular Bundle via usage of the present method.
  • Radio lucent and/or imaging compatible Arch making Simultaneous contact with the Spine of the Scapula , with no less than 4 ligaments UNDERNEATH this Point of Contact acting as a natural cushion , IS ABLE to REPLICATE the NATURLISTIC Function of the Shoulder Girdle migrating Caudally as presented in Figure 16 ...WITHOUT the risks of Shoulder Separation, Compression of the Brachial plexus or Sub Clavial BloodFlow , or Impingement of the Thoracic Outlet, as described in Figure 20 .
  • Figure 20 illustrates the Thoracic Outlet 2001 , thru which the subclavial artery and subclavial vein , as well as the brachial plexus are enabled to pass without impingement as the natural mechanism of the shoulder girdle articulates caudally. This is as opposed to exposure to prolonged compression as with the Traditional Means of Shoulder Migration employed
  • the present embodiment thru the method of replicating the natural function of the articulating shoulder girdle as it migrates these structures caudally via the application distal migratory force directly AT the AC Joint or very proximately medial at the Acromial Head of the Clavicle , allows unimpeded communication of bloodflow and nerve function THRU this Thoracic outlet , thereby avoiding the compression and stretching to these structures as is ubiquitous with the employment of the Traditional Means.
  • Figure 20 Thoracic Outlet for Brachial Plexus and SubClavial Blood Flow
  • Figures 21 A to 21 F illustrate a plan, anterior view of the Supine Patient undergoing the exemplary naturalistic replication of the caudal migration of the shoulder girdle via the exemplary method of usage shown in Figures 17-20.
  • the present embodiment thru delivery of distal migration at the AC Joint and / or very proximately medial at the acromial head of the clavicle , further illustrating the uninterrupted travel of the brachial plexus and sub clavial arterial and veinous formations thru the Thoracic Outlet without impingement.
  • Figures 22 A-F illustrates an exemplary posterior overhead view of the Prone Patient from Figures 21 A-F, in accordance with an embodiment of the present invention.
  • the present embodiment and method of usage of The present embodiment replicates the naturalistic caudal migration of the shoulder girdle , via the controlled application of caudal migratory force across the natural bridge formed by the Acromioclavicular Joint and the Spine of the Scapula. ...without concentrating any stress to ligaments , and without compressing the Brachjial Plexus or suppressing subclavial bloodflow to and from the upper extremities.
  • Figures 22 A-F present an Anterior View of Method and Placement in the Prone Position having the following features: [00216] 1001 Acromioclavicular Joint
  • Figures 23 A and B illustrate an exemplary Superior View of the method of Usage shown in Figures 21 A-F, in accordance with an embodiment of the present invention.
  • the present embodiment in the Supne Patient clearly depicting the method of application of distal migratory force AT the Acromioclavicular Joint and/ or Very proximately medial to said joint at the Acromial Head of the Clavicle , and furthermore depicts the distribution of said caudal migratory force EVENLY across the strongest portions of the shoulder girdle , namely , ATOP or Very proximately medial to the Acromial Clavicular Joint and Across the shoulder to the Spine of the Scapula .
  • Figure 23 A Superior View of Method of Placement and Usage with the Supine Patient
  • Figures 24 A and B depict a same or similar Method of Usage of the foregoing embodiment with all of the same or similar benefits as is depicted in Figures 23 A and B, except in the instance shown, usage is illustrated with a PRONE Patient. No alteration to the technique of set up or usage is necessary , as The present embodiment corrects automatically for changes in angulation as will be below described in some detail in connection with Figures 27 thru 29.
  • Figures 25 A to D illustrate a Lateral View of the Supine Patient undergoing Caudal Migration at the Acromioclavicular Joint or Very proximately medial to said Joint at the Acromial head of the Clavicle , in accordance with the foregoing embodiment. As shown, there is simultaneous contact with the Spine of the Scapula.
  • Figures 25C and 25D illustrate the much improved Lateral Scans available to the Surgeon as the natural occlusion of the Bones of the Humerus and the Glenoid Fossa and the Acromial Clavicular Joint Itself are migrated caudally so as to no longer directly interpose the line of sight imaging of the structures of the Lower Cervical Vertebral Structures. The so called Traditional Means are unable to replicate this level of Safe Caudal Migration and Temporary Traction as currently enabled via usage of the present method of usage of the apparatus of The present embodiment.
  • Figures 25 A to D Lateral View of Method Utilized for Caudal Shoulder Migration in the Supine Position show the following features:
  • Figure 26 A to D depicts the same results as Figures 25 A to D, except in the PRONE
  • the Points of contact are the Acromioclavicular Joint and/or the Acromial head very proximately medial and CONNECTED to the AC Joint and cushioned below by 4 ligaments , with the Caudal Migratory Force spread evenly across the Shoulder Girdle via contact posteriorly with the Spine of the Scapula .
  • these optimal points of vertical contact autocorrect themselves whether the patient is Prone or Supine , or no matter the Table and Pad Height Arrangement of the Patient Support , all due to the angled articulation of the Radio lucent and/or imaging compatible Arch within the Framework of the present embodiment, as is explained in Figures 27 thru 29.
  • the width of the assembly needs to be adjusted by the Operator.
  • FIGs 27 thru 29 depict the Autcorrection of Angulation of the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention. Shown as the apparatus articulates within the Table mount Assembly, thereby enabled to make correct contact with the structures of the AC Joint and the Acromion Head of the Clavicle very proximately medial to the AC Joint , and simultaneously to make contact with the Spine of the Scapula regardless of whether the patient is Prone of Supine, Diminutive of Bariatric , atop a patient platform rendering the Arch Horizontal to the floor or at an acute angle to the floor....with the direction of Caudal Migration ALWAYS dictated by the Rail 715 as depicted in Figure 7.
  • the Operator typically need only adjust for width via knob 700 as depicted in Figure 7.
  • Figure 27 illustrates an exemplary Auto correction of Radiolucent and/or imaging compatible Arch for most any practical Bed Pad Height, in accordance with an embodiment of the present invention.
  • Figure 28 illustrates the forgoing Method for Auto correction of Angulation and positioning for Prone Patient, in accordance with an embodiment of the present invention.
  • Figure 29 illustrates the forgoing Method for Auto correction of Angulation and positioning for Supine Patient, in accordance with an embodiment of the present invention.
  • the proper area of placement of the Radio lucent and/or imaging compatible Arch as per the present method is bounded LATERALLY by the Ligaments of the AC Joint , presenting a natural boundary to slippage laterally of the Radio lucent and/or imaging compatible Arch during Caudal Migration and traction, while concurrently allowing the Brachial Plexus Nerve Bundle as well as the Bloodflow to the Upper Extremities to travel without IMPINGEMENT thru the Thoracic Outlet .
  • ALSO presents an eccentric surface which differs widely in shape from patient to patient, and which varies in angulation TOWARDS the Patients Feet as it is migrated Caudally.
  • slippage Laterally of the Radio lucent and/or imaging compatible Arch as it is migrated caudally is enabled via placement at the anatomic structure at the acromion , As such , Placement at the acromion is counterindicated.
  • Figures 30 A-C and 31 A and B illustrate an exemplary version of the foregoing embodiment that is fully compatible with and able to fit inside of the fixed or rotating Imaging Bore of the C-Arm Fluoroscope, in accordance with an embodiment of the present invention.
  • the apparatus is ingressed and egressed throughout the Procedure. There is little, if no, need to remove the equipment from the Operating Table.
  • the present embodiment is substantially, if not entirely, compatible with the C-arm.
  • Figures 30 A-C illustrate an example C-Arm Compatibility, in accordance with an embodiment of the present invention.
  • Figures 31 A and B illustrate the C-Arm Compatibility with an exemplary patient in the prone position, in accordance with an embodiment of the present invention.
  • Figure 32 illustrates an exemplary O-arm / Body Tom Compatible version, in accordance with an embodiment of the present invention.
  • the present invention via Elongation of the Pusher Arm of the Radio lucent and/or imaging compatible Arch , placement of the Metallic Portions OUTSIDE of the IMAGING Bores of the Newly Emerging Imaging Arrays is enabled , such that usage of the present invention can proceed with little to no Metallic Interference, little to no Streak Artifact ,and without High Attentuation Artifact , all associated with the presence of METAL in the Imaging Bores of these Emerging Technologies.
  • a method is provided, in accordance with an embodiment of the present invention, for using the foregoing shoulder migration apparatus of the Present Invention, having the
  • Fit Pathogen Barrier 725 / Figure 7 with Padding 727 / Figure 7 over Radiolucent and/or imaging compatible Arches 705/ figure 7 Applying finger pressure to Triggers 723/ Figure 7, migrate Vertical Risers 713 / Figure 7 along Rails 715/ figure 7 until Radiolucent and/or imaging compatible Arches 705/ Figure 7 are in contact with the patient's shoulders , but without applying Caudal Pressure to the Patient Shoulders. Adjust Crossbar 707 / Figure 7 Width via Adjustment Knob 700 / Figure 7, such that Radiolucent and/or imaging compatible Arches 705 / Figure 7 makes contact at the
  • this exemplary point of contact is illustrated from the Operators view in Figure 24, with Figure 24 depicting exemplary placement of Radiolucent and/or imaging compatible Arches 1701/ Figure 24A for the Prone Patient, with contact between the Radiolucent and/or imaging compatible Arches 1701 / Figure 24A at points 1001/ Figure 24 A , the Acromionclavicular Joint , and at points 1202 / Figure 24 A , the Spine of the Scapula.
  • Figures 23B and 24B Further identify these exemplary points of anatomic contact 1001 the AC Joint and 1202 the Spine of the Scapula as depicted from an Operator's viewpoint of a Naturalistic appearing Patient.
  • Triggers 723/ Figure 7 migrate Vertical Risers 713 / Figure 7 along Rails 715/ figure 7 until Radiolucent and/or imaging compatible Arches 705/ Figure 7 have achieved full migration of the patients Shoulder Girdle caudally. Release of triggers 723/ Figure 7 aill
  • Figure 25 depicts usage of the present invention via the present method in the Supine patient, with 1901 / Figure 25C demonstrating the typical lateral view of the 4th Cervical Vertebrae WITHOUT caudal migration of the structures of the shoulder , such that Cervical Vertebrae C5, C6 , and C7 are occluded.
  • 1902 Figure 25D depicts the optimized lateral view of C7 without occlusion, due to usage of the present invention for purposes of migrating the shoulder Caudally in order to alleviate the Density Artifact of the Shoulders from Line of Sight Occlusion of the Lateral Imaging of the Cervical Vertebra.
  • Figure 26 depicts usage of the present invention via the present method in the Prone patient , with 1901 / Figure 26C demonstrating the typical lateral view of the 4th Cervical Vertebrae WITHOUT caudal migration of the structures of the shoulder , such that Cervical Vertebrae C5, C6 , and C7 are occluded.
  • 1902 Figure 26D depicts the optimized lateral view of C7 without occlusion, due to usage of the present invention for purposes of migrating the shoulder Caudally in order to alleviate the Density Artifact of the Shoulders from Line of Sight Occlusion of the Lateral Imaging of the Cervical Vertebra
  • Alternate embodiments of the foregoing AC joint shoulder method may not employ the foregoing Auto correction of vertical Angulation feature, and instead rely upon the medical professional's skilled ability to manually guide a shoulder migration means to suitably and safely contact and apply force onto the AC joint in accordance with the foregoing teachings of the present invention.

Abstract

In one version, a system is provided having or supporting a shoulder positioner apparatus comprising a tapered arm and arch for applying a motive force to engage a shoulder of a patientwith an auto correction means. A method for using the apparatus for shoulder migration at the AC joint is also provide.

Description

A System, Apparatus and Method for Shoulder Migration
CROSS- REFERENCE TO RELATED APPLICATIONS
[0001 ] The present PCT patent application claims priority benefit of the U.S. Utility patent application serial number 13/902,932, entitled "A System, Apparatus and Method for Shoulder Migration", and filed on 27-MAY-2013. The contents of this related Utility application are incorporated herein by reference for all purposes to the extent that such subject matter is not inconsistent herewith or limiting hereof.
FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable.
REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER LISTING APPENDIX [0003] Not applicable. COPYRIGHT NOTICE
[0004] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or patent disclosure as it appears in the Patent and Trademark Office, patent file or records, but otherwise reserves all copyright rights whatsoever.
FIELD OF THE INVENTION
[0005] One or more embodiments of the invention generally relate to medical equipment.
More particularly, the invention relates to a table mount for use with an anatomical positioner. BACKGROUND OF THE INVENTION
[0006] The following background information may present examples of specific aspects of the prior art (e.g., without limitation, approaches, facts, or common wisdom) that, while expected to be helpful to further educate the reader as to additional aspects of the prior art, is not to be construed as limiting the present invention, or any embodiments thereof, to anything stated or implied therein or inferred thereupon.
[0007] By way of educational background, an aspect of the prior art generally useful to be aware of is that, traditionally, said migration of a subject's shoulders is effected via the following means. One traditional method of migrating the subject's shoulders involves Kurlix Bandages that are wrapped around the forearms or wrists of the subject and pulled upon forcefully during live radiography for the purpose of temporary distal migration of the shoulder structures. This method may result in injury for example, without limitation, Brachial Plexus injury or insult to the subject's shoulder capsule due to over-application of distal migratory force. Such an injury is referred to as shoulder separation, wherein the injury is typically characterized by the Rockwood Classification as Ligament Sprain to the Acromioclavicular Joint (AC Joint), possible Ligament Disruption and tearing , and vertical disruption of the Ac Joint as the acromion is separated from the acromial head of the clavicle . Another traditional method of moving the subject's shoulders involves taping down the subject's shoulder's and trapezius muscles for the entirety of the procedure. Using this method, the shoulders are typically immobilized for the entirety of the procedure, which may result in some unintended results including, without limitation, Brachial Palsy Injury , sore trapezius, nerve damage, tingling hands, reduced digital sensation, and numbness as a consequence of extended unnatural positioning.
[0008] In view of the foregoing, it is clear that these traditional techniques are not perfect and leave room for more optimal approaches.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The present invention is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which: [0010] Figure 1 illustrates an exemplary universal table mount for a shoulder press in use on a surgical table, in accordance with an embodiment of the present invention;
[0011] Figure 2 illustrates an exemplary mount for a shoulder press for use on patient surfaces without side rails, in accordance with an embodiment of the present invention;
[0012] Figures 3 A and 3B illustrate an exemplary shoulder pusher, in accordance with the prior art. Figure 3A is a diagrammatic top view, and Figure 3B is a diagrammatic side view;
[0013] Figure 4 is a diagrammatic side view of an exemplary shoulder pusher, in accordance with an embodiment of the present invention;
[0014] Figures 5 A, 5B and 5C illustrate an exemplary one-piece shoulder pusher, in accordance with an embodiment of the present invention. Figure 5 A is a diagrammatic side view. Figure 5B is a diagrammatic top view, and Figure 5C is a diagrammatic front view;
[0015] Figures 6A through 6C illustrate an exemplary shoulder pusher in accordance with an embodiment of the preset invention. Figure 6A is a side perspective view. Figure 6B is a diagrammatic top view, and Figure 6C is a diagrammatic side view;
[0016] Figure 7 is a side perspective view of an exemplary anatomical positioning system comprising a shoulder pusher and universal table mounts, in accordance with an embodiment of the present invention;
[0017] Figure 8 is a diagrammatic side view of an exemplary mounting clamp, in accordance with an embodiment of the present invention;
[0018] Figure 9 is an exemplary diagrammatic side view of the Visualization of the Lower
Cervical Vertebral Levels in the Supine Position;
[0019] Figures 10 A-C show an exemplary diagrammatic front view of the anatomic structures of the shoulders , to include the Acromioclavicular joint , the Sternoclavicular Joint as well as the Brachial Plexus Nerve Bundle and Sub Clavial Arterial and veinous formations, in accordance with an embodiment of the present invention;
[0020] Figures 11 A - E further depicts the anatomy of the Acromioclavicular joint by way of presenting a diagrammatic view of the bony structures of this joint, namely , the Acromion and the Clavicle both with and without the accompanying capsule and ligaments ; [0021] Figure 12 illustrates a superior view of the entirety of the " Shoulder Girdle " , comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention
[0022] Figure 13 identifies the specific exemplary points of caudal migratory contact which are often directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub C la vial Arterial and Veinous formations;
[0023] Figure 14 further identifies exemplary points of compromise to the Brachial Plexus and
Sub-Clavial Arterial and Veinous formations, often associated both with compression of the Trapezius as well as associated with " Pulling on the Arms ", Taping the Trapezius , and with the usage of Compression Harnesses during radiography;
Figure 15 illustrates an exemplary mechanism of possible damage expected to the Shoulder capsule via the application of force LATERAL to the Acromioclavicular Joint;
[0024] Figure 16 illustrates various exemplary views depicting the normal anatomic function of the Shoulder Girdle as it migrates caudally;
[0025] Figures 17-20 illustrate various procedural aspects of an exemplary method of using a means of migration apparatus such as, without limitation, that of Figure 7, to more safely perform a shoulder migration procedure, in accordance with an embodiment of the present invention;
Figure 17 illustrates an exemplary angle of approach and exemplary contact points of the present shoulder migration procedure method, in accordance with the foregoing embodiment of the present invention;
[0026] Figure 18 further illustrates the exemplary Method of anatomic contact with the means of migration, e.g., without limitation, the Radiolucent and/or imaging compatible Arch, at the natural prominence of the Acromionclavicular Joint or Very proximately medial to the Joint at the Acromial Head of the Clavicle for the Radiolucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention;
[0027] Figures 19A and 19B illustrate a diagramatic side view of the method of usage shown in Figure 18; [0028] Figure 20 illustrates the Thoracic Outlet 2001 , thru which the subclavial artery and subclavial vein , as well as the brachial plexus are enabled to pass without impingement as the natural mechanism of the shoulder girdle articulates caudally;
[0029] Figures 21 A to 21 F illustrate a plan, anterior view of the Supine Patient undergoing the exemplary naturalistic replication of the caudal migration of the shoulder girdle via the exemplary method of usage shown in Figures 17-20;
[0030] Figures 22 A-F illustrates an exemplary posterior overhead view of the Prone Patient from Figures 21 A-F, in accordance with an embodiment of the present invention;
[0031 ] Figures 23 A and B illustrate an exemplary Superior View of the method of Usage shown in Figures 21 A-F, in accordance with an embodiment of the present invention;
[0032] Figures 24 A and B depict a same or similar Method of Usage of the foregoing embodiment with all of the same or similar benefits as is depicted in Figures 23 A and B, except in the instance shown, usage is illustrated with a PRONE Patient;
[0033] Figures 25 A to D illustrate a Lateral View of the Supine Patient undergoing Caudal
Migration at the Acromioclavicular Joint or Very proximately medial to said Joint at the Acromial head of the Clavicle , in accordance with the foregoing embodiment;
[0034] Figure 26 A to D depicts the same results as Figures 25 A to D, except in the PRONE
Patient position, viewed laterally;
[0035] Figures 27 thru 29 depict the Autcorrection of Angulation of the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention;
[0036] Figure 28 illustrates the forgoing Method for Auto correction of Angulation and positioning for Prone Patient, in accordance with an embodiment of the present invention;
[0037] Figure 29 illustrates the forgoing Method for Auto correction of Angulation and positioning for Supine Patient, in accordance with an embodiment of the present invention;
[0038] Figures 30 A-C and 31 A and B illustrate an exemplary version of the foregoing embodiment that is fully compatible with and able to fit inside of the fixed or rotating;
[0039] Figures 30 A-C illustrate an example C-Arm Compatibility, in accordance with an embodiment of the present invention; [0040] Figures 31 A and B illustrate the C-Arm Compatibility with an exemplary patient in prone position, in accordance with an embodiment of the present invention; and,
[0041] Figure 32 illustrates an exemplary O-arm / Body Tom Compatible version, in accordance with an embodiment of the present invention.
[0042] Unless otherwise indicated illustrations in the figures are not necessarily drawn to scale.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0043] The present invention is best understood by reference to the detailed figures and description set forth herein.
[0044] Embodiments of the invention are discussed below with reference to the Figures.
However, those skilled in the art will readily appreciate that the detailed description given herein with respect to these figures is for explanatory purposes as the invention extends beyond these limited embodiments. For example, it should be appreciated that those skilled in the art will, in light of the teachings of the present invention, recognize a multiplicity of alternate and suitable approaches, depending upon the needs of the particular application, to implement the functionality of any given detail described herein, beyond the particular implementation choices in the following embodiments described and shown. That is, there are numerous modifications and variations of the invention that are too numerous to be listed but that all fit within the scope of the invention. Also, singular words should be read as plural and vice versa and masculine as feminine and vice versa, where appropriate, and alternative embodiments do not necessarily imply that the two are mutually exclusive.
[0045] It is to be further understood that the present invention is not limited to the particular methodology, compounds, materials, manufacturing techniques, uses, and applications, described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include the plural reference unless the context clearly dictates otherwise. Thus, for example, a reference to "an element" is a reference to one or more elements and includes equivalents thereof known to those skilled in the art. Similarly, for another example, a reference to "a step" or "a means" is a reference to one or more steps or means and may include sub-steps and subservient means. All conjunctions used are to be understood in the most inclusive sense possible. Thus, the word "or" should be understood as having the definition of a logical "or" rather than that of a logical "exclusive or" unless the context clearly necessitates otherwise. Structures described herein are to be understood also to refer to functional equivalents of such structures. Language that may be construed to express approximation should be so understood unless the context clearly dictates otherwise.
[0046] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. Preferred methods, techniques, devices, and materials are described, although any methods, techniques, devices, or materials similar or equivalent to those described herein may be used in the practice or testing of the present invention. Structures described herein are to be understood also to refer to functional equivalents of such structures. The present invention will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings.
[0047] From reading the present disclosure, other variations and modifications will be apparent to persons skilled in the art. Such variations and modifications may involve equivalent and other features which are already known in the art, and which may be used instead of or in addition to features already described herein.
[0048] Although Claims have been formulated in this Application to particular combinations of features, it should be understood that the scope of the disclosure of the present invention also includes any novel feature or any novel combination of features disclosed herein either explicitly or implicitly or any generalization thereof, whether or not it relates to the same invention as presently claimed in any Claim and whether or not it mitigates any or all of the same technical problems as does the present invention.
[0049] Features which are described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. The Applicants hereby give notice that new Claims may be formulated to such features and/or combinations of such features during the prosecution of the present Application or of any further Application derived therefrom.
[0050] References to "one embodiment," "an embodiment," "example embodiment," "various embodiments," etc., may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase "in one
embodiment," or "in an exemplary embodiment," do not necessarily refer to the same embodiment, although they may.
[0051 ] As is well known to those skilled in the art many careful considerations and
compromises typically must be made when designing for the optimal manufacture of a commercial implementation any system, and in particular, the embodiments of the present invention. A commercial implementation in accordance with the spirit and teachings of the present invention may configured according to the needs of the particular application, whereby any aspect(s), feature(s), function(s), result(s), component(s), approach(es), or step(s) of the teachings related to any described embodiment of the present invention may be suitably omitted, included, adapted, mixed and matched, or improved and/or optimized by those skilled in the art, using their average skills and known techniques, to achieve the desired implementation that addresses the needs of the particular application.
[0052] It is to be understood that any exact measurements/dimensions or particular construction materials indicated herein are solely provided as examples of suitable configurations and are not intended to be limiting in any way. Depending on the needs of the particular
application, those skilled in the art will readily recognize, in light of the following teachings, a multiplicity of suitable alternative implementation details.
[0053] An aspect of the present invention is to recognize the problems caused by conventional shoulder migration methods, and to identify a more optimal approach, as will be explained in some detailed in the form of exemplary embodiments. Regarding some pertinent problems identified by the present invention, as mentioned above, various prior art methods of shoulder migration may result in injury for example, without limitation, Brachial Plexus injury or insult to the subject's shoulder capsule due to over-application of distal migratory force. Such an injury is referred to as shoulder separation, wherein the injury characterized by the Rockwood Classification as Ligament Sprain to the Acromioclavicular Joint , possible Ligament Disruption and tearing , and vertical disruption of the Ac Joint as the acromion is separated from the acromial head of the clavicle . Another traditional method of moving the subject's shoulders involves taping down the subject's shoulder's and trapezius muscles for the entirety of the procedure. Using this method, the shoulders are typically immobilized for the entirety of the procedure, which may result in some unintended results including, without limitation, Brachial Palsy Injury , sore trapezius, nerve damage, tingling hands, reduced digital sensation, and numbness as a consequence of extended unnatural positioning, as well as the prolonged restriction of blood flow to the extremities of the arm and hand, due to prolonged compression of blood flow thru the sub -clavial artery and sub -clavial vein. Another related method involves the usage of cloth or fabric harnesses , which replicate the effects of compressing the the trapezius thru taping , and actually aggravate these complications as the harness based solution applies significantly more compressive force not only across the trapezius but to the Acromioclavicular joint as well , migrating the AC Joint not caudally, but medialy as well , thereby not only compressing the brachial plexus and sub clavial arterial and veinous formations, but impinging the thoracic outlet thru which this neurovascular bundle would normally travel unimpeded.
[0054] Some embodiments of the present invention may provide a table attached device, or universal table mount, for a shoulder press that provides a firm and stable, horizontal cradled platform upon which the shoulder press can travel and lock in such a way as to effectively and consistently replicate the action and application of sustained force for the duration of an X-Ray, which would otherwise be delivered by a live operator. By providing a generally consistent and reliable platform, the table mount allows for the reliable and correct positioning and quick release of the shoulder press without the necessity or presence of a live operator during the actual patient X- Ray, thereby generally eliminating the possibility of exposure to radiation for all personnel.
Without a table mount according to preferred embodiments, the handheld nature of the shoulder press device offers no such protection and precludes the use of the shoulder press device in environments where a C-ARM (i.e., Intraoperative Flouroscope) is utilized due to harmful exposure levels. Additionally, by providing a stable platform for the shoulder press throughout the entire duration of a surgical procedure, the table mount allows for one time set-up and continuous positioning of the shoulder press in immediate proximity to the usage site, thereby generally eliminating the complicated procedure of maneuvering and positioning the shoulder press in the ubiquitous environment of leads, lines, anesthesia and monitoring equipment, as well as greatly simplifying the usage of the shoulder press without disturbing these sensitive arrays. Additionally, by offering the stable platform with radio lucent and/or imaging compatible caudal migration at the Acromioclavicular Joint and/or the Acromial Head of the Clavicle situated very proximately medial to the AC Joint as described, some preferred embodiments of the present invention enable the application of continuous and consistent traction/ migration of the shoulders for the entirety of the approximate 10 minute duration of either an actual screw placement during a cervical vertebral plating procedure, or for the approximate 10 minute duration of trial placement and implantation of an artificial cervical disc during a cervical arthroplasty disc placement procedure, thereby allowing fully optimized live , real time fluoroscopy of the entirety of these crucial phases of the surgical procedure. In so doing, some embodiments of the present invention may offer significant clinical benefit to correct placement of implants with commensurate significant benefit to surgical outcome for the patient.
[0055] However, alternate usages for some embodiments of the present invention may be conceived such as, but not limited to, usage in an X-Ray room, usage by paramedics, usage in the trauma specialty for diagnosis, usage by orthopedic surgeons as a surgical positioner for patient extremities during revision hip arthroplasty, etc. Further alternate usages for preferred embodiments of the present invention may also be conceived such as, but not limited to, usage in various surgical, diagnostic and imaging procedures as an anatomical positioner for applications throughout the entire human anatomy relating to all aspects of patient care and specialties. Yet other alternative usages for preferred embodiments of the present invention may also be conceived such as, but not limited to, usage relating to all surgical specialties as a platform for the positioning and manipulation of tools, equipment, and necessities relating to all aspects of patient care, including, but not be limited to, surgical, diagnostic and imaging of patients. It is further contemplated that alternate usages for preferred embodiments of the present invention may also be conceived such as, but not limited to, usages relating to all aspects of veterinary care.
[0056] Figure 1 illustrates an exemplary universal table mount 101 for a shoulder press 103 in use on a surgical table 105, in accordance with an embodiment of the present invention. In the present embodiment, table mount 101 is comprised of two distinct yet mirror imaged sections, a dedicated right section 107 and a dedicated left section 109. Alternate embodiments may be implemented in which the left and right sections of the mount are connected. In the present embodiment, right section 107 and left section 109 clamp onto surgical table 105, which is equipped with industry standard accessory side rails 111 provided by table manufacturers for the use of the surgical staff in mounting various necessary equipment to surgical table 105 for use during surgery. Accessory side rails 111 may use American standard or metric measurements, and universal table mounts according to preferred embodiments of the present invention may be available in distinct clamping sizes to accommodate these industry standards. Right section 107 and left section 109 of table mount 101 slide easily onto accessory side rails 111, and an attachment mechanism 113 fully seats and is secured with a simple twist dial 115. Guide rails 117 extend from attachment mechanisms 113 onto which upward supports 118 are slidably attached with slides 119. Attachment mechanisms 113 are preferably made of aluminum; however, the attachment mechanisms in alternate embodiments may be made of different materials such as, but not limited to, different metals or plastic. Guide rails 117 and upward supports 118 are preferably one-inch square aluminum bars. However, those skilled in the art, in light of the present teachings, will readily recognize that the mount rails and upward supports in alternate embodiments may be made in different shapes and sizes and be made of various different materials such as, but not limited to, different metals or plastic. Furthermore, slides 119 are preferably made of plastic; however, alternate materials such as, but not limited to, various metals may also be used. In the present embodiment, slides 119 comprise handbrakes 121 that enable upward supports 118 to be locked into place on guide rails 117.
[0057] It should be noted that medical procedures involving the cervical spine, particularly surgery, often require correct visualization of the vertebrae during radiography (e.g., X-Ray, fluoroscopy, CT, MRI). Typically, a subject's shoulders obscure the lateral imaging of the cervical vertebrae and are generally migrated via the applications of either Compressive Force from Taping or Harness at the Trapezius , or via the application of traction force to the arms and shoulders , whereas the present method embodiment utilizes the application of dista;/ caudal migratory force at the AC Joint or very proximately medial to the acromioclavicular joint of the shoulder and out of the line of sight of the lateral image of the cervical vertebrae during radiography.
[0058] In typical use of the present embodiment, after mounting table mount 101 to accessory side rails 111, placement of shoulder press 103 within a shoulder press cradle is quick and easy, and shoulder press 103 is secured within the shoulder press cradle with adjustable/pivoting L-Shaped restraints 123 provided to accommodate this function. After positioning and adjusting shoulder press 103 to the proper width to effectively migrate the shoulders distally within table mount 101, an operator may apply the 24 to 37 pounds of motive force upon the acromioclavicular joint and/or the Acromial head of the clavicle very proximately medial to the AC Joint with shoulder press 103 by squeezing handbrakes 121 and pushing upward supports 118 or shoulder press 103 toward the patient on surgical table 105. The application of motive force by the operator along with the hand actuation of handbrakes 121 advances the position of shoulder press 103. When shoulder press 103 is correctly positioned, the operator releases handbrakes 121 to lock sliders 119 and therefore shoulder press 103 in place. The operator may swiftly and easily unlock and move shoulder press 103 away from the patient by squeezing handbrakes 121 and pulling back. Some embodiments may also comprise a quick release mechanism for the handbrakes so that the shoulder press may be immediately moved away from the patient in case of an emergency.
[0059] In alternate embodiments, the travel of the upward supports and the shoulder press within the shoulder press cradle along the guide rails is unidirectional toward the patient. In these embodiments the upward supports are able to move freely toward the patient and are prevented from moving away from the patient through the incorporation of an internal friction braking system. The actuation of a brake release allows for a reversal of travel away from the patient by releasing the internal friction braking system. The friction brake resists all backward motion due to tilting and comprises a hand control that reorients the tilt by finger tapping in order to enable backward movement. The friction brake preferably uses a large trigger somewhat akin to a bicycle handbrake lever. However, a bicycle brake uses a caliper style set of rubber pads whereas this friction brake uses no calipers, discs or pads and instead utilizes the slight offset of a channel and the guide rail of the table mount to halt backward motion unless the internal offset is lessened through application of the trigger/brake release. Other alternative embodiments may employ differing means for halting the backward motion. These other alternative means will also have at least one hand control means for enabling backward movement.
[0060] In another alternative embodiment, guide rails 107 and 117 are equipped with a toothed rack assembly situated within an internal channel, such that the toothed rack assembly provides an additional means of braking to the internal friction braking system when actuated via the release of the trigger mechanism 121, such braking system to enable a spring loaded caliper to mesh with the toothed rack assembly for purposes of halting travel across guide rails 107 and 117 upon release of trigger actuator 121, and said spring loaded caliper to be released from communication with the toothed rack assembly for purposes of restoration of free travel across guide rails 107 and 117 upon application of pressure to trigger actuator 121. [0061] Figure 2 illustrates an exemplary mount 201 for a shoulder press 203 for use on patient surfaces without side rails, in accordance with an embodiment of the present invention. In the present embodiment, mount 201 comprises variable clamps 207 rather than attachment mechanisms for sliding onto an accessory side rail. Variable clamps 207 slide over the edges of a patient surface and are held in place by actuating plates 209 that squeeze the edges of the patient surface when clamp locks 211 are employed. In other alternative embodiments clamps may be locked into position by any number of devices such as, but not limited to, levers, dials, knobs, etc. that are deemed appropriate to the patient anatomy the alternate embodiments address. This enables mount 201 to be attached to surfaces other than operating room surgical tables with side rails for example, without limitation, other types of patient beds and tables, paramedic long boards, imaging tables, exam tables, etc., any other patient care surfaces unrestricted to unrestricted to horizontal positions, and whatever variable geometry offered by the patient care surface, whether fixed or movable during usage
[0062] Paramedics often carry patients on long boards, and when a patient has a suspected subluxation injury (i.e., broken neck), they are brought to the emergency room (ER) on such a long board and typically remain on this long board throughout the ER experience. In typical use of the present embodiment, shoulder press 203 may be attached to a long board with mount 201 to quickly assist in correct visualization of the cervical spine of the patient to determine if there is an injury.
[0063] One aspect of the present invention is the of identifying and solving problems attendant to prior art approaches is to discover approaches that more optimally achieve a very difficult balance between the competing properties of sufficient strength and sufficient radio lucent and/or imaging compatible properties. Some embodiments of the present invention provide means for shoulder migration during radiography that alleviate line of sight overlayment of the vertebral structures while maintaining sufficient strength to exert the motive force necessary to migrate the shoulders.
Preferred embodiments are implemented without a carbon/glue interface, which directly overlays the lower cervical vertebral bodies in the prior art. Preferred embodiments also provide density reduction to all structures of the shoulder pusher as compared to the prior art.
[0064] The Shoulder Pusher is a rigid radiolucent and/or imaging compatible positioning device utilized for migrating the shoulders. The Shoulder Pusher is a radiolucent and/or imaging compatible U shaped member that is positioned on the shoulders to transmit motive force.
However, the structure of this device does not have a method of construction that can accomplish this feat effectively. The difficulty of construction of such a device stems from the occurrence of an artifact, which refers to the obscuration of radiography via structural density. Dense objects cause an opaque shadow during X-ray which obscure a clear view of pertinent structures necessary for diagnostic and intra-operative radiography. Additionally, none of the prior arts which have been cited in reference to the Shoulder Pusher involved any radio lucent and/or imaging compatible function as a pertinent part of their designs. They are all merely simple uniform density arches which shared a simple external appearance to the arch as illustrated in the shoulder pusher. In regards to these prior arts, even if they are constructed from a radio lucent and/or imaging compatible material, they would fail for the same reason the shoulder pusher fails; too much density is generated by the structure. Simply constructing something from radio lucent and/or imaging compatible materials does not render it radiolucent and/or imaging compatible . Furthermore, simply reducing the density of the structures of the shoulder pusher as described does not result in a workable remedy, as it lacks sufficient strength while still directly overlaying the vertebral column.
[0065] Figures 3A and 3B illustrate an exemplary shoulder pusher 300, in accordance with the prior art. Figure 3A is a diagrammatic top view, and Figure 3B is a diagrammatic side view. Shoulder pusher 300 comprises a pair of simple arches 303 of uniform density that are bisected by a pair of simple pusher tubes 305. Pusher tubes 305 are connected by an adjustable connection tube 306. Shoulder pusher 300 provides a means of temporary migration of the shoulders via the handheld application of bilateral motive force during cervical vertebral radiography for the purpose of obtaining optimized lateral imaging of a subject's cervical vertebral column unimpeded by the unintended imaging of the structures of the subjects shoulders. Arch 303 is permanently attached to pusher tube 305 via a carbon/glue interface 307 at the point of bisection. In that carbon fiber is an essentially brittle material, the thickness and density of arch design are essential for purposes of strength as is the placement of pusher tubes 305 in such a manner as to bisect the circumference of arches 303. In typical use, arches 303 of shoulder pusher 300 are positioned on the subject's shoulders and, when pusher tubes 305 are pushed by an operator, transmit a motive force upon the shoulders, facilitating the transient movement of these structures to visualize an additional two to three vertebrae.
[0066] Although shoulder pusher 300 actually alleviates some artifact due to a clear view of the cervical vertebral structures via a temporary migration of the shoulders, shoulder pusher 300 concurrently contributes artifact. In fact, surgeons have reported that shoulder pusher 300 actually contributes as much artifact as it alleviates, rendering shoulder pusher 300 a partial, as opposed to complete, improvement over the traditional means of optimization of radiography via migration of the subject's shoulders. Through study of radiographic views obtained from various surgeons, it has been determined that this artifact originated directly from three specific portions of shoulder pusher 300, resulting in the simultaneous introduction a small yet significant artifact directly in the optimum line of site, even as shoulder pusher 300 alleviated the majority of the artifact caused by the shoulders via migration of the structures of the shoulders. These three causes of artifact are as follows: direct/partial obscuration of the cervical vertebral structures due to line of sight positional obscuration and interference of pusher tube 305 as viewed from the crucial lateral perspective, direct/partial obscuration of the lower vertebral structures by arch 303, and direct/partial obscuration of the critical vertebral structures due to the direct interposition and occlusion of carbon/glue interface 307.
[0067] Figure 4 is a diagrammatic side view of an exemplary shoulder pusher 400, in accordance with an embodiment of the present invention. In the present embodiment, shoulder pusher 400 comprises an arch 403 and a pusher tube 405 similar to shoulder pusher 300 shown by way of example in Figure 3. However, pusher tube 405 in shoulder pusher 400 is asymmetrically positioned at the lower portion of arch 403 as opposed to bisecting the arch from a straight position, as in the prior art. This generally eliminates the direct line of sight occlusion of the vertebral column by pusher tube 405 as viewed laterally.
[0068] In order to further alleviate any artifact introduced into the radiographic visualization of the cervical vertebral column, shoulder pusher 400 incorporates a method to reduce the density in the construction of arch 403 in portions where arch 403 directly overlays the radiographic line of sight of the vertebral column when viewed laterally. In many practical applications, this is achieved via elimination and replacement of the tube component and accompanying carbon/glue interface to the arch portion with a single unified composition planar sheet of radiolucent and/or imaging compatible material including, without limitation, Carbon Fiber, PEEK, Beryllium, Glass Fiber Reinforced Acrylic (which may also be referred to as fiberglass) , Thermoplastics,
Polycarbonates, Polyketones, and any other such compositions as prove amenable to usage in Rigid Radiolucent and/or imaging compatible Positioning as shown by way of example in Figures 5A through 5C. [0069] In the present embodiment, arch 403 comprises an advanced curvilinear design employing eccentric geometry in order to further reduce density as much as possible. This eccentric geometry uses segments of circles with different centers to create arch 403, rather than an arch that is a composed of a single circle segment with a single center point. Incorporating what may be thought of by analogy to a "Stealth Technology". This variable density curvilinear architecture is constructed so as to present the thinnest portions of the planar segment to the lateral radiographic view of the cervical vertebral structures, while concurrently widening in the portions outside of the critical beam path, thus distributing the acceptable force load evenly across the shoulders as they are migrated temporarily via the application of distal motive force by the handheld operator. Additionally, the present embodiment eliminates the carbon/ glue plug as a means of fixating the various portions, and instead fashions the entirety of the portions into a one-piece composition as referenced above. It is important that strength be preserved in this more gracile design, while simultaneously preserving sufficient thickness so as to not cause overt of pressure to the subject's shoulders during the application of motive force. As previously stated, the original conception of the shoulder pusher arch according to the prior art calls for uniform thickness and density in order to insure strength of the essentially brittle material. Instead, shoulder pusher 400 comprises a thin, invisible buttress 407 (being constructed of a radiolucent and/or imaging compatible material) attached to the top of the thin, eccentric, curvilinear arch 403 for purposes of strength and stability. The present embodiment may also comprise an ergonomic handgrip at the end of pusher tube 405 away from arch 403 for the operator to hold during use. Shoulder pusher 400 is preferably made of carbon fiber; however, other radiolucent and/or imaging compatible materials may be used such as, but not limited to Carbon Fiber, PEEK, Beryllium a non-Magnetic Metal, Glass Fiber Reinforced Acrylic, Thermoplastics, Polycarbonates, Polyketones, and any other such compositions as prove amenable to usage in Rigid Radiolucent and/or imaging compatible Positioning. Clinical trials of shoulder pushers according to the present embodiment have resulted in vast improvements in radiographic results as artifact is significantly reduced.
[0070] The construction and manufacture of the embodiment illustrated by way of example in
Figure 4 relies upon glue to join the disparate parts of complex arch 403. Some embodiments of the present invention seek to generally eliminate any inherent weaknesses while concurrently seeking to reduce any and all artifact to virtually non-existent levels with the ultimate goal of producing a virtually invisible and virtually indestructible radiolucent and/or imaging compatible arch. Buttress 407 is focused on for optimization to improve the entire design via an increase of strength and radiolucent and/or imaging compatible properties since buttress 407 is the main load bearing component of shoulder pusher 400 and the most radiolucent and/or imaging compatible component. Preferred embodiments extend the buttress to create the main body of the shoulder pusher as a one- piece structure to provide strength and to eliminate glue interfaces which may produce artifact.
[0071] Figures 5 A, 5B and 5C illustrate an exemplary one-piece shoulder pusher 500, in accordance with an embodiment of the present invention. Figure 5 A is a diagrammatic side view. Figure 5B is a diagrammatic top view, and Figure 5C is a diagrammatic front view. In the present embodiment, shoulder pusher 500 is a one-piece anatomic radiolucent and/or imaging compatible positioning device of variable density comprising a variable width radiolucent and/or imaging compatible arch 503 formed at the terminus of an asymmetrically offset tapered arm 505 of radiolucent and/or imaging compatible sheeting. In the present embodiment, shoulder pusher 500 is preferably made of carbon; however, alternate embodiments may be made of various different radiolucent and/or imaging compatible materials such as, but not limited to, Carbon Fiber, PEEK, Beryllium, Glass Fiber Reinforced Acrylic/Fiberglass, Thermoplastics, Polycarbonates,
Polyketones, and any other such compositions as prove amenable to usage in Rigid Radiolucent and/or imaging compatible Positioning, etc. In the present embodiment, tapered arm 505 is asymmetrically positioned at the lower portion of arch 503 and is slightly angled. This positioning of tapered arm 505 generally eliminates artifact caused by the shoulder pusher directly overlaying the vertebral column when in use, as in the prior art, while still enabling an operator to transmit the necessary motive force to migrate the shoulders. Alternate embodiments may be implemented where the tapered arm is positioned at the top of the arch. In the present embodiment, the reduced density of the thin yet strong combination of all of the radiolucent and/or imaging compatible structures into one low density sheet renders shoulder pusher 500 virtually free of artifact.
[0072] Referring to Figures 5B and 5C, the thickness of shoulder pusher 500 varies throughout its structure. This enables the density of shoulder pusher 500 to be lower over key anatomical features to be visualized while still preserving the mechanical integrity necessary to efficiently and comfortably migrate the shoulders. For example, without limitation, a middle portion 511 of arch 503 is thinner than outer portions 513. This enables arch 503 to be thick enough where needed to comfortably migrate a subject's shoulders without the excessive pressure that would be caused by a uniformly thin arch while providing low density in the area over the cervical vertebrae. Those skilled in the art, in light of the present teachings, will readily recognize that the variance in density of the structure of the shoulder pusher may be different in alternate embodiments. For example, without limitation, one alternate embodiment may have a uniform thin density except for a thickened edge, similar to a lip, along the arch where the shoulder pusher comes into contact with the subject. Some embodiments may be implemented to view specific portions of the subject's anatomy; for example, without limitation, one such embodiment may have a thicker density near the arch and a lower density away from the arch in order to obtain radiographic images of the higher cervical vertebrae. Some embodiments may include padding along the edge of the arch for the comfort of the subject.
[0073] In the present embodiment, arch 503 has an eccentric curvilinear design that also contributes to the low density of shoulder pusher 500. Alternate embodiments of the present invention may have eccentric arches of various different shapes and sizes to accommodate a variety of subjects, such that the density reduction methodologies described herein may be applied to various anatomical structures outside of the cervical vertebral bodies, while still utilizing the single piece planar composition of radio lucent and/or imaging compatible material combined with the eccentric geometry of the variable density arch. One practical embodiment of the variable density arch employs variation in the structural geometry of the arch itself in order to minimize radiographic artifact while still preserving crucial structural strength and integrity. The geometry principles taught by way of example can readily be applied to other portions of the anatomy with relatively strait forward modifications specific to the structures needing to be visualized radiographically. Furthermore some alternate embodiments may be implemented without an eccentric arch, but with a variable density, eccentric curvilinear segments of polygon which most specifically attend to the essential requirements of radiographic visualization. The polygons by way of example, without limitation, may include ovals, triangles, trapezoids, etc. with usage of the variable density / variable geometric components and methods as described herein as regards to the arch. In the present embodiment, shoulder pusher 500 comprises attachment means 509 for a connection tube, a handle, a table mount, or other such equipment that aids in the use of shoulder pusher 500.
[0074] In typical use of the present embodiment, two shoulder pushers 500 are used to migrate the shoulders of a subject during a radiographic procedure. Some procedures may only require the use of one shoulder pusher 500 to migrate one shoulder. In cases where two shoulder pushers 500 are used, shoulder pushers 500 may be coupled together, for example, without limitation, with an adjustable connecting tube, as shown by way of example in Figure 3. Shoulder pusher 500 is typically used to migrate the shoulders of a subject toward the subject's feet in a pushing mode. In the pushing mode, arch 503 of shoulder pusher 500 is placed on the subject's shoulder and an operator pushes shoulder pusher 500 into the subject's shoulder in order to cause the shoulder to migrate toward the subject's feet. Once the procedure is complete, the operator releases shoulder pusher 500 from the subject's shoulder, and the shoulder returns to its natural position. In the present embodiment, shoulder pusher 500 not only has utility in the pushing mode but also in a pulling mode and an encircling mode for various usages where radiographic anatomical positioning may be necessary for example, without limitation, MRI compatible anatomic limb positioning, Scoliosis positioning, diagnostic positioning, etc. In the pulling mode, whereas the present arch would be fashioned so as to transmit proximal migratory pressure for purposes of rigid radio lucent and/or imaging compatible positioning, the unified composition could be altered slightly while simultaneously making full usage of the density reduction methodology herein described. In the pulling modality, the present arch would be constructed so as to reverse the direction of the arch such that in the hand held or table mounted functions, the method of the variable density / variable geometry arch could pull as opposed to push the shoulders with attachment points to a Patient Positioning Platform, which, in many practical applications, could be of significant clinical and diagnostic value as regards Radiography for Emergent Trauma in the E.R. In the encircling mode, whereas the present arch would be fashioned to work in tandem so as to encircle limbs, etc. for purposes of rigid radio lucent and/or imaging compatible positioning of limbs, etc, during intraoperative and diagnostic procedures incorporating Radiography, MRI and CT Scanning, the unified composition could be altered slightly while simultaneously making full usage of the density reduction methodology herein described, it should be noted that in the encircling modality it is contemplated that the present arch would have practical value and implementations as a limb / anatomical positioner in the clinical / surgical / diagnostic settings of the, without limitation, MRI / CT and other emerging imaging environments , where the method and discipline of rigid radio lucent and/or imaging compatible positioning is being pioneered and made possible by the present embodiment of the arch method of mechanically usable / viable density reduction of radio lucent and/or imaging compatible structures. A multiplicity of alternative usages of the present arch embodiment as a lateral anatomic rigid radio lucent and/or imaging compatible positioner for clinical / diagnostic / surgical settings will be readily apparent to those skilled in the art in light of the teaching of the present invention. Examples of which include, without limitation, spinal and hip positioners for usage during surgery to correct for scoliosis , possible usage for pinpoint mammography , head positioners ( halos) which would capture and gently fixate the patients head in encircling radio lucent and/or imaging compatible arches without resort to percutaneous pin fixation thru the patients skin. Testing with shoulder pusher 500 has shown near total elimination of all density artifact such that the usage of shoulder pusher 500 appears to occur almost invisibly.
Shoulder pusher 500 also exhibits tremendous strength of design, such that a pair of shoulder pushers according to the present embodiment can withstand load bearing of weight up to and beyond 1200 pounds.
[0075] The embodiments illustrated and described in the foregoing are hand-held, manually operated devices. However, those skilled in the art, in light of the present teachings, will readily recognize that alternate embodiments may be implemented to be machine operated or otherwise automated. For example, without limitation, one such embodiment may comprise a shoulder pusher that is coupled to a table and operated with a hand crank or ratchet, or that is hand operated yet locks unidirectionally when released , so as to not expose a hand held operator to radiation. Other automated embodiments may be motorized or operated by pneumatics or hydraulics.
[0076] It will be further readily apparent to those skilled in the art, in light of the teaching of the present invention, that the foregoing embodiments may be readily configured, depending upon the needs of the particular application, to work as a scoliosis positioner in pushing mode with attachment points to the patient positioning platform for purposes of directing motive force against the Hips and trunk of the patient, as a limb positioner in encircling mode with 2 variable density / variable geometry arches facing one another and adjusted and locked via a locking pin at the lower portions. As a suspected subluxation visualizer in the pulling mode with attachment points to a Patient positioning Platform for purposes of migrating the shoulders while substantially not interfering with the Foam Stabilizers placed around the Neck for purposes of Fixating a suspected Neck Breakage. In addition to shoulder pushing/ pulling, as well as the imaging compatible limb positioners as described. A multiplicity of alternative applications of the present arch as a lateral anatomic rigid radio lucent and/or imaging compatible positioner for clinical / diagnostic / surgical settings will be obvious to those skilled in the art. Examples of which include, without limitation, spinal and hip positioners for usage during surgery to correct for scoliosis, possible usage for pinpoint mammography, head positioners (halos) which would capture and gently fixate the patients head in encircling radio lucent and/or imaging compatible arches without resort to percutaneous pin fixation thru the patients skin. A multiplicity of alternative usages as rigid radio lucent and/or imaging compatible positioners is possible for use throughout the anatomy.
[0077] Some shoulder pushers are hand held radiolucent and/or imaging compatible shoulder positioning devices designed to effect the transient distal migration of a subject's shoulders during lateral radiography, thereby allowing optimized visualization of the cervical vertebrae under X-Ray or other radiography. The utilization of such shoulder pushers in this modality is effected by a live operator positioned at the head of a surgical table delivering this motive force thru handheld positioning and manipulation. Thus, the live operator is exposed to radiation from the radiography, which is an undesirable consequence of using hand held shoulder pushers. Furthermore, these shoulder pushers are often used in a complex surgical environment comprising a multitude of leads, lines and monitoring equipment around which the operator must maneuver, which may be a difficult task. Furthermore, shoulder presses are typically utilized below sterile draping, which is
commonplace in surgery, and therefore not subject to sterile technique. Generally, during the application of distal migratory pressure to the subject's shoulders via usage of a shoulder pusher, said device routinely delivers an average of 12 to 16 lbs. of pressure directly to area of the acromioclavicular joint and to points very proximately medial, namely , the acromial head of the clavicle, all the while coming into simultaneous contact with the subject's epidermis. Therefore it is contemplated that some embodiments may comprise sufficient padding so as to alleviate said distal migratory pressure for the comfort of the subject, while concurrently providing an impermeable layer between the shoulder press and the subject's epidermis for purposes of generally preventing pathogen transfer from subject to subject.
[0078] A practical embodiment of the present invention provides means for rigid radiolucent and/or imaging compatible shoulder positioning for purposes of improved intraoperative and diagnostic lateral radiographic visualization of the cervical vertebral column during lateral views. Many practical embodiments alleviate density artifacts while maintaining strength in a rigid radiolucent and/or imaging compatible shoulder positioning apparatus. Additionally many practical embodiments comprise means for attaching said improved rigid radiolucent and/or imaging compatible shoulder positioning devices to a patient positioning table in an operating room setting such that direct manual operation of the device is typically rendered unnecessary during live radiography of the subject. Furthermore, some practical embodiments comprise a padded, substantially impermeable sheath for purposes of subject comfort, safety, and the general prevention of pathogen transfer from subject to subject.
[0079] One practical embodiment of the present invention provides a hands free, variably positioning, variably position-able, table mounted system comprising a pair of fully radio lucent and/or imaging compatible , asymmetrically offset, high strength, parallel laminar sheets yoked in tandem via an adjustable width crossbar. These laminar sheets are equipped with a pair of radio lucent and/or imaging compatible , ergonomically padded, disposable sheaths provided for the dual purpose of creating a substantially impermeable barrier against subject to subject pathogen transfer, while concurrently providing a cushioned layer to dissipate and ameliorate the distal migratory motive force transferred via the yoked tandem arches to the shoulders of the subject. In this embodiment, the shoulder pusher may be variably and universally mounted to an operating room table to be brought into contact with a subject's shoulders and made to temporarily migrate and hold said shoulders under conditions of live lateral radiography, without radiation exposure to an operator holding the shoulder pusher in place.
[0080] Figures 6A through 6C illustrate an exemplary shoulder pusher 600 in accordance with an embodiment of the preset invention. Figure 6A is a side perspective view. Figure 6B is a diagrammatic top view, and Figure 6C is a diagrammatic side view. In the present embodiment, shoulder pusher 600 comprises two parallel laminar sheets 603, which are yoked in tandem by an adjustable width cross member 605. Laminar sheets 603 are made of a radio lucent and/or imaging compatible material and are asymmetrically offset terminating in complex geometric, variable density arches 607. Laminar sheets 603 generally do not overlay the vertebral column during radiography, and the unified construction of laminar sheets 603 offers strength and low density due to the lack of glue joints. This reduced density makes laminar sheets 603 virtually invisible under radiography. Laminar sheets 603 also comprise an optimized geometry that is thinner over a target point for radiology and thicker in other areas to provide strength. Variable density arches 607 provide the typical point of contact between shoulder pusher 600 and the anatomy of the subject at or very proximately medial to the acromioclavicular joint. In the present embodiment, cross member 605 comprises an adjustment dial 611, which enables a user to extend or retract cross member 605 to make the space between laminar sheets 603 wider or narrower. In some alternate embodiments, this cross member may not be adjustable, and other alternate embodiments may be implemented without a cross member. In embodiments without a cross member, the laminar sheets may be used independently from each other or may be connected by various different means such as, but not limited to, a curved handlebar-type mechanism, a flexible connector, a cable, etc. In the present embodiment, cross member 605 comprises ergonomic handles 613. However, handles in alternate embodiments may have a multiplicity of suitable shapes, and some alternate embodiments may be implemented without handles on the cross member.
[0081] Those skilled in the art, in light of the teachings of the present invention, will readily recognize that a multiplicity of suitable variations may be made to the shoulder pusher assembly in some alternate embodiments. For example, without limitation, in some alternate embodiments, the pusher member(s) may comprise a variety of different shapes and sizes including, without limitation, tubes, bars, lattice-like networks, sheets with or without openings, etc. all of which may be solid or hollow. Also, some alternate embodiments may comprise more or fewer pusher members. Embodiments comprising a plurality of pusher members may be fashioned so as to make contact of the pusher member with the arch member along the full continuum of the arch
irrespective of whether this includes one pusher member positioned anywhere along the arch to two pusher members in contact at the upper and lower extremities of the arch, to more than two pusher members positioned anywhere in contact with the arch in order to deliver caudal migratory pressure upon the acromioclavicular joint and the very proximately medial portion of the acromial head of the clavicle of the subject. Some alternate embodiments may comprise solid pusher members which are contiguous in all ways with the arch members. Other alternate embodiments may comprise pusher members that are laminar sheets of varying shapes and sizes such as, but not limited to, L-shapes, triangular shapes, rectangular shapes, etc.
[0082] In the present embodiment, the point of contact between arch 607 and the subject is typically at the anatomic feature identified as the acromioclavicular joint and/or very proximately medial to this structure at the acromial head of the clavicle , said acromial head involving itself with the ligaments of the capsule of the Acromioclavicular Joint, as this narrow point of contact typically yields an excellent result for distal migration of the shoulders, replicating the functionality of the articulating shoulder girdle as it migrates caudally. However, in some alternate embodiments, contact may be established between the arch and areas adjacent to the acromioclavicular joint very proximately medial, such as, without limitation, the acromial head of the clavicle , as the application of distal migratory motive force to these anatomical points of interface with a rigid radio lucent and/or imaging compatible member will replicate the function of the shoulder girdle without either compression or elongation to the brachial plexus and sub-clavial bloodflow as is commonplace with the Traditional means , thereby delivering significantly safer and more efficient clinical results. Therefore some embodiments of the present invention provide temporary distal migration and temporary traction of the acromioclavicular joint and the area of the Acromial head of the Clavicle , situated very proximately medial to the acromioclavicular joint, in order to facilitate optimized intraoperative and diagnostic lateral radiographic views of the cervical vertebral column.
[0083] Figure 7 is a side perspective view of an exemplary anatomical positioning system comprising a shoulder pusher 700 and universal table mounts 701, in accordance with an embodiment of the present invention. In the present embodiment, shoulder pusher 700, comprising two high strength, radio lucent and/or imaging compatible, parallel laminar sheets 703 terminating in complex variable density arches 705 connected by an adjustable cross member 707, is seated in a pair of cradles 709, one on each table mount 701, equipped with swivel locks 711 for purposes of supporting and affixing shoulder pusher 700 variably to a patient platform 719. Swivel locks 711 allow for full width adjustment of cross member 707 while concurrently allowing for automatic correct angulation of laminar sheets 703 to provide a proper interface between arches 705 and the anatomy of a subject's shoulders. Swivel locks 711 swivel around in both clockwise and counterclockwise fashion thus allowing the T-intersections of cross member 707 and laminar sheets 703 to pass through swivel locks 711 during length adjustment of cross member 707. Cradles 709 connect to a pair of movable slides 713 offering full travel along the length of twin rail assemblies 715, which are mountable anywhere along the full continuum of a typical accessory side rail 717, which runs along the full length of both sides of patient platform 719. Rail assemblies 715 attach to side rails 717 via a set of lockable clamps 721, which are variably position-able and lockable anywhere along the full continuum and length of side rails 717, making universal table mounts 701 compatible with virtually all, tables, surgical set-ups, and techniques common and uncommon to cervical vertebral surgery. Movable slides 713 offer full travel along the length of rail assemblies 715 and are equipped with trigger mechanisms 723 for releasing and actuating a braking mechanism within each slide 713. Slides 713 allow for back and forth directional movement along rail assemblies 715 when triggers 723 are depressed by a user. Braking mechanisms within slides 713 automatically halt travel along rail assemblies 715 when triggers 723 are released. Those skilled in the art, in light of the teachings of the present invention, will readily recognize that a multiplicity of suitable modifications may be made to the system to provide a sliding function for the shoulder pusher in some alternate embodiments such as, but not limited to, providing various different means of ratcheting, gearing or pulleys constructed of radio lucent and/or imaging compatible materials or non-radio lucent and/or imaging compatible materials, interlocking collapsible and extendible tubes, forms or members, replicating the slide feature with various segments resembling a monorail such that a movable platform travels atop, under, through, or alongside these segments, wheeled members, etc.
[0084] In the present embodiment, the braking mechanisms within slides 713 interlock with a toothed rack within rail assemblies 715 to provide a unidirectional automatic braking system.
Engaging triggers 723 actuates the braking mechanisms away from the toothed racks to enable free movement of slides 713, and letting go of triggers 723 releases the braking mechanisms back into the toothed racks thereby resulting in automatic hands free braking of travel of slides 713 cradling shoulder pusher 700 against the shoulders of the patient. Those skilled in the art, in light of the teachings of the present invention, will readily recognize that a multiplicity of suitable braking systems may be implemented in some alternate embodiments including, but not limited to, a friction braking system, a ratcheting brake system, a pneumatic brake system, an electromechanical braking system, a spring loaded braking system, an air cylinder braking system, a bladder/inflation actuated braking system, etc. Furthermore, any of these braking systems may be fitted with remotely or non- remotely operated electromechanical means of single or multiple operator actuation. Also, the braking systems in some alternate embodiments may be configured to provide bidirectional braking. In the present embodiment the braking system is operator actuated via passive means, whereby the release of triggers 723 (i.e., the absence of the operator) renders automatic braking and the actuation of triggers 723 retards the braking system, restoring travel. In light of the teachings of the present embodiments, in some alternate embodiments, various different direct means of operating, actuating and/or releasing the braking system may be apparent to those skilled in the art. Some non-limiting examples of such direct means include, without limitation, dials, twist knobs, handles, buttons, levers, rods, etc. In these alternate embodiments, the actuation of the direct means of operation variously apply and set the braking system, thereby retarding travel, while the opposite actuation of which releases the braking system and restores full functionality of travel. Yet other alternate embodiments may comprise various different indirect means of operation of the braking system, including, but not limited to, any and all mechanical and electromechanical remote means which would affect simultaneous hands free locking and release of the brake by a single operator or multiple operators. [0085] In the present embodiment, the anatomical positioning system also comprises a pathogen guard 725, which is a padded, impermeable, disposable sheath that covers portions of laminar sheets 703 that come into contact with or are near the subject. In some prefered
embodiment, pathogen guard 725 comprises a Polyolefm material. In other embodiments transparent materials such as, but not limited to, PVC or polycarbonate may be used. Pathogen guard 725 comprises a radio lucent and/or imaging compatible pad 727 at the point of contact with the subject (i.e., without limitation, the acromioclavicular joint and/or slightly medial at the acromial end of the clavicle /shoulder). Radio lucent and/or imaging compatible pad 727 may comprise a medical grade foam such as, but not limited to, polyether, polyester, polyethylene, cross-link polypropylene, & flexible urethane. Pathogen guard 725 acts as a padded prophylaxis generally preventing subject to subject transfer of pathogens such as, but not limited to, MRSA, as well as providing padding for patient comfort and to generally prevent abrasions to the subject thru which pathogens may enter the body. In some alternate embodiments, the pathogen guard may be a pad which is permanently affixed to the arch portion of the laminar sheet where it makes patient contact or a variably affixed pad or may be non-disposable pads that slip over the ends of the laminar sheets. In the present embodiment, pathogen guard 725 may be form fitting or loosely configured. In some embodiments the pathogen guard may be fixated via various different means such as, but not limited to, a press seal, hook and loop material, tape, elastic, adhesive, etc. Other alternate embodiments may provide separate padding and protection from pathogens. These embodiments enable the padding to be reused, and the pathogen guard alone to be discarded after use. Yet other
embodiments may be implemented without a padding feature, without a pathogen guard or with neither of these features.
[0086] In typical use of the present embodiment, the anatomical positioning system is mounted to patient platform 719. Initially, the shoulder pusher 700 may be positioned with the arches 705 in a vertical position such that the patient may be positioned on the table and/or other equipment is placed on or about the table. Then, the position of shoulder pusher 700 is rotated and adjusted so that arches 705 are brought into contact with the shoulders of the subject. A user may temporarily migrate the shoulders by depressing triggers 723 and pushing on shoulder press 700. Once the shoulders are properly migrated, the user releases triggers 723 to activate the braking mechanisms and hold shoulder press 700 in place. This enables the shoulders to remain in the migrated position under conditions of live lateral radiography, typically without the need of a hand held operator. The system may or may not be used with pathogen guards 725 on one or both laminar sheets 703. The positioning system according to the present embodiment is compatible with the three most common surgical set-ups in addition to other types of set-ups. Furthermore, the positioning system is compatible with virtually all tables and virtually all surgeon stances and techniques. The operation of the positioning system does not require a user to exert much strength and can be easily operated by a single user in accordance with some safety considerations. The positioning system also provides automatic hands free locking and means for immediate withdrawal by a single user. In a non-limiting example, a user may tap the release triggers 723 to withdraw the shoulder press 700 from the patient. Complete withdrawal of shoulder press 700 from a surigal field is accomplished by simply disengaging swivel locks 711. Additionally, the positioning systems allows for variable intra-operative migration, as opposed to static migration provided by some traditional techniques such as, but not limited to, sand bags on straps, harnesses, or tape. The positioning system provides high strength braking under continuous load. Furthermore, the positioning system fits within the already crowded area of a typical cervical surgical environment, generally without interference to other commonplace and necessary equipment.
[0087] In typical use of the present embodiment, a user can push as hard as he likes on shoulder pusher 700. Mechanically, the acromioclavicular joint typically migrates until it reaches the best caudal (i.e., towards the feet) migration, and then it stops. This migrating motion is similar to a subject placing a 15 to 20 pound bag on his shoulder. By placing arches 705 on the
acromioclavicular joint and/or very proximately medial , the user pushes the acromioclavicular joint in the direction in which it is designed to migrate, without significantly compressing either the brachial plexus or subclavial arterial and veinous formations , thereby significantly avoiding both impingement to the nerves and restriction of bloodflow associated with the traditional means of taping the trapezius. Some alternate embodiments may comprise mechanical force gauges to provide feedback to the medical personnel as to the force being applied to the subject's
acromioclavicular joints and/or the acromial head of the clavicle situated very proximately medial to the acromioclavicular joint.. In other alternate embodiments, electronic sensors and displays may be incorporated to monitor the forces applied. In yet other alternate embodiments, automatic safety releases may activate to release the braking mechanisms if an amount of force exceeds a preset limit. Some alternate embodiments may comprise an emergency brake in the form of a clamshell-like rail clamp that can open and drop down. A rail clamp, shuch as shown in Figure 8, may be quickly removed without removing other equipment from the rail. [0088] In the present embodiment, mounting clamps 721 of the universal table mounts are shown to slide onto accessory side rails 717, as provided ubiquitously and to standard measurements by many manufacturers of operating room tables. Mounting clamps 721 may also be attached to drop down side rail attachments configured as temporary rails which can be added to radio lucent and/or imaging compatible tops available in newer tables being offered with compatibility to the evolving CT, MRI and O-Arm imaging environments as these tables typically do not include permanently affixed accessory side rails. In some alternate embodiments, the mounting clamps may be configured to fit the standard rail dimensions as applicable to all international usage including, without limitation, metric standards as well as Japanese standards. In another alternate embodiment, the mounting clamps may be attached to the end or side of the operating table itself and not to the accessory side rails. In such an embodiment, the laminar sheets may be lengthened to accommodate this alternative clamp. In another alternate embodiment, the rail assemblies may be made to attach to a central cantilevered column (i.e., pylon) of a Jackson Table, offering a Jackson Table specific solution. Yet other alternate embodiments may be configured to fit various different types of tables at specific locations such as, but not limited to, mounting clamps which fit universally at the peripheries of the head of the bed , specifically at the upper corners of the bead , to which the rail assembly is attached, such that the system can be universally attached without resort to the use of any side rails. Additionally, some alternate embodiments may be configured to function with a particular type of surgical set-up, as opposed to a universal solution as disclosed in the present embodiment. Non-limiting examples of such embodiments include, without limitation, a clamp which fits onto the same portion of the operating table that a typical Mayfield head holder attaches or a clamp which may work with a head on a typical bed set-up, yet would not be compatible with the Jackson Table or the various surgical head holders commonplace in cervical vertebral surgery. Yet another alternative embodiment comprises a clamp which mounts under the patient platform. Such an embodiment may also comprise a U-shaped member to enable the universal table mount to reach the correct position to affect distal migration of a subject's shoulders. Yet other alternate embodiments may be implemented with attachment means other than clamps such as, but not limited to, screwed or bolted connections, hooks, clips, magnets, adhesives, etc.
[0089] Figure 8 is a diagrammatic side view of an exemplary mounting clamp 800, in accordance with an embodiment of the present invention. In the present embodiment, mounting clamp 800 comprises an offset open channel 801 at the bottom of clamp 800, allowing clamp 800 to mount by being dropped down onto an accessory side rail while preserving the equivalent slide function and locking ability. A setscrew 803 enables a user to tighten or loosen clamp 800 upon the side rail at a desired location. A rail assembly of a table mount may be connected to clamp 800 through a hole 805.
[0090] Referring to Figure 7, in this exemplary embodiment, clamps 721 of rail assemblies
715 are shown attached to a standard sized operating table, patient platform 719, anywhere along accessory side rails 717. However, it is contemplated that in some alternate embodiments the table mounts may be attached to the patient platform in various different locations using various different means or may be separate from the patient platform. Some alternate embodiments may be implemented as pole-mounted systems; for example, without limitation, the rail assemblies and clamps may be mounted to their own independent poles, or the system may be configured to attach to a typical two pole stand routinely provided at the head of operation tables for purposes of supporting sterile drapes. Another alternative embodiment provides a floor-mounted system comprising a rail assembly and clamp mounted to a variably position-able, wheeled carriage, such that the rail guides can be brought in immediately behind the shoulders, generally without interfering with any table mounted accessories such as, but not limited to, a Mayfield Head Holder while still being workable with a Jackson Table. Yet another alternative embodiment provides a ceiling-mounted system, similar to the fashion of surgical operating microscopes, lighting arrays, and various other components commonly used in surgical settings. Yet another alternative embodiment comprises a swivel mechanism to attach the system to a patient platform. This embodiment enables the system to be mounted to the patient platform before the subject is on the table and rotated out of the way while the subject is transferred to the patient platform. Then, the system can be rotated into a functional position before draping the subject under sterile field conditions.
[0091] Referring to Figure 7, the anatomical positioning system of the present embodiment is shown using height and angle parameters of universal table mounts 701 and size parameters of laminar sheets 703 that generally eliminate difficulty in set-up. To help achieve more universal table mounting capabilities, these measurements preferably are configured to form an acute angle of 63 degrees to 65 degrees (from the horizontal) for support members 731 of cradles 709 with a 1 inch gap between rail assemblies 715 and accessory side rails 717. In many practical table mount applications, an angle of 62 degrees or less may cause table mounts 701 or shoulder pusher 700 to rub padding that may be present on patient platform 719 yet may be suitable in some alternate embodiments. In some other embodiments, in accordance with the needs of the particular application, the range of the angle may be broader. By way of example, and not limitation, an alternative embodiment of the present invention includes configurations adapted to enable the user to adjust height and angulation of the apparatus thru support members which can lengthen and shorten via the operation of a set-screw, a clamp, or via any number of means of varying the height and angulation of these members., depending upon many practical consideration, including, without limitation, the configuration of the gap and padding. In the present embodiment, laminar sheets 703 are 17 ½ inches long from where shoulder pusher 700 fits into cradles 709 to the location on arches 705 that make contact with the subject. These parameters enable universal table mounts 701 to be mounted to virtually any commercially available patient positioning and operating table without the need for adjustment. Furthermore, these parameters provide a single surgical solution, generally free from the need for adjustment that is compatible with all three surgical set-ups currently common to the field of cervical vertebral surgery. However, alternate embodiments of the present invention are not limited to the use of these parameters. Within such a rapidly evolving field as medical devices, a new paradigm may emerge which may require different parameters. As such, the preferred angle or lack thereof may be changed to adapt to changing standards in the filed or to be compatible with uncommon platforms or set-ups currently available. As such, one alternative embodiment of the present invention comprises a fully adjustable platform that is adaptable to any platform or set-up. In said embodiment, the universal table mounts may include, without limitation, a multiplicity of height, width, and angle adjustments for purposes of maintaining universal compatibility. It is contemplated that other alternate embodiments may be implemented with a multiplicity of suitable parameters for use in various different set-ups and with various different patient platforms.
[0092] Figure 9 is an exemplary diagrammatic side view of the Visualization of the Lower
Cervical Vertebral Levels in the Supine Position.
[0093] Figure 10 is a exemplary diagrammatic front view of the anatomic structures of the shoulders , to include the Acromioclavicular joint , the Sternoclavicular Joint as well as the Brachial Plexus Nerve Bundle and Sub Clavial Arterial and veinous formations, in accordance with an embodiment of the present invention.
[0094] Figure 10 AC Joint and Shoulder Girdle
[0095] 1001 Acromioclavicular Joint [0096] 1002 Acromial End of the Clavicle
[0097] 1003 Clavicle
[0098] 1004 Acromion
[0099] 1008 Sternoclavicular Joint
[00100] 1006 Sub C la vial Vein
[00101] 1007 Sub C la vial Artery
[00102] 1005 Brachial Plexus
[00103] Figure 10 illustrates the anatomy of the Shoulder Girdle with which the present invention makes contact. Figure 10 A depicts the Acromioclavicular Joint comprised of the Acromion 104 connected to the Clavicle 1003 at the Acromion Head of the Clavicle 1002 via the Ligaments and capsule of the ACROMIOCLAVICULAR JOINT 1001. Figure 10B Illustrates the Brachial Plexus Nerve Bundle which communicates to the Upper Extremity of the Arm and Hand, as well as the sub clavial Artery 1007 and Subclavial Vein 1006, which communicate thru to the arm unde the Clavicle 1003. Figure 10c depicts the same structures with the addition of 1008 the sternoclavicular joint which articulates distally and proximally with the clavicle.
[00104]
[00105] Figures 11 A to E further depict the anatomy of the Acromioclavicular joint by way of presenting a diagrammatic view of the bony structures of this joint, namely, the Acromion and the Clavicle both with and without the accompanying capsule and ligaments, as well as illustrating the various shapes of the acromion within the population in accordance with the Bigliani Classification of these structures. Said variations can make caudal migration at the Acromion itself problematic, as the Curved and the Hooked Acromion Processes as depicted in Figure 1 ID and Figure H E, focus all of the distal migratory force at ONE Point on the Acromion, which is then translated as stress to the Acromial Ligament of the Shoulder Capsule, rendering the capsule susceptible to separation of the Acromion from the Clavicle (As id Illustrated fully in Figure 15). According to Bigliani, the noted authority on the Acromion, these two problematic shapes account for 83 % of the Global Population. As such, the Method of Usage of the Present Invention avoids contact at the Acromion which in addition to being a point of contact which inherently communicates stress to the shoulder capsule ( as occurs during the Traditional Means of "Pulling on the Arms", which can result in Shoulder Separation) , ALSO is connected to the Scapula by only a thin portion of the Acromion Process , which is subject to fracture. As such, the Present method of Usage of the Present Invention avoids contact with the Acromion as a point of Caudal Migration.
[00106] Figure 11 AC Joint and Acromion Process
[00107] 1001 Acromioclavicular Joint
[00108] 1004 Acromion
[00109] 1003 Clavicle
[00110] 1101 Coracoid Process
[00111] 1102 Humerus
[00112] 1103 Glenoid
[00113] 1002 Acromial End of the Clavicle
[00114] 1105 Trapezoid Ligament
[00115] 1106 Conoid Ligament
[00116] 1104 Coraco acromial ligament
[00117]
[00118] 1107 Flat Acromion (17% of Population Bigliani Classification) [00119] 1108 Curved Acromion (43% of Population Bigliani Classification) [00120] 1109 Hooked Acromion (40% of Population Bigliani Classification) [00121]
[00122] Figure 11 A depicts the bony structures of the Acromioclacicular Joint and the
Shoulder illustrated without the ligaments. 1103 the Glenoid Fossa connects to 1102 the Humerus. 1004 is the Acromion, which butts against 1002 the Acromial Head of the Clavicle 1003. 1101 is the Coracoid Process, an attachment point for ligaments and muscle of the shoulder and chest. Figure 1 lb illustrates the Shoulder and the Acromioclavicular Joint with associated ligaments. 1001 represents the shoulder capsule of the Acromioclavicular Join, which involves the Acromion Head of the Clavicle 1002 with the Acromion 1004. 1003 depicts the clavicle itself, connected to Coracoid Process 1101 via the Trapezoid Ligament 1105 and the Conoid Ligament 1106. Figures l lC, 1 ID, and 1 IE represent the variations within the population of the Acromion, with Said variations rendering caudal migration at the Acromion itself problematic, as the Curved and the Hooked Acromion Processes as depicted in Figure 1 ID and Figure H E, focus all of the distal migratory force at ONE Point on the Acromion, which is then translated as stress to the Acromial Ligament of the Shoulder Capsule, rendering the capsule susceptible to separation of the Acromion from the Clavicle (As id Illustrated fully in Figure 15). According to Bigliani, the noted authority on the Acromion, these two problematic shapes account for 83 % of the Global Population. As such, the Method of Usage of the Present Invention avoids contact at the Acromion which in addition to being a point of contact which inherently communicates stress to the shoulder capsule (as occurs during the Traditional Means of "Pulling on the Arms", which can result in Shoulder Separation), ALSO is connected to the Scapula by only a thin portion of the Acromion Process, which is subject to fracture. As such, the Present method of Usage of the Present Invention avoids contact with the Acromion as a point of Caudal Migration.
[00123] Figure 12 illustrates a superior view of the entirety of the "Shoulder Girdle", comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention
[00124] Figure 12 Supine Shoulder Girdle Superior View
[00125] 1002 Acromial End of the Clavicle
[00126] 1003 Clavicle
[00127] 1004 Acromion
[00128] 1005 Acromion Process
[00129] 1008 Sternoclavicular Joint
[00130] 1009 Sternum
[00131] 1201 Scapula
[00132] 1202 Spine of the Scapula
[00133] 1203 Spinal Column [00134] 1101 Coracoid Process
[00135] Figure 12 illustrates a superior view of the entirety of the "Shoulder Girdle", comprising the various articulating structures which make up the anatomy of the shoulder, the naturalistic articulation of which is replicated via the method of usage of the apparatus of the present invention. 1005 depicts the Acromion Process and 1004 depicts the Acromion itself, the application of caudal migration to which can be problematic in that it can result in "Shoulder Separation", which is an associated risk entailed with the Traditional Method of "Pullling on the Arms" for purposes of Shoulder Migration. 1001 represents the ACROMIONCLAVICULAR Joint itself, which along with the Acromion Head of the Clavicle 1002 located very proximately medial to the AC Joint, represent the METHOD of Application of Caudal Migratory Force via the present Invention. 1003 represents the Clavicle itself, which articulates superiorly and inferiorly via the 1008 the
sternoclavicular joint as it connects to the Sternum 1009. 1202 illustrates a thick portion of bone referred to as the Spine of the Scapula, the Scapula itself depicted as 1201. 1203 represents the Spinal Column.
[00136] Figure 13 identifies the specific exemplary points of caudal migratory contact which are often directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub Clavial Arterial and Veinous formations, all of which commonly associated with usage of the so -called "traditional means" of shoulder migration, namely, these points of contact being the Trapezius and the Acromion Process which is LATERAL to the ACROMIOCLAVICULAR Joint. Stress to the Acromion Process resulting in Shoulder Separation, and compression to the trapezius resulting in deleterious consequence to the Brachial Plexus and Sub Clavial Arterial and Veinous formations. 13A depicts 1502, a Grade 1 Shoulder Separation according to the Rockwood Classification, which is a Separation of the Ligaments of the Acromialclavicular Joint 1001 from the Acromion 1004, from the Clavicle 1003. Figure 13B represents insult or Injury to the Brachial Plexus nerve bundle either thru compression of the trapezius of thru aggressive pulling on the wrists and Arms for purposes of caudal migration of the shoulders. Figure 13C identifies two points of contact associated with the Traditional Means of Shoulder Migration, these two points of contact associated with the traditional means.
[00137] Figure 13 Illustrates typical complications associated with Traditional Means of Shoulder Migration.
[00138] 1004 Acromion [00139] 1502 Shoulder Separation Grade 1
[00140] 1003 Clavicle
[00141] 1703 Distal Pressure at the Acromion / Acromion Process
[00142] 1001 Acromioclavicular Joint
[00143] 1002 Acromial End of the Clavicle
[00144] 1004 Acromion
[00145] 1006 Sub Clavial Vein
[00146] 1007 Sub Clavial Artery
[00147] 1704 Compression of the Trapezius
[00148] Figure 13 identifies the specific points of caudal migratory contact which are directly contributory to complications to the shoulder girdle as well as contributory to Complications to the Brachial Plexus and Sub Clavial Arterial and Veinous formations, all of which commonly associated with usage of the so -called "traditional means" of shoulder migration. These points of contact being the Trapezius and the Acromion Process which is LATERAL to the
ACROMIOCLAVICULAR Joint. Stress to the Acromion Process resulting in Shoulder Separation, and compression to the trapezius resulting in deleterious consequence to the Brachial Plexus and Sub Clavial Arterial and Veinous formations.
[00149] Figure 14 further identifies exemplary points of compromise to the Brachial Plexus and Sub-Clavial Arterial and Veinous formations, often associated both with compression of the Trapezius as well as associated with "Pulling on the Arms", Taping the Trapezius , and with the usage of Compression Harnesses during radiography.
[00150] Figure 14 Complications to Brachial Plexus and Sub Clavial Bloodflow associated with Traditional Means of Shoulder Migration
[00151] 1401 Brachial Plexus Insult / Stingers & Burners
[00152] 1402 Brachial Palsy Symptomatology
[00153] 1006 Sub Clavial Vein
[00154] 1007 Sub Clavial Artery [00155] [00156]
[00157] Figure 15 illustrates an exemplary mechanism of possible damage expected to the Shoulder capsule via the application of force LATERAL to the Acromioclavicular Joint, said diagrammatic view depicted in accordance with the " Rockwood Scale ", said damage commonly referred to as " Shoulder Separation", with said insult and/or injury to the shoulder capsule associated with the traditional means of Shoulder migration via Pulling the Arms. Said anatomic contact to be avoided.
[00158] Figure 15 Shoulder Separation Complications from Traditional Means of Shoulder Migration
[00159] 1001 Acromioclavicular Joint [00160] 1004 Acromion [00161] 1002 Acromial End of the Clavicle [00162] 1502 Shoulder Separation Grade 1 [00163] 1503 Shoulder Separation Grade 2
[00164] 1504 Shoulder Separation Grade 3 (AC Ligament Disruption Vertical Separation / Coraco clavicular Ligament Separation )
[00165] 1105 Trapezoid Ligament
[00166] 1106 Conoid Ligament
[00167]
[00168] Figure 16 illustrates various exemplary views depicting the normal anatomic function of the Shoulder Girdle as it migrates caudally, as well as illustrating the normal interaction of the brachial plexus and sub clavial arterial and veinous structures within the structures of the articulating shoulder Girdle without exposure to impingement and/or stretching or compression, all of which as are generally associated with the so-called "Traditional Means" of Shoulder Migration.
[00169] Figure 16 illustrates exemplary Normal Function of AC Joint and Superior Scapula During Caudal Migration
[00170] 1201 Scapula [00171] 1001 Acromioclavicular Joint
[00172] 1003 Clavicle
[00173] 1008 Sternoclavicular Joint
[00174] 1007 Sub C la vial Artery
[00175] 1005 Brachial Plexus
[00176] 1901 C4 Cervical Vertebrae 4 Visible Laterally under Imaging
[00177] 1902 C7 Cervical Vertebrae 7 Visible Laterally under Imaging
[00178] 1202 Spine of the Scapula
[00179]
[00180] Figures 17-20 illustrate various procedural aspects of an exemplary method of using a means of migration apparatus such as, without limitation, that of Figure 7, to more safely perform a shoulder migration procedure, in accordance with an embodiment of the present invention. The exemplary method shown seeks to significantly replicate the normal function of the articulating shoulder girdle as presented in Figure 16, said replication of proper caudal migration effected via the application of caudal migration directly at the Acromionclavicular Joint and/or very proximately medial to the joint at the Acromion Head of the Clavicle , usage of said method in the operation of the apparatus of the present invention REPLICATING the Function of the natural motion of the shoulder girdle without exposure to the risks of "Shoulder Separation", Brachial Plexus Insult and Injury, Impingement Syndrome, and suppression of blood flow thru the sub clavial arterial and veinous formations, all of which complications are typically associated with the "Traditional Means" of Shoulder Migration. Figure 17 also designates the anatomic portions to be avoided for the application of caudal migratory force, these areas associated with the "Traditional Means" of Shoulder migration, namely, the Acromion Process and the Trapezius, as the application of cauda migratory force to these areas replicates the complications of the so-called "traditional means" of shoulder migration, risking shoulder separation, loss of adequate blood flow to the upper extremities, and brachial plexus insult and injury.
[00181] Figure 17 illustrates an exemplary angle of approach and exemplary contact points of the present shoulder migration procedure method, in accordance with the foregoing embodiment of the present invention. In particular, the present method of caudal migration is substantially at the ac joint and slightly medial at the acromial head of the clavicle.
[00182] 1701 Radio lucent and/or imaging compatible Arch
[00183] 1702 Method of Placement / Contact / Caudal Migration at the Acomionclavicular Joint & Acromial End of the Clavicle for Safe Shoulder Migration and Distal Traction
[00184] 1002 Acromial End of the Clavicle
[00185] 1001 Acromioclavicular Joint
[00186] 1703 Distal Pressure at the Acromion / Acromion Process
[00187] Figure 18 further illustrates the exemplary Method of anatomic contact with the means of migration, e.g., without limitation, the Radio lucent and/or imaging compatible Arch, at the natural prominence of the Acromionclavicular Joint or Very proximately medial to the Joint at the Acromial Head of the Clavicle for the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention. In the present embodiment, the means of migration delivers a Caudal Migratory Force in such a method so as to substantially approximate the Normal function of the Articulating Shoulder Girdle without risk of slipping laterally as the geometry of the shoulder is altered thru distal motion, and without risk of application of force Lateral to the
Acromioclavicular Joint, thereby substantially reducing, if not eliminating, exposure to Shoulder Separation as identified by the Rockwood Scale.
[00188] Figure 18 Natural Prominence of the AC Joint as a Barrier to Lateral Slippage [00189] 1701 Radio lucent and/or imaging compatible Arch
[00190] 1801 AC Joint forming Natural Anatomic Barrier to Lateral Slippage of the
Radio lucent and/or imaging compatible Arch during Safe Caudal Migration of the Shoulder
[00191] Figures 19A and 19B illustrate a diagramatic side view of the method of usage shown in Figure 18. As shown, the natural function of the Shoulder Girdle is substantially replicates as it articulates caudally , said method offering no compression to the brachial plexus or sub clavial blood flow, said method spreading the caudal migratory force across the two major migratory points of the shoulder girdle, namely at both the Acromioclavicular Joint and at the Spine of the Scapula, as opposed to focusing all of the motive force upon the ligaments of the ACROMION, or via COMPRESSION of the trapezius, said Method of usage of the present invention exposing the patient to little, if no, possibility of Shoulder Separation and to little, if no, compression of the Neurovascular Bundle via usage of the present method. Furhtermore , the Spine of the Scapula connects across the posterior segment of the Scapula with the Acromion Itself . In this way , the Present Method of Caudal Migration AT or Very proximately medial to the AC Joint , the
Radio lucent and/or imaging compatible Arch making Simultaneous contact with the Spine of the Scapula , with no less than 4 ligaments UNDERNEATH this Point of Contact acting as a natural cushion , IS ABLE to REPLICATE the NATURLISTIC Function of the Shoulder Girdle migrating Caudally as presented in Figure 16 ...WITHOUT the risks of Shoulder Separation, Compression of the Brachial plexus or Sub Clavial BloodFlow , or Impingement of the Thoracic Outlet, as described in Figure 20 .
[00192] Figures 19 A and B showing Lateral View of the Method of Placement of the
Radiolucent and/or imaging compatible Arch w AC Joint.
[00193] 1701 Radiolucent and/or imaging compatible Arch
[00194] 1901 C4 Cervical Vertebrae 4 Visible Laterally under Imaging
[00195] 1001 Acromioclavicular Joint
[00196] 1202 Spine of the Scapula
[00197] 1201 Scapula
[00198] 1103 Glenoid
[00199] 1901 C4 Cervical Vertebrae 4 Visible Laterally under Imaging [00200] 1902 C7 Cervical Vertebrae 7 Visible Laterally under Imaging [00201]
[00202] Figure 20 illustrates the Thoracic Outlet 2001 , thru which the subclavial artery and subclavial vein , as well as the brachial plexus are enabled to pass without impingement as the natural mechanism of the shoulder girdle articulates caudally. This is as opposed to exposure to prolonged compression as with the Traditional Means of Shoulder Migration employed
intraoperatively. The present embodiment , thru the method of replicating the natural function of the articulating shoulder girdle as it migrates these structures caudally via the application distal migratory force directly AT the AC Joint or very proximately medial at the Acromial Head of the Clavicle , allows unimpeded communication of bloodflow and nerve function THRU this Thoracic outlet , thereby avoiding the compression and stretching to these structures as is ubiquitous with the employment of the Traditional Means.
[00203] Figure 20 Thoracic Outlet for Brachial Plexus and SubClavial Blood Flow
[00204] 2001 Thoracic Outlet (Natural Sub-clavial Pathway for the Brachial Plexus and Sub-Clavial Artery and Sub-clavial vein)
[00205] 1007 Sub Clavial Artery
[00206] 1005 Brachial Plexus
[00207]
[00208] Figures 21 A to 21 F illustrate a plan, anterior view of the Supine Patient undergoing the exemplary naturalistic replication of the caudal migration of the shoulder girdle via the exemplary method of usage shown in Figures 17-20. The present embodiment thru delivery of distal migration at the AC Joint and / or very proximately medial at the acromial head of the clavicle , further illustrating the uninterrupted travel of the brachial plexus and sub clavial arterial and veinous formations thru the Thoracic Outlet without impingement.
[00209] Figure 21 Anterior View Method of Placement and Migration in the Supine Position
[00210] 1001 Acromioclavicular Joint
[00211] 1008 Sternoclavicular Joint
[00212] 1005 Brachial Plexus
[00213]
[00214] Figures 22 A-F illustrates an exemplary posterior overhead view of the Prone Patient from Figures 21 A-F, in accordance with an embodiment of the present invention. The present embodiment and method of usage of The present embodiment replicates the naturalistic caudal migration of the shoulder girdle , via the controlled application of caudal migratory force across the natural bridge formed by the Acromioclavicular Joint and the Spine of the Scapula. ...without concentrating any stress to ligaments , and without compressing the Brachjial Plexus or suppressing subclavial bloodflow to and from the upper extremities.
[00215] Figures 22 A-F present an Anterior View of Method and Placement in the Prone Position having the following features: [00216] 1001 Acromioclavicular Joint
[00217] 1202 Spine of the Scapula
[00218]
[00219] Figures 23 A and B illustrate an exemplary Superior View of the method of Usage shown in Figures 21 A-F, in accordance with an embodiment of the present invention. The present embodiment in the Supne Patient, clearly depicting the method of application of distal migratory force AT the Acromioclavicular Joint and/ or Very proximately medial to said joint at the Acromial Head of the Clavicle , and furthermore depicts the distribution of said caudal migratory force EVENLY across the strongest portions of the shoulder girdle , namely , ATOP or Very proximately medial to the Acromial Clavicular Joint and Across the shoulder to the Spine of the Scapula . Via this Method of Usage of The present embodiment , little, if no, Ligaments are exposed to an undue concentration of force thereby avoiding shoulder separation , no compression of the neurovascular bundle beneath the trapezius ensues , and no impingement to the Thoracic Outlet is enabled.
[00220] Figure 23 A Superior View of Method of Placement and Usage with the Supine Patient
[00221] 1701 Radiolucent and/or imaging compatible Arch
[00222] 1001 Acromioclavicular Joint
[00223] 1004 Acromion
[00224] 1202 Spine of the Scapula
[00225] 1003 Clavicle
[00226] 1201 Scapula
[00227] 1008 Sternoclavicular Joint
[00228] 1201 Scapula
[00229] 1203 Spinal Column
[00230] 1202 Spine of the Scapula
[00231]
[00232] Figure 23B
[00233] 1001 Acromioclavicular Joint [00234] 1202 Spine of the Scapula
[00235] Figures 24 A and B depict a same or similar Method of Usage of the foregoing embodiment with all of the same or similar benefits as is depicted in Figures 23 A and B, except in the instance shown, usage is illustrated with a PRONE Patient. No alteration to the technique of set up or usage is necessary , as The present embodiment corrects automatically for changes in angulation as will be below described in some detail in connection with Figures 27 thru 29.
[00236]
[00237] Figure 24A Superior View of Method of Placement and usage in the Prone Position
[00238] 1001 Acromioclavicular Joint
[00239] 1004 Acromion
[00240] 1202 Spine of the Scapula
[00241] 1203 Spinal Column
[00242] 1005 Acromion Process
[00243] 1701 Radio lucent and/or imaging compatible Arch [00244] 1008 Sternoclavicular Joint [00245] 1003 Clavicle [00246]
[00247] Figure 24B
[00248] 1202 Spine of the Scapula
[00249] 1004 Acromion
[00250] 1001 Acromioclavicular Joint
[00251] Figures 25 A to D illustrate a Lateral View of the Supine Patient undergoing Caudal Migration at the Acromioclavicular Joint or Very proximately medial to said Joint at the Acromial head of the Clavicle , in accordance with the foregoing embodiment. As shown, there is simultaneous contact with the Spine of the Scapula. Figures 25C and 25D illustrate the much improved Lateral Scans available to the Surgeon as the natural occlusion of the Bones of the Humerus and the Glenoid Fossa and the Acromial Clavicular Joint Itself are migrated caudally so as to no longer directly interpose the line of sight imaging of the structures of the Lower Cervical Vertebral Structures. The so called Traditional Means are unable to replicate this level of Safe Caudal Migration and Temporary Traction as currently enabled via usage of the present method of usage of the apparatus of The present embodiment.
[00252] Figures 25 A to D Lateral View of Method Utilized for Caudal Shoulder Migration in the Supine Position show the following features:
[00253] 1202 Spine of the Scapula
[00254] 1001 Acromioclavicular Joint
[00255] 1901 C4 Cervical Vertebrae 4 Visible Laterally under Imaging
[00256] 1902 C7 Cervical Vertebrae 7 Visible Laterally under Imaging
[00257]
[00258] Figure 26 A to D depicts the same results as Figures 25 A to D, except in the PRONE
Patient position, viewed laterally. Again, the Points of contact are the Acromioclavicular Joint and/or the Acromial head very proximately medial and CONNECTED to the AC Joint and cushioned below by 4 ligaments , with the Caudal Migratory Force spread evenly across the Shoulder Girdle via contact posteriorly with the Spine of the Scapula . As will be explained with regard to Figure 27 below, these optimal points of vertical contact autocorrect themselves whether the patient is Prone or Supine , or no matter the Table and Pad Height Arrangement of the Patient Support , all due to the angled articulation of the Radio lucent and/or imaging compatible Arch within the Framework of the present embodiment, as is explained in Figures 27 thru 29. Primarily, if not only, the width of the assembly needs to be adjusted by the Operator.
[00259]
[00260] Figures 27 thru 29 depict the Autcorrection of Angulation of the Radio lucent and/or imaging compatible Arch, in accordance with an embodiment of the present invention. Shown as the apparatus articulates within the Table mount Assembly, thereby enabled to make correct contact with the structures of the AC Joint and the Acromion Head of the Clavicle very proximately medial to the AC Joint , and simultaneously to make contact with the Spine of the Scapula regardless of whether the patient is Prone of Supine, Diminutive of Bariatric , atop a patient platform rendering the Arch Horizontal to the floor or at an acute angle to the floor....with the direction of Caudal Migration ALWAYS dictated by the Rail 715 as depicted in Figure 7. The Operator typically need only adjust for width via knob 700 as depicted in Figure 7.
[00261]
[00262] Figure 26 Lateral View of Method utilized for Caudal Migration in the Prone Position [00263] 1001 Acromioclavicular Joint [00264] 1202 Spine of the Scapula
[00265] 1901 C4 Cervical Vertebrae 4 Visible Laterally under Imaging [00266] 1902 C7 Cervical Vertebrae 7 Visible Laterally under Imaging [00267]
[00268] Figure 27 illustrates an exemplary Auto correction of Radiolucent and/or imaging compatible Arch for most any practical Bed Pad Height, in accordance with an embodiment of the present invention.
[00269] 2701 Operating Table Bed Pad
[00270] 2702 Variable Auto-Angulation of the Radiolucent and/or imaging compatible Arch [00271]
[00272] Figure 28 illustrates the forgoing Method for Auto correction of Angulation and positioning for Prone Patient, in accordance with an embodiment of the present invention.
[00273] 1001 Acromioclavicular Joint
[00274] 1202 Spine of the Scapula
[00275] 2701 Operating Table Bed Pad
[00276] 2702 Variable Auto-Angulation of the Radiolucent and/or imaging compatible Arch [00277]
[00278] Figure 29 illustrates the forgoing Method for Auto correction of Angulation and positioning for Supine Patient, in accordance with an embodiment of the present invention.
[00279] 1001 Acromioclavicular Joint
[00280] 1202 Spine of the Scapula [00281 ] 2701 Operating Table Bed Pad
[00282] 2702 Variable Auto-Angulation of the Radiolucent and/or imaging compatible Arch
[00283] Migration at the AC Joint and Immediately MEDIAL at the Acromion End of the Clavicle is shown in the figures.
[00284] In the present embodiment, it should be noted that migration at the AC Joint and Immediately MEDIAL at the Acromion End of the Clavicle does NOT compress the Brachial Plexus Nerve Bundle ( No Brachial Palsy / Brachial Plexus Insult or Injury ) , as is commonplace with compression of the trapezius , as is seen with taping and harnesses. Placement of the Motive force upon the Trapezius muscle has the effect of COMPRESING the Brachial Plexus AND restricting bloodflow to the upper extremities thru the Sub Clavial Artery and the sub clavial vein. The present method AVOIDS these difficulties.
[00285] Furthermore, migration at the AC Joint and Immediately MEDIAL at the Acromion End of the Clavicle does not likely lead to Shoulder Separation of the Acromion from the Clavicle via focusing of all of the caudal motive force directly upon the Acromion process, as can occur when the ACROMION and the Acromion Process are utilized as the point of Distal Migratory Force. Such Concentration of motive force directly on the acromion causes Stretching of Ligament of the Ac Joint, which is the mechanism of AC Joint Separation ( As illustrated) RATHER , placement of Motive Force at or immediately MEDIAL to the AC Joint PUSHES upon the Clavicle from ABOVE , while Concurrently Pushing upon the SPINE of the Scapula from above thereby spreading the motive force across the entire shoulder girdle while insuring that No Ligaments are stretched. In fact , PUSHING on the AC Joint and/or at the Acromial End of the Clavicle are CUSHIONED by 4 Ligaments beneath. ( See Diagrams) Additionally, with the present method , the Brachial Plexus and Sub Clavial Artery are allowed to travel naturally and without compression or impingement thru the THORACIC OUTLET as the AC Joint and Scapula are migrated Caudally , in accordance with the designs of nature.
[00286] Additionally, migration at the AC Joint and Immediately MEDIAL at the Acromion End of the Clavicle presents a naturally stable and FLAT Surface , said flat anatomic surface found across the entire spectrum of the patient population , and which is designed by nature to articulate horizontally and vertically thru natural interaction with the Sterno Clavicular Joint .Whereas , as per Bigliani , only 13 % o the population have a FLAT Acromion , with the Curved and the Hooked Acromion found in 87% of the population , presenting even MORE difficulty , as pushing ON the Acromion focuses ALL of the Motive Force DIRECTLY On the AC Joint's Ligament , leading to shoulder sprain and separation. This difficulty is ELIMINATED via the present Method.
Furthermore , the proper area of placement of the Radio lucent and/or imaging compatible Arch as per the present method , is bounded LATERALLY by the Ligaments of the AC Joint , presenting a natural boundary to slippage laterally of the Radio lucent and/or imaging compatible Arch during Caudal Migration and traction, while concurrently allowing the Brachial Plexus Nerve Bundle as well as the Bloodflow to the Upper Extremities to travel without IMPINGEMENT thru the Thoracic Outlet . Whereas placement of the Arch upon the ACROMION , in addition to focusing ALL of the Motive Force UPON the AC Joint Ligament , ALSO presents an eccentric surface which differs widely in shape from patient to patient, and which varies in angulation TOWARDS the Patients Feet as it is migrated Caudally. As such , slippage Laterally of the Radio lucent and/or imaging compatible Arch as it is migrated caudally is enabled via placement at the anatomic structure at the acromion , As such , Placement at the acromion is counterindicated.
[00287] AUTOCORRECTION of ANGULATION.
[00288] As can be seen in the Figures ....whether PRONE or SUPINE ....Head ON the BED or
HEAD in a Mayfield Horshoe Head Holder and no matter the PAD thickness ....the present
Invention AUTOcorrects for angulation such that the Radio lucent and/or imaging compatible Arch makes anatomic Contact with the AC Joint and or immediately Medial at the Acriomial End of the Clavicle and with the SPINE of the SCAPULA Simultaneously. This is accomplished via the free rotation of 707 Figure 7, within Cradles 709 , until such time as even the slightest caudal pressure is applied, at which time the Curvature of Carbon Arch 705 and 703 makes anatomic contact with the natural protrusions of the shoulder girdle , the AC Joint and to the Spine of the Scapula , cease to rotate vertically , and instead translate this Caudal Migratory Force to the these anatomic areas as distal motion towards the patients feet as directed via Rail Gude 715.
[00289] Figures 30 A-C and 31 A and B illustrate an exemplary version of the foregoing embodiment that is fully compatible with and able to fit inside of the fixed or rotating Imaging Bore of the C-Arm Fluoroscope, in accordance with an embodiment of the present invention. As shown, the apparatus is ingressed and egressed throughout the Procedure. There is little, if no, need to remove the equipment from the Operating Table. The present embodiment is substantially, if not entirely, compatible with the C-arm.
[00290] Figures 30 A-C illustrate an example C-Arm Compatibility, in accordance with an embodiment of the present invention.
[00291] 3001 Superior View of The present embodiment [00292] 2701 Operating Table Bed Pad
[00293] 3002 C-Arm Fluoroscopy Imaging Bore in Lateral Configuration
[00294] 3003 C-Arm Fluoroscopy Imaging Bore in AP ( anterior posterior ) configuration
[00295] Figures 31 A and B illustrate the C-Arm Compatibility with an exemplary patient in the prone position, in accordance with an embodiment of the present invention.
[00296] 3100 Present Method with Patient in the C-Arm
[00297] 3002 C-Arm Fluoroscopy Imaging Bore in Lateral Configuration
[00298] 3003 C-Arm Fluoroscopy Imaging Bore in AP ( anterior posterior ) configuration
[00299] Figure 32 illustrates an exemplary O-arm / Body Tom Compatible version, in accordance with an embodiment of the present invention. As shown, via Elongation of the Pusher Arm of the Radio lucent and/or imaging compatible Arch , placement of the Metallic Portions OUTSIDE of the IMAGING Bores of the Newly Emerging Imaging Arrays is enabled , such that usage of the present invention can proceed with little to no Metallic Interference, little to no Streak Artifact ,and without High Attentuation Artifact , all associated with the presence of METAL in the Imaging Bores of these Emerging Technologies. The Current Iteration of the present invention, namely , elongation ( and Buttressing ) of the Pusher Arms of the Radio lucent and/or imaging compatible Arches ENABLES usage of the present Invention WITHIN these emerging Imaging Bores of the O-Arm / C-arm / Postitron Emission Scanner , as well as with C-Arm Fluoroscopy and x-ray.
[00300] A method is provided, in accordance with an embodiment of the present invention, for using the foregoing shoulder migration apparatus of the Present Invention, having the
Auto correction of vertical Angulation capability, to migrate shoulders at the foregoing described AC joint area of contact. A typical implementation of the present method in at least one practical application, may proceed, with reference to the named figures, according to the Steps as follows: Attach Clamps 721/ Figure 7 of the Table Mounted Rail Guides 715 /Figure 7 to both sides of the Patient Support Platform via attachment of said clamps to the Ubiquitous Accessory Side Rails 717 /figure 7 of the Patient Support Platform 719 /Figure 7 . In instances of the ABSENCE of Accessory Support Side Rails, one may utilize the Ubiquitous CLAMP ON Accessory Side Rails which are well known within the field of expertise. Rotate BOTH Swivel Locks 711/Figure 7 into an UPWARD Position. Rest Adjustable Crossbar 707 / Figure 7 into BOTH Cradles 709/ Figure 7 Rotate BOTH swivel locks 711 /Figure 7 into a DOWNWARD Facing Position AS ILLUSTRATED. in Figure7 , thereby securing Crossbar 707/ Figure 7 within Cradles 709 /Figure 7 . Fit Pathogen Barrier 725 /Figure 7 with Padding 727 /Figure 7 over Radiolucent and/or imaging compatible Arches 705/ figure 7 Applying finger pressure to Triggers 723/ Figure 7, migrate Vertical Risers 713 / Figure 7 along Rails 715/ figure 7 until Radiolucent and/or imaging compatible Arches 705/ Figure 7 are in contact with the patient's shoulders , but without applying Caudal Pressure to the Patient Shoulders. Adjust Crossbar 707 /Figure 7 Width via Adjustment Knob 700 / Figure 7, such that Radiolucent and/or imaging compatible Arches 705 / Figure 7 makes contact at the
ACROMIOCLAVICULAR Joint or Immediately Medial at the Acromial End of the Clavicle as illustrated in 1702 / Figure 17. For purposes of clarity, this exemplary point of contact is further illustrated from the Operators view in Figures 23, with Figure 23 depicting exemplary placement of Radiolucent and/or imaging compatible Arches 1701 / Figure 23 A for the Supine Patient , with contact between the Radiolucent and/or imaging compatible Arch at points 1001 / Figure 23 A , the Acromioclavicular Joint , and at points 1202/ Figure 23A , the Spine of the Scapula. For purposes of further clarity, this exemplary point of contact is illustrated from the Operators view in Figure 24, with Figure 24 depicting exemplary placement of Radiolucent and/or imaging compatible Arches 1701/ Figure 24A for the Prone Patient, with contact between the Radiolucent and/or imaging compatible Arches 1701 / Figure 24A at points 1001/ Figure 24 A , the Acromionclavicular Joint , and at points 1202 / Figure 24 A , the Spine of the Scapula. Figures 23B and 24B Further identify these exemplary points of anatomic contact 1001 the AC Joint and 1202 the Spine of the Scapula as depicted from an Operator's viewpoint of a Naturalistic appearing Patient. Figure 23B depicting a Naturalistic
Operator's view of the Supine Patient and Figure 24B depicting a Naturalistic Operator's View of the Prone Patient. Adjust the Width of Crossbar so that the Radio lucent and/or imaging compatible Arches make contact with the Acromionclavicular Joint and the Spine of the Scapula as described in 7A, 7B, and 7C. No Vertical Adjustment is necessary. After having adjusted for proper width the Vertical Angulation of the Radio lucent and/or imaging compatible Arches will
automatically make optimal contact with the Acromionclavicular Joint and the Spine of the Scapula , no matter the Height of the Bed Pad , the size of the Patient , or whether the patient is positioned in either the Supine or the Prone Position. This Auto-correction of Vertical Angulation is accomplished via the free rotation of 707 Figure 7, within Cradles 709 , until such time as even the slightest caudal pressure is applied, at which time the Curvature of Carbon Arch 705 and 703 makes anatomic contact with the natural protrusions of the shoulder girdle , the AC Joint and to the Spine of the Scapula , cease to rotate vertically , and instead translate this Caudal Migratory Force to the these anatomic areas as distal motion towards the patients feet as directed via Rail Guide 715. This Auto-correction of vertical angulation is clearly illustrated in Figures 27, 28, and 29, with figure 27 illustrating the automatic vertical angulation of Radio lucent and/or imaging compatible Arch 2702/ Figure 27 as it freely rotates to accommodate the varying bed pad thicknesses illustrated in 2701 / Figure 27. This Auto-correction of vertical angulation is further illustrated with a Supine Patient in Figure 28 which depicts the Radio lucent and/or imaging compatible Arch 2702/ Figure 28 as it maintains proper anatomic contact with the Acromionclavicular Joint 1001 / Figure 28 and with the Spine of the Scapula 1202/ Figure 27, despite variations in the thickness of bed pad 2701/ Figure 28. 15. This Auto-correction of Vertical Angulation is further illustrated with the Prone Patient in Figure 29 which depicts the Radio lucent and/or imaging compatible Arch 2702/ Figure 29 And with the Spine of the Scapula 1202/ Figure 29 as it maintains proper anatomic contact with the Acromionclavicular Joint 1001 / Figure 29 despite variations in the thickness of bed pad 2701/ Figure 29.
16. Apply Caudal Migration to the Patients Shoulders. Applying finger pressure to
Triggers 723/ Figure 7, migrate Vertical Risers 713 / Figure 7 along Rails 715/ figure 7 until Radiolucent and/or imaging compatible Arches 705/ Figure 7 have achieved full migration of the patients Shoulder Girdle caudally. Release of triggers 723/ Figure 7 aill
automnatically engage the " Hands Free " Braking System, thereby maintaining the patients shoulders in a state of safe traction. Apply finger pressure to Triggers 723/ Figure 7 to release traction and to migrate the Radiolucent and/or imaging compatible Arches 705 away from the patient.
[00301 ] Figure 25 depicts usage of the present invention via the present method in the Supine patient, with 1901 / Figure 25C demonstrating the typical lateral view of the 4th Cervical Vertebrae WITHOUT caudal migration of the structures of the shoulder , such that Cervical Vertebrae C5, C6 , and C7 are occluded. 1902 Figure 25D depicts the optimized lateral view of C7 without occlusion, due to usage of the present invention for purposes of migrating the shoulder Caudally in order to alleviate the Density Artifact of the Shoulders from Line of Sight Occlusion of the Lateral Imaging of the Cervical Vertebra.
[00302] Figure 26 depicts usage of the present invention via the present method in the Prone patient , with 1901 / Figure 26C demonstrating the typical lateral view of the 4th Cervical Vertebrae WITHOUT caudal migration of the structures of the shoulder , such that Cervical Vertebrae C5, C6 , and C7 are occluded. 1902 Figure 26D depicts the optimized lateral view of C7 without occlusion, due to usage of the present invention for purposes of migrating the shoulder Caudally in order to alleviate the Density Artifact of the Shoulders from Line of Sight Occlusion of the Lateral Imaging of the Cervical Vertebra
[00303]
[00304] Experimental Observations [00305] Experiments were conducted by Applicant to help determine the safe parameters regarding how long such application of caudal force could be sustained. Two findings became apparent:
[00306] 1. At the acromion ... There would be slippage laterally .
[00307] 2. At the acromion , soreness persisted for days, which, speculatively, suggests that the mechanisms of stress to the ligaments of the AC joint what a patient will endure.
[00308] However, when the Arch was moved medically to make contact either AT the AC joint or immediately Medial to the AC joint at the Acromisl head of the Clavicle ... Not only was slippage essentially eliminate, but superior caudal migration was experienced with next to no pain.
[00309] The foregoing possible, yet speculative, mechanism of the present method generally may provide the following features for many practical implementations:
[00310] 1. Very little, in any, concentration of stress to the one point of contact in the acromion process ... Translated entirely as stress up the AC ligament . My method eliminated this problem
[00311 ] 2. Natural cushioning of 4 ligaments being pushed upon with MY method , rather that one ligament being pulled upon as happens with placement at the Acromion / Acromion Process
[00312] 3. Spreading of caudal force across both the AC joint and or medial at the Acromial head of the Clavicle ... And the Spine of the Scapula... Thereby , my method enabled migration of the entire shoulder girdle at strong points . As opposed to the concentration of all caudal force concentrated at the acromion and translating all force to the AC ligament, as occurs when placing the arch at the acromion / acromion process .
[00313] Alternate embodiments of the foregoing AC joint shoulder method may not employ the foregoing Auto correction of vertical Angulation feature, and instead rely upon the medical professional's skilled ability to manually guide a shoulder migration means to suitably and safely contact and apply force onto the AC joint in accordance with the foregoing teachings of the present invention.
[00314] Those skilled in the art will readily recognize, in light of and in accordance with the teachings of the present invention, that any of the foregoing steps may be suitably replaced, reordered, removed and additional steps may be inserted depending upon the needs of the particular application. Moreover, the prescribed method steps of the foregoing embodiments may be implemented using any physical and/or hardware system that those skilled in the art will readily know is suitable in light of the foregoing teachings. Thus, the present invention is not limited to any particular tangible means of implementation.
[00315] All the features disclosed in this specification, including any accompanying abstract and drawings, may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
[00316] Having fully described at least one embodiment of the present invention, other equivalent or alternative methods of providing anatomic positioning device according to the present invention will be apparent to those skilled in the art. The invention has been described above by way of illustration, and the specific embodiments disclosed are not intended to limit the invention to the particular forms disclosed. For example, the particular implementation of the shoulder pusher may vary depending upon the particular type of material used. The shoulder pushers described in the foregoing were directed to radio lucent and/or imaging compatible implementations; however, similar techniques are to provide shoulder pushers that are made of materials that are not radio lucent and/or imaging compatible such as, but not limited to, plastic or metal for purposes other than radiography, for example, without limitation, holding a subject' shoulders stationary during other types of procedures or while transporting the subject. Non-radio lucent and/or imaging compatible implementations of the present invention are contemplated as within the scope of the present invention. The invention is thus to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the following claims.
[00317] Claim elements and steps herein may have been numbered and/or lettered solely as an aid in readability and understanding. Any such numbering and lettering in itself is not intended to and should not be taken to indicate the ordering of elements and/or steps in the claims.
[00318] Detailed Descriptions with respect to the Method of Usage of the Present Invention
[00319]

Claims

What is claimed is: CLAIMS
1. An apparatus comprising: a first platform mounting apparatus comprising:
a clamping mechanism being configured to quickly and securely engage the apparatus to a first side of a patient care platform; a guide rail member being rigidly engaged with said clamping mechanism to extend away from an end of the patient care platform in a plane defined by sides of the patient care platform; a slide mechanism being slidably engaged to said guide rail member to enable positioning of said slide mechanism along at least a portion of said guide rail member; a brake mechanism being engaged to said slide mechanism to stop movement of said slide mechanism in a direction away from a patient laying on the patient care platform and to selectively enable free movement of said slide mechanism; and a support member being engaged to said slide mechanism, said support member comprising an upward portion and a cradle being configured to hold a shoulder positioner apparatus configured to apply a motive force to an acromioclavicular joint.
2. The apparatus as recited in claim 0, further comprising a second platform mounting
apparatus mirroring said first platform mounting apparatus and being configured to engage the apparatus to a second side of the patient care platform.
3. The apparatus as recited in claim 0, in which said upward support member is positioned at an acute angle relative to a central line of the patient care platform.
4. The apparatus as recited in claim 3, in which said angle is in a range of 63 degrees to 65 degrees.
5. The apparatus as recited in claim 0, in which said clamping mechanism further comprises an offset open channel enabling said clamping mechanism to engage an accessory side rail of the patient care platform by being dropped down onto the accessory side rail.
6. The apparatus as recited in claim 0, in which said clamping mechanism further comprises a setscrew to secure said clamping mechanism to a selected position on the accessory rail.
7. The apparatus as recited in claim 0, in which said cradle further comprises a swivel lock permitting automatic correct angulation of the shoulder positioner apparatus.
8. The apparatus as recited in claim 7, in which, when the shoulder positioner apparatus is properly installed in said cradle, said automatic correction angulation mechanism is configured to enable proper AC joint shoulder contact and migration by only requiring the operator to adjusted for a shoulder positioner width while said automatic correction angulation mechanism substantially performs the required vertical guidance of the shoulder positioner apparatus .
9. An apparatus comprising: a first platform mounting apparatus comprising:
a clamping mechanism being configured to quickly and securely engage the apparatus to a first lengthwise side of a patient care platform; a guide rail member being rigidly engaged with said clamping mechanism to extend away from an end of the patient care platform only in a plane defined by lengthwise sides of the patient care platform; a slide mechanism being slidably engaged to said guide rail member to enable positioning of said slide mechanism along at least a portion of said guide rail member; a brake mechanism being engaged to said slide mechanism to stop movement of said slide mechanism in a direction away from a patient laying on the patient care platform and to selectively enable free movement of said slide mechanism; and a support member being engaged to said slide mechanism, said support member comprising an upward portion and a cradle being configured to restrain a shoulder positioner apparatus configured to apply a motive force to an acromioclavicular joint, said upward support member being positioned at an acute angle relative to a central line of the patient care platform.
10. The apparatus as recited in claim 9, further comprising a second platform mounting
apparatus mirroring said first platform mounting apparatus and being configured to engage the apparatus to a second lengthwise side of the patient care platform.
11. The apparatus as recited in claim 9, in which said clamping mechanism further comprises an offset open channel enabling said clamping mechanism to engage an accessory side rail of the patient care platform by being dropped down onto the accessory side rail.
12. The apparatus as recited in claim 9, in which said clamping mechanism further comprises a setscrew to secure said clamping mechanism to a selected position on the accessory rail.
13. The apparatus as recited in claim 9, in which said cradle further comprises a swivel lock permitting automatic correct angulation of the shoulder positioner apparatus.
14. The apparatus as recited in claim 9, in which said angle is in a range of 63 degrees to 65 degrees.
15. An apparatus comprising: a first shoulder positioner comprising:
a tapered arm configured to be operable for applying a motive force to an acromioclavicular joint, said tapered arm comprising a substantially radio lucent and/or imaging compatible material, said tapered arm comprising a first end being configured to be removably retained in a cradle, said first end further comprising a handle to enable a user to apply the motive force, and a second end comprising an arch being configured to engage a first shoulder of a patient laying on a patient care platform, said arch comprising a varying width and a varying density, said arch being asymmetrically offset from a longitudinal axis of said tapered arm, said longitudinal axis extending through a lower portion of said arch.
16. The apparatus as recited in claim 15, , in which said radio lucent and/or imaging compatible material comprises at least one substantially flat laminar sheet
17. A system comprising: a first platform mounting apparatus comprising:
a clamping mechanism being configured to quickly and securely engage the system to a first side of a patient care platform; a guide rail member being engaged with said clamping mechanism to extend away from an end of the patient care platform in a plane defined by sides of the patient care platform; a slide mechanism being slidably engaged to said guide rail member to enable positioning of said slide mechanism along at least portions of said guide rail member; a brake mechanism being engaged to said slide mechanism to stop movement of said slide mechanism in a direction away from a patient laying on the patient care platform and to selectively enable free movement of said slide mechanism; and a support member being engaged to said slide mechanism, said support member comprising an upward portion and a cradle, said upward support member being positioned to mitigate contacting the patient platform; and a first shoulder positioner apparatus comprising:
a tapered arm for applying a motive force, said tapered arm comprising a first end being configured to be removably retained in said cradle, and a second end comprising an arch being configured to engage a first shoulder of a patient laying on the patient care platform, said arch comprising a varying width and a varying density, said arch being asymmetrically offset from a longitudinal axis of said tapered arm where said longitudinal axis extends through a lower portion of said first arch, said cradle being operable to position said shoulder positioner apparatus by movement of said slide mechanism along said guide rail member and held in place by said brake mechanism to selectively hold said shoulder positioner apparatus pressured onto the first shoulder with the first shoulder resting on the patient care platform.
18. The system as recited in claim 17, further comprising:
a second platform mounting apparatus mirroring said first platform mounting apparatus and being configured to engage the system to a second side of the patient care platform; and a second shoulder positioner apparatus mirroring said first shoulder positioner apparatus and being configured to engage a second shoulder of the patient laying on the patient care platform.
19. The system as recited in claim 18, further comprising a cross member in engagement with said first shoulder positioner apparatus and said second shoulder positioner apparatus to yoke said first shoulder positioner apparatus and said second shoulder positioner in tandem.
20. The system as recited in claim 17, in which said upward support member is positioned at an acute angle relative to a central line of the patient care platform.
21. The apparatus as recited in claim 20, in which said angle is in a range of 63 degrees to 65 degrees.
22. The system as recited in claim 17, in which said arch is configured to be operable to apply said motive force to an acromioclavicular joint of the shoulder.
23. The system as recited in claim 17, in which said tapered arm comprises a radio lucent and/or imaging compatible material.
24. The system as recited in claim 23, in which said radio lucent and/or imaging compatible material comprises a flat laminar sheet.
25. The system as recited in claim 17, in which said cradle further comprises means for
automatic correct angulation of said shoulder positioner apparatus to enable proper AC joint shoulder contact and migration by only requiring the operator to adjust for said shoulder positioner width while said automatic correction angulation means substantially performs the required vertical guidance of said shoulder positioner apparatus .
26. The system as recited in claim 17, in which said system is configured to properly fit and function within the imaging bore of a C-Arm Fluoroscope.
27. The system as recited in claim 17, in which said system is configured to properly fit and function within an O-A M and Body Tom when configured with an elongated Carbon Pusher / Arch device.
28. A system comprising: a first platform mounting apparatus comprising:
means being configured for engaging the system to a first side of a patient care platform; means for extending away from an end of the patient care platform in a plane defined by sides of the patient care platform; means for positioning along at least portions of said extending means; means for stopping movement of said positioning means in a direction away from a patient laying on the patient care platform and for selectively enabling free movement; and means for supporting above said positioning means; and a first shoulder positioner apparatus comprising:
means for applying a motive force to an acromioclavicular joint, said applying means being configured to be removably retained in said supporting means, said supporting means being operable to position the shoulder positioner apparatus by movement of said positioning means along said extending means and held in place by said stopping means to selectively hold the first shoulder positioner apparatus pressured onto the first shoulder with the first shoulder resting on the patient care platform.
29. The system as recited in claim 28, further comprising:
a second platform mounting apparatus mirroring said first platform mounting apparatus and being configured to engage the system to a second side of the patient care platform; and a second shoulder positioner apparatus mirroring said first shoulder positioner apparatus and being configured to engage a second shoulder of the patient laying on the patient care platform.
30. The system as recited in claim 29, further comprising means for yoking said first shoulder positioner apparatus and said second shoulder positioner in tandem.
31. The system as recited in claim 28, further comprising means for guarding against pathogen transfer and for padding said means for applying a motive force.
32. A method of using the system of claim 25, comprising the steps of: securely engaging said system to the first side of a patient care platform; while the patient is on the patient platform, rotating said first shoulder positioner apparatus in said cradle to engage said arch to the first shoulder of the patient; operating said brake mechanism to enable free movement of said slide mechanism along said guide rail member; applying the motive force to said first end of said tapered arm in the direction of the patient; and operating said brake mechanism to stop movement of said slide mechanism in a direction away from the patient to hold said shoulder positioner apparatus pressured onto the first shoulder at a contact location while the patient is at rest on the patient care platform.
33. The method as recited in claim 32, in which said contact location is an acromioclavicular joint of the first shoulder, and said method further comprising the step of guiding said arch to contact an acromioclavicular joint of the first shoulder.
34. The method as recited in claim 32, in which said contact location is an acromioclavicular joint of the first shoulder and very proximately medial at the acromial head of the clavicle.
PCT/US2014/039255 2013-05-27 2014-05-23 A system, apparatus and method for shoulder migration WO2014193739A1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021061573A1 (en) * 2019-09-26 2021-04-01 University Of Miami Stereotactic frame holder
CN114469644A (en) * 2022-01-24 2022-05-13 四川大学华西医院 Rehabilitation equipment for preventing hemiplegic shoulder joint subluxation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010033289A1 (en) * 2008-09-20 2010-03-25 Design Md Llc An apparatus for mounting an anatomical positioner on a patient care platform
US20120260923A1 (en) * 2010-12-09 2012-10-18 Design Md Llc. Apparatus and Method for Migrating Anatomic Parts
US20120271142A1 (en) * 2010-12-09 2012-10-25 Design Md Llc. Apparatus for Migrating Anatomic Parts and Method of Using the Apparatus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010033289A1 (en) * 2008-09-20 2010-03-25 Design Md Llc An apparatus for mounting an anatomical positioner on a patient care platform
US20120260923A1 (en) * 2010-12-09 2012-10-18 Design Md Llc. Apparatus and Method for Migrating Anatomic Parts
US20120271142A1 (en) * 2010-12-09 2012-10-25 Design Md Llc. Apparatus for Migrating Anatomic Parts and Method of Using the Apparatus

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021061573A1 (en) * 2019-09-26 2021-04-01 University Of Miami Stereotactic frame holder
CN114469644A (en) * 2022-01-24 2022-05-13 四川大学华西医院 Rehabilitation equipment for preventing hemiplegic shoulder joint subluxation
CN114469644B (en) * 2022-01-24 2023-08-25 四川大学华西医院 Rehabilitation device for preventing hemiplegia and shoulder joint subluxation

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