Mounted body part support device and method

The wearable support device addresses the lack of adjustability in conventional neck support devices by using a variable stiffness member with a head and torso harness, providing customizable support and reducing spinal load.

JP2025516362APending Publication Date: 2025-05-27マルコムロジャー ジェイ +1
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Patent Information

Application Number
JP2024565288
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-05-05
Filing Date
2023-05-04
Publication Date
2025-05-27

AI Technical Summary

Technical Problem

Conventional neck support devices lack adjustability for different body types and amounts of tilt, leading to inadequate support and potential harm to the spine due to constant flexion.

Method used

A wearable support device featuring a pair of spaced body harnesses secured to a variable stiffness member, which includes a head harness, a torso harness, and a fiber-reinforced composite structural member with tapered rods joined by a webbing strip, allowing for adjustable stiffness and support.

Benefits of technology

The device provides customizable support that reduces the load on the neck and spine, minimizing the risk of degenerative joint disease, arthritis, and muscle tension, while allowing for flexible movement.

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Abstract

A wearable device (10) for flexibly supporting a body part such as the head (3) in a hunched posture as when a surgeon performs surgery. 【Solution means】The device (10) can include a head harness (11) connected to a torso harness (12) by a dedicated elongated variable stiffness beam (20) that extends upward along the back of the wearer's (1) spine. The beam can include a variable stiffness member having a complex tapered geometry. The member can be fabricated from a single fiber composite piece in which the fiber orientation varies to provide both bending strength and stiffness and torsional strength and stiffness that vary along the length of the member. The beam and harness can include a plurality of interconnected mechanisms to provide greater adjustability.
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Description

Technical Field

[0001] This application is a continuation of co-pending U.S. Patent Application No. 17 / 737,881, filed on May 5, 2022, which is incorporated herein by reference. The present invention relates to a wearable support, and more particularly to a wearable support including a structural member having variable stiffness.

Background Art

[0002] In many manual activities, a person needs to look down while hunched forward during a particular task. In many occupations such as surgeons, dentists, technicians, warehouse workers, etc., their bodies are required to keep their heads down while their neck muscles are in a certain flexed state, in a tilted or hunched posture. Such a tilted posture, when repeatedly and over time, imposes harmful loading conditions on the human spine. The mass of the head is normally supported by the precise alignment of the spinal column in an upright posture. Forward tilting causes compression of the front spine, muscles, blood vessels and intervertebral discs. Chronic flexion around the neck can cause degenerative joint disease and arthritis. This chronic flexion can also cause tension headaches and paravertebral muscle tension.

[0003] Grenander's U.S. Patent No. 9,072,595, incorporated herein by reference, describes the use of a spring-biased neck relief device including a head fixation point and a body fixation point. It is clear that this device provides a reactive tension when the position of the head moves forward beyond a predetermined limit.

[0004] One problem associated with some conventional neck support devices that provide only elastic tension by a flexible flexible band or spring is that there is little adjustability for different body types and different amounts of tilt.

[0005] Composite materials such as carbon fiber reinforced polymers have been used for a long time to fabricate structural elements because these materials are lightweight and have high stiffness / strength against bending moments along the orientation of the elongated fibers.

[0006] Furthermore, in many conventional devices, the elastic coefficient is substantially constant over the range of motion of the head. In fact, as the jaw approaches the chest, the tension increases, and thus the load on the anterior neck muscles increases.

[0007] Such conventional semi-rigid support members can provide an excellent response to dynamic longitudinal bending moments, but may not exhibit sufficient strength and rigidity with respect to dynamic torsional moments. This can be a problem when the cross-section of the member is not angularly uniform and when the support is loosely engaged by the body attachment of the support.

[0008] An electric limb assist device as disclosed in U.S. Patent No. 10,485,681 to Herr et al. provides exoskeletal assistance to the legs for many repetitive activities involving relatively long durations such as running and walking. Such devices can potentially limit the degrees of freedom of the legs and the movement of other parts of the body.

[0009] Accordingly, there is a need for a device that addresses one or more of the above-identified drawbacks.

PRIOR ART DOCUMENTS

PATENT DOCUMENTS

[0010]

PATENT DOCUMENT 1

PATENT DOCUMENT 2

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0011] The main and secondary objects of the present invention are to provide an improved wearable body part support device.

MEANS FOR SOLVING THE PROBLEMS

[0012] These and other objects can be achieved with a pair of spaced body harnesses secured to at least one variable stiffness member.

[0013] In some embodiments, a combination of a head harness, a torso harness, and a variable stiffness beam is provided, the beam comprising at least one fiber-reinforced composite structural member, the fiber-reinforced composite structural member comprising a pair of substantially parallel spaced tapered rods joined laterally by a webbing strip.

[0014] In some embodiments, an apparatus for flexibly supporting a body part is provided, the apparatus comprising an elongate beam having variable stiffness along its longitudinal length, a first harness secured to a first position on the beam, and a second harness secured to a second position on the beam, the first position being longitudinally spaced from the second position, the first harness being configured to be secured to a first body part, the second harness being configured to be secured to a second body part, whereby the beam is oriented to support a load component generated by the first body part when the first harness is secured to the first body part and the second harness is secured to the second body part.

[0015] In some embodiments, the first harness comprises a connector connecting the first harness to the first position on the beam.

[0016] In some embodiments, the apparatus further comprises a mounting structure for securing the second harness to the second position on the beam.

[0017] In some embodiments, the beam is elongate and the variable stiffness is variable along the longitudinal length of the beam.

[0018] In some embodiments, the variable stiffness is adjustable.

[0019] In some embodiments, the beam comprises a cable extending along the longitudinal length of the beam, such that when the cable is under tension, the rigidity of the beam is increased.

[0020] In some embodiments, the cable forms a loop running through a first lumen extending along the longitudinal length and a second lumen laterally spaced from the first lumen and extending along the longitudinal length.

[0021] In some embodiments, the cable runs over at least one pulley disposed near an end of the beam.

[0022] In some embodiments, the second harness comprises a wearable garment.

[0023] In some embodiments, the apparatus further comprises an elastic cushion adjustably secured to the garment, the cushion contacting an intermediate portion of the beam.

[0024] In some embodiments, the apparatus further comprises a first member having a first elongated shape in a longitudinal direction, the first member having a proximal end and a distal end, and a second member having a second elongated shape in a longitudinal direction, the second member having a proximal end and a distal end, wherein the first member and the second member are spaced apart from each other by a separation distance, and the apparatus further comprises a first block connecting the first member to the second member and a second block connecting the first member to the second member, and the first block and the second block are longitudinally spaced apart with an interval therebetween.

[0025] In some embodiments, the second member has a rigidity that is variable in the longitudinal direction.

[0026] In some embodiments, the second member tapers between the proximal end and the distal end.

[0027] In some embodiments, the second member slides between a first longitudinal position and a second longitudinal position spaced from the first longitudinal position by a longitudinal length.

[0028] In some embodiments, the first block comprises a first fastener that releasably secures the first block to the second member, and the second block comprises a second fastener that releasably secures the second block to the second member.

[0029] In some embodiments, at least one of the first block and the second block comprises a third fastener that releasably secures at least one of the first block and the second block to the first member.

[0030] In some embodiments, the first block has a first longitudinal position relative to the member, the second block has a second longitudinal position relative to the member, and the first longitudinal position and the second longitudinal position are adjustable.

[0031] In some embodiments, the separation distance is adjustable.

[0032] In some embodiments, spacing is adjustable.

[0033] In some embodiments, the first block is fixed relative to the member and the longitudinal position of the second block is adjustable.

[0034] In some embodiments, the first harness is flexibly and adjustably secured to the beam.

[0035] In some embodiments, the first harness comprises a headgear configured to attach to the wearer's head and a connector that connects the headgear to a first position on the beam.

[0036] In some embodiments, the first harness further comprises a housing slidably attached to the beam, a cable extending between the housing and the headgear, and a guide bracket hingedly connected to the headgear, the guide bracket abutting a portion of the cable.

[0037] In some embodiments, the first harness further comprises a spool attached to the guide bracket for adjusting the length of the cable.

[0038] In some embodiments, the first harness further comprises a stop mechanism that prevents longitudinal movement of the housing relative to the beam, the stop mechanism including a spring-loaded pin attached to the housing and shaped and dimensioned to engage a hole in the beam located near an end of the beam.

[0039] In some embodiments, the beam is secured to the first harness via a connector that extends the connector distance between the first harness and the beam, the connector distance being adjustable.

[0040] In some embodiments, the connector includes a releasable lock for fixing the connector distance.

[0041] In some embodiments, the connector includes a flexible tether having an adjustable length.

[0042] In some embodiments, the tether is elastic, thereby forming a spring.

[0043] In some embodiments, the connector includes a spool around which a portion of the flexible tether is wound.

[0044] In some embodiments, the apparatus further comprises a motor for driving the spool and a microprocessor for controlling the motor in response to a command received wirelessly from a computerized mobile device.

[0045] In some embodiments, the beam is secured to the body harness by an attachment structure shaped and dimensioned to firmly position the proximal end of the beam.

[0046] In some embodiments, the attachment structure comprises a pocket and at least one keeper structure engaged by an intermediate portion of the beam.

[0047] In some embodiments, at least one keeper is shaped and dimensioned to loosely engage the beam, thereby restricting lateral movement of the beam relative to the body harness and allowing longitudinal movement.

[0048] In some embodiments, the attachment structure comprises a plurality of keeper structures longitudinally spaced along the length of the beam, each keeper structure being shaped and dimensioned to be loosely engaged by the beam.

[0049] In some embodiments, the variable stiffness structure beam further comprises a proximal end and a distal end, the beam having a first cross-sectional area near the proximal end and a second cross-sectional area near the distal end, the first cross-sectional area being larger than the second cross-sectional area.

[0050] In some embodiments, the variable stiffness structure beam comprises a pair of substantially parallel and elongated spaced rods laterally joined by a webbing strip, the rods each having a variable cross-sectional geometry along the length of the beam.

[0051] In some embodiments, each of the pair of rods tapers gradually from the proximal end towards the distal end.

[0052] In some embodiments, the first rod of the pair of rods comprises an axially hollow portion.

[0053] In some embodiments, the rods each have a substantially conical shape.

[0054] In some embodiments, both of the pair of rods are made to have similar shapes and dimensions.

[0055] In some embodiments, the first cross-sectional geometry is made to be substantially in a barb shape.

[0056] In some embodiments, the first cross-sectional geometry includes a pair of geometric shapes that are spaced apart and interconnected and symmetric in the diametrical direction.

[0057] In some embodiments, the shape is selected from the group consisting of a circle, an ellipse, a triangle, a square, a rectangle, a trapezoid, a pentagon, a hexagon, a heptagon, an octagon, a nonagon, and a decagon.

[0058] In some embodiments, the first cross-sectional geometry has a width dimension corresponding to the width of the webbing strip and a height dimension corresponding to the outer diameter of one of the rods, and the width dimension is equal to or greater than the diameter dimension.

[0059] In some embodiments, the beam further includes a beam having a first width dimension at the proximal end and a second width dimension at the distal end, and the first width dimension is equal to or greater than the second width dimension.

[0060] In some embodiments, the beam is formed by a single piece of composite material.

[0061] In some embodiments, the beam further includes a fiber-reinforced material having a first fiber orientation and a second fiber orientation.

[0062] In some embodiments, the first orientation is rotated substantially 90 degrees with respect to the second fiber orientation.

[0063] In some embodiments, the beam further includes a fiber-reinforced material having a third fiber orientation that is rotated substantially 45 degrees with respect to the second fiber orientation.

[0064] In some embodiments, the beam further includes a plurality of separate zones, wherein a first zone of the zones includes a first set of a plurality of fiber orientations, and a second zone of the zones includes a second set of a plurality of fiber orientations different from the first set of a plurality of fiber orientations.

[0065] In some embodiments, the apparatus further comprises a tension cable extending along the longitudinal length of the beam, the tension cable contacting the beam such that an increase in the tension of the cable increases the longitudinal rigidity of the beam.

[0066] In some embodiments, the tension cable contacts a first portion of the beam near the distal end and a second portion of the beam near the proximal end.

[0067] In some embodiments, an apparatus for supporting a person's head, neck, and spine is provided, the apparatus comprising a torso harness, a head harness spaced apart from the torso harness, and an elongated beam mechanically connected to the torso harness and mechanically connected to the head harness, the elongated beam exhibiting sufficient rigidity to at least partially counteract the force of gravity acting on the person's head.

[0068] In some embodiments, a method of supporting a first body part of a person is provided, the method comprising selecting a support apparatus comprising a beam having variable rigidity, a first harness secured to a first position on the beam, and a second harness secured to a second position on the beam spaced apart from the first position; attaching the first harness to the first body part of the person; attaching the second harness to a second body part of the person, the second body part being spaced apart from the first body part; varying a load on the first body part; and supporting a component of the load on the second body part via the beam.

[0069] In some embodiments, the method further includes adjusting the stiffness of the beam, adjusting the distance between the first position and the first body part, and enabling unrestricted rotational movement of the first body part.

[0070] In some embodiments, an adjustable stiffness wearable body part support device includes a beam having variable stiffness, a first harness for securing the body part to the beam, and a second harness for securing the beam to a position on the body spaced from the body part. The beam includes a first member having a first elongated shape in a first longitudinal direction, the first member having a proximal end and a distal end; a second member having a second elongated shape in a second longitudinal direction, the second member having a proximal end and a distal end, the first member and the second member being spaced apart from each other by a separation distance; a first block connecting the first member to the second member; and a second block connecting the first member to the second member, the first block and the second block being spaced apart in the first longitudinal direction.

[0071] In some embodiments, the first longitudinal direction and the second longitudinal direction are substantially parallel.

[0072] The original claim text is incorporated herein by reference as describing features in some embodiments.

Brief Description of the Drawings

[0073]

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DETAILED DESCRIPTION OF THE INVENTION

[0074] As used herein, references to up, down, upward, downward, upper, lower, vertical, horizontal, sideways, lateral, rear, front, proximal, distal, etc. can be used to provide a clear reference frame for various structures relative to other structures that are normally oriented in the drawings being referred to. These references should not be treated as absolute when the reference frame is changed, such as when the device is inverted, shown sideways, or disassembled.

[0075] As used herein, the term "substantially" can be used with respect to manufacturing inaccuracies and inaccuracies that can lead to asymmetries and other inaccuracies in the shape, dimensional settings, orientation, and positioning of various structures. Further, the use of "substantially" in relation to specific geometries and orientations such as "parallel" and "perpendicular" can be provided as a guide for generally describing the functions of various structures and also as a guide for allowing minor deviations from exact mathematical geometries such as cylinders, discs, and cones and their orientations while still providing a similar function. One of ordinary skill in the art will readily understand the degree to which deviations from mathematically exact geometric standards can be made.

[0076] As used herein, the term "axial" is for referring to a direction, movement, or force that acts substantially parallel to or along the axis in question, and not for referring to a rotational direction, a radial direction, an angular direction, a movement or force, or a torsional force.

[0077] In this specification, the unit "millimeter" or "millimeters" can be abbreviated as "mm", and the unit "centimeter" or "centimeters" can be abbreviated as "cm".

[0078] This specification may refer to the use of multiple patches or layers of hook and loop fabric fasteners, such as VELCRO brand fasteners available from Velcro USA Inc. of Manchester, New Hampshire, where patches of a first type (either hook or loop) of hook and loop fabric fastener can be releasably fastened to patches of the opposite type. For example, a hook type patch can be releasably adhered to a loop type patch or some other common loosely woven fabric. For clarity, such fasteners are referred to herein as fabric fasteners, and patches of fabric fasteners adhere to corresponding patches of fabric fasteners. One of ordinary skill in the art will readily understand which type is best used for any given patch and whether the types of mating patches can be interchanged.

[0079] Referring now to the drawings, FIGS. 1 and 2 show embodiments of a variable stiffness support device for supporting a body part of a wearer, where the wearer is a surgeon 1 operating on a patient 2 in this case. The patient is supported in a supine position on an operating table that has been lifted from the floor to near the height of the standing surgeon's waist. The surgeon is performing the operation on the patient in a hunched posture, in which the surgeon's head 3 is temporarily and repeatedly cantilevered over the patient so that the surgeon can closely observe the movement of his own hand 4. In this position, the surgeon's posterior neck and back muscles can rapidly fatigue.

[0080] In some embodiments including this, a surgeon, referred to as user or wearer 1, can wear a body part support device 10, which in this embodiment provides a first harness 11 fixed to a first body part, which is the head 3 in this embodiment, and a second harness 12 separated from the first harness and fixed to a second body part, which is the lower back region 5 of the torso in this embodiment. Thus, in this embodiment, the first harness can be referred to as the head harness 11 and the second harness as the torso harness 12. The head harness can be separated from and spaced apart from the torso harness. The variable rigidity structure beam can be formed of a single elongated variable rigidity structure member 20 fixed to the head harness 11 at a first position 36 near its distal end and can be fixed to the torso harness 12 at a second position 35 near its proximal end. All the structures used in the device can be fabricated from materials that can be surgically sterilized.

[0081] The head harness 11 can include headgear 16 in the form of a helmet-like device that firmly attaches to the wearer's head 3 and thus remains substantially stationary relative to the head. A connector 13 can attach the headgear to the first position 36 of the member 20. Thus, the connector can be a component of the head harness and a component of the body part support device 10. The connector can include a tether 14 of flexible material wound around a spindle 15 rotatably mounted within a housing 19 attached to the member. The free end of the tether can be fixed to the headgear at a landing 14a, which can include a fastener that operates quickly to enable rapid attachment and separation of the headgear from the device. For example, the landing can include a patch of fabric fastener that removably adheres to a corresponding patch attached to the outer surface of the headgear. In some embodiments, the tether can be made of a material that allows it to be elastic and thereby form a spring.

[0082] As mainly shown in FIG. 2, the distance between the headgear 16 and the member 20 can be adjusted by adjusting the amount of the tether 14 wound around the spindle 15, which can be achieved by rotating the knob 17 that drives the worm gear 18a engaged with the sprocket 18b that drives the rotation of the spindle. By using the sprocket and the worm gear, the amount of the tether wound around the spindle can be substantially locked when the knob is stationary even when the tether is under tension. In this way, the head harness 11 can be flexibly and adjustably fixed to the member 20.

[0083] Referring again to FIG. 1, the torso harness 12 can include an attachment structure for attaching the second position 35 near the proximal end of the member 20 to the wearer near the base of the spine, thus firmly fixing the position of the proximal end of the member. The attachment structure can include a base 31 that can firmly fix the proximal end of the member 20. The base can form a substantially stationary connection point that is fixed near the lower back of the wearer. The torso harness can also include a waist belt 32 and a pair of shoulder straps 33, 34 for firmly and adjustably fixing the torso harness to the wearer 1.

[0084] FIG. 3 shows the member 20 of this embodiment removed from the support device and laid flat. The member can have a shape similar to the sail battens disclosed in Malcolm's U.S. Patent No. 10315745, which is incorporated herein by reference. The member can have an elongated substantially rectangular shape extending from a proximal end 21 that can be fixed to the torso to a distal end 22 on the opposite side that can be fixed to the head. The member can include a pair of substantially parallel elongated tapered rods 23, 24 joined laterally by an intermediate webbing strip 25. In this way, the proximal portion of the member can have higher rigidity against bending and torsional forces than the more distal portion. The mechanical properties of the member will be described in more detail below.

[0085] Referring mainly to FIGS. 4 - 8 here, the member 20 can include a pair of substantially parallel, elongated, laterally spaced rods 23, 24 that form the opposing outer edges 26, 27 of the member and extend from the proximal end 21 to the distal end 22 substantially along the entire longitudinal length L of the member. Each rod can have a substantially conical shape with a substantially circular cross - section, in which circular cross - section, the diameter DR varies according to its longitudinal position on the member, tapering gradually from a wide proximal diameter DP to a narrow distal diameter DD. The substantially conical shape can be characterized by the ratio DD / DP of these two diameters, and this ratio is in the range of about 0.05 - 0.5. This provides a substantially linear taper along the length of the rod. The substantially conical shape can be an oblique cone such that a cross - section perpendicular to the elongation axis of the member forms a circle. Alternatively, the substantially conical shape can be a right cone with a very low eccentricity, such that a cross - section perpendicular to the elongation axis of the member forms an ellipse. The term "substantially" is used to cover both these deformed forms and other uniformly tapering geometric shapes. In this way, each rod can have a variable cross - section geometry along the longitudinal length L of the member.

[0086] The rods 23, 24 can be interconnected by an intermediate webbing strip 25 having substantially parallel trapezoidal front and rear faces. Thus, the webbing strip can be substantially planar and have a substantially uniform thickness T along the entire longitudinal length of the member.

[0087] The rods can be angled outward so that the lateral extent of the member remains substantially uniform. In other words, the overall width W of the member can be kept constant. This allows the width of the webbing strip Ww to vary between a narrower width Wwp at the proximal end of the member and a wider width Wwd at the distal end of the member. Thus, the overall width of the member can be defined as W = Ww + 2(Dr).

[0088] Referring now to FIG. 8, by making both rods 23, 24 substantially the same shape and dimensions, the member 20 can be made symmetric with respect to a plane 28 that vertically bisects the webbing strip 25. In this way, the symmetric member can be conveniently loaded into the support device regardless of whether the rod is disposed on the left or right side of the device. It should be noted that the transition between each rod and the webbing strip is gentle in the form of a concave fillet 29 having a radius of about 5% to 25% of the cross-sectional diameter of the rod at the fillet and the contact point. The member is shown having a barbell-shaped cross-section in which the rods form a pair of circles, but other shapes, such as ellipses, rounded squares, rounded rectangles, oval shapes, or other polygons having rounded vertices, etc. are also available.

[0089] Referring now to FIGS. 9-12, an alternative embodiment of the variable stiffness structural member 40 is shown, and the variable stiffness structural member 40 can be further configured such that the rods 41, 42 are hollow and each rod has an axial hollow portion in the form of a central lumen 43, 44 that extends longitudinally along the length of the rod. The intermediate webbing strip 45 interconnecting the rods can remain solid. The shape and dimensions of the lumen can be selected such that the wall formed between the outer surface of the rod and the inner surface facing the lumen is in the shape of a ring having a circular outer surface cross-section and a circular inner surface cross-section. Thus, the wall thickness can be angularly uniform at any cross-section and linearly uniform from end to end. The lumen can terminate at openings at the distal and proximal ends. Alternatively, the lumen can terminate at a closure cup at the distal end of the lumen. The lumen can serve to reduce the mass and amount of material contained in the member while maintaining appropriate bending and torsional stiffness and bending and torsional strength.

[0090] The stiffness characteristics of the member can be adjusted by forming the member from a fiber resin composite material such as a carbon fiber epoxy resin composite. The uncured epoxy can be combined with carbon fibers using techniques well known in the art. In this example, a thermosetting prepreg resin tape or “prepreg” such as a unidirectional fiber tape available from American Cyanamid Co., Wayne, New Jersey can be used. The layers of tape can be continuously wound around each other to form an uncured member body corresponding to the desired size of the member. When cured, the body becomes a single fiber composite variable stiffness structural member.

[0091] The orientation of the fibers can be selected to enhance the stiffness with respect to bending moments away from the elongation direction of the member.

[0092] As shown schematically in FIGS. 13 and 14, successive layers 61, 62, 63 of tape can be applied, with the direction of the fibers within each layer being different from the direction of the fibers within successive layers in order to tailor the stiffness characteristics to the forces applied over time from various directions and magnitudes. For example, the first layer 61 can be oriented at 0 degrees such that the elongation direction of the embedded fibers is parallel to the elongation axis 65 of the member 60. The second layer 62 can be oriented such that the elongation direction 66 of the embedded fibers is at an angle A1 of about 45 degrees with respect to the elongation axis of the member. Similarly, the third layer 63 can be oriented such that the elongation direction 67 of the embedded fibers is at an angle A2 of about 90 degrees with respect to the elongation axis of the member. The fourth layer can be oriented such that the elongation direction 68 of the embedded fibers is at an angle A3 of about 135 degrees with respect to the elongation axis of the member.

[0093] Referring now to FIG. 15, the structural member can be divided into a plurality of zones, and the fiber orientations of the various layers within a zone can be different from the orientations of other zones in order to selectively and preferentially stiffen different zones of the member. By way of example, member 70 can be divided into three separate zones 71, 72, 73 in the longitudinal direction, and the first distal zone 71 can have a set of fiber layers oriented in the 0 degree direction as well as in the 30 degree and 150 degree directions. The second intermediate zone 72 can have a set of fiber layers oriented in the 0 degree direction as well as in the 45 degree and 135 degree directions. The third proximal zone 73 can have a set of fiber layers oriented in the 0 degree direction as well as in the 45 degree, 90 degree and 135 degree directions. Thus, the set of fiber layers within a particular zone will have a plurality of different fiber orientations. Further, the plurality of fiber orientations of one set will be different from the plurality of fiber orientations of another set. These different sets of fiber orientations combined over the length of the member preferentially stiffen the proximal zone against greater bending and torsional loads than the distal zone. In this way, the member can be a multidimensional reinforced fiber composite that can provide lightweight stiffening. Further, in the context of a head and neck support device, these different fiber orientations can allow the spring constant or deflection force to vary along the length of the member to mimic the size and strength of the spinal column.

[0094] Referring now to FIG. 16, as shown previously, the cross-sectional shape of member 80 can include rods 81, 82 having a substantially circular shape. However, depending on the application in which the member is used and due to manufacturing concerns, other shapes may be useful for other structural members. For example, the rod can have an elliptical shape 83, or a quadrilateral shape including a square and a rectangle 84. Rods having other radially symmetric polygonal shapes such as a hexagon 85, an octagon, and a decagon can be used to provide a member cross-section that is symmetric with respect to the left-right transverse axis 86 and the front-back transverse axis 88. Other shapes that are radially symmetric depending on the orientation, such as a trapezoid 88, a pentagon, and a heptagon, can also be used. Innumerable other more complex shapes that provide symmetry with respect to both transverse axes, such as a substantially semi-circular shape 89, are available. In most applications, such symmetry is preferred to facilitate the manufacture, maintenance, and adjustment of the body part support device. However, an asymmetric rod cross-section can also be used depending on the application.

[0095] Referring now to FIGS. 17 - 19, an alternative embodiment of the body part support device 100 is shown that is similar to that described above in connection with FIG. 1, but with some important differences. In some embodiments including this one, the device can provide a variable stiffness structural beam formed by a single variable stiffness structural member 110 having adjustable stiffness, and can provide a mechanism for adjusting the position at which at least one of the harnesses connects to the member. The device can include a head harness 103 and a torso harness 104 attached to the wearer 101 and attached at spaced positions on the member.

[0096] The variable stiffness structural member 110 can be similar to the embodiment of the member shown in FIG. 9, but there are some important differences. The member can include a pair of substantially parallel, elongated, laterally spaced, tapered rods 111, 112 interconnected by an intermediate webbing strip 113. Each rod can be hollow and have a central longitudinal lumen 114, 115 running the length L2 of the rod. A loop of a tension cable 120 can run through both lumens over a pair of pulleys 121, 122 disposed near the distal end 116 of the member. A first end 123 of the cable can be fixed near the proximal end of one lumen 115, and a second end of the cable can be wound around a spool 124 near the proximal end of the other lumen 114. A locking crank 125 can be used to adjust the tension applied to the cable. The spool and locking crank mechanism can be housed within a housing 126 at the base of the body harness, and the housing 126 can securely attach the proximal end 117 of the member. In this way, the tension cable can extend along the longitudinal length of the beam and contact the beam such that an increase in the tension of the cable causes an increase in the longitudinal stiffness of the beam.

[0097] The head harness 103 can include a headgear 130 similar to the embodiment of FIG. 1. In some embodiments including this, the headgear can also provide a mount 130b for a lamp, magnifying lens, display screen, or other item useful for an operation performed by the wearer. A connector 131 can secure the headgear to a position on the member 110. That position can be adjusted by moving a housing 133 longitudinally along the member 132. The position of the housing on the member can be locked by a pair of opposing, engaging, elastic pressure pads 134, 135 whose spacing is adjusted by turning a threaded knob 136. In this way, the housing can enable a connection between the member and the headgear.

[0098] Similar to the embodiment of FIG. 1, the connector can include a tether 137 of flexible material having a free end that is secured to the headgear at landing 130a. The length of the tether can be adjusted by turning a crank 138 that drives a pair of pinch rollers 139 disposed within a housing 133 that holds the tether. A gearing arrangement (not shown) can ensure that the pinch rollers remain locked in place unless the crank is moved.

[0099] Note that pulleys 121, 122 can be mounted within a housing 118 disposed near the distal end 116 of member 110. The housing can have a cross-sectional shape and dimensions that can prevent the connector housing 133 from accidentally moving beyond the distal end of the member during longitudinal adjustment of the connector housing position.

[0100] Understand that some or all of the components that require the use of manually actuated knobs and cranks can be driven by a motor. Further, the variable stiffness structural member can derive its stiffness variability from differences in the static structure at various portions of the member or through an adjustable structure such as the tension cable shown in the embodiment of FIG. 1, or both. Further, the adjustable structure can be dynamically adjusted by a servo motor or other actuator during use to allow for continuous or intermittent adjustment of the variable stiffness.

[0101] Referring now to FIG. 20, an alternative embodiment of the body part support device 140 is shown which is similar to that described above in connection with the embodiment of FIG. 17, but with some important differences. In some embodiments including this one, manually operable cranks and knobs have been replaced with several electrically actuated servo motors. The electric motor 148 can be attached to a housing 145 that secures the proximal end of the variable stiffness structural member 141 to the torso harness 142. The motor 148 can engage a spool around which an internal cable runs through a lumen within a laterally spaced rod of the member. The operation of the motor can adjust the tension on the cable and thus the stiffness of the member. The motor is powered by a battery held within the base housing 145 of the torso harness 142 and can be controlled by a microprocessor circuit 152 installed within the base. A smartphone 160 or other computer can use a standard wireless communication regime such as WiFi, Bluetooth or other well-known regimes and protocols to instruct the operation of the microprocessor circuit via a wireless communication link 161.

[0102] Similarly, in the head harness 146, a motor 149 can replace the crank 131 used in the embodiment of FIG. 17. In this way, the operation of the motor 149 can adjust the length of the flexible tether 144 within a connector 143 that secures the headgear to the member 141. The motor 149 can be controlled by the microprocessor 152. Another motor 147 can drive and adjust the longitudinal position 139 of the housing. In this way, sensors such as accelerometers, tension gauges and / or sensors within the head harness can detect changes in the position of the head, dynamically move the housing, and / or shorten or lengthen the flexible tether to maintain support without restricting or interfering with the required movement of the head and neck. Signals and power can be supplied to the motors as will be described later.

[0103] Referring mainly to FIG. 21 here, in addition to controlling the motors 147, 148, 149 or programming the control of the motors in response to any of the mounted sensors of the support device 140, the smartphone 160 or computer issues operation commands, tracks various parameters related to the state of the support device, and executes an app or other software routine that accesses a database related to the operation of the support device, such as the member stiffness setting 162 and the tether length setting 163, and can maintain a record of those parameters so that various users can quickly load their preferred configurations. The database can be mounted on a computer or accessed via a wirelessly connected computer network such as the Internet. It should be understood that various sensors, such as orientation sensors, strain gauges or other electronic sensors, are attached to the support device and can supply signals indicating the state of these parameters to be utilized by the microprocessor and / or software routine during operation. The routine also tracks and displays various information 164, including, for example, the date and time, the duration of the current activity, and patient information, including, for example, name and the procedure being performed, thereby improving patient safety.

[0104] Referring to FIG. 22 here, power and communication signals can be carried on the wirings 151, 152 that run through the channel 153 formed in the webbing portion 150 of the member 141. In this way, a relatively heavy and bulky battery power source and control unit can be held on the base 145 of the torso harness 142 to supply power and distribute and receive electrical signals traveling to and from the head harness 146. Further, power and signals can be carried on the member without mechanical interference with the member cables 154, rods 155, 156 and lumens 157, 158. A ribbon cable or other movable electrical signal carrier can provide the electrical connection between the member and the connector 143 of the head harness. Alternatively, a wireless communication circuit can be used for communication between the harnesses 142, 146 and either the smartphone 160 or another computerized mobile device.

[0105] Referring now to FIGS. 23 and 24, an alternative embodiment of the body part support device 170 is shown which is similar to that described above in connection with the embodiment of FIG. 1, but with some important differences. In some embodiments including this one, the variable stiffness structural beam 171 can include a pair of mating nested members 172, 173. The first distal member 172 can have a distal end 174 fixed and secured to the head harness connector 175 and a proximal end 176 slidably engaged within an opening 177 in the distal end 178 of the proximal member 173, and the proximal end 176 communicates with a passage 179 extending longitudinally within the proximal member toward the proximal end of the proximal member fixed and secured to the base 184 of the torso harness from the opening. Thereby, the distal member can be moved longitudinally with respect to the proximal member 183. The position of the distal member with respect to the proximal member can be locked by a friction pad 180 that abuts against the surface 182 of the distal member. The amount of friction applied by the pad can be adjusted by a threaded knob 181. In this way, the longitudinal position of the head harness can be adjusted with respect to the torso harness. Both members taper from the proximal end of the member toward the distal end of the member and can provide a substantially trapezoidal cross-section as shown in FIG. 24. In this way, the members can each have variable stiffness along the longitudinal length of the member. Further, the stiffness of the beam 171 can be made adjustable by the relative movement of the two members.

[0106] Referring now to FIG. 25, an alternative embodiment of the body part support device 190 is shown that is partially similar to that described above in connection with the embodiment of FIG. 1 and includes a variable stiffness structure beam. In some embodiments including this, the body part support device 190 can be formed by a single variable stiffness structure member 191 that is fixed at its distal end to the head harness connector 192 and at its proximal end to the torso harness base 193. However, there are some important differences from the embodiment of FIG. 1. In some embodiments including this, the device can provide a mechanism for adjusting the position where the torso harness connects to the member, provide a reduced torsional stiffness, and provide a greater resistance to longitudinal loads.

[0107] The member 191 can include a first longitudinal proximal region 194 and a second longitudinal distal region 195. The proximal region 194 can include a pair of laterally spaced rods 185, 186 joined by an intermediate web 187. The rods can optionally taper as they extend distally, similar to the rods of the embodiment of FIG. 1. The distal region 195 can include a single rod 188 that can optionally taper as it extends distally toward the distal end fixed to the head harness connector 192. The transition region 189 joins the proximal region to the distal region. When the member is manufactured as a single integrated composite material piece, the transition region can be designed such that the shape gradually changes between the shape of the proximal region and the shape of the distal region. The single rod of the distal region can form a delta that separates into two rods that become the double rods of the proximal region.

[0108] The device 190 can include a mechanism similar to that shown in connection with the embodiment of FIG. 24, which can enable adjustment of the longitudinal position of the member 191 relative to the torso harness base 193 by allowing telescoping longitudinal movement 197 between the member and the base. The relative position of the member can be fixed by a friction pad driven by a threaded knob 196 attached to the torso harness base.

[0109] The head harness connector 192 can include a rigid strut 198 that extends between a housing 199 attached to the member 191 near its distal end and a landing 200 secured to a headgear (not shown) similar to that of the embodiment of FIG. 1. The attachment of the strut to the housing and the landing can be rigid. In this way, the head harness connector can provide greater resistance to longitudinal loads. The housing 199 can have a swivel connection to the member, and the swivel connection allows angular movement 201 of the strut about the longitudinal axis 202 of the distal end of the member to reduce torsional stiffness. The structure of the rigid strut rigidly attached to the housing and the landing of the headgear provides a cantilevered support to the headgear and thus to the wearer's head and neck.

[0110] FIG. 26 shows an alternative embodiment of a variable stiffness structural member 210 that is similar to the member described in relation to the embodiment of FIG. 25 but has some important differences. The important differences provide a smoother shape, for example, to avoid obstacles when the wearer moves around equipment in the operating room. In some embodiments including this, the member can include a first longitudinally proximal region 211 and a second longitudinally distal region 212. The proximal region 211 can include a pair of laterally spaced rods 213, 214 joined by an intermediate web 215. The rods can optionally taper as they extend distally, similar to the rods of the embodiment of FIG. 1. The distal region 212 can include a single rod 216 that can optionally taper as it extends distally toward the distal end 222. The single rod can have a substantially elliptical cross-section when viewed perpendicular to the longitudinal axis of the member. The intermediate web can terminate at a distal rounded end 217 in a transition region 218 where the proximal and distal regions meet.

[0111] In some embodiments including this, the width W26 of the member 210 can taper substantially linearly from the proximal end 221 to the distal end 222. Thus, the outer edges 219, 220 of the member maintain a smooth contour, thereby avoiding snagging. It should be noted that the width of the member can remain constant, but the thickness of the member measured perpendicular to the width can taper from the proximal end to the distal end, providing appropriate variable longitudinal rigidity to the member.

[0112] Referring now to FIG. 27, an alternative embodiment of the body part support device 250 is shown which is similar to that described above in relation to the embodiment of FIG. 1 but with some important differences. In some embodiments including this, the variable rigidity structure beam can be formed of a single variable rigidity structure member 251, and this member 251 can be fabricated as a single tapered rod that is attached to a garment 252 in the form of a fabric vest that forms the torso harness 253. To minimize complexity and weight, a simplified flexible cord connector 254 can be used when forming the head harness 255. The member can be fabricated from a single piece of carbon fiber composite material to form a semi-rigid rod that tapers from the proximal end 256 to the distal end 257.

[0113] The garment 252 can be constructed of a tough, lightweight, breathable, non-stretchable material with elastomeric panels and zones to accommodate movement as needed while controlling the position of the body part support device. Various adjustments and cinch straps can be added if required for sizing to different users. The garment can be of the jacket or vest type. The garment can include a ventilation function, active cooling and heating functions, and various closure and fastening functions to facilitate donning and removal.

[0114] The member 251 can be fixed to the fabric vest 252 by engaging with the proximal end 256 of the member within the pocket 258 of the fabric vest disposed near the base of the wearer 260's spine. The member can be further fixed to the fabric vest by one or more fabric loops forming a keeper structure 259 arranged to engage the middle portion of the member. Both the pocket structure and the keeper structure can be shaped and sized to hold the engaged portion of the member by friction. For example, the pocket can have a shape corresponding to the shape of the proximal end of the member. If the proximal end of the member is substantially cylindrical or has a very gentle conical taper, the pocket can also be cylindrical with an inner diameter matching the maximum outer diameter of the member. The keeper can have a slightly oversized through-hole to allow for a small restricted lateral movement of the member therein and a slight relative longitudinal movement that can occur when the wearer transitions between an upright and a hunched posture.

[0115] The member 251 can be fixed to the head harness 255 by a flexible cord connector 254 having a distal end attached to a landing 262 fixed to a headgear 263 worn by the wearer 260 and a proximal end attached to the distal end 257 of the member. The flexible cord can be made of an elastic material to be substantially inelastic or to form a spring that provides greater resistance to elongation as it is stretched.

[0116] Referring now to FIGS. 28 - 30, an alternative embodiment of a body part support device 300 configured to support the head and neck of a wearer 301 during repetitive activities is shown, where during the repetitive activities, the head is temporarily and repeatedly cantilever - supported in front of the wearer in a mild to moderate hunched posture. In some embodiments including this, the variable - rigidity beam 310 can include a pair of individual members, namely, a first rear member 311 and a second front member 312 that are fixed to each other by a pair of spaced - apart adjustable blocks 370, 380. The front member can be the longer of the two members that provide attachment positions 313, 314 for the first harness 320 and the second harness 350, while the rear member can provide rigidity adjustability as will be described in more detail below. The rear and front positions of the members are in line with the plane including both members in response to the primary load on the head of the cantilever beam, providing a great deal of adjustability to the beam's rigidity, as opposed to a laterally - spaced alternating left - right orientation. In other words, both members can be present within a substantially vertical plane that substantially bisects the wearer into left and right sides.

[0117] The device 300 can include a first harness 320 fixed to a first body part that can be the head 303 of the wearer, and a second harness 350, spaced from the first harness, fixed to a second body part that can be the lower back region 305 of the torso. Thus, in some embodiments including this, the first harness can be referred to as the head harness 320 and the second harness as the torso harness 350. The head harness can be separated and spaced from the torso harness. Both harnesses can be fixed to a variable - rigidity structural beam 310 that includes a rear member 311 and a front member 312 separated front - to - back by a pair of longitudinally - spaced adjustable blocks 370, 380. The head harness 320 can be fixed to the beam at a first position 313 near the distal end 316 of the beam on the front member 312. The torso harness can be fixed to the beam at a second position 314 near the proximal end 315 of the beam on the front member.

[0118] The head harness 320 can include a headgear 321 in the form of a helmet-like garment that firmly attaches to the wearer's head 303 and thus remains substantially stationary relative to the head. The adjustment portion 322 can adjust the headgear to comfortably fit and attach to the wearer's head. These adjustment portions can use various means known in the art, such as separate plastic snap fasteners, corresponding patches of hook-and-loop type fabric fasteners, and spring-loaded posts that engage separate holes as shown, for example, to releasably attach overlapping straps to each other.

[0119] The connector 330 can attach the headgear 321 to a first position 313 on the front member 312 of the beam 310. The connector can include a flexible cable 331 with both ends attached to both sides of the headgear. The first end of the cable can be attached to a spindle 332 rotatably mounted on a guide bracket 333 attached to the headgear by a swivel mount 334. The spindle can form a landing for the cable end on the headgear. The guide bracket 333 can include a cable guide 335 through which the cable can slide and abut. The opposite end of the cable can be attached to a similar guide bracket (not shown) attached to the opposite side of the headgear, with or without an adjustable spindle that forms another landing for the cable on the headgear. The distance between the headgear and the member can be adjusted by adjusting the amount of cable wound around the spindle. In this orientation, a single plane can intersect the wearer and both members and bisect them vertically and substantially symmetrically.

[0120] As mainly shown in FIG. 30, the middle portion 331a of the cable 331 can be slidably engaged with a housing 340 attached to the beam 310. A pair of round funnel-shaped cable guides 341 slidably support the cable, allowing the left-right movement 342 of the cable with respect to the housing. In this way, those skilled in the art will easily understand that the user can have the freedom to comfortably twist their head in a swaying manner with little resistance. This arrangement can enable an essentially unrestricted rotational movement of the head with respect to the beam while the beam provides its support.

[0121] Each cable guide 341 can have a round edge 343 surrounding a central hole to facilitate passing the cable through it during assembly and to reduce cable wear. Similar to the embodiment shown in FIG. 19, the position of the member 312, and thus the housing with respect to the beam, can be adjusted by moving the housing longitudinally along the member. The position of the housing on the member can be locked by a pair of opposing elastic pressure pads 344, 345 whose spacing is adjusted by turning a threaded knob 346. In this way, the housing can provide a part of the connector 330 that secures the beam to the headgear 321 and can be a component of the head harness 320. In this way, the head harness can be flexibly and adjustably secured to the beam.

[0122] Referring back to FIG. 28, the torso harness 350 can take the form of a fabric vest or clothing 351 worn on the user's torso. The torso harness can include an attachment structure for securing the beam 310 to the base of the spine at the second position 314 or the proximal end of the front member 312. The attachment structure can include a base located near the base of the wearer's spine in the form of a pocket 352 engaged by the proximal end 316 of the front member. The front member can be further secured to the clothing by one or more fabric loops forming keepers 353, 354 arranged to engage the middle portion of the front member.

[0123] Similar to the embodiment of FIG. 27, both the pocket 352 and the keeper structures 353, 354 can be shaped and dimensioned to frictionally hold the engaging portion of the front member 312 of the adjustable variable stiffness beam 310. For example, the pocket can have a shape corresponding to the shape of the proximal end of the member. If the proximal end of the member is substantially square in shape or has a very gradual trapezoidal taper, the pocket can also be square in shape with an inner diameter that matches the maximum outer diameter of the member. The keeper can have a slightly oversized through-hole to allow for a small restricted lateral movement of the member therein and a slight relative longitudinal movement that can occur when the wearer transitions between an upright and a hunched posture.

[0124] A cushion 360 made of a durable elastic material such as fabric-coated foam rubber can be secured to the garment 351 by one or more corresponding fabric fasteners 361. The cushion can be placed on the upper back of the user 301 to abut against the beam 310, thereby enhancing comfort. Cushions of different thicknesses can be easily exchanged to adjust the amount of contact with the beam and further enhance comfort. The use of fabric fastener patches also allows for a slight adjustment of the position of the cushion on the garment to change the point of contact with the beam, thereby potentially changing its stiffness and providing padding for accidental contact between the middle portion of the beam and the user.

[0125] Referring mainly to FIG. 29, various components of an adjustable variable stiffness beam 310 according to an exemplary embodiment of the present invention are shown. The beam can extend along a longitudinal axis La1. The beam can include a first solid but elastically flexible elongated rear member 311 and a second solid but elastically flexible elongated front member 312 separated from each other by a pair of blocks 370, 380, and they are themselves longitudinally separated by a distance S1. The members are spaced apart substantially parallel to each other by a distance D1 perpendicular to the longitudinal axis, and thus the members can be laterally spaced apart. In this way, the members can be prevented from coming into direct contact with each other or substantially branching. In other words, the members can be arranged so that there is no direct contact between the two members. The members can be made of a solid but elastically flexible material such as steel, aluminum, plastic, or a fiber-injected composite material such as a glass fiber or carbon fiber composite material. Those skilled in the art will understand that the components or members shown in the drawings may be over-sized or under-sized, and their shapes may be exaggerated for clarity.

[0126] The first solid but elastically flexible elongated rear member 311 can have a substantially rectangular elongated shape with a maximum dimension in the longitudinal direction terminating at a proximal or near end 313 and a distal or far end 314. The overall shape of the member can be similar to the member shown in FIGS. 3-8 having a pair of spaced tapered rods joined by an intermediate web. The member has a substantially uniform width but a substantially tapered thickness and can thus provide variable stiffness and variable torsional stiffness along its longitudinal length. Alternatively, the rear member can have a substantially uniform width, a substantially uniform thickness, and variable stiffness of the member provided by a unique fiber orientation zone as described in connection with FIGS. 13-15. Alternatively, the rear member can have a substantially uniform stiffness along its longitudinal length and can form a substantially uniform stiffness member. Whether the rear member has variable stiffness or uniform stiffness along its longitudinal length, the stiffness of the beam 310 can be adjusted by adjusting the longitudinal positioning of the block separating the two members as described below. Or, if the rear member exhibits variable longitudinal stiffness, the stiffness of the beam can be adjusted by adjusting the longitudinal position of the rear member relative to the block as indicated by arrows 317a, 317b.

[0127] Similar to the rear member 311, the second solid but elastically flexible elongated front member 312 can have a substantially rectangular elongated shape with a maximum dimension in the longitudinal direction terminating at a proximal or near end 315 and a distal or far end 316. The second member has a substantially uniform width but, as described in connection with FIGS. 13-15, a substantially tapered thickness and / or a unique fiber orientation zone and can thus provide variable stiffness and variable torsional stiffness along its longitudinal length. Again, the shape of the front member can be similar to the member shown in FIGS. 3-8 having a pair of spaced tapered rods joined by an intermediate web.

[0128] Furthermore, it is assumed that it is obvious that the rear member 311 can achieve variable rigidity by having a cross-sectional geometry that varies along its longitudinal length. Specifically, the member can be made thinner from the proximal end 313 of the member with a large thickness T1 to the distal end 314 of the member with a small thickness T2. In this way, the more distal portion of the member can be made more flexible than the proximal portion, and the member has a variable cross-sectional geometry along the longitudinal length of the member. The same applies to the front member 312.

[0129] The members 311, 312 can be held in a longitudinally spaced-apart orientation by a pair of blocks 370, 380 separated by a longitudinal spacing S1. The spacing can be adjusted by changing the longitudinal position of one or both of the blocks.

[0130] Each block, for example 380, can be locked in its longitudinal position by engaging a first friction pad 381 with the rear member 311 and a second friction pad 382 with the front member 312. The friction provided by each pad can be adjusted by turning the respective threaded fasteners 385, 386 of the pads. In some embodiments including this, the threaded fastener 386 for the friction pad 382 that engages the front member can be actuated by placing it in a recess using a tool such as an Allen wrench. In this way, the position of each block relative to the front member is more permanent and cannot be adjusted while the device is being worn, but the threaded fastener 385 for the friction pad 381 that engages the rear member can be actuated by an exposed knob 387 so that the position of the block relative to the rear member can be adjusted while the device is being worn. The other block 370 can be configured similarly.

[0131] In this way, the longitudinal position of the rear member 311 can be adjusted as shown by the arrows 317a and 317b by loosening the friction pads of each of the two blocks and sliding the rear member longitudinally in order to adjust the variable rigidity of the entire beam 310. Therefore, both blocks 370 and 380 can be fixedly attached to one of the members 312 while the device is being worn, and releasably attached to the other member 311. In this way, the device provides means for attaching to and supporting the user's head and spine in an adjustable variable rigidity manner while being worn.

[0132] Referring now to FIG. 31, an alternative embodiment of a block 390 used to help maintain the relative positions of a rear member 391 and a front member 392 is shown. In some embodiments including this, the block can be adjusted to change a separation distance D4 perpendicular to the longitudinal axis between the members. The separation distance can be adjusted by a distance adjustment mechanism such as turning a turnbuckle type wheel 395 having a pair of alternately threaded coaxial posts that engage threaded holes in a pair of platforms 393, 394 that abut the surfaces facing the inside of the members. Friction pads actuated by threaded knobs 398, 399 can be used to releasably attach the block to the members and allow longitudinal movement of the members relative to the block. In this way, a single separation distance adjustable block can be used to adjust an angle A1 of one member relative to the other member so that the mutual orientation of the two members can be parallel or non-parallel. By adjusting the angle between the members, the rigidity of the beam can also be further adjusted. Two such separation distance adjustable blocks can be used to separate the members while maintaining the angular orientation of the members relative to each other. In other words, the first member can be lengthened along a first longitudinal direction, the second member can be lengthened along a second longitudinal direction, and the adjustable blocks can be made to allow their longitudinal directions to be parallel or non-parallel.

[0133] Referring now to FIGS. 32 and 33, an alternative embodiment of the body part support device 400 is shown which is similar to that described above in connection with the embodiment of FIG. 28, but with some important differences. In some embodiments including this one, the beam 410 can have a curved extension bracket member 420 fixed to the front member 412 distal to and near the distal end 416 of a pair of separator blocks 470, 480, whereby the distance D3 between the housing 440 and the head 403 of the wearer 401 can be increased. This allows for a more free movement of the head in an extended or head-up motion while maintaining a compact profile for the support device, thereby reducing the likelihood that the device will catch on other equipment, for example, in a surgical setting.

[0134] The extension bracket member 420 can be adjustably fixed to the front member 412 using an adjustable gripper 450 having a friction pad similar in function to the block 380 shown in connection with the embodiment of FIG. 28, which is fixedly attached to the extension bracket member. The gripper can be tightened or loosened by turning a knob 451. Loosening the friction pad allows for longitudinal movement of the extension bracket member relative to the front member.

[0135] The housing 440 of the headgear connector 430 can be similar to the housing shown in the embodiment of FIG. 28, but the position of the housing relative to the extension bracket member 420, and thus the beam 410, can be adjusted by moving the housing longitudinally along the bracket member. The position of the housing on the member can be locked by a pair of opposing resilient pressure pads 444, 445 whose spacing is adjusted by turning a threaded knob 446. The housing can similarly slidably support a laterally engaged cable 431 adjustably connected to the headgear 460.

[0136] Unlike the embodiment of FIG. 28, in some embodiments including this one, the housing 440 can include a stop mechanism 441 that prevents inadvertent longitudinal movement of the housing beyond the distal end 422 of the extension bracket member 420 and thus beyond the distal end of the beam 410. The stop mechanism can include a spring-loaded stop pin 446 rotatably attached to the housing on a shaft 442. A spring 443 biases the pin against the smooth outer surface 423 of the extension bracket member 420. The pin is shaped and dimensioned to engage a hole 421 formed near the distal end 422 of the extension bracket member when the housing is moved longitudinally distally beyond a certain point. In this way, engagement of the pin with the hole prevents the housing from being inadvertently moved distally from the distal end of the bracket.

[0137] FIG. 34 shows that an adjustable and variable stiffness support beam 510 has a curved extension bracket member 515 integrally formed with a front member 512, thus avoiding the need for a gripping mechanism.

[0138] FIG. 35 shows that an adjustable and variable stiffness support beam 520 can have a curved extension bracket member 525 integrally formed with a rear member 521.

[0139] Next, referring now to FIG. 36, an exemplary embodiment of a method 600 for supporting a body part of a wearer such as a person will be described. The method can include selecting a support device (601) that includes a substantially rigid variable stiffness beam that is connected or otherwise secured to a first harness at a first position on the beam and connected or otherwise secured to a second harness at a second position on the beam, where the first position and the second position are spaced apart. The first harness of the support device can be attached (602) to a first body part of the person, such as the person's head. The second harness of the support device can be attached (603) to a second body part of the person, such as the person's torso. In this way, the two body parts can be spaced apart from each other.

[0140] When the support device is attached to a body part of the wearer, it is possible to change the load applied to the first body part (604). For example, in the case of a standing person wearing the device, when the head is tilted forward, the load, which is the weight of the head, changes such that the moment applied to the person's neck increases. This change in load enables the components of the load to be supported by the second body part via the beam (605). In other words, the weight of the head is then partially supported by the torso via the force supported by the device.

[0141] Referring now to FIGS. 37 and 38, an alternative embodiment of a body part support device 700 configured to support the thoracic spine of a wearer 701 during repetitive activities is shown, in which the wearer temporarily and repeatedly assumes a mildly to moderately hunched posture. In some embodiments including this, the variable stiffness beam 710 can include a first curved rear member 711 and a curved front member 712 that are spaced apart from each other front and back by a pair of individual members, namely a pair of adjustable blocks 770, 780.

[0142] The body part support device 700 can be similar to that described above in relation to the embodiment of FIG. 28, but there are some important differences. In some embodiments including this, the curvature of the member can be selected to more closely match the typical lordotic curvature of the spine. Thus, the front member 712 can have a substantially S-shaped appearance with a distal convexity 791 and a proximal concavity 792 when viewed from the back. Further, the front member can have a variable stiffness that is stiffer in the proximal direction and less stiff in the distal direction so as to more closely match the typical stiffness of the spine. In this way, the front member can support rather than constrain the anatomical structure. Similar to the previous embodiment, the variable stiffness can be achieved by the geometry of the member, such as by tapering its thickness and / or by changing the orientation of the fiber layers as described in relation to FIGS. 13 - 15.

[0143] The rear member 711 can have a variable rigidity or a uniform rigidity similar to that of the front member 712. The adjustability of the rigidity of the beam 710 can be achieved by the longitudinal movement of one or both of the adjustable separator blocks 770, 780 and / or the longitudinal sliding of the rear member relative to the front member. It should be noted that the flexibility of the rear member allows for this slight relative longitudinal movement even if the rest shape of the member is S-shaped. By longitudinally sliding the rear member relative to the front member to place the rear member under bending stress, the variable rigidity of the beam can be adjusted.

[0144] The body part support device 700 provides, in this embodiment, a first harness 721 fixed to a first body part which is the upper thoracic region of the spine, and a second harness 722 fixed to a second body part which is the lower lumbar region of the spine in this embodiment, and spaced apart from the first harness. Thus, in this embodiment, the first harness can be referred to as the chest harness 721 and the second harness can be referred to as the lumbar harness 722. The chest harness can be separated from and spaced apart from the lumbar harness. The chest harness can be formed at the member end that holds the chest pocket 753 formed within the chest region on the body-worn garment 705. The lumbar harness can be formed at the member end that holds the lumbar pocket 752 formed within the lumbar region of the same garment. The front member can be further fixed to the garment by one or more fabric loops that form a keeper 754 arranged to engage the middle portion of the front member.

[0145] The variable stiffness beam 710 can be fixed to the chest harness 721 at a first position 713 near the distal end 715 of the front member 712 and can be attached to the waist harness 722 at a second position 714 near the proximal end 716. Thus, the chest pocket can form a connector that connects the first position on the beam to the chest harness, and the waist pocket can form a mounting structure that attaches the second position on the beam to the waist harness. In this way, a part of the load applied to the thoracic vertebra can be transmitted by the beam to the lumbar vertebra and then transmitted to the buttocks via the waist belt portion 732 of the garment 705. In fact, the amount of support for the load can increase as the curvature of the chest region increases and the curvature of the lumbar region decreases.

[0146] The above-described embodiment of the variable stiffness beam can provide a bending stiffness as a function of the distance from the proximal end of the beam. The stiffness can be determined according to the geometry of one or more members used, the material properties of the members such as the fiber orientation in embodiments using fiber composite materials within various zones of the members, and the settings of the above-described adjustable features such as the positioning of the tension cable, adjustable blocks, and the longitudinal positioning of the rear member.

[0147] The characteristics shown by the above-described embodiment of the structural beam have been found to be potentially useful in a body part support device due to the exact dynamic moments applied to such a structure and the variable stiffness of the beam along its length.

[0148] In the context of head, neck, and / or back support for a surgeon, the above-described embodiment provides sufficient flexibility to allow free movement of these body parts by flexion, extension, lateral movement, and rotation while reducing the load on the neck and back due to the gravity acting on the head. When used over time, the typical constant overloading of the paravertebral muscles is reduced, leading to a reduction in pain and discomfort during work and reducing wear and tear of the facet joints in the upper chest and neck.

[0149] In this way, the device can provide an external spinal support system for reducing the loads on the back, neck, spine and head during work and work-related postures and body positioning. In this way, in some embodiments, a variable stiffness beam attached to the headgear can provide a balancing force to help support the head, neck and upper back. In some embodiments, the variable stiffness beam can include one or more members shaped as a cylindrical member, a tapered flat plate or rod, or any combination of geometries. In some embodiments, each member can be a flat plate having an integral tapered longitudinal edge that is thicker than the thickness of the flat plate. Such a geometry can ideally place tapered rods along and over the length of the paraspinal muscle group to provide medial, lateral and torsional support to the spine. In some embodiments, the connector for attaching the variable stiffness beam to the headgear can have a quick coupling mechanism that allows for easy engagement and disengagement with the support beam.

[0150] In some embodiments, the bending stiffness of the variable stiffness beam can vary along its length and can be infinitely adjustable for an individual user. In some embodiments, the beam can include one or more members having a tapered geometry where the edges can be bridged by flat plates, and the members can provide torsional support to the head and neck in left and right torsional movements while maintaining balanced support in bending and lateral movements. In some embodiments, the variable stiffness beam can include one or more members made of a composite structure designed to function as a lightweight balancing spring. In some embodiments, the spring constant or deflection force can vary along the length of the beam to mimic the size and strength of the spinal column. In some embodiments, a tension cable may be included to apply tension to increase the performance and stiffness of the beam. The cable may be tensioned by a screw, spring or motor.

[0151] Although the preferred embodiments of the present invention have been described, modifications can be made and other embodiments can be devised without departing from the spirit of the present invention and the scope of the appended claims.

Claims

1. An apparatus for softly supporting a body part, comprising: The apparatus includes: An elongated beam having variable stiffness along its longitudinal length; A first harness fixed to a first position on the beam; A second harness fixed to a second position on the beam, The first position being longitudinally spaced from the second position; The first harness being configured to be fixed to a first body part; The second harness being configured to be fixed to a second body part; Thereby, when the first harness is fixed to the first body part and the second harness is fixed to the second body part, the beam is oriented to support the load component generated by the first body part.

2. The apparatus according to claim 1, wherein the first harness comprises a connector connecting the first harness to the first position on the beam.

3. The apparatus according to claim 1, further comprising a mounting structure for fixing the second harness to the second position on the beam.

4. The beam is elongated, The variable stiffness is variable along the longitudinal length of the beam, as claimed in claim 1.

5. The variable stiffness is adjustable, as claimed in claim 1.

6. The beam comprises a cable extending along the longitudinal length of the beam, Thereby, when the cable is under tension, the stiffness of the beam is increased, as claimed in claim 5.

7. The apparatus includes: A first member having a first elongated shape in the longitudinal direction, the first member having a proximal end and a distal end; A second member having a second elongated shape in the longitudinal direction, the second member having a proximal end and a distal end, The first member and the second member being spaced apart from each other by a separation distance; The apparatus includes: A first block connecting the first member to the second member; A second block connecting the first member to the second member, The first block and the second block being longitudinally spaced apart with an interval, as claimed in claim 1.

8. The second member has a stiffness that is variable in the longitudinal direction, as claimed in claim 7.

9. The first harness includes: A headgear configured to be attached to the wearer's head; The apparatus according to claim 1, further comprising a connector that connects the headgear to the first position on the beam.

10. The first harness comprises a housing slidably attached to the beam, a cable extending between the housing and the headgear, and a guide bracket hingedly connected to the headgear, and the guide bracket abuts against a part of the cable, the apparatus according to claim 9.

11. The apparatus according to claim 10, wherein the first harness further comprises a spool attached to the guide bracket for adjusting the length of the cable.

12. The first harness further comprises a stop mechanism that prevents longitudinal movement of the housing relative to the beam, the stop mechanism comprises a spring-loaded pin attached to the housing, and the spring-loaded pin is shaped and dimensioned to engage a hole in the beam disposed near an end of the beam, the apparatus according to claim 10.

13. The beam is fixed to the first harness via a connector that extends the connector distance between the first harness and the beam, the connector distance is adjustable, the apparatus according to claim 1.

14. The apparatus according to claim 13, wherein the connector comprises a releasable lock for fixing the connector distance.

15. The apparatus according to claim 13, wherein the connector comprises a flexible tether having an adjustable length.

16. The flexible tether is elastic, thereby forming a spring, the apparatus according to claim 15.

17. The apparatus according to claim 15, wherein the connector comprises a spool around which a part of the flexible tether is wound.

18. a motor for driving the spool, and a microprocessor for controlling the motor in response to a command received wirelessly from a computerized mobile device, the apparatus according to claim 17.

19. The apparatus according to claim 1, wherein the beam is fixed to the body harness by a mounting structure shaped and dimensioned to firmly position the proximal end of the beam.

20. The mounting structure comprises a pocket and at least one keeper structure engaged by an intermediate portion of the beam, the apparatus according to claim 19.

21. The variable stiffness structural beam further comprises a proximal end and a distal end, the beam having a first cross-sectional area near the proximal end and a second cross-sectional area near the distal end, the first cross-sectional area being larger than the second cross-sectional area, the apparatus according to claim 1. **Claim 22** The variable stiffness structural beam comprises a pair of substantially parallel and elongated spaced rods joined laterally by a webbing strip, each rod having a variable cross-sectional geometry along the length of the beam, the apparatus according to claim 1. **Claim 23** The apparatus according to claim 1, further comprising a tension cable extending along the longitudinal length of the beam and contacting the beam such that an increase in the tension of the cable increases the longitudinal stiffness of the beam. **Claim 24** An apparatus for supporting a person's head, neck and spine, a torso harness, a head harness spaced from the torso harness, and an elongated structural beam mechanically connected to the torso harness and mechanically connected to the head harness, the elongated structural beam exhibiting sufficient stiffness to partially counteract the gravitational force acting on the person's head. **Claim 25** A method of supporting a first body part of a person, comprising the steps of selecting a support device comprising a beam having variable stiffness, a first harness fixed to a first position on the beam and a second harness fixed to a second position on the beam spaced from the first position, attaching the first harness to the first body part of the person, attaching the second harness to a second body part of the person, the second body part being spaced from the first body part, changing the load on the first body part, and supporting a component of the load on the second body part via the beam. **Claim 26** The method according to claim 25, further comprising the steps of adjusting the stiffness of the beam, adjusting the distance between the first position and the first body part, and enabling unrestricted rotational movement of the first body part.

Citation Information

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