# Patent

## Title
Panel attachment and circumference adjustment systems for an orthopedic device

## Abstract

A spinal orthosis includes posterior panels arranged with a flat spinal curvature to create a reverse three-point pressure system to the spine. The reverse three-point pressure system relieves pressure on the posterior side of the vertebrae beneficial for certain indications. Various arrangements allow for securing the posterior panel to the spinal orthosis. The spinal orthosis includes a belt member length adjustment system including belt members having end portions reducible in length and a belt panel adapted to secure to the end portion of the belt member reduced in length to form at least in part a belt circumference of the spinal orthosis.

## Background
FIELD OF THE DISCLOSURE
The disclosure relates to a panel and attachment system for an orthopedic device, and more particularly to a rigid or semi-rigid panel and a system for attaching the panel to a spinal orthosis and a belt circumference system for reducing a length of belt members.
BACKGROUND
A spinal orthosis or lumbar belt is an orthopedic device designed for pain relief, protecting injured ligaments or muscles and post-surgical immobilization. A spinal orthosis is arranged to relieve pressure over the spinous processes while applying an even pressure to the paraspinal musculature to ensure comfortable and effective healing. Typical indications for lumbar supports include spinal stenosis, herniated discs, post-surgical stabilization, stable and non-displaced spinal fractures, spondylolithesis, spondylolysis, and degenerative spinal pathologies.
In a known spinal orthosis in FIGS. 1-3, such as the exemplary spinal orthosis described in U.S. Pat. No. 8,172,779, granted on May 8, 2012 and incorporated by reference, the spinal orthosis has outer and inner sides configurations 10A, 10B, with the inner side arranged to be adjacent the wearer's back. The orthosis has first and second belts 12, 14, and a compression system 16 adapted to exert pressure onto the lumbar region of a wearer's back. The compression system 16 includes tightening elements or drawstrings 18 that permit the wearer to adjust pressure over the back and a cover 20 extending over the compression system 16.
A flexible or semi-rigid back plate 22 extends over at least part of the compression system 16, and is arranged to be adjacent the back. The back plate 22 includes a posterior attachment system 24 for a rigid posterior panel 26, which includes a single hook and loop system connected at a single attachment point or flap 25 centered on the back plate 22. An anterior panel may be attached to the spinal orthosis at an anterior attachment system 29 on one of the belts.
The posterior panel provides enhanced support to satisfy the immobilization needs of the wearer. Since the immobilization needs may change over treatment, it is desirable that the posterior panel is removable if additional support is required or the support by the posterior panel is excessive such that no posterior panel is required. Posterior panels may have different shapes depending on the type and level of required support, and the size of the wearer should it change over course of treatment. In the depicted embodiment of FIG. 3, the posterior panel has lateral supports 27.
As depicted in FIG. 3, the posterior panel 26 is substantially larger than the back plate 22, and is anatomically shaped for hugging the contours of the back. The anatomically shaped panel of this example has approximately 15 degrees of lordotic curve built into the contour of the panel. This allows for the panel and the spinal orthosis to apply a three-point pressure system creating an extension moment to the spine, with two forces in the front, and one force in the center of the back.
In the exemplary prior art spinal orthosis, it has been found it is difficult to maintain rotational control of the posterior panel relative to the back plate with the known attachment system. The adjustment system does not allow for visible adjustment of the connection of the posterior panel, and it is easy to poorly adjust and ineffectively secure the posterior panel to the spinal orthosis.
Known posterior panels are ill-suited for post-operative use, particular when they are not customized for wearers. Known panels lack means to avoid incision sites on wearers that result from back operations.
SUMMARY
Under embodiments of the invention, posterior panels are arranged with a flat spinal curvature to create a reverse three-point pressure system over the prior art posterior panels that create a flexion moment to the spine. This reverse three-point pressure system is provided to relieve pressure on the posterior side of the vertebrae beneficial for certain indications such as spinal stenosis.
The embodiments are flexible in the sense that prior to placement against a wearer's back, the panel can flex in flexion or extension around the spinal area and laterally around a lateral support if provided on the panel. The panels become semi-rigid or rigid when the panel is coupled to a spinal orthosis, and placed against the lumbar region of the wearer. The compression system draws the panel firmly against the back so it conforms to the wearer's anatomy, and the panel becomes semi-rigid or rigid against the wearer's back due to the pressure exerted by the compression system and due to a cylindrical effect that occurs because of the panel being urged to conform to the anatomy of the wearer.
In a variation of the embodiment, an opening is provided around the spinal area of the posterior panels to ensure there is no risk of the panel coming into contact with a wearer's incision site or otherwise sensitive area along the spinal area.
In another variation of the embodiment, the posterior panel is provided with lateral supports with peripheral cut-out sections between the lateral supports and a main body portion. The cut-outs have the benefit of creating flexibility for the panel during compression and rigidifying the panel against the wearer to accommodate different body shapes.
An attachment system may be on a cover of a back plate that permits more user-friendly securement and rotational control of the posterior panel on the spinal orthosis. According to an embodiment of the attachment system, the cover of the back panel includes a pair of vertical slits and corresponding openings that allow for opposed straps secured to the posterior panel to couple therewith. This arrangement permits full visibility of the straps as they secure to the cover, and the provision of two attachment points inhibits rotation of the posterior panel relative to the back panel and improves the strength of the connection.
The attachment system may be similarly employed for attaching an anterior panel to a spinal orthosis by providing the attachment system along one of the belt members, and aligning the same so it centrally faces the abdomen of the wearer.
In another embodiment, the orthopedic device includes a belt circumference adjustment system permitting a reduction in the circumference of the spinal orthosis. The spinal orthosis includes a back unit, and first and second belt members connected to the back panel and having first and second end portions. Each of the first and second belt members is arranged for being reduced in length at the first and second end portions. The first and second belt members are formed a belt having a circumference with the back unit. Each of the belt members may include a belt panel having opposed sections arranged for coupling to one of the first and second end portions of at least one of the first and second belt members, and a leading section arranged for coupling one of the first and second belt members.
The back unit may include first and second tabs each defining an elongate slot through which the first and second end portions extend. The leading section of the at least one belt panel secures to a surface of a respective one of the belt members onto which the at least one panel is secured. The at least one belt panel may be extended through the elongate slot while carried by a respective one of the belt members.
In another variation, the belt panel may be secured onto a first end portion of the first belt member, and the second end portion of the first belt member securing to the back unit.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other features, aspects, and advantages of the present invention will become better understood regarding the following description, appended claims, and accompanying drawings.
FIG. 1 shows an outer side of a prior art spinal orthosis.
FIG. 2 shows an inner side of the prior art spinal orthosis of FIG. 1.
FIG. 3 is a perspective view of the prior art spinal orthosis of FIG. 1 having a posterior panel and placed on a wearer.
FIG. 4 shows an embodiment of a posterior panel.
FIG. 5 shows another posterior panel embodiment.
FIG. 6 shows a posterior panel embodiment having lateral supports.
FIG. 7 illustrates outer and inner sides of a strap for an attachment system.
FIG. 8 shows the posterior panel of FIG. 6 having the straps in FIG. 7.
FIG. 9 shows a back plate having a cover including part of an attachment system.
FIG. 10 shows the posterior panel of FIG. 5 including the straps in FIG. 7.
FIG. 11 is a schematic view showing a step of attaching the posterior panel to the back plate.
FIG. 12 is another schematic view showing a step of attaching the posterior panel to the back plate.
FIG. 13 is yet another schematic view showing a step of attaching the posterior panel to the back plate.
FIG. 14 is a schematic view showing the visibility of the attachment of the strap to the cover.
FIG. 15 is a schematic view showing the attachment of the back plate to the posterior panel with rotational control.
FIG. 16 is a schematic view showing another embodiment of a spinal orthosis.
FIG. 17 is a detailed schematic view showing the spinal orthosis of FIG. 16.
FIG. 18 is a detailed schematic view showing attachment of a belt segment of the spinal orthosis of FIG. 16.
FIG. 19 is a schematic view showing another embodiment of a spinal orthosis.
FIG. 20 is a perspective view of size adjustment of a belt segment of the spinal orthosis of FIG. 19.
FIG. 21 is a plan view showing the spinal orthosis of FIG. 19.



The drawing figures are not drawn to scale, but instead are drawn to provide a better understanding of the components, and are not intended to be limiting in scope, but rather to provide exemplary illustrations.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
A. Overview
A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements.
While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings and are described below. It should be understood, however, there is no intention to limit the disclosure to the specific embodiments disclosed, but on the contrary, the intention covers all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure.
It will be understood that, unless a term is expressly defined in this disclosure to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning.
The panel embodiments described are configured for use as posterior panels for placement against the back of a wearer. It should be remembered, however, that the same concepts and methods described may be similarly used for anterior panels adapted for a spinal orthosis.
B. Embodiments of the Panel and Attachment System
In referring to FIGS. 4-6, different posterior panels may be used with a spinal orthosis. Each of these panels is preferably flexible in the sense that prior to placement against a wearer's back, the panel can flex in flexion or extension around the spinal area and laterally around a lateral support if provided on the panel. The panels become semi-rigid or rigid when the panel is coupled to a spinal orthosis, and placed against the lumbar region of the wearer. The compression system draws the panel firmly against the back so it conforms to the wearer's anatomy, and the panel become semi-rigid or rigid against the wearer's back due to the pressure exerted by the compression system and due to a cylindrical effect that occurs because of the panel being urged to conform to the anatomy of the wearer. Alternatively, the panel may be wholly rigid or fully flexible before, during and after use with the compression system.
FIG. 4 shows a flat flexible non-lateral posterior panel 28, having at least a pair of attachment strips 30. FIG. 5 shows a flat-flexible lateral posterior panel 32 having attachment strips and lateral supports. As with the panels described, each panel may include a padded cover comprising foam, textile or a combination. An example of a cover 72 is in part in reference to the schematic views of FIGS. 11-14.
FIG. 6 illustrates a posterior panel 36 having a top portion 38 tapering from a main body portion 52, a bottom portion 40 having a greater width than the top portion, and lateral supports 42 extending laterally from the main body portion 52. The panel 36 defines notches 44 including upper and lower portions and located between the lateral supports 42 and the main body portion 52. The notches 44 facilitate bending of the panel about the torso of the wearer without compromising eventual rigidity of the panel 36 when used in combination with the compression system.
The panel 36 defines an elongate central opening 46 provided around the spinal area of the panel 36 to ensure there is no risk of the panel coming into contact with a wearer's incision site or otherwise sensitive area along the spinal area. The panel also defines a plurality of apertures in part to improve ventilation of the panel when worn by the wearer. The apertures may also be improved bending of the panel about the anatomy of the wearer. The apertures are arranged in combination with the lateral supports in an arcuate configuration that allows the panel to bend in an anatomically friendly manner. The panel 36 also defines at least two vertically arranged slits 48, 50 arranged for receiving a strap.
The strap may be configured as shown in the embodiment of FIG. 7. In this embodiment, the strap 60 has a hook surface 68 and a hook-receivable surface 70. The strap 60 defines a base portion 62 have a greater width than the slits 48, 50 to prevent the base portion 62 from passing through the slits. The strap further defines an elongate arm 66, which is extended through a passageway 64 formed between the base portion 62 and the arm 66.
As depicted in FIG. 8, the arm 66 is adapted to extend through a first slit, through the passageway 64, and a second slit to secure the strap to the panel, with the hook surface 68 securable to the hook-receivable surface 70.
In reference to FIG. 9, the cover of the back plate 22 includes the attachment system 24. The attachment system 24 includes a hook receivable central segment including pair of laterally extending slits 54 for receiving a single prior art strap used to attach the posterior panel to the spinal orthosis. The attachment system 24 also includes a pair of vertically extending slits 56 and a laterally extending hook-receivable segments 74 spaced apart from one another by the central segment and having openings 76 which permit a strap to extend to the slits 56. The laterally extending segments 74 are spaced apart to accommodate panel embodiments having an elongate vertical opening as in the embodiment of FIG. 6.
Turning to FIG. 10, the panel embodiment of FIG. 5 includes the straps 60 of FIG. 7 extending through slits 58, 60.
FIGS. 11-14 depict a method for attaching the posterior panel of FIG. 10 including a cover 72 and the straps 60 to the attachment system 24 of the back plate 22 of FIG. 9. According to the first step in FIG. 11, the arm 66 of the strap is threaded through the opening 57 of the laterally extending segment 74. Next, FIG. 12 depicts the arm 66 as pulled through the vertically extending slit 56. The arm 66 is tensioned in view of the base 62 serving as an anchor and the hook surface of the arm 66 is tightly secured against the laterally extending segment 74 has a hook-receivable surface to engage the hook and hook-receivable material together.
FIG. 14 shows the hook surface of the base 62 as likewise extending along the laterally extending surface 74 and likewise preventing slippage of the strap 60 from the panel. In view of the laterally extending nature of the arm, the clinician securing the panel to the back plate can view how the arm is secured to the back plate that assures the strap is properly secured and aligned. In view of the straps being on the sides, an easier work environment is provided for the clinician when the spinal orthosis is assembled for a wearer. The panel and back plate are rotated 180 degrees and the strap on the opposite side is secured as in FIGS. 11-14.
FIG. 15 depicts how the two straps securing the posterior panel 32 to the back plate 22 prevent rotation of the panel relative to the plate. Any movement of the posterior panel is mitigated or eliminated in view of the attachment system. The hook and loop connection only works in shear since the strap base creates an anchor point to retain the strap in a lateral position and has strength to retain the strap to the posterior panel.
C. Embodiments of the Belt Member Length Adjustment System
Turning to the embodiment of FIGS. 16-18, the spinal orthosis 110 has a belt member length adjustment system enable a reduction in circumference of a belt circumference of the spinal orthosis. The belt circumference includes first and second belt segments 112, 114 arranged to be connected to one another on the anterior of the wearer, and are connected on the posterior side by a back unit, preferably including a compression system 116, to form a belt circumference.
Elongate tensioning elements 118 extend from first and second sides of the spinal orthosis, coupling to the compression system 116 and secured over the anterior of the wearer on the first and second belt segments 112, 114. A handle 128 is secured to an end of the tensioning elements 118 and is securable to the first and second belt segments. A cover 120 is provided to extend over the compression system 116.
Each of the belt segments 112, 114 is reducible in length preferably at its posterior end, and the posterior end is securable to the compression system 116 after the belt segment 112, 114 is reduced in length.
The reduced end of the belt segment 112, 114 is attached to the compression system 116 by looping a segment 122 of the belt segment 112, 114 through a slot 132 formed on a plate 134 of the compression system 116. The plate 134 is modified over the plate in U.S. Pat. No. 8,172,779, and carries a plurality of reduction elements 136, such as pulleys or posts, and at least one cable 138. The belt member 112, 114 may be reduced in length along a plurality of locations 140. The locations 140 may be identified on the belt member 112, 114 by indicia defining different lengths.
The segment 122 attaches to an outer surface of the belt member 112, 114 by a clip or belt panel having two opposed clamping sections 126, 130 clamped onto opposed sides of the segment 122, and a leading section 124 extending from the clamping sections 126, 130 and removably securing to the outer surface of the belt member 112, 114. The clamping sections 126, 130 preferably engage the segment 122 by fasteners, such as by a hook and loop wherein the clamping sections 126, 130 include hook material and the outer and an inner surface of the belt segment 112, 114 includes a loop material that is hook receivable. The leading section 128 likewise may include hook material and secure to the hook receivable surface of the belt members 112, 114.
The segment 122 may be looped through the slot 132 in either orientation, so the leading section 128 secures over the outer or inner surfaces of the belt member 112, 114.
FIGS. 19-21 illustrate another embodiment including a belt member length adjustment system wherein the spinal orthosis includes belt panels 150, 152 removably securable to the belt members 112, 114. In this embodiment, rather than reduce the length of the belt member 112, 114 at the posterior end, the belt member is reduced in length at the anterior end 164.
The belt panels 150, 152 have clamping sections 156, 160 secured to opposed sides of the belt members 112, 114 and terminate at a stitched or termination point 154 leaving a forward end 158 of the front panels 150, 152 to secure on the opposing belt panel carried by an opposing belt member. The clamping sections 156, 160 may include a fastener material 162 secured to the surface of the belt members 112, 114. A segment 166 of the belt member 112, 114 may be reduced at the anterior end 164 and removed by cutting or other appropriate means. The front panels 150, 152 may include padding or may be reinforced with rigid, semi-rigid or flexible shells.
While the foregoing embodiments have been described and shown, alternatives and modifications of these embodiments, such as those suggested by others may be made to fall within the scope of the invention. While the orthosis has been described in combination with a spinal orthosis, it will be understood that the principles described may be extended to other types of orthopedic and prosthetic devices.

## Claims

1. A method for sizing a spinal orthosis including a back unit and first and second belt members connected to the back unit and having first and second end portions, the second end portions of the first and second belt members securing to opposed sides of the back unit at a posterior side of the spinal orthosis, the first end portions of the first and second belt members arranged for removably securing to one another at an anterior side of the spinal orthosis, the method comprising:
extending first end portion of the first belt member from the back unit;
selecting a segment of the first belt member from a first anterior end of the first end;
reducing a first length of the first belt member from the first anterior end to form a second anterior end corresponding to a second length of the first belt member shorter than the first length by removing the segment;
applying at least one clamping section of a first belt panel onto the second anterior end of the first end portion of the first belt member;
attaching a first outer surface of the first belt panel to the first end portion of the second belt member to form a circumferential belt with the back unit and the first and second belt members.

2. The method of claim 1, wherein the at least one clamping section includes first and second clamping sections opposed to one another and have a fastener material securable to first and second surfaces of the first member.

3. The method of claim 2, further comprising the step of securing the first and second clamping sections to the first and second surfaces of the first end portion of the first belt member.

4. The method of claim 2, wherein the first and second clamping sections terminate at a termination point from which extends a forward end of the first belt panel having the first outer surface to secure to a surface the second belt member.

5. The spinal orthosis of claim 1, wherein the back unit is a compression system arranged to adjust a distance separating the second end portions of the first and second belt members.

6. The spinal orthosis of claim 5, wherein the compression system includes elongate tensioning elements coupling to the compression system and securing over the anterior side of the first and second belt members.

7. The spinal orthosis of claim 1, wherein the first outer surface of the first belt panel has a fastener material engageable with the first end of the second belt member.

8. A spinal orthosis, comprising:
a back unit located at a posterior side of the spinal orthosis;
first and second belt members having second end portions secured to the back unit, each of the first and second belt members arranged for being reduced in length from a first end portion located at an opposite end from the second end portions and extending freely relative to the back unit at an anterior side of the spinal orthosis, the first and second belt members arranged to form a belt having a circumference with the back unit;
a first belt panel has at least one clamping section arranged for fastening to the first end portion of the first belt member, and the first belt member has a surface for securing to the first end portion of the second belt member;
wherein the first belt member is arranged to be reduced in length from a first length starting from a first anterior end at the first end portion to the second end portion whereat it secures to the back panel, to a second length having a second anterior end replacing the first anterior end at the first end portion to the second end portion whereat it secures to the back panel such that after being reduced in length the spinal orthosis goes from having a first circumference when the first end portions of the first and second belt members are secured to each other via at least the first belt panel to a second circumference shorter than the first circumference.

9. The spinal orthosis of claim 8, wherein the at least one clamping section includes first and second clamping sections opposed to one another and have a fastener material securable to first and second surfaces of the first belt member.

10. The spinal orthosis of claim 9, wherein the first and second clamping sections secure to the first and second surfaces of the first end portion of the first belt member by a hook and loop system.

11. The spinal orthosis of claim 9, wherein the first and second clamping sections terminate at a termination point from which extends a forward end of the first belt panel having the first outer surface to secure to a surface the second belt member.

12. The spinal orthosis of claim 8, wherein the back unit is a compression system arranged to adjust a distance separating the second end portions of the first and second belt members.

13. The spinal orthosis of claim 12, wherein the compression system includes elongate tensioning elements coupling to the compression system and securing over the anterior side of the first and second belt members.

14. The spinal orthosis of claim 8, wherein the first outer surface of the first belt panel has a fastener material engageable with the first end of the second belt member.

15. A spinal orthosis, comprising:
a back unit;
first and second belt members connected to the back unit and having first and second end portions, each of the first and second belt members arranged for being reduced in length from said first end portion, the first and second belt members arranged to form a belt having a circumference with the back unit by the first end portions removably securing to one another, the second end portions of the first and second belt members securing to opposed sides of the back unit;
at least one belt panel having opposed first and second clamping sections arranged for coupling to the first end portion of at least one of the first and second belt members, and a forward section arranged for coupling to one of the first and second belt members;
wherein the first end portion of the first and second belt members corresponds to an anterior side of the spinal orthosis and the first and second belt members are reducible in length of the respective one of the first and second belt members defined as a length between an anterior end of the first end portion to the second end portion secured to back panel;
wherein the at least one belt panel includes a fastener material within the clamping sections securable to a surface of the first end portion of the first and second belt members.

16. The spinal orthosis of claim 15, wherein the back unit is a compression system arranged to adjust a distance separating the second end portions of the first and second belt members.

17. The spinal orthosis of claim 16, wherein the compression system includes elongate tensioning elements coupling to the compression system and securing over the anterior side of the first and second belt members.

18. The spinal orthosis of claim 15, wherein each of the first and second clamping sections terminate at a termination point leaving a forward section of the first and second belt panels to secure on the opposing belt panel carried by an opposing one of the first and second belt members.