US3434469A - Orthopedic appliance - Google Patents

Description

March 25, 1969 P. c. SWIFT 'ORTHOPEDIC APPLIANCE Filed June 5, 1966 m N E V W PAUL C. SWIFT Int. Cl. A61f /02 US. Cl. 128-78 20 Claims ABSTRACT OF THE DISCLOSURE Orthopedic appliance with brace plate of resilient resinous material conforming to the lower back of a patient and held in contact therewith by a waistband, a forward projection at the lower edge of the brace plate entering between the buttocks and bearing upwardly upon the sacrum.

This application is a continuation-in-part of my copending application Ser. No. 531,888, filed Mar. 4, 1966, which, in turn, is a continuation-in-part of my application Ser. No. 390,036, filed Aug. 17, 1964, both abandoned.

This invention relates, in general, to an orthopedic appliance and more particularly to a light-Weight backbrace unit which is designed for use in connection with a waistband which is closable around the body for applying and holding the brace unit firmly against the wearers back.

The main supporting structure of the back is the spinal column, a curved structure consisting of 33 vertebrae comprising 7 cervical, 12 dorsal, 5 lumbar, 5 sacral, and 4 coccygeal vertebrae. Each vertebra is separated from the next adjacent vertebra by a tough, fibrous, elastic disc, and each vertebra articulates with its adjacent vertebra; the entire structure is held together by strong ligaments and moved by an intricate system of paired muscles. The 5 sacral vertebrae are united to form a single, triangular bone called the sacrum which is attached to the ilium.

It is this structure that provides the major support and strength for the entire trunk of the body and enables man to walk upright. Proper alignment of the spinal vertebrae ensures a more uniform distribution of the weight on the intervertebral discs, affording greater static stability, dynamic flexibility, and nerve freedom. In this system much of the burden falls on the sacrum.

Owing to injuries, disease, overweight, pregnancy, and/ or a gradual weakening of the muscles and ligaments from lack of exercise or aging, many persons suffer from discomfort and pain because the back structure cannot properly perform its normal functions. The most frequent site of such painful manifestations is the lumbo-sacral region of the lower back and, in particular, the region where normally the fifth lumbar vertebra rests squarely upon the sacrum.

While there have been devised many appliances for the express purpose of giving relief and comfort to sufferers of such pain by way of supplying additional support to the body so as to relieve the spine, at least in part, of its duties in this regard, most of these appliances are so designed as to enclose the body and indirectly hold the spine in an arbitrary position with a limited freedom of action, through the use of stays, heavy braces, and other like rigid contrivances. The known devices attempt to bypass the affected region of the spine and to transfer its supporting and strength functions to the device or appliance. As such, the known appliances were frequently heavy, cumbersome, painful in themselves, and prevented or severely limited the normal movement of the torso. In addition, they created unsightly bulges or ridges visible through the wearers outer garments. The continuous use of such devices also created the danger of undesirable side effects, such as further weakening of the muscles and/or shrinkage of the ligaments.

It is a general object of the present invention to overcome the foregoing difficulties and to provide an orthopedic appliance which is unobstrus'ive and which clearly and beneficially engages a portion of the wearers body for the purpose of relieving discomfort and/or correcting a deformity.

A more specific object of this invention is to provide an appliance of this type designed to relieve pain and discomfort in the lumbo sacral-iliac region of the back.

Another object of the invention is to reinforce the supporting function of the spine wthout interfering with its normal articulated freedom of motion.

Still another object of the present invention is to provide a brace light in weight, less cumbersome than those heretofore employed, and designed to be combined with a binder means such as a waistband to provide localized back support and resiliently resist deformation incident to the normal body movement.

It is also an object of the present invention to provide an appliance whose basic form and character can be suitably modified as required for use as a 'dorsal and/ or cervical splint.

Still further objects and advantages of the present invention will be apparent from a consideration of the following disclosure.

For purposes of illustration, the orthopedic appliance of the present invention will be described as it pertains to a support for the back and in particular for the lower back. Such an appliance comprises broadly a preformed, resilient, substantially rigid brace unit shaped to conform to the surface of the lower back encompassing the posterior curvatures and the mediolateral curvatures and extending from the sacrum upwardly at least for a distance sufiicient to stabilize the lumbosacral-iliac region. Usually, this will encompass the region extending to at least the twelfth dorsal vertebra vertically and laterally toward the median later-a1 midline. This brace unit is intended for use in combination with a binder means such as a waistband comprisng an elongated flexible panel of elastic fabric or other material adapted to encircle the waist of the wearer and to apply anatomical pressure to hold the brace firmly and securely against the conforming body surface of the wearers back while resiliently resisting deformation incident to normal body movement.

In order to provide a correct anatomical fit of the brace and the underlying body surface, a cast or impression may be taken of the back region of the actual wearer. The brace unit is prepared with the aid of this cast or a mold prepared therefrom and, as noted above, constitutes a relatively thin, light-weight, resilient, substantially rigid unit anatomically conforming to the region of the back to be supported.

The invention will be described in greater detail with reference to the accompanying drawing, in which:

FIG. 1 is a view showing the back of a person wearing an orthopedic appliance, including a brace unit incorporating the principles of the present invention;

FIG. 2 is a perspective front view of the appliance shown in FIG. 1;

FIG. 3 is a rear elevational view of the same appliance;

FIG. 4 is a cross-sectional view of the appliance taken on the line IV-IV of 'FIG. 3, with part of the human body shown in point-dotted lines;

FIG. 5 is a rear elevational view, partly in section, of the brace unit forming part of the device shown in FIGS. 1-4; and

FIG. 6 is a top view of the brace unit taken on the line VI-VI of FIG. 5.

Referring now to the drawing in detail, it will be seen that the orthopedic appliance which is the subject of this invention is designated, in general, by the numeral 10. The orthopedic appliance includes a brace unit 11 and a waistband 15. The central portion of the waistband is designed to overlie the lower back of the patient as is shown in FIG. 1 and is formed with a pocket 13, which is open at the top and closed at the bottom to receive the brace unit 11. Extending forwardly from this central portion are side portions which have forwardly converging upper and lower edges 21, 23 and 22, 24, respectively. These side portions terminate in a pair of overlapping ends 25, 26, engageable with each other while overlying the abdomen of the wearer. The overlapping ends 25 and 26 are provided with suitable fastening means which can take a variety of forms but which, advantageously, as shown, are of the type comprising cooperating burtype loops and hooks 18, 19 of nylon or the like, as known per se from U.S. Patent No. 3,194,234. This type of fastener enables the ends of the waistband to be releasably interconnected in any desired position selected according to the girth of the wearer. To remove or unfasten the end portions with this type of fastener, all that is required is to apply a peeling effect to the joined surfaces and the end portions will become disengaged.

The brace unit 11 is shaped to conform to the contour of the lower back encompassing at least the posterior curvatures and the mediolateral curvatures and extending from the sacrum upwardly at least for a distance sufficient to stabilize the lurnbosacral-iliac region. Preferably, the brace unit 11 will have side portions 14 and 16 extending beyond the mediolateral curvature toward the lateral midline and will extend upwardly from the sacrum to at least the twelfth dorsal vertebra as illustrated in FIG. 4. This area must, of necessity, include part of the buttocks on each side of the spine. In order to ensure supporting contact with the sacrum S, as best seen in FIG. 4, the brace unit is formed at its lower edge 27 with a central projection 28 which, when viewed from the side, has a generally triangular profile with a downwardly sloping forward edge 29, extending generally at right angles to a nearly horizontal plane which includes the brace units bottom edge 27 as well as the lower edges 22, 24 of the closed waistband.

If desired, a pad of soft and flexible material, such as foam rubber or plastic, may be cemented or otherwise secured onto the concave forward side of plate 11. This pad, however, will usually be required only by unusually sensitive patients inasmuch as the plate 11 is separated from the body of the wearer by a fabric layer forming part of pocket 13 and, if desired, by undergarments which in many instances can be worn between the appliance and the body.

The brace unit 11, as shown in FIGS. l and 5, may also be extended upwardly to serve as a splint for a fractured back and/or neck. Such an upward extension 34, indicated only fragmentarily in FIG. 5, may have any desired dimension. Thus, for example, the area of usefulness of the orthopedic appliance in accordance with the invention can include the dorsal back and neck, i.e. the appliance may serve as a dorsal or neck brace, a clavicular brace and the like, and even as a brace for controlling the movement of the head and/or limbs of spastics, etc. The brace unit is contoured to the portion of the anatomy to be supported and the encircling garment is likewise adapted to comfort and ease of application. After the fracture is sufficiently healed, it may be cut off at to leave just the brace unit 11. Auxiliary retaining straps 36 for the extension 34 may, of course, be provided if necessary.

The height of the brace unit 11 may vary but, in general, ought to extend upwardly to at least the twelfth dorsal or thoracic vertebra, i.e., the one immediately above the first lumbar, for the purpose of forming a firm but resilient support for the lower back which, while heing similarly effective as a plaster case, nevertheless allows for almost unimpeded posture changes as well as muscular contractions and expansions during normal body movement. It should be noted that the improved back support stabilizes but does not immobilize the backbone or ilium and will not weaken the spine and the associated muscles, as will generally be the case with braces bearing upon the backbone only at widely spaced locations, but on the contrary keeps these body parts occupied in their normal position and permits them to perform their normal functions of bearing and distributing the body weight with only the absorption of abnormal stresses by the surrounding appliance.

The waistband should be at least partly elastic and, for this purpose, may comprise portions of ordinary fabric with inserted gussets 17 of elastic fabric. However, it is preferred for proper anatomical pressure that the waistband material be entirely elastic. Thus, the brace unit 11 together with the waistband 15 will resiliently but firmly encase the lower back region of the body without unduly interfering with its movements. Also, the elastic nature of the waistband insures that the maximum retaining and support forces will be applied to the area of greatest stresses during movement of the body.

As the entire lower back region of the body is tightly enclosed by the appliance, and is further snugly and anatomically fitted to the contour of this region, the lumbosacral-iliac region of the back is stabilized and maintained in its normal position and assisted in performing its normal weight-bearing and distribution functions. Furthermore, since the back brace plate is thin and of light weight, as well as body conforming, its presence will generally not be apparent, even under closely fitted clothing.

In order to insure a dependable fit of the brace and the adjacent body surface, the brace is shaped or molded as a relatively thin, lightweight, resilient, substantially rigid plate capable of holding the shape of the contours formed therein while being subjected to the normal stresses and strains to which the body is exposed is everyday living.

Although many materials, for example, certain metals or composite sheet material will suggest themselves to one skilled in the art, it is preferred because of the need for close conformance to the particular contours of the individual who is to wear the brace, and particularly to the contours of the lumbosacral-iliac region of the lower back, that the brace unit comprise resinous materials and be shaped with the aid of a cast taken from the body of the actual wearer or a mold prepared therefrom. It is also permissible to combine various materials such as a resinous material and a substantially inelastic reinforcement, such as glass fibers (embedded cloth or fiber mat), to achieve proper dimensional stability, mechanical strength and rigidity.

As can be appreciated, the use of resinous materials in the manufacture of the brace unit 11 permits individual attention to each individuals back problem, and by forming the brace unit from a cast of the individual wearers back any abnormality in the back will be accommodated since the mold of plaster of Paris will merely duplicate the abnormality for purposes of shaping the brace-unit material. The problem of supporting an abnormally formed back, as mentioned above, has never been satisfactorily solved prior to this invention.

It can be also appreciated, however, that while individual attention can be given to each persons individual back problem, the back-supporting device herein disclosed lends itself equally well to mass production inasmuch as it has been found that a group of standard sizes of brace units are suitable for men and for women respectively and will fit approximately of the adult population. As a result, this invention not only meets the specific needs of any individual person but can be made embodied in standardized appliances as well.

Is is also possible, in accordance with the invention, to allow for breathability of the brace unit by providing pores or openings in the brace unit. As used herein, the term breathability means the ability to transpire water vapor and air. The openings or perforations, illustrated at 40 in FIG. 1, can be made in the conventional manner utilizing either chemical or mechanical means, as, for instance, with the aid of pore-forming agents, needles or other puncturing devices, etc.

The following examples illustrate various embodiments of the invention.

Examplel A plaster-of-Paris cast was made of the Wearers lower back generally extending upward from the sacrum to at least the twelfth dorsal vertebra and encircling the body to the lateral midline thereof. From this plaster cast, a male mold was prepared upon which two layers of 8 /2 oz. glass cloth impregnated with a catalyzed polyester resin were laid up and pressed to conform to the contour of the mold and then permitted to cure at room temperature. The polyester resin was identified as Polyester Resin 9407 supplied by Allied Chemical of Morristown, N.J., while the catalyst was methyl ethyl ketone peroxide.

The cured brace unit closely and snugly fitted the area of the lower back of the patient from which the plaster cast was taken and when worn with an elastic Waistband maintained the lumbosacral-iliac and hip region in its desired position and contributed significantly to relieving the discomfort and pain associated with lower-back affliction.

Example 11 A male mold prepared as in Example I is placed in an open-top receptacle. A sheet of unoriented high impact polystyrene having a thickness of 85 mils and precut to match the size of the mold is laid on top of the mold. A heater unit is moved into position covering the top of the receptacle and directly over the sheet material on the mold. After heating the sheet material for 75 seconds, the heated unit is removed and a rubber sheet diaphragm is forced down upon and around the sheet material and mold to press and shape the plastic sheet to conform to the contours of the mold. The shaped brace unit after cooling and removal from the mold likewise closely fitted the area of the lower back of the patient from which the plaster cast was taken.

Although several methods of preparing the brace plate of. the present invention are illustrated above wherein a cast and/ or mold of the body of the patient is used, it is also contemplated that, in some instances, the brace plate will be formed directly upon the body of the patient. Likewise, it is obvious that many other materials and combinations of materials will perform satisfactorily. It is equally obvious that many different methods of forming or shaping also are applicable.

Resinous materials usually used in the molding industry such as polystyrene, acrylics, polyesters, epoxies and phenolics are illustrative of the materials that have been used successfully, with and without substantially inelastic reinforcing materials as indicated at 41 in FIG. 5, in preparing the brace unit of the invention. Likewise, matched die forming, vacuum forming, pressure-bag forming and combinations thereof, as Well as other methods have been used to provide the brace unit.

As mentioned previously, the critical requirement for properly assisting the spinal colum in performing its functions is for the brace unit to make supporting contact with the region encompassing at least the posterior curvatures and the mediolateral curvatures laterally and the sacrum and lumbar vertebrae vertically with their associated muscular and ligamentous structure.

It is in this region 33, shown in dotted outline in FIG. 5, that the brace unit must have sufiicient rigidity to maintain the stability of the contours (see FIG. 6) molded therein and provide the contacting support required during movement of the body.

In general, this region will encompass an area having a vertical height of about 7 to 8 inches, and a width at the buttocks of about 6 to 7 inches, tapering to a width in the region of the twelfth dorsal of about 5 to 6 inches. Although the brace unit must have suflicient thickness to give the required rigidity, for comfort and ease of wearing this should be in the range of about 50 mils to 100 mils, with a thickness in the range of 65 to mils being preferred.

Although brace plates encompassing only the region described above have been used successfully in many cases, it is preferred that, for maximum support, the brace unit be shaped with integrally attached lateral extensions 14 and 16 so as to conform to the entire region of the lower back and part of the buttocks on each side of the spine. Such extensions naturally follow all of the curvatures of the back and partially encircle the body preferably to at least the lateral midline of the body. They should be shaped so as inherently to be more flexible than the central portion of the brace unit.

This unique combination of rigid and fiexible brace unit and associated firmly elastic binder means, such as a waistband, belt, girdle or wrapping, etc., enables the orthopedic appliance to provide maximum support yet allows it to adapt to torsional, stooping, lifting, bending or kneeling movemnt of the body while resiliently resisting deformation incident thereto.

As clearly seen in FIGS. 4 and 6, the curved brace plate 11 (including its projection 28) is of substantially uniform thickness, e.g., 85 mils as described above in connection with Example II.

It is intended that the brace unit including the binder means of this invention be manufactured and sold as a unit. It will be obvious, however, that the brace unit may be manufactured and sold as a separate unit without departing from the spirit of the invention.

Further modifications of the devices described and illustrated, e.g., as concerns the construction of the hinder or waistband or the construction of the brace unit and their combination with each other, will be readily apparent to persons skilled in the art and are intended to be encompassed within the spirit and scope of the invention as defined in the appended claims.

What is claimed is:

1. A back support comprising a brace plate with a generally concave forward side portion conforming to an area of the back of a wearer,

said area extending upwardly from the sacrum to at least the twelfth dorsal vertebra and including at least part of the buttocks on opposite sides of the spine,

and a flexible waistband closable around the abdomen of the wearer,

said waistband engaging said plate for applying the plate against the body of the wearer over substantially the full extent of said area;

said brace plate having a lower edge formed on said forward side with a forward projection positioned to come to rest between the buttocks against the sacrum. of the wearer,

said projection being formed with a downwardly and forwardly inclined front edge diverging at an acute angle from said forward side.

2. A back support as defined in claim 1 wherein said front edge extends generally perpendicularly to the lateral lower edges of the closed waistband as projected upon a vertical plane bisecting said brace plate.

3. An orthopedic appliance for giving support to a part of the human body comprising a rigid brace having a generally concave side shaped to conform to a surface of the body part to be supported,

said brace having a lower edge provided on said concave side with at least one projection shaped to contact a cleavage of the human torso underneath the pelvic girdle,

said projection having a downwardly inclined edge diverging at an acute angle from said concave side, and a waistband associated with said brace,

said waistband being closable around the body for applying said brace against the conforming body surface with exertion of an upward stress component upon the pelvic girdle through said projection.

4. An appliance as defined in claim 3 wherein said waistband is provided with a central pocket receiving said brace and with co-operating fastening means on opposite extremities substantially equispaced from said pocket.

5. An appliance as defined in claim 4 wherein said fastening means comprises adhesive surface portions releasably interengageable in different positions for ad justing the effective length of said waistband.

6. An appliance as defined in claim 3 wherein said brace is a plate of thermosetting resin with imbedded glass fiber reinforcements.

7. An appliance as defined in claim 3 further comprising a soft resilient pad lining the said concave side of said brace.

8. An orthopedic appliance comprising a thin sheet of resilient substantially rigid, light-weight material shaped to conform to a large area of the body, said sheet having a substantially uniform thickness and being adapted to maintain conformity with the body part to be supported while allowing the body its normal freedom of motion.

9. An appliance as defined in claim 8 wherein said sheet is shaped to conform to the contours of the lower back encompassing laterally at least the posterior curvatures and the mediolateral curvatures and extending from the sacrum upwardly for at least a distance sufficient to stabilize the lumbosacral-iliac area.

10. An appliance as defined in claim 9 wherein said distance extends from the sacrum to at least the twelfth dorsal vertebra.

11. An appliance as defined in claim 8 wherein said sheet is perforated.

12. An appliance as defined in claim 8 wherein said sheet consists essentially of resinous material.

13. An appliance as defined in claim 12 wherein said resinous material is supplemented by substantially inelastic reinforcement.

14. An appliance as defined in claim 8, further comprising flexible binder means connected with said sheet and adapted to encircle the body part to be supported whereby said sheet is firmly and securely held in intimate contact with and in conforming relation to the contours of said body part.

15. An appliance as defined in claim 14 wherein said binder means comprises a resilient waistband resistant to deformation incident to body movement.

16. A method of supporting a part of the human body which comprises applying to the area to be supported a thin sheet of resilient, substantially rigid, light-weight material of substantially uniform thickness shaped to conform to the contours of the surface of the part of the body to be supported, and maintaining said sheet in position by a flexible binder closable around said part of the body.

17. An orthopedic appliance comprising a thin, resilient, substantially rigid, light-weight brace member shaped to conform to the contours of the lower back of a wearer and to maintain said conformity while allowing the body its normal freedom of motion, said member encompassing at least part of the buttocks on opposite sides of the spine and being provided at a lower edge portion thereof with a forwardly directed projection disposed to be positioned between the buttocks for firmly contacting and supporting the sacrum.

18. An orthopedic appliance comprising a thin, light-weight brace plate shaped to conform to the contours of the surface of the lower back of the body and dimensioned to cover an area extending upwardly from the sacrum to at least the twelfth dorsal vertebra and downwardly to at least the upper part of the buttocks on opposite sides of the spine, said brace plate being provided with an inward projection positioned to come to rest between the buttocks against the sacrum for support thereof, and

a resilient belt encircling the brace plate closable around the lower part of the body for urging said brace plate towards said surface,

said brace plate being sufficiently resilient to permit unrestricted movement of muscles of the lower back and to maintain conformance to the body contours during such movement,

said brace plate being sufficiently rigid to provide support for the lower back.

19. An appliance as defined in claim 18 wherein said belt has a width substantially commensurate with the vertical dimensions of said brace plate.

20. An appliance as defined in claim 18 wherein said brace plate has lateral extensions of greater flexibility disposed to lie against the sides of the lower back.

References Cited UNITED STATES PATENTS 1,401,056 12/1921 Doyle 128-78 2,541,487 2/ l 1 Triplett l2878 2,730,096 1/1956 Pease 12878 2,828,737 4/1958 Hale 128-78 3,307,535 3/1967 Locke 12878 L. W. TRAPP, Primary Examiner.

US. Cl. X.R. 12887

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